Ponalgic Forte 500mg Film-Coated Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Mefenamic acid

Tilgængelig fra:

Mercury Pharmaceuticals (Ireland) Ltd

ATC-kode:

M01AG; M01AG01

INN (International Name):

Mefenamic acid

Dosering:

500 milligram(s)

Lægemiddelform:

Film-coated tablet

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Fenamates; mefenamic acid

Autorisation status:

Not marketed

Autorisation dato:

1987-10-23

Indlægsseddel

PONALGIC® 250MG HARD CAPSULES AND
PONALGIC® FORTE 500MG FILM-COATED TABLETS
(MEFENAMIC ACID)
Read all 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 nurse.
-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 nurse. This
includes any possible side effects not listed
in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1. What Ponalgic 250mg hard capsules and Ponalgic Forte 500mg
film-coated tablets are and what they
are used for
2. What you need to know before you take Ponalgic
3. How to take Ponalgic
4. Possible side effects
5. How to store Ponalgic
6. Contents of the pack and other information
1.WHAT PONALGIC 250MG HARD CAPSULES AND PONALGIC FORTE 500MG
FILM-COATED TABLETS ARE AND WHAT
THEY ARE USED FOR
Ponalgic 250mg Hard Capsules contain 250mg Mefenamic Acid, the active
ingredient.
Ponalgic Forte 500mg Film-Coated Tablets contain 500mg Mefenamic Acid.
Mefenamic acid belongs to a group of medicines called Non-Steroidal
Anti-inflammatory (NSAID) agents.
Ponalgic 250mg Hard Capsules and Ponalgic Forte 500mg Film-Coated
Tablets may be used
• for relief of mild to moderate pain associated with rheumatic
muscular or arthritic disorders,
including rheumatoid arthritis, and osteoarthritis
• for relief of mild to moderate pain due to an injury, headache,
toothache, or following an
operation or after childbirth
• to relieve the type of period pains for which no cause can be
shown
• in the management of excessively heavy periods(where the irregular
excessive bleeding may
not have an obvious cause)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PONALGIC
DO NOT TAKE PONALGIC IF:
• you have or ever had an ulcer or inflammation in your stomach or
intestine
• you have had a history of two or more dis

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ponalgic Forte 500mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 500 mg of Mefenamic Acid.
Excipients: Also contains Lactose Monohydrate
“For a full list of excipients, see section 6.1”
3 PHARMACEUTICAL FORM
Film coated tablet.
Caplet shaped yellow film coated tablets embossed with Antigen logo
'a'
and 'MA 500’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1)
For relief of mild to moderate pain associated with rheumatic muscular
or arthritic disorders (including
rheumatoid arthritis) trauma, headache, dental pain, and
post-operative or post-partum states.
2)
In the management of dysfunctional menorrhagia.
3)
Primary dysmenorrhoea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
Adults Only: The usual total daily dose is 1500mg in divided doses.
Ponalgic capsules should be taken preferably with or after food.
Older people: NSAID's should be used with particular caution in
elderly patients who are more prone to adverse events.
The lowest dose compatible with adequate safe clinical control should
be employed. See also Section 4.4.
Undesirable effects may be minimised by using the shortest duration
necessary to control symptoms (see section 4.4).
4.3 CONTRAINDICATIONS
1.
Use in patients with gastric and/or intestinal ulceration or
inflammation.
2.
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).
3.
Use in pregnancy or lactation (See section 4.6).
4.
Use in patients with renal or hepatic impairment.
5.
Hypersensitivity to mefenamic acid or to any of the excipients listed
in section 6.1.
6.
Hypersensitivity to other non-steroidal anti-inflammatory drugs
7.
Use in children.
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