Trazec
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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
TRAZEC 60 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each film-coated tablet contains 60 mg nateglinide. 
 
Excipients: 
Lactose monohydrate: 141.5 mg per tablet. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet 
 
60 mg pink, round, bevelled-edge tablets with “NVR” marked on one side and “TS” on the other. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients 
inadequately controlled despite a maximally tolerated dose of metformin alone. 
 
4.2 Posology and method of administration 
 
Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner). 
 
The dosage of nateglinide should be determined by the physician according to the patient’s 
requirements. 
 
The recommended starting dose is 60 mg three times daily before meals, particularly in patients who 
are near goal HbA1c. This may be increased to 120 mg three times daily. 
 
Dose adjustments should be based on periodic glycosylated haemoglobin (HbA1c) measurements. 
Since the primary therapeutic effect of Trazec is to reduce mealtime glucose, (a contributor to HbA1c), 
the therapeutic response to Trazec may also be monitored with 1–2 hour post-meal glucose. 
 
The recommended maximum daily dose is 180 mg three times daily to be taken before the three main 
meals. 
 
Specific patient groups 
Elderly 
The clinical experience in patients over 75 years of age is limited. 
 
Children and adolescents 
There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its 
use in this age group is not recommended. 
 
Patients with hepatic impairment 
No dose adjustment is necessary for patients with mild to moderate hepatic impairment. As patients 
with severe liver disease were not studied, nateglinide is contraindicated in this group. 



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Patients with renal impairment 
No dose adjustment is necessary in patients with mild to moderate renal impairment. Although there is 
a 49% decrease in Cmax of nateglinide in dialysis patients, the systemic availability and half-life in 
diabetic subjects with moderate to severe renal insufficiency (creatinine clearance 15–50 ml/min) was 
comparable between renal subjects requiring haemodialysis and healthy subjects. Although safety was 
not compromised in this population dose adjustment may be required in view of low Cmax. 
 
Others 
In debilitated or malnourished patients the initial and maintenance dosage should be conservative and 
careful titration is required to avoid hypoglycaemic reactions. 
 
4.3 Contraindications 
 
Trazec is contraindicated in patients with: 
• Hypersensitivity to the active substance or to any of the excipients 
• Type 1 diabetes (insulin-dependent diabetes mellitus, C-peptide negative) 
• Diabetic ketoacidosis, with or without coma 
• Pregnancy and breast-feeding (see section 4.6) 
• Severe hepatic impairment 
 
4.4 Special warnings and precautions for use 
 
General 
Nateglinide should not be used in monotherapy. 
 
Like other insulin secretagogues, nateglinide is capable of producing hypoglycaemia. 
 
Hypoglycaemia has been observed in patients with type 2 diabetes on diet and exercise, and in those 
treated with oral antidiabetic agents (see section 4.8). Elderly, malnourished patients and those with 
adrenal or pituitary insufficiency or severe renal impairment are more susceptible to the glucose-
lowering effect of these treatments. The risk of hypoglycaemia in type 2 diabetic patients may be 
increased by strenuous physical exercise, or ingestion of alcohol. 
 
Symptoms of hypoglycaemia (unconfirmed by blood glucose levels) were observed in patients whose 
baseline HbA1c was close to the therapeutic target (HbA1c <7.5%). 
 
Combination with metformin is associated with an increased risk of hypoglycaemia compared to 
monotherapy. 
 
Hypoglycaemia may be difficult to recognise in subjects receiving beta blockers. 
 
When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, 
infection or surgery, a loss of glycaemic control may occur. At such times, it may be necessary to 
discontinue oral hypoglycaemic treatment and replace it with insulin on a temporary basis. 
 
Trazec contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, 
of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine. 
 
Specific patient groups 
Nateglinide should be used with caution in patients with moderate hepatic impairment. 
 
No clinical studies have been conducted in patients with severe hepatic impairment or children and 
adolescents. Treatment is therefore not recommended in these patient groups. 
 



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4.5 Interaction with other medicinal products and other forms of interaction 
 
A number of medicinal products influence glucose metabolism and possible interactions should 
therefore be taken into account by the physician: 
 
The following agents may enhance the hypoglycaemic effect of nateglinide: angiotensin-converting 
enzyme inhibitors (ACEI). 
 
The following agents may reduce the hypoglycaemic effect of nateglinide: diuretics, corticosteroids, 
and beta2 agonists. 
 
When these medicinal products are administered to or withdrawn from patients receiving nateglinide, 
the patient should be observed closely for changes in glycaemic control. 
 
Data available from both in vitro and in vivo experiments indicate that nateglinide is predominantly 
metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent. 
 
In an interaction trial with sulfinpyrazone, a CYP2C9 inhibitor, a modest increase in nateglinide AUC 
(~28%) was observed in healthy volunteers, with no changes in the mean Cmax and elimination 
half-life. A more prolonged effect and possibly a risk of hypoglycaemia cannot be excluded in patients 
when nateglinide is co-administered with CYP2C9 inhibitors. 
 
Particular caution is recommended when nateglinide is co-administered with other more potent 
inhibitors of CYP2C9, e.g. fluconazole or gemfibrozil, or in patients known to be poor metabolisers 
for CYP2C9. 
 
Interaction studies with a 3A4 inhibitor have not been carried out in vivo. 
 
In vivo, nateglinide has no clinically relevant effect on the pharmacokinetics of medicinal products 
metabolised by CYP2C9 and CYP3A4. The pharmacokinetics of warfarin (a substrate for CYP3A4 
and CYP2C9), diclofenac (a substrate for CYP2C9), and digoxin were unaffected by coadministration 
with nateglinide. Conversely, these medicinal products had no effect on the pharmacokinetics of 
nateglinide. Thus, no dosage adjustment is required for digoxin, warfarin or other drugs that are 
CYP2C9 or CYP3A4 substrates upon coadministration with Trazec. Similarly, there was no clinically 
significant pharmacokinetic interaction of Trazec with other oral antidiabetic agents such as metformin 
or glibenclamide. 
 
Nateglinide has shown a low potential for protein displacement in in vitro studies. 
 
4.6 Pregnancy and lactation 
 
Studies in animals have shown developmental toxicity (see section 5.3). 
 
There is no experience in pregnant women, therefore the safety of Trazec in pregnant women cannot 
be assessed. Trazec, like other oral antidiabetic agents, is not recommended for use in pregnancy. 
 
Nateglinide is excreted in the milk following a peroral dose to lactating rats. Although it is not known 
whether nateglinide is excreted in human milk, the potential for hypoglycaemia in breast-fed infants 
may exist and therefore nateglinide should not be used in lactating women. 
 
4.7 Effects on ability to drive and use machines 
 
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving or operating 
machinery. This is particularly important in those who have reduced or absent awareness of the 
warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of 
driving should be considered in these circumstances. 
 



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4.8 Undesirable effects 
 
Based on the experience with nateglinide and with other hypoglycaemic agents, the following adverse 
reactions have been seen. Frequencies are defined as: common (>1/100, <1/10); uncommon (>1/1,000, 
<1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000). 
 
Hypoglycaemia 
As with other antidiabetic agents, symptoms suggestive of hypoglycaemia have been observed after 
administration of nateglinide. These symptoms included sweating, trembling, dizziness, increased 
appetite, palpitations, nausea, fatigue, and weakness. These were generally mild in nature and easily 
handled by intake of carbohydrates when necessary. In completed clinical trials, symptoms of 
hypoglycaemia were reported in 10.4% with nateglinide monotherapy, 14.5% with 
nateglinide+metformin combination, 6.9% with metformin alone, 19.8% with glibenclamide alone, 
and 4.1% with placebo. 
 
Immune system disorders 
Rare: Hypersensitivity reactions such as rash, itching and urticaria. 
 
Metabolism and nutrition disorders 
Common: Symptoms suggestive of hypoglycaemia. 
 
Gatrointestinal disorders 
Common: Abdominal pain, diarrhoea, dyspepsia, nausea. 
Uncommon: Vomiting. 
 
Hepatobiliary disorders 
Rare: Elevations in liver enzymes. 
 
Other events 
Other adverse events observed in clinical studies were of a similar incidence in Trazec-treated and 
placebo-treated patients. 
 
Post-marketing data revealed very rare cases of erythema multiforme.  
 
4.9 Overdose 
 
In a clinical study in patients, Trazec was administered in increasing doses up to 720 mg a day for 
7 days and was well tolerated. There is no experience of an overdose of Trazec in clinical trials. 
However, an overdose may result in an exaggerated glucose-lowering effect, with the development of 
hypoglycaemic symptoms. Hypoglycaemic symptoms without loss of consciousness or neurological 
findings should be treated with oral glucose and adjustments in dosage and/or meal patterns. Severe 
hypoglycaemic reactions with coma, seizure or other neurological symptoms should be treated with 
intravenous glucose. As nateglinide is highly protein-bound, dialysis is not an efficient means of 
removing it from the blood. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: D-phenylalanine derivative, ATC code: A10 BX 03 
 
Nateglinide is an amino acid (phenylalanine) derivative, which is chemically and pharmacologically 
distinct from other antidiabetic agents. Nateglinide is a rapid, short-acting oral insulin secretagogue. 
Its effect is dependent on functioning beta cells in the pancreas islets. 
 
