Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil
PCO Manufacturing Ltd.
C09CA; C09CA08
Olmesartan medoxomil
40 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; olmesartan medoxomil
Authorised
2011-04-08
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER OMESAR ® 10 MG, 20 MG, 40 MG FILM-COATED TABLETS olmesartan medoxomil 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 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. Ssee section 4. WHAT IS IN THIS LEAFLET 1. What Omesar is and what it is used for 2. What you need to know before you take Omesar 3. How to take Omesar 4. Possible side effects 5. How to store Omesar 6. Contents of the pack and other information 1. WHAT OMESAR IS AND WHAT IT IS USED FOR Omesar belongs to a group of medicines called angiotensin-II receptor antagonists. They lower blood pressure by relaxing the blood vessels. Omesar is used for the treatment of high blood pressure (also known as ‘hypertension’) in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain and eyes. In some cases this may lead to a heart attack, heart or kidney failure, stroke or blindness. Usually high blood pressure has no symptoms. It is important to have your blood pressure checked to prevent damage occurring. High blood pressure can be controlled with medicines such as Omesar tablets. Your doctor has probably also recommended that you make some changes in your lifestyle to help lower your blood pressure (for example losing weight, giving up smoking, reducing the amount of alcohol you drink and reducing the amount of salt in your diet). Your doctor may also have urged you to take regular exercise, such as walking or swimming. It is important to follow this advice from your doctor. 2. WHAT Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 05 May 2021 CRN00CC3S Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omesar 40 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Olmesartan medoxomil Each tablet contains 40 mg of olmesartan medoxomil Excipient with known effect: Lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets. _Product imported from Italy, France, Portugal and Greece:_ White oval film-coated tablets with C15 embossed on one side. 4 CLINICAL PARTICULARS As per PA0865/011/003 5 PHARMACOLOGICAL PROPERTIES As per PA0865/011/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Cellulose, microcrystalline Lactose monohydrate Hydroxypropylcellulose Low substituted hydroxypropylcellulose Magnesium stearate Titanium dioxide (E171) Talc Hypromellose 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the blister pack and the outer package of the product on the market in the country of origin. Health Products Regulatory Authority 05 May 2021 CRN00CC3S Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs of 28 or 30 film-coated tablets. 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 No special requirements_._ 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 8th April 2011 10 DATE OF REVISION OF THE TEXT May 2021 Կարդացեք ամբողջական փաստաթուղթը