Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VERAPAMIL HYDROCHLORIDE
Abbott Laboratories Ireland Ltd
VERAPAMIL HYDROCHLORIDE
240 Milligram
Prolonged Release Capsules
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
ISOPTIN ® SR 240 MG PROLONGED-RELEASE TABLETS (verapamil hydrochloride) IMPORTANT INFORMATION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet as you may need to read it again. This leaflet provides a summary of the information currently available about Isoptin SR. For further information or advice ask your doctor or pharmacist. This medicine is for you only and should never be given to anyone else, even if they appear to have the same symptoms as you. Tell your doctor or pharmacist if you experience any side effects. See Section 4. Leaflet contents: 1. What is Isoptin SR and what is it used for? 2. What you need to know before you take Isoptin SR 3. How should you take your tablets? 4. Possible side effects 5. How should you store your tablets? 6. Further information 1. WHAT IS ISOPTIN SR AND WHAT IS IT USED FOR? Isoptin SR tablets belong to a group of medicines called calcium channel blockers. Calcium channel blockers change the amount of calcium getting into the muscle cells in your heart and blood vessels. This can change the strength and speed with which your heart beats. It also opens up the blood vessels so blood can be pumped around the body more easily. This helps more oxygen to get to your heart muscle and can lower your blood pressure. Isoptin SR tablets are used to treat hypertension (high blood pressure) and to prevent angina (chest pain) attacks. The active ingredient in Isoptin SR tablets is verapamil hydrochloride. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOPTIN SR DO NOT TAKE ISOPTIN SR IF: you are sensitive (allergic) to verapamil or any of the ingredients in the tablets? (See Section 6) your blood pressure is extremely low as a result of heart problems (such as during shock) you have Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isoptin SR 240 mg Prolonged-Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Isoptin SR Prolonged-Release tablet contains 240 mg Verapamil Hydrochloride. Excipients: Each prolonged release tablet contains up to 32mg (1.39mmol) Sodium. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged-release film-coated tablet The oblong tablets are film-coated and light green colour, with a breakline on both sides and the Knoll logo on one side.The tablets can be divided into equal halves but must not be crushed or chewed. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mild to moderate hypertension and coronary heart disease, i.e. prophylaxis of myocardial ischaemia, angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose of verapamil hydrochloride should be adjusted individually in accordance with the severity of disease. Long- standing clinical experience shows that the average daily dose in all indications is between 240 mg and 360 mg. The daily dose should not exceed 480 mg on a long-term basis, although a higher dose may be used for a short period. There is no limitation on the duration of use. Verapamil hydrochloride should not be discontinued abruptly after long- term use. It is recommended to taper the dosage. Verapamil hydrochloride 240 mg tablets should be used for patients likely to display a satisfactory response to low doses (e.g., patients with hepatic dysfunction or elderly patients). For patients requiring higher dosages (e.g., 240 mg to 480 mg verapamil hydrochloride per day), formulations with a more suitable active drug content should be used. Adults _Hypertension: _The adult dose is one tablet (240 mg) in the morning, increasing if necess Read the complete document