FENAMIN - 250 CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS MEFENAMIC ACID 250,0 mg

Authorization status:

Registered

Authorization date:

1994-03-04

Patient Information leaflet

Date of approval: 18/08/2023
Page 1 of 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
FENAMIN 250, 250 MG CAPSULES
MEFENAMIC ACID
CONTAINS SUGAR:
LACTOSE MONOHYDRATE 55 MG
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR
YOU
FENAMIN 250 is available without a doctor’s prescription, for you to
treat a mild
illness. Nevertheless, you still need to use FENAMIN 250 carefully to
get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share FENAMIN 250 with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
5 days.
WHAT IS IN THIS LEAFLET
1. What FENAMIN 250 is and what it is used for
2. What you need to know before you take FENAMIN 250
3. How to take FENAMIN 250
4. Possible side effects
5. How to store FENAMIN 250
6. Contents of the pack and other information
S2
Date of approval: 18/08/2023
Page 2 of 9
1. WHAT FENAMIN 250 IS AND WHAT IT IS USED FOR
FENAMIN 250 contains mefenamic acid. Mefenamic acid is a non-steroidal
anti-
inflammatory medicine (NSAID) with antipyretic (helps against fever)
and analgesic (pain-
killing) properties. It is used for the relief of mild to moderate
pain and relief of swelling and
inflammation.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENAMIN 250
DO NOT TAKE FENAMIN 250
•
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 250 (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
NSAIDs.
•
If you have inflammatory bowel disease such as ulcerative colitis and
Crohn’s
disease (inflammatory conditions of the small intestine or colon).
•
If you have epilepsy (a disorder that causes seizures).
•
If you have

Summary of Product characteristics

Date of approval: 18/08/2023
Page 1 of 16
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S2
1. NAME OF THE MEDICINE
FENAMIN 250, capsules
STRENGTH
Mefenamic acid 250 mg per capsule
PHARMACEUTICAL FORM
Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Mefenamic acid 250 mg
Contains sugar :
Lactose monohydrate 55 mg
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsules.
An off-white, free-flowing powder encapsulated within a no. 1 capsule
with a turquoise cap and a
pale-yellow body.
Date of approval: 18/08/2023
Page 2 of 16
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FENAMIN 250 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 250 should not be given for longer than 5 days.
ADULTS
TREATMENT OF POST-TRAUMATIC CONDITIONS:
RELIEF OF MILD TO MODERATE PAIN: 500 mg three times a day.
ACUTE PAIN: An initial dosage of 500 mg, thereafter 250 mg every 6
hours.
PAEDIATRIC POPULATION
No information available.
METHOD OF ADMINISTRATION
For oral administration.
4.3 CONTRAINDICATIONS
FENAMIN is contraindicated in:
•
Hypersensitivity to mefenamic acid and other NSAIDs, with
prostaglandin synthetase inhibiting
activity or to any of the ingredients of FENAMIN (see section 6.1).
Date of approval: 18/08/2023
Page 3 of 16
•
Because of the possibility of cross-sensitivity among NSAIDs exists,
FENAMIN should not be
given to patients in whom these medicines induce symptoms of
bronchospasm, allergic
rhinitis, or urticaria.
•
History of gastrointestinal perforation, ulceration or bleeding (PUBs)
related to previous
NSAIDs, including FENAMIN.
•
Patients with an active or a history of recurrent peptic and/or
intestinal ulceration/
haemorrhage/ perforations.
•
Chronic inflammation of either the upper or lower gastrointestinal
trac