Azarga
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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 

AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

One ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate). 

 

Excipient with known effect: 

 

One ml of suspension contains 0.10 mg benzalkonium chloride. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Eye drops, suspension (eye drops) 

 

White to off-white uniform suspension, pH 7.2 (approximately). 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 

 

Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular 

hypertension for whom monotherapy provides insufficient IOP reduction (see section 5.1). 

 

4.2 Posology and method of administration 

 

Posology 

 

Use in adults, including the elderly 

The dose is one drop of AZARGA in the conjunctival sac of the affected eye(s) twice daily. 

 

When using nasolacrimal occlusion or closing the eyelids, the systemic absorption is reduced. This 

may result in a decrease in systemic side effects and an increase in local activity (see section 4.4). 

 

If a dose is missed, treatment should be continued with the next dose as planned. The dose should not 

exceed one drop in the affected eye (s) twice daily. 

 

When substituting another ophthalmic antiglaucoma medicinal product with AZARGA, the other 

medicinal product should be discontinued and AZARGA should be started the following day. 

 

Special populations 

 

Paediatric population 

The safety and efficacy of AZARGA in children and adolescents aged 0 to 18 years have not yet been 

established. No data are available. 

 

Hepatic and renal impairment 

No studies have been conducted with AZARGA or with timolol 5 mg/ml eye drops in patients with 

hepatic or renal impairment. No dosage adjustment is necessary in patients with hepatic impairment or 

in patients with mild to moderate renal impairment. 



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AZARGA has not been studied in patients with severe renal impairment (creatinine 

clearance <30 ml/min) or in patients with hyperchloraemic acidosis (see section 4.3). Since 

brinzolamide and its main metabolite are excreted predominantly by the kidney, AZARGA is therefore 

contraindicated in patients with severe renal impairment (see section 4.3). 

 

AZARGA should be used with caution in patients with severe hepatic impairment (see section 4.4). 

 

Method of administration 

 

For ocular use. 

 

Patients should be instructed to shake the bottle well before use. After cap is removed, if tamper 

evident snap collar is loose, remove before using product. 

 

To prevent contamination of the dropper tip and the suspension, care must be taken not to touch the 

eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Instruct patients to keep 

the bottle tightly closed when not in use. 

 

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be 

administered at least 5 minutes apart. Eye ointments should be administered last. 

 

4.3 Contraindications 

 

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

 Hypersensitivity to other beta-blockers. 

 Hypersensitivity to sulphonamides (see section 4.4). 

 Reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe 
chronic obstructive pulmonary disease. 

 Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree 
atrioventricular block not controlled with pace-maker. Overt cardiac failure, cardiogenic shock. 

 Severe allergic rhinitis 

 Hyperchloraemic acidosis (see section 4.2). 

 Severe renal impairment. 
 

4.4 Special warnings and precautions for use 
 

Systemic effects 

 

 Brinzolamide and timolol are absorbed systemically. Due to the beta-adrenergic blocking 
component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions 

seen with systemic beta-adrenergic blocking agents may occur. The incidence of systemic 

adverse reactions after topical ophthalmic administration is lower than for systemic 

administration. To reduce the systemic absorption, see section 4.2. 

 Hypersensitivity reactions common to all sulphonamide derivates can occur in patients 
receiving AZARGA as it is absorbed systemically. 

 

Cardiac disorders 

 

In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac 

failure) and hypotension, therapy with beta-blockers should be critically assessed and the therapy with 

other active substances should be considered. Patients with cardiovascular diseases should be watched 

for signs of deterioration of these diseases and of adverse reactions. 

 

Due to its negative effect on conduction time, beta-blockers should only be given with caution to 

patients with first degree heart block. 

 



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Vascular disorders 

 

Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud’s 

disease or Raynaud’s syndrome) should be treated with caution. 

 

Hyperthyroidism 

 

Beta-blockers may also mask the signs of hyperthyroidism. 

 

Muscle weakness 

 

Beta-adrenergic blocking medicinal products have been reported to potentiate muscle weakness 

consistent with certain myasthenic symptoms (e.g. diplopia, ptosis and generalised weakness). 

 

Respiratory disorders 

 

Respiratory reactions, including death due to bronchospasm in patients with asthma have been 

reported following administration of some ophthalmic beta-blockers. AZARGA should be used with 

caution, in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the 

potential benefit outweighs the potential risk. 

 

Hypoglycaemia/diabetes 

 

Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia 

or to patients with labile diabetes, as beta-blockers may mask the signs and symptoms of acute 

hypoglycaemia. 

 

Acid/base disturbances 

 

AZARGA contains brinzolamide, a sulphonamide. The same types of adverse reactions that are 

attributable to sulphonamides may occur with topical administration. Acid-base disturbances have 

been reported with oral carbonic anhydrase inhibitors. This medicinal product should be used with 

caution in patients with risk of renal impairment because of the possible risk of metabolic acidosis. If 

signs of serious reactions or hypersensitivity occur, discontinue the use of this medicinal product. 

 

Mental alertness 

 

Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness 

and/or physical coordination. AZARGA is absorbed systemically and therefore this may occur with 

topical administration. 

 

Anaphylactic reactions 

 

While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction 

to a variety of allergens may be more reactive to repeated challenge with such allergens and 

unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions. 

 

Choroidal detachment 

 

Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. 

timolol, acetazolamide) after filtration procedures. 

 

Surgical anaesthesia 

 

Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. of 

adrenaline. The anaesthesiologist should be informed when the patient is receiving timolol. 

 



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Concomitant therapy 

 

The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated 

when timolol is given to the patients already receiving a systemic beta-blocking agent. The response of 

these patients should be closely observed. The use of two topical beta-adrenergic blocking agents or 

two local carbonic anhydrase inhibitors is not recommended (see section 4.5). 

 

There is potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition 

in patients receiving an oral carbonic anhydrase inhibitor and AZARGA. The concomitant 

administration of AZARGA and oral carbonic anhydrase inhibitors has not been studied and is not 

recommended (see section 4.5). 

 

Ocular effects 

 

There is limited experience with AZARGA in the treatment of patients with pseudoexfoliative 

glaucoma or pigmentary glaucoma. Caution should be utilised in treating these patients and close 

monitoring of IOP is recommended. 

 

AZARGA has not been studied in patients with narrow-angle glaucoma and its use is not 

recommended in these patients. 

 

Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated 

with caution. 

 

The possible role of brinzolamide on corneal endothelial function has not been investigated in patients 

with compromised corneas (particularly in patients with low endothelial cell count). Specifically, 

patients wearing contact lenses have not been studied and careful monitoring of these patients when 

using brinzolamide is recommended, since carbonic anhydrase inhibitors may affect corneal hydration. 

