Starlix
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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 



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1. NAME OF THE MEDICINAL PRODUCT 

 

STARLIX 60 mg film-coated tablets 

STARLIX 120 mg film-coated tablets 

STARLIX 180 mg film-coated tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

STARLIX 60 mg film-coated tablets 

 

Each film-coated tablet contains 60 mg nateglinide. 

 

Excipient with known effect 

Lactose monohydrate: 141.5 mg per tablet. 

 

STARLIX 120 mg film-coated tablets 

 

Each film-coated tablet contains 120 mg nateglinide. 

 

Excipient with known effect 

Lactose monohydrate: 283 mg per tablet. 

 

STARLIX 180 mg film-coated tablets 

 

Each film-coated tablet contains 180 mg nateglinide. 

 

Excipient with known effect 

Lactose monohydrate: 214 mg per tablet. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Film-coated tablet. 

 

STARLIX 60 mg film-coated tablets 

 

60 mg pink, round, bevelled-edge tablets with “STARLIX” marked on one side and “60” on the other. 

 

STARLIX 120 mg film-coated tablets 

 

120 mg yellow, ovaloid tablets with “STARLIX” marked on one side and “120” on the other. 

 

STARLIX 180 mg film-coated tablets 

 

180 mg red, ovaloid tablets with “STARLIX” marked on one side and “180” 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. 



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4.2 Posology and method of administration 

 

Posology 

 

Adults 

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 Starlix is to reduce mealtime glucose (a contributor to HbA1c), 

the therapeutic response to Starlix 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. 

 

Special populations 

 

Elderly 

The clinical experience in patients over 75 years of age is limited. 

 

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. 

 

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. 

 

Paediatric population 

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. 

 

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 

 

Starlix is contraindicated in patients with: 

 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 

 Type 1 diabetes (C-peptide negative) 

 Diabetic ketoacidosis, with or without coma 

 Pregnancy and breast-feeding (see section 4.6) 

 Severe hepatic impairment 



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4.4 Special warnings and precautions for use 

 

General 

 

Nateglinide should not be used in monotherapy. 

 

Hypoglycaemia 

 

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. 

 

Patients with severe renal impairment (see section 5.2) who have not undergone haemodialysis are 

more susceptible to the glucose-lowering effect of Starlix. Discontinuation should be considered in 

patients with severe renal impairment who present with potentiation of the hypoglycaemic effect. 

 

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. 

 

Excipients 

 

Starlix 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. 

 

Special populations 
 

Hepatic impairment 

Nateglinide should be used with caution in patients with moderate hepatic impairment. 

 

Severe hepatic impairment, children and adolescents 

No clinical studies have been conducted in patients with severe hepatic impairment, or in children and 

adolescents. Treatment is therefore not recommended in these patient groups. 

 

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. 

 

Combination with ACE-inhibitors, NSAIDs, salicylates, monoamine oxidase inhibitors, non-selective 

beta-adrenergic-blocking agents and anabolic hormones 

 

The following agents may enhance the hypoglycaemic effect of nateglinide: angiotensin-converting 

enzyme inhibitors (ACEI), non-steroidal anti-inflammatory agents, salicylates, monoamine oxidase 



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inhibitors, non-selective beta-adrenergic-blocking agents and anabolic hormones (e.g. 

methandrostenolone). 

 

Diuretics, corticosteroids, beta2 agonists, somatropin, somatostatin analogues, rifampin, phenytoin and 

St. John’s Wort (Hypericum perforatum) 

 

The following agents may reduce the hypoglycaemic effect of nateglinide: diuretics, corticosteroids, 

beta2 agonists, somatropin, somatostatin analogues (e.g. lanreotide, octreotide), rifampin, phenytoin 

and St. John’s Wort (Hypericum perforatum). 

 

When these medicinal products - that enhance or reduce the hypoglycaemic effect of nateglinide - are 

administered to or withdrawn from patients receiving nateglinide, the patient should be observed 

closely for changes in glycaemic control. 

 

CYP2C9 and CYP3A4 substrates 

 

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, gemfibrozil or sulfinpyrazone), or in patients known to be 

poor metabolisers for CYP2C9 substrates. 