Early insulin secretion is a mechanism for the maintenance of normal glycaemic control. Nateglinide, 



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when taken before a meal, restores early or first phase insulin secretion, which is lost in patients with 
type 2 diabetes, resulting in a reduction in post-meal glucose and HbA1c. 
 
Nateglinide closes ATP-dependent potassium channels in the beta-cell membrane with characteristics 
that distinguish it from other sulphonylurea receptor ligands. This depolarises the beta cell and leads to 
an opening of the calcium channels. The resulting calcium influx enhances insulin secretion. 
Electrophysiological studies demonstrate that nateglinide has 45–300-fold selectivity for pancreatic 
beta cell versus cardiovascular K+ATP channels. 
 
In type 2 diabetic patients, the insulinotropic response to a meal occurs within the first 15 minutes 
following an oral dose of nateglinide. This results in a blood-glucose-lowering effect throughout the 
meal period. Insulin levels return to baseline within 3 to 4 hours, reducing post-meal 
hyperinsulinaemia. 
 
Nateglinide-induced insulin secretion by pancreatic beta cells is glucose-sensitive, such that less 
insulin is secreted as glucose levels fall. Conversely, the coadministration of food or a glucose infusion 
results in an enhancement of insulin secretion. 
 
In combination with metformin, which mainly affected fasting plasma glucose, the effect of 
nateglinide on HbA1c was additive compared to either agent alone. 
 
Nateglinide efficacy was inferior to that of metformin in monotherapy (decrease in HbA1c (%) with 
metformin 500 mg three times daily monotherapy: –1.23 [95% CI: –1.48; –0.99] and with nateglinide 
120 mg three times daily monotherapy –0.90 [95% CI: –1.14; –0.66]). 
 
The efficacy of nateglinide in combination with metformin has been compared to the combination of 
gliclazide plus metformin in a 6-month randomised, double-blind trial in 262 patients using a 
superiority design. The decrease from baseline in HbA1c was –0.41% in the nateglinide plus metformin 
group and –0.57% in the gliclazide plus metformin group (difference 0.17%, [95% CI –0.03, 0.36]). 
Both treatments were well tolerated. 
 
An outcome study has not been conducted with nateglinide, therefore the long-term benefits associated 
with improved glycaemic control have not been demonstrated. 
 
5.2 Pharmacokinetic properties 
 
Absorption and bioavailability 
Nateglinide is rapidly absorbed following oral administration of Trazec tablets prior to a meal, with 
mean peak drug concentration generally occurring in less than 1 hour. Nateglinide is rapidly and 
almost completely (≥ 90%) absorbed from an oral solution. Absolute oral bioavailability is estimated 
to be 72%. In type 2 diabetic patients given Trazec over the dose range 60 to 240 mg before three 
meals per day for one week, nateglinide showed linear pharmacokinetics for both AUC and Cmax, and 
tmax was independent of dose. 
 
Distribution 
The steady-state volume of distribution of nateglinide based on intravenous data is estimated to be 
approximately 10 litres. In vitro studies show that nateglinide is extensively bound (97–99%) to serum 
proteins, mainly serum albumin and to a lesser extent alpha1-acid glycoprotein. The extent of serum 
protein binding is independent of drug concentration over the test range of 0.1–10 μg Trazec/ml. 
 
Metabolism 
Nateglinide is extensively metabolised. The main metabolites found in humans result from 
hydroxylation of the isopropyl side-chain, either on the methine carbon, or one of the methyl groups; 
activity of the main metabolites is about 5–6 and 3 times less potent than nateglinide, respectively. 
Minor metabolites identified were a diol, an isopropene and acyl glucuronide(s) of nateglinide; only 
the isopropene minor metabolite possesses activity, which is almost as potent as nateglinide. Data 
available from both in vitro and in vivo experiments indicate that nateglinide is predominantly 



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metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent. 
 
Excretion 
Nateglinide and its metabolites are rapidly and completely eliminated. Most of the [14C] nateglinide is 
excreted in the urine (83%), with an additional 10% eliminated in the faeces. Approximately 75% of 
the administered [14C] nateglinide is recovered in the urine within six hours post-dose. Approximately 
6–16% of the administered dose was excreted in the urine as unchanged drug. Plasma concentrations 
decline rapidly and the elimination half-life of nateglinide typically averaged 1.5 hours in all studies of 
Trazec in volunteers and type 2 diabetic patients. Consistent with its short elimination half-life, there is 
no apparent accumulation of nateglinide upon multiple dosing with up to 240 mg three times daily. 
 
Food effect 
When given post-prandially, the extent of nateglinide absorption (AUC) remains unaffected. However, 
there is a delay in the rate of absorption characterised by a decrease in Cmax and a delay in time to peak 
plasma concentration (tmax). It is recommended that Trazec be administered prior to meals. It is usually 
taken immediately (1 minute) before a meal but may be taken up to 30 minutes before meals. 
 
Sub-populations 
Elderly: Age did not influence the pharmacokinetic properties of nateglinide. 
 
Hepatic impairment: The systemic availability and half-life of nateglinide in non-diabetic subjects 
with mild to moderate hepatic impairment did not differ to a clinically significant degree from those in 
healthy subjects. 
 
Renal impairment: The systemic availability and half-life of nateglinide in diabetic patients with mild, 
moderate (creatinine clearance 31–50 ml/min) and severe (creatinine clearance 15–30 ml/min) renal 
impairment (not undergoing dialysis) did not differ to a clinically significant degree from those in 
healthy subjects. There is a 49% decrease in Cmax of nateglinide in dialysis-dependent diabetic 
patients. The systemic availability and half-life in dialysis-dependent diabetic patients was comparable 
with healthy subjects. Although safety was not compromised in this population dose adjustment may 
be required in view of low Cmax. 
 
Gender: No clinically significant differences in nateglinide pharmacokinetics were observed between 
men and women. 
 
5.3 Preclinical safety data 
 
Preclinical data revealed no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to fertility and 
post-natal development. Nateglinide was not teratogenic in rats. In rabbits, at maternally toxic doses a 
higher incidence of foetuses with no gallbladder was observed. 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Lactose monohydrate 
Cellulose, microcrystalline 
Povidone 
Croscarmellose sodium 
Magnesium stearate 
Red iron oxide (E172) 
Hypromellose 
Titanium dioxide (E171) 
Talc 
Macrogol 
Silica, colloidal anhydrous 



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6.2 Incompatibilities 
 
Not applicable 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Do not store above 30°C. 
 
Store in the original package. 
 
6.5 Nature and contents of container 
 
Blisters: PVC/PE/PVDC moulded foil with aluminium lidding foil. 
 
Packs contain 12, 60, 84, 120 and 360 tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Novartis Europharm Limited 
Wimblehurst Road 
Horsham 
West Sussex, RH12 5AB 
United Kingdom 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/01/175/001 
EU/1/01/175/004-007 
 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 03.04.2001 
Date of first renewal: 03.04.2006 
 
 
10. DATE OF REVISION OF THE TEXT 



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1. NAME OF THE MEDICINAL PRODUCT 
 
TRAZEC 120 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each film-coated tablet contains 120 mg nateglinide. 
 
Excipients: 
Lactose monohydrate: 283 mg per tablet  
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet 
 
120 mg yellow, ovaloid tablets with “NVR” marked on one side and “TSL” on the other. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients 
inadequately controlled despite a maximally tolerated dose of metformin alone. 
 
4.2 Posology and method of administration 
 
Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner). 
 
The dosage of nateglinide should be determined by the physician according to the patient’s 
requirements. 
 
The recommended starting dose is 60 mg three times daily before meals, particularly in patients who 
are near goal HbA1c. This may be increased to 120 mg three times daily. 
 
Dose adjustments should be based on periodic glycosylated haemoglobin (HbA1c) measurements. 
Since the primary therapeutic effect of Trazec is to reduce mealtime glucose, (a contributor to HbA1c), 
the therapeutic response to Trazec may also be monitored with 1–2 hour post-meal glucose. 
 
The recommended maximum daily dose is 180 mg three times daily to be taken before the three main 
meals. 
 
Specific patient groups 
Elderly 
The clinical experience in patients over 75 years of age is limited. 
 
Children and adolescents 
There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its 
use in this age group is not recommended. 
 
Patients with hepatic impairment 
No dose adjustment is necessary for patients with mild to moderate hepatic impairment. As patients 
with severe liver disease were not studied, nateglinide is contraindicated in this group. 



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Patients with renal impairment 
No dose adjustment is necessary in patients with mild to moderate renal impairment. Although there is 
a 49% decrease in Cmax of nateglinide in dialysis patients, the systemic availability and half-life in 
diabetic subjects with moderate to severe renal insufficiency (creatinine clearance 15–50 ml/min) was 
comparable between renal subjects requiring haemodialysis and healthy subjects. Although safety was 
not compromised in this population dose adjustment may be required in view of low Cmax. 
 
