Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diltiazem hydrochloride
Mawdsley-Brooks & Company Ltd
C08DB01
Diltiazem hydrochloride
180mg
Modified-release capsule
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 02060200
1109-6 _ADIZEM_ ® _-SR _90 MG, 120 MG AND 180 MG PROLONGED-RELEASE CAPSULES Diltiazem hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE USER 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 or pharmacist. • 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 any get side talk with your doctor.This includes any possible side effects not listed in this leaflet.See section 4. WHAT IS IN THIS LEAFLET: 1. What _ADIZEM-SR_ capsules are and what they are used for 2. What you need to know before you take _ADIZEM-SR_ capsules 3. How to take _ADIZEM-SR_ capsules 4. Possible side effects 5. How to store _ADIZEM-SR_ capsules 6. Contents of the pack and other information 1. WHAT _ADIZEM-SR _CAPSULES ARE AND WHAT THEY ARE USED FOR These capsules have been prescribed for you to treat angina (chest pain caused by a reduction of oxygen to the heart muscle) or high blood pressure (hypertension). They contain the active ingredient diltiazem. Diltiazem belongs to a group of medicines called calcium antagonists. Calcium antagonists help more blood to reach the heart and reduce blood pressure. The other ingredients of _ADIZEM-SR _ capsules are listed in section 6 of this leaflet. _ADIZEM-SR _CAPSULES ARE DESIGNED TO WORK PROPERLY OVER 12 HOURS. IF THE CAPSULES ARE CRUSHED OR CHEWED, THE ENTIRE 12‑HOUR DOSE MAY BE ABSORBED RAPIDLY INTO YOUR BODY. THIS CAN BE DANGEROUS, CAUSING SERIOUS PROBLEMS SUCH AS AN OVERDOSE. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _ADIZEM-SR_ CAPSULES DO NOT TAKE _ADIZEM-SR _CAPSULES IF YOU: • are allergic (hypersensitive) to diltiazem or any of the other ingredients of the capsules (see section 6 ‘Further Information’); • have a slow or irregular heart beat; • have heart failure (which can cause shortness of brea Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ADIZEM-SR capsules 180 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 180 mg diltiazem hydrochloride. Excipients: also contains sucrose 36.53 mg per capsule. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged release capsules Capsules with white bodies and pale brown caps marked "180 mg" containing prolonged release microgranules. 4.1 THERAPEUTIC INDICATIONS For the management of angina pectoris. For the treatment of mild to moderate hypertension. _ _ _ADIZEM-SR_ capsules are indicated for use in adults only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Angina Adults: The usual initial dose is 90 mg twice daily. Dosage may be increased gradually to 120 mg twice daily or 180 mg twice daily if required. Patients’ responses may vary and dosage requirements can differ significantly between individual patients. Elderly and patients with impaired renal or hepatic function: In the elderly, dosage should commence at 60 mg diltiazem hydrochloride twice daily and the dose carefully titrated as required. Hypertension: Adults: The usual dose is one _ADIZEM-SR_ 120 tablet or capsule twice daily. Patients may benefit by titrating from a lower total daily dose. Elderly and patients with impaired renal or hepatic function: The starting dose should be 60 mg diltiazem hydrochloride twice daily, increasing to one _ADIZEM-SR_ 90 mg capsule twice daily and then to one _ADIZEM-SR_ 120 mg tablet or capsule twice daily if clinically indicated. Paediatric population: The _ADIZEM_ preparations are not recommended for children. Safety and efficacy in children has not been established. Method of administration Oral. To be taken at 12 hour intervals. Dosage may be taken with or without food, and should be swallowed whole and not chewed. In order to avoid confusion, it is suggested that patients once titrated to an effective dose using either _ADIZEM-SR_ tablets or capsules should remain on this treatment and should Прочитать полный документ