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amoxicillin trihydrate B.P.
Athlone Pharmaceuticals Limited
J01CA04
amoxicillin trihydrate B.P.
125mg/5m
powder for reconstitution as suspension
Oral use
100ml
POM - Prescription Only Medicine
Athlone Pharmaceuticals Limited
Beta-lactam antibacterials, Penicillins with extended spectrum
It is a broad spectrum antibiotic indicated for the treatment of commonlyoccurring bacterial infections including: Acute and chronic bronchitis Pneumonia Ear, nose and throat infections Otitis media Urinary tract infection Gonorrhoea Invasive salmonellosis Gynaecological infections Peritonitis Osteomyelitis Meningitis Endocarditis Typhoid fever
Authorised
2015-04-09
PATIENT INFORMATION LEAFLET – NON-SYRINGE AMOXICILLIN 125MG/5ML & 250MG/5ML ORAL SUSPENSION SUGAR FREE PATIENT INFORMATION LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR PHARMACIST. THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD NOT PASS IT ON TO OTHERS. IT MAY HARM THEM EVEN IF THEIR SYMPTOMS ARE THE SAME AS YOURS. IF ANY OF THE SIDE EFFECTS GET SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THE LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST. In This Leaflet 1. What your medicine is and what it is used for 2. Before you take your medicine 3. How to take your medicine 4. Possible side effects 5. How to store your medicine 6. Further information 1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR Amoxicillin is one of a group of antibiotic medicines called penicillins. Amoxicillin works by interfering with the bacteria that cause the infection. Amoxicillin can treat a wide range of infections including those of the following: -chest (bronchitis or pneumonia) -tonsils (tonsillitis) -skin -ears (otitis media) -sinuses (sinusitis) -kidneys -teeth -gums (abscesses) -heart (endocarditis) -blood (septicaemia) -bone -the bladder or the urethra (the tube which carries urine from the bladder) -the female reproductive system including infections caused by difficulties during childbirth (puerperal sepsis and septic abortion) -abdomen (intra-abdominal sepsis and peritonitis) -gonorrhoea (a sexually transmitted infection) -infections associated with pregnancy -typhoid and paratyphoid (fevers caused by a group of bacteria called Salmonella) Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxicillin 125mg/5ml Oral Suspension Sugar Free 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amoxicillin Sugar Free Suspension 125mg/5ml contains amoxicillin trihydrate B.P. equivalent to amoxicillin 125mg For the full list of excipients, please see section 6.1 3 PHARMACEUTICAL FORM Pale yellow powder for reconstitution as suspension 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxicillin is a broad spectrum antibiotic indicated for the treatment of commonly- occurring bacterial infections including: Acute and chronic bronchitis Pneumonia Ear, nose and throat infections Otitis media Urinary tract infection Gonorrhoea Invasive salmonellosis Gynaecological infections Peritonitis Osteomyelitis Meningitis Endocarditis Typhoid fever Prophylaxis of endocarditis in patients at risk from such procedures as dental extractions. In some of these infections initiation of treatment or indeed the whole course of treatment may need to be by the parenteral route. In children with urinary tract infection, the need for further clinical investigation should be considered. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULT DOSAGE (INCLUDING ELDERLY PATIENTS) STANDARD ADULT DOSAGE: 5ml of 250mg/5ml suspension three times daily, increasing to 10ml of 250mg/5ml suspension three times daily for more severe infections. High dose and short course therapies, requiring doses of up to 6gm, daily, a more appropriate dosage form is recommended. CHILDREN Children weighing more than 40 kg should be given the usual adult dosage. Children weighing < 40 kg The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses* (not exceeding 3 g/day) depending on the indication, severity Lue koko asiakirja