ALPHAGAN

Posology Recommended dosage in adults (including the elderly) The recommended dose is one drop of Alphagan in the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required for the use in elderly patients.

4). Paediatric population No clinical studies have been performed in adolescents (12 to 17 years). 9). It is known that severe adverse reactions can occur in neonates. The safety and efficacy of Alphagan have not been established in children aged 2 to 12 years.

Method of administration 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 one minute. This should be performed immediately following the instillation of each drop.

This may result in a decrease of systemic side effects and an increase in local activity. To avoid contamination of the eye or eye drops do not allow the dropper tip to come into contact with any surface. If more than one topical ophthalmic drug is to be used, the different drugs should be instilled 5-15 minutes apart

2% of patients. They are usually transient and not commonly of a severity requiring discontinuation of treatment. 5% of subjects) in clinical trials with the onset between 3 and 9 months in the majority of patients. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The following terminologies have been used in order to classify the occurrence of undesirable effects: 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 (cannot be estimated from the available data).

Table 1:

Tabulated list of adverse reactions System Organ Class Frequency Adverse reaction Immune system disorders Uncommon Allergic reactions Uncommon DepressionPsychiatric disorders Very rare Insomnia Very common HeadacheNervous system disorders Common Dizziness Abnormal taste Very common Ocular hyperaemia Burning and stinging Blurred vision Foreign body sensation Conjunctival folliculosis Pruritus Ocular allergic reaction (includes allergic blepharitis, allergic blepharoconjunctivitis, allergic conjunctivitis and follicular conjunctivitis) Common Eyelid hyperaemia Eyelid oedema Blepharitis Conjunctival oedema Conjunctival discharge Eye pain Tearing Photophobia Eyelid erythema Corneal erosion and staining Eye dryness Conjunctival blanching Abnormal vision Conjunctivitis Eye irritation Conjunctival papillae Eye disorders Very rare Iritis Miosis Cardiac disorders Uncommon Palpitations/arrhythmias (including bradycardia and tachycardia) Vascular disorders Very rare Hypertension Hypotension Common Upper respiratory symptoms Uncommon Nasal dryness Respiratory, thoracic and mediastinal disorders Rare Dyspnoea Very common Oral drynessGastrointestinal disorders Common Gastrointestinal symptoms Very common Fatigue/drowsinessGeneral disorders and administration site conditions Common Asthenia The following adverse reactions have been identified during post-marketing use of Alphagan in clinical practice.

8). Cardiac disorders Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular disease. 8 for details). If allergic reactions are observed, treatment with Alphagan should be discontinued.

2%, with some reported to be associated with an increase in IOP. Vascular disorders Alphagan should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.

Hepatic and renal insufficiency Alphagan has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients. Benzalkonium chloride The preservative in Alphagan, benzalkonium chloride, may cause eye irritation, symptoms of dry eyes, and may affect the tear film and corneal surface.

Patients should remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Patients should avoid contact with soft contact lenses. Alphagan should be used with caution in dry eye patients and in patients where the cornea may be compromised.

Patients should be monitored in case of prolonged use.

1. 8). g. tricyclic antidepressants and mianserin).