Others 
In debilitated or malnourished patients the initial and maintenance dosage should be conservative and 
careful titration is required to avoid hypoglycaemic reactions. 
 
4.3 Contraindications 
 
Trazec is contraindicated in patients with: 
• Hypersensitivity to the active substance or to any of the excipients 
• Type 1 diabetes (insulin-dependent diabetes mellitus, C-peptide negative) 
• Diabetic ketoacidosis, with or without coma 
• Pregnancy and breast-feeding (see section 4.6) 
• Severe hepatic impairment 
 
4.4 Special warnings and precautions for use 
 
General 
Nateglinide should not be used in monotherapy. 
 
Like other insulin secretagogues, nateglinide is capable of producing hypoglycaemia. 
 
Hypoglycaemia has been observed in patients with type 2 diabetes on diet and exercise, and in those 
treated with oral antidiabetic agents (see section 4.8). Elderly, malnourished patients and those with 
adrenal or pituitary insufficiency or severe renal impairment are more susceptible to the glucose-
lowering effect of these treatments. The risk of hypoglycaemia in type 2 diabetic patients may be 
increased by strenuous physical exercise, or ingestion of alcohol. 
 
Symptoms of hypoglycaemia (unconfirmed by blood glucose levels) were observed in patients whose 
baseline HbA1c was close to the therapeutic target (HbA1C <7.5%). 
 
Combination with metformin is associated with an increased risk of hypoglycaemia compared to 
monotherapy. 
 
Hypoglycaemia may be difficult to recognise in subjects receiving beta blockers. 
 
When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, 
infection or surgery, a loss of glycaemic control may occur. At such times, it may be necessary to 
discontinue oral hypoglycaemic treatment and replace it with insulin on a temporary basis. 
 
Trazec contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, 
of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine. 
 
Specific patient groups 
Nateglinide should be used with caution in patients with moderate hepatic impairment. 
 
No clinical studies have been conducted in patients with severe hepatic impairment or children and 
adolescents. Treatment is therefore not recommended in these patient groups. 
 



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4.5 Interaction with other medicinal products and other forms of interaction 
 
A number of medicinal products influence glucose metabolism and possible interactions should 
therefore be taken into account by the physician: 
 
The following agents may enhance the hypoglycaemic effect of nateglinide: angiotensin-converting 
enzyme inhibitors (ACEI). 
 
The following agents may reduce the hypoglycaemic effect of nateglinide: diuretics, corticosteroids, 
and beta2 agonists. 
 
When these medicinal products are administered to or withdrawn from patients receiving nateglinide, 
the patient should be observed closely for changes in glycaemic control. 
 
Data available from both in vitro and in vivo experiments indicate that nateglinide is predominantly 
metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent. 
 
In an interaction trial with sulfinpyrazone, a CYP2C9 inhibitor, a modest increase in nateglinide AUC 
(~28%) was observed in healthy volunteers, with no changes in the mean Cmax and elimination 
half-life. A more prolonged effect and possibly a risk of hypoglycaemia cannot be excluded in patients 
when nateglinide is co-administered with CYP2C9 inhibitors. 
 
Particular caution is recommended when nateglinide is co-administered with other more potent 
inhibitors of CYP2C9, e.g. fluconazole or gemfibrozil, or in patients known to be poor metabolisers 
for CYP2C9. 
 
Interaction studies with a 3A4 inhibitor have not been carried out in vivo. 
 
In vivo, nateglinide has no clinically relevant effect on the pharmacokinetics of medicinal products 
metabolised by CYP2C9 and CYP3A4. The pharmacokinetics of warfarin (a substrate for CYP3A4 
and CYP2C9), diclofenac (a substrate for CYP2C9), and digoxin were unaffected by coadministration 
with nateglinide. Conversely, these medicinal products had no effect on the pharmacokinetics of 
nateglinide. Thus, no dosage adjustment is required for digoxin, warfarin or other drugs that are 
CYP2C9 or CYP3A4 substrates upon coadministration with Trazec. Similarly, there was no clinically 
significant pharmacokinetic interaction of Trazec with other oral antidiabetic agents such as metformin 
or glibenclamide. 
 
Nateglinide has shown a low potential for protein displacement in in vitro studies. 
 
4.6 Pregnancy and lactation 
 
Studies in animals have shown developmental toxicity (see section 5.3). 
 
There is no experience in pregnant women, therefore the safety of Trazec in pregnant women cannot 
be assessed. Trazec, like other oral antidiabetic agents, is not recommended for use in pregnancy. 
 
Nateglinide is excreted in the milk following a peroral dose to lactating rats. Although it is not known 
whether nateglinide is excreted in human milk, the potential for hypoglycaemia in breast-fed infants 
may exist and therefore nateglinide should not be used in lactating women. 
 
4.7 Effects on ability to drive and use machines 
 
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving or operating 
machinery. This is particularly important in those who have reduced or absent awareness of the 
warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of 
driving should be considered in these circumstances. 
 



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4.8 Undesirable effects 
 
Based on the experience with nateglinide and with other hypoglycaemic agents, the following adverse 
reactions have been seen. Frequencies are defined as: common (>1/100, <1/10); uncommon (>1/1,000, 
<1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000). 
 
Hypoglycaemia 
As with other antidiabetic agents, symptoms suggestive of hypoglycaemia have been observed after 
administration of nateglinide. These symptoms included sweating, trembling, dizziness, increased 
appetite, palpitations, nausea, fatigue, and weakness. These were generally mild in nature and easily 
handled by intake of carbohydrates when necessary. In completed clinical trials, symptoms of 
hypoglycaemia were reported in 10.4% with nateglinide monotherapy, 14.5% with 
nateglinide+metformin combination, 6.9% with metformin alone, 19.8% with glibenclamide alone, 
and 4.1% with placebo. 
 
Immune system disorders 
Rare: Hypersensitivity reactions such as rash, itching and urticaria. 
 
Metabolism and nutrition disorders 
Common: Symptoms suggestive of hypoglycaemia. 
 
Gatrointestinal disorders 
Common: Abdominal pain, diarrhoea, dyspepsia, nausea. 
Uncommon: Vomiting. 
 
Hepatobiliary disorders 
Rare: Elevations in liver enzymes. 
 
Other events 
Other adverse events observed in clinical studies were of a similar incidence in Trazec-treated and 
placebo-treated patients. 
 
Post-marketing data revealed very rare cases of erythema multiforme. 
 
4.9 Overdose 
 
In a clinical study in patients, Trazec was administered in increasing doses up to 720 mg a day for 
7 days and was well tolerated. There is no experience of an overdose of Trazec in clinical trials. 
However, an overdose may result in an exaggerated glucose-lowering effect, with the development of 
hypoglycaemic symptoms. Hypoglycaemic symptoms without loss of consciousness or neurological 
findings should be treated with oral glucose and adjustments in dosage and/or meal patterns. Severe 
hypoglycaemic reactions with coma, seizure or other neurological symptoms should be treated with 
intravenous glucose. As nateglinide is highly protein-bound, dialysis is not an efficient means of 
removing it from the blood. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: D-phenylalanine derivative, ATC code: A10 BX 03 
 
Nateglinide is an amino acid (phenylalanine) derivative, which is chemically and pharmacologically 
distinct from other antidiabetic agents. Nateglinide is a rapid, short-acting oral insulin secretagogue. 
Its effect is dependent on functioning beta cells in the pancreas islets. 
 
Early insulin secretion is a mechanism for the maintenance of normal glycaemic control. Nateglinide, 



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when taken before a meal, restores early or first phase insulin secretion, which is lost in patients with 
type 2 diabetes, resulting in a reduction in post-meal glucose and HbA1c. 
 
Nateglinide closes ATP-dependent potassium channels in the beta-cell membrane with characteristics 
that distinguish it from other sulphonylurea receptor ligands. This depolarises the beta cell and leads to 
an opening of the calcium channels. The resulting calcium influx enhances insulin secretion. 
Electrophysiological studies demonstrate that nateglinide has 45–300-fold selectivity for pancreatic 
beta cell versus cardiovascular K+ATP channels. 
 
In type 2 diabetic patients, the insulinotropic response to a meal occurs within the first 15 minutes 
following an oral dose of nateglinide. This results in a blood-glucose-lowering effect throughout the 
meal period. Insulin levels return to baseline within 3 to 4 hours, reducing post-meal 
hyperinsulinaemia. 
 
Nateglinide-induced insulin secretion by pancreatic beta cells is glucose-sensitive, such that less 
insulin is secreted as glucose levels fall. Conversely, the coadministration of food or a glucose infusion 
results in an enhancement of insulin secretion. 
 
In combination with metformin, which mainly affected fasting plasma glucose, the effect of 
nateglinide on HbA1c was additive compared to either agent alone. 
 
Nateglinide efficacy was inferior to that of metformin in monotherapy (decrease in HbA1c (%) with 
metformin 500 mg three times daily monotherapy: –1.23 [95% CI: –1.48; –0.99] and with nateglinide 
120 mg three times daily monotherapy –0.90 [95% CI: –1.14; –0.66]). 
 
