Alfoxan 500 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEFENAMIC ACID

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

M01AG01

INN (International Name):

MEFENAMIC ACID 500 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

MEFENAMIC ACID 500 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2006-11-23

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALFOXAN 500 MG FILM-COATED TABLETS
Mefenamic acid
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
effect not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Alfoxan is and what it is used for
2. What you need to know before you take Alfoxan
3. How to take Alfoxan
4. Possible side effects
5. How to store Alfoxan
6. Contents of the pack and other information
1.
WHAT ALFOXAN IS AND WHAT IT IS USED FOR
Alfoxan tablets contain the active substance mefenamic acid which is a
non-steroidal anti-
inflammatory drug (NSAID).
Alfoxan 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 ALFOXAN
DO NOT TAKE ALFOXAN
•
if you are allergic to mefenamic acid or to any other
anti-inflammatory medicines (such as
aspirin, ibuprofen, celecoxib), or to 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).
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•
if you have severe heart, liver or kidney proble

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alfoxan 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each film-coated tablet contains 500 mg mefenamic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, oval, film-coated tablets with Remedica’s logo on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
As an anti-inflammatory analgesic for the 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
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control the symptoms
_(see section 4.4, Special warnings and precautions _
_for use). _
Posology
_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
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use). Treatment should be reviewed at regular intervals and
discontinued if no benefit is seen
or intolerance occurs.
_Paediatric population: _
Not recommended for children under 12 years of age.
Do not exceed the stated dose.
Alfoxan should be taken preferably with or after food.
Method of administration
Oral administration.
_ _
4.3
CONTRAINDICATIONS
1.
Use in patients with intestinal ulceration or inflammation in patients
with inflammatory