Ganfort

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (as 6.8 mg of timolol maleate). 
 
Excipient with known effect 
Each ml of solution contains 0.05 mg of benzalkonium chloride. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Eye drops, solution. 
 
Colourless to slightly yellow solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular 
hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. 
 
4.2 Posology and method of administration 
 
Posology 
Recommended dosage in adults (including older people) 
The recommended dose is one drop of GANFORT in the affected eye(s) once daily, administered 
either in the morning or in the evening. It should be administered at the same time each day. 
 
Existing literature data for GANFORT suggest that evening dosing may be more effective in IOP 
lowering than morning dosing. However, consideration should be given to the likelihood of 
compliance when considering either morning or evening dosing (see section 5.1). 
 
If one dose is missed, treatment should continue with the next dose as planned. The dose should not 
exceed one drop in the affected eye(s) daily. 
 
Renal and hepatic impairment 
GANFORT has not been studied in patients with hepatic or renal impairment. Therefore caution 
should be used in treating such patients.   
 
Paediatric population 
The safety and efficacy of GANFORT in children aged 0 to 18 years has not been established. No data 
are available. 

Method of administration 
If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at 
least 5 minutes apart. 
 
When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is 
reduced. This may result in a decrease in systemic side effects and an increase in local activity. 



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4.3 Contraindications 
 
 Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
 Reactive airway disease including bronchial asthma or a history of bronchial asthma, 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. 
 
4.4 Special warnings and precautions for use 
 
Like other topically applied ophthalmic medicinal products, the active substances (timolol/ 
bimatoprost) in GANFORT may be absorbed systemically. No enhancement of the systemic 
absorption of the individual active substances has been observed. Due to the beta-adrenergic 
component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions as seen 
with systemic beta-blockers may occur. Incidence of systemic ADRs after topical ophthalmic 
administration is lower than for systemic administration. To reduce the systemic absorption, see 
section 4.2. 
 
Cardiac disorders 
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 its negative effect on conduction time, beta-blockers should only be given with caution to 
patients with first degree heart block. 

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. 
 
GANFORT 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. 
 
Endocrine disorders 
Beta-adrenergic blocking medicinal products should be administered with caution in patients subject 
to spontaneous hypoglycemia or to patients with labile diabetes as beta-blockers may mask the signs 
and symptoms of acute hypoglycemia. 
 
Beta-blockers may also mask the signs of hyperthyroidism. 
 
Corneal diseases 
Ophthalmic β-blockers may induce dryness of eyes. Patients with corneal diseases should be treated 
with caution. 
 
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 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 is 
not recommended (see section 4.5). 
 
Anaphylactic reactions 



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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. 
 
Choroidal detachment 
Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. 
timolol, acetazolamide) after filtration procedures. 
 
Surgical anaesthesia 
β-blocking ophthalmological preparations may block systemic β-agonist effects e.g. of adrenaline. The 
anaesthesiologist should be informed when the patient is receiving timolol. 
 
Hepatic 
In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate 
aminotransferase (AST) and/or bilirubin at baseline, bimatoprost had no adverse reactions on liver 
function over 24 months. There are no known adverse reactions of ocular timolol on liver function. 
 
Ocular  
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, 
darkening of the eyelid or periocular skin and increased brown iris pigmentation since these have been 
observed during treatment with bimatoprost and GANFORT. Increased iris pigmentation is likely to 
be permanent, and may lead to differences in appearance between the eyes if only one eye is treated. 
After discontinuation of GANFORT, pigmentation of iris may be permanent. After 12 months 
treatment with GANFORT, the incidence of iris pigmentation was 0.2%. After 12 months treatment 
with bimatoprost eye drops alone, the incidence was 1.5% and did not increase following 3 years 
treatment. The pigmentation change is due to increased melanin content in the melanocytes rather than 
to an increase in the number of melanocytes. The long term effects of increased iridial pigmentation 
are not known.  Iris colour changes seen with ophthalmic administration of bimatoprost may not be 
noticeable for several months to years. Neither nevi nor freckles of the iris appear to be affected by 
treatment. Periorbital tissue pigmentation has been reported to be reversible in some patients. 
 
Macular oedema, including cystoid macular oedema, has been reported with GANFORT. Therefore, 
GANFORT should be used with caution in aphakic patients, in pseudophakic patients with a torn 
posterior lens capsule, or in patients with known risk factors for macular oedema (e.g. intraocular 
surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy).   
GANFORT should be used with caution in patients with active intraocular inflammation (e.g. uveitis) 
because the inflammation may be exacerbated. 
 
Skin  
There is a potential for hair growth to occur in areas where GANFORT solution comes repeatedly in 
contact with the skin surface. Thus, it is important to apply GANFORT as instructed and avoid it 
running onto the cheek or other skin areas.  
 
Excipients 
The preservative in GANFORT, benzalkonium chloride, may cause eye irritation. Contact lenses must 
be removed prior to application, with at least a 15-minute wait before reinsertion. Benzalkonium 
chloride is known to discolour soft contact lenses.  Contact with soft contact lenses must be avoided. 
 
Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative 
keratopathy. Therefore monitoring is required with frequent or prolonged use of GANFORT in dry 
eye patients or where the cornea is compromised. 
 
Other conditions 
GANFORT has not been studied in patients with inflammatory ocular conditions, neovascular, 
inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma. 
 



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In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been 
shown that more frequent exposure of the eye to more than 1 dose of bimatoprost daily may decrease 
the IOP-lowering effect. Patients using GANFORT with other prostaglandin analogues should be 
monitored for changes to their intraocular pressure. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No specific interaction studies have been performed with the bimatoprost / timolol fixed combination. 
 
There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when  
ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers, 
guanethidine, beta-adrenergic blocking agents, parasympathomimetics, anti-arrhythmics (including 
amiodarone) and digitalis glycosides. 
 
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. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no adequate data from the use of the bimatoprost / timolol fixed combination in pregnant 
women. GANFORT should not be used during pregnancy unless clearly necessary. To reduce the 
systemic absorption, see section 4.2. 
 
Bimatoprost 
No adequate clinical data in exposed pregnancies are available. Animal studies have shown 
reproductive toxicity at high maternotoxic doses (see section 5.3). 
 
Timolol  
Epidemiological studies have not revealed malformative effects but shown 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 
GANFORT is administered until delivery, the neonate should be carefully monitored during the first 
days of life. Animal studies with timolol have shown reproductive toxicity at doses significantly 
higher than would be used in clinical practice (see section 5.3).  
 
Breast-feeding 
 
Timolol  
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. 
 
Bimatoprost 
It is not known if bimatoprost is excreted in human breast milk but it is excreted in the milk of the 
lactating rat. GANFORT should not be used by breast-feeding women. 
 
Fertility 
There are no data on the effects of GANFORT on human fertility. 
 
4.7 Effects on ability to drive and use machines 
 



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GANFORT has negligible influence on the ability to drive and use machines. As with any ocular 
treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears 
before driving or using machines. 
 
4.8 Undesirable effects 
 
GANFORT 
Summary of the safety profile 
The adverse reactions reported in clinical studies using GANFORT were limited to those earlier 
reported for either of the single active substances bimatoprost and timolol. No new adverse reactions 
specific for GANFORT have been observed in clinical studies.  
 
The majority of adverse reactions reported in clinical studies using GANFORT were ocular, mild in 
severity and none were serious. Based on 12-month clinical data, the most commonly reported adverse 
reaction was conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory 
nature) in approximately 26% of patients and led to discontinuation in 1.5% of patients. 
 
Tabulated list of adverse reactions 
Table 1 presents the adverse reactions that have been reported during clinical studies with all 
GANFORT formulations (multi-dose and single-dose) (within each frequency grouping, adverse 
reactions are presented in order of decreasing seriousness) or in the post-marketing period. 
 
The frequency of possible adverse reactions listed below is defined using 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 
Not known Frequency cannot be estimated from available data 
 
Table 1 
 
System Organ Class Frequency Adverse reaction 
Immune system disorders Not known hypersensitivity reactions 

including signs or symptoms of 
allergic dermatitis, angioedema, 
eye allergy 

Psychiatric disorders Not known Insomnia2, nightmare2 
Nervous system disorders 
 

Common headache 
Not known Dysgeusia2, dizziness 

Eye disorders 
 

Very common conjunctival hyperaemia. 
Common punctuate keratitis, corneal 

erosion2, burning sensation2, 
conjunctival irritation1, eye 
pruritus, stinging sensation in 
the eye2, foreign body sensation, 
dry eye, erythema of eyelid, eye 
pain, photophobia, eye 
discharge, visual disturbance2, 
eyelid pruritus, visual acuity 
worsened2, blepharitis2, eyelid 
oedema, eye irritation, 
lacrimation increased, growth of 
eyelashes. 

 Uncommon iritis2, conjunctival oedema2, 



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eyelid pain2, abnormal sensation 
in the eye1, asthenopia, 
trichiasis2, iris 
hyperpigmentation2, deepening 
of eyelid sulcus, eyelid 
retraction2, eyelash 
discolouration (darkening)1. 

