DuoTrav

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 

DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Each mL of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate). 

 

Excipient(s) with known effect 

 

Each mL of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 5 mg 

and polyoxyethylene hydrogenated castor oil 40 1 mg (see section 4.4). 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Eye drops, solution (eye drops). 

 

Clear, colourless solution. 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

DuoTrav is indicated in adults for the decrease of intraocular pressure (IOP) in patients with 

open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta blockers 

or prostaglandin analogues (see section 5.1). 

 

4.2 Posology and method of administration 
 

Posology 

 

Use in adults, including the elderly 

The dose is one drop of DuoTrav in the conjunctival sac of the affected eye(s) once daily, in the 

morning or evening. It should be administered at the same time each day. 

 

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) daily. 

 

Special populations 

Hepatic and renal impairment 

No studies have been conducted with DuoTrav or with timolol 5 mg/mL eye drops in patients with 

hepatic or renal impairment. 

 

Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with 

mild to severe renal impairment (creatinine clearance as low as 14 mL/min). No dose adjustment was 

necessary in these patients. 

 

Patients with hepatic or renal impairment are unlikely to require dose adjustment with DuoTrav (see 

section 5.2). 

 



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Paediatric population 

The safety and efficacy of DuoTrav in children and adolescents below the age of 18 years have not 

been established. No data are available. 

 

Method of administration 

 

For ocular use. 

 

The patient should remove the protective overwrap immediately prior to initial use. To prevent 

contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding 

areas or other surfaces with the dropper tip of the bottle. 

 

When nasolacrimal occlusion is used or the eyelids are closed for 2 minutes, 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 more than one topical ophthalmic medicinal product is being used, the medicinal products must be 

administered at least 5 minutes apart (see section 4.5). 

 

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

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

 

Patients must be instructed to remove soft contact lenses prior to application of DuoTrav and wait 

15 minutes after instillation of the dose before reinsertion (see section 4.4). 

 

4.3 Contraindications 

 

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

Hypersensitivity to other beta blockers. 

Reactive airway disease including bronchial asthma, or a history of bronchial asthma, severe chronic 

obstructive pulmonary disease. 

Sinus bradycardia, sick sinus syndrome, including sino-atrial block, second- or third-degree 

atrioventricular block not controlled with pacemaker. Overt cardiac failure, cardiogenic shock. Severe 

allergic rhinitis and corneal dystrophies. 

 

4.4 Special warnings and precautions for use 

 

Systemic effects 

 

Like other topically applied ophthalmic agents, travoprost and timolol are absorbed systemically. Due 

to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other 

adverse reactions seen with systemic beta-adrenergic blocking medicinal products may occur. The 

incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic 

administration. For information on how to reduce systemic absorption, see section 4.2. 

 

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 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 their 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. 

 

Respiratory disorders 

 

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

reported following administration of some ophthalmic beta blockers. 

 

DuoTrav 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 in patients with labile diabetes, as beta blockers may mask the signs and symptoms of acute 

hypoglycaemia. 

 

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). 

 

Corneal diseases 

 

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

with caution. 

 

Choroidal detachment 

 

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

timolol, acetazolamide) after filtration procedures. 

 

Other beta-blocking agents 

 

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

when timolol is given to patients already receiving a systemic beta-blocking medicinal product. The 

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

agents is not recommended (see section 4.5). 

 

Surgical anaesthesia 

 

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

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

 

Hyperthyroidism 

 

Beta blockers may mask the signs of hyperthyroidism. 

 



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Skin contact 

 

Prostaglandins and prostaglandin analogues are biologically active substances that may be absorbed 

through the skin. Women who are pregnant or attempting to become pregnant should exercise 

appropriate precautions to avoid direct exposure to the contents of the bottle. In the unlikely event of 

coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the 

exposed area immediately. 

 

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 dose of adrenaline used to treat anaphylactic reactions. 

 

Concomitant therapy 

 

Timolol may interact with other medicinal products (see section 4.5). 

 

The use of two local prostaglandins is not recommended. 

 

Ocular effects 

 

Travoprost may gradually change the eye colour by increasing the number of melanosomes (pigment 

granules) in melanocytes. Before treatment is instituted, patients must be informed of the possibility of 

a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia. The 

long-term effects on the melanocytes and any consequences thereof are currently unknown. The 

change in iris colour occurs slowly and may not be noticeable for months to years. The change in eye 

colour has predominantly been seen in patients with mixed coloured irides, i.e. blue-brown, 

grey-brown, yellow-brown and green-brown; however, it has also been observed in patients with 

brown eyes. Typically, the brown pigmentation around the pupil spreads concentrically towards the 

periphery in affected eyes, but the entire iris or parts of it may become more brownish. After 

discontinuation of therapy, no further increase in brown iris pigment has been observed. 