 

Interaction studies with a CYP3A4 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 Starlix. Similarly, there was no clinically 

significant pharmacokinetic interaction of Starlix 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 Fertility, pregnancy and lactation 

 

Pregnancy 

 

Studies in animals have shown developmental toxicity (see section 5.3). There is no experience in 

pregnant women, therefore the safety of Starlix in pregnant women cannot be assessed. Starlix, like 

other oral antidiabetic agents, must not be used in pregnancy. 

 

Breast-feeding 

 

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. 

 



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Fertility 

 

Nateglinide did not impair fertility in male or female rats (see section 5.3). 

 

4.7 Effects on ability to drive and use machines 

 

The effect of Starlix on the ability to drive or operate machinery has not been studied. 

 

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. 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. 

 

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: very common (1/10); common (1/100 to 

<1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000); not 

known (cannot be estimated from the available data). 

 

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. 

 

Gastrointestinal 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 Starlix-treated and 

placebo-treated patients. 

 

Post-marketing experience 

 

Post-marketing data revealed very rare cases of erythema multiforme. 

 



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Reporting of suspected adverse reactions 

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 
 

4.9 Overdose 

 

In a clinical study in patients, Starlix 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 Starlix 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 

 

Mechanism of action 

 

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, 

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. 

 

Pharmacodynamic effects 

 

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. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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Clinical efficacy and safety 

 

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 

 

Nateglinide is rapidly absorbed following oral administration of Starlix 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%. 

 

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 g Starlix/ml. 

 

Biotransformation 

 

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 

metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent. 

 

Elimination 

 

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 [
14

C] 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 

Starlix 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. 

 

Linearity/non-linearity 

 

In patients with type 2 diabetes who were given Starlix with a dose range of 60 mg to 240 mg before 

meals three times a day for one week, nateglinide showed linear pharmacokinetics for both AUC and 

Cmax. Tmax was independent of dose. 

 



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Special 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. 

 

Repeated dosing with 90 mg once daily for 1 to 3 months in diabetic patients with end-stage renal 

disease (ESRD) showed pronounced M1 metabolite accumulation up to 1.2 ng/ml despite the reduced 

dose. M1 concentration decreased markedly after haemodialysis. Although M1 metabolites show only 

slight hypoglycaemic activity (approximately 5 times lower than nateglinide), metabolite 

accumulation might increase the hypoglycaemic effect of the administered dose. Therefore, dose 

discontinuation is advisable in patients with severe renal impairment who present with potentiation of 

hypoglycaemic effect while on Starlix. 
 

Gender 

No clinically significant differences in nateglinide pharmacokinetics were observed between men and 

women. 
 

Pharmacokinetic/pharmacodynamic relationship(s) 

 

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 Starlix 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. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal 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, embryonic development 

was adversely affected and the incidence of gallbladder agenesis or small gallbladder was increased at 

doses of 300 and 500 mg/kg (approximately 24 and 28 times the human therapeutic exposure with a 

maximum recommended nateglinide dose of 180 mg, three times daily before meals), but not at 

150 mg/kg (approximately 17 times the human therapeutic exposure with a maximum recommended 

nateglinide dose of 180 mg, three times daily before meals). 

 

 



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6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

STARLIX 60 mg film-coated tablets 

 

Lactose monohydrate 

Cellulose, microcrystalline 

Povidone 

Croscarmellose sodium 

Magnesium stearate 

Red iron oxide (E172) 

Hypromellose 

Titanium dioxide (E171) 

Talc 

Macrogol 

Silica, colloidal anhydrous 

 

STARLIX 120 mg film-coated tablets 

 

Lactose monohydrate 

Cellulose, microcrystalline 

Povidone 

Croscarmellose sodium 

Magnesium stearate 

Yellow iron oxide (E172) 

Hypromellose 

Titanium dioxide (E171) 

Talc 

Macrogol 

Silica, colloidal anhydrous 

 

STARLIX 180 mg film-coated tablets 

 

Lactose monohydrate 

Cellulose, microcrystalline 

Povidone 

Croscarmellose sodium 

Magnesium stearate 

Red iron oxide (E172) 

Hypromellose 

Titanium dioxide (E171) 

Talc 

Macrogol 

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. 



