MEFAC 250 mg Hard Capsules

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Mefenamic acid

Tilgængelig fra:

Rowa Pharmaceuticals Limited

ATC-kode:

M01AG; M01AG01

INN (International Name):

Mefenamic acid

Dosering:

250 milligram(s)

Lægemiddelform:

Capsule, hard

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Fenamates; mefenamic acid

Autorisation status:

Not marketed

Autorisation dato:

1988-04-28

Indlægsseddel

MEFAC 250MG HARD CAPSULES
MEFENAMIC ACID
50 Hard Capsules
100 Hard Capsules
500 Hard Capsules
PA Holder:
Rowa Pharmaceuticals Ltd., Bantry Co. Cork, Ireland
PA 74/15/1
Marketed by:
Rowex Ltd., Bantry, Co. Cork, Ireland
COMPOSITION:
Each hard capsule contains 250mg mefenamic acid. Also includes lactose
monohydrate. See leaflet
for further information.
DOSAGE:
For oral use as directed by the Physician. Do not exceed the stated
dose. Capsules should be taken
preferably with food.
Do not store above 25°C. Keep out of the sight and reach of children.
Package leaflet: Information for the user
MEFAC 250MG HARD CAPSULES
Mefenamic Acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Mefac is and what it is used for
2. What you need to know before you take Mefac
3. How to take Mefac
4. Possible side effects
5. How to store Mefac
6. Contents of the pack and other information
1.WHAT MEFAC IS AND WHAT IT IS USED FOR
Mefac contains an active substance called mefenamic acid. This belongs
to the group of medicines
called NSAIDs (non-steroidal anti-inflammatory drugs). Mefac is used
for the relief of mild to
moderate pain and inflammation associated with rheumatic, muscular or
arthritic disorders, trauma,
headache, dental pain, pain following surgery or childbirth, fever in
children over 12 years. Mefac is
also used for relief of period pains, management of excessively heavy
periods and symptoms of
premenstrual syndrome (PMS).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEFAC
DO NOT TAKE MEFAC IF YOU:
• are all

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MEFAC 250 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Mefenamic Acid 250 mg.
Excipient(s) with known effect:
Also contains lactose monohydrate, 36.0mg per capsule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules.
Size 1, opaque, hard gelatin capsules with blue caps and white bodies,
printed ‘MEFAC 250’ in grey containing a white
powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
As an anti-inflammatory analgesic for symptomatic relief of mild to
moderate pain associated with rheumatic
muscular or arthritic disorders (including rheumatoid arthritis,
Still’s Disease and osteoarthritis), trauma, headache,
dental pain, post - operative or post - partum states.
2.
For control of pyrexia in children
3.
In the management of dysfunctional menorrhagia
4.
Primary dysmenorrhoea.
5.
Premenstrual syndrome
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
Route of Administration
Oral.
Recommended Dosage Schedule
Adults Only:
The usual total daily dose is 1500 mg in divided doses.
Children:
Not recommended for children under 12 years of age.
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