 

In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of 

travoprost has been reported. 

 

Periorbital and lid changes, including deepening of the eyelid sulcus, have been observed with 

prostaglandin analogues. 

 

Travoprost may gradually change eyelashes in the treated eye(s); these changes were observed in 

about half of the patients in clinical trials and include: increased length, thickness, pigmentation, 

and/or number of lashes. The mechanism of eyelash changes and their long-term consequences are 

currently unknown. 

 

Travoprost has been shown to cause slight enlargement of the palpebral fissure in studies in the 

monkey. However, this effect was not observed during the clinical trials and is considered to be 

species specific. 

 

There is no experience of DuoTrav in inflammatory ocular conditions, nor in neovascular, 

angle-closure, narrow-angle or congenital glaucoma, and only limited experience in thyroid eye 

disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative 

glaucoma. 

 

Macular oedema has been reported during treatment with prostaglandin F2 analogues. Caution is 

recommended when using DuoTrav in aphakic patients, pseudophakic patients with a torn posterior 

lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular 

oedema. 



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In patients with known predisposing risk factors for iritis/uveitis, and in patients with active 

intraocular inflammation, DuoTrav can be used with caution. 

 

Excipients 

 

DuoTrav contains propylene glycol which may cause skin irritation. 

 

DuoTrav contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions. 

 

Patients must be instructed to remove contact lenses prior to application of DuoTrav and wait 

15 minutes after instillation of the dose before reinsertion (see section 4.2). 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

No specific drug interaction studies have been performed with travoprost or timolol. 

 

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

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

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

parasympathomimetics or guanethidine. 

 

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

blockers. 

 

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. 

 

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

has been reported occasionally. 

 

Beta blockers may increase the hypoglycaemic effect of antidiabetic medicinal products. Beta blockers 

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

 

4.6 Fertility, pregnancy and lactation 
 

Women of childbearing potential/contraception 

 

DuoTrav must not be used in women of child-bearing age/potential unless adequate contraceptive 

measures are in place (see section 5.3). 

 

Pregnancy 

 

Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/newborn child. 

 

There are no or limited amount of data from the use of DuoTrav or the individual components in 

pregnant women. Timolol should not be used during pregnancy unless clearly necessary. 

 

Epidemiological studies have not revealed malformative effects but show a risk for intrauterine 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 DuoTrav is 

administered until delivery, the neonate should be carefully monitored during the first days of life. 

 

DuoTrav should not be used during pregnancy unless clearly necessary. For information on how to 

reduce systemic absorption, see section 4.2. 



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Breast-feeding 

 

It is unknown whether travoprost from eye drops is excreted in human breast milk. Animal studies 

have shown excretion of travoprost and metabolites in breast milk. Timolol is excreted in breast milk 

and has the potential to cause serious adverse reactions in the breast-fed infant. 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. For information on how to 

reduce systemic absorption, see section 4.2. 

 

The use of DuoTrav by breast-feeding women is not recommended. 

 

Fertility 

 

There are no data on the effects of DuoTrav on human fertility. Animal studies showed no effect of 

travoprost on fertility at doses up to 75 times the maximum recommended human ocular dose, whereas 

no relevant effect of timolol was noted at this dose level. 

 

4.7 Effects on ability to drive and use machines 
 

DuoTrav has no or negligible influence on the ability to drive and use machines. 

 

As with any eye drops, temporary blurred vision or other visual disturbances may occur. If blurred 

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

machines. 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

In clinical studies involving 2,170 patients treated with DuoTrav the most frequently reported 

treatment-related adverse reaction was ocular hyperaemia (12.0%). 

 

Tabulated summary of adverse reactions 

 

The adverse reactions listed in the table below were observed in clinical studies or with post-marketing 

experience. They are ranked according to system organ class and 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 <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available 

data). Within each frequency grouping, adverse reactions are presented in decreasing order of 

seriousness. 