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Store in the original package. 

 

6.5 Nature and contents of container 

 

Blisters: PVC/PE/PVDC blisters, backed with a heat-sealable lacquered aluminium foil. 

 

Packs contain 12, 24, 30, 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 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

STARLIX 60 mg film-coated tablets 

 

EU/1/01/174/001-007 

 

STARLIX 120 mg film-coated tablets 

 

EU/1/01/174/008-014 

 

STARLIX 180 mg film-coated tablets 

 

EU/1/01/174/015-021 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 03 April 2001 

Date of latest renewal: 24 April 2006 

 

 

10. DATE OF REVISION OF THE TEXT 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu 

http://www.ema.europa.eu/


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ANNEX II 

 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 



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A. MANUFACTURER 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 OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to medical prescription. 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

 Periodic Safety Update Reports 
 

The requirements for submission of periodic safety update reports for this medicinal product are set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and any subsequent updates published on the European medicines web-portal. 

 

 

D. 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 



15 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Starlix 60 mg film-coated tablets 

nateglinide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each film-coated tablet contains 60 mg nateglinide. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose monohydrate. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablet 

 

12 film-coated tablets 

24 film-coated tablets 

30 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 

 

Read the package leaflet before use. 

Oral use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



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9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

Store in the original package. 

 

 

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 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/01/174/001 12 film-coated tablets 

EU/1/01/174/002 24 film-coated tablets 

EU/1/01/174/003 30 film-coated tablets 

EU/1/01/174/004 60 film-coated tablets 

EU/1/01/174/005 84 film-coated tablets 

EU/1/01/174/006 120 film-coated tablets 

EU/1/01/174/007 360 film-coated tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Starlix 60 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



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18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Starlix 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 

 

Starlix 120 mg film-coated tablets 

nateglinide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each film-coated tablet contains 120 mg nateglinide. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose monohydrate. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablet 

 

12 film-coated tablets 

24 film-coated tablets 

30 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 

 

Read the package leaflet before use. 

Oral use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



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9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

Store in the original package. 

 

 

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 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/01/174/008 12 film-coated tablets 

EU/1/01/174/009 24 film-coated tablets 

EU/1/01/174/010 30 film-coated tablets 

EU/1/01/174/011 60 film-coated tablets 

EU/1/01/174/012 84 film-coated tablets 

EU/1/01/174/013 120 film-coated tablets 

EU/1/01/174/014 360 film-coated tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Starlix 120 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



22 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



23 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Starlix 120 mg tablets 

nateglinide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 



24 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Starlix 180 mg film-coated tablets 

nateglinide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each film-coated tablet contains 180 mg nateglinide. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose monohydrate. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablet 

 

12 film-coated tablets 

24 film-coated tablets 

30 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 

 

Read the package leaflet before use. 

Oral use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



25 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

Store in the original package. 

 

 

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 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/01/174/015 12 film-coated tablets 

EU/1/01/174/016 24 film-coated tablets 

EU/1/01/174/017 30 film-coated tablets 

EU/1/01/174/018 60 film-coated tablets 

EU/1/01/174/019 84 film-coated tablets 

EU/1/01/174/020 120 film-coated tablets 

EU/1/01/174/021 360 film-coated tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Starlix 180 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



26 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 



27 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Starlix 180 mg tablets 

nateglinide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 



28 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 
 



29 

Package leaflet: Information for the user 

 

Starlix 60 mg film-coated tablets 

Starlix 120 mg film-coated tablets 

Starlix 180 mg film-coated tablets 

nateglinide 

 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet: 
1. What Starlix is and what it is used for 

2. What you need to know before you take Starlix 

3. How to take Starlix 

4. Possible side effects 

5. How to store Starlix 

6. Contents of the pack and other information 

 

 

1. What Starlix is and what it is used for 

 

What Starlix is 

The active substance of Starlix, nateglinide, belongs to a group of medicines called oral antidiabetics. 

