BRIMONIDINE TARTRATE

Posology Recommended dosage in adults (including the elderly) The recommended dose is one drop of Brimonidine Tartrate 2 mg/ml Eye drops, solution in the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required for the use in elderly patients.

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.

If more than one topical ophthalmic drug is to be used, the different drugs should be instilled 5-15 minutes apart. 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 Brimonidine Tartrate 2 mg/ml Eye drops, solution have not been established in children. Method of administration Brimonidine Tartrate 2 mg/ml Eye drops, solution comes as eye drops. Always wash your hands before applying eye drops.

Your prescription label tells you how many drops to use at each dose. If you use Brimonidine Tartrate 2 mg/ml Eye drops, solution with another eye drop, wait 5-15 minutes before applying the second eye drop. Apply your eye drops in the following way: 1.

Tilt your head back and look at the ceiling. 2. Gently pull the lower eyelid down until there is a small pocket. 3. Squeeze the upturned dropper bottle to release a drop into your eye. 4. Whilst keeping the affected eye closed, press your finger against the corner of the closed eye (the side where the eye meets the nose) and hold for 1 minute.

Avoid touching the dropper tip against your eye or anything else. Replace and tighten the cap straight after use.

Summary of the safety profile The most commonly reported ADRs are oral dryness, ocular hyperaemia and burning/stinging, all occurring in 22 to 25% 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. Summary of adverse reactions 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).

Cardiac disorders Uncommon: palpitations/arrhythmias (including bradycardia and tachycardia) Nervous system disorders Very common: headache, drowsiness Common: dizziness, abnormal taste Very rare: syncope Eye disorders Very common: − ocular irritation (hyperaemia, burning and stinging, pruritus, foreign body sensation, conjunctival follicles) − blurred vision − allergic blepharitis, allergic blepharoconjunctivitis, allergic conjunctivitis, ocular allergic reaction, and follicular conjunctivitis Common: − local irritation (eyelid hyperaemia and oedema, blepharitis, conjunctival oedema and discharge, ocular pain and tearing) − photophobia − corneal erosion and staining − ocular dryness − conjunctival blanching − abnormal vision − conjunctivitis Very rare: − iritis − miosis Respiratory, thoracic and mediastinal disorders Common: upper respiratory symptoms Uncommon: nasal dryness Rare: dyspnoea Gastrointestinal disorders Very common: oral dryness Common: gastrointestinal symptoms Vascular disorders Very rare: hypertension, hypotension General disorders and administration site conditions Very common: fatigue Common: asthenia Immune system disorders Uncommon: systemic allergic reactions Psychiatric disorders Uncommon: depression Very rare: insomnia The following adverse reactions have been identified during post-marketing use of brimonidine eye drops 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 Brimonidine Tartrate 2 mg/ml Eye drops should be discontinued.

2%, with some reported to be associated with an increase in IOP. Other Information Brimonidine Tartrate 2 mg/ml Eye drops should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.

Brimonidine Tartrate 2 mg/ml Eye drops has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients. The preservative in Brimonidine Tartrate 2 mg/ml Eye drops, benzalkonium chloride, may cause eye irritation.

Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.

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