Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Celiprolol hydrochloride
DE Pharmaceuticals
C07AB08
Celiprolol hydrochloride
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000
CELECTOL 200MG TABLETS / CELIPROLOL HYDROCHLORIDE 200MG TABLETS (celiprolol hydrochloride) Please note that the leaflet also contains information about other strengths of the medicine Celectol 400mg Tablets or Celiprolol Hydrochloride 400mg Tablets. PATIENT INFORMATION LEAFLET 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 further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you only. Do not pass it onto 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: What Celectol is and what it is used for What you need to know before you take Celectol How to take Celectol Possible side effects How to store Celectol Contents of the pack and other information WHAT CELECTOL IS AND WHAT IT IS USED FOR WHAT CELECTOL IS The name of your medicine is Celectol 200 or 400 Tablets (called Celectol throughout this leaflet). Celectol contains a medicine called celiprolol hydrochloride. This belongs to a group of medicines called beta-blockers. HOW CELECTOL WORKS It works by slowing your heart rate or lowering your blood pressure. WHAT CELECTOL IS USED FOR It is used to treat high blood pressure (hypertension). WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELECTOL DO NOT TAKE CELECTOL IF: * You are allergic (hypersensitive) to celiprolol or any of the other ingredients in Celectol (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. * You have or have had asthma or wheezing. * You have a very slow heart beat (bradycardia). * You have heart problems – where you have difficulty breathing and swollen ankles. * You have kidney problems. * You have a tumour of th Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celectol 200 Tablets (Celiprolol Hydrochloride 200mg Tablets for “own label” distribution). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Celiprolol Hydrochloride 200 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White film coated biconvex heart shaped tablets engraved with 200 and a breakline on one face and the Celectol logo on the other face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The management of mild to moderate hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults The initial dose is 200 mg orally taken once daily with a glass of water. Celectol should preferably be taken first thing in the morning, 30 minutes before food or 2 hours after a meal. If response is inadequate, the dose may be increased to 400 mg 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 the blood pressure is recommended. Elderly Dosage as for adults. However close monitoring of elderly patients should be exercised, as renal and hepatic functions may be decreased in this population. Paediatric population Not recommended. Renal impairment Dosage may require adjustment (see section 4.4). For patients with a creatinine clearance 15 – 40 ml per minute, heart rate should be monitored and treatment must be reconsidered in case of bradycardia (less than 50 – 55 beats per minute at rest) (see section 4.3). Celiprolol is not recommended in patients with a creatinine clearance less than 15 ml per minute (see section 4.3). Method of administration Oral administration. 4.3 CONTRAINDICATIONS As with other beta-adrenoceptor antagonists, celiprolol should not be used in cases of: • Hypersensitivity to the active substance or any of the excipients (see section 6.1). • Cardiogenic shock, uncontrolled heart failure, sick-sinus syndrome, (inclu Прочитать полный документ