Alphamox
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
26-11-2019
Summary of Product characteristics
(SPC)
26-08-2019
Active ingredient:
Amoxicillin trihydrate 575mg equivalent to amoxycillin 500 mg;
Available from:
Viatris Limited
INN (International Name):
Amoxicillin trihydrate 575 mg (=amoxycillin 500 mg)
Dosage:
500 mg
Pharmaceutical form:
Capsule
Composition:
Active: Amoxicillin trihydrate 575mg equivalent to amoxycillin 500 mg Excipient: Gelatin Colloidal anydrous silica Magnesium stearate Purified talc Sodium starch glycolate
Units in package:
Blister pack, PVC/PVDC/AL, 30 capsules
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
DSM Sinochem Pharmaceuticals India Private Limited
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. 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.
Product summary:
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
Authorization date:
1984-06-22
Patient Information leaflet
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
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Summary of Product characteristics
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
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