Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Verapamil hydrochloride
Mylan IRE Healthcare Limited
C08DA; C08DA01
Verapamil hydrochloride
80 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Phenylalkylamine derivatives; verapamil
Marketed
1980-04-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ISOPTIN ® 40MG FILM-COATED TABLETS ISOPTIN ® 80MG FILM-COATED 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, pharmacist or nurse. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4 WHAT IS IN THIS LEAFLET 1. What Isoptin is and what it is used for 2. What you need to know before you take Isoptin tablets 3. How to take Isoptin tablets 4. Possible side effects 5. How to store Isoptin tablets? 6. Contents of the pack and other information 1. WHAT ISOPTIN IS AND WHAT IT IS USED FOR Isoptin 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 tablets are used to treat hypertension (high blood pressure), abnormal heart rhythms and to prevent and treat angina (chest pain) attacks. The active ingredient in Isoptin tablets is verapamil hydrochloride. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOPTIN TABLETS DO NOT TAKE ISOPTIN TABLETS IF: your blood pressure is extremely low as a result of severe heart problems (such as during shock) you have heart failure or second or third degree heart block (impaired nerve signal in the heart – causing a very slow heartbeat) or an electrical abnormality of the heart (atrial fibrillat Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 26 January 2022 CRN00CS2G Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isoptin 80 mg film‐coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 80mg of Verapamil Hydrochloride. For a full list of excipents, see section 6.1. 3 PHARMACEUTICAL FORM Film‐coated tablets Circular, biconvex, white, film‐coated tablet, embossed 'Isoptin 80' on one side and 'Knoll' above the scoreline on the other side. The scoreline is to allow breaking for ease of swallowing. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis and/or treatment of: – Angina pectoris, including Prinzmetal’s angina (coronary spasm, vasospastic angina). – Supraventricular tachycardias such as paroxysmal supraventricular tachycardia, atrial fibrillation/flutter with rapid ventricular response (except in WPW syndrome or LGL syndrome, see “Contraindications”). – Mild to moderate essential hypertension. 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. Isoptin 40mg 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: For the treatment of angina, including Prinzmetal’s angina, the usual dose is 120 mg 3 to 4 times daily. Although 80 mg 3 times daily may be adequate in Διαβάστε το πλήρες έγγραφο