ALLMOX 250 CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Innovata Pharmaceuticals

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS AMOXYCILLIN TRIHYDRATE EQUIVALENT TO AMOXYCILLIN 250 mg

Authorization status:

Registered

Authorization date:

1992-10-10

Patient Information leaflet

_ _
_ _
_APPLICANT/PHCR: INNOVATA PHARMACEUTICALS (PTY) LTD _
_PRODUCT PROPRIETARY NAME: ALLMOX 250 & 500 _
_DOSAGE FORM & STRENGTH: CAPSULES, AMOXYCILLIN 250 & 500 MG _
_ _
_CTD, MODULE 1_
Date of PIL: 21/11/2023
Page 1 of 10
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
ALLMOX 250 HARD GELATIN CAPSULES
ALLMOX 500 HARD GELATIN CAPSULES
AMOXICILLIN TRIHYDRATE
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
ALLMOX
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care provider.
•
ALLMOX has been prescribed for you personally and you should not
share your medicine with other people. It may harm them, even if their
symptoms are the same as yours.
WHAT IS IN THIS LEAFLET
1.
What ALLMOX is and what it is used for
2.
What you need to know before you take ALLMOX
3.
How to take ALLMOX
4.
Possible side effects
5.
How to store ALLMOX
6.
Contents of the pack and other information
S4
_ _
_ _
_APPLICANT/PHCR: INNOVATA PHARMACEUTICALS (PTY) LTD _
_PRODUCT PROPRIETARY NAME: ALLMOX 250 & 500 _
_DOSAGE FORM & STRENGTH: CAPSULES, AMOXYCILLIN 250 & 500 MG _
_ _
_CTD, MODULE 1_
Date of PIL: 21/11/2023
Page 2 of 10
1.
WHAT ALLMOX IS AND WHAT IT IS USED FOR
ALLMOX is an antibiotic, belonging to a group of medicines called
penicillins.
ALLMOX is used to treat infections caused by bacteria in different
parts of the body. ALLMOX may also be used in combination with
other medicines to treat stomach ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLMOX
DO NOT TAKE ALLMOX:
•
if you are hypersensitive (allergic) to amoxicillin, penicillin or any
of
the other ingredients of ALLMOX (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 or throat.
•
if you have infectious mononucleosis, also known as glandular fever
(fever,
sore throat, swollen glands and extreme tiredness). A high percentage
of
patients with mononucleosis who receive

Summary of Product characteristics

_APPLICANT/PHCR: INNOVATA PHARMACEUTICALS (PTY) LTD _
_PRODUCT PROPRIETARY NAME: ALLMOX 250 & 500 _
_DOSAGE FORM & STRENGTH: CAPSULES, AMOXYCILLIN 250 & 500 MG _
_ _
_CTD, MODULE 1_
Date of PI: 21/11/2023
Page 1 of 17
SCHEDULING STATUS:
1. NAME OF THE MEDICINE:
ALLMOX 250 CAPSULES
ALLMOX 500 CAPSULES
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
ALLMOX 250 contains amoxicillin trihydrate the equivalent of 250 mg
amoxicillin per
capsule.
ALLMOX 500 contains amoxicillin trihydrate the equivalent of 500 mg
amoxicillin per
capsule.
3. PHARMACEUTICAL FORM:
ALLMOX 250: Purple/blue hard, size 2, gelatine capsules containing a
white granular
powder.
ALLMOX 500: Purple/blue hard, size 0, gelatine capsules containing a
white granular
powder.
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
Infections caused by susceptible, non-penicillinase – producing
organisms including:
S4
_APPLICANT/PHCR: INNOVATA PHARMACEUTICALS (PTY) LTD _
_PRODUCT PROPRIETARY NAME: ALLMOX 250 & 500 _
_DOSAGE FORM & STRENGTH: CAPSULES, AMOXYCILLIN 250 & 500 MG _
_ _
_CTD, MODULE 1_
Date of PI: 21/11/2023
Page 2 of 17
•
Respiratory tract infections (upper and lower): sinusitis,
pharyngitis, epiglottitis,
acute and chronic bronchitis and acute typical pneumonia.
•
Otitis media;
•
Urinary tract infections;
•
Uncomplicated gonococcal infections;
•
Meningitis (sensitivity tests must be performed);
•
Gastrointestinal infections including salmonella and typhoid;
•
Uncomplicated gastro-enteritis and enteric fever;
•
Miscellaneous: Skin and soft tissue infections, bacteraemia and as
adjunct in the
treatment of sepsis caused by gram-negative bacteria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN OVER 12 YEARS
•
250 mg to 500 mg every 8 hours depending on the severity of the
infection.
•
Gonorrhoea: 3 g amoxicillin (e.g. six ALLMOX 500 capsules) as a single
dose
usually combined with 1 g probenecid.
•
In the treatment of beta-haemolytic streptococcal infections, a
therapeutic dose
should be administered for at