Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Amoxicillin trihydrate 287.5mg equivalent to amoxycillin 250 mg;
Viatris Limited
Amoxicillin trihydrate 287.5 mg (=amoxycillin 250 mg)
250 mg
Capsule
Active: Amoxicillin trihydrate 287.5mg equivalent to amoxycillin 250 mg Excipient: Gelatin Magnesium stearate Microcrystalline cellulose Purified talc Sodium starch glycolate
Blister pack, PVC/PVDC/AL, 30 capsules
Prescription
Prescription
DSM Sinochem Pharmaceuticals India Private Limited
Amoxicillin should be used in accordance with local antibiotic-prescribing information guidelines and local susceptibility data. Amoxicillin may be useful in instituting therapy prior to bacteriology; however bacteriological studies to determine the causative organisms and their sensitivity to Amoxicillin should be performed. Susceptibility to amoxicillin will vary with geography and time and local susceptibility data should be consulted where available and microbiological sampling and susceptibility testing performed where necessary. Treatment of infection: Amoxicillin is indicated in the treatment of infections due to susceptible organisms. Skin and skin structure: Staphylococcus, non-penicillinase producing; Streptococcus; E. coli. Respiratory (Acute and Chronic): H. influenzae; Streptococcus; S. pneumoniae; staphylococcus, non-penicillinase-producing; E.coli. Genitourinary Tract (complicated and uncomplicated, Acute and Chronic): E.Coli, P. mirabilis and S. faecalis. Gonorrhoea: N. gonorrhoeae (non-penicillinase producing). Prophylaxis for endocarditis: Amoxicillin may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis, such as those with a prosthetic heart valve or those who have previously had endocarditis.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/AL - 30 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL - 500 capsules - 24 months from date of manufacture stored at or below 25°C
1984-06-22
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION ALPHAMOX _AMOXICILLIN 250 MG AND 500 MG CAPSULES_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Alphamox. This leaflet answers some common questions about Alphamox. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Alphamox against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ALPHAMOX IS USED FOR Alphamox contains the active ingredient amoxicillin, which is an antibiotic that belongs to a group of medicines called penicillins. These medicines work by killing the bacteria that are causing the infection. Alphamox is used to treat infections in different parts of the body caused by bacteria. Alphamox can also be used to prevent endocarditis (heart infection) in some people. Alphamox will not work against infections caused by viruses, such as colds or flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Alphamox for another reason. Alphamox is available only with a doctor's prescription. BEFORE YOU TAKE ALPHAMOX _WHEN YOU MUST NOT TAKE _ _IT:_ DO NOT TAKE ALPHAMOX IF YOU HAVE AN ALLERGY TO: • any medicine containing amoxicillin • penicillin or any other similar antibiotics such as cephalosporins or other beta-lactam medicines • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. If you have had an allergic reaction (such as a rash) when taking an antibiotic, you should tell your doctor before you take Alphamox. DO NOT TAK Read the complete document
Page 1 of 17 NEW ZEALAND DATA SHEET ALPHAMOX 1. PRODUCT NAME Alphamox, 250 mg and 500 mg, capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Alphamox 250 mg capsule contains 250 mg of amoxicillin (as trihydrate) Each Alphamox 500 mg capsule contains 500 mg of amoxicillin (as trihydrate) EXCIPIENT(S) WITH KNOWN EFFECT: Microcrystalline cellulose and gelatin ALLERGEN DECLARATION: Contains sulfites. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM ALPHAMOX 250 mg Capsules: Size 2 hard gelatin capsule with ivory body and green cap, filled with almost white granular powder. ALPHAMOX 500 mg Capsules: Size 0 l hard gelatin capsule with ivory body and green cap, filled with almost white granular powder. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Amoxicillin should be used in accordance with local antibiotic-prescribing information guidelines and local susceptibility data. Amoxicillin may be useful in instituting therapy prior to bacteriology; however bacteriological studies to determine the causative organisms and their sensitivity to Amoxicillin should be performed. Susceptibility to amoxicillin will vary with geography and time and local susceptibility data should be consulted where available and microbiological sampling and susceptibility testing performed where necessary (see section 5.1). TREATMENT OF INFECTION: Amoxicillin is indicated in the treatment of infections due to susceptible organisms. Page 2 of 17 _SKIN AND SKIN STRUCTURE: _ Staphylococcus, non-penicillinase producing; Streptococcus; E. coli (see section 5.1 – Microbiology). _RESPIRATORY (ACUTE AND CHRONIC): _ H. influenzae; Streptococcus; S. pneumoniae; staphylococcus, non-penicillinase-producing; E.coli (see section 5.1 – Microbiology). _GENITOURINARY TRACT (COMPLICATED AND UNCOMPLICATED, ACUTE AND CHRONIC): _ E.coli (see section 5.1 – Microbiology), P. mirabilis and S. faecalis. _GONORRHOEA: _ N. gonorrhoeae (non-penicillinase producing). _PROPHYLAXIS FOR ENDOCARDITIS: _ Amoxicillin may be used for t Read the complete document