Ponstan Forte 500 mg Film-coated Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
12-02-2019
Summary of Product characteristics
(SPC)
23-08-2018
Active ingredient:
Mefenamic acid
Available from:
Chemidex Pharma Limited
ATC code:
M01AG; M01AG01
INN (International Name):
Mefenamic acid
Dosage:
500 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Fenamates; mefenamic acid
Authorization status:
Marketed
Authorization date:
1997-01-24
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
PONSTAN FORTE 500 MG FILM-COATED TABLETS
mefenamic acid
IR1-2/L/x/1
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 FORTE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PONSTAN FORTE
3. HOW TO TAKE PONSTAN FORTE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PONSTAN FORTE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT PONSTAN FORTE IS AND WHAT IT IS USED FORE
d for
Ponstan Forte tablets 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
pain after operations, trauma
childbirth pain
painful or heavy periods
symptoms of premenstrual syndrome (PMS).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PONSTAN FORTE
2. BEFORE YOU TAKE
DO NOT TAKE PONSTAN FORTE:
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
if you ar
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ponstan Forte 500 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg mefenamic acid
Excipients with known effect:
Each film-coated tablet contains 22.73 mg lactose monohydrate, 0.067
mg Sunset yellow (E110) and less than 1 mmol
sodium (23 mg)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet. (Tablet)
Ovoid tablets with yellow film-coating inscribed ‘PONSTAN FORTE’
on one side.
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 and
osteoarthritis), trauma, headache, dental pain,
post-operative or post-partum states.
2.
In the management of dysfunctional menorrhagia.
3.
Primary dysmenorrhoea.
4.
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 dosage 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.
_CHILDREN:_
Not recommended for children under 12 years of age.
Do not exceed the stated dose.
Ponstan should be taken preferably with or after food.
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