 

System organ class Frequency Adverse reactions 

Immune system disorders Uncommon Hypersensitivity 

Psychiatric disorders Rare Nervousness 

Not known Depression 

Nervous system disorders Uncommon Dizziness, headache 

Not known Cerebrovascular accident, syncope, paraesthesia 



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Eye disorders Very common Ocular hyperaemia 

Common Punctate keratitis, eye pain, visual disturbance, 

vision blurred, dry eye, eye pruritus, ocular 

discomfort, eye irritation 

Uncommon Keratitis, iritis, conjunctivitis, anterior chamber 

inflammation, blepharitis, photophobia, visual acuity 

reduced, asthenopia, eye swelling, lacrimation 

increased, erythema of eyelid, growth of eyelashes, 

eye allergy, conjunctival oedema, eyelid oedema 

Rare Corneal erosion, meibomianitis, conjunctival 

haemorrhage, eyelid margin crusting, trichiasis, 

distichiasis 

Not known Macular oedema, eyelid ptosis, lid sulcus deepened, 

iris hyperpigmentation, corneal disorder 

Cardiac disorders Uncommon Bradycardia 

Rare Arrhythmia, heart rate irregular 

Not known Cardiac failure, tachycardia, chest pain, palpitations 

Vascular disorders Uncommon Hypertension, hypotension 

Not known Oedema peripheral 

Respiratory, thoracic and 

mediastinal disorders 

Uncommon Dyspnoea, postnasal drip 

Rare Dysphonia, bronchospasm, cough, throat irritation, 

oropharyngeal pain, nasal discomfort 

Not known Asthma 

Gastrointestinal disorders Not known Dysgeusia 

Hepatobiliary disorders Rare Alanine aminotransferase increased, aspartate 

aminotransferase increased 

Skin and subcutaneous tissue 

disorders 

Uncommon Dermatitis contact, hypertrichosis, skin 

hyperpigmentation (periocular) 

Rare Urticaria, skin discolouration, alopecia 

Not known Rash 

Musculoskeletal and 

connective tissue disorders 

Rare Pain in extremity 

Renal and urinary disorders Rare Chromaturia 

General disorders and 

administration site conditions 

Rare Thirst, fatigue 

 



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Additional adverse reactions that have been seen with one of the active substances and may potentially 

occur with DuoTrav: 

 

Travoprost 

 

System organ class MedDRA preferred term 

Immune system disorders Seasonal allergy 

Psychiatric disorders Anxiety, insomnia 

Eye disorders Uveitis, conjunctival follicles, eye discharge, 

periorbital oedema, eyelids pruritus, ectropion, 

cataract, iridocyclitis, ophthalmic herpes simplex, 

eye inflammation, photopsia, eczema eyelids, 

halo vision, hypoaesthesia eye, anterior chamber 

pigmentation, mydriasis, eyelash 

hyperpigmentation, eyelash thickening, visual 

field defect 

Ear and labyrinth disorders Vertigo, tinnitus 

Vascular disorders Blood pressure diastolic decreased, blood 

pressure systolic increased 

Respiratory, thoracic and mediastinal disorders Asthma aggravated, rhinitis allergic, epistaxis, 

respiratory disorder, nasal congestion, nasal 

dryness  

Gastrointestinal disorders Peptic ulcer reactivated, gastrointestinal disorder, 

diarrhoea, constipation, dry mouth, abdominal 

pain, nausea, vomiting 

Skin and subcutaneous tissue disorders Skin exfoliation, hair texture abnormal, dermatitis 

allergic, hair colour changes, madarosis, pruritus, 

hair growth abnormal, erythema 

Musculoskeletal and connective tissue disorders Musculoskeletal pain, arthralgia 

Renal and urinary disorders Dysuria, urinary incontinence 

General disorders and administration site 

conditions 

Asthenia 

Investigations Prostatic specific antigen increased 

 



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Timolol 

 

Like other topically applied ophthalmic medicinal products, timolol is absorbed into the systemic 

circulation. This may cause undesirable effects similar to those seen with systemic beta-blocking 

agents. Additional listed adverse reactions include reactions seen within the class of ophthalmic beta 

blockers. The incidence of systemic ADRs after topical ophthalmic administration is lower than for 

systemic administration. For information on how to reduce systemic absorption, see section 4.2. 

