Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
RAMIPRIL
LTT Pharma Limited
C09AA05
RAMIPRIL
5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain
Authorised
2014-07-04
Tell your doctor if you are taking any of the following medicines. They can make Tritace work less well: * Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin) * Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline. Your doctor will need to check your blood pressure. Tell your doctor if you are taking any of the following medicines. They can increase the chance of getting side effects if you take them with Tritace: * Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin) * Medicines for cancer (chemotherapy) * Medicines to stop the rejection of organs after a transplant such as ciclosporin * Diuretics (water tablets) such as furosemide * Medicines which can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (for thinning blood) * Steroid medicines for inflammation such as prednisolone * Allopurinol (used to lower the uric acid in your blood) * Procainamide (for heart rhythm problems). * Temsirolimus (for cancer) * Sirolimus, everolimus (for prevention of graft rejection) * Vildagliptin (used for treating type 2 diabetes) * Your doctor may need to change your dose and/or to take other precautions if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Tritace” and “Warnings and precautions”). Tell your doctor if you are taking any of the following medicines. They may be affected by Tritace: * Medicines for diabetes such as oral glucose lowering medicines and insulin. Tritace may lower your blood sugar amounts. Check your blood sugar amounts closely while taking Tritace * Lithium (for mental health problems). Tritace may increase the amount of l Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TRITACE 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets Each tablet contains ramipril 5 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets _Product imported from the United Kingdom:_ Pale red oblong tablet with score line, upper stamp 5 and company logo, lower stamp HMP and 5. The tablet can be divided into equal halves 4 CLINICAL PARTICULARS As per PA0540/084/007 5 PHARMACOLOGICAL PROPERTIES As per PA0540/084/007 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Hypromellose Pregelatinized maize starch Microcrystalline cellulose Sodium stearyl fumarate Red ferric oxide (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on the market in the country of origin. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 26/10/2016_ _CRN 2181079_ _page number: 1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Packs of 28, tablets in PVC/Alu blisters 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT Any unused product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER LTT Pharma Limited Unit 18 Oxleasow Road East Moons Moat Redditch Worcestershire B98 0RE United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1562/118/003 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 4 Perskaitykite visą dokumentą