 Not known cystoid macular oedema2, eye 
swelling, vision blurred2, ocular 
discomfort 

Cardiac disorders Not known Bradycardia 
Vascular disorders Not known Hypertension 
Respiratory, thoracic and 
mediastinal disorders 
 

Common Rhinitis2 
Uncommon dyspnoea 

 Not known bronchospasm (predominantly 
in patients with pre-existing 
bronchospastic disease) 2, 
asthma  

Skin and subcutaneous tissue 
disorders 
 

Common blepharal pigmentation2, 
hirsutism2, skin 
hyperpigmentation (periocular). 

Not known Alopecia, skin discolouration 
(periocular) 

General disorders and 
administration site conditions 

Not known fatigue 

1adverse reactions only observed with Ganfort single-dose formulation 
2adverse reactions only observed with Ganfort multi-dose formulation  
 
Like other topically applied ophthalmic drugs, GANFORT (bimatoprost/timolol) is absorbed into the 
systemic circulation. Absorption of timolol may cause similar undesirable effects as seen with 
systemic beta-blocking agents.  The incidence of systemic ADRs after topical ophthalmic 
administration is lower than for systemic administration. To reduce the systemic absorption, see 
section 4.2. 
 
Additional adverse reactions that have been seen with either of the active substances (bimatoprost or 
timolol), and may potentially occur also with GANFORT are listed below in Table 2: 
 
Table 2 
 
System Organ Class Adverse reaction 
Immune system disorders systemic allergic reactions including 

anaphylaxis1 
Metabolism and nutrition disorders hypoglycaemia1 
Psychiatric disorders depression1, memory loss1, hallucination1 
Nervous system disorders syncope1, cerebrovascular accident1, increase in 

signs and symptoms of myasthenia gravis1, 
paraesthesia1, cerebral ischaemia1 

Eye disorders decreased corneal sensitivity1, diplopia1, ptosis1, 
choroidal detachment following filtration surgery 
(see section 4.4)1, keratitis1, blepharospasm2, 
retinal haemorrhage2, uveitis2,  

Cardiac disorder atrioventricular block1, cardiac arrest1, 
arrhythmia1, cardiac failure1, congestive heart 
failure1, chest pain1, palpitations1, oedema1 

Vascular disorders hypotension1, Raynaud’s phenomenon1, cold 



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hands and feet1 
Respiratory, thoracic and mediastinal disorders Asthma exacerbation2, COPD exacerbation2, 

cough1 
Gastrointestinal disorders nausea1,2, diarrhoea1, dyspepsia1, dry mouth1, 

abdominal pain1, vomiting1 
Skin and subcutaneous tissue disorders psoriasiform rash1 or exacerbation of psoriasis1, 

skin rash1 
Musculoskeletal and connective tissue disorders myalgia1  
Reproductive system and breast disorders sexual dysfunction1, decreased libido1 
General disorders and administration site 
conditions 

asthenia1,2 

Investigations liver function tests (LFT) abnormal2 
1 adverse reactions observed with Timolol  
2 adverse reactions observed with Bimatoprost  
 
Adverse reactions reported in phosphate containing eye drops 
 
Cases of corneal calcification have been reported very rarely in association with the use of phosphate 
containing eye drops in some patients with significantly damaged corneas. 
 
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 GANFORT is not likely to occur or to be associated with toxicity. 
 
Bimatoprost 
If GANFORT is accidentally ingested, the following information may be useful: in two-week oral rat 
and mouse studies, doses of bimatoprost up to 100 mg/kg/day did not produce any toxicity. This dose 
expressed as mg/m2 is at least 70-times higher than the accidental dose of one bottle of GANFORT in 
a 10 kg child. 
 
Timolol 
Symptoms of systemic timolol overdose include: bradycardia, hypotension, bronchospasm, headache, 
dizziness, shortness of breath, and cardiac arrest.  A study of patients with renal failure showed that 
timolol did not dialyse readily. 
 
If overdose occurs treatment should be symptomatic and supportive. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Ophthalmological,– beta-blocking agents – ATC code: S01ED51 
 
Mechanism of action 
GANFORT consists of two active substances: bimatoprost and timolol. These two components 
decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and the 
combined effect results in additional IOP reduction compared to either compound administered alone. 
GANFORT has a rapid onset of action. 
 



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Bimatoprost is a potent ocular hypotensive active substance .  It is a synthetic prostamide, structurally 
related to prostaglandin F2α (PGF2α) that does not act through any known prostaglandin receptors.  
Bimatoprost selectively mimics the effects of newly discovered biosynthesised substances called 
prostamides.  The prostamide receptor, however, has not yet been structurally identified.  The 
mechanism of action by which bimatoprost reduces intraocular pressure in man is by increasing 
aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow. 
 
Timolol is a beta1 and beta2 non-selective adrenergic receptor blocking agent that does not have 
significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic 
(membrane-stabilising) activity.  Timolol lowers IOP by reducing aqueous humour formation.  The 
precise mechanism of action is not clearly established, but inhibition of the increased cyclic AMP 
synthesis caused by endogenous beta-adrenergic stimulation is probable.  
 
Clinical effects 
The IOP-lowering effect of GANFORT is non-inferior to that achieved by adjunctive therapy of 
bimatoprost (once daily) and timolol (twice daily). 
 
Existing literature data for GANFORT suggest that evening dosing may be more effective in IOP 
lowering than morning dosing. However, consideration should be given to the likelihood of 
compliance when considering either morning or evening dosing. 
 
Paediatric population 
The safety and efficacy of GANFORT in children aged 0 to 18 years has not been established. 

5.2 Pharmacokinetic properties 
 
GANFORT medicinal product 
Plasma bimatoprost and timolol concentrations were determined in a crossover study comparing the 
monotherapy treatments to GANFORT treatment in healthy subjects.  Systemic absorption of the 
individual components was minimal and not affected by co-administration in a single formulation. 
 
In two 12-month studies where systemic absorption was measured, no accumulation was observed 
with either of the individual components. 
 
Bimatoprost 
Bimatoprost penetrates the human cornea and sclera well in vitro.  After ocular administration, the 
systemic exposure of bimatoprost is very low with no accumulation over time. After once daily ocular 
administration of one drop of 0.03% bimatoprost to both eyes for two weeks, blood concentrations 
peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025 
ng/ml) within 1.5 hours after dosing.  Mean Cmax and AUC 0-24hrs values were similar on days 7 and 14 
at approximately 0.08 ng/ml and 0.09 ng•hr/ml respectively, indicating that a steady drug 
concentration was reached during the first week of ocular dosing. 
 
Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in 
humans at steady-state was 0.67 1/kg. In human blood, bimatoprost resides mainly in the plasma. The 
plasma protein binding of bimatoprost is approximately 88%. 
 
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation 
following ocular dosing. Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to 
form a diverse variety of metabolites. 
 
Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered 
to healthy volunteers was excreted in the urine, 25% of the dose was excreted via the faeces. The 
elimination half-life, determined after intravenous administration, was approximately 45 minutes; the 
total blood clearance was 1.5 1/hr/kg. 
 



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Characteristics in older people 
After twice daily dosing, the mean AUC 0-24hrs value of 0.0634 ng•hr/ml bimatoprost in the elderly 
(subjects 65 years or older) were significantly higher than 0.0218 ng•hr/ml in young healthy adults. 
However, this finding is not clinically relevant as systemic exposure for both elderly and young 
subjects remained very low from ocular dosing. There was no accumulation of bimatoprost in the 
blood over time and the safety profile was similar in elderly and young patients. 
 
Timolol 
After ocular administration of a 0.5% eye drops solution in humans undergoing cataract surgery, peak 
timolol concentration was 898 ng/ml in the aqueous humour at one hour post-dose.  Part of the dose is 
absorbed systemically where it is extensively metabolised in the liver. The half-life of timolol in 
plasma is about 4 to 6 hours.  Timolol is partially metabolised by the liver with timolol and its 
metabolites excreted by the kidney.  Timolol is not extensively bound to plasma.  
 
5.3 Preclinical safety data 
 
GANFORT medicinal product 
Repeated dose ocular toxicity studies on GANFORT showed no special hazard for humans. The ocular 
and systemic safety profile of the individual components is well established. 
 
Bimatoprost 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, genotoxicity, carcinogenic potential. Studies in rodents produced species-specific 
abortion at systemic exposure levels 33- to 97-times that achieved in humans after ocular 
administration.  
 
Monkeys administered ocular bimatoprost concentrations of ≥0.03% daily for 1 year had an increase 
in iris pigmentation and reversible dose-related periocular effects characterised by a prominent upper 
and/or lower sulcus and widening of the palpebral fissure. The increased iris pigmentation appears to 
be caused by increased stimulation of melanin production in melanocytes and not by an increase in 
melanocyte number. No functional or microscopic changes related to the periocular effects have been 
observed, and the mechanism of action for the periocular changes is unknown. 
 
