PONAC SUSPENSION

البلد: جنوب أفريقيا

اللغة: الإنجليزية

المصدر: South African Health Products Regulatory Authority (SAHPRA)

متاح من:

Pharmacorp (Pty) Ltd

جرعة:

See ingredients

الشكل الصيدلاني:

SUSPENSION

تركيب:

EACH 5 ML SUSPENSION CONTAINS MEFENAMIC ACID 50 MG

الوضع إذن:

Registered

تاريخ الترخيص:

1992-11-08

نشرة المعلومات

PONAC SUSPENSION, mefenamic acid 50 mg per 5 ml
Approved Patient Information Leaflet
SCHEDULING STATUS: S2
PONAC SUSPENSION
MEFENAMIC ACID 50 MG PER 5 ML
PRESERVATIVES:
BUTYL HYDROXYBENZOATE 0,015 % M/V
METHYL HYDROXYBENZOATE 0,03 % M/V
PROPYL HYDROXYBENZOATE 0,015 % M/V
CONTAINS SWEETENER:
SACCHARIN SODIUM 1,000 MG PER 5 ML
SORBITOL SOLUTION 2,000 ML PER 5 ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PONAC
SUSPENSION
•
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.
•
PONAC SUSPENSION have 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 PONAC SUSPENSION is and what it is used for
2.
What you need to know before you take PONAC SUSPENSION
3.
How to take PONAC SUSPENSION
4.
Possible side effects
5.
How to store PONAC SUSPENSION
PONAC SUSPENSION, mefenamic acid 50 mg per 5 ml
Approved Patient Information Leaflet
6.
Contents of the pack and other information
1. WHAT PONAC SUSPENSION IS AND WHAT IT IS USED FOR
PONAC SUSPENSION contain mefenamic acid. Mefenamic acid belongs to a
group of
medicinal products called non-steroidal anti-inflammatory medicines
(NSAIDs).
PONAC SUSPENSION are used for the relief of acute and mild to moderate
pain and can also
be used for primary dysmenorrhoea (painful cramps during
menstruation).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PONAC SUSPENSION
DO NOT TAKE PONAC SUSPENSION
•
if you are allergic (hypersensitive) to mefenamic acid or any of the
other ingredients of
PONAC SUSPENSION (listed in section 6).
•
if you have or are taking other non-steroidal anti-inflammatory
medicine and have
experienced symptoms of bronchospasm (spasmodic contraction of the
muscular lining of
the bronchi, as in asthma, causing difficulty in breathing), allergic
rhinitis (referred to as
hay
fever,
is
inflammation
of
the
nasal
passages)
or

خصائص المنتج

PONAC SUSPENSION, mefenamic acid 50 mg per 5 ml
Approved Professional Information
SCHEDULING STATUS
S2
1 NAME OF THE MEDICINE
PONAC SUSPENSION, mefenamic acid 50 mg per 5 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml PONAC SUSPENSION contains 50,000 mg mefenamic acid.
Preservatives:
Butyl hydroxybenzoate 0,015 % m/v
Methyl hydroxybenzoate 0,03 % m/v
Propyl hydroxybenzoate 0,015 % m/v
Contains sweetener:
Saccharin Sodium 1,000 mg per 5 ml
Sorbitol solution 2,000 ml per 5 ml
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
An off-white suspension of pourable consistency with a fruity odour
and taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
PONAC SUSPENSION is indicated for the treatment of post traumatic
conditions such as pain,
swelling and inflammation, for a maximum period of five (5) days.
PONAC SUSPENSION is
PONAC SUSPENSION, mefenamic acid 50 mg per 5 ml
Approved Professional Information
also indicated as treatment of primary dysmenorrhoea, subject to a
maximum daily dose of
500 mg three (3) times a day for a maximum of three (3) days.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
Use the lowest effective dose for the shortest possible duration of
treatment.
PONAC SUSPENSION must be taken with meals.
RELIEF OF MILD TO MODERATE PAIN: 500 mg three (3) times a day.
ACUTE PAIN: an initial dosage of 500 mg, thereafter 250 mg every six
(6) hours for a maximum
treatment period of five (5) days.
PRIMARY DYSMENORRHOEA: a maximum daily dose of 500 mg three (3) times
a day and a
maximum treatment period of three (3) days.
PAEDIATRIC POPULATION
The dosage for children is 25 mg per kg body weight daily in divided
doses.
The following dose may be repeated as necessary, up to three (3) times
daily:
6 months to 1 year: One (1) measureful (5 ml).
2 years to 4 years: Two (2) measureful (10 ml).
5 years to 8 years: Three (3) measureful (15 ml).
9 years to 12 years: Four (4) measureful (20 ml).
METHOD OF ADMINISTRATION
Oral use only.
PONAC SUSPENSION, mefenamic acid 50 mg per 5