This may lead to a corneal decompensation and oedema and wearing contact lenses might increase the 

risk for the cornea. Careful monitoring of patients with compromised corneas, such as patients with 

diabetes mellitus or corneal dystrophies, is recommended. 

 

AZARGA may be used while wearing contact lenses with careful monitoring (see below under 

‘Benzalkonium chloride’). 

 

Benzalkonium chloride 

 

AZARGA contains benzalkonium chloride which may cause eye irritation and is known to discolour 

soft contact lenses. Contact with soft contact lenses should be avoided. Patients must be instructed to 

remove contact lenses prior to the application of AZARGA and wait 15 minutes after instillation of the 

dose before reinsertion. 

 

Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative 

keratopathy. Close monitoring is required with frequent or prolonged use. 

 

Hepatic impairment 

 

AZARGA should be used with caution in patients with severe hepatic impairment. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

No specific drug interaction studies have been performed with AZARGA. 

 

AZARGA contains brinzolamide, a carbonic anhydrase inhibitor and, although administered topically, 

is absorbed systemically. Acid-base disturbances have been reported with oral carbonic anhydrase 

inhibitors. The potential for interactions must be considered in patients receiving AZARGA. 

 



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There is a potential for an additive effect on the known systemic effects of carbonic anhydrase 

inhibition in patients receiving an oral carbonic anhydrase inhibitor and brinzolamide eye drops. The 

concomitant administration of eye drops containing brinzolamide and oral carbonic anhydrase 

inhibitors is not recommended. 

 

The cytochrome P-450 isozymes responsible for metabolism of brinzolamide include CYP3A4 (main), 

CYP2A6, CYP2B6, CYP2C8 and CYP2C9. It is expected that inhibitors of CYP3A4 such as 

ketoconazole, itraconazole, clotrimazole, ritonavir and troleandomycin will inhibit the metabolism of 

brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly. 

However, accumulation of brinzolamide is unlikely as renal elimination is the major route. 

Brinzolamide is not an inhibitor of cytochrome P-450 isozymes. 

 

There is a potential for additive effects resulting in hypotension and/or marked bradycardia when an 

ophthalmic beta-blocker solution is administered concomitantly with oral calcium channel blockers, 

beta-adrenergic blocking agents, antiarrhythmics (including amiodarone), digitalis glycosides, 

parasympathomimetics, guanethidine. 

Beta blockers can decrease the response to adrenaline used to treat anaphylactic reactions. Special 

caution should be exercised in patients with a history of atopy or anaphylaxis (see section 4.4). 

 

The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-

blockers. Caution is recommended in the concomitant use of this medicinal product with clonidine. 

 

Potentiated systemic beta-blockade (e.g. decreased heart rate, depression) has been reported during 

combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol. 

Caution is recommended. 

 

Beta-blockers may increase the hypoglycaemic effect of antidiabetic agents. Beta-blockers can mask 

the signs and symptoms of hypoglycaemia (see section 4.4). 

 

Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) 

has been reported occasionally. 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

 

There are no adequate data regarding the use of ophthalmic brinzolamide and timolol in pregnant 

women. Studies in animals with brinzolamide have shown reproductive toxicity following systemic 

administration, see section 5.3. AZARGA should not be used during pregnancy unless clearly 

necessary. To reduce the systemic absorption, see section 4.2. 

 

Epidemiological studies have not revealed malformative effects but show a risk for intra uterine 

growth retardation when beta-blockers are administered by the oral route. In addition, signs and 

symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) 

have been observed in the neonate when beta-blockers have been administered until delivery. If 

AZARGA is administered until delivery, the neonate should be carefully monitored during the first 

days of life. 

 

Breast-feeding 

 

It is not known whether ophthalmic brinzolamide is excreted in human breast milk. Studies in animals 

have shown that following oral administration brinzolamide is excreted in breast milk, see section 5.3. 

 

Beta-blockers are excreted in breast milk. However, at therapeutic doses of timolol in eye drops it is 

not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of 

beta-blockade in the infant. To reduce the systemic absorption, see section 4.2. 

 



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However, a risk to the suckling child cannot be excluded. A decision must be made whether to 

discontinue breast-feeding or to discontinue/abstain from AZARGA therapy taking into account the 

benefit of breast-feeding for the child and the benefit of therapy for the woman. 

 

Fertility 

 

Studies have not been performed to evaluate the effect of topical ocular administration of Azarga on 

human fertility. 

 

Non clinical data do not show any effects of either brinzolamide or timolol on male or female fertility 

following oral dosing. No effects on male or female fertility are anticipated from the use of AZARGA. 

 

4.7 Effects on ability to drive and use machines 

 

AZARGA has minor influence on the ability to drive and use machines. 

 

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. 

If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or 

using machines. 

 

Carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness 

and/or physical coordination (see section 4.4). 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

In clinical trials, the most common adverse reactions were blurred vision, eye irritation and eye pain, 

occurring in approximately 2% to 7% of patients. 

 

Tabulated summary of adverse reactions 

 

The following adverse reactions have been reported during clinical studies and post-marketing 

surveillance with AZARGA and the individual components brinzolamide and timolol. They are 

classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), 

uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known 

(cannot be estimated from the available data). Within each frequency grouping, adverse reactions are 

presented in order of decreasing seriousness. 

 

System Organ 

Classification 

MedDRA Preferred Term (v. 18.0) 

Infections and infestations Not known: nasopharyngitis3, pharyngitis3, sinusitis3, rhinitis3 

Blood and lymphatic 

system disorders 

Uncommon: white blood cell count decreased1 

Not known: decreased red blood cell count3, increased blood 

chloride3  

Immune system disorders Not known: anaphylaxis2, anaphylactic shock1, systemic allergic 

reactions including angioedema, 2 localised and generalised rash2, 

hypersensitivity1, urticaria2, pruritus2  

Metabolism and nutrition 

disorders 

Not known: hypoglycaemia2 

Psychiatric disorders Rare: insomnia1 

Not known: hallucinations2, depression1, memory loss2, apathy3, 

depressed mood3, decreased libido3, nightmare2,3, nervousness3  

  



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Nervous system disorders Common: dysgeusia1 