Timolol 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Benzalkonium chloride 
Sodium chloride 
Sodium phosphate dibasic heptahydrate 
Citric acid monohydrate 
Hydrochloric acid or sodium hydroxide (to adjust pH) 
Purified water 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 



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2 years 
 
Chemical and physical in-use stability has been demonstrated for 28 days at 25°C. 
 
From a microbiological point of view, the in-use storage times and conditions are the responsibility of 
the user and would normally not be longer than 28 days at 25°C. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
White opaque low-density polyethylene bottles with polystyrene screw cap. Each bottle has a fill 
volume of 3 ml. 
 
The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml. Not all pack sizes 
may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/06/340/001-002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation 19 May 2006 
Date of latest renewal 23 June 2011 
 
 
10. DATE OF REVISION OF THE TEXT 
 
<{MM/YYYY}> 
<{DD/MM/YYYY}> 
<{DD month YYYY}> 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency: http://www.ema.europa.eu/. 



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1. NAME OF THE MEDICINAL PRODUCT 
 
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (as 6.8 mg of timolol maleate). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Eye drops, solution, in single-dose container. 
 
Colourless to slightly yellow solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular 
hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. 
 
4.2 Posology and method of administration 
 
Posology 
Recommended dosage in adults (including older people) 
The recommended dose is one drop of GANFORT single-dose in the affected eye(s) once daily, 
administered either in the morning or in the evening.  It should be administered at the same time each 
day. 
 
Existing literature data for GANFORT (multi-dose formulation) suggest that evening dosing may be 
more effective in IOP lowering than morning dosing. However, consideration should be given to the 
likelihood of compliance when considering either morning or evening dosing (see section 5.1). 
 
The single-dose container is for single use only; one container is sufficient to treat both eyes.  Any 
unused solution should be discarded immediately after use.  If one dose is missed, treatment should 
continue with the next dose as planned.  The dose should not exceed one drop in the affected eye(s) 
daily. 
 
Renal and hepatic impairment 
GANFORT single-dose has not been studied in patients with hepatic or renal impairment.  Therefore 
caution should be used in treating such patients.   
 
Paediatric population 
The safety and efficacy of GANFORT single-dose in children aged less than 18 years has not been 
established.  No data are available. 

Method of administration 
If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at 
least 5 minutes apart. 
 
When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is 
reduced. This may result in a decrease in systemic side effects and an increase in local activity. 



13 

4.3 Contraindications 
 
 Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
 Reactive airway disease including bronchial asthma or a history of bronchial asthma, 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. 
 
4.4 Special warnings and precautions for use 
 
Like other topically applied ophthalmic medicinal products, the active substances (timolol/ 
bimatoprost) in GANFORT single-dose may be absorbed systemically.  No enhancement of the 
systemic absorption of the individual active substances has been observed with GANFORT 
(multi-dose formulation).  Due to the beta-adrenergic component, timolol, the same types of 
cardiovascular, pulmonary and other adverse reactions (ADRs) as seen with systemic beta-blockers 
may occur. Incidence of systemic ADRs after topical ophthalmic administration is lower than for 
systemic administration.  To reduce the systemic absorption, see section 4.2. 
 
Cardiac disorders 
Patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac 
failure) and receiving 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 the negative effect on conduction time, beta-blockers should only be given with caution to 
patients with first degree heart block. 

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. 
 
GANFORT single-dose 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. 
 
Endocrine disorders: 
Beta-adrenergic blocking medicinal products 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 hypoglycemia. 
 
Beta-blockers may also mask the signs of hyperthyroidism. 
 
Corneal diseases 
Ophthalmic beta-blockers may induce dryness of eyes.  Patients with corneal diseases should be 
treated with caution. 
 
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 agent.  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). 
 



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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. 
 
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. 
 
Hepatic 
In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate 
aminotransferase (AST) and/or bilirubin at baseline, bimatoprost eye drops had no adverse reactions 
on liver function over 24 months.  There are no known adverse reactions of ocular timolol on liver 
function. 
 
Ocular  
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, and 
periorbital skin hyperpigmentation since these have been observed during treatment with GANFORT 
single-dose.  Increased brown iris pigmentation has also been observed during treatment with 
GANFORT (multi-dose formulation).  Increased iris pigmentation is likely to be permanent, and may 
lead to differences in appearance between the eyes if only one eye is treated. After discontinuation of 
GANFORT, pigmentation of iris may be permanent.  After 12 months of treatment with GANFORT 
(multi-dose formulation), the incidence of iris pigmentation was 0.2%. After 12 months of treatment 
with bimatoprost eye drops alone, the incidence was 1.5% and did not increase following 3 years of 
treatment. The pigmentation change is due to increased melanin content in the melanocytes rather than 
to an increase in the number of melanocytes. The long term effects of increased iridial pigmentation 
are not known.  Iris colour changes seen with ophthalmic administration of bimatoprost may not be 
noticeable for several months to years. Neither nevi nor freckles of the iris appear to be affected by 
treatment. Periorbital tissue pigmentation has been reported to be reversible in some patients. 
 
Macular oedema, including cystoid macular oedema has been reported with GANFORT (multi-dose 
formulation).  Therefore, GANFORT single-dose should be used with caution in aphakic patients, in 
pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for 
macular oedema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and 
diabetic retinopathy).   
GANFORT should be used with caution in patients with active intraocular inflammation (e.g. uveitis) 
because the inflammation may be exacerbated. 
 
Skin  
There is a potential for hair growth to occur in areas where GANFORT solution comes repeatedly in 
contact with the skin surface. Thus, it is important to apply GANFORT as instructed and avoid it 
running onto the cheek or other skin areas.  
 
Other conditions 
GANFORT single-dose has not been studied in patients with inflammatory ocular conditions, 
neovascular, inflammatory, angle-closure, congenital or narrow-angle glaucoma. 
 
In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been 
shown that more frequent exposure of the eye to more than 1 dose of bimatoprost daily may decrease 
the IOP-lowering effect. Patients using GANFORT with other prostaglandin analogues should be 
monitored for changes to their intraocular pressure. 
 



15 

4.5 Interaction with other medicinal products and other forms of interaction 
 
No specific interaction studies have been performed with the bimatoprost / timolol fixed combination. 
 
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, 
guanethidine, beta-adrenergic blocking agents, parasympathomimetics, anti-arrhythmics (including 
amiodarone) and digitalis glycosides.  
 
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. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no adequate data from the use of the bimatoprost / timolol fixed combination in pregnant 
women.  GANFORT single-dose should not be used during pregnancy unless clearly necessary. To 
reduce the systemic absorption, see section 4.2. 
 
Bimatoprost 
No adequate clinical data in exposed pregnancies are available. Animal studies have shown 
reproductive toxicity at high maternotoxic doses (see section 5.3). 
 
Timolol  
Epidemiological studies have not revealed malformative effects but have shown 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 
GANFORT single-dose is administered until delivery, the neonate should be carefully monitored 
during the first days of life.  Animal studies with timolol have shown reproductive toxicity at doses 
significantly higher than would be used in clinical practice (see section 5.3).  
 
Breast-feeding 
Timolol  
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. 
 
Bimatoprost 
It is not known if bimatoprost is excreted in human breast milk but it is excreted in the milk of the 
lactating rat. GANFORT single-dose should not be used by breast-feeding women. 
 
Fertility 
There are no data on the effects of GANFORT single-dose on human fertility. 
 
4.7 Effects on ability to drive and use machines 
 
GANFORT single-dose has negligible influence on the ability to drive and use machines. As with any 
topical ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until 
the vision clears before driving or using machines. 
 
4.8 Undesirable effects 
 
GANFORT single-dose 



16 

Summary of the safety profile 
The adverse reactions reported in the clinical study using GANFORT single-dose were limited to 
those earlier reported for either GANFORT (multi-dose formulation) or for the single active 
substances bimatoprost or timolol.  No new adverse reactions specific for GANFORT single-dose 
have been observed in clinical studies.  
 
The majority of adverse reactions reported with GANFORT single-dose were ocular, mild in severity 
and none were serious.  Based on a 12-week study of GANFORT single-dose administered once daily, 
the most commonly reported adverse reaction with GANFORT single-dose was conjunctival 
hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in approximately 
21% of patients and led to discontinuation in 1.4% of patients. 
 
Tabulated list of adverse reactions 
Table 1 presents the adverse reactions that were reported during clinical studies of both GANFORT 
single-dose and Ganfort multi-dose formulations (within each frequency grouping, adverse reactions 
are presented in order of decreasing seriousness) or in the post-marketing period. 
 