 

System organ class MedDRA preferred term 

Immune system disorders Systemic allergic reactions including 

angioedema, urticaria, localised and generalised 

rash, pruritus, anaphylaxis 

Metabolism and nutrition disorders Hypoglycaemia 

Psychiatric disorders Insomnia, nightmares, memory loss 

Nervous system disorders Cerebral ischaemia, increases in signs and 

symptoms of myasthenia gravis 

Eye disorders Signs and symptoms of ocular irritation (e.g. 

burning, stinging, itching, tearing, redness), 

choroidal detachment following filtration surgery 

(see section 4.4), decreased corneal sensitivity, 

diplopia 

Cardiac disorders Oedema, congestive heart failure, atrioventricular 

block, cardiac arrest 

Vascular disorders Raynaud’s phenomenon, cold hands and feet 

Gastrointestinal disorders Nausea, dyspepsia, diarrhoea, dry mouth, 

abdominal pain, vomiting 

Skin and subcutaneous tissue disorders Psoriasiform rash or exacerbation of psoriasis 

Musculoskeletal and connective tissue disorders Myalgia 

Reproductive system and breast disorders Sexual dysfunction, decreased libido 

General disorders and administration site 

conditions 

Asthenia 

 

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 

 

A topical overdose with DuoTrav is not likely to occur or to be associated with toxicity. 

 

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

bradycardia, hypotension, bronchospasm and heart failure. 

 

If overdose with DuoTrav occurs, treatment should be symptomatic and supportive. Timolol does not 

dialyse readily. 

 

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


11 

 

5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 
 

Pharmacotherapeutic group: Ophthalmologicals; Antiglaucoma preparations and miotics, ATC code: 

S01ED51. 

 

Mechanism of action 

 

DuoTrav contains two active substances: travoprost and timolol maleate. These two components lower 

intraocular pressure by complementary mechanisms of action and the combined effect results in 

additional IOP reduction compared to either compound alone. 

 

Travoprost, a prostaglandin F2α analogue, is a full agonist which is highly selective and has a high 

affinity for the prostaglandin FP receptor, and reduces the intraocular pressure by increasing the 

outflow of aqueous humour via trabecular meshwork and uveoscleral pathways. Reduction of IOP in 

man starts within approximately 2 hours after administration and maximum effect is reached after 

12 hours. Significant lowering of intraocular pressure can be maintained for periods exceeding 

24 hours with a single dose. 

 

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. 

 

Secondary pharmacology 

 

Travoprost significantly increased optic nerve head blood flow in rabbits following 7 days of topical 

ocular administration (1.4 micrograms once daily). 

 

Pharmacodynamic effects 

 

Clinical effects 

In a twelve-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 DuoTrav 

dosed once daily in the morning was 8 to 10 mmHg. The non-inferiority of DuoTrav as compared to 

latanoprost 50 micrograms/mL + timolol 5 mg/mL in the mean IOP reduction was demonstrated 

across all time-points at all visits. 

 

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

and baseline mean IOP of 27 to 30 mmHg, the mean IOP-lowering effect of DuoTrav dosed once daily 

in the morning was 9 to 12 mmHg, and was up to 2 mmHg greater than that of travoprost 

40 micrograms/mL dosed once daily in the evening and 2 to 3 mmHg greater than that of timolol 

5 mg/mL dosed twice daily. A statistically superior reduction in morning mean IOP (08:00, 24 hours 

after the last dose of DuoTrav) was observed compared to travoprost at all visits throughout the study. 

 

In two three-month controlled clinical studies in patients with open-angle glaucoma or ocular 

hypertension and baseline mean IOP of 23 to 26 mmHg, the mean IOP-lowering effect of DuoTrav 

dosed once daily in the morning was 7 to 9 mmHg. Mean IOP reductions were non-inferior, although 

numerically lower, to those achieved by concomitant therapy with travoprost 40 micrograms/mL 

dosed once daily in the evening and timolol 5 mg/mL dosed once daily in the morning. 

 

In a 6-week controlled clinical study in patients with open-angle glaucoma or ocular hypertension and 

baseline mean IOP of 24 to 26 mmHg, the mean IOP-lowering effect of DuoTrav 

(polyquaternium-1-preserved) dosed once daily in the morning was 8 mmHg and equivalent to that of 

DuoTrav (benzalkonium chloride-preserved). 



12 

 

Inclusion criteria were common across the studies, with the exception of the IOP entry criteria and 

response to previous IOP therapy. The clinical development of DuoTrav included both patients naive 

and on therapy. Insufficient responsiveness to monotherapy was not an inclusion criterion. 

 

Existing data suggest that evening dosing might have some advantages as regards mean IOP reduction. 

Consideration should be given to patient convenience and their likely compliance when 

recommending morning vs. evening dosing. 

