País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Celiprolol hydrochloride
CST Pharma Ltd
C07AB08
Celiprolol hydrochloride
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5055946804538
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Celiprolol Hydrochloride is and what it is used for 2. What you need to know before you take Celiprolol Hydrochloride 3. How to take Celiprolol Hydrochloride 4. Possible side effects 5. How to store Celiprolol Hydrochloride 6. Contents of the pack and other information. 1. WHAT CELIPROLOL HYDROCHLORIDE IS AND WHAT IT IS USED FOR The name of your medicine is Celiprolol Hydrochloride 200 mg or 400 mg Tablets (called Celiprolol Hydrochloride throughout this leaflet). Celiprolol Hydrochloride contains a medicine called celiprolol hydrochloride. This belongs to a group of medicines called beta-blockers. It works by slowing your heart rate or lowering your blood pressure. It is used to treat high blood pressure (hypertension). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELIPROLOL HYDROCHLORIDE DO NOT TAKE CELIPROLOL HYDROCHLORIDE IF YOU: • are allergic to celiprolol hydrochloride or any of the ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • have suffered an allergic reaction to a beta-blocker (propranolol, sotalol, timolol etc.) in the past • suffer from an irregular/very slow heartbeat (known as bradycardia) or low blood pressure (hypotension) • suffer from heart failure which is not under control (heart failure is a condition in which your heart is not pumping blood as well as it should), have Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celiprolol Hydrochloride Tablets, 200 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 200 mg tablet contains celiprolol hydrochloride 200 mg. Excipient with known effect: Each 200 mg tablet contains 2 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow film-coated, round biconvex tablets, 9.5 mm diameter, imprinted ‘CL breakline 200’ on one side and ‘G’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Celiprolol hydrochloride is indicated for the management of mild to moderate hypertension and for prophylaxis of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults _Hypertension _ The initial dose is 200mg orally, taken once daily with a glass of water. Celiprolol should be taken on rising, 30 minutes before meals, or 2 hours after meals. If the response is inadequate, the dose may be increased to two 200mg tablets in one single administration of 400mg or one 400mg tablet once daily according to the therapeutic response. In hypertensive patients additional treatment with other anti-hypertensive agents is possible, in particular with diuretics. When a combination is initiated an increased monitoring of the blood pressure is recommended. Treatment with celiprolol should not be discontinued abruptly, but should be discontinued gradually (i.e. over a period of 15 days), as discontinuing treatment abruptly may lead to an acute worsening of the patient’s condition. _Angina Pectoris _ The initial dose is 200mg orally, taken once daily with a glass of water. Celiprolol should be taken on rising, 30 minutes before meals, or 2 hours after meals. If the response is inadequate, the dose may be increased to two 200mg in one single administration of 400mg, or one 400mg tablet once daily, after 2 to 4 weeks of treatment with 200mg once daily. Treatment with celiprolol should be discontinued gradually (i.e. over a period of 15 days), as discont Llegiu el document complet