The frequency of possible adverse reactions listed below is defined using 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 
Not known Frequency cannot be estimated from available data 
 
Table 1 
 
System Organ Class Frequency Adverse reaction 
Immune system disorders Not known hypersensitivity reactions 

including signs or symptoms of 
allergic dermatitis, angioedema, 
eye allergy 

Psychiatric disorders Not known Insomnia2, nightmare2 
Nervous system disorders 
 

Common headache 
Not known Dysgeusia2, dizziness 

Eye disorders 
 

Very common conjunctival hyperaemia. 
Common punctuate keratitis, corneal 

erosion2, burning sensation2, 
conjunctival irritation1, eye 
pruritus, stinging sensation in 
the eye2, foreign body sensation, 
dry eye, erythema of eyelid, eye 
pain, photophobia, eye 
discharge, visual disturbance2, 
eyelid pruritus, visual acuity 
worsened2, blepharitis2, eyelid 
oedema, eye irritation, 
lacrimation increased, growth of 
eyelashes. 

 Uncommon iritis2, conjunctival oedema2, 
eyelid pain2, abnormal sensation 
in the eye1, asthenopia, 
trichiasis2, iris 
hyperpigmentation2, deepening 
of eyelid sulcus, eyelid 



17 

retraction2, eyelash 
discolouration (darkening)1. 

 Not known cystoid macular oedema2, eye 
swelling, vision blurred2, ocular 
discomfort 

Cardiac disorders Not known Bradycardia 
Vascular disorders Not known Hypertension 
Respiratory, thoracic and 
mediastinal disorders 
 

Common Rhinitis2 
Uncommon dyspnoea 
Not known bronchospasm (predominantly 

in patients with pre-existing 
bronchospastic disease) 2, 
asthma  

Skin and subcutaneous tissue 
disorders 
 

Common blepharal pigmentation2, 
hirsutism2, skin 
hyperpigmentation (periocular). 

Not known Alopecia, skin discolouration 
(periocular) 

General disorders and 
administration site conditions 

Not known fatigue 

1adverse reactions only observed with Ganfort single-dose formulation 
2adverse reactions only observed with Ganfort multi-dose formulation  
 
Like other topically applied ophthalmic drugs, GANFORT (bimatoprost/timolol) is absorbed into the 
systemic circulation. Absorption of timolol may cause similar undesirable effects as seen with 
systemic beta-blocking agents.  The incidence of systemic ADRs after topical ophthalmic 
administration is lower than for systemic administration. To reduce the systemic absorption, see 
section 4.2. 
 
Additional adverse reactions that have been seen with either of the active substances (bimatoprost or 
timolol), and may potentially occur also with GANFORT are listed below in Table 2: 
 
Table 2 
 
System Organ Class Adverse reaction 
Immune system disorders systemic allergic reactions including 

anaphylaxis1 
Metabolism and nutrition disorders hypoglycaemia1 
Psychiatric disorders depression1, memory loss1, hallucination 1 
Nervous system disorders syncope1, cerebrovascular accident1, increase in 

signs and symptoms of myasthenia gravis1, 
paraesthesia1, cerebral ischaemia1 

Eye disorders decreased corneal sensitivity1, diplopia1, ptosis1, 
choroidal detachment following filtration surgery 
(see section 4.4)1, keratitis1, blepharospasm2, 
retinal haemorrhage2, uveitis2,  

Cardiac disorder atrioventricular block1, cardiac arrest1, 
arrhythmia1, cardiac failure1, congestive heart 
failure1, chest pain1, palpitations1, oedema1 

Vascular disorders hypotension1, Raynaud’s phenomenon1, cold 
hands and feet1 

Respiratory, thoracic and mediastinal disorders Asthma exacerbation2, COPD exacerbation2, 
cough1 

Gastrointestinal disorders nausea1,2, diarrhoea1, dyspepsia1, dry mouth1, 
abdominal pain1, vomiting1 

Skin and subcutaneous tissue disorders psoriasiform rash1 or exacerbation of psoriasis1, 



18 

skin rash1 
Musculoskeletal and connective tissue disorders myalgia1  
Reproductive system and breast disorders sexual dysfunction1, decreased libido1 
General disorders and administration site 
conditions 

asthenia1,2 

Investigations liver function tests (LFT) abnormal2 
1 adverse reactions observed with Timolol  
2 adverse reactions observed with Bimatoprost  
 
Adverse reactions reported in phosphate containing eye drops 
 
Cases of corneal calcification have been reported very rarely in association with the use of phosphate 
containing eye drops in some patients with significantly damaged corneas. 
 
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 GANFORT single-dose is not likely to occur or to be associated with toxicity. 
 
Bimatoprost 
 
If GANFORT single-dose is accidentally ingested, the following information may be useful:  in 
2-week oral mice and rats studies, doses of bimatoprost up to 100 mg/kg/day did not produce any 
toxicity; this corresponds to a human equivalent dose of 8.1 and 16.2 mg/kg, respectively.  These 
doses are at least 7.5 times higher than the amount of bimatoprost in an accidental dose of the entire 
contents of a carton of GANFORT single-dose (90 single-dose containers x 0.4 mL; 36 mL) in a 10 kg 
child [(36 mL*0.3 mg/mL bimatoprost)/10 kg; 1.08 mg/kg].   
 
Timolol 
 
Symptoms of systemic timolol overdose include: bradycardia, hypotension, bronchospasm, headache, 
dizziness, shortness of breath, and cardiac arrest.  A study of patients with renal failure showed that 
timolol did not dialyse readily. 
 
If overdose occurs treatment should be symptomatic and supportive. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group:  Ophthalmological, beta-blocking agents – ATC code:  S01ED51. 
 
Mechanism of action 
GANFORT single-dose consists of two active substances: bimatoprost and timolol.  These two 
components decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and 
the combined effect results in additional IOP reduction compared to either compound administered 
alone.  GANFORT single-dose has a rapid onset of action. 
 
Bimatoprost is a potent ocular hypotensive active substance.  It is a synthetic prostamide, structurally 
related to prostaglandin F2α (PGF2α) that does not act through any known prostaglandin receptors.  



19 

Bimatoprost selectively mimics the effects of newly discovered biosynthesised substances called 
prostamides.  The prostamide receptor, however, has not yet been structurally identified.  The 
mechanism of action by which bimatoprost reduces intraocular pressure in man is by increasing 
aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow. 
 
Timolol is a beta1 and beta2 non-selective adrenergic receptor blocking agent that does not have 
significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic 
(membrane-stabilising) activity.  Timolol lowers IOP by reducing aqueous humour formation.  The 
precise mechanism of action is not clearly established, but inhibition of the increased cyclic AMP 
synthesis caused by endogenous beta-adrenergic stimulation is probable.  
 
Clinical effects 
A 12-week (double-masked, randomized, parallel group) clinical study compared the efficacy and 
safety of GANFORT single-dose with GANFORT (multi-dose formulation) in patients with glaucoma 
or ocular hypertension.  GANFORT single-dose achieved noninferior IOP-lowering efficacy to 
GANFORT (multi-dose formulation):  the upper limit of the 95% CI of the between-treatment 
difference was within the pre-defined 1.5 mm Hg margin at each timepoint evaluated (hours 0, 2, and 
8) at week 12 (for the primary analysis), and also at weeks 2 and 6, for mean worse eye IOP change 
from baseline (worse eye IOP refers to the eye with the higher mean diurnal IOP at baseline).  In fact, 
the upper limit of the 95% CI did not exceed 0.14 mm Hg at week 12.     
 
Both treatment groups showed statistically and clinically significant mean decreases from baseline in 
worse eye IOP at all follow up timepoints throughout the study (p < 0.001).  Mean changes from 
baseline worse eye IOP ranged from -9.16 to -7.98 mm Hg for GANFORT (single-dose) group, and 
from -9.03 to -7.72 mm Hg for the GANFORT (multi-dose formulation) group across the 12-week 
study. 
 
GANFORT single-dose also achieved equivalent IOP-lowering efficacy to GANFORT (multi-dose 
formulation) in average eye and worse eye IOP at each follow-up timepoint at weeks 2, 6 and 12. 
 
Based on studies of GANFORT (multi-dose formulation), the IOP-lowering effect of GANFORT is 
non-inferior to that achieved by adjunctive therapy of bimatoprost (once daily) and timolol (twice 
daily).  
 
Existing literature data for GANFORT (multi-dose formulation) suggest that evening dosing may be 
more effective in IOP lowering than morning dosing.  However, consideration should be given to the 
likelihood of compliance when considering either morning or evening dosing. 

Paediatric population 
The safety and efficacy of GANFORT single-dose in children aged less than 18 years has not been 
established. 
 
5.2 Pharmacokinetic properties 
 
GANFORT medicinal product 
Plasma bimatoprost and timolol concentrations were determined in a crossover study comparing the 
monotherapy treatments to GANFORT (multi-dose formulation) treatment in healthy subjects.  
Systemic absorption of the individual components was minimal and not affected by co-administration 
in a single formulation. 
 
In two 12-month studies of GANFORT (multi-dose formulation) in which systemic absorption was 
measured, no accumulation was observed of either of the individual components. 
 
