Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Celiprolol hydrochloride
Teva UK Ltd
C07AB08
Celiprolol hydrochloride
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5017007341512
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 Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celiprolol hydrochloride 400 mg film coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg celiprolol hydrochloride. EACH TABLET CONTAINS 3.6MG LACTOSE. FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White coloured, capsule shaped, biconvex film coated tablets, debossed with ‘400’ on one side of the breakline and a deep breakline on the other side. THE TABLET CAN BE DIVIDED INTO EQUAL DOSES. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Celiprolol is indicated for the treatment of hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Adults: _The initial dose is 200 mg orally, taken once daily with a glass of water. Celiprolol should be taken on rising, one hour before meals, or 2 hours after meals. If response is inadequate, the dose may be increased to 400 mg once daily, after 2 to 4 weeks of treatment with 200mg once daily. It may take several weeks of treatment for the anti-hypertensive effect of celiprolol to be fully established. There is no limit for the duration of treatment. This depends on the nature and severity of the disease. Treatment with celiprolol should not be discontinued abruptly, but should be discontinued gradually (i.e. over a period of 7-10 days), as discontinuing treatment abruptly may lead to an acute worsening of the patient’s condition. In hypertensive patients, additional treatment with other anti-hypertensive agents according to clinical guidelines is possible, in particular with diuretics. When a combination is initiated an increased monitoring of the blood pressure is recommended _Elderly: _ The pharmacokinetics of celiprolol is not significantly different in the elderly people however a close monitoring of elderly patients should be exercised, as renal and hepatic functions may be decreased in this population _Dosage in renal impairment: _The dosage of celiprolol should be reduced by half in patients with creatinine clear Læs hele dokumentet