Not known: cerebral ischaemia2, cerebrovascular accident2, 

syncope2, increases in the signs and symptoms of myasthenia 

gravis2, somnolence3, motor dysfunction3, amnesia3, memory 

impairment3, paraesthesia2,3, tremor3, hypoaesthesia3, ageusia3, 

dizziness1, headache1 

Eye disorders Common: punctate keratitis1, blurred vision1, eye pain1, eye 

irritation1 

Uncommon: keratitis1,2,3, dry eye1, vital dye staining cornea 

present1, eye discharge1, eye pruritus1, foreign body sensation in 

eyes1, ocular hyperaemia1, conjunctival hyperaemia1 

Rare: corneal erosion1, anterior chamber flare1, photophobia1, 

lacrimation increased1, scleral hyperaemia1, erythema of eyelid1, 

eyelid margin crusting1 

Not known: increased optic nerve cup/disc ratio3, choroidal 

detachment following filtration surgery2 (see section 4.4 Special 

warnings and precautions for use), keratopathy3, corneal epithelium 

defect3, corneal epithelium disorder3, increased intraocular 

pressure3, eye deposit3, corneal staining3, corneal oedema3, 

decreased corneal sensitivity2, conjunctivitis3, meibomianitis3, 

diplopia2, 3, glare3, photopsia3, reduced visual acuity3, visual 

impairment1, pterygium3, ocular discomfort3, keratoconjunctivitis 

sicca3, hypoaesthesia of the eye3, scleral pigmentation3, 

subconjunctival cyst3, visual disturbance3, eye swelling3, eye 

allergy3, madarosis3, eyelid disorder3, eyelid oedema1, ptosis2  

Ear and labyrinth disorders Not known: vertigo3, tinnitus3 

Cardiac disorders Common: heart rate decreased1 

Not known: cardiac arrest2, cardiac failure2, congestive heart 

failure2, atrioventricular block2, cardio-respiratory distress3, angina 

pectoris3, bradycardia2,3, irregular heart rate3, arrhythmia2,3, 

palpitations2,3, tachycardia3, increased heart rate3, chest pain2, 

oedema2  

Vascular disorders Uncommon: decreased blood pressure1 

Not known: hypotension2, hypertension3, blood pressure increased1, 

Raynaud’s phenomenon2, cold hands and feet2 

Respiratory, thoracic and 

mediastinal disorders 

Uncommon: cough1 

Rare: oropharyngeal pain1, rhinorrhoea1 

Not known: bronchospasm2 (predominantly in patients with pre-

existing bronchospastic disease), dyspnoea1, asthma3, epistaxis1, 

bronchial hyperactivity3, throat irritation3, nasal congestion3, upper 

respiratory tract congestion3, postnasal drip3, sneezing3, nasal 

dryness3 

Gastrointestinal disorders Not known: vomiting2,3, abdominal pain upper1, abdominal pain2, 

diarrhoea1, dry mouth1, nausea1, oesophagitis3, dyspepsia2,3, 

abdominal discomfort3, stomach discomfort3, frequent bowel 

movements3, gastrointestinal disorder3, oral hypoaesthesia3, oral 

paraesthesia3, flatulence3 

Hepatobiliary disorders Not known: abnormal liver function test3 

Skin and subcutaneous 

tissue disorders 

 

Not known: urticaria3, maculo-papular rash3, generalised pruritus3, 

skin tightness3, dermatitis3, alopecia1, psoriasiform rash or 

exacerbation of psoriasis2, rash1, erythema1 

Musculoskeletal and 

connective tissue disorders 

Not known: myalgia1, muscle spasms3, arthralgia3, back pain3, pain 

in extremity3 

Renal and urinary disorders Uncommon: blood urine present1 

Not known: renal pain3, pollakiuria3  

Reproductive system and 

breast disorders 

Not known: erectile dysfunction3, sexual dysfunction2, decreased 

libido2 



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General disorders and 

administration site 

conditions 

Uncommon: malaise1,3 

Not known: chest pain1, pain3, fatigue1, asthenia2,3, chest 

discomfort3, feeling jittery3, irritability3, peripheral oedema3, 

medication residue3 

Investigations Uncommon: blood potassium increase1, blood lactate 

dehydrogenase increased1  
1 adverse reactions observed for Azarga 
2 additional adverse reactions observed with timolol monotherapy 
3 additional adverse reactions observed with brinzolamide monotherapy 

 

Description of selected adverse reactions 

 

Dysgeusia (bitter or unusual taste in the mouth following instillation) was a frequently reported 

systemic adverse reaction associated with the use of AZARGA during clinical trials. It is likely to be 

caused by passage of the eye drops in the nasopharynx via the nasolacrimal canal and is attributable to 

brinzolamide. Nasolacrimal occlusion or gently closing the eyelid after instillation may help reduce 

the occurrence of this effect (see section 4.2). 

 

AZARGA contains brinzolamide which is a sulphonamide inhibitor of carbonic anhydrase with 

systemic absorption. Gastrointestinal, nervous system, haematological, renal and metabolic effects are 

generally associated with systemic carbonic anhydrase inhibitors. The same type of adverse reactions 

attributable to oral carbonic anhydrase inhibitors may occur with topical administration. 

 

Timolol is absorbed into the systemic circulation. This may cause similar adverse reactions as seen 

with systemic beta-blocking medicinal products. Listed adverse reactions include reactions seen within 

the class of ophthalmic beta-blockers. Additional adverse reactions associated with the use of the 

individual components that may potentially occur with AZARGA are included in the table above. The 

incidence of systemic adverse reactions after topical ophthalmic administration is lower than for 

systemic administration. To reduce the systemic absorption, see section 4.2. 

 

Paediatric population 

 

AZARGA is not recommended for use in children and adolescents below 18 years due to a lack of 

data on safety and efficacy. 

 

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 case of accidental ingestion, symptoms of overdose from beta blockade may include bradycardia, 

hypotension, cardiac failure and bronchospasm. 

 

If overdose with AZARGA eye drops occurs, treatment should be symptomatic and supportive. Due to 

brinzolamide, electrolyte imbalance, development of an acidotic state, and possibly central nervous 

system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels 

should be monitored. Studies have shown that timolol does not dialyse readily. 

 

 

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


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5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Ophthalmologicals, Antiglaucoma preparation and miotics 

ATC code: S01ED51 

 

Mechanism of action 

 

AZARGA contains two active substances: brinzolamide and timolol maleate. These two components 

decrease elevated IOP primarily by reducing aqueous humour secretion, but do so by different 

mechanisms of action. The combined effect of these two active substances results in additional IOP 

reduction compared to either compound alone. 

 

Brinzolamide is a potent inhibitor of human carbonic anhydrase II (CA-II), the predominant iso-

enzyme in the eye. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases 

aqueous humour secretion, presumably by slowing the formation of bicarbonate ions with subsequent 

reduction in sodium and fluid transport. 

 

Timolol is a non-selective adrenergic-blocking agent that has no intrinsic sympathomimetic, direct 

myocardial depressant or membrane-stabilising activity. Tonography and fluorophotometry studies in 

man suggest that its predominant action is related to reduced aqueous humour formation and a slight 

increase in outflow facility. 

 

Pharmacodynamic effects 

 

Clinical effects: 

In a twelve-month, controlled clinical trial in patients with open-angle glaucoma or ocular 

hypertension who, in the investigator’s opinion could benefit from a combination therapy, and who 

had baseline mean IOP of 25 to 27 mmHg, the mean IOP-lowering effect of AZARGA dosed twice 

daily was 7 to 9 mmHg. The non-inferiority of AZARGA as compared to dorzolamide 

20 mg/ml + timolol 5 mg/ml in the mean IOP reduction was demonstrated across all time-points at all 

visits. 

