TIMOPTOL -LA OPHTHALMIC

25% solution in each affected eye once a day. 5% solution in each affected eye once a day. If needed, Timoptol-LA may be used with other agent(s) for lowering intra-ocular pressure. Other topically applied medication should be administered not less than 10 minutes before Timoptol-LA.

4). Intra-ocular pressure should be reassessed approximately four weeks after starting treatment because response to Timoptol-LA may take a few weeks to stabilise. Transfer from other agents When transferring a patient from Timoptol to Timoptol-LA, discontinue Timoptol after a full day of therapy, starting treatment with the same concentration of Timoptol-LA on the following day.

25% Timoptol-LA in each affected eye once a day. 5% solution in each affected eye once a day if the response is not adequate. 25% Timoptol-LA in each affected eye once a day. On the following day, discontinue the previous agent completely, and continue with Timoptol-LA.

1). Paediatric population Not currently indicated. Elderly There has been wide-experience with the use of timolol maleate in elderly patients. The dosage recommendations given above reflect the clinical data derived from this experience.

Method of administration Invert the closed container and shake once before each use. It is not necessary to shake the container more than once. 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. Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections.

Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

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.

0%), lasting from 30 seconds to 5 minutes following instillation. The following possibly, probably, or definitely drug-related adverse reactions occurred with frequency of at least 1% in parallel active treatment controlled clinical trials: Ocular: burning and stinging, discharge, foreign body sensation, itching.

The following adverse reactions reported with Timoptol, either in clinical trials or since the drug has been marketed, are potential side effects of Timoptol-LA. Additional adverse reactions have been reported in clinical experiences with systemic timolol, and may be considered potential effects of ophthalmic timolol.

Also listed are adverse reactions seen within the class of ophthalmic beta-blockers and may potentially occur with Timoptol-LA. g. burning, stinging, itching, tearing, redness), conjunctivitis, blepharitis, keratitis, dry eyes, decreased corneal sensitivity, and corneal erosion.

4). Ear and labyrinth disorders Ocular: tinnitus. Cardiac disorder: ocular: bradycardia, chest pain, arrhythmia, heart block, congestive heart failure, palpitations, cardiac arrest, atrioventricular block, cardiac failure, oedema. systemic: AV block (second- or third-degree), sino-atrial block, pulmonary oedema, worsening of arterial insufficiency, worsening of angina pectoris, vasodilation.

Vascular disorders ocular: claudication, hypotension, Raynaud's phenomenon, cold hands and feet. Respiratory, thoracic and mediastinal disorders ocular: bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnoea, cough.

systemic: rales. General disorders and administration site conditions ocular: asthenia, fatigue. systemic: extremity pain, decreased exercise tolerance. Skin and subcutaneous tissue disorders ocular: alopecia, skin rash, psoriasiform rash or exacerbation of psoriasis.

systemic: sweating, exfoliative dermatitis. Immune system disorders ocular: systemic lupus erythematosus, pruritus. systemic: signs and symptoms of allergic reactions including anaphylaxis, angioedema, urticaria, localised and generalised rash, anaphylactic reaction.

Psychiatric disorders ocular: depression, insomnia, nightmares, memory loss, hallucination. systemic: diminished concentration, increased dreaming. Nervous system disorders ocular: syncope, cerebrovascular accident, cerebral ischaemia, headache, dizziness, increase in signs and symptoms of myasthenia gravis, paraesthesia.

systemic: vertigo, local weakness. Gastrointestinal disorders ocular: nausea, diarrhoea, dyspepsia, dry mouth, dysgeusia, abdominal pain, vomiting. Reproductive system and breast disorders ocular: decreased libido, Peyronie’s disease, sexual dysfunction such as impotence.

systemic: micturition difficulties. Metabolism and nutrition disorders ocular: hypoglycaemia. systemic: hyperglycaemia. Musculoskeletal and connective tissue disorders ocular: myalgia. systemic: arthralgia. Blood and lymphatic system disorders systemic: non-thrombocytopenic purpura.

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.

Like other topically applied ophthalmic agents, timolol is absorbed systemically. Due to beta-adrenergic component, timolol, 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.

Cardiac failure should be adequately controlled before beginning therapy with Timoptol-LA. Patients with a history of severe cardiac disease should be watched for signs of cardiac failure and have their pulse rates monitored. 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. Timoptol-LA 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 hypoglycaemia or to patients with labile diabetes, as beta- blockers may mask the signs and symptoms of acute hypoglycaemia.

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 patients already receiving a systemic beta-blocking agent.

The response of these patients should be closely observed. 5). There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenoreceptor blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when treatment was withdrawn.

Discontinuation of the drug should be considered if any such reaction is not otherwise explicable. Cessation of therapy involving beta-blockade should be gradual. The dispenser of Timoptol-LA contains benzododecinium bromide as a preservative.

In a clinical study, the time required to eliminate 50% of the gellan solution from the eye was up to 30 minutes. In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil with a miotic.

Timoptol-LA has little or no effect on the pupil. When Timoptol-LA is used to reduce elevated intra-ocular pressure in angle-closure glaucoma it should be used with a miotic and not alone. g. timolol, acetazolamide) after filtration procedures.

g. of epinephrine (adrenaline). The anaesthesiologist should be informed when the patient is receiving timolol. Transient blurred vision following instillation may occur, generally lasting from 30 seconds to 5 minutes, and in rare cases up to 30 minutes or longer.

Blurred vision and potential visual disturbances may impair the ability to perform hazardous tasks such as operating machinery or driving a motor vehicle. g. 2). There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products.

These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. 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 may be unresponsive to the usual dose of epinephrine (adrenaline) used to treat anaphylactic reactions.

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. Timoptol-LA should not be used in patients wearing contact lenses as it has not been studied in these patients.