The efficacy of nateglinide in combination with metformin has been compared to the combination of 
gliclazide plus metformin in a 6-month randomised, double-blind trial in 262 patients using a 
superiority design. The decrease from baseline in HbA1c was –0.41% in the nateglinide plus metformin 
group and –0.57% in the gliclazide plus metformin group (difference 0.17%, [95% CI –0.03, 0.36]). 
Both treatments were well tolerated. 
 
An outcome study has not been conducted with nateglinide, therefore the long-term benefits associated 
with improved glycaemic control have not been demonstrated. 
 
5.2 Pharmacokinetic properties 
 
Absorption and bioavailability 
Nateglinide is rapidly absorbed following oral administration of Trazec tablets prior to a meal, with 
mean peak drug concentration generally occurring in less than 1 hour. Nateglinide is rapidly and 
almost completely (≥ 90%) absorbed from an oral solution. Absolute oral bioavailability is estimated 
to be 72%. In type 2 diabetic patients given Trazec over the dose range 60 to 240 mg before three 
meals per day for one week, nateglinide showed linear pharmacokinetics for both AUC and Cmax, and 
tmax was independent of dose. 
 
Distribution 
The steady-state volume of distribution of nateglinide based on intravenous data is estimated to be 
approximately 10 litres. In vitro studies show that nateglinide is extensively bound (97–99%) to serum 
proteins, mainly serum albumin and to a lesser extent alpha1-acid glycoprotein. The extent of serum 
protein binding is independent of drug concentration over the test range of 0.1–10 μg Trazec/ml. 
 
Metabolism 
Nateglinide is extensively metabolised. The main metabolites found in humans result from 
hydroxylation of the isopropyl side-chain, either on the methine carbon, or one of the methyl groups; 
activity of the main metabolites is about 5–6 and 3 times less potent than nateglinide, respectively. 
Minor metabolites identified were a diol, an isopropene and acyl glucuronide(s) of nateglinide; only 
the isopropene minor metabolite possesses activity, which is almost as potent as nateglinide. Data 
available from both in vitro and in vivo experiments indicate that nateglinide is predominantly 



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metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent. 
 
Excretion 
Nateglinide and its metabolites are rapidly and completely eliminated. Most of the [14C] nateglinide is 
excreted in the urine (83%), with an additional 10% eliminated in the faeces. Approximately 75% of 
the administered [14C] nateglinide is recovered in the urine within six hours post-dose. Approximately 
6–16% of the administered dose was excreted in the urine as unchanged drug. Plasma concentrations 
decline rapidly and the elimination half-life of nateglinide typically averaged 1.5 hours in all studies of 
Trazec in volunteers and type 2 diabetic patients. Consistent with its short elimination half-life, there is 
no apparent accumulation of nateglinide upon multiple dosing with up to 240 mg three times daily. 
 
Food effect 
When given post-prandially, the extent of nateglinide absorption (AUC) remains unaffected. However, 
there is a delay in the rate of absorption characterised by a decrease in Cmax and a delay in time to peak 
plasma concentration (tmax). It is recommended that Trazec be administered prior to meals. It is usually 
taken immediately (1 minute) before a meal but may be taken up to 30 minutes before meals. 
 
Sub-populations 
Elderly: Age did not influence the pharmacokinetic properties of nateglinide. 
 
Hepatic impairment: The systemic availability and half-life of nateglinide in non-diabetic subjects 
with mild to moderate hepatic impairment did not differ to a clinically significant degree from those in 
healthy subjects. 
 
Renal impairment: The systemic availability and half-life of nateglinide in diabetic patients with mild, 
moderate (creatinine clearance 31–50 ml/min) and severe (creatinine clearance 15–30 ml/min) renal 
impairment (not undergoing dialysis) did not differ to a clinically significant degree from those in 
healthy subjects. There is a 49% decrease in Cmax of nateglinide in dialysis-dependent diabetic 
patients. The systemic availability and half-life in dialysis-dependent diabetic patients was comparable 
with healthy subjects. Although safety was not compromised in this population dose adjustment may 
be required in view of low Cmax. 
 
Gender: No clinically significant differences in nateglinide pharmacokinetics were observed between 
men and women. 
 
5.3 Preclinical safety data 
 
Preclinical data revealed no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to fertility and 
post-natal development. Nateglinide was not teratogenic in rats. In rabbits, at maternally toxic doses a 
higher incidence of foetuses with no gallbladder was observed. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Lactose monohydrate 
Cellulose, microcrystalline 
Povidone 
Croscarmellose sodium 
Magnesium stearate 
Yellow iron oxide (E172) 
Hypromellose 
Titanium dioxide (E171) 
Talc 
Macrogol 



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Silica, colloidal anhydrous 
 
6.2 Incompatibilities 
 
Not applicable 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Do not store above 30°C. 
 
Store in the original package. 
 
6.5 Nature and contents of container 
 
Blisters: PVC/PE/PVDC moulded foil with aluminium lidding foil. 
 
Packs contain 12, 60, 84, 120 and 360 tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Novartis Europharm Limited 
Wimblehurst Road 
Horsham 
West Sussex, RH12 5AB 
United Kingdom 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/01/175/008 
EU/1/01/175/011-014 
 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 03.04.2001 
Date of first renewal: 03.04.2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
TRAZEC 180 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each film-coated tablet contains 180 mg nateglinide. 
 
Excipients: 
Lactose monohydrate: 214 mg per tablet  
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet 
 
180 mg red, ovaloid tablets with “NVR” marked on one side and “TSX” on the other. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients 
inadequately controlled despite a maximally tolerated dose of metformin alone. 
 
4.2 Posology and method of administration 
 
Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner). 
 
The dosage of nateglinide should be determined by the physician according to the patient’s 
requirements. 
 
The recommended starting dose is 60 mg three times daily before meals, particularly in patients who 
are near goal HbA1c. This may be increased to 120 mg three times daily. 
 
Dose adjustments should be based on periodic glycosylated haemoglobin (HbA1c) measurements. 
Since the primary therapeutic effect of Trazec is to reduce mealtime glucose, (a contributor to HbA1c), 
the therapeutic response to Trazec may also be monitored with 1–2 hour post-meal glucose. 
 
The recommended maximum daily dose is 180 mg three times daily to be taken before the three main 
meals. 
 
Specific patient groups 
Elderly 
The clinical experience in patients over 75 years of age is limited. 
 
Children and adolescents 
There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its 
use in this age group is not recommended. 
 
Patients with hepatic impairment 
No dose adjustment is necessary for patients with mild to moderate hepatic impairment. As patients 
with severe liver disease were not studied, nateglinide is contraindicated in this group. 



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Patients with renal impairment 
No dose adjustment is necessary in patients with mild to moderate renal impairment. Although there is 
a 49% decrease in Cmax of nateglinide in dialysis patients, the systemic availability and half-life in 
diabetic subjects with moderate to severe renal insufficiency (creatinine clearance 15–50 ml/min) was 
comparable between renal subjects requiring haemodialysis and healthy subjects. Although safety was 
not compromised in this population dose adjustment may be required in view of low Cmax. 
 
Others 
In debilitated or malnourished patients the initial and maintenance dosage should be conservative and 
careful titration is required to avoid hypoglycaemic reactions. 
 
4.3 Contraindications 
 
Trazec is contraindicated in patients with: 
• Hypersensitivity to the active substance or to any of the excipients 
• Type 1 diabetes (insulin-dependent diabetes mellitus, C-peptide negative) 
• Diabetic ketoacidosis, with or without coma 
• Pregnancy and breast-feeding (see section 4.6) 
• Severe hepatic impairment 
 
4.4 Special warnings and precautions for use 
 
General 
Nateglinide should not be used in monotherapy. 
 
Like other insulin secretagogues, nateglinide is capable of producing hypoglycaemia. 
 
Hypoglycaemia has been observed in patients with type 2 diabetes on diet and exercise, and in those 
treated with oral antidiabetic agents (see section 4.8). Elderly, malnourished patients and those with 
adrenal or pituitary insufficiency or severe renal impairment are more susceptible to the glucose-
lowering effect of these treatments. The risk of hypoglycaemia in type 2 diabetic patients may be 
increased by strenuous physical exercise, or ingestion of alcohol. 
 
Symptoms of hypoglycaemia (unconfirmed by blood glucose levels) were observed in patients whose 
baseline HbA1c was close to the therapeutic target (HbA1C <7.5%). 
 
Combination with metformin is associated with an increased risk of hypoglycaemia compared to 
monotherapy. 
 
Hypoglycaemia may be difficult to recognise in subjects receiving beta blockers. 
 
When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, 
infection or surgery, a loss of glycaemic control may occur. At such times, it may be necessary to 
discontinue oral hypoglycaemic treatment and replace it with insulin on a temporary basis. 
 
Trazec contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, 
of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine. 
 
Specific patient groups 
Nateglinide should be used with caution in patients with moderate hepatic impairment. 
 