 

In a six-month, controlled clinical study in patients with open-angle glaucoma or ocular hypertension 

and baseline mean IOP of 25 to 27 mmHg, the mean IOP-lowering effect of AZARGA dosed twice 

daily was 7 to 9 mmHg, and was up to 3 mmHg greater than that of brinzolamide 10 mg/ml dosed 

twice daily and up to 2 mmHg greater than that of timolol 5 mg/ml dosed twice daily. A statistically 

superior reduction in mean IOP was observed compared to both brinzolamide and timolol at all time-

points and visits throughout the study. 

 

In three controlled clinical trials, the ocular discomfort upon instillation of AZARGA was significantly 

lower than that of dorzolamide 20 mg/ml + timolol 5 mg/ml. 

 

  



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5.2 Pharmacokinetic properties 

 

Absorption 

 

Following topical ocular administration, brinzolamide and timolol are absorbed through the cornea 

and into the systemic circulation. In a pharmacokinetic study, healthy subjects received oral 

brinzolamide (1 mg) twice daily for 2 weeks to shorten the time to reach steady-state prior to starting 

AZARGA administration. Following twice daily dosing of AZARGA for 13 weeks, red blood cell 

(RBC) concentrations of brinzolamide averaged 18.8  3.29 µM, 18.1  2.68 µM and 18.4  3.01 µM 

at weeks 4, 10 and 15, respectively, indicating that steady-state RBC concentrations of brinzolamide 

were maintained 

 

At steady state, following administration of AZARGA, the mean plasma Cmax and AUC0-12h of timolol 

were 27% and 28% lower (Cmax: 0.824 ± 0.453 ng/ml; AUC0-12h: 4.71 ± 4.29 ng·h/ml), respectively, in 

comparison to the administration of timolol 5 mg/ml (Cmax: 1.13 ± 0.494 ng/ml; 

AUC0-12h: 6.58 ± 3.18 ng·h/ml). The lower systemic exposure to timolol following AZARGA 

administration is not clinically relevant. Following administration of AZARGA, mean Cmax of timolol 

was reached at 0.79 ± 0.45 hours. 

 

Distribution 

 

Plasma protein binding of brinzolamide is moderate (about 60%). Brinzolamide is sequestered in 

RBCs due to its high affinity binding to CA-II and to a lesser extent to CA-I. Its active N-desethyl 

metabolite also accumulates in RBCs where it binds primarily to CA-I. The affinity of brinzolamide 

and metabolite to RBC and tissue CA results in low plasma concentrations. 

 

Ocular tissue distribution data in rabbits showed that timolol can be measured in aqueous humour up 

to 48 hours after administration of AZARGA. At steady-state, timolol is detected in human plasma for 

up to 12 hours after administration of AZARGA. 

 

Biotransformation 

 

The metabolic pathways for the metabolism of brinzolamide involve N-dealkylation, O-dealkylation 

and oxidation of its N-propyl side chain. N-desethyl brinzolamide is a major metabolite of 

brinzolamide formed in humans, which also binds to CA-I in the presence of brinzolamide and 

accumulates in RBCs. In vitro studies show that the metabolism of brinzolamide mainly involves 

CYP3A4 as well as at least four other isozymes (CYP2A6, CYP2B6, CYP2C8 and CYP2C9). 

 

Timolol is metabolised by two pathways. One route yields an ethanolamine side chain on the 

thiadiazole ring and the other giving an ethanolic side chain on the morpholine nitrogen and a second 

similar side chain with a carbonyl group adjacent to the nitrogen. Timolol metabolism is mediated 

primarily by CYP2D6. 

 

Elimination 

 

Brinzolamide is eliminated primarily by renal excretion (approximately 60%). About 20% of the dose 

has been accounted for in urine as metabolite. Brinzolamide and N-desethyl-brinzolamide are the 

predominant components found in the urine along with trace levels (<1%) of the N-desmethoxypropyl 

and O-desmethyl metabolites. 

 

Timolol and its metabolites are primarily excreted by the kidneys. Approximately 20% of a timolol 

dose is excreted in the urine unchanged and the remainder excreted in urine as metabolites. The 

plasma t1/2 of timolol is 4.8 hours after administration of AZARGA. 

 



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5.3 Preclinical safety data 

 

Brinzolamide 

 

Non-clinical data reveal no special hazard for humans with brinzolamide based on conventional 

studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. 

 

Developmental toxicity studies in rabbits with oral doses of brinzolamide of up to 6 mg/kg/day 

(214 times the recommended daily clinical dose of 28 µg/kg/day) revealed no effect on foetal 

development despite significant maternal toxicity. Similar studies in rats resulted in slightly reduced 

ossification of skull and sternebrae of foetuses of dams receiving brinzolamide at doses 

of 18 mg/kg/day (642 times the recommended daily clinical dose), but not 6 mg/kg/day. These 

findings occurred at doses that caused metabolic acidosis with decreased body weight gain in dams 

and decreased foetal weights. Dose-related decreases in foetal weights were observed in pups of dams 

receiving brinzolamide orally ranging from a slight decrease (about 5-6%) at 2 mg/kg/day to 

nearly 14% at 18 mg/kg/day. During lactation, the no adverse effect level in the offspring was 

5 mg/kg/day. 

 

Timolol 

 

Non-clinical data reveal no special hazard for humans with timolol based on conventional studies of 

safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Reproduction 

toxicity studies with timolol showed delayed foetal ossification in rats with no adverse effects on 

postnatal development (at 50 mg/kg/day or 3,500 times the daily clinical dose of 14 g/kg/day) and 

increased foetal resorptions in rabbits (at 90 mg/kg/day or 6,400 times the daily clinical dose). 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Benzalkonium chloride 

Mannitol (E421) 

Carbopol 974P 

Tyloxapol 

Disodium edetate 

Sodium chloride 

Hydrochloric acid and/or sodium hydroxide (for pH adjustment) 

Purified water 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

2 years 

 

4 weeks after first opening. 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions. 

 



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6.5 Nature and contents of container 

 

5 ml round opaque low density polyethylene bottles with a dispensing plug and white polypropylene 

screw cap (DROP-TAINER) containing 5 ml suspension. 

 

Cartons containing 1 or 3 bottles. 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) 

 

EU/1/08/482/001-002 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first Authorisation: 25 November 2008 

Date of latest renewal: 26 August 2013 

 

 

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/


14 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 
 

A. MANUFACTURER(S) 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 



15 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer(s) responsible for batch release 

 

S.A. Alcon-Couvreur N.V. 

Rijksweg 14 

B-2870 Puurs 

Belgium 

 

or 

 

Alcon Cusí, S.A. 

