LATANOPROST

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. Pediatric population Safety and effectiveness of Latanoprost 50micrograms/ml and Timolol 5mg/ml Eye Drops, Solution in children and adolescents has not been established.

4). If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. 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.

For latanoprost, the majority of adverse events relate to the ocular system. In data from the extension phase of the latanoprost/timolol eye drops, solution pivotal trials, 16-20% of patients developed increased iris pigmentation, which may be permanent.

4). Other ocular adverse events are generally transient and occur on dose administration. For timolol, the most serious adverse events 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 events seen in clinical trials with latanoprost/timolol eye drops, solution are listed below. Adverse events are categorized by frequency as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000).

Table 1:

Adverse reactions seen in Latanoprost/Timolol 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 latanoprost/timolol eye drops, solution in either in clinical studies, spontaneous reports or in the available literature.

, burning, stinging, itching, tearing and redness), dry eyes, ptosis, blepharitis, blurred vision Ear and labyrinth disorders Tinnitus Cardiac disorders Cardiac arrest, cardiac failure, atrioventricular block, congestive heart failure, chest pain, arrhythmia, bradycardia, oedema, palpitations Vascular disorders Cold hands and feet, hypotension, Raynaud's phenomenon Respiratory, thoracic and mediastinal disorders Bronchospasm (predominately in patients with pre-existing bronchospastic disease), cough, dyspnoea Gastrointestinal disorders Abdominal pain, vomiting, diarrhoea, dry mouth, dysgeusia, dyspepsia, nausea Skin and subcutaneous tissue disorders Skin rash, psoriasiform rash, exacerbation of psoriasis, alopecia Musculoskeletal and connective tissue disorders Myalgia Reproductive system and breast disorders Sexual dysfunction, decreased libido General disorders and administration site conditions Asthenia, fatigue 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 the Google Play or Apple App Store.

Systemic effects Like other topically applied ophthalmic agents, Latanoprost 50micrograms/ml and Timolol 5mg/ml Eye Drops, Solution 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 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.

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.

Latanoprost 50micrograms/ml and Timolol 5mg/ml Eye Drops, Solution 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.

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

The response of these patients should be closely observed. 5). Anaphylactic reactions While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens and unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions.

g. timolol, acetazolamide) after filtration procedures. g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving timolol. Concomitant therapy Timolol may interact with other drugs see section

Latanoprost 50micrograms/ml and Timolol 5mg/ml Eye Drops, Solution 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. 1.