দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Amoxicillin trihydrate; Clavulanic acid
Lexon Pharmaceuticals (Ireland) Limited
J01CR; J01CR02
Amoxicillin trihydrate; Clavulanic acid
875/125 milligram(s)
Film-coated tablet
Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor
2018-03-16
AUGMENTIN 875 MG/125 MG FILM-COATED TABLETS amoxicillin/clavulanic acid 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 (or for your child) 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 What Augmentin is and what it is used for What you need to know before you take Augmentin How to take Augmentin Possible side effects How to store Augmentin Contents of the pack and other information WHAT AUGMENTIN IS AND WHAT IT IS USED FOR Augmentin is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening. Augmentin is used in adults and children to treat the following infections: * middle ear and sinus infections * respiratory tract infections * urinary tract infections * skin and soft tissue infections including dental infections * bone and joint infections. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AUGMENTIN DO NOT TAKE AUGMENTIN:_ _ * if you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6). * if you have ever had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face or throat. * if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. DO NOT TAKE AUGMENTIN IF ANY OF THE ABOVE APPLY TO YOU. If you are not sure, t সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 04 February 2022 CRN00CS1K Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Augmentin 875 mg/125 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains amoxicillin trihydrate equivalent to 875 mg amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from the Czech Republic_ White to off-white, capsule shaped tablets debossed with “AC” on both sides and a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS As per PA1077/019/005 5 PHARMACOLOGICAL PROPERTIES As per PA1077/019/005 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Tablet core_ Magnesium stearate Sodium carboxymethyl starch (Type A) Colloidal anhydrous silica Microcrystalline cellulose _Tablet film-coat_ Titanium dioxide (E171) Hypromellose (2506/5, 2506/15) Macrogol (4000, 6000) Dimeticone 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the pouch, blister and outer package of the product on the market in the country of origin. Tablets in desiccated pouch packs should be used within 30 days of opening. Health Products Regulatory Authority 04 February 2022 CRN00CS1K Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25ºC Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Blister enclosed within a pouch containing a dessicant sachet, referred to as a desiccated pouch pack (DPP) containing 14 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Lexon Pharmaceuticals (Ireland) Limited Block 3 Harcourt Centre Har সম্পূর্ণ নথি পড়ুন