Almiral 50mg gastro-resistant tablets

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

DICLOFENAC SODIUM

Verfügbar ab:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC-Code:

M01AB05

INN (Internationale Bezeichnung):

DICLOFENAC SODIUM 50 mg

Darreichungsform:

GASTRO-RESISTANT TABLET

Zusammensetzung:

DICLOFENAC SODIUM 50 mg

Verschreibungstyp:

POM

Therapiebereich:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2007-06-18

Gebrauchsinformation

PILdicltabsMT3.2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALMIRAL 25MG GASTRO-RESISTANT TABLETS
ALMIRAL 50 MG GASTRO-RESISTANT TABLETS
Diclofenac sodium
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 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 Almiral is and what it is used for
2. What you need to know before you take Almiral
3. How to take Almiral
4. Possible side effects
5. How to store Almiral
6. Contents of the pack and other information
1. WHAT ALMIRAL IS AND WHAT IT IS USED FOR
Diclofenac sodium, the active ingredient in Almiral tablets, is one of
a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and
inflammation.
Almiral tablets relieve pain, reduce swelling and ease inflammation in
conditions