Bimatoprost 
Bimatoprost penetrates the human cornea and sclera well in vitro.  After ocular administration, the 
systemic exposure of bimatoprost is very low with no accumulation over time. After once daily ocular 



20 

administration of one drop of 0.03% bimatoprost to both eyes for two weeks, blood concentrations 
peaked within 10 minutes after dosing and declined to below the lower limit of detection 
(0.025 ng/ml) within 1.5 hours after dosing.  Mean Cmax and AUC 0-24hrs values were similar on days 7 
and 14 at approximately 0.08 ng/ml and 0.09 ng•hr/ml respectively, indicating that a steady drug 
concentration was reached during the first week of ocular dosing. 
 
Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in 
humans at steady-state was 0.67 1/kg. In human blood, bimatoprost resides mainly in the plasma.  The 
plasma protein binding of bimatoprost is approximately 88%. 
 
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation 
following ocular dosing. Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to 
form a diverse variety of metabolites. 
 
Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered 
to healthy volunteers was excreted in the urine, 25% of the dose was excreted via the faeces.  The 
elimination half-life, determined after intravenous administration, was approximately 45 minutes; the 
total blood clearance was 1.5 1/hr/kg. 
 
Characteristics in older people 
After twice daily dosing of bimatoprost 0.3 mg/ml, the mean AUC 0-24hrs value of 0.0634 ng•hr/ml 
bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 0.0218 ng•hr/ml 
in young healthy adults. However, this finding is not clinically relevant as systemic exposure for both 
elderly and young subjects remained very low from ocular dosing. There was no accumulation of 
bimatoprost in the blood over time and the safety profile was similar in elderly and young patients. 
 
Timolol 
After ocular administration of a 0.5% eye drops solution in humans undergoing cataract surgery, peak 
timolol concentration was 898 ng/ml in the aqueous humour at one hour post-dose.  Part of the dose is 
absorbed systemically where it is extensively metabolised in the liver. The half-life of timolol in 
plasma is about 4 to 6 hours.  Timolol is partially metabolised by the liver with timolol and its 
metabolites excreted by the kidney.  Timolol is not extensively bound to plasma.  
 
5.3 Preclinical safety data 
 
GANFORT medicinal product 
Repeated dose ocular toxicity studies of GANFORT (multi-dose formulation) showed no special 
hazard for humans. The ocular and systemic safety profile of the individual components is well 
established. 
 
Bimatoprost 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, genotoxicity, carcinogenic potential. Studies in rodents produced species-specific 
abortion at systemic exposure levels 33- to 97-times that achieved in humans after ocular 
administration.  
 
Monkeys administered ocular bimatoprost concentrations of ≥0.03% daily for 1 year had an increase 
in iris pigmentation and reversible dose-related periocular effects characterised by a prominent upper 
and/or lower sulcus and widening of the palpebral fissure. The increased iris pigmentation appears to 
be caused by increased stimulation of melanin production in melanocytes and not by an increase in 
melanocyte number. No functional or microscopic changes related to the periocular effects have been 
observed, and the mechanism of action for the periocular changes is unknown. 
 



21 

Timolol 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride 
Sodium phosphate dibasic heptahydrate 
Citric acid monohydrate 
Hydrochloric acid or sodium hydroxide (to adjust pH) 
Purified water 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
Once the single-dose container is removed from the pouch use within 7 days. All single-dose 
containers should be kept in the pouch and discarded after 10 days from the first opening of the pouch. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special temperature storage conditions.  Keep the single-
dose containers in the pouch and place the pouch back in carton in order to protect against light and 
moisture. 
 
6.5 Nature and contents of container 
 
Clear, single-dose low density polyethylene (LDPE) containers with a twist-off tab. 
 
Each single-dose container contains 0.4 ml solution. 
 
The following pack sizes are available:   
Carton containing 5 single-dose containers in an aluminium foil pouch. 
Carton containing 30 or 90 single-dose containers in three or nine aluminium foil pouches 
respectively. Each pouch contains 10 single-dose containers. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 



22 

Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/06/340/003 5 single-dose containers 
EU/1/06/340/004 30 single-dose containers 
EU/1/06/340/005 90 single-dose containers 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation 19 May 2006 
Date of latest renewal 23 June 2011 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 <{MM/YYYY}> 
<{DD/MM/YYYY}> 
<{DD month YYYY}> 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency web site: http://www.ema.europa.eu/. 
 



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OF 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 

 

 



24 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 
 
 
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 (PSURs) 
 
The requirements for submission of PSURs 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 marketing authorisation holder (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. 

 

 



25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



27 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR SINGLE BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution 
bimatoprost/timolol  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate). 
 
 
3. LIST OF EXCIPIENTS 
 
Benzalkonium chloride, sodium chloride, sodium phosphate dibasic heptahydrate, citric acid 
monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water. 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Eye drops, solution, 3 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
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 
 
Remove contact lenses before use. 
 
 
8. EXPIRY DATE 
 
EXP 
Discard four weeks after first opening. 
Opened: 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



28 

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 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/06/340/001 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
GANFORT 

17. UNIQUE IDENTIFIER – 2D BARCODE 

2D barcode carrying the unique identifier included. 
 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

PC:  

SN:  

NN:  

 



29 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON CONTAINING THREE BOTTLES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution 
bimatoprost/timolol  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate) 
 
 
3. LIST OF EXCIPIENTS 
 
Benzalkonium chloride, sodium chloride, sodium phosphate dibasic heptahydrate, citric acid 
monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water. 
See leaflet for further information. 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Eye drops, solution, 3 x 3 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
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 
 
Remove contact lenses before use. 
 
 
8. EXPIRY DATE 
 
EXP 
Discard four weeks after first opening. 
Opened (1) 
Opened (2) 
Opened (3) 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



30 

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 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/06/340/002 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
GANFORT 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

2D barcode carrying the unique identifier included. 
 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

PC:  

SN:  

NN: 



31 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
GANFORT 0.3 mg /ml + 5 mg/ml eye drops, solution 
bimatoprost/timolol 
Ocular use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml 
 
 
6. OTHER 
 
 



32 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
POUCH CONTAINING STRIP OF 5 SINGLE-DOSE CONTAINERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container 
bimatoprost/timolol  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate). 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid 
or sodium hydroxide (to adjust pH) and purified water. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Eye drops, solution 
5 x 0.4 ml  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
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 
Once the container is removed from the pouch use within 7 days. 
All containers should be kept in the pouch and carton to protect from light and moisture and discarded 
10 days after first opening the pouch. 
 
 



33 

9. SPECIAL STORAGE CONDITIONS 
 
Keep single-dose containers in the pouch in order to protect from light and moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard the opened container immediately after use. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road, 
Westport, 
Co. Mayo, 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/06/340/003-005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
For single use only 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

2D barcode carrying the unique identifier included. 
 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

PC:  

SN:  

NN: 



34 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
POUCH CONTAINING STRIP OF 10 SINGLE-DOSE CONTAINERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container 
bimatoprost/timolol 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals Ireland 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Ocular use. 
10 single-dose containers. 
For single use only. 
Read the package leaflet before use.  
Once the container is removed from the pouch use within 7 days. 
All containers should be kept in the pouch and carton to protect from light and moisture and discarded 
10 days after first opening the pouch. 
Discard the opened container immediately after use. 
 
 
 
 



35 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR POUCH CONTAINING STRIP OF 5 SINGLE-DOSE CONTAINERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container 
bimatoprost/timolol  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate). 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid 
or sodium hydroxide (to adjust pH) and purified water. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Eye drops, solution 
5 x 0.4 ml  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep single-dose containers in the pouch in order to protect from light and moisture. 
 
 



36 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard the opened single-dose container immediately after use. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road, 
Westport, 
Co. Mayo, 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/06/340/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
For single use only 
 
 
16. INFORMATION IN BRAILLE 
 
GANFORT single-dose 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

PC 

SN:  

NN:  



37 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON CONTAINING 30 SINGLE-DOSE CONTAINERS (PROVIDED IN 3 POUCHES, 
EACH CONTAINING 10 SINGLE-DOSE CONTAINERS) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container 
bimatoprost/timolol  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate). 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid 
or sodium hydroxide (to adjust pH) and purified water. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Eye drops, solution 
30 x 0.4 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep single-dose containers in the pouch in order to protect from light and moisture. 
 
 



38 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard the opened single-dose container immediately after use. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road, 
Westport, 
Co. Mayo, 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/06/340/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
For single use only 
 
 
16. INFORMATION IN BRAILLE 
 
GANFORT single-dose 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

2D barcode carrying the unique identifier included. 
 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

PC:  

SN:  

NN:  



39 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON CONTAINING 90 SINGLE-DOSE CONTAINERS (PROVIDED IN 9 POUCHES, 
EACH CONTAINING 10 SINGLE-DOSE CONTAINERS) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container 
bimatoprost/timolol  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate). 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid 
or sodium hydroxide (to adjust pH) and purified water. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Eye drops, solution 
90 x 0.4 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep single-dose containers in the pouch in order to protect from light and moisture. 
 
