SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET Page 1 of 26 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 26 1. NAME OF THE MEDICINAL PRODUCT Betaxolol Hydrochloride 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg betaxolol hydrochloride (equivalent to 17.88 mg betaxolol). Excipient with known effect Each film-coated tablet contains 100.00 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex film-coated tablets with a break-line on one face. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Betaxolol Hydrochloride is indicated in adults for: Treatment of essential hypertension. Chronic, stable angina pectoris. 4.2 Posology and method of administration Posology Adults Essential hypertension The initial dose is 10 mg once daily. In case of insufficient effect this dosage can be increased to 20 mg per day. In moderate hypertension the standard dose is 20 mg once daily. In certain cases it could be necessary to increase the daily dose to 40 mg. Stable angina pectoris The dosage should be adjusted individually. The starting dose is 10 mg a day, which can be increased to the usual dose of 20 mg once daily. In certain cases it could be necessary to increase the daily dose to 40 mg. Patients with impaired renal or liver function In patients with renal impairment (creatinine clearance up to 20 ml/minute) there is no need to adjust the daily dose, however, clinical monitoring at the beginning of the treatment until steady plasma levels of the medicinal product are attained (over 4 days on average) is recommended. Page 3 of 26 In patients with severe renal impairment (creatinine clearance below 20 ml/minute) and in patients with haemo- or peritoneal dialysis the dose of 10 mg/day should not be exceeded. In patients on dialysis the daily dose can be given independent of the time of dialysis. In patients with liver failure there is no need to adjust the dose. Careful clinical monitoring is recommended at the beginning of the treatment. Elderly patients The treatment of elderly patients should be started cautiously with low doses and under close monitoring (see section 4.4). Paediatric population The safety and efficacy of betaxolol in children has not yet been established. Betaxolol hydrochloride should not be used in children (see section 4.4). Method of administration Oral use. Betaxolol Hydrochloride should always be taken at the same time of the day, preferably in the early morning. The tablets may be taken with or without food. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Severe forms of bronchial asthma and chronic obstructive pulmonary disease Decompensated heart failure Cardiogenic shock Second and third degree atrioventricular block, unless a pacemaker is inserted Prinzmetal's variant angina pectoris (pure form and with monotherapy) Sick-sinus syndrome, including sinoatrial block Bradycardia (less than 45-50 beats/min) Severe forms of Raynaud's phenomenon and peripheral arterial disorders Untreated pheochromocytoma Hypotension History of anaphylactic reaction Metabolic acidosis Concurrent administration with floctafenine or sultopride (see section 4.5) 4.4 Special warnings and precautions for use The treatment must not be discontinued suddenly in patients with stable angina pectoris: this could result in serious heart rhythm disorders, myocardial infarction or sudden death. Discontinuation of treatment The treatment should not be discontinued suddenly, especially in patients with ischaemic heart disease. The doses should be reduced gradually, within a one to two-week period. If necessary, with simultaneous introduction of replacement therapy to prevent any aggravation of angina pectoris. Asthma and chronic obstructive lung disease Beta-blockers may be administered only in mild forms of the disease, cardio selective beta-blockers at the lowest possible doses should be preferably used and it is recommended to carry out pulmonary function tests before and after the start of beta-blocker treatment. During an asthma attack beta2-agonist bronchodilators may be used. Page 4 of 26 Heart failure In patients with compensated heart failure, betaxolol can be administered in gradually increasing doses, if necessary. At the start of treatment very low doses should be administered. Close monitoring of the patient's condition is required. Bradycardia Beta-blockers may induce bradycardia. The dosage of betaxolol hydrochloride must be decreased, if the resting heart rate of the patient drops below 50-55 beats per minute and symptoms of bradycardia appear. First degree atrioventricular block With respect to the negative dromotropic effect of beta-blockers, betaxolol should be administered with caution to patients with first-degree atrioventricular block. Prinzmetal variant of angina Beta-blockers may increase the number and duration of angina attacks in patients suffering from the Prinzmetal’s variant angina pectoris (see section 4.3). Cardioselective beta-blockers may be used in minor and mixed forms, provided that a vasodilator is co-administered. Peripheral arterial disorders In patients with peripheral arterial disorders (Raynaud's syndrome or disease, arteritis, or chronic occlusive arterial disease of the lower limbs), beta-blockers should be used with great caution as they may result in an aggravation of the condition. In severe forms of Raynaud’s phenomenon and peripheral arterial circulatory disorders, beta-blockers are contraindicated (see section 4.3). Pheochromocytoma The use of beta-blockers in the treatment of hypertension caused by treated pheochromocytoma requires close monitoring of the patient's blood pressure (see section 4.3).Beta blockers should only be used after prior administration if alpha inhibitors Paediatric population The safety and efficacy of betaxolol has not yet been established, therefore betaxolol is not recommended in children and adolescents. Elderly patients In elderly patients, the treatment should be initiated at low doses and the patient´s clinical condition must be closely monitored (see section 4.2). Patients with renal impairment In patients with renal impairment, the dosage should be adjusted according to the serum creatinine levels or creatinine clearance (see section 4.2). Diabetic patients Beta-blockers may mask some signs of hypoglycaemia, particularly tachycardia, palpitations and sweats (see section 4.5 and 4.8). The patient must be informed about the necessity of blood glucose monitoring at shorter intervals, in particular at the start of treatment. Psoriasis The benefit of beta-blockers in patients with a personal or family history of psoriasis should be carefully weighed, as it has been reported that psoriasis has been aggravated in patients treated with beta-blockers (see section 4.8). Page 5 of 26 Allergic reactions In patients liable to have a severe anaphylactic reaction, irrespective of its cause, especially after the administration of iodine-containing contrast media or floctafenine (see sections 4.3 and 4.5) or during desensitising therapy, beta-blocker treatment may result in an aggravated allergic reaction and resistance to treatment by the usual doses of adrenaline. General anaesthesia Beta-blockers attenuate reflex tachycardia and increase the risk of hypotension. Continuation of beta- blocker therapy reduces the risk of arrhythmias, myocardial ischemia and hypertensive crisis. Anaesthetists should be informed that the patient is being treated with a beta-blocker. Anaesthetics with the least possible myocardial depressant effects should be used. It is necessary to take into account the probability of anaphylaxis. If discontinuation of the treatment is necessary, a 48-hour period is considered sufficient to restore the normal sensitivity to the catecholamines. In some cases, beta-blocker therapy should not be interrupted: in patients with coronary insufficiency, due to a risk associated with an abrupt beta-blocker withdrawal, it is advisable to continue the treatment until the surgery in emergency or in cases when discontinuation is impossible, the patient must be protected from parasympathetic predominance by a sufficient premedication with atropine, repeated as needed Ophthalmology Beta-adrenergic blockade reduces intraocular pressure and may hamper the glaucoma screening. The ophthalmologist should be informed that the patient is being treated with betaxolol. Patients with general and ocular beta-blocker therapy should be monitored due to a potential additive effect. Thyrotoxicosis Beta-blockers can mask the cardiovascular signs of thyrotoxicosis. Hypoglycaemia There is an increased susceptibility to hypoglycaemia, for example during prolonged fasting or heavy physical exertion. Excipients Betaxolol hydrochloride contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 4.5 Interaction with other medicinal products and other forms of interaction Contraindicated combinations Floctafenine In the event of shock or hypotension caused by floctafenine, beta-blockers reduce the compensation reaction. Sultopride Disorders of cardiac automatism (excessive bradycardia) due to their common bradycardic effect. Not recommended combinations Page 6 of 26 Amiodarone Concomitant