Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Diltiazem hydrochloride
Mundipharma Pharmaceuticals Limited
C08DB; C08DB01
Diltiazem hydrochloride
240 milligram(s)
Prolonged-release capsule, hard
Product subject to prescription which may be renewed (B)
Benzothiazepine derivatives; diltiazem
Marketed
1994-12-16
PACKAGE LEAFLET: INFORMATION FOR THE USER _ADIZEM_ _®_ _-XL _120 MG, 180 MG, 240 MG AND 300 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-XL _ capsules are and what they are used for 2. What you need to know before you take _ADIZEM-XL_ capsules 3. How to take _ADIZEM-XL_ capsules 4. Possible side effects 5. How to store _ADIZEM-XL _ capsules 6. Contents of the pack and other information 1. WHAT _ADIZEM-XL_ 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-XL _ capsules are listed in section 6 of this leaflet. _ADIZEM-XL _CAPSULES ARE DESIGNED TO WORK PROPERLY OVER 24 HOURS. IF THE CAPSULES ARE CRUSHED OR CHEWED, THE ENTIRE 24 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-XL _CAPSULES DO NOT TAKE _ADIZEM-XL _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 minutes) or irregular hear Baca dokumen lengkap
Health Products Regulatory Authority 25 May 2023 CRN00DKRF Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ADIZEM-XL 240 mg prolonged release capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release capsule contains 240 mg diltiazem hydrochloride. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release capsules, hard. Size 1 hard gelatin capsules approximately 19mm long with a dark red body and a blue cap, marked ‘DCR 240’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Management of angina pectoris. 2. Treatment of mild to moderate hypertension. ADIZEM-XL capsules are indicated for use in adults only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: The usual starting dose is one 240 mg capsule daily. However, patients' responses may vary and dosage requirements can differ significantly between individual patients. There is no evidence of any decrease in efficacy at higher doses. If necessary the dose may be gradually increased to 300 mg or 360 mg per day. Doses of 480 mg/day have been used with benefit in some angina patients. Elderly: The usual starting dose is one 120 mg capsule daily. If necessary the dose may be gradually increased but careful monitoring of this group of patients is advised. Paediatric population: Not recommended for use in children. Route of administration Oral. To be taken at 24 hour intervals. The capsules should be swallowed whole and not chewed. ADIZEM-XL 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). P Baca dokumen lengkap