FIXAPOST

Posology Adults (including the elderly) Recommended therapy is one eye drop in the affected eye(s) once daily. 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.

Paediatric population The safety and efficacy of Fixapost in children and adolescents has not been established. Method of administration Ocular use. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for two minutes.

This should be performed immediately following the instillation of each drop. Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. If more than one topical ophthalmic medicine is being used, the medicinal products should be administered at least five minutes apart.

A single-dose contains enough eye drops solution to treat both eyes. For single use only. This medicinal product is a sterile solution that does not contain a preservative. The solution from one individual single dose container is to be used immediately after opening for administration to the affected eye(s).

Since sterility cannot be maintained after the individual single dose container is opened, any remaining contents must be discarded immediately after administration. Patients should be instructed: − to avoid contact between the dropper tip and the eye or eyelids, − to use the eye drops solution immediately after first opening the single- dose container and to discard the single-dose after use, − to store the unopened single-dose containers in the sachet.

For latanoprost, the majority of adverse reactions relate to the ocular system. In data from the extension phase of pivotal trials on the combined latanoprost/timolol preserved reference product, 16-20% of patients developed increased iris pigmentation, which may be permanent.

4). Other ocular adverse reactions are generally transient and occur on dose administration. For timolol, the most serious adverse reactions are systemic in nature, including bradycardia, arrhythmia, congestive heart failure, bronchospasm and allergic reactions.

Like other topically applied ophthalmic drugs, timolol is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta blocking agents. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.

Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers. Treatment related adverse reactions seen in clinical trials with the combined latanoprost/timolol preserved reference product are listed below.

Adverse events are categorised by frequency as follows: 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) and very rare (<1/10,000), not known (frequency cannot be estimated from the available data).

Table 1:

Adverse reactions seen in clinical trials System Organ Class Very common (≥1/10) Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Nervous system disorders Headache Eye disorders Iris hyperpigmentation Eye pain, eye irritation (including stinging, burning, itching, foreign body sensation) Corneal disorders, conjunctivitis, blepharitis, eye hyperaemia, vision blurred, lacrimation increased Skin and subcutaneous tissue disorders Rash, pruritus Additional adverse events have been reported specific to the use of the individual components of Fixapost in either clinical studies, spontaneous reports or in the available literature.

Systemic effects Like other topically applied ophthalmic agents, Fixapost is absorbed systemically. Due to the beta-adrenergic component timolol, the same types of cardiovascular, pulmonary and other adverse reactions as seen with systemic beta-adrenergic blocking agents may occur.

Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. 2. g. coronary heart disease, Prinzmetal’s angina and cardiac failure) and hypotension therapy with beta-blockers should be critically assessed and the therapy with other active substances should be considered.

Patients with cardiovascular diseases should be watched of signs of deterioration of these diseases and for 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.

Cardiac reactions and, rarely, death in association with cardiac failures have been reported following administration of timolol. 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.

Fixapost 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. Hypoglycemia/diabetes Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or in patients with labile diabetes, as beta-blockers may mask the signs and symptoms of acute hypoglycaemia.

Hyperthyroidism 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 the patients already receiving a systemic beta-blocking agent.

Fixapost is contraindicated in patients with: • 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.

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