Alfoxan 250 mg hard capsules

Country: Malta

Bahasa: Inggeris

Sumber: Malta Medicines Authority

Bahan aktif:

MEFENAMIC ACID

Boleh didapati daripada:

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

Kod ATC:

M01AG01

INN (Nama Antarabangsa):

MEFENAMIC ACID 250 mg

Borang farmaseutikal:

HARD CAPSULE

Komposisi:

MEFENAMIC ACID 250 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Status kebenaran:

Authorised

Tarikh kebenaran:

2006-11-23

Risalah maklumat

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALFOXAN 250 MG HARD CAPSULES
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 hard capsules 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.
•
fever in children over 12 years.
•
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, 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).
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•
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 pr

Ciri produk

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alfoxan 250 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 250 mg mefenamic acid.
Excipient(s) with known effect
This product contains 64.9mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules.
Light blue / ivory capsules.
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,
Still's Disease and osteoarthritis), trauma, headaches, dental pain,
post-operative or post-
partum states.
2.
For control of pyrexia in children.
3.
In the managements of dysfunctional menorrhagia.
4.
Primary dysmenorrhoea.
5.
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 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:_
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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.
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 fo