Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Amoxicillin trihydrate
McDermott Laboratories Ltd., T/A Gerard Laboratories
J01CA; J01CA04
Amoxicillin trihydrate
500 milligram(s)
Capsule, hard
Penicillins with extended spectrum; amoxicillin
Not marketed
1984-11-28
PACKAGE LEAFLET: INFORMATION FOR THE USER GERAMOX 250 MG AND 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 Geramox is and what it is used for 2. What you need to know before you take Geramox 3. How to take Geramox 4. Possible side effects 5. How to store Geramox 6. Contents of the pack and other information 1. WHAT GERAMOX IS AND WHAT IT IS USED FOR WHAT GERAMOX IS Geramox contains a medicine called amoxicillin, which belongs to the Penicillin group of antibiotics. WHAT GERAMOX IS USED FOR Geramox can be used to treat a variety of infections in different parts of the body caused by bacteria. Geramox may also be used in combination with other medicines to treat stomach ulcers. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GERAMOX DO NOT TAKE GERAMOX: if you are allergic 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, throat or neck. Do not take Geramox if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking Geramox. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Geramox • if you have glandular fever (a viral infection which causes fever, sore throat, swollen glands and extreme tiredness) • if you suffer from kidney problems • if you are not passing water (urinating) regularly If you are not sure Baca dokumen lengkapnya
Health Products Regulatory Authority 05 September 2019 CRN0091Z4 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Geramox 500 mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Red cap with a yellow body size OE hard gelatin capsules marked ‘AX500’ and ‘G’ in black ink, containing a white to off white granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Geramox 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 ·Prosthetic joint infections ·Helicobacter pylori eradication ·Lyme disease Geramox 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 Geramox 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 Health Products Regulatory Authority 05 September 2019 CRN0091Z4 Page 2 of 12 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 regarding prolonged therapy). ADULTS AND CHILDREN ≥ 40 KG INDICATION* DOSE* Acute bacterial sinusitis 250 m Baca dokumen lengkapnya