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

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Fenamates; mefenamic acid

Authorization status:

Marketed

Authorization date:

1974-12-20

Patient Information leaflet

_Continued over page_
Read all of this leaflet carefully before you start using this
medicine.

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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
Ponstan 250 mg Capsules
Mefenamic acid
IR1-1/L/x/1
IR1-1/L/x/1
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1. What this medicine 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

headache or toothache

fever in children over 12 years

pain after operations, trauma

childbirth pain

painful or heavy periods

symptoms of premenstrual syndrome (PMS).
2. Before you take
Do NOT take Ponstan if you:

are allergic to mefenamic acid, to any other
anti-inflammatory medicines (such as aspirin, ibuprofen,
celecoxib), or to any of the other ingredients (see
Section 6)

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

have an inflammatory bowel disease (e.g. ulcerative
colitis, Crohn's disease)

have severe heart, liver or kidney problems

are seeking pain relief after heart bypass surgery

take any other non-steroidal anti-inflammatory drug
(NSAID) including cyclooxygenase-2-inhibitor (e.g.
ibuprofen, diclofenac, celecoxib, etoricoxib)

are pregnant or breast-feeding.
If any of the above apply to you, sp

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ponstan 250 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains Mefenamic Acid 250mg.
Excipients - contains Lactose Monohydrate 77.61mg.
For a 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
Oral.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms_ (see section 4.4, Special warnings and precautions for
use)._
_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,_
_Special warnings and precautions for use)._
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
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