Riik: Armeenia
keel: inglise
Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
amoxicillin (amoxicillin trihydrate)
Medopharm Private Limited
J01CA04
amoxicillin (amoxicillin trihydrate)
500mg
capsules
(10/1x10/) in blister, (100/10x10/) in blister
Prescription
Registered
2023-03-04
1 PACKAGE LEAFLET: INFORMATION FOR THE USER AMOXICILLIN 250 MG _CAPSULES _ AMOXICILLIN 500 MG _CAPSULES_ 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 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 AMOXICILLIN is and what it is used for 2. What you need to know before you take AMOXICILLIN 3. How to take AMOXICILLIN 4. Possible side effects 5. How to store AMOXICILLIN 6. Contents of the pack and other information 1. WHAT AMOXICILLIN IS AND WHAT IT IS USED FOR The name of this medicine is AMOXICILLIN 250 mg _ capsules_ and AMOXICILLIN 500 mg_ _ _capsules_ referred to as AMOXICILLIN throughout the package leaflet. AMOXICILLIN contains the active ingredient amoxicillin (in form of amoxicillin trihydrate). It belongs to a group of antibiotics medicines called ’penicillins’. AMOXICILLIN is used to treat infections caused by bacteria in different parts of the body. AMOXICILLIN may also be used in combination with other medicines to treat stomach ulcers. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXICILLIN DO NOT TAKE AMOXICILLIN if you are allergic (hypersensitivity) to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6). if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat. Do not take AMOXICILLIN if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking AMOXICILLIN. 2 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking AMOXICILLIN if you: have glandular fever Lugege kogu dokumenti
1 SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE MEDICINAL PRODUCT AMOXICILLIN 250 mg _capsules _ AMOXICILLIN 500 mg _capsules _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AMOXICILLIN 250 MG _CAPSULES _ Each capsule contains 250 mg amoxicillin (in form of amoxicillin trihydrate)_ _ Excipient with known effect Contains Ponceau 4R (E124) - please refer to section 4.4 for further details. _For the full list of excipients, see section 6.1. _ AMOXICILLIN 500 MG _CAPSULES _ Each capsule contains 500 mg amoxicillin (in form of amoxicillin trihydrate)_ _ Excipient with known effect Contains Ponceau 4R (E124) - please refer to section 4.4 for further details. _For the full list of excipients, see section 6.1._ 3. PHARMACEUTICAL FORM Capsules, hard AMOXICILLIN 250 MG_ CAPSULES: _ Maroon and yellow hard capsules printed with “AMOXI 250“ and TROGE ® logo. AMOXICILLIN 500 MG_ CAPSULES: _ Maroon and yellow hard capsules printed with “AMOXI 500“ and TROGE ® logo. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Amoxicillin capsules is indicated for the treatment of the following infections in adults and children: • Acute bacterial sinusitis • Acute otitis media 2 • Acute streptococcal tonsillitis and pharyngitis • Acute exacerbations of chronic bronchitis • Community acquired pneumonia • Acute cystitis • Asymptomatic bacteriuria in pregnancy • Acute pyelonephritis • Typhoid and paratyphoid fever • Dental abscess with spreading cellulitis • Prosthetic joint infections • Helicobacter pylori eradication • Lyme disease AMOXICILLIN capsules is also indicated for the prophylaxis of endocarditis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ The dose of AMOXICILLIN capsules that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to antibacterial agents • The severity and the site of the infection • Lugege kogu dokumenti