Ponstan Forte 500mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Mefenamic acid

Tilgængelig fra:

Essential Generics Ltd

ATC-kode:

M01AG01

INN (International Name):

Mefenamic acid

Dosering:

500mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 10010100; GTIN: 5050204100292

Indlægsseddel

_Continued over page_
PACKAGE LEAFLET: INFORMATION FOR THE USER
PONSTAN FORTE 500 MG TABLETS
mefenamic acid
7/L/x/2
OTHER MEDICINES AND PONSTAN FORTE
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Some medicines may be affected by Ponstan Forte or
they may affect how well Ponstan Forte 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 (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).
PONSTAN WITH ALCOHOL
Avoid drinking alcohol. It may increase your risk of
stomach bleeding.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before takin

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ponstan™ Forte Tablets 500mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg mefenamic acid
Excipients with known effect
Each tablet contains 22.73 mg lactose monohydrate and 0.067 mg sunset
yellow (E 110).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow, biconvex elliptical film coated tablet, inscribed ‘Ponstan
Forte’ on one side.
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.
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
1 tablet (500 mg) three times daily.
In menorrhagia to be administered on the first day of excessive
bleeding and continued
according to the judgement of the physician.
In dysmenorrhoea to be administered at the onset of menstrual pain and
continued according
to the judgement 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 Forte, 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 f