Mefenamic acid 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mefenamic acid

Available from:

Essential Generics 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; GTIN: 5050204100063

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 250mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 250 mg mefenamic acid.
Excipients with known effect
Each capsule contains 77.61 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Hard capsule.
A practically white to greyish or creamy-white powder in a No 1 hard
gelatin capsule
having an ivory opaque body and powder blue opaque cap imprinted
“MEF 250”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mefenamic acid is a non-steroidal anti-inflammatory agent with
analgesic
properties, and a demonstrable antipyretic effect. It has been shown
to inhibit
prostaglandin activity.
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
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see section 4.4).
Do not exceed the stated dose.
Posology
ADULTS
2 capsules (500 mg) three times daily.
In menorrhagia to be administered on the first day of excessive
bleeding and
continued according to the judgment of the physician.
In dysmenorrhoea to be administered at the onset of menstrual pain and
continued
according to the judgment of the physician.
ELDERLY (OVER 65 YEARS)
As for adults.
Whilst no pharmacokinetic or clinical studies specific to the elderly
have been
undertaken with mefenamic acid, it has been used at normal dosage in
trials, which
included many elderly patients.
The elderly are at increased risk of the serious consequences of
adverse reactions. If
an NSAID is consi