 

5.2 Pharmacokinetic properties 
 

Absorption 

 

Travoprost and timolol are absorbed through the cornea. Travoprost is a prodrug that undergoes rapid 

ester hydrolysis in the cornea to the active free acid. Following once-daily administration of DuoTrav 

PQ in healthy subjects (N=22) for 5 days, travoprost free acid was not quantifiable in plasma samples 

from the majority of subjects (94.4%) and generally was not detectable one hour after dosing. When 

measurable (0.01 ng/mL, the assay limit of quantitation), concentrations ranged from 

0.01 to 0.03 ng/mL. The mean timolol steady-state Cmax was 1.34 ng/ml and Tmax was approximately 

0.69 hours after once-daily administration of DuoTrav. 

 

Distribution 

 

Travoprost free acid can be measured in the aqueous humour during the first few hours in animals and 

in human plasma only during the first hour after ocular administration of DuoTrav. Timolol can be 

measured in human aqueous humour after ocular administration of timolol and in plasma for up to 

12 hours after ocular administration of DuoTrav. 

 

Biotransformation 

 

Metabolism is the major route of elimination of both travoprost and the active free acid. The systemic 

metabolic pathways parallel those of endogenous prostaglandin F2 which are characterised by 

reduction of the 13-14 double bond, oxidation of the 15-hydroxyl and -oxidative cleavages of the 

upper side chain. 

 

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

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

similar side chain with a carbonyl group adjacent to the nitrogen. The plasma t1/2 of timolol is 4 hours 

after ocular administration of DuoTrav. 

 

Elimination 

 

Travoprost free acid and its metabolites are mainly excreted by the kidneys. Less than 2% of an ocular 

dose of travoprost was recovered in urine as free acid. 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. 

 

5.3 Preclinical safety data 
 

In monkeys, administration of DuoTrav twice daily was shown to induce increased palpebral fissure 

and to increase iris pigmentation similar to that observed with ocular administration of prostanoids. 

 

DuoTrav preserved with polyquaternium-1 induced minimal ocular surface toxicity, compared to eye 

drops preserved with benzalkonium chloride, on cultured human corneal cells and following topical 

ocular administration in rabbits. 

 



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Travoprost 

 

Topical ocular administration of travoprost to monkeys at concentrations of up to 0.012% to the right 

eye, twice daily for one year resulted in no systemic toxicity. 

 

Reproduction toxicity studies with travoprost have been undertaken in rats, mice and rabbits using the 

systemic route. Findings are related to FP receptor agonist activity in uterus with early 

embryolethality, post-implantation loss and foetotoxicity. In pregnant rats, systemic administration of 

travoprost at doses more than 200 times the clinical dose during the period of organogenesis resulted 

in an increased incidence of malformations. Low levels of radioactivity were measured in amniotic 

fluid and foetal tissues of pregnant rats administered 
3
H-travoprost. Reproduction and development 

studies have demonstrated a potent effect on foetal loss with a high rate observed in rats and mice 

(180 pg/mL and 30 pg/mL plasma, respectively) at exposures 1.2 to 6 times the clinical exposure (up 

to 25 pg/mL). 

 

Timolol 

 

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

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

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

postnatal development (7000 times the clinical dose) and increased foetal resorptions in rabbits 

(14000 times the clinical dose). 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Polyquaternium-1 

Mannitol (E421) 

Propylene glycol (E1520) 

Polyoxyethylene hydrogenated castor oil 40 (HCO-40) 

Boric acid 

Sodium chloride 

Sodium hydroxide and/ or hydrochloric acid (for pH adjustment) 

Purified water 

 

6.2 Incompatibilities 
 

Not applicable. 

 

6.3 Shelf life 
 

2 years. 

 

Discard 4 weeks after first opening. 

 

6.4 Special precautions for storage 
 

Do not store above 30°C. 

 



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6.5 Nature and contents of container 
 

2.5 mL oval polypropylene (PP) or low-density polyethylene (LDPE) bottle and PP or LDPE 

dispensing plug  with PP screw cap, presented in an overwrap. 

 

Pack sizes of 1, 3 or 6 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/1/06/338/001-6 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 24 April 2006 

Date of last renewal: 07 October 2010 

 

 

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/


15 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 



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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturers responsible for batch release 

 

S.A. Alcon Couvreur N.V. 

Rijksweg 14 

B-2870 Puurs 

Belgium 

 

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. 

 



17 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



18 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
A. LABELLING 



19 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON FOR SINGLE BOTTLE 2.5 mL + CARTON FOR 3 x 2.5 mL BOTTLES + CARTON 

FOR 6 x 2.5 mL BOTTLES 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution 

travoprost/timolol 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each mL of solution contains 40 micrograms travoprost and 5 mg timolol (as timolol maleate). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains: Polyquaternium-1, mannitol (E421), propylene glycol (E1520), polyoxyethylene 

hydrogenated castor oil 40 (HCO-40), boric acid, sodium chloride, sodium hydroxide and/or 

hydrochloric acid (to adjust pH), purified water. 