Camil Fabra 58 

08320 El Masnou 

Barcelona 

Spain 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

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 

 

 Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent 

updates of the RMP. 

 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 

 Whenever the risk management system is modified, especially as the result of new information 
being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached. 

 

  



16 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



17 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

  



18 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON FOR SINGLE BOTTLE 5 ml + CARTON FOR 3 x 5 ml BOTTLES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension 

brinzolamide/timolol 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

1 ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains: benzalkonium chloride, mannitol (E421), carbopol 974P, tyloxapol, disodium edetate, 

sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water. 

 

See the package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Eye drops, suspension 

 

1 x 5 ml 

3 x 5 ml 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Shake well before use. 

Read the package leaflet before use. 

Ocular 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 

Discard 4 weeks after first opening. 

Opened: 

 



19 

 

9. SPECIAL STORAGE CONDITIONS 

 

 

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 NUMBERS 

 

EU/1/08/482/001 1 x 5 ml 

EU/1/08/482/002 3 x 5 ml 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

azarga 

 

 

17. UNIQUE IDENTIFIER-2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



20 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

BOTTLE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 

 

AZARGA 10 mg/ml + 5 mg/ml eye drops 

brinzolamide/timolol 

Ocular use 

 

 

2. METHOD OF ADMINISTRATION 

 

Read the package leaflet before use. 

 

 

3. EXPIRY DATE 

 

EXP 

Discard 4 weeks after first opening. 

Opened: 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

5 ml 

 

 

6 OTHER 

  



21 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



22 

Package leaflet: Information for the user 

 

AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension 

brinzolamide/timolol 

 

Read all of this leaflet carefully before you start using 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 or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them 

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

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

 

What is in this leaflet 

 

1. What AZARGA is and what it is used for 

2. What you need to know before you use AZARGA 

3. How to use AZARGA 

4. Possible side effects 

5. How to store AZARGA 

6. Contents of the pack and other information 

 

 

1. What AZARGA is and what it is used for 

 

AZARGA contains two active substances, brinzolamide and timolol, which work together to reduce 

pressure within the eye. 

 

AZARGA is used to treat high pressure in the eyes, also called glaucoma or ocular hypertension, in 

adult patients that are more than 18 years of age and in whom high pressure in the eyes cannot be 

controlled effectively by one medicine alone. 

 

 

2. What you need to know before you use AZARGA 

 

Do not use AZARGA 

 If you are allergic to brinzolamide, medicines called sulphonamides (examples include 
medicines used to treat diabetes, infections and also diuretics (water tablets)), timolol, beta-

blockers (medicines used to lower blood pressure or to treat heart disease) or any of the other 

ingredients of this medicine (listed in section 6). 

 If you have now or have had in the past respiratory problems such as asthma, severe long lasting 
obstructive bronchitis (severe lung condition which may cause wheezing, difficulty in breathing 

and/or long standing cough) or other types of breathing problems. 

 If you have severe hay fever 

 If you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heartbeats). 

 If you have too much acidity in your blood (a condition called hyperchloraemic acidosis). 

 If you have severe kidney problems. 
 

  



23 

Warnings and precautions 

Only use AZARGA for dropping in your eye(s). 

 

If signs of serious reactions or hypersensitivity occur, discontinue the use of this product and talk to 

your doctor. 

 

Talk to your doctor or pharmacist before using AZARGA if you have or have had in the past: 

 coronary heart disease (symptoms can include chest pain or tightness, breathlessness or 
choking), heart failure, low blood pressure 

 disturbances of heart rate such as slow heart beat 

 breathing problems, asthma or chronic obstructive pulmonary disease 

 poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome) 

 diabetes as timolol may mask signs and symptoms of low blood sugar 

 overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid disease 

 muscular weakness (myasthenia gravis) 

 tell your doctor before you have an operation that you are using AZARGA as timolol may 
change effects of some medicines used during anaesthesia. 

 if you have a history of atopy (a tendency to develop an allergic reaction) and severe allergic 
reactions you may be more sensitive to developing an allergic reaction whilst using AZARGA 

and adrenaline may not be as effective to treat an allergic reaction. When receiving any other 

treatment please tell the doctor or nurse that you are taking AZARGA. 

 if you have liver problems. 

 if you have dry eyes or cornea problems. 

 if you have problems with your kidneys. 
 

Children and adolescents 
AZARGA is not recommended for children and adolescents under 18 years. 

 

Other medicines and AZARGA 

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 

 

AZARGA can affect, or be affected by, other medicines you are taking, including other eye drops for 

the treatment of glaucoma. Tell your doctor if you are taking or intent to take medicines to lower 

blood pressure like parasympathomimetics and guanetidine, or other heart medicines including 

quinidine (used to treat heart conditions and some types of malaria), amiodarone or other medicines to 

treat heart rhythm disorders and glycosides to treat heart insufficiency. Also tell your doctor if you are 

taking or intend to take medicines to treat diabetes, or to treat gastric ulcers, antifungal, antiviral or 

antibiotic medicines, or antidepressants such as fluoxetine and paroxetine. 

 

If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide), talk to your 

doctor. 

Increase in pupil size when taking Azarga and adrenaline (epinephrine) together has been reported 

occasionally. 

 

Pregnancy and breast-feeding 

You should not use AZARGA if you are pregnant or might get pregnant, unless your doctor considers 

it necessary. Talk to your doctor before you use AZARGA. 

 

Do not use AZARGA if you are breast feeding, timolol may get into your milk. 

Ask your doctor for advice before taking any medicine during breastfeeding. 

 

Driving and using machines 

Do not drive or use machines until your vision is clear. You may find that your vision is blurred for 

some time just after using AZARGA. 

 



24 

One of the active ingredients may impair the ability to perform tasks requiring mental alertness and/or 

physical coordination. If affected take care when driving or using machines. 

 

AZARGA contains benzalkonium chloride 

 

This medicine contains 3.34 µg benzalkonium chloride per drop (= 1 dose) which is equivalent to 

0.01% or 0.1 mg/ml. 

 

AZARGA contains a preservative (benzalkonium chloride) which may be absorbed by soft contact 

lenses and may change the colour of the contact lenses. You should remove contact lenses before 

using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause 

eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of 

the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk 

to your doctor. 

 

 

3. How to use AZARGA 
 

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are not sure. 

If you are changing from another eye drop medicine used to treat glaucoma to AZARGA, you should 

stop using the other medicine and start using AZARGA the following day. Check with your doctor or 

pharmacist if you are not sure 

 

To prevent contamination of the dropper tip and the suspension, care must be taken not to touch 

the eyelids, surrounding areas or other surfaces with the dropper tip. Keep the bottle tightly closed 

when not in use. 

 

The following measure is useful to limit the amount of medicine that will come into the blood after 

application of eye drops: 

- Keep the eyelid closed, while simultaneously applying gentle pressure to the corner of the eye 
next to the nose with a finger for at least 2 minutes. 

