Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Diltiazem hydrochloride
Mundipharma Pharmaceuticals Limited
C08DB; C08DB01
Diltiazem hydrochloride
90 milligram(s)
Prolonged-release capsule, hard
Product subject to prescription which may be renewed (B)
Benzothiazepine derivatives; diltiazem
Marketed
1995-04-20
PACKAGE LEAFLET: INFORMATION FOR THE USER _ADIZEM_ _®_ _-SR_ 90 MG,_ _120 MG AND 180 MG PROLONGED-RELEASE_ _CAPSULES Diltiazem hydrochloride 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 you get any of the side effects talk to 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 very slow (less than 40 beats per minute) or irregular heart beat; • Прочитайте повний документ
Health Products Regulatory Authority 25 May 2023 CRN00DKRF Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adizem-SR 90 mg Prolonged Release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 90 mg diltiazem hydrochloride. Excipients: also contains sucrose 18.26 mg per capsule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsules, hard. Size 3, hard gelatin, capsules with an opaque white body and an opaque white cap, printed ‘90 mg’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of stable angina pectoris. In the management of mild to moderate hypertension. ADIZEM-SR capsules are indicated for use in adults only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: The usual initial dose is 90 mg twice daily. Dosage may be increased gradually to 120 mg twice daily if required, or 180 mg twice daily. Elderly and patients with impaired renal or hepatic function In the elderly dosage should commence at the lowest level of 90 mg twice daily and be increased very slowly. Dosage adjustments are not necessary in the presence of renal dysfunction. Paediatric population Not recommended for use in children. Route 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. _ADIZEM-SR_ should not be taken at the same time as an alcoholic beverage (see section 4.5). 4.3 CONTRAINDICATIONS Patients with severe bradycardia (less than 40 beats per minute), second or third degree heart block, or sick sinus syndrome, decompensated cardiac failure or left ventricular failure with pulmonary congestion. Health Products Regulatory Authority 25 May 2023 CRN00DKRF Page 2 of 8 Concurrent use with dantrolene infusion due to the risk of ventricular fibrillation (see section 4.5). Concurrent use with lomitapide (see section 4.5). Pregnant women or women of child bearing potential. Hypersensitivity to diltiazem or to any of the Прочитайте повний документ