 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS  

 

Eye drops, solution. 

 

1 x 2.5 mL 

3 x 2.5 mL 

6 x 2.5 mL 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Ocular use 

Read the package leaflet before use. 

 

 

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

OF THE REACH AND SIGHT OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 



20 

 

8. EXPIRY DATE 

 

EXP 

Discard 4 weeks after first opening. 

Opened: 

Opened (1): 

Opened (2): 

Opened (3): 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

 

 

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/1/06/338/001 1 x 2.5 ml – PP bottle 

EU/1/06/338/002 3 x 2.5 ml – PP bottle 

EU/1/06/338/003 6 x 2.5 ml – PP bottle 

EU/1/06/338/004 1 x 2.5 ml – LDPE bottle 

EU/1/06/338/005 3 x 2.5 ml – LDPE bottle 

EU/1/06/338/006 6 x 2.5 ml – LDPE bottle 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 



21 

 

15. INSTRUCTIONS ON USE 

 

 

16 INFORMATION IN BRAILLE 

 

duotrav 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 
 



22 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

BOTTLE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 

 

DuoTrav 40 micrograms/mL + 5 mg/mL eye drops 

travoprost/timolol 

Ocular use 

 

 

2. METHOD OF ADMINISTRATION 

 

Read the package leaflet before use. 

Open here 

 

 

3. EXPIRY DATE 

 

EXP 

Discard 4 weeks after first opening. 

Opened: 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

2.5 mL 

 

 

6 OTHER 



23 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

OVERWRAP 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 

 

DuoTrav 40 micrograms/mL + 5 mg/mL eye drops 

travoprost/timolol 

 

 

2. METHOD OF ADMINISTRATION 

 

Read the package leaflet before use. 

 

 

3. EXPIRY DATE 

 

EXP 

Discard 4 weeks after first opening. 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

2.5 mL 

 

 

6 OTHER 



24 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



25 

Package leaflet: Information for the user 
 

DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution 

travoprost/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 illness 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 DuoTrav is and what it is used for 

2. What you need to know before you use DuoTrav 

3. How to use DuoTrav 

4. Possible side effects 

5. How to store DuoTrav 

6. Contents of the pack and other information  

 

 

1. What DuoTrav is and what it is used for 

 

DuoTrav eye drop solution is a combination of two active substances (travoprost and timolol). 

Travoprost is a prostaglandin analogue which works by increasing the outflow of aqueous fluid from 

the eye, which lowers its pressure. Timolol is a beta blocker which works by reducing the production 

of fluid within the eye. The two substances work together to reduce pressure within the eye. 

 

DuoTrav eye drops are used to treat high pressure in the eye in adults, including the elderly. This 

pressure can lead to an illness called glaucoma. 

 

 

2. What you need to know before you use DuoTrav 

 

Do not use DuoTrav 

 if you are allergic to travoprost, prostaglandins, timolol, beta blockers 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 chronic 
obstructive bronchitis (severe lung disease which may cause wheeziness, 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 heartbeat, heart failure or a disorder of heart rhythm (irregular heartbeat). 

 if the surface of your eye is cloudy. 
 

Ask your doctor for advice if any of these applies to you. 

 



26 

Warning and precautions 

Talk to your doctor before using DuoTrav if you have now 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 heartbeat. 

 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). 

 myasthenia gravis (chronic neuromuscular weakness). 

 cataract surgery. 

 eye inflammation. 
 

If you need to have any type of surgery, tell your doctor that you are using DuoTrav as timolol may 

change the effects of some medicines used during anaesthesia. 

 

If you get any severe allergic reaction (skin rash, redness and itching of the eye) while  using 

DuoTrav, whatever the cause, adrenaline treatment may not be as effective. It is therefore important to 

tell the doctor that you are using DuoTrav when you are to receive any other treatment. 

 

DuoTrav may change the colour of your iris (the coloured part of your eye). This change may be 

permanent. 

 

DuoTrav may increase the length, thickness, colour and/or number of your eyelashes and may cause 

unusual hair growth on your eyelids. 

 

Travoprost may be absorbed through the skin and therefore should not be used by women who are 

pregnant or are attempting to become pregnant. If any of the medicine comes into contact with the skin 

then it should be washed off straight away. 