 

The recommended dose is 

One drop in the affected eye or eyes, twice a day. 

Only use AZARGA in both eyes if your doctor told you to. Take it for as long as your doctor told you 

to. 

 

How to use 

    
  1 2 3 

 

 Get the AZARGA bottle and a mirror. 

 Wash your hands. 

 Shake well before use. 

 Twist off the bottle cap. After the cap is removed, if the tamper evident snap collar is loose, 
remove before using product. 

 Hold the bottle, pointing down, between your thumb and fingers. 

 Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between 
the eyelid and your eye. The drop will go in here (picture 1). 

 Bring the bottle tip close to the eye. Use the mirror if it helps. 



25 

 Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could 
infect the drops. 

 Gently press on the base of the bottle to release one drop of AZARGA at a time. 

 Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs 
(picture 2). 

 After using AZARGA, press a finger into the corner of your eye, by the nose for 2 minutes 
(picture 3). This helps to stop AZARGA getting into the rest of the body. 

 If you use drops in both eyes, repeat the steps for your other eye. 

 Close the bottle cap firmly immediately after use. 

 Use up one bottle before opening the next bottle. 
 

If a drop misses your eye, try again. 

 

If you are using other eye drop or eye ointment medicines leave at least 5 minutes between each 

medicine. Eye ointments should be administered last. 

 

If you use more AZARGA than you should, rinse your eye with warm water. Do not put in any 

more drops until it is time for your next regular dose. 

 

You may experience a decreased heart rate, decreased blood pressure, heart failure, difficulty 

breathing and your nervous system may be affected 

 

If you forget to use AZARGA, continue with the next dose as planned. Do not use a double dose to 

make up for the forgotten dose. Do not use more than one drop in the affected eye(s) twice daily. 

 

If you stop using AZARGA without speaking to your doctor, the pressure in your eye will not be 

controlled which could lead to loss of sight. 

 

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

 

 

4. Possible side effects 

 

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

 

Stop using this medicine and contact your doctor immediately if you develop skin rash, severe skin 

reaction, or severe redness and itching of the eye. These could be the signs of an allergic reaction 

(frequency is not known). 

 

You can usually carry on taking the drops, unless the effects are serious. If you are worried, talk to 

your doctor or pharmacist. Do not stop using Azarga without speaking to your doctor first. 

 

Common side effects (may affect up to 1 in 10 people) 

 Effects in the eye: eye surface inflammation, blurred vision, signs and symptoms of eye 
irritation (e.g. burning, stinging, itching, tearing, redness), eye pain. 

 General side effects: heart rate decreased, taste disturbances. 
 

Uncommon side effects (may affect up to 1 in 100 people) 

 Effects in the eye:corneal erosion (damage to the front layer of the eyeball), Eye surface 
inflammation with surface damage, inflammation inside the eye, corneal staining, abnormal 

sensation in the eyes, eye discharge, dry eye, tired eyes, itchy eye, eye redness, eyelid redness. 

 General side effects: decrease in white blood cell count, decreased blood pressure, cough, 
blood in urine, body weakness. 

 



26 

Rare side effects (may affect up to 1 in 1,000 people) 

 Effects in the eye: corneal disorder, sensitivity to light, increased tear production, eyelid 
crusting 

 General side effects: difficulty sleeping (insomnia), throat pain, running nose 

 

Not known (frequency cannot be estimated from the available data) 

 Effects in the eye: eye allergy, disturbance of vision, damage to the optic nerve, increased 
pressure in eye, deposits on the eye surface, decreased eye sensation, inflammation or infection 

of the conjunctiva (white of the eye), abnormal, double or reduced vision, increased 

pigmentation of the eye, growth on surface of eye, eye swelling, sensitivity to light, decreased 

growth or number of eyelashes, drooping of the upper eyelids (making the eye stay half closed), 

inflammation of the eyelid and eye lid glands, inflammation in the cornea and detachment of the 

layer below the retina that contains blood vessels following filtration surgery which may cause 

visual disturbances, decreased corneal sensitivity. 

 Heart and circulation: changes in rhythm or rate of the heartbeat, slow heart rate, palpitations, 
a type of heart rhythm disorder, abnormal increase in heart rate, chest pain, reduced heart 

function, heart attack, increased blood pressure, reduced blood supply to the brain, stroke, 

oedema (fluid build up), congestive heart failure (heart disease with shortness of breath and 

swelling of the feet and legs due to fluid build up), swelling of the extremities, low blood 

pressure, discoloration of the fingers, toes, and occasionally other areas of the body (Raynaud’s 

phenomenon), cold hands and feet. 

 Respiratory: Constriction of the airways in the lungs (predominantly in patients with pre-
existing disease) shortness of breath or difficulty breathing, cold symptoms, chest congestion, 

sinus infection, sneezing, stuffy nose, dry nose, nose bleeds, asthma, throat irritation. 

 Nervous system and general disorders: hallucinations, depression, nightmares, memory loss, 
headache, nervousness, irritability, tiredness, shaking, feeling abnormal, fainting, dizziness, 

drowsiness, generalised or severe weakness, unusual sensations like pins and needles. 

 Gastric: nausea, vomiting, diarrhoea, intestinal gas or abdominal discomfort, inflammation of 
the throat, dry or abnormal sensation in mouth, indigestion, stomach ache. 

 Blood: abnormal liver function values, increased blood chlorine levels, or decreased red blood 
cell count as seen in a blood test. 

 Allergy: increased allergic symptoms, generalised allergic reactions including swelling beneath 
the skin that can occur in areas such as the face and limbs and can obstruct the airway which 

may cause difficulty swallowing or breathing, hives, localised and generalised rash, itchiness, 

severe sudden life-threatening allergic reaction. 

 Ear: ringing in the ears, sensation of spinning or dizziness. 

 Skin: rash, skin redness or inflammation, abnormal or decreased skin sensation, hair loss, rash 
with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis. 

 Muscular: generalised back, joint, or muscle pain not caused by exercise, muscle spasms, pain 
in extremities, muscle weakness/tiredness, increases in the signs and symptoms of myasthenia 

gravis (muscle disorder). 

 Kidney: kidney pain such as lower back pain, frequent urination. 

 Reproduction: sexual dysfunction, decreased libido, male sexual difficulty. 

 Metabolism: low blood sugar levels. 
 

Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. 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. 

 

 

  

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


27 

5. How to store AZARGA 
 

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 bottle and the carton after EXP. 

The expiry date refers to the last day of that month. 

 

This medicine does not require any special storage conditions. 

 

Throw away the bottle 4 weeks after first opening to prevent infections, and use a new bottle. Write 

down the date of opening on the bottle label and carton label in the space provided. 

 

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 AZARGA contains 

 The active substances are brinzolamide and timolol. One ml of suspension contains 10 mg of 
brinzolamide and 5 mg of timolol (as maleate). 

