מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Betaxolol HCL
KOMEDIC SDN BHD
Betaxolol HCL
100 Tablets; 30 Tablets
MEDOCHEMIE (FAR EAST) LTD - ORAL FACILITY
_ _ _ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ BETAC Betaxolol Hydrochloride (20mg) 1 WHAT IS IN THIS LEAFLET: 1. What BETAC is used for 2. How BETAC works 3. Before you use BETAC 4. How to use BETAC 5. While you are using it 6. Side effects 7. Storage and Disposal of BETAC 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision _ _ WHAT BETAC IS USED FOR BETAC is used to treat high blood pressure (hypertension) or a certain type of chest pain called Angina pectoris. HOW BETAC WORKS BETAC is one of a group of medicines called cardioselective beta- adrenoceptor blocking agents. It works by affecting the response to nerve impulses in certain parts of the body, to relax the blood vessels and slow down the heart beat and thus decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart, to avoid heart pain. BEFORE YOU USE BETAC _When you must not use it _ Do not use BETAC if: ▪ you are ALLERGIC to betaxolol or any of the other ingredients of this medicine (listed in PRODUCT DESCRIPTION ) ▪ you have a HEART OR BLOOD VESSEL DISEASE (OTHER THAN THE ONE YOU ARE TAKING BETAC FOR) ▪ you are taking some medicines called floctafenine or sultopride _ _ _Before you start to use it _ Before you take BETAC you should tell your doctor if: ▪ you have asthma or other conditions affecting the respiratory tract ▪ you have DIABETES AND YOU ARE TAKING INSULIN ▪ you have LIVER or RENAL disease ▪ you have THYROIDAL problems where the thyroid glands, produce either too much or too little thyroid hormones ▪ you have GLAUCOMA, a condition of increased pressure in the eyeball causing gradual loss of sight ▪ you have PSORIASIS, a skin disease causing the skin to be itchy and red If any of the above applies to you, talk to your doctor who will decide what to do. In the case of surgery, you should inform the anaesthetist that you take BETAC. _Taking other medicines _ Tell your doctor or pharmacist if you are taking קרא את המסמך השלם
BETAC (BETAXOLOL HYDROCHLORIDE) COMPOSITION AND PHARMACEUTICAL FORM Each 'Betac' 20mg tablet contains 20mg Betaxolol hydrochloride. 'Betac' 20mg tablets are film-coated tablets for oral administration. DESCRIPTION Film coated, white, round, convex, scored tablet with nucleus diameter of 9.5 mm. INDICATIONS • Hypertension • Prophylaxis of exertional angina episodes DOSAGE AND ADMINISTRATION: The usual dosage for the two therapeutic indications is one tablet of 20 mg per day, taken once daily. _Dosage in patients with renal insufficiency: _ It is advisable to adjust the dosage according to the state of the renal function; for a creatinine clearance over 20 ml per minute, it is not necessary to change the dosage. However, clinical monitoring is recommended at the start of the treatment until the equilibration of blood levels is reached (4 days on average). In case of severe renal insufficiency (creatinine clearance < 20m l/m in), the initial recommended dose is I 0 mg/day (taken irrespective of the frequency and timing of dialysis sessions for dialysed patients). In patients with hepatic insufficiency, no modification of the dosage is necessary, though clinical monitoring is advised at the start of treatment. CONTRA-INDICATIONS: • Severe forms of asthma and chronic obstructive pulmonary disease • Cardiac insufficiency not controlled with treatment • Cardiogenic shock • Second and third-degree atrioventricular blocks, without pacemakers • Prinzmetal’s angina (as monotherapy in its isolated/typical form) • Sinus mode dysfunction (including sinoatrial block) • Bradycardia (<45-50 beats per minute) • Severe forms of Raynaud’s phenomenon and peripheral arterial disorders • Untreated pheochromocytoma • Hypotension • Hypersensitivity to betaxolol • Previous history of anaphylactic reaction • In combination with floctafenine and sultopride (see interactions with other medicinal products and other forms of interaction) • The use of this medicine is generally in combination with amiodarone, קרא את המסמך השלם