No clinical studies have been conducted in patients with severe hepatic impairment or children and 
adolescents. Treatment is therefore not recommended in these patient groups. 
 



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4.5 Interaction with other medicinal products and other forms of interaction 
 
A number of medicinal products influence glucose metabolism and possible interactions should 
therefore be taken into account by the physician: 
 
The following agents may enhance the hypoglycaemic effect of nateglinide: angiotensin-converting 
enzyme inhibitors (ACEI). 
 
The following agents may reduce the hypoglycaemic effect of nateglinide: diuretics, corticosteroids, 
and beta2 agonists. 
 
When these medicinal products are administered to or withdrawn from patients receiving nateglinide, 
the patient should be observed closely for changes in glycaemic control. 
 
Data available from both in vitro and in vivo experiments indicate that nateglinide is predominantly 
metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent. 
 
In an interaction trial with sulfinpyrazone, a CYP2C9 inhibitor, a modest increase in nateglinide AUC 
(~28%) was observed in healthy volunteers, with no changes in the mean Cmax and elimination 
half-life. A more prolonged effect and possibly a risk of hypoglycaemia cannot be excluded in patients 
when nateglinide is co-administered with CYP2C9 inhibitors. 
 
Particular caution is recommended when nateglinide is co-administered with other more potent 
inhibitors of CYP2C9, e.g. fluconazole or gemfibrozil, or in patients known to be poor metabolisers 
for CYP2C9. 
 
Interaction studies with a 3A4 inhibitor have not been carried out in vivo. 
 
In vivo, nateglinide has no clinically relevant effect on the pharmacokinetics of medicinal products 
metabolised by CYP2C9 and CYP3A4. The pharmacokinetics of warfarin (a substrate for CYP3A4 
and CYP2C9), diclofenac (a substrate for CYP2C9), and digoxin were unaffected by coadministration 
with nateglinide. Conversely, these medicinal products had no effect on the pharmacokinetics of 
nateglinide. Thus, no dosage adjustment is required for digoxin, warfarin or other drugs that are 
CYP2C9 or CYP3A4 substrates upon coadministration with Trazec. Similarly, there was no clinically 
significant pharmacokinetic interaction of Trazec with other oral antidiabetic agents such as metformin 
or glibenclamide. 
 
Nateglinide has shown a low potential for protein displacement in in vitro studies. 
 
4.6 Pregnancy and lactation 
 
Studies in animals have shown developmental toxicity (see section 5.3). 
 
There is no experience in pregnant women, therefore the safety of Trazec in pregnant women cannot 
be assessed. Trazec, like other oral antidiabetic agents, is not recommended for use in pregnancy. 
 
Nateglinide is excreted in the milk following a peroral dose to lactating rats. Although it is not known 
whether nateglinide is excreted in human milk, the potential for hypoglycaemia in breast-fed infants 
may exist and therefore nateglinide should not be used in lactating women. 
 
4.7 Effects on ability to drive and use machines 
 
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving or operating 
machinery. This is particularly important in those who have reduced or absent awareness of the 
warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of 
driving should be considered in these circumstances. 
 



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4.8 Undesirable effects 
 
Based on the experience with nateglinide and with other hypoglycaemic agents, the following adverse 
reactions have been seen. Frequencies are defined as: common (>1/100, <1/10); uncommon (>1/1,000, 
<1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000). 
 
Hypoglycaemia 
As with other antidiabetic agents, symptoms suggestive of hypoglycaemia have been observed after 
administration of nateglinide. These symptoms included sweating, trembling, dizziness, increased 
appetite, palpitations, nausea, fatigue, and weakness. These were generally mild in nature and easily 
handled by intake of carbohydrates when necessary. In completed clinical trials, symptoms of 
hypoglycaemia were reported in 10.4% with nateglinide monotherapy, 14.5% with 
nateglinide+metformin combination, 6.9% with metformin alone, 19.8% with glibenclamide alone, 
and 4.1% with placebo. 
 
Immune system disorders 
Rare: Hypersensitivity reactions such as rash, itching and urticaria. 
 
Metabolism and nutrition disorders 
Common: Symptoms suggestive of hypoglycaemia. 
 
Gatrointestinal disorders 
Common: Abdominal pain, diarrhoea, dyspepsia, nausea. 
Uncommon: Vomiting. 
 
Hepatobiliary disorders 
Rare: Elevations in liver enzymes. 
 
Other events 
Other adverse events observed in clinical studies were of a similar incidence in Trazec-treated and 
placebo-treated patients. 
 
Post-marketing data revealed very rare cases of erythema multiforme. 
 
4.9 Overdose 
 
In a clinical study in patients, Trazec was administered in increasing doses up to 720 mg a day for 
7 days and was well tolerated. There is no experience of an overdose of Trazec in clinical trials. 
However, an overdose may result in an exaggerated glucose-lowering effect, with the development of 
hypoglycaemic symptoms. Hypoglycaemic symptoms without loss of consciousness or neurological 
findings should be treated with oral glucose and adjustments in dosage and/or meal patterns. Severe 
hypoglycaemic reactions with coma, seizure or other neurological symptoms should be treated with 
intravenous glucose. As nateglinide is highly protein-bound, dialysis is not an efficient means of 
removing it from the blood. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: D-phenylalanine derivative, ATC code: A10 BX 03 
 
Nateglinide is an amino acid (phenylalanine) derivative, which is chemically and pharmacologically 
distinct from other antidiabetic agents. Nateglinide is a rapid, short-acting oral insulin secretagogue. 
Its effect is dependent on functioning beta cells in the pancreas islets. 
 
Early insulin secretion is a mechanism for the maintenance of normal glycaemic control. Nateglinide, 



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when taken before a meal, restores early or first phase insulin secretion, which is lost in patients with 
type 2 diabetes, resulting in a reduction in post-meal glucose and HbA1c. 
 
Nateglinide closes ATP-dependent potassium channels in the beta-cell membrane with characteristics 
that distinguish it from other sulphonylurea receptor ligands. This depolarises the beta cell and leads to 
an opening of the calcium channels. The resulting calcium influx enhances insulin secretion. 
Electrophysiological studies demonstrate that nateglinide has 45–300-fold selectivity for pancreatic 
beta cell versus cardiovascular K+ATP channels. 
 
In type 2 diabetic patients, the insulinotropic response to a meal occurs within the first 15 minutes 
following an oral dose of nateglinide. This results in a blood-glucose-lowering effect throughout the 
meal period. Insulin levels return to baseline within 3 to 4 hours, reducing post-meal 
hyperinsulinaemia. 
 
Nateglinide-induced insulin secretion by pancreatic beta cells is glucose-sensitive, such that less 
insulin is secreted as glucose levels fall. Conversely, the coadministration of food or a glucose infusion 
results in an enhancement of insulin secretion. 
 
In combination with metformin, which mainly affected fasting plasma glucose, the effect of 
nateglinide on HbA1c was additive compared to either agent alone. 
 
Nateglinide efficacy was inferior to that of metformin in monotherapy (decrease in HbA1c (%) with 
metformin 500 mg three times daily monotherapy: –1.23 [95% CI: –1.48; –0.99] and with nateglinide 
120 mg three times daily monotherapy –0.90 [95% CI: –1.14; –0.66]). 
 
The efficacy of nateglinide in combination with metformin has been compared to the combination of 
gliclazide plus metformin in a 6-month randomised, double-blind trial in 262 patients using a 
superiority design. The decrease from baseline in HbA1c was –0.41% in the nateglinide plus metformin 
group and –0.57% in the gliclazide plus metformin group (difference 0.17%, [95% CI –0.03, 0.36]). 
Both treatments were well tolerated. 
 
An outcome study has not been conducted with nateglinide, therefore the long-term benefits associated 
with improved glycaemic control have not been demonstrated. 
 
5.2 Pharmacokinetic properties 
 
Absorption and bioavailability 
Nateglinide is rapidly absorbed following oral administration of Trazec tablets prior to a meal, with 
mean peak drug concentration generally occurring in less than 1 hour. Nateglinide is rapidly and 
almost completely (≥ 90%) absorbed from an oral solution. Absolute oral bioavailability is estimated 
to be 72%. In type 2 diabetic patients given Trazec over the dose range 60 to 240 mg before three 
meals per day for one week, nateglinide showed linear pharmacokinetics for both AUC and Cmax, and 
tmax was independent of dose. 
 
Distribution 
The steady-state volume of distribution of nateglinide based on intravenous data is estimated to be 
approximately 10 litres. In vitro studies show that nateglinide is extensively bound (97–99%) to serum 
proteins, mainly serum albumin and to a lesser extent alpha1-acid glycoprotein. The extent of serum 
protein binding is independent of drug concentration over the test range of 0.1–10 μg Trazec/ml. 
 
Metabolism 
Nateglinide is extensively metabolised. The main metabolites found in humans result from 
hydroxylation of the isopropyl side-chain, either on the methine carbon, or one of the methyl groups; 
activity of the main metabolites is about 5–6 and 3 times less potent than nateglinide, respectively. 
Minor metabolites identified were a diol, an isopropene and acyl glucuronide(s) of nateglinide; only 
the isopropene minor metabolite possesses activity, which is almost as potent as nateglinide. Data 
available from both in vitro and in vivo experiments indicate that nateglinide is predominantly 



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metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent. 
 
