Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
Imbat Limited
C01DA; C01DA14
ISOSORBIDE MONONITRATE
25
Prolonged-release capsule
Product subject to prescription which may be renewed (B)
Organic nitrates; isosorbide mononitrate
Authorised
2009-03-13
_Page 1 of 2 _ ELANTAN ® LA 25MG PROLONGED RELEASE CAPSULES, HARD (isosorbide mononitrate) PATIENT INFORMATION LEAFLET Your medicine is available using the above name but will be referred to as Elantan LA 25 throughout this leaflet. 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. IN THIS LEAFLET: 1. What Elantan LA 25 is for 2. Before you take Elantan LA 25 3. How to take Elantan LA 25 4. Possible side effects 5. How to store Elantan LA 25 6. Further information. 1. WHAT ELANTAN LA 25 IS FOR Elantan LA 25 belongs to a group of medicines called organic nitrates. Organic nitrates work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it. Elantan LA 25 is used to prevent angina pectoris. Angina usually feels like a tight pain in the chest, neck or arm area. The pain comes from the heart muscle and is a sign that part of it is not getting enough oxygen for the amount of work it is doing. 2. BEFORE YOU TAKE ELANTAN LA 25 DO NOT TAKE ELANTAN LA 25 IF: You are allergic to isosorbide mononitrate, other nitrates or any of the other ingredients of Elantan LA 25 (see section 6) You suffer from anaemia You have had a heart attack (myocardial infarction) You have had a brain haemorrhage (bleeding) You have had a head injury (trauma) You have a low blood volume (hypovolaemia) You have very low blood pressure You are suffering from “shock” as the blood has stopped circulating properly around your body (circulatory failure) You take sildenafil tadalfil or vardenafil (medicines to treat erectile dysfunction and/or pulmonary hypertension) or any other phosphodiesterase inhibitor. You have an eye disease called glaucoma You have been diagnosed with any o Lestu allt skjalið
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1151/078/002 Case No: 2069197 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to IMBAT LIMITED UNIT L2 , NORTH RING BUSINESS PARK , SANTRY , DUBLIN 9 an authorisation, subject to the provisions of the said Regulations, in respect of the product ELANTAN LA 25, 25 --UNKNOWN-- The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 26/08/2009 . Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _4_ _/_ _0_ _9_ _/_ _2_ _0_ _0_ _9_ _C_ _R_ _N_ _ _ _2_ _0_ _6_ _9_ _1_ _9_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elantan LA 25 mg Prolonged Release Capsules, hard. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release hard capsule contains 25 mg isosorbide mononitrate. Excipients: contains lactose monohydrate and sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsule, hard. Product imported from th Lestu allt skjalið