 



40 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard the opened single-dose container immediately after use. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road, 
Westport, 
Co. Mayo, 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/06/340/005 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
For single use only 
 
 
16. INFORMATION IN BRAILLE 
 
GANFORT single-dose 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

2D barcode carrying the unique identifier included. 
 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

PC:  

SN:  

NN: 



41 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SINGLE-DOSE CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
GANFORT  
bimatoprost/timolol 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.4 ml 
 
6. OTHER 
 



42 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



43 

Package leaflet: Information for the user 
 
 

GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution  
Bimatoprost/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, please ask your doctor,  pharmacist, or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What GANFORT is and what it is used for 
2. What you need to know before you use GANFORT 
3. How to use GANFORT 
4. Possible side effects 
5 How to store GANFORT 
6. Contents of the pack and other information 
 
 
1.  What GANFORT is and what it is used for 
 
GANFORT contains two different active substances (bimatoprost and timolol) that both reduce 
pressure in the eye. Bimatoprost belongs to a group of medicines called prostamides, a prostaglandin 
analogue. Timolol belongs to a group of medicines called beta-blockers.    
 
Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being 
drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly 
enough, the pressure inside the eye builds up and could eventually damage your sight (an illness called 
glaucoma). GANFORT works by reducing the production of liquid and also increasing the amount of 
liquid that is drained. This reduces the pressure inside the eye. 
  
GANFORT eye drops are used to treat high pressure in the eye in adults, including the elderly. This 
high pressure can lead to glaucoma. Your doctor will prescribe you GANFORT when other eye drops 
containing beta-blockers or prostaglandin analogues  have not worked sufficiently on their own. 
 
 
2. What you need to know before you use GANFORT 
 
Do not use GANFORT eye drops, solution 
 
- if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients of 

GANFORT (listed in section 6) 
- if you have now or have had in 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)  

- if you have heart problems such as low heart rate, heart block, or heart failure  
 
Warnings and precautions 
Before you use this medicine, tell your doctor 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,  



44 

- 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) 
-    overactivity of the thyroid gland as timolol may mask signs and symptoms of  
       thyroid disease 
-     diabetes as timolol may mask signs and symptoms of low blood sugar  
-     severe allergic reactions 
-   liver or kidney problems 
-  eye surface problems 
-  separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye 
-  known risk factors for macular oedema (swelling of the retina within the eye leading to 

worsening vision), for example, cataract surgery 
 
Tell your doctor before surgical anaesthesia that you are using GANFORT as timolol may change 
effects of some medicines used during anaesthesia. 
GANFORT may cause your eyelashes to darken and grow, and cause the skin around the eyelid to 
darken too. The colour of your iris may also go darker over time.  These changes may be permanent. 
The change may be more noticeable if you are only treating one eye. GANFORT may cause hair 
growth when in contact with the skin surface. 
 
Children and adolescents  
GANFORT should not be used in children and teenagers under 18.  
 
Other medicines and GANFORT 
GANFORT can affect or be affected by other medicines you are using, including other eye drops for 
the treatment of glaucoma. Please tell your doctor or pharmacist if you are taking, have recently taken 
or might take any other medicines. Tell your doctor if you are using or intend to use medicines to 
lower blood pressure, heart medicine, medicines to treat diabetes, quinidine (used to treat heart 
conditions and some types of malaria) or medicines to treat depression known as fluoxetine and 
paroxetine. 
 
Pregnancy and breast-feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. Do not use GANFORT if you are 
pregnant unless your doctor still recommends it. 
 
Do not use GANFORT if you are breast-feeding. Timolol may get into your breast milk. 
Ask your doctor for advice before taking any medicine during breast-feeding. 
 
Driving and using machines 
GANFORT may cause blurred vision in some patients. Do not drive or use machines until the 
symptoms have cleared. 
 
GANFORT contains Benzalkonium chloride 
Ganfort contains a preservative called benzalkonium chloride.  
This medicine contains 0.15 mg benzalkonium chloride in each 3 ml of solution which is equivalent to 
0.05 mg/ml.  
Benzalkonium chloride 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 GANFORT 
 



45 

Always use GANFORT exactly as your doctor or pharmacist has told you. Check with your doctor or 
pharmacist if you are not sure.  
 
The usual dose is one drop once a day, either in the morning or in the evening in each eye that needs 
treatment.  Use at the same time each day. 
 
Instructions for use 
You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it. 
 
 

5. 

 
 
1. Wash your hands. Tilt your head back and look at the ceiling. 
2. Gently pull down the lower eyelid until there is a small pocket. 
3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment. 
4. Let go of the lower lid, and close your eye. 
5. Whilst keeping the eye closed, press your finger against the corner of the closed eye (the site where 
the eye meets the nose) and hold for 2 minutes. This helps to stop GANFORT getting into the rest of 
the body. 
 
If a drop misses your eye, try again. 
 
To avoid contamination, do not let the tip of the bottle touch your eye or anything else. Put the cap 
back on and close the bottle straight after you have used it. 
 
If you use GANFORT with another eye medicine, leave at least 5 minutes between putting in 
GANFORT and the other medicine. Use any eye ointment or eye gel last. 
 
If you use more GANFORT than you should 
If you use more GANFORT than you should, it is unlikely to cause you any serious harm. Put your 
next dose in at the usual time. If you are worried, talk to your doctor or pharmacist. 
 
If you forget to use GANFORT 
If you forget to use GANFORT, use a single drop as soon as you remember, and then go back to your 
regular routine. Do not use a double dose to make up for a forgotten dose. 
 
If you stop using GANFORT 
GANFORT should be used every day to work properly. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 



46 

Like all medicines, GANFORT can cause side effects, although not everybody gets them.  You can 
usually carry on taking the drops, unless the effects are serious. If you’re worried, talk to a doctor or 
pharmacist. Do not stop using Ganfort without speaking to your doctor.  
 
The following side effects may be seen with GANFORT (multi-dose and/or single-dose):  
 
Very common side effects 
These may affect more than 1 user in 10 
Affecting the eye 
redness. 
 
Common side effects 
These may affect 1 to 9 users in 100 
Affecting the eye 
burning, itching, stinging, irritation of the conjunctiva (see-through layer of the eye), sensitivity to 
light, eye pain, sticky eyes, dry eyes, a feeling of something in the eye, small breaks in the surface of 
the eye with or without inflammation, difficulty in seeing clearly, redness and itching of the eyelids, 
hair growing around the eye, darkening of the eyelids, darker skin colour around the eyes, longer 
eyelashes, eye irritation, watery eyes, swollen eyelids, reduced vision.  
 
Affecting other parts of the body 
runny nose, headache. 
 
Uncommon side effects 
These may affect 1 to 9 users in 1,000 
Affecting the eye 
abnormal sensation in the eye, iris inflammation, swollen conjunctiva (see-through layer of the eye), 
painful eyelids, tired eyes, in-growing eyelashes, darkening of iris colour, eyes appear sunken, eyelid 
has moved away from the surface of the eye, darkening of eyelashes.  
 
Affecting other parts of the body 
shortness of breath. 
 
Side effects where the frequency is not known  
Affecting the eye 
cystoid macular oedema (swelling of the retina within the eye leading to worsening vision), eye 
swelling, blurred vision, ocular discomfort. 
 
Affecting other parts of the body 
difficulty breathing / wheezing, symptoms of allergic reaction (swelling, redness of the eye and rash of 
the skin), changes in your taste sensation, dizziness, slowing of heart rate, high blood pressure, 
difficulty sleeping, nightmare, asthma, hair loss, skin discolouration (periocular), tiredness. 
  
 
Additional side effects have been seen in patients using eye drops containing timolol or bimatoprost 
and so may possibly be seen with GANFORT. Like other medicines applied into eyes, timolol is 
absorbed into the blood. This may cause similar side effects as seen with ”intravenous” and /or “oral” 
beta-blocking agents. The chance of having side effects after using eye drops is lower than when 
medicines are for example, taken by mouth or injected. Listed side effects include reactions seen 
within bimatoprost and timolol when used for treating eye conditions: 

• Severe allergic reactions with swelling and difficulty breathing which could be life-threatening  
• Low blood sugar 
• Depression; memory loss; hallucination 
• Fainting; stroke; decreased blood flow to the brain; worsening of myasthenia gravis (increased 

muscle weakness); tingling sensation 



47 

• Decreased sensation of your eye surface; double vision; drooping eyelid; separation of one of 
the layers within the eyeball after surgery to reduce the pressure in the eye; inflammation of 
the surface of the eye, bleeding in the back of the eye (retinal bleeding), inflammation within 
the eye, increased blinking 

• Heart failure; irregularity or stopping of the heartbeat; slow or fast heartbeat; too much fluid, 
mainly water, accumulating in the body; chest pain 

• Low blood pressure, swelling or coldness of your hands, feet and extremities, caused by 
constriction of your blood vessels 

• Cough, worsening of asthma, worsening of the lung disease called chronic obstructive 
pulmonary disease (COPD)  

• Diarrhoea; stomach pain; feeling and being sick; indigestion; dry mouth 
• Red scaly patches on skin; skin rash 
• Muscle pain 
• Reduced sexual urge; sexual dysfunction 
• Weakness 
• An increase in blood test results that show how your liver is working  

 
 
Other side effects reported with eye drops containing phosphates 
This medicine contains 2.85 mg phosphates in each 3 ml of solution which is equivalent to 0.95 
mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), 
phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during 
treatment.  
 
