BRIMONIDINE TARTRATE

Posology 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 has not been established in children.

Adults including the elderly:

One drop into the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required in elderly patients. To reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute immediately after the instillation of each drop.

If more than one topical ophthalmic drug is to be administered, they should be instilled 5 to 15 minutes apart. 4). Method of administration Precautions to be taken before handling or administering the medicinal product

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 nature serious enough to require discontinuation of treatment.

5% of subjects), with onset being between 3 and 9 months in the majority of patients. The following convention has been used for classification of frequency of undesirable effects: Very common : ≥1 in 10. Common : ≥1 in 100 and <1 in 10.

Uncommon : ≥1 in 1,000 and <1 in 100. Rare : ≥1 in 10,000 and <1 in 1,000. Very rare : < 1 in 10,000. Not known (cannot be estimated from the available data) Within each frequency grouping, undesired effects are presented in order of decreasing seriousness.

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 including allergic reactions (hyperaemia, burning, stinging, pruritis, foreign body sensation, conjunctival follicles); blurred vision, allergic blepharitis, allergic blepharoconjuctivitis, 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 (anterior uveitis); 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. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

3). In a 3 month, phase 3 study in children aged 2 to 7 years with glaucoma, inadequately controlled by beta-blockers, a high prevalence of somnolence (55%) was reported with brimonidine eye drops as adjunctive treatment. In 8% of children, this was severe and led to discontinuation of treatment in 13%.

4). 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. uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store.

8). Caution is required in treating patients with: - severe or unstable and uncontrolled cardiovascular disease. - depression - cerebral or coronary insufficiency - Raynaud’s phenomenon - orthostatic hypotension - thromboangiitis obliterans The use of Brimonidine Eye Drops has not been studied in patients with hepatic or renal impairment, therefore, caution should be exercised when treating such patients.

8); if allergic reactions are apparent, treatment should be discontinued. Delayed ocular hypersensitivity reactions have been reported with Brimonidine Eye Drops, with some reported to be associated with an increase in IOP. 05mg/ml benzalkonium chloride as preservative which may be deposited in soft contact lenses.

Hence, Brimonidine eye drops should not be used while wearing these lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface.

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.

8) Contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy or those on antidepressants which affect noradrenergic transmission (eg. tricyclic antidepressants and mianserin).