 

Starlix is used to treat adult patients with type 2 diabetes. It helps to control the level of sugar in the 

blood. Your doctor will prescribe Starlix together with metformin, if inadequately controlled despite a 

maximally tolerated dose of metformin. 

 

How Starlix works 
Insulin is a substance produced in the body by the pancreas. It helps to decrease blood sugar levels, 

especially after meals. If you have type 2 diabetes, your body may not start producing insulin quickly 

enough after meals. Starlix works by stimulating the pancreas to produce insulin more quickly, which 

helps to keep blood sugar levels under control after meals. 

 

Starlix tablets start to act within a very short time after they are swallowed and are eliminated from the 

body rapidly. 

 

 

2. What you need to know before you take Starlix 

 

Follow all instructions given to you by your doctor, pharmacist or nurse carefully, even if they are 

different from what is in this leaflet. 

 

Do not take Starlix 

- if you are allergic to nateglinide or any of the other ingredients of this medicine (listed in 
section 6). 

- if you have type 1 diabetes (i.e. your body does not produce any insulin). 
- if you are experiencing any symptoms of severe hyperglycaemia (very high blood sugar and/or 

diabetic ketoacidosis). These symptoms include excessive thirst, frequent urination, weakness, 

fatigue, nausea, shortness of breath or confusion. 



30 

- if you know that you have a severe liver problem. 
- if you are pregnant or planning to become pregnant. 
- if you are breast-feeding. 

If any of these apply to you, do not take Starlix and talk to your doctor. 
 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before taking Starlix. 

Diabetic patients may develop symptoms associated with low blood sugar (also called 

hypoglycaemia). Oral antidiabetics, including Starlix, may also produce symptoms of hypoglycaemia. 

 

If you have low blood sugar you may experience sweating, tremors (feeling shaky), anxiety, difficulty 

concentrating, confusion, weakness or fainting or have other signs listed in section 4, “Possible side 

effects”. 

 

If this happens to you, eat or drink something containing sugar, and talk to your doctor. 
 

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. 

 

Watch carefully for signs of low blood sugar, especially: 

- if you have exercised more strenuously than usual. 
- if you have drunk alcohol. 
 

Talk to your doctor before taking Starlix 

- if you know that you have a liver problem. 
- if you have a severe kidney problem. 
- if you have problems with drug metabolism. 
- if you are due to have an operation. 
- if you have recently suffered a fever, an accident or an infection. 
Your treatment may need to be adjusted. 

 

Children and adolescents 

Starlix is not recommended for children and adolescents (under 18 years of age) because its effects in 

this age group have not been studied. 

 

Elderly 

Starlix can be used by people over 65 years of age. Such patients should take special care to avoid low 

blood sugar. 

 

Other medicines and Starlix 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

The amount of Starlix 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, pharmacist or nurse if you are taking: 

- Non-steroidal anti-inflammatory agents (used, for example, to treat muscle and joint pain). 
- Salicylates such as aspirin (used as painkillers). 
- Monoamine oxidase inhibitors (used to treat depression). 
- Beta blockers or ACE inhibitors (angiotensin-converting enzyme inhibitors) (used, for example, 

to treat high blood pressure and certain heart conditions). 

- Diuretics (used to treat high blood pressure). 



31 

- 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). 

- Sympathomimetics (used, for example, to treat asthma). 
- Anabolic hormones (e.g. methandrostenolone). 
- St. John’s Wort, also known as Hypericum perforatum (a herbal medicine). 
- Somatropin (a growth hormone). 
- Somatostatin analogues such as lanreotide and octreotide (used to treat acromegaly). 
- Rifampin (used, for example, to treat tuberculosis). 
- Phenytoin (used, for example, to treat seizures). 
Your doctor may adjust the dose of these medicines. 

 

Starlix with food, drink and alcohol 

Take Starlix before meals (see section 3, “How to take Starlix”); its effect may be delayed if it is taken 

during or after meals. 

 

Alcohol may disturb the control of your blood sugar so you are advised to talk to your doctor about 

drinking alcohol while taking Starlix. 

 

Pregnancy, breast-feeding and fertility 

Do not take Starlix 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 Starlix. 

