Ponstan Capsules 250mg
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Active ingredient
mefenamic acid
Legal Category
POM: Prescription only medicine
1. Name of the medicinal product
Ponstan™ Capsules 250mg
2. Qualitative and quantitative composition
Mefenamic acid BP 250mg
For a full list of excipients, see section 6.1
3. Pharmaceutical form
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 'PONSTAN 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)
For oral administration
Adults
2 capsules ( 500mg ) 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 Ponstan, 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 considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy
Ponstan should be used with caution in elderly patients suffering from dehydration and renal disease. Non-oliguric renal failure and proctocolitis have been reported mainly in elderly patients who have not discontinued mefenamic acid after the development of diarrhoea.
Children
It is recommended that children under 12 years of age should be given Mefenamic Acid Suspension (50mg / 5ml).
Ponstan Capsules should be taken preferably with or after food.
Do not exceed the stated dose.
4.3 Contraindications
Hypersensitivity to mefenamic acid or any of the other ingredients.
Inflammatory bowel disease
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Severe heart failure, hepatic failure and renal failure (see section 4.4).
Because the potential exists for cross-sensitivity to aspirin, ibuprofen, or other non-steroidal anti-inflammatory drugs, mefenamic acid must not be given to patients who have previously shown hypersensitivity reaction (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) to these medicines.
During the last trimester of pregnancy (s |
