Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VERAPAMIL HYDROCHLORIDE
Rowex Ltd
C08DA; C08DA01
VERAPAMIL HYDROCHLORIDE
240 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Phenylalkylamine derivatives; verapamil
Marketed
2001-10-05
PACKAGE LEAFLET: INFORMATION FOR THE USER VERAP 120MG & 240MG PROLONGED RELEASE TABLETS Verapamil 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Verap is and what it is used for 2. What you need to know before you take Verap 3. How to take Verap 4. Possible side effects 5. How to store Verap 6. Contents of the pack and other information 1 WHAT VERAP IS AND WHAT IT IS USED FOR Verap belongs to a group of medicines called calcium antagonists. The active substance in Verap is verapamil hydrochloride. Verap is used to: • treat mild to moderate high blood pressure • prevent a certain type of chest pain called angina pectoris If you suffer from high blood pressure Verap works by relaxing blood vessels, so that blood passes through them more easily. If you suffer from angina Verap works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Verapamil does not provide immediate relief of chest pain from angina. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE VERAP DO NOT TAKE VERAP if you have any of the following conditions: • allergic to verapamil or to any of the other ingredients of this medicine (listed in section 6). • insufficient blood supply to your tissues, e.g. caused by severe heart troubles (cardiovascular shock) • very low blood pressure • acute heart attack complicated by slow heartbeat • second or third degree heart block or an electrical abnormality of the heart (atrial fibrillation/flutter) cau Read the complete document
Health Products Regulatory Authority 16 March 2021 CRN00C63M Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Verap 240mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Verapamil Hydrochloride 240.00 mg. Excipient(s) with known effect: Each tablet contains lactose monohydrate 8.84 mg and sodium 29.4mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet Green, oblong, biconvex, film‐coated prolonged release tablet with a score notch on both sides. The score notch should not be used to break the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VERAP tablets are indicated for the treatment of mild to moderate hypertension and coronary heart disease, i.e. prophylaxis of myocardial ischemia and angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. _Hypertension:_ The adult dose of 240 mg [1 tablet] in the morning is indicated increasing if necessary after one week to 240 mg in the morning and 240 mg in the evening with an interval of 12 hours. _Elderly_ In elderly patients the initial dose is 120 mg in the morning, increasing by 120 mg increments at weekly intervals according to the patient’s response. _Angina Pectoris:_ The usual dose is 120‐240 mg twice daily according to patient’s response. It is recommended that low initial doses with upward titration be used in new patients. SPECIAL POPULATIONS _Renal impairment_ Currently available data are described in Read the complete document