Ponstan 250 mg Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mefenamic acid

Available from:

Chemidex Pharma Limited

ATC code:

M01AG; M01AG01

INN (International Name):

Mefenamic acid

Dosage:

250 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Fenamates; mefenamic acid

Authorization status:

Marketed

Authorization date:

2004-03-25

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PONSTAN 250 MG 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 Ponstan is and what it is used for
2.
What you need to know before you take Ponstan
3.
How to take Ponstan
4.
Possible side effects
5.
How to store Ponstan
6.
Contents of the pack and other information
1.
WHAT PONSTAN IS AND WHAT IT IS USED FOR
Ponstan 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
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headache or toothache
-
fever in children over 12 years
-
pain after operations, trauma
-
childbirth pain
-
painful or heavy periods
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symptoms of premenstrual syndrome (PMS).
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PONSTAN
DO NOT TAKE PONSTAN
-
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, intestines or bowel, or severe gastritis, especially if you
have taken NSAIDs before
-
if you have an inflammatory bowel disease (e.g. ulcerative colitis,
Crohn's disease)
-
if you have severe heart, liver or kidney problems
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if you are seeking pain relief after heart bypass surgery
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if you take any oth

Summary of Product characteristics

Health Products Regulatory Authority
23 May 2023
CRN00DGVS
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ponstan 250 mg 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.
No. 1 opaque hard gelatin capsule with ivory body and aqua blue cap,
containing a white to faintly greyish-white powder, and
printed ‘Ponstan 250’.
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, headaches,
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).
Do not exceed the stated dose.
Posology
_ADULTS_
The usual total daily dose is 1500 mg in divided doses.
_ELDERLY_
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse events, especially with
long-term use. Therefore, the risks versus the benefits of chronic
therapy in the elderly should be carefully considered. The
lowest dose compatible with adequate safe clinical control should be
employed (see section 4.4).
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
Paediatric population
Not recommended for children under 12 years of age.
Method of administration
For oral administration.
Health Products Regulatory Authority
23 May 2023
CRN00DGVS
Page 2 of 11
Ponstan should be taken preferably with