Mefenamic acid 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mefenamic acid

Available from:

Viatris UK Healthcare Ltd

ATC code:

M01AG01

INN (International Name):

Mefenamic acid

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

BACK
FRONT
TARUS
TARUS
_Continued over page_
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.
4/L/x/2c
WHAT IS IN THIS LEAFLET
1. WHAT MEFENAMIC ACID IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MEFENAMIC ACID
3. HOW TO TAKE MEFENAMIC ACID
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MEFENAMIC ACID
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT MEFENAMIC ACID IS AND WHAT IT IS USED FOR
Mefenamic Acid capsules contain mefenamic acid
which is a non-steroidal anti-inflammatory drug
(NSAID).
They can help to relieve:
•
symptoms of inflammation, such as redness and
swelling
• pain and discomfort caused by arthritis, muscular or
rheumatic disorders
• headache, muscle ache or toothache
• pain after operations, trauma
• childbirth pain
• fever in children
• painful or heavy periods. 2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE MEFENAMIC ACID
DO NOT TAKE MEFENAMIC ACID:
• if you are allergic to mefenamic acid, to any other
anti-inflammatory medicines (such as aspirin,
ibuprofen, celecoxib), or any of the other
ingredients of this medicine (listed in section 6)
• if you have, or have ever had, stomach or intestinal
conditions such as peptic ulcer, bleeding in the
stomach or severe gastritis
• if you have an inflammatory bowel disease (e.g.
ulcerative colitis, Crohn’s disease)
• if you have severe heart, liver or kidney problems
• if you have just had heart bypass surgery
• if you are more than 6 months pregnant.
If any of the above apply to you, speak to your doctor or
pharmacist.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mefenamic Acid 250 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mefenamic Acid 250 mg
Excipient(s) with known effect
Lactose
Monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Hard gelatin capsule with a blue cap and a buff body, printed with
“MEF 250” both
on body and cap.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
1.
As an anti-inflammatory analgesic for the symptomatic relief of
rheumatoid arthritis (including Still’s disease), osteoarthritis,
and pain
including muscular, traumatic and dental pain, headaches of most
aetiology, post-operative and post-partum pain; pyrexia in children.
2.
Primary dysmenorrhoea.
3.
Menorrhagia due to dysfunctional causes and presence of an IUD when
other pelvic pathology has been ruled out.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
The capsules should be swallowed with a drink of water. To be taken
preferably with
or after food.
Undesirable effects may be minimised by using the shortest duration
necessary to
control symptoms (see section 4.4). The patient should be monitored
regularly for
gastrointestinal bleeding during NSAID therapy.
Adults: 2 capsules (500mg) three times daily
In
menorrhagia
to
be administered
on
the first
day
of
excessive
bleeding
and
continued according to the judgement of the physician
In dysmenorrhoea to be administered at the onset of menstrual pain and
continued
according to the judgement of the physician
Elderly:
The elderly are at increased risk of the serious consequences of
adverse reactions. If
an NSAID is considered necessary, the lowest dose should be used and
for the
shortest possible duration. The patient should be monitored for GI
bleeding during
NSAID therapy.
Children (under 12 years): Not recommended
4.3
CONTRAINDICATIONS
•
Hypersensitivity to mefenamic acid or to any of the excipients.
•
Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinct episodes