BETAXOLOL

5% Eye Drops to be instilled into the affected eye(s) twice a day.

Children:

No clinical studies have been performed to establish safety and efficacy in children. Therefore, this product is currently not recommended for use in children. 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. 5% Eye Drops may take a few weeks to stabilise. If necessary, concomitant treatment with miotics, adrenaline and/or carbonic anhydrase inhibitors can be instituted.

In order to prevent the active substance(s) from being washed out when additional ophthalmic medication is used, an interval of at least 10 minutes between each application is recommended. The use of two topical beta-adrenergic agents is not recommended.

5% Eye Drops in each affected eye twice daily. 5% Eye Drops. When several antiglaucoma agents are being used, the patient should be assessed on an individual basis. Adjustment should involve one agent at a time at intervals of not less than one week.

Patients should be instructed to remove soft contact lenses before using betaxolol.

Like other topically applied ophthalmic drugs, betaxolol 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. 0% of patients. The following undesirable effects have been observed and reported with the following frequencies: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Rare: may affect up to 1 in 1,000 people Very rare: may affect up to 1 in 10,000 people Not known: frequency unknown/cannot be estimated from the available data Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.

System Organ Classification MedDRA Preferred Term Immune system disorders Frequency unknown: hypersensitivity Psychiatric disorders Rare: anxiety, insomnia, depression Nervous system disorders Common: headache Rare: syncope Frequency unknown: dizziness Eye disorders Very common: ocular discomfort Common: vision blurred, lacrimation increased Uncommon: punctate keratitis, keratitis, conjunctivitis, blepharitis, visual impairment, photophobia, eye pain, dry eye, asthenopia, blepharospasm, eye pruritus, eye discharge, eyelid margin crusting, eye inflammation, eye irritation, conjunctival disorder, conjunctival oedema, ocular hyperaemia Rare: Cataract, decreased corneal sensitivity, erythema of eyelid Cardiac disorders Uncommon: bradycardia, tachycardia Frequency unknown: arrhythmia Vascular disorders Rare: hypotension Respiratory, thoracic and mediastinal Disorders Uncommon: asthma, dyspnoea, rhinitis Rare: cough, rhinorrhea Gastrointestinal disorders Uncommon: nausea Rare: dysgeusia Skin and subcutaneous tissue disorders Rare: dermatitis, rash, alopecia Reproductive system and breast disorders Rare: libido decreased General disorders and administration site conditions Frequency unknown: asthenia Description of selected adverse reactions Additional adverse reactions have been seen with ophthalmic beta-blockers and may potentially occur with Betaxolol eye drops solution: System Organ Classification MedDRA Preferred Term Immune system disorders: Frequency unknown: Systemic allergic reactions including angioedema, urticaria, localized and generalized rash, pruritus, anaphylactic reaction.

For ocular use only.

General:

Like other topically applied ophthalmic drugs, betaxolol is absorbed systemically. Due to beta-adrenergic component, betaxolol, the same types of cardiovascular, pulmonary and other adverse reactions 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 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.

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. Patients with mild/moderate bronchial asthma, a history of mild/moderate bronchial asthma or, mild/moderate chronic obstructive pulmonary disease (COPD) should be treated with caution.

Hypoglycaemia/diabetes:

Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile diabetes, as beta- blockers may mask the signs and symptoms of acute hypoglycaemia. While Betaxolol has demonstrated a low potential for systemic effects, it should be used with caution in patients suspected of developing thyrotoxicosis.

1 or other beta-blocking agents. - Reactive airway disease including severe bronchial asthma or a history of severe bronchial asthma, severe chronic obstructive pulmonary disease.