 The other ingredients are benzalkonium chloride (see section 2 ‘AZARGA contains 
benzalkonium’), carbopol 974P, disodium edetate, mannitol (E421), purified water, sodium 

chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide. 

Tiny amounts of hydrochloric acid and/or sodium hydroxide are added to keep acidity levels 

(pH levels) normal. 

 

What AZARGA looks like and contents of the pack 

AZARGA is a liquid (white to off-white uniform suspension) supplied in a pack containing one 5 ml 

plastic bottle with a screw cap or in a pack containing three 5 ml bottles. 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 
Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

S.A. Alcon-Couvreur N.V. 

Rijksweg 14 

B-2870 Puurs 

Belgium 

 

or 
 

Alcon Cusí, S.A., 

Camil Fabra 58, 

08320 El Masnou, 

Barcelona, 

Spain 

 

  



28 

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 2 489 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 88 04 52 111 

 

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 

  



29 

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 web site: 

http://www.ema.europa.eu 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) 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
{'Title': '1. what azarga is and what it is used for', 'Section_Content': 'azarga contains two active substances, brinzolamide and timolol, which work together to reduce pressure within the eye. azarga is used to treat high pressure in the eyes, also called glaucoma or ocular hypertension, in adult patients that are more than 18 years of age and in whom high pressure in the eyes cannot be controlled effectively by one medicine alone.', 'Entity_Recognition': [{'Text': 'azarga', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 3, 'BeginOffset': 0, 'EndOffset': 6, 'Score': 0.6573197841644287, 'Text': 'azarga', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 4, 'BeginOffset': 39, 'EndOffset': 51, 'Score': 0.9973950386047363, 'Text': 'brinzolamide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 56, 'EndOffset': 63, 'Score': 0.9934948086738586, 'Text': 'timolol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'pressure within the eye', 'Type': 'PROBLEM', 'BeginOffset': 95, 'EndOffset': 118}, {'Id': 6, 'BeginOffset': 120, 'EndOffset': 126, 'Score': 0.7195781469345093, 'Text': 'azarga', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'high pressure in the eyes', 'Type': 'PROBLEM', 'BeginOffset': 144, 'EndOffset': 169}, {'Id': 8, 'BeginOffset': 183, 'EndOffset': 191, 'Score': 0.9960435628890991, 'Text': 'glaucoma', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.950746476650238}]}, {'Id': 9, 'BeginOffset': 195, 'EndOffset': 214, 'Score': 0.9729996919631958, 'Text': 'ocular hypertension', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.968343198299408}]}, {'Text': '18', 'Type': 'NUMBER', 'BeginOffset': 253, 'EndOffset': 255}, {'Id': 10, 'BeginOffset': 281, 'EndOffset': 294, 'Score': 0.6554294228553772, 'Text': 'high pressure', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.45010262727737427}], 'Attributes': [{'Type': 'SYSTEM_ORGAN_SITE', 'Score': 0.9077284336090088, 'RelationshipScore': 0.9992895126342773, 'RelationshipType': 'SYSTEM_ORGAN_SITE', 'Id': 2, 'BeginOffset': 302, 'EndOffset': 306, 'Text': 'eyes', 'Category': 'ANATOMY', 'Traits': []}]}, {'Id': 2, 'BeginOffset': 302, 'EndOffset': 306, 'Score': 0.9077284336090088, 'Text': 'eyes', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}]}
{'Title': '2. what you need to know before you use azarga', 'Section_Content': "do not use azarga if you are allergic to brinzolamide, medicines called sulphonamides (examples include medicines used to treat diabetes, infections and also diuretics (water tablets)), timolol, beta- blockers (medicines used to lower blood pressure or to treat heart disease) or any of the other ingredients of this medicine (listed in section 6). if you have now or have had in the past respiratory problems such as asthma, severe long lasting obstructive bronchitis (severe lung condition which may cause wheezing, difficulty in breathing and/or long standing cough) or other types of breathing problems. if you have severe hay fever if you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heartbeats). if you have too much acidity in your blood (a condition called hyperchloraemic acidosis). if you have severe kidney problems. warnings and precautions only use azarga for dropping in your eye(s). if signs of serious reactions or hypersensitivity occur, discontinue the use of this product and talk to your doctor. talk to your doctor or pharmacist before using azarga if you have or have had in the past: coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure disturbances of heart rate such as slow heart beat breathing problems, asthma or chronic obstructive pulmonary disease poor blood circulation disease (such as raynaud's disease or raynaud's syndrome) diabetes as timolol may mask signs and symptoms of low blood sugar overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid disease muscular weakness (myasthenia gravis) tell your doctor before you have an operation that you are using azarga as timolol may change effects of some medicines used during anaesthesia. if you have a history of atopy (a tendency to develop an allergic reaction) and severe allergic reactions you may be more sensitive to developing an allergic reaction whilst using azarga and adrenaline may not be as effective to treat an allergic reaction. when receiving any other treatment please tell the doctor or nurse that you are taking azarga. if you have liver problems. if you have dry eyes or cornea problems. if you have problems with your kidneys. children and adolescents azarga is not recommended for children and adolescents under 18 years. other medicines and azarga tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. azarga can affect, or be affected by, other medicines you are taking, including other eye drops for the treatment of glaucoma. tell your doctor if you are taking or intent to take medicines to lower blood pressure like parasympathomimetics and guanetidine, or other heart medicines including quinidine (used to treat heart conditions and some types of malaria), amiodarone or other medicines to treat heart rhythm disorders and glycosides to treat heart insufficiency. also tell your doctor if you are taking or intend to take medicines to treat diabetes, or to treat gastric ulcers, antifungal, antiviral or antibiotic medicines, or antidepressants such as fluoxetine and paroxetine. if you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide), talk to your doctor. increase in pupil size when taking azarga and adrenaline (epinephrine) together has been reported occasionally. pregnancy and breast-feeding you should not use azarga if you are pregnant or might get pregnant, unless your doctor considers it necessary. talk to your doctor before you use azarga. do not use azarga if you are breast feeding, timolol may get into your milk. ask your doctor for advice before taking any medicine during breastfeeding. driving and using machines do not drive or use machines until your vision is clear. you may find that your vision is blurred for some time just after using azarga. one of the active ingredients may impair the ability to perform tasks requiring mental alertness and/or physical coordination. if affected take care when driving or using machines. azarga contains benzalkonium chloride this medicine contains 3.34 µg benzalkonium chloride per drop (= 1 dose) which is equivalent to 0.01% or 0.1 mg/ml. azarga contains a preservative (benzalkonium chloride) which may be absorbed by soft contact lenses and may change the colour of the contact lenses. you should remove contact lenses before using this medicine and put them back 15 minutes afterwards. benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). if you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.", 'Entity_Recognition': [{'Text': 'azarga', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 14, 'BeginOffset': 11, 'EndOffset': 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{'Title': '3. how to use azarga', 'Section_Content': "always use this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure. if you are changing from another eye drop medicine used to treat glaucoma to azarga, you should stop using the other medicine and start using azarga the following