Excretion 
Nateglinide and its metabolites are rapidly and completely eliminated. Most of the [14C] nateglinide is 
excreted in the urine (83%), with an additional 10% eliminated in the faeces. Approximately 75% of 
the administered [14C] nateglinide is recovered in the urine within six hours post-dose. Approximately 
6–16% of the administered dose was excreted in the urine as unchanged drug. Plasma concentrations 
decline rapidly and the elimination half-life of nateglinide typically averaged 1.5 hours in all studies of 
Trazec in volunteers and type 2 diabetic patients. Consistent with its short elimination half-life, there is 
no apparent accumulation of nateglinide upon multiple dosing with up to 240 mg three times daily. 
 
Food effect 
When given post-prandially, the extent of nateglinide absorption (AUC) remains unaffected. However, 
there is a delay in the rate of absorption characterised by a decrease in Cmax and a delay in time to peak 
plasma concentration (tmax). It is recommended that Trazec be administered prior to meals. It is usually 
taken immediately (1 minute) before a meal but may be taken up to 30 minutes before meals. 
 
Sub-populations 
Elderly: Age did not influence the pharmacokinetic properties of nateglinide. 
 
Hepatic impairment: The systemic availability and half-life of nateglinide in non-diabetic subjects 
with mild to moderate hepatic impairment did not differ to a clinically significant degree from those in 
healthy subjects. 
 
Renal impairment: The systemic availability and half-life of nateglinide in diabetic patients with mild, 
moderate (creatinine clearance 31–50 ml/min) and severe (creatinine clearance 15–30 ml/min) renal 
impairment (not undergoing dialysis) did not differ to a clinically significant degree from those in 
healthy subjects. There is a 49% decrease in Cmax of nateglinide in dialysis-dependent diabetic 
patients. The systemic availability and half-life in dialysis-dependent diabetic patients was comparable 
with healthy subjects. Although safety was not compromised in this population dose adjustment may 
be required in view of low Cmax. 
 
Gender: No clinically significant differences in nateglinide pharmacokinetics were observed between 
men and women. 
 
5.3 Preclinical safety data 
 
Preclinical data revealed no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to fertility and 
post-natal development. Nateglinide was not teratogenic in rats. In rabbits, at maternally toxic doses a 
higher incidence of foetuses with no gallbladder was observed. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Lactose monohydrate 
Cellulose, microcrystalline 
Povidone 
Croscarmellose sodium 
Magnesium stearate 
Red iron oxide (E172) 
Hypromellose 
Titanium dioxide (E171) 
Talc 
Macrogol 



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Silica, colloidal anhydrous 
 
6.2 Incompatibilities 
 
Not applicable 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Do not store above 30°C. 
 
Store in the original package. 
 
6.5 Nature and contents of container 
 
Blisters: PVC/PE/PVDC moulded foil with aluminium lidding foil. 
 
Packs contain 12, 60, 84, 120 and 360 tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Novartis Europharm Limited 
Wimblehurst Road 
Horsham 
West Sussex, RH12 5AB 
United Kingdom 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/01/175/015 
EU/1/01/175/018-021 
 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 03.04.2001 
Date of first renewal: 03.04.2006 
 
 
10. DATE OF REVISION OF THE TEXT 



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ANNEX II 
 
A. MANUFACTURING AUTHORISATION HOLDER 

RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 



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A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE 

 
Name and address of the manufacturer responsible for batch release 
 
Novartis Farma S.p.A. 
Via Provinciale Schito, 131 
I-80058 Torre Annunziata - Napoli 
Italy 
 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
Medicinal product subject to medical prescription 
 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT  
 
Not applicable. 
 
 
 



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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



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A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trazec 60 mg film-coated tablets 
Nateglinide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 60 mg nateglinide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
12 film-coated tablets 
60 film-coated tablets 
84 film-coated tablets 
120 film-coated tablets 
360 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
Store in the original package. 



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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Novartis Europharm Limited 
Wimblehurst Road 
Horsham 
West Sussex, RH12 5AB 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/01/175/001 12 film-coated tablets 
EU/1/01/175/004 60 film-coated tablets 
EU/1/01/175/005 84 film-coated tablets 
EU/1/01/175/006 120 film-coated tablets 
EU/1/01/175/007 360 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Trazec 60 mg 



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trazec 60 mg tablets 
Nateglinide 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Novartis Europharm Limited 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trazec 120 mg film-coated tablets 
Nateglinide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 120 mg nateglinide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
12 film-coated tablets 
60 film-coated tablets 
84 film-coated tablets 
120 film-coated tablets 
360 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
Store in the original package. 



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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Novartis Europharm Limited 
Wimblehurst Road 
Horsham 
West Sussex, RH12 5AB 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/01/175/008 12 film-coated tablets 
EU/1/01/175/011 60 film-coated tablets 
EU/1/01/175/012 84 film-coated tablets 
EU/1/01/175/013 120 film-coated tablets 
EU/1/01/175/014 360 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Trazec 120 mg 
 



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trazec 120 mg tablets 
Nateglinide 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Novartis Europharm Limited 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trazec 180 mg film-coated tablets 
Nateglinide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 180 mg nateglinide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
12 film-coated tablets 
60 film-coated tablets 
84 film-coated tablets 
120 film-coated tablets 
360 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
Store in the original package. 



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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Novartis Europharm Limited 
Wimblehurst Road 
Horsham 
West Sussex, RH12 5AB 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/01/175/015 12 film-coated tablets 
EU/1/01/175/018 60 film-coated tablets 
EU/1/01/175/019 84 film-coated tablets 
EU/1/01/175/020 120 film-coated tablets 
EU/1/01/175/021 360 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Trazec 180 mg 
 



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trazec 180 mg tablets 
Nateglinide 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Novartis Europharm Limited 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



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B. PACKAGE LEAFLET 
 



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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Trazec 60 mgfilm-coated tablets 
Trazec 120 mg film-coated tablets 
Trazec 180 mg film-coated tablets 

Nateglinide 
 
Read all of this leaflet carefully before you start taking this medicine. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even 

if their symptoms are the same as yours. 
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist. 
 
 
In this leaflet: 
1. What Trazec is and what it is used for 
2. Before you take Trazec 
3. How to take Trazec 
4. Possible side effects 
5. How to store Trazec 
6. Further information 
 
 
1. WHAT TRAZEC IS AND WHAT IT IS USED FOR 
 
Trazec is a medicine to lower blood sugar (glucose), which is taken by mouth (these medicines are 
also known as oral anti-diabetics). 
 
It is used by people with type 2 diabetes. (This kind of diabetes is also called non-insulin-dependent 
diabetes mellitus.) 
 
Insulin is a substance produced by a body organ called the pancreas. It helps to decrease blood sugar 
levels, especially after meals. In patients with type 2 diabetes, the body may not start producing insulin 
quickly enough after meals. Trazec works by stimulating the pancreas to produce insulin more 
quickly. This helps to keep the blood sugar controlled after meals. 
 
Your doctor will prescribe Trazec together with another oral anti-diabetic containing metformin. 
 
Trazec tablets start to act quickly after you take them and are eliminated from the body rapidly. 
 
 
2. BEFORE YOU TAKE TRAZEC 
 
Follow all instructions given to you by your doctor and pharmacist carefully, even if they are different 
from what is in this leaflet. 
 
Do not take Trazec 
- if you are allergic (hypersensitive) to nateglinide or any of the other ingredients of Trazec. 
- if you have type 1 diabetes (i.e. your body does not produce any insulin). 
- if you know that you have a severe liver problem. 
- if you are pregnant or planning to become pregnant. 
- if you are breast-feeding. 
Talk to your doctor if you have any further questions or you think that any of these may apply to you. 
 



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Take special care with Trazec 
People with diabetes sometimes get symptoms of low blood sugar (also called hypoglycaemia). 
Medicines, including Trazec, may also produce symptoms of low blood sugar. 
 
If you get any of these symptoms – feeling dizzy, light-headed, hungry, shaky or any of the other signs 
in section 4, “Possible side effects” – eat or drink something containing sugar. 
 
Some people are more likely to get symptoms of low blood sugar than others. Take care 
- if you are over 65 years of age. 
- if you are undernourished. 
- if you have another medical condition that may cause low blood sugar (e.g. an under-active 

pituitary or adrenal gland). 
 
If any of these apply to you, monitor your blood sugar levels more carefully. 
 
Talk to your doctor 
- if you know that you have a liver problem. 
- if you have a severe kidney problem. 
- if you have problems of drug metabolism. 
- if you are due to have an operation. 
- if you have suffered a fever, an accident or an infection. 
Your treatment may need to be adjusted. 
 
Taking other medicines 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, 
including medicines obtained without a prescription. 
 
The amount of Trazec that you need may change if you take other medicines as these may cause your 
blood sugar levels to go up or down. 
 