 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor, pharmacist or nurse for advice before taking this medicine. 

 

Driving and using machines 

Your ability to concentrate or react may be reduced if you have low blood sugar (hypoglycaemia). 

Bear this in mind if you drive a car or operate machines as you might put yourself or others at risk. 

 

You should ask for doctor advice on driving if you have frequent episodes of hypoglycaemia or if you 

are not aware of the first signs of hypoglycaemia. 

 

Starlix contains lactose 

Starlix 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 medicine. 

 

 

3. How to take Starlix 

 

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your 

doctor, pharmacist or nurse if you are not sure. 

 

The recommended starting dose of Starlix is 60 mg three times daily, taken before each of the three 

main meals. Your doctor may check the amount of Starlix that you are taking on a regular basis and 
may adjust the dose according to your needs. The maximum recommended dose is 180 mg three times 

daily, taken before each of the three main meals. 

 

Take Starlix before meals. Its effect may be delayed if it is taken during or after meals. 

Take Starlix 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. 



32 

 

Do not take it if you are not going to eat a main meal. If you miss a meal, skip that dose of Starlix and 

wait until your next meal. 

 

Swallow the tablets whole with a glass of water. 

 

Even though you are taking medicines for your diabetes, it is important to keep following the diet 

and/or exercise programme your doctor has recommended for you. 

 

If you take more Starlix than you should 

If you have accidentally taken too many tablets, or if someone else takes your tablets, talk to a doctor 

or pharmacist immediately. Medical attention may be necessary. If you experience symptoms of low 

blood sugar (listed 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 have to go to a doctor or hospital, take the pack and this leaflet with you. 

 

If you forget to take Starlix 

If you forget to take a tablet, simply take the next one before your next meal. Do not take a double 

dose to make up for a forgotten dose. 

 

If you stop taking Starlix 

Continue to take this medicine as long as your doctor prescribes it so that it can continue to control 

your blood sugar. Do not stop taking Starlix unless your doctor tells you to. 

 

If you have any further questions on the use of this medicine, talk to your doctor, pharmacist or nurse. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

The side effects caused by Starlix are usually mild to moderate. 

 

Common (may affect up to 1 in 10 people): 

These 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) 
 

These symptoms 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. 

 

Other side effects may include: 

 Common (may affect up to 1 in 10 people): abdominal pain, indigestion, diarrhoea, nausea 

 Uncommon (may affect up to 1 in 100 people): vomiting 

 Rare (may affect up to 1 in 1,000 people): mild abnormalities in liver function tests, allergic 
(hypersensitivity) reactions such as rash and itching 

 Very rare (may affect up to 1 in 10,000 people): skin rash with blisters affecting the lips, eyes 



33 

and/or mouth, sometimes with headache, fever and/or diarrhoea 

 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Starlix 

 

Keep this medicine out of the sight and reach of children. 

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date 

refers to the last day of that month. 

Store in the original package. 

Do not store above 30°C. 

Do not use any Starlix pack that is damaged or shows signs of tampering. 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Starlix contains 
- The active substance is nateglinide. Each tablet contains 60, 120 or 180 mg 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 Starlix looks like and contents of the pack 
Starlix 60 mg film-coated tablets are pink, round tablets with “STARLIX” marked on one side and 

“60” on the other. 

 

Starlix 120 mg film-coated tablets are yellow, ovaloid tablets with “STARLIX” marked on one side 

and “120” on the other. 

 

Starlix 180 mg film-coated tablets are red, ovaloid tablets with “STARLIX” marked on one side and 

“180” on the other. 

 

Each blister pack contains 12, 24, 30, 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 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Farma S.p.A. 