Reporting side effects 
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V*. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5.  How to store GANFORT 
 
Keep GANFORT out of the sight and reach of children.  
 
Do not use GANFORT after the expiry date which is stated on the bottle label 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. 
 
Once opened, solutions may become contaminated, which can cause eye infections. Therefore, you 
must throw away the bottle 4 weeks after you first opened it, even if some solution is left. To help you 
remember, write down the date that you opened it in the space on the carton. 
 
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 to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What GANFORT contains 
 
• The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml corresponding to timolol 

maleate 6.8 mg/ml. 
 



48 

• The other ingredients are benzalkonium chloride (a preservative), sodium chloride, sodium 
phosphate dibasic heptahydrate, citric acid monohydrate and purified water. Small amounts of 
hydrochloric acid or sodium hydroxide may be added to bring the solution to the correct pH 
(acidity) level. 

 
What GANFORT looks like and contents of the pack 
GANFORT is a colourless to slightly yellow, clear eye drop solution in a plastic bottle. Each pack 
contains either 1 or 3 plastic bottles each with a screw-cap. Each bottle is about half full and contains 
3 millilitres of solution. This is enough for 4 weeks’ usage. Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder. 
 
België/Belgique/Belgien/ 
Luxembourg/Luxemburg/Nederland 
Allergan n.v. 
Tél/Tel: +32 (0)2 351 24 24 
 

Ísland 
Actavis Pharmaceuticals Iceland ehf. 
Sími: +354 550 3300 

България 
Алерган България ЕООД 
Тел.: +359 (0) 800 20 280 
 

Italia 
Allergan S.p.A 
Tel: + 39 06 509 562 90 
 

Česká republika 
Allergan CZ s.r.o. 
Tel: +420 800 188 818 
 

Latvija/Lietuva 
Allergan Baltics UAB 
Tel: + 371 676 60 831 (LV); + 37 052 072 777 
(LT) 

Danmark/Norge/Suomi/Finland/Sverige 
Allergan Norden AB 
Tlf/Puh/Tel: + 4580884560 (DK); +47 80 01 04 
97 (NO); + 358 800 115 003 (FI); +46 (0)8 594 
100 00 (SE) 
 

Magyarország 
Allergan Hungary Kft. 
Tel.: +36 80 100 101 
 

Deutschland 
Pharm-Allergan GmbH 
Tel: +49 69 92038 10 50 
 

Österreich 
Pharm-Allergan GmbH 
Tel: +43 1 99460 6355 
 

Eesti 
Allergan Baltics UAB 
Tel: + 37 2634 6109  
 

Polska 
Allergan Sp.z o.o. 
Tel.: +48 22 256 3700 
 

Ελλάδα/Κύπρος 
Allergan Hellas Pharmaceuticals S.A. 
Tηλ: +30 210 74 73 300 
 

Portugal 
Profarin Lda. 
Tel: +351 21 425 3242 
 

España 
Allergan S.A 
Tel: +34 91 807 6130 
 

România 
Allergan S.R.L. 
Tel: +40 21 301 53 02 
 

France Slovenija 



49 

Allergan France SAS 
Tél: +33 (0)1 49 07 83 00 
 

Ewopharma d.o.o. 
Tel: +386 (0) 590 848 40 
 

Hrvatska 
Ewopharma d.o.o. 
Tel: +385 1 6646 563 

Slovenská republika 
Allergan SK s.r.o. 
Tel: + 421 800 221 223 
 

Ireland/Malta 
Allergan Pharmaceuticals Ireland 
Tel: 1800 931 787 (IE); +356 27780331 (MT) 
 

United Kingdom 
Allergan Ltd 
Tel: +44 (0) 1628 494026 

 
This leaflet was last revised in  <{MM/YYYY}> <{month YYYY} 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 
 

 
 
 



50 

Package leaflet: Information for the user 
 
 

GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container  
Bimatoprost/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, please ask your doctor, pharmacist, or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What GANFORT single-dose is and what it is used for 
2. What you need to know before you use GANFORT single-dose 
3. How to use GANFORT single-dose 
4. Possible side effects 
5 How to store GANFORT single-dose 
6. Contents of the pack and other information 
 
 
1.  What GANFORT single-dose is and what it is used for 
 
GANFORT single-dose contains two different active substances (bimatoprost and timolol) that both 
reduce pressure in the eye. Bimatoprost belongs to a group of medicines called prostamides, a 
prostaglandin analogue.  Timolol belongs to a group of medicines called beta-blockers.    
 
Your eye contains a clear, watery liquid that feeds the inside of the eye.  Liquid is constantly being 
drained out of the eye and new liquid is made to replace this.  If the liquid cannot drain out quickly 
enough, the pressure inside the eye builds up and could eventually damage your sight (an illness called 
glaucoma). GANFORT single-dose works by reducing the production of liquid and also increasing the 
amount of liquid that is drained.  This reduces the pressure inside the eye. 
  
GANFORT single-dose eye drops are used to treat high pressure in the eye in adults, including the 
elderly.  This high pressure can lead to glaucoma.  Your doctor will prescribe you GANFORT 
single-dose when other eye drops containing beta-blockers or prostaglandin analogues have not 
worked sufficiently on their own. 
 
This medicine does not contain a preservative. 
 
 
2. What you need to know before you use GANFORT single-dose 
 
Do not use GANFORT single-dose eye drops, solution 
 
- if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients of 

GANFORT single-dose (listed in section 6) 
- if you have now or have had in 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)  

- if you have heart problems such as low heart rate, heart block, or heart failure  
 



51 

Warnings and precautions 
Before you use this medicine, tell your doctor 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 heart beat  
- breathing problems, asthma or chronic obstructive pulmonary disease 
- poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome) 
- overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid disease 
- diabetes as timolol may mask signs and symptoms of low blood sugar 
- severe allergic reaction 
- liver or kidney problems 
- eye surface problems 
- separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye 
- known risk factors for macular oedema (swelling of the retina within the eye leading to worsening 

vision), for example, cataract surgery 
 
Tell your doctor before surgical anaesthesia that you are using GANFORT single-dose as timolol may 
change effects of some medicines used during anaesthesia. 
 
GANFORT single-dose may cause your eyelashes to darken and grow, and cause the skin around the 
eye to darken too. The colour of your iris may also go darker over time.  These changes may be 
permanent. The change may be more noticeable if you are only treating one eye. GANFORT single-
dose may cause hair growth when in contact with the skin surface.  
 
Children and adolescents  
GANFORT single-dose should not be used in children and teenagers under 18.  
 
Other medicines and GANFORT single-dose 
GANFORT single-dose can affect or be affected by other medicines you are using, including other eye 
drops for the treatment of glaucoma.  Please tell your doctor or pharmacist if you are taking, have 
recently taken or might take any other medicines.  Tell your doctor if you are using or intend to use 
medicines to lower blood pressure, heart medicine, medicines to treat diabetes, quinidine (used to treat 
heart conditions and some types of malaria) or medicines to treat depression known as fluoxetine and 
paroxetine. 
 
Pregnancy and breast-feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine.  Do not use GANFORT single-dose 
if you are pregnant unless your doctor still recommends it. 
 
Do not use GANFORT single-dose if you are breast-feeding. Timolol may get into your breast milk. 
Ask your doctor for advice before taking any medicine during breast-feeding. 
 
Driving and using machines 
GANFORT single-dose may cause blurred vision in some patients. Do not drive or use machines until 
the symptoms have cleared. 
 
 
3. How to use GANFORT single-dose 
 
Always use GANFORT single-dose exactly as your doctor or pharmacist has told you.  Check with 
your doctor or pharmacist if you are not sure.  
 
The usual dose is one drop once a day, either in the morning or in the evening in each eye that needs 
treatment.  Use at the same time each day. 
 



52 

Instructions for use 
Wash your hands before use. Make sure that the single-dose container is intact before use. The 
solution should be used immediately after opening. To avoid contamination, do not let the open-end of 
the single-dose container touch your eye or anything else. 
 

 
 
1.  Tear 1 single-dose container from the strip. 
2.  Hold the single-dose container upright (with the cap pointing upwards) and twist off the cap. 
3.  Gently pull down the lower eyelid to form a pocket. Turn the single-dose container upside 

down and squeeze it to release 1 drop into the affected eye(s).  
4.  Whilst keeping the eye closed, press your finger against the corner of the closed eye (the site 

where the eye meets the nose) and hold for 2 minutes. This helps to stop GANFORT 
single-dose getting into the rest of the body. 

5.  Throw away the single-dose container after you have used it, even if there is some solution 
left. 

 
If a drop misses your eye, try again.  Wipe off any excess that runs down the cheek. 
 
