TIMOLOL MALEATE

Posology:

The lowest possible dosage should be given first in order to be able to identify cardiac decompensation or bronchial phenomena at an early stage; this is especially important in the elderly. g. once a week) under control or on the basis of clinical effect.

For angina:

The recommended dose range is 5 - 30 mg twice daily. The initial dose should be 5 mg twice daily, increasing the daily dose by 10 mg not more frequently than every 3 to 4 days to achieve optimum results.

Hypertension:

The recommended dose range is 10 - 60 mg daily. Most hypertensive patients will be controlled by 10 - 30 mg timolol which can be administered once daily or in two divided doses if preferred. Doses in excess of 30 mg daily should be given in two equally divided doses.

The dose of Timolol maleate 10 mg tablets may need adjustment when used in conjunction with other antihypertensive drugs.

After myocardial infarction:

Start with 5 mg (½ tablet) twice daily for two days. If there are no adverse effects, increase dosage to 10 mg twice daily and maintain at this dose. For the prophylactic treatment of migraine: 10 to 20 mg once daily or in two divided doses.

Dosage in the elderly:

Initiate treatment with lowest adult dose and thereafter adjust according to response.

Paediatric population:

The safety and efficacy of Timolol maleate 10 mg tablets in children has not been established. No data are available.

Route of administration:

Oral.

System Organ Class Rare ≥ 1/10,000, < 1/1000 Frequency Not Known Immune system disorders Systemic lupus erythematosus; systemic allergic reactions including urticaria; localized and generalized rash; pruritus; anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia.

burning stinging; itching; tearing,redness);blepharitis, keratitis; blurred vision; decreased corneal sensitivity; corneal erosion, ptosis; diplopia Ear and labyrinth disorders Vertigo Cardiac disorders Atrioventricular block; bradycardia; cardiac failure; cyanosis; chest pain; palpitations; oedema; arrhythmia; congestive heart failure; cardiac arrest Vascular disorders Hypotension; Raynaud's phenomenon; increase of an existing intermittent claudication; peripheral coldness Respiratory, thoracic and mediastinal disorders Dyspnoea; bronchospasm (in patients with bronchial asthma or a history of asthmatic complaints); cough Gastrointestinal disorders Retroperitoneal fibrosis Dyspepsia; vomiting; nausea; diarrhoea; dysgeusia; dry mouth; abdominal pain Skin and subcutaneous tissue Disorders Dermatitis allergic; dermatitis psoriasiform; rash erythematous Alopecia; angioedema; psoriaform rash or exacerbation of psoriasis, skin rash Musculoskeletal and connective tissue disorders Arthralgia Myalgia Reproductive system and breast Disorders Sexual dysfunction (such as impotence); decreased libido General disorders and administration site conditions Fatigue; weakness Investigations Antinuclear antibody increased 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. By reporting side effects, you can help provide more information on the safety of this medicine.

Cardiovascular:

Although Timolol maleate 10 mg tablets have no direct myocardial depressant activity, the continued depression of sympathetic drive through beta blockade may lead to cardiac failure in patients with latent cardiac insufficiency. All patients should be observed for evidence of cardiac failure and, if it occurs, then treatment with beta blockers should be gradually withdrawn.

If it is not possible to withdraw beta blocker treatment, then digitalisation and diuretic therapy should be considered. 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. Beta blockers should not be used in patients with untreated congestive heart failure. This condition should first be stabilised.

In patients with ischaemic heart disease, treatment should not be discontinued suddenly. e. over 1-2 weeks. If necessary, replacement therapy should be initiated at the same time, to prevent exacerbation of angina pectoris. Beta blockers may induce bradycardia.

If the pulse rate decreases to less than 50-55 beats per minute at rest and the patient experiences symptoms related to the bradycardia, the dosage should be reduced. In patients with peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication), beta blockers should be used with great caution as aggravation of these disorders may occur.

Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.

Respiratory disorders:

Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some beta-blockers. Timolol 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.

Metabolic/endocrine:

Timolol maleate 10 mg tablets should be administered with caution to patients with impaired renal function or impaired hepatic function. Patients with liver or kidney insufficiency may need a lower dosage. Timolol maleate 10 mg tablets may be used safely in diabetes.

It may, however, interfere with the cardiovascular and possibly the metabolic responses to hypoglycaemia and, therefore, should be used with caution in diabetic patients treated with insulin or oral hypoglycaemic agents as well as patients subject to spontaneous hypoglycaemia.

Beta-blockers could further increase the risk of severe hypoglycaemia when used concurrently with sulfonylureas. Diabetic patients should be advised to carefully monitor blood glucose levels. 5). 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 symptoms of thyrotoxicosis or hypoglycaemia.

Beta-blockers may also mask the signs of hyperthyroidism.

Corneal diseases:

Beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution.

Other beta-blocking agents:

The known effects of systemic beta-blockade may be potentiated when timolol maleate is given to the patients already receiving a systemic betablocking agent. The response of these patients should be closely observed. 5).

Anaphylactic reactions:

While taking beta-blockers, patients with 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 dose of adrenaline used to treat anaphylactic reactions.

Beta blockers may increase sensitivity to allergens and the seriousness of anaphylactic reactions. g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving timolol maleate.

Other warnings:

Patients with a history of psoriasis should take beta blockers only after careful consideration. There have been reports of skin rashes and/or dry eyes associated with the use of beta- adrenergic blocking drugs. The reported incidence is rare and in most cases the symptoms have cleared when treatment was withdrawn.

Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Cessation of therapy with the beta blocker should be gradual although withdrawal symptoms with timolol are infrequent. The following statement will appear on the label of this product: `Do not take this medicine if you have a history of wheezing or asthma'.

1. Heart failure, unless adequately controlled, sinus bradycardia (<45 - 50 bpm) or heart block. History of bronchospasm and bronchial asthma. Chronic obstructive pulmonary disease. Patients receiving monoamine oxidase inhibitors. Pregnancy.

Sick sinus syndrome (including sino-atrial block), severe peripheral vascular disease or Raynaud's disease. Prinzmetal's angina. Untreated phaeochromocytoma. Metabolic acidosis. Hypotension. Severe peripheral circulatory disturbances.