Via Provinciale Schito, 131 

I-80058 Torre Annunziata - Napoli 

Italy 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


34 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA „Novartis Baltics“ Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 976 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 26 37 82 111 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

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 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia 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 (0)10 6133 200 

 



35 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA “Novartis Baltics” 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

This leaflet was last revised in 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency website: 

http://www.ema.europa.eu 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you take starlix', 'Section_Content': 'follow all instructions given to you by your doctor, pharmacist or nurse carefully, even if they are different from what is in this leaflet. do not take starlix - if you are allergic to nateglinide or any of the other ingredients of this medicine (listed in section 6). - if you have type 1 diabetes (i.e. your body does not produce any insulin). - if you are experiencing any symptoms of severe hyperglycaemia (very high blood sugar and/or diabetic ketoacidosis). these symptoms include excessive thirst, frequent urination, weakness, fatigue, nausea, shortness of breath or confusion. - if you know that you have a severe liver problem. - if you are pregnant or planning to become pregnant. - if you are breast-feeding. if any of these apply to you, do not take starlix and talk to your doctor. warnings and precautions talk to your doctor, pharmacist or nurse before taking starlix. diabetic patients may develop symptoms associated with low blood sugar (also called hypoglycaemia). oral antidiabetics, including starlix, may also produce symptoms of hypoglycaemia. if you have low blood sugar you may experience sweating, tremors (feeling shaky), anxiety, difficulty concentrating, confusion, weakness or fainting or have other signs listed in section 4, "possible side effects". if this happens to you, eat or drink something containing sugar, and talk to your doctor. 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. watch carefully for signs of low blood sugar, especially: - if you have exercised more strenuously than usual. - if you have drunk alcohol. talk to your doctor before taking starlix - if you know that you have a liver problem. - if you have a severe kidney problem. - if you have problems with drug metabolism. - if you are due to have an operation. - if you have recently suffered a fever, an accident or an infection. your treatment may need to be adjusted. children and adolescents starlix is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied. elderly starlix can be used by people over 65 years of age. such patients should take special care to avoid low blood sugar. other medicines and starlix tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. the amount of starlix 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, pharmacist or nurse if you are taking: - non-steroidal anti-inflammatory agents (used, for example, to treat muscle and joint pain). - salicylates such as aspirin (used as painkillers). - monoamine oxidase inhibitors (used to treat depression). - beta blockers or ace inhibitors (angiotensin-converting enzyme inhibitors) (used, for example, to treat high blood pressure and certain heart conditions). - diuretics (used to treat 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). - sympathomimetics (used, for example, to treat asthma). - anabolic hormones (e.g. methandrostenolone). - st. john\'s wort, also known as hypericum perforatum (a herbal medicine). - somatropin (a growth hormone). - somatostatin analogues such as lanreotide and octreotide (used to treat acromegaly). - rifampin (used, for example, to treat tuberculosis). - phenytoin (used, for example, to treat seizures). your doctor may adjust the dose of these medicines. starlix with food, drink and alcohol take starlix before meals (see section 3, "how to take starlix"); its effect may be delayed if it is taken during or after meals. alcohol may disturb the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking starlix. pregnancy, breast-feeding and fertility do not take starlix 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 starlix. if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. driving and using machines your ability to concentrate or react may be reduced if you have low blood sugar (hypoglycaemia). bear this in mind if you drive a car or operate machines as you might put yourself or others at risk. you should ask for doctor advice on driving if you have frequent episodes of hypoglycaemia or if you are not aware of the first signs of hypoglycaemia. starlix contains lactose starlix 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 medicine.', 'Entity_Recognition': [{'Text': 'starlix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 3, 'BeginOffset': 153, 'EndOffset': 160, 'Score': 0.5138441920280457, 'Text': 'starlix', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 174, 'EndOffset': 182}, {'Id': 4, 'BeginOffset': 186, 'EndOffset': 197, 'Score': 0.9842026233673096, 'Text': 'nateglinide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 233, 'EndOffset': 246}, {'Id': 12, 'BeginOffset': 284, 'EndOffset': 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{'Title': '3. how to take starlix', 'Section_Content': 'always take this medicine exactly as your doctor, pharmacist or