Страна: Мальта
Язык: английский
Источник: Medicines Authority
L
Doc Generici srl Via Turati, 40-20121, Milano, Italy
C08CA09
Lacidipine 2 mg
FILM-COATED TABLET
Lacidipine 2 mg
POM
CALCIUM CHANNEL BLOCKERS
Authorised
2015-04-24
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LACIDIPINE DOC GENERICI 2 MG FILM-COATED TABLETS LACIDIPINE DOC GENERICI 4 MG FILM-COATED TABLETS LACIDIPINE DOC GENERICI 6 MG FILM-COATED TABLETS Lacidipine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Lacidipine DOC Generici is and what it is used for 2. What you need to know before you use Lacidipine DOC Generici 3. How to use Lacidipine DOC Generici 4. Possible side effects 5. How to store Lacidipine DOC Generici 6. Contents of the pack and other information 1. WHAT LACIDIPINE DOC GENERICI IS AND WHAT IT IS USED FOR Lacidipine DOC Generici contains a medicine called lacidipine. It belongs to a group of medicines called ‘calcium channel blockers’. Lacidipine DOC Generici helps to relax your blood vessels so that they get wider. This helps the blood to flow more easily and lowers the blood pressure. Lacidipine DOC Generici tablets taken regularly as prescribed by your doctor will help to lower your blood pressure (to treat hypertension). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LACIDIPINE DOC GENERICI DO NOT USE LACIDIPINE DOC GENERICI • If you are allergic to lacidipine, other calcium channel blocker medicines or any of the other ingredients of this medicine (listed in section 6). • If you have the heart problem ‘aortic stenosis’. This is a narrowing of a valve in your heart, which restricts blood flow. • If you have had a heart attack within the last month. • If you are pregnant or breastfeeding (see section ”Pregnancy Прочитать полный документ
09/18 aggiunta conf 28 cpr x 6 mg; var.07 IAIN A.3 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lacidipine DOC Generici 2 mg film-coated tablets Lacidipine DOC Generici 4 mg film-coated tablets Lacidipine DOC Generici 6 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lacidipine DOC Generici 2 mg film-coated tablets Each film-coated tablet contains lacidipine 2 mg. Excipient with known effect: lactose 137 mg. Lacidipine DOC Generici 4 mg film-coated tablets Each film-coated tablet contains lacidipine 4 mg. Excipient with known effect: lactose 274 mg. Lacidipine DOC Generici 6 mg film-coated tablets Each film-coated tablet contains lacidipine 6 mg. Excipient with known effect: lactose 411 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Lacidipine DOC Generici 2 mg film-coated tablets White, round, biconvex, film-coated tablets Lacidipine DOC Generici 4 mg film-coated tablets White, oval, biconvex, film-coated tablets with score line on one side. The tablet can be divided into two equal doses. Lacidipine DOC Generici 6 mg film-coated tablets White, oval, biconvex, film-coated tablets, debossed with “6 mg” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lacidipine is indicated for the treatment of hypertension either alone or in combination with other antihypertensive agents, including ß-adrenoceptor antagonists, diuretics, and ACE-inhibitors. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lacidipine is available in the following strengths: • Lacidipine, 2 mg, film-coated tablets • Lacidipine, 4 mg, film-coated tablets • Lacidipine, 6 mg, film-coated tablets 2 POSOLOGY Adults The treatment of hypertension should be adapted to the severity of the condition, and according to the individual response. The recommended initial dose is 2 mg once daily. The dose may be increased to 4 mg (and then, if necessary, to 6 mg) after adequate time has been allowed for the full pharmacological effect to occur. In practic Прочитать полный документ