FENAMIN SUSPENSION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

SUSPENSION

Composition:

EACH 5 ML SUSPENSION CONTAINS MEFENAMIC ACID 50 MG

Authorization status:

Registered

Authorization date:

1994-02-04

Patient Information leaflet

Date of approval: 18/08/2023
Page 1 of 10
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
FENAMIN SUSPENSION
EACH 5 ML SUSPENSION CONTAINS 50 MG MEFENAMIC ACID
CONTAINS SUGAR: SORBITOL 2,1 G
CONTAINS SWEETENER: SODIUM CYCLAMATE 24 MG, SACCHARIN SODIUM 1 MG
WHAT IS IN THIS LEAFLET
1.
What FENAMIN SUSPENSION is and what it is used for.
2.
What you need to know before you take FENAMIN SUSPENSION.
3.
How to take FENAMIN SUSPENSION.
4.
Possible side effects.
5.
How to store FENAMIN SUSPENSION.
6.
Contents of the pack and other information.
S2
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION
FOR YOU.
FENAMIN SUSPENSION is available without a doctor’s prescription, for
you to treat
a mild illness. Nevertheless, you still need to use FENAMIN SUSPENSION
carefully
to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share FENAMIN SUSPENSION with any other person.
•
Ask your health care provider if you need more information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
5
days.
Date of approval: 18/08/2023
Page 2 of 10
1. WHAT FENAMIN SUSPENSION IS AND WHAT IT IS USED FOR
FENAMIN SUSPENSION contains mefenamic acid as an active substance.
Mefenamic acid
is a non-steroidal anti-inflammatory drug (NSAID) with antipyretic
(helps against fever) and
analgesic (pain-killing) properties.
FENAMIN SUSPENSION is used for the treatment of post traumatic
conditions such as pain,
swelling and inflammation, for a maximum period of 5 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENAMIN SUSPENSION
DO NOT TAKE FENAMIN SUSPENSION:
•
If you are hypersensitive (allergic) to or have had an allergic
reaction to mefenamic
acid or aspirin or other related painkillers (NSAIDs), or any other
ingredient in
FENAMIN SUSPENSION, (listed in section 6).
•
If you have ever had symptoms of bronchospasm, allergic rhinitis, or
urticaria after
using a NSAID.
•
If you have or ever had a stomach ulcer, perforation or bleeding due
to the use of

Summary of Product characteristics

Date of approval: 18/08/2023
Page 1 of 18
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S2
1. NAME OF THE MEDICINE
FENAMIN SUSPENSION
STRENGTH
Each 5 ml contains 50 mg of mefenamic acid.
PHARMACEUTICAL FORM
Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 50 mg of mefenamic acid.
Contains sugar: Sorbitol 2,1 g per 5 ml
Contains sweetener: Sodium cyclamate 24 mg, saccharin sodium 1 mg per
5 ml
_Preservatives: _
Butyl hydroxybenzoate 0,015 % m/v
Methyl hydroxybenzoate 0,030 % m/v
Propyl hydroxybenzoate 0,015 % m/v
For full list of excipients, see section 6.1.
Date of approval: 18/08/2023
Page 2 of 18
3. PHARMACEUTICAL FORM
Suspension.
An off-white suspension with a fruity odour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FENAMIN SUSPENSION is indicated for the
treatment of post traumatic conditions such as pain, swelling and
inflammation, for a maximum period of 5 days.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Use the lowest effective dose for the shortest possible duration of
treatment.
FENAMIN must be taken with meals.
FENAMIN SUSPENSION should not be given for longer than 5 days.
CHILDREN
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 times
daily:
6 months to 1 year: One medicine measure (5 ml).
2 years to 4 years: Two medicine measures (10 ml).
5 years to 8 years: Three medicine measures (15 ml).
9 years to 12 years: Four medicine measures (20 ml).
SPECIAL POPULATIONS
No information available.
Date of approval: 18/08/2023
Page 3 of 18
PAEDIATRIC POPULATION
Refer to posology in children above.
METHOD OF ADMINISTRATION
For oral administration.
4.3 CONTRAINDICATIONS
FENAMIN SUSPENSION is contraindicated in:
•
Hypersensitivity to mefenamic acid and other NSAIDs, with
prostaglandin synthetase
inhibiting activity or to any of the ingredients of FENAMIN SUSPENSION
(see section
6.1).
•
Because the possibility of cross-sensitivity among NSAIDs exists,
FENAMIN
SUSPENSION should not be giv