FENAMIN - 500 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS MEFENAMIC ACID 500 MG

Authorization status:

Registered

Authorization date:

1993-01-06

Patient Information leaflet

Date of approval:
18/08/2023
Page 1 of 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
FENAMIN-500
EACH FILM COATED TABLET CONTAINS 500MG OF MEFENAMIC ACID.
CONTAINS SUGAR: LACTOSE MONOHYDRATE 143 MG
WHAT IS IN THIS LEAFLET
1. What FENAMIN-500 is and what it is used for
2. What you need to know before you take FENAMIN-500
3. How to take FENAMIN-500
4.Possible side effects
5. How to store FENAMIN-500
6. Contents of the pack and other information
S2
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
FENAMIN-500 is available without a doctor’s prescription, for you to
treat a mild
illness. Nevertheless, you still need to use FENAMIN-500 carefully to
get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share FENAMIN-500 with any other person.
•
Ask your pharmacist if you need more information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
3
days.
Date of approval:
18/08/2023
Page 2 of 9
1. WHAT FENAMIN-500 IS AND WHAT IT IS USED FOR
A 2.7 Antipyretic and anti-inflammatory analgesics
FENAMIN-500 is used for the relief of period pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENAMIN-500
DO NOT TAKE FENAMIN-500
•
If you are hypersensitive (allergic) to or have had an allergic
reaction to mefenamic
acid or any other ingredient in FENAMIN-500, aspirin or other related
painkillers (see
What FENAMIN-500 contains).
•
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 a liver or kidney problem.
•
If you have heart problems.
•
If you are pregnant, do not use NSAIDs at 20 weeks or later in your
pregnancy
unless specifically advised to do so by your health care professional
because these
medicines may ca

Summary of Product characteristics

Date of approval:
18/08/2023
Page 1 of 16
PROFESSIONAL INFORMATION
SCHEDULING STATUS
1. NAME OF THE MEDICINE
FENAMIN-500 (film-coated tablet)
STRENGTH
Mefenamic acid 500 mg per film-coated tablet
PHARMACEUTICAL FORM
Tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains mefenamic acid 500 mg
Contains sugar:
Lactose monohydrate 143 mg
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
A pale yellow, round, film-coated, bevelled edge biconvex tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FENAMIN – 500 is indicated for:
•
Treatment of primary dysmenorrhoea, for a maximum treatment period of
3 days.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
S2
Date of approval:
18/08/2023
Page 2 of 16
POSOLOGY
Use the lowest effective dose for the shortest possible duration of
treatment.
FENAMIN – 500 must be taken with meals.
FENAMIN – 500 should not be given for longer than 3 days.
ADULTS
FENAMIN - 500
TREATMENT OF PRIMARY DYSMENORRHOEA:
A maximum daily dose of 500 mg every 8 hours.
PAEDIATRIC POPULATION
FENAMIN - 500 is not indicated for use in children
4.3 CONTRAINDICATIONS
FENAMIN - 500 is contraindicated in:
•
Hypersensitivity to mefenamic acid and other NSAIDs, with
prostaglandin synthetase
inhibiting activity or to any of the ingredients of FENAMIN - 500 (see
COMPOSITION
section 6.1).
•
Because of the possibility of cross-sensitivity among NSAIDs exists,
FENAMIN – 500
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 - 500.
•
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
tract such as
Inflammatory bowel disease.
•
Epilepsy.
Date of approval:
18/08/2023
Page 3 of 16
•
Patients with impaired hepatic or renal functio