Ganfort

/ AbbVie

Recommended dosage in adults (including the elderly): 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.
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.

Reduction of IOP in patients with open-angle glaucoma or ocular hypertension, who are insufficiently responsive to topical beta-blockers or prostaglandin analogs.

Hypersensitivity to the active substances or to any of the excipients. Reactive airway disease, including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock.

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.
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.
See prescribing information for full details.

Very common: Conjunctival hyperemia.
Common: Headache, dizzines, punctuate keratitis, corneal erosion, burning sensation, eye pruritus, stinging sensation in the eye, foreign body sensation, dry eye, erythema of eyelid, eye pain, photophobia, eye discharge, visual disturbance, eyelid pruritus, visual acuity worsened, blepharitis, eyelid oedema, eye irritation, lacrimation increased, growth of eyelashes, rhinitis, blepharal pigmentation, hirsutism, skin hyperpigmentation (periocular).
See prescribing information for full details.

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.

Pregnancy: Should not be used during pregnancy unless clearly necessary.
Lactation: Should not be used by breast-feeding women.
See prescribing information for full details.

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.

Shelf life: After first opening, use within one month.
Storage: Store at a temperature up to 25°C.