Ponstan 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: 5050204100056

Patient Information leaflet

_Continued over page_
Ponstan Capsules 250 mg
Mefenamic acid
6/L/x/1
6/L/x/1
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription, and herbal
preparations.
Some medicines may be affected by Ponstan or they may
affect how well Ponstan will work. Tell your doctor or
pharmacist if you are taking:

medicines that can increase the chance of getting ulcers
or a bleed in the stomach or gut, such as:
- corticosteroids used to treat arthritis and
inflammation
- medicines such as anti-platelet agents, used to thin
the blood (e.g. warfarin, aspirin, clopidogrel)
- antidepressants called selective serotonin re-uptake
inhibitors (SSRIs) (e.g. paroxetine)
- any other anti-inflammatory medicines (e.g.
diclofenac, celecoxib)

aspirin including low doses of aspirin used to prevent
your blood from clotting in certain heart conditions

medicines used for high blood pressure (e.g. atenolol,
ramipril, valsartan)

diuretics (water tablets) or heart medicines (e.g. digoxin,
sotalol, diltiazem)

some diabetic medicines such as (e.g. glipizide,
glibenclamide)

medicines which suppress the immune system (e.g.
ciclosporin, tacrolimus, methotrexate)

lithium, a medicine used to treat mood swings and some
types of depression

a medicine usually prescribed through hospitals, called
mifepristone (taken within the last 12 days)

quinolone antibiotics (antibiotics used to treat infections)

aminoglycoside antibiotics, used under medical
supervision in hospitals

zidovudine, a medicine used for HIV

probenecid, a medicine used in special cases, to protect
the kidneys

medicines which bind to protein in the blood - (check
with your pharmacist).
Blood tests
Your doctor may test your blood during treatment.
Pregnancy and breast-feeding
Pregnancy
Mefenamic acid will be passed to your unborn baby. It is
not known how much it will affect your unborn baby in the
first 6 months of pregnancy.
DO N

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.
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).
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 Ponstan, it has been used at normal dosage in trials
which
included many elderly patients.
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).