nurse has told you. check with your doctor, pharmacist or nurse if you are not sure. the recommended starting dose of starlix is 60 mg three times daily, taken before each of the three main meals. your doctor may check the amount of starlix that you are taking on a regular basis and may adjust the dose according to your needs. the maximum recommended dose is 180 mg three times daily, taken before each of the three main meals. take starlix before meals. its effect may be delayed if it is taken during or after meals. take starlix 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 starlix and wait until your next meal. swallow the tablets whole with a glass of water. even though you are taking medicines for your diabetes, it is important to keep following the diet and/or exercise programme your doctor has recommended for you. if you take more starlix than you should if you have accidentally taken too many tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately. medical attention may be necessary. if you experience symptoms of low blood sugar (listed 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 have to go to a doctor or hospital, take the pack and this leaflet with you. if you forget to take starlix if you forget to take a tablet, simply take the next one before your next meal. do not take a double dose to make up for a forgotten dose. 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. the side effects caused by starlix are usually mild to moderate. common (may affect up to 1 in 10 people): these 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) these symptoms 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. other side effects may include: common (may affect up to 1 in 10 people): abdominal pain, indigestion, diarrhoea, nausea uncommon (may affect up to 1 in 100 people): vomiting rare (may affect up to 1 in 1,000 people): mild abnormalities in liver function tests, allergic (hypersensitivity) reactions such as rash and itching very rare (may affect up to 1 in 10,000 people): skin rash with blisters affecting the lips, eyes 33 and/or mouth, sometimes with headache, fever and/or diarrhoea reporting of side effects if you get any side effects, talk to your doctor, pharmacist or nurse. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.', 'Entity_Recognition': [{'Text': 'starlix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 9, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9658887982368469, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7406846880912781}]}, {'Text': 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{'Title': '5. how to store starlix', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the carton after exp. the expiry date refers to the last day of that month. store in the original package. do not store above 30. do not use any starlix pack that is damaged or shows signs of tampering. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': [{'Text': 'starlix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': '30.', 'Type': 'NUMBER', 'BeginOffset': 251, 'EndOffset': 254}, {'Text': 'any starlix pack', 'Type': 'TREATMENT', 'BeginOffset': 266, 'EndOffset': 282}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what starlix contains - the active substance is nateglinide. each tablet contains 60, 120 or 180 mg 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 starlix looks like and contents of the pack starlix 60 mg film-coated tablets are pink, round tablets with "starlix" marked on one side and "60" on the other. starlix 120 mg film-coated tablets are yellow, ovaloid tablets with "starlix" marked on one side and "120" on the other. starlix 180 mg film-coated tablets are red, ovaloid tablets with "starlix" marked on one side and "180" on the other. each blister pack contains 12, 24, 30, 60, 84, 120 or 360 tablets. not all pack sizes or tablet strengths may be available in your country.', 'Entity_Recognition': [{'Text': 'starlix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 5, 'EndOffset': 12, 'Score': 0.2877004146575928, 'Text': 'starlix', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.5988049507141113, 'RelationshipScore': 0.5858248472213745, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 66, 'EndOffset': 72, 'Text': 'tablet', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 1, 'BeginOffset': 48, 'EndOffset': 59, 'Score': 0.9875401258468628, 'Text': 'nateglinide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.5988049507141113, 'RelationshipScore': 0.9999140501022339, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 66, 'EndOffset': 72, 'Text': 'tablet', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9212114810943604, 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{'Text': 'the tablet coating', 'Type': 'TREATMENT', 'BeginOffset': 278, 'EndOffset': 296}, {'Text': 'hypromellose; titanium dioxide', 'Type': 'TREATMENT', 'BeginOffset': 306, 'EndOffset': 336}, {'Text': 'talc', 'Type': 'TREATMENT', 'BeginOffset': 345, 'EndOffset': 349}, {'Id': 16, 'BeginOffset': 351, 'EndOffset': 359, 'Score': 0.8462395071983337, 'Text': 'macrogol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.9905422329902649, 'RelationshipScore': 0.9732232093811035, 'RelationshipType': 'FORM', 'Id': 21, 'BeginOffset': 410, 'EndOffset': 417, 'Text': 'tablets', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 17, 'BeginOffset': 364, 'EndOffset': 367, 'Score': 0.29338887333869934, 'Text': 'red', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.5727274417877197, 'RelationshipScore': 0.999975323677063, 'RelationshipType': 'DOSAGE', 'Id': 18, 'BeginOffset': 369, 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