Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Amoxicillin (as trihydrate)
Centrient Pharmaceuticals Netherlands B.V
J01CA; J01CA04
Amoxicillin (as trihydrate)
500 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Penicillins with extended spectrum; amoxicillin
Not marketed
2013-07-26
1 r9.0 Classification: CONFIDENTIAL PACKAGE LEAFLET 2 r9.0 Classification: CONFIDENTIAL PACKAGE LEAFLET: INFORMATION FOR THE USER AMOXICILLINE DSM SINOCHEM PHARMACEUTICALS 500 MG CAPSULES, HARD Amoxicillin 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 1. What Amoxicillin DSM Sinochem Pharmaceuticals is and what it is used for 2. What you need to know before you take Amoxicillin DSM Sinochem Pharmaceuticals 3. How to take Amoxicillin DSM Sinochem Pharmaceuticals 4. Possible side effects 5. How to store Amoxicillin DSM Sinochem Pharmaceuticals 6. Contents of the pack and other information 1. WHAT AMOXICILLIN DSM SINOCHEM PHARMACEUTICALS IS AND WHAT IT IS USED FOR WHAT AMOXICILLIN DSM SINOCHEM PHARMACEUTICALS IS Amoxicillin DSM Sinochem Pharmaceuticals is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called ‘penicillins’. WHAT AMOXICILLIN DSM SINOCHEM PHARMACEUTICALS IS USED FOR Amoxicillin DSM Sinochem Pharmaceuticals is used to treat infections caused by bacteria in different parts of the body. Amoxicillin DSM Sinochem Pharmaceuticals may also be used in combination with other medicines to treat stomach ulcers. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXICILLIN DSM SINOCHEM PHARMACEUTICALS _ _ DO NOT TAKE AMOXICILLIN DSM SINOCHEM PHARMACEUTICALS • if you are allergic to amoxicillin, penicillins, or any of the other ingredients of this medicine (listed in section 6). • if you have ever had an allergic reaction to any antibi Lugege kogu dokumenti
Health Products Regulatory Authority 04 July 2023 CRN00DKW4 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxicillin DSM Sinochem Pharmaceuticals 500 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin. Excipient with known effect Contains allura red (E129). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard. Hard gelatin capsules with red cap and white body, cylindrical, with rounded ends, smooth, opaque and uniform surface, filled with white to off white granular powder. The capsule is 21.0 to 21.6 mm long and approximately 7.64 wide. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxicillin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): Acute bacterial sinusitis Acute otitis media 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 _Helicobacter pylori _eradication Lyme disease Amoxicillin 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 that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) • The severity and the site of the infection • The age, weight and renal function of the patient; as shown below The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections require longer periods of treatment (see section 4.4 rega Lugege kogu dokumenti