If you wear contact lenses, take your lenses out before using this medicine.  Wait 15 minutes after 
using the drops, and before you put your lenses back in. 

If you use GANFORT single-dose with another eye medicine, leave at least 5 minutes between putting 
in GANFORT single-dose and the other medicine. Use any eye ointment or eye gel last. 
 
If you use more GANFORT single-dose than you should 
If you use more GANFORT single-dose than you should, it is unlikely to cause you any serious harm. 
Put your next dose in at the usual time. If you are worried, talk to your doctor or pharmacist. 
 
If you forget to use GANFORT single-dose 
If you forget to use GANFORT single-dose, use a single drop as soon as you remember, and then go 
back to your regular routine. Do not use a double dose to make up for a forgotten dose. 
 
If you stop using GANFORT single-dose 
GANFORT single-dose should be used every day to work properly. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, GANFORT single-dose can cause side effects, although not everybody gets them.  
You can usually carry on taking the drops, unless the effects are serious. If you’re worried, talk to a 
doctor or pharmacist. Do not stop using GANFORT single-dose without speaking to your doctor.  
 



53 

The following side effects may be seen with GANFORT (single-dose and/or multi-dose):  
 
Very common side effects 
These may affect more than 1 user in 10 
Affecting the eye 
redness. 
 
Common side effects 
These may affect 1 to 9 users in 100 
Affecting the eye 
burning, itching, stinging, irritation of the conjunctiva (see-through layer of the eye), sensitivity to 
light, eye pain, sticky eyes, dry eyes, a feeling of something in the eye, small breaks in the surface of 
the eye with or without inflammation, difficulty in seeing clearly, redness and itching of the eyelids, 
hair growing around the eye, darkening of the eyelids, darker skin colour around the eyes, longer 
eyelashes, eye irritation, watery eyes, swollen eyelids, reduced vision.  
 
Affecting other parts of the body 
runny nose, headache. 
 
Uncommon side effects 
These may affect 1 to 9 users in 1,000 
Affecting the eye 
abnormal sensation in the eye, iris inflammation, swollen conjunctiva (see-through layer of the eye), 
painful eyelids, tired eyes, in-growing eyelashes, darkening of iris colour, eyes appear sunken, eyelid 
has moved away from the surface of the eye, darkening of eyelashes.  
 
Affecting other parts of the body 
shortness of breath. 
 
Side effects where the frequency is not known  
Affecting the eye 
cystoid macular oedema (swelling of the retina within the eye leading to worsening vision), eye 
swelling, blurred vision, ocular discomfort. 
 
Affecting other parts of the body 
difficulty breathing / wheezing, symptoms of allergic reaction (swelling, redness of the eye and rash of 
the skin), changes in your taste sensation, dizziness, slowing of heart rate, high blood pressure, 
difficulty sleeping, nightmare, asthma, hair loss, skin discolouration (periocular), tiredness. 
 
 
Additional side effects have been seen in patients using eye drops containing timolol or bimatoprost 
and so may possibly be seen with GANFORT. Like other medicines applied into eyes, timolol is 
absorbed into the blood. This may cause similar side effects as seen with ”intravenous” and /or “oral” 
beta-blocking agents. The chance of having side effects after using eye drops is lower than when 
medicines are for example, taken by mouth or injected. Listed side effects include reactions seen 
within bimatoprost and timolol when used for treating eye conditions: 

• Severe allergic reactions with swelling and difficulty breathing which could be life-threatening  
• Low blood sugar 
• Depression; memory loss; hallucination 
• Fainting; stroke; decreased blood flow to the brain; worsening of myasthenia gravis (increased 

muscle weakness); tingling sensation 
• Decreased sensation of your eye surface; double vision; drooping eyelid; separation of one of 

the layers within the eyeball after surgery to reduce the pressure in the eye; inflammation of 
the surface of the eye, bleeding in the back of the eye (retinal bleeding), inflammation within 
the eye, increased blinking 



54 

• Heart failure; irregularity or stopping of the heartbeat; slow or fast heartbeat; too much fluid, 
mainly water, accumulating in the body; chest pain 

• Low blood pressure, swelling or coldness of your hands, feet and extremities, caused by 
constriction of your blood vessels 

• Cough, worsening of asthma, worsening of the lung disease called chronic obstructive 
pulmonary disease (COPD)  

• Diarrhoea; stomach pain; feeling and being sick; indigestion; dry mouth 
• Red scaly patches on skin; skin rash 
• Muscle pain 
• Reduced sexual urge; sexual dysfunction 
• Weakness 
• An increase in blood test results that show how your liver is working  

 
Other side effects reported with eye drops containing phosphates 
This medicine contains 0.38 mg phosphates in each 0.4 ml of solution which is equivalent to 0.95 
mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), 
phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during 
treatment.  
 
Reporting side effects 
If you get any side effects, talk to your doctor, pharmacist, or nurse.  This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V*. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store GANFORT single-dose 
 
Keep GANFORT single-dose out of the sight and reach of children.  
 
Do not use GANFORT single-dose after the expiry date which is stated on the single-dose container 
and the carton.  The expiry date refers to the last day of that month. 
 
This medicine is for single use only and does not contain preservatives.  Do not keep any unused 
solution. 
 
This medicinal product does not require any special temperature storage conditions.  Keep the 
single-dose containers in the pouch and place the pouch back in carton in order to protect from light 
and moisture.  Once the single-dose container is removed from the pouch use within 7 days. All 
single-dose containers should be kept in the pouch and discarded after 10 days from the first opening 
of the pouch. 
 
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 to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What GANFORT single-dose contains 
 
• The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml corresponding to timolol 

maleate 6.8 mg/ml. 
 
• The other ingredients are sodium chloride, sodium phosphate dibasic heptahydrate, citric acid 

monohydrate and purified water. Small amounts of hydrochloric acid or sodium hydroxide may 
be added to bring the solution to the correct pH (acidity) level. 



55 

 
What GANFORT single-dose looks like and contents of the pack 
GANFORT single-dose is a colourless to slightly yellow solution supplied in single-dose plastic 
containers, each containing 0.4 ml of solution. 
 
Pack contains 1 foil pouch containing 5 single-dose containers in a carton.   
 
Packs contain 3 or 9 foil pouches, each containing 10 single-dose containers, for a total of 30 or 90 
single-dose containers in a carton, respectively. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Allergan Pharmaceuticals Ireland 
Castlebar Road, 
Westport, 
Co. Mayo, 
Ireland 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder. 
 
België/Belgique/Belgien/ 
Luxembourg/Luxemburg/Nederland 
Allergan n.v. 
Tél/Tel: +32 (0)2 351 24 24 
 

Ísland 
Actavis Pharmaceuticals Iceland ehf. 
Sími: +354 550 3300 

България 
Алерган България ЕООД 
Тел.: +359 (0) 800 20 280 
 

Italia 
Allergan S.p.A 
Tel: + 39 06 509 562 90 
 

Česká republika 
Allergan CZ s.r.o. 
Tel: +420 800 188 818 
 

Latvija/Lietuva 
Allergan Baltics UAB 
Tel: + 371 676 60 831 (LV); + 37 052 072 777 
(LT) 

Danmark/Norge/Suomi/Finland/Sverige 
Allergan Norden AB 
Tlf/Puh/Tel: + 4580884560 (DK); +47 80 01 04 
97 (NO); + 358 800 115 003 (FI); +46 (0)8 594 
100 00 (SE) 
 

Magyarország 
Allergan Hungary Kft. 
Tel.: +36 80 100 101 
 

Deutschland 
Pharm-Allergan GmbH 
Tel: +49 69 92038 10 50 
 

Österreich 
Pharm-Allergan GmbH 
Tel: +43 1 99460 6355 
 

Eesti 
Allergan Baltics UAB 
Tel: + 37 2634 6109  
 

Polska 
Allergan Sp.z o.o. 
Tel.: +48 22 256 3700 
 

Ελλάδα/Κύπρος 
Allergan Hellas Pharmaceuticals S.A. 
Tηλ: +30 210 74 73 300 
 

Portugal 
Profarin Lda. 
Tel: +351 21 425 3242 
 



56 

España 
Allergan S.A 
Tel: +34 91 807 6130 
 

România 
Allergan S.R.L. 
Tel: +40 21 301 53 02 
 

France 
Allergan France SAS 
Tél: +33 (0)1 49 07 83 00 
 

Slovenija 
Ewopharma d.o.o. 
Tel: +386 (0) 590 848 40 
 

Hrvatska 
Ewopharma d.o.o. 
Tel: +385 1 6646 563 

Slovenská republika 
Allergan SK s.r.o. 
Tel: + 421 800 221 223 
 

Ireland/Malta 
Allergan Pharmaceuticals Ireland 
Tel: 1800 931 787 (IE); +356 27780331 (MT) 
 

United Kingdom 
Allergan Ltd 
Tel: +44 (0) 1628 494026 

 
This leaflet was last revised in <{MM/YYYY}> <{month YYYY} 
 
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 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