Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diltiazem hydrochloride
Thornton & Ross Ltd
C08DB01
Diltiazem hydrochloride
300mg
Modified-release capsule
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 02060200; GTIN: 5030451001788
02500148P00360148L03-M060UWASS HEAD FRONT 1ST BAR 1ST BAR LAST BAR LAST BAR >> READ DIRECTION >> READ DIRECTION PACKAGE LEAFLET: INFORMATION FOR THE USER VIAZEM ® XL DILTIAZEM HYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Viazem ® XL is and what it is used for 2. Before you take Viazem ® XL 3. How to take Viazem ® XL 4. Possible side-effects 5. How to store Viazem ® XL 6. Further information 1. WHAT VIAZEM ® XL IS AND WHAT IT IS USED FOR The active ingredient in this medicine is called diltiazem. It belongs to a group of medicines called calcium antagonists which are used to treat high blood pressure, or to help control angina. 2. BEFORE YOU TAKE VIAZEM ® XL DO NOT TAKE VIAZEM ® XL: • if you are allergic to diltiazem or any of the other ingredients in Viazem ® XL (see list under ‘What Viazem ® XL contains). Azorubine can cause allergic reactions including asthma. Allergy is more common in those people allergic to aspirin • if you have serious heart problems, particularly if a doctor has told you that you have any of the following conditions; - Severe bradycardia (a very slow pulse) - Heart block or pre-excitation syndrome or sick sinus syndrome (conditions in which there are problems with the control of your heart rate) - Left ventricular failure • if you are already taking a medicine containing invabradine for the treatment of certain heart diseases • if you have unstable angina • if the patient is a child • if you are pregnant or are breast-feeding. If you are not sure, talk to your doctor or pharmacist before taking this medici Read the complete document
OBJECT 1 VIAZEM XL 300MG Summary of Product Characteristics Updated 20-Oct-2015 | Thornton & Ross Ltd 1. Name of the medicinal product VIAZEM XL 300mg 2. Qualitative and quantitative composition Diltiazem hydrochloride: 300 mg capsule. For excipients, see section 6.1 3. Pharmaceutical form Prolonged release capsule, hard. White and lavender opaque capsules. Each capsule is printed on the cap and body, in black ink, with Viazem XL 300. 4. Clinical particulars 4.1 Therapeutic indications VIAZEM XL is indicated for the management of stable angina pectoris and the treatment of mild to moderate hypertension. 4.2 Posology and method of administration Dosage requirements may differ between patients with angina and patients with hypertension. In addition individual patients response may vary, necessitating careful titration. The range of strengths facilitates titration to the optimal dose. One capsule of VIAZEM XL is to be taken before or during a meal. The dose should be taken at approximately the same time each day. The capsule should not be chewed but swallowed whole, with a glass of water. Due to the variability of release profile in individual patients, when changing from one type of sustained release diltiazem preparation to another, it may be necessary to adjust the dose. Adults Hypertension: The usual starting dose is 180 mg once daily. The dose may be increased after 2-4 weeks according to the patient's response and the usual maintenance dose is 240mg-360mg once daily. The maximum daily dose is 360 mg. However, the single daily doses of 300 mg and 360 mg should only be administered to patients when no satisfactory therapeutic effect has been effected with lower doses and after the benefit risk-ratio has been carefully assessed by the doctor. Angina: Care should be taken when titrating patients with stable angina in order to establish the optimal dose. The usual starting dose is 180 mg once daily. The dose may be increased after 2-4 weeks according to the patient's response. The maximum daily dose is 360 mg. Howe Read the complete document