It is especially important that you tell your doctor or pharmacist if you are taking: 
- Beta blockers or angiotensin-converting enzyme inhibitors (used, for example, to treat high 

blood pressure and certain heart conditions). 
- Diuretics (used in the treatment of high blood pressure). 
- Corticosteroids such as prednisone and cortisone (used to treat inflammatory disorders). 
- Inhibitors of drug metabolism such as fluconazole (used to treat fungal infection), gemfibrozil 

(used to treat dyslipidaemia) or sulfinpyrazone (used to treat chronic gout). 
Your doctor may adjust the dose of these medicines. 
 
Food, drink and exercise 
Take Trazec before meals (see section 3, “How to take Trazec”). Its effect may be delayed if it is taken 
during or after meals. 
 
Even though you are taking medicines for your diabetes, it is important to keep following the diet 
and/or exercise your doctor has recommended for you. 
 
Watch carefully for signs of low blood sugar, especially 
- if you have exercised more strenuously than usual. 
- if you have drunk alcohol. 
 
Alcohol may upset the control of your blood sugar so you are advised to talk to your doctor about 
drinking alcohol while taking Trazec. If you do get symptoms of low blood sugar, eat or drink 
something containing sugar and talk to your doctor. 
 
Trazec and older people 
Trazec can be used by people over 65 years of age. Take special care to avoid low blood sugar. 
 



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Trazec and children and adolescents 
Trazec is not recommended for children and adolescents (under 18 years of age) because its effects in 
this age group have not been studied. 
 
Pregnancy and breast-feeding 
Do not take Trazec if you are pregnant or planning to become pregnant. See your doctor as soon as 
possible if you become pregnant during treatment. 
 
Do not breast-feed during treatment with Trazec. 
 
Ask your doctor or pharmacist for advice before taking any medicine while you are pregnant or breast-
feeding. 
 
Driving and using machines 
You are advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly 
important if you have reduced or absent awareness of the warning signs of hypoglycaemia or if you 
have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these 
circumstances. 
 
Important information about some of the ingredients of Trazec 
Trazec tablets contain lactose monohydrate. If you have been told by your doctor that you have an 
intolerance to some sugars, contact your doctor before taking this medicinal product. 
 
 
3. HOW TO TAKE TRAZEC 
 
Always take Trazec exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are not sure. 
 
When to take Trazec 
Take Trazec before the three main meals, usually: 
- 1 dose before breakfast 
- 1 dose before lunch 
- 1 dose before dinner 
 
It is best to take it right before a main meal but you can take it up to 30 minutes before. 
 
Do not take it if you are not going to eat a main meal. If you miss a meal, skip that dose of Trazec and 
wait until your next meal. 
 
How much to take 
Take Trazec as your doctor told you to. Your doctor will determine the dosage you require. 
 
The usual dose of Trazec to start with is 60 mg before the three main meals. In some cases your doctor 
may prescribe higher doses. The recommended maximum daily dose is 180 mg three times daily to be 
taken before the three main meals. 
 
Swallow the tablets whole with a glass of water before the meal. 
 
How long to take Trazec 
Take Trazec daily until your doctor tells you to stop. 
 
If you take more Trazec than you should 
If you have accidentally taken too many tablets, talk to a doctor straight away. If you experience 
symptoms of low blood sugar – if you feel dizzy, light-headed, hungry, shaky, or any of the other 
signs in section 4, “Possible side effects” – eat or drink something containing sugar. 
 



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If you feel as if you are about to have a severe hypoglycaemic attack (which may lead to loss of 
consciousness or seizure), call for urgent medical help – or make sure that someone else does this for 
you. 
 
If you forget to take Trazec 
If you forget to take a tablet simply take the next one before your next meal. Do not take a double dose 
of Trazec to make up for the one that you missed. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Trazec can cause side effects, although not everybody gets them. The side effects 
caused by Trazec are usually mild to moderate. 
 
The most common side effects are symptoms of low blood sugar (hypoglycaemia), which are usually 
mild. These include 
- sweating, 
- dizziness, 
- shaking, 
- weakness, 
- hunger, 
- feeling your heart beating fast, 
- tiredness, 
- feeling sick (nausea). 
 
They can also be caused by lack of food or too high a dose of any anti-diabetic medicine you are 
taking. If you do get symptoms of low blood sugar, eat or drink something containing sugar. 
 
Abdominal pain, indigestion, diarrhoea, nausea and vomiting have been reported. 
 
Rare effects are mild abnormalities in liver function tests and allergic (hypersensitivity) reactions such 
as rash and itching. 
 
A very rare effect is skin rash with blisters affecting the lips, eyes, mouth, sometimes with headache, 
fever and/or diarrhoea. 
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist. 
 
 
5. HOW TO STORE TRAZEC 
 
Keep out of the reach and sight of children. 
Store in the original package. 
Do not use Trazec after the expiry date stated on the carton after EXP. The expiry date refers to the 
last day of that month. 
Do not use any Trazec pack that is damaged or shows signs of tampering. 
Do not store above 30°C. 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 



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6. FURTHER INFORMATION 
 
What Trazec contains 
- The active substance is nateglinide. 
- The other ingredients are lactose monohydrate; cellulose, microcrystalline; povidone; 

croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous. 
- The tablet coating contains hypromellose; titanium dioxide (E171); talc; macrogol and red (60 

and 180 mg tablets) or yellow (120 mg tablets) iron oxide (E172). 
 
What Trazec looks like and contents of the pack 
Trazec 60 mg film-coated tablets are pink, round tablets with “NVR” marked on one side and “TS” on 
the other. 
 
Trazec 120 mg film-coated tablets are yellow, ovaloid tablets with “NVR” marked on one side and 
“TSL” on the other. 
 
Trazec 180 mg film-coated tablets are red, ovaloid tablets with “NVR” marked on one side and “TSX” 
on the other. 
 
Each blister pack contains 12, 60, 84, 120 or 360 tablets. Not all pack sizes or tablet strengths may be 
available in your country. 
 
Marketing Authorisation Holder 
Novartis Europharm Limited 
Wimblehurst Road 
Horsham 
West Sussex, RH12 5AB 
United Kingdom 
 
Manufacturer 
Novartis Farma S.p.A. 
Via Provinciale Schito, 131 
I-80058 Torre Annunziata - Napoli 
Italy 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
België/Belgique/Belgien 
Novartis Pharma N.V. 
Tél/Tel: +32 2 246 16 11 
 

Luxembourg/Luxemburg 
Novartis Pharma GmbH 
Tél/Tel: +49 911 273 0 
 

България 
Novartis Pharma Services Inc. 
Тел.: +359 2 489 98 28 
 

Magyarország 
Novartis Hungária Kft. Pharma 
Tel.: +36 1 457 65 00 

Česká republika 
Novartis s.r.o. 
Tel: +420 225 775 111 
 

Malta 
Novartis Pharma Services Inc. 
Tel: +356 2298 3217 

Danmark 
Novartis Healthcare A/S 
Tlf: +45 39 16 84 00 
 

Nederland 
Novartis Pharma B.V. 
Tel: +31 26 37 82 111 

Deutschland 
Novartis Pharma GmbH 
Tel: +49 911 273 0 

Norge 
Novartis Norge AS 
Tlf: +47 23 05 20 00 



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Eesti 
Novartis Pharma Services Inc. 
Tel: +372 60 62 400 
 

Österreich 
Novartis Pharma GmbH 
Tel: +43 1 86 6570 

Ελλάδα 
Novartis (Hellas) A.E.B.E. 
Τηλ: +30 210 281 17 12 
 

Polska 
Novartis Poland Sp. z o.o. 
Tel.: +48 22 550 8888 

España 
Novartis Farmacéutica, S.A. 
Tel: +34 93 306 42 00 
 

Portugal 
Novartis Farma - Produtos Farmacêuticos, S.A. 
Tel: +351 21 000 8600 

France 
Novartis Pharma S.A.S. 
Tél: +33 1 55 47 66 00 
 

România 
Novartis Pharma Services Inc. 
Tel: +40 21 31299 01 

Ireland 
Novartis Ireland Limited 
Tel: +353 1 260 12 55 
 

Slovenija 
Novartis Pharma Services Inc. 
Tel: +386 1 300 75 77 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Novartis s.r.o. 
Tel: +421 2 5542 5439 
 

Italia 
Novartis Farma S.p.A. 
Tel: +39 02 96 54 1 

Suomi/Finland 
Novartis Finland Oy 
Puh/Tel: +358 9 61 33 22 11 
 

Κύπρος 
Δημητριάδης και Παπαέλληνας Λτδ 
Τηλ: +357 22 690 690 
 

Sverige 
Novartis Sverige AB 
Tel: +46 8 732 32 00 
 

Latvija 
Novartis Pharma Services Inc. 
Tel: +371 7 887 070 
 

United Kingdom 
Novartis Pharmaceuticals UK Ltd. 
Tel: +44 1276 698370 
 

Lietuva 
Novartis Pharma Services Inc. 
Tel: +370 5 269 16 50 
 

 

