TIMOLOL MALEATE / BENDROFLUMETHIAZIDE

Posology The recommended dosage range is 1 to 4 tablets daily. The dosage can be taken in the morning or in two divided doses, morning and evening. If blood pressure control is not achieved on 4 tablets daily, consideration should be given to titrating timolol and bendroflumethiazide separately or adding another agent with hypotensive activity.

Dosage in the elderly Initiate treatment with 1 tablet daily and thereafter adjust according to response. Paediatric population The safety and efficacy of Timolol maleate/Bendroflumethiazide in children has not been established. No data are available.

5 mg tablets are for oral use

) Gastrointestinal disorders Retroperitoneal fibrosis Acute pancreatitis; dyspepsia; vomiting; nausea; diarrhoea Skin and subcutaneous tissue disorders Allergic dermatitis; psoriasiform dermatitis; erythematous rash Rash with associated photosensitivity Musculoskeletal and connective tissue disorders Arthralgia Muscle pain Renal and urinary disorders Oliguria; glucosuria (in diabetic and other susceptible patients) Reproductive system and breast disorders Erectile dysfunction General disorders and administration site conditions Fatigue; weakness; thirst Investigations Increased blood urea (most pronounced in patients with renal disease and pre- existing retention of nitrogen); increased antinuclear antibody Thiazide diuretics may cause excessive depletion of fluid and electrolytes during prolonged or intense use.

Symptoms are muscle pain or fatigue, thirst and oliguria. With thiazide diuretics hypokalaemia is more severe in patients already depleted of potassium, as in renal or hepatic insufficiency. Cases of choroidal effusion with visual field defect have been reported after the use of thiazide and thiazide-like diuretics.

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.

Cardiovascular The continued depression of sympathetic drive through beta-blockade may lead to cardiac failure. 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be observed for evidence of cardiac failure, and if it occurs, then treatment with beta blockers should be gradually withdrawn.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. Beta blockers should not be used in patients with untreated congestive heart failure. This condition should first be stabilised.

Caution should be exercised in patients in patients with first-degree atrioventricular block or portal hypertension. 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.

Metabolic/endocrine Caution should be exercised in patients with diabetes mellitus, spontaneous hypoglycaemia, and impaired renal or hepatic function. 3). Thiazides may decrease urinary calcium excretion and may cause intermittent and slight elevation of serum calcium.

Marked hypercalcaemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function. As all diuretics produce changes in fluid and electrolyte balance, caution should be exercised in patients with existing fluid and electrolyte imbalance.

Electrolytes and fluids should be monitored, especially with high doses, long- term use or in renal impairment. Thiazide diuretics should also be used with caution in patients with nephrotic syndrome, hyperaldosteronism and malnourishment.

Beta blockers may mask the symptoms of thyrotoxicosis or 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). Thiazide diuretics can exacerbate gout and systemic lupus erythematosus.

Choroidal effusion, acute myopia and secondary angle-closure glaucoma:

Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.

Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue drug intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.

Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. Other warnings Beta blockers may unmask myasthenia gravis. Psoriasis can be aggravated by beta blockers. Therefore patients with a history of psoriasis should take Timolol maleate/Bendroflumethiazide only after careful consideration.

Beta blockers may increase sensitivity to allergens and the seriousness of anaphylactic reactions. 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'.

There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when treatment was withdrawn. Discontinuance of Timolol maleate/Bendroflumethiazide should be considered if any such reaction is not otherwise explicable, cessation of therapy with the beta-blocker should be gradual.

1. Severe renal impairment or anuria. Severe hepatic impairment. Significant electrolyte disturbance including refractory hypokalaemia, hyponatraemia and hypercalcaemia, symptomatic hyperuricaemia and Addison`s disease. Uncontrolled heart failure, bradycardia, cardiogenic shock, history of bronchospasm, bronchial asthma, chronic obstructive pulmonary disease, patients receiving adrenergic augmenting drugs (monoamine oxidase inhibitors and tricyclic antidepressants), sick sinus syndrome (including sino-atrial block), Prinzmetals angina, untreated phaeochromocytoma, second- or third-degree heart block, metabolic acidosis, hypotension and severe peripheral circulatory disturbances.

Anaesthesia with agents that produce myocardial depression, such as chloroform and ether. Timolol maleate/Bendroflumethiazide is contraindicated in pregnancy.