day. check with your doctor or pharmacist if you are not sure to prevent contamination of the dropper tip and the suspension, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip. keep the bottle tightly closed when not in use. the following measure is useful to limit the amount of medicine that will come into the blood after application of eye drops: - keep the eyelid closed, while simultaneously applying gentle pressure to the corner of the eye next to the nose with a finger for at least 2 minutes. the recommended dose is one drop in the affected eye or eyes, twice a day. only use azarga in both eyes if your doctor told you to. take it for as long as your doctor told you to. how to use 1 2 3 get the azarga bottle and a mirror. wash your hands. shake well before use. twist off the bottle cap. after the cap is removed, if the tamper evident snap collar is loose, remove before using product. hold the bottle, pointing down, between your thumb and fingers. tilt your head back. pull down your eyelid with a clean finger, until there is a 'pocket' between the eyelid and your eye. the drop will go in here (picture 1). bring the bottle tip close to the eye. use the mirror if it helps. do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. it could infect the drops. gently press on the base of the bottle to release one drop of azarga at a time. do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs (picture 2). after using azarga, press a finger into the corner of your eye, by the nose for 2 minutes (picture 3). this helps to stop azarga getting into the rest of the body. if you use drops in both eyes, repeat the steps for your other eye. close the bottle cap firmly immediately after use. use up one bottle before opening the next bottle. if a drop misses your eye, try again. if you are using other eye drop or eye ointment medicines leave at least 5 minutes between each medicine. eye ointments should be administered last. if you use more azarga than you should, rinse your eye with warm water. do not put in any more drops until it is time for your next regular dose. you may experience a decreased heart rate, decreased blood pressure, heart failure, difficulty breathing and your nervous system may be affected if you forget to use azarga, continue with the next dose as planned. do not use a double dose to make up for the forgotten dose. do not use more than one drop in the affected eye(s) twice daily. if you stop using azarga without speaking to your doctor, the pressure in your eye 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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. stop using this medicine and contact your doctor immediately if you develop skin rash, severe skin reaction, or severe redness and itching of the eye. these could be the signs of an allergic reaction (frequency is not known). you can usually carry on taking the drops, unless the effects are serious. if you are worried, talk to your doctor or pharmacist. do not stop using azarga without speaking to your doctor first. common side effects (may affect up to 1 in 10 people) effects in the eye: eye surface inflammation, blurred vision, signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), eye pain. general side effects: heart rate decreased, taste disturbances. uncommon side effects (may affect up to 1 in 100 people) effects in the eye:corneal erosion (damage to the front layer of the eyeball), eye surface inflammation with surface damage, inflammation inside the eye, corneal staining, abnormal sensation in the eyes, eye discharge, dry eye, tired eyes, itchy eye, eye redness, eyelid redness. general side effects: decrease in white blood cell count, decreased blood pressure, cough, blood in urine, body weakness. rare side effects (may affect up to 1 in 1,000 people) effects in the eye: corneal disorder, sensitivity to light, increased tear production, eyelid crusting general side effects: difficulty sleeping (insomnia), throat pain, running nose not known (frequency cannot be estimated from the available data) effects in the eye: eye allergy, disturbance of vision, damage to the optic nerve, increased pressure in eye, deposits on the eye surface, decreased eye sensation, inflammation or infection of the conjunctiva (white of the eye), abnormal, double or reduced vision, increased pigmentation of the eye, growth on surface of eye, eye swelling, sensitivity to light, decreased growth or number of eyelashes, drooping of the upper eyelids (making the eye stay half closed), inflammation of the eyelid and eye lid glands, inflammation in the cornea and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity. heart and circulation: changes in rhythm or rate of the heartbeat, slow heart rate, palpitations, a type of heart rhythm disorder, abnormal increase in heart rate, chest pain, reduced heart function, heart attack, increased blood pressure, reduced blood supply to the brain, stroke, oedema (fluid build up), congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), swelling of the extremities, low blood pressure, discoloration of the fingers, toes, and occasionally other areas of the body (raynaud's phenomenon), cold hands and feet. respiratory: constriction of the airways in the lungs (predominantly in patients with pre- existing disease) shortness of breath or difficulty breathing, cold symptoms, chest congestion, sinus infection, sneezing, stuffy nose, dry nose, nose bleeds, asthma, throat irritation. nervous system and general disorders: hallucinations, depression, nightmares, memory loss, headache, nervousness, irritability, tiredness, shaking, feeling abnormal, fainting, dizziness, drowsiness, generalised or severe weakness, unusual sensations like pins and needles. gastric: nausea, vomiting, diarrhoea, intestinal gas or abdominal discomfort, inflammation of the throat, dry or abnormal sensation in mouth, indigestion, stomach ache. blood: abnormal liver function values, increased blood chlorine levels, or decreased red blood cell count as seen in a blood test. allergy: increased allergic symptoms, generalised allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs and can obstruct the airway which may cause difficulty swallowing or breathing, hives, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction. ear: ringing in the ears, sensation of spinning or dizziness. skin: rash, skin redness or inflammation, abnormal or decreased skin sensation, hair loss, rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis. muscular: generalised back, joint, or muscle pain not caused by exercise, muscle spasms, pain in extremities, muscle weakness/tiredness, increases in the signs and symptoms of myasthenia gravis (muscle disorder). kidney: kidney pain such as lower back pain, frequent urination. reproduction: sexual dysfunction, decreased libido, male sexual difficulty. metabolism: low blood sugar levels. reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed 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{'Title': '5. how to store azarga', '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 bottle and the carton after exp. the expiry date refers to the last day of that month. this medicine does not require any special storage conditions. throw away the bottle 4 weeks after first opening to prevent infections, and use a new bottle. write down the date of opening on the bottle label and carton label in the space provided. 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': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': "what azarga contains the active substances are brinzolamide and timolol. one ml of suspension contains 10 mg of brinzolamide and 5 mg of timolol (as maleate). the other ingredients are benzalkonium chloride (see section 2 'azarga contains benzalkonium'), carbopol 974p, disodium edetate, mannitol (e421), purified water, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide. tiny amounts of hydrochloric acid and/or sodium hydroxide are added to keep acidity levels (ph levels) normal. what azarga looks like and contents of the pack azarga is a liquid (white to off-white uniform suspension) supplied in a pack containing one 5 ml plastic bottle with a screw cap or in a pack containing three 5 ml bottles. not all pack sizes may be marketed.", 'Entity_Recognition': [{'Text': 'azarga', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 5, 'EndOffset': 11, 'Score': 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