 
This leaflet was last approved in 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
	CONDITIONS OF THE MARKETING AUTHORISATION
	LABELLING
	PACKAGE LEAFLET
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{'Title': '2. before you take trazec', 'Section_Content': 'follow all instructions given to you by your doctor and pharmacist carefully, even if they are different from what is in this leaflet. do not take trazec - if you are allergic (hypersensitive) to nateglinide or any of the other ingredients of trazec. - if you have type 1 diabetes (i.e. your body does not produce any insulin). - if you know that you have a severe liver problem. - if you are pregnant or planning to become pregnant. - if you are breast-feeding. talk to your doctor if you have any further questions or you think that any of these may apply to you. take special care with trazec people with diabetes sometimes get symptoms of low blood sugar (also called hypoglycaemia). medicines, including trazec, may also produce symptoms of low blood sugar. if you get any of these symptoms feeling dizzy, light-headed, hungry, shaky or any of the other signs in section 4, "possible side effects" eat or drink something containing sugar. some people are more likely to get symptoms of low blood sugar than others. take care - if you are over 65 years of age. - if you are undernourished. - if you have another medical condition that may cause low blood sugar (e.g. an under-active pituitary or adrenal gland). if any of these apply to you, monitor your blood sugar levels more carefully. talk to your doctor - if you know that you have a liver problem. - if you have a severe kidney problem. - if you have problems of drug metabolism. - if you are due to have an operation. - if you have suffered a fever, an accident or an infection. your treatment may need to be adjusted. taking other medicines please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. the amount of trazec that you need may change if you take other medicines as these may cause your blood sugar levels to go up or down. it is especially important that you tell your doctor or pharmacist if you are taking: - beta blockers or angiotensin-converting enzyme inhibitors (used, for example, to treat high blood pressure and certain heart conditions). - diuretics (used in the treatment of high blood pressure). - corticosteroids such as prednisone and cortisone (used to treat inflammatory disorders). - inhibitors of drug metabolism such as fluconazole (used to treat fungal infection), gemfibrozil (used to treat dyslipidaemia) or sulfinpyrazone (used to treat chronic gout). your doctor may adjust the dose of these medicines. food, drink and exercise take trazec before meals (see section 3, "how to take trazec"). its effect may be delayed if it is taken during or after meals. even though you are taking medicines for your diabetes, it is important to keep following the diet and/or exercise your doctor has recommended for you. watch carefully for signs of low blood sugar, especially - if you have exercised more strenuously than usual. - if you have drunk alcohol. alcohol may upset the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking trazec. if you do get symptoms of low blood sugar, eat or drink something containing sugar and talk to your doctor. trazec and older people trazec can be used by people over 65 years of age. take special care to avoid low blood sugar. trazec and children and adolescents trazec is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied. pregnancy and breast-feeding do not take trazec if you are pregnant or planning to become pregnant. see your doctor as soon as possible if you become pregnant during treatment. do not breast-feed during treatment with trazec. ask your doctor or pharmacist for advice before taking any medicine while you are pregnant or breast- feeding. driving and using machines you are advised to take precautions to avoid hypoglycaemia whilst driving. this is particularly important if you have reduced or absent awareness of the warning signs of hypoglycaemia or if you have frequent episodes of hypoglycaemia. the advisability of driving should be considered in these circumstances. important information about some of the ingredients of trazec trazec tablets contain lactose monohydrate. if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.', 'Entity_Recognition': [{'Text': 'trazec', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 4, 'BeginOffset': 147, 'EndOffset': 153, 'Score': 0.24744601547718048, 'Text': 'trazec', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 167, 'EndOffset': 175}, {'Id': 9, 'BeginOffset': 177, 'EndOffset': 191, 'Score': 0.7305088639259338, 'Text': 'hypersensitive', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': []}, {'Id': 5, 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your doctor tells you to stop. if you take more trazec than you should if you have accidentally taken too many tablets, talk to a doctor straight away. if you experience symptoms of low blood sugar if you feel dizzy, light-headed, hungry, shaky, or any of the other signs in section 4, "possible side effects" eat or drink something containing sugar. if you feel as if you are about to have a severe hypoglycaemic attack (which may lead to loss of consciousness or seizure), call for urgent medical help or make sure that someone else does this for you. if you forget to take trazec if you forget to take a tablet simply take the next one before your next meal. do not take a double dose of trazec to make up for the one that you missed.', 'Entity_Recognition': [{'Text': 'trazec', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 138, 'EndOffset': 144, 'Score': 0.7459972500801086, 'Text': 'trazec', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [], 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, trazec can cause side effects, although not everybody gets them. the side effects caused by trazec are usually mild to moderate. the most common side effects are symptoms of low blood sugar (hypoglycaemia), which are usually mild. these include - sweating, - dizziness, - shaking, - weakness, - hunger, - feeling your heart beating fast, - tiredness, - feeling sick (nausea). they can also be caused by lack of food or too high a dose of any anti-diabetic medicine you are taking. if you do get symptoms of low blood sugar, eat or drink something containing sugar. abdominal pain, indigestion, diarrhoea, nausea and vomiting have been reported. rare effects are mild abnormalities in liver function tests and allergic (hypersensitivity) reactions such as rash and itching. a very rare effect is skin rash with blisters affecting the lips, eyes, mouth, sometimes with headache, fever and/or diarrhoea. if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'trazec', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Id': 6, 'BeginOffset': 20, 'EndOffset': 26, 'Score': 0.34380587935447693, 'Text': 'trazec', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 8, 'BeginOffset': 37, 'EndOffset': 49, 'Score': 0.9592241644859314, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6216953992843628}]}, {'Id': 9, 'BeginOffset': 89, 'EndOffset': 101, 'Score': 0.8712767362594604, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6483694911003113}]}, {'Id': 10, 'BeginOffset': 165, 'EndOffset': 177, 'Score': 0.8579558730125427, 'Text': 'side effects', 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{'Type': 'SYSTEM_ORGAN_SITE', 'Score': 0.9882931113243103, 'RelationshipScore': 0.9916765689849854, 'RelationshipType': 'SYSTEM_ORGAN_SITE', 'Id': 5, 'BeginOffset': 865, 'EndOffset': 870, 'Text': 'mouth', 'Category': 'ANATOMY', 'Traits': []}]}, {'Text': 'blisters affecting the lips', 'Type': 'PROBLEM', 'BeginOffset': 830, 'EndOffset': 857}, {'Id': 4, 'BeginOffset': 859, 'EndOffset': 863, 'Score': 0.9954264760017395, 'Text': 'eyes', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 5, 'BeginOffset': 865, 'EndOffset': 870, 'Score': 0.9882931113243103, 'Text': 'mouth', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 36, 'BeginOffset': 887, 'EndOffset': 895, 'Score': 0.9974073767662048, 'Text': 'headache', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9620528221130371}]}, {'Id': 37, 'BeginOffset': 897, 'EndOffset': 902, 'Score': 0.9958547949790955, 'Text': 'fever', 'Category': 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{'Title': '5. how to store trazec', 'Section_Content': 'keep out of the reach and sight of children. store in the original package. do not use trazec after the expiry date stated on the carton after exp. the expiry date refers to the last day of that month. do not use any trazec pack that is damaged or shows signs of tampering. do not store above 30. medicines should not be disposed of via wastewater or household waste. ask your pharmacist how to dispose of medicines no longer required. these measures will help to protect the environment.', 'Entity_Recognition': [{'Text': 'trazec', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'trazec', 'Type': 'TREATMENT', 'BeginOffset': 87, 'EndOffset': 93}, {'Text': 'any trazec pack', 'Type': 'TREATMENT', 'BeginOffset': 213, 'EndOffset': 228}, {'Text': 'tampering', 'Type': 'PROBLEM', 'BeginOffset': 263, 'EndOffset': 272}, {'Text': '30.', 'Type': 'NUMBER', 'BeginOffset': 293, 'EndOffset': 296}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 297, 'EndOffset': 306}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 406, 'EndOffset': 415}, {'Text': 'these measures', 'Type': 'TREATMENT', 'BeginOffset': 436, 'EndOffset': 450}]}
{'Title': '6. further information', 'Section_Content': 'what trazec contains - the active substance is nateglinide. - the other ingredients are lactose monohydrate; cellulose, microcrystalline; povidone; croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous. - the tablet coating contains hypromellose; titanium dioxide (e171); talc; macrogol and red (60 and 180 mg tablets) or yellow (120 mg tablets) iron oxide (e172). what trazec looks like and contents of the pack trazec 60 mg film-coated tablets are pink, round tablets with "nvr" marked on one side and "ts" on the other. trazec 120 mg film-coated tablets are yellow, ovaloid tablets with "nvr" marked on one side and "tsl" on the other. trazec 180 mg film-coated tablets are red, ovaloid tablets with "nvr" marked on one side and "tsx" on the other. each blister pack contains 12, 60, 84, 120 or 360 tablets. not all pack sizes or tablet strengths may be available in your country.', 'Entity_Recognition': [{'Text': 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