 

Children 

DuoTrav is not to be used by children and adolescents under 18 years of age. 

 

Other medicines and DuoTrav 

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

medicines, including medicines obtained without a prescription. 

 

DuoTrav can affect or be affected by other medicines you are using, including other eye drops for the 

treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower blood 

pressure, heart medicines including quinidine (used to treat heart conditions and some types of 

malaria), medicines to treat diabetes or the antidepressants fluoxetine or paroxetine. 

 

Pregnancy, breast-feeding and fertility 

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

your doctor for advice before taking this medicine. 

 

Do not use DuoTrav if you are pregnant unless your doctor considers it necessary. If you could get 

pregnant you must use adequate contraception whilst you use the medicine. 

 

Do not use DuoTrav if you are breast-feeding. DuoTrav may get into your milk. 

 

Driving and using machines 

You may find that your vision is blurred for a time just after you use DuoTrav. Do not drive or use 

machines until this has worn off. 

 



27 

DuoTrav contains hydrogenated castor oil and propylene glycol which may cause skin reactions 

and irritation. 

 

 

3. How to use DuoTrav 

 

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

you are not sure. 

 

The recommended dose is one drop in the affected eye or eyes once a day in the morning or in the 

evening. Use at the same time each day. 

 

Only use DuoTrav in both eyes if your doctor told you to do so. 

 

Only use DuoTrav as eye drops. 

 

    
1 2 3 4 

 

 Immediately before using a bottle for the first time, tear open the overwrap (picture 1), remove 
the bottle and write the date of opening on the label in the space provided. 

 Make sure you have a mirror available. 

 Wash your hands. 

 Twist off the bottle cap. 

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

 Tilt your head back. Pull your lower eyelid down with a clean finger until there is a “pocket” 
between the eyelid and your eye. The drop will go in here (picture 2). 

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

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

 Gently squeeze the bottle to release one drop of DuoTrav at a time (picture 3). If a drop misses 
your eye, try again. 

 After using DuoTrav, press your finger into the corner of your eye by your nose for 2 minutes 
(picture 4). This helps to stop DuoTrav getting into the rest of the body. 

 If you have to use DuoTrav in both eyes, repeat the above steps for your other eye. 

 Close the bottle cap firmly immediately after use. 

 Only use one bottle at a time. Do not open the overwrap until you need to use the bottle. 
 

Use DuoTrav for as long as your doctor has told you to. 

 

If you use more DuoTrav than you should 
If you use more DuoTrav than you should, rinse it all out with warm water. Do not put in any more 

drops until it is time for your next regular dose. 

 

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

make up for the forgotten dose. The dose should not exceed one drop daily in the affected eye(s). 

 



28 

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

controlled, which could lead to loss of sight. 

 

If you are using other eye drops in addition to DuoTrav, leave at least 5 minutes between applying 

DuoTrav and the other drops. 

 

If you wear soft contact lenses do not use the drops with your lenses in. After using the drops wait 

15 minutes before putting your lenses back in. 

 

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. 

 

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

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

 

Very common side effects (may affect more than 1 in 10 people) 
Effects in the eye 

Eye redness. 

 

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

Eye surface inflammation with surface damage, eye pain, blurred vision, abnormal vision, dry eye, 

itchy eye, eye discomfort, signs and symptoms of eye irritation (e.g. burning, stinging). 

 

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

Inflammation of the eye surface, inflammation of the eyelid, swollen conjunctiva, increased growth of 

eyelashes, iris inflammation, eye inflammation, sensitivity to light, reduced vision, tired eyes, eye 

allergy, eye swelling, increased tear production, eyelid redness, eyelid colour change, skin darkening 

(around the eye). 

 

General side effects 

Allergic reaction to active substance, dizziness, headache, increased or decreased blood pressure, 

shortness of breath, excessive hair growth, drip at back of throat, skin inflammation and itching, 

decreased heart rate. 

 

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

Thinning of the eye surface, inflammation of the eyelid glands, broken blood vessel in the eye, eyelid 

crusting, abnormally positioned eyelashes, abnormal growth of lashes. 

 

General side effects 

Nervousness, irregular heart rate, loss of hair, voice disorders, difficulty breathing, cough, throat 

irritation, hives, abnormal liver blood tests, skin discolouration, thirst, tiredness, discomfort inside of 

nose, coloured urine, pain in hands and feet. 

 



29 

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

Droopy eyelid (making the eye stay half closed), sunken eyes (eyes appear more inset), changes in the 

colour of the iris (coloured part of the eye). 

 

General side effects 

Rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, numbness or 

tingling sensation, palpitations, swelling in the lower limbs, bad taste. 

 

Additionally: 
DuoTrav is a combination of two active substances, travoprost and timolol. Like other medicines 

administered to the eyes, travoprost and timolol (a beta blocker) are absorbed into the blood. This may 

cause side effects similar to those seen when beta-blocking medicines that are administered by mouth 

or by injection. The incidence of side effects after administration to the eyes is lower than after 

administration by mouth or by injection. 

 

The side effects listed below include reactions seen with the class of beta blockers used for treating 

eye conditions or reactions seen with travoprost alone: 

 

Effects in the eye 

Inflammation of the eyelid, inflammation in the cornea, detachment of the layer below the retina that 

contains blood vessels following filtration surgery which may cause visual disturbances, decreased 

corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye 

discharge, swelling around the eye, eyelid itching, outward turning of eyelid with redness, irritation 
and excessive tears, blurred vision (sign of clouding of the eye lens), swelling of a section of the eye 

(uvea), eczema of the eyelids, halo vision, decreased eye sensation, pigmentation inside the eye, 

dilatated pupils, change in eyelash colour, change in the texture of the eyelashes, abnormal field of 

vision. 

 

General side effects 

Ear and labyrinth disorders: dizziness with spinning sensation, ringing in the ears. 

 

Heart and circulation: slow heart rate, palpitations, oedema (fluid build-up), changes in heartbeat 

rhythm or speed, congestive heart failure (heart disease with shortness of breath and swelling of the 

feet and legs due to fluid build-up), a type of heart rhythm disorder, heart attack, low blood pressure, 

Raynaud’s phenomenon, cold hands and feet, reduced blood supply to the brain. 

 

Respiratory: constriction of the airways in the lungs (predominantly in patients with pre-existing 

disease), runny or stuffy nose, sneezing (due to allergy), difficulty breathing, nose bleed, nasal 

dryness. 

 

Nervous system and general disorders: difficulty sleeping (insomnia), nightmares, memory loss, loss 

of strength and energy, anxiety (excessive emotional distress). 

 

Gastrointestinal: taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, 

vomiting and constipation. 

 

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, localised and generalised rash, itchiness, severe sudden 

life-threatening allergic reaction. 

 

Skin: skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, 

peeling skin, abnormal hair texture, inflammation of the skin with itchy rash and redness, hair colour 

change, loss of eyelashes, itching, abnormal hair growth, skin redness. 

 



30 

Muscular: increases in signs and symptoms of myasthenia gravis (muscle disorder), unusual 

sensations like pins and needles, muscle weakness/tiredness, muscle pain not caused by exercise, joint 

pain. 

 

Renal and urinary disorders: difficulty and pain when passing urine, involuntary leakage of urine,  

 

Reproduction: sexual dysfunction, decreased libido. 

 

Metabolism: low blood sugar levels, increase in prostate cancer marker. 

 

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. 

 

 

5. How to store DuoTrav 

 

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 label and carton after EXP. 

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

 

Do not store above 30°C. 

 

You must throw away the bottle 4 weeks after you first opened it to prevent the risk of infections. 

Each time you start a new bottle write down the date you open it in the spaces on the bottle label and 

carton. 

 

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

throw away medicines you longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What DuoTrav contains 

 

- The active substances are travoprost and timolol. Each mL of solution contains 40 micrograms 
of travoprost and 5 mg of timolol (as timolol maleate). 

- The other ingredients are Polyquaternium-1, mannitol (E421), propylene glycol (E1520), 
polyoxyethylene hydrogenated castor oil 40, boric acid, sodium chloride, sodium hydroxide or 

hydrochloric acid (to adjust pH), purified water. 

Tiny amounts of sodium hydroxide or hydrochloric acid are added to keep acidity levels (pH 

levels) normal. 

 

What DuoTrav looks like and contents of the pack 

DuoTrav is a liquid (a clear, colourless solution) supplied in a 2.5 mL plastic bottle with a screw cap. 

Each bottle is packed in an overwrap. 

 

Packs of 1, 3 or 6 bottles. 

 

Not all pack sizes may be marketed. 

 

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


31 

Marketing Authorisation Holder 
Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

S.A. Alcon-Couvreur N.V. 

Rijksweg 14 

B-2870 Puurs 

Belgium 

 

Alcon Cusí, S.A. 

Camil Fabra 58 

08320 El Masnou 

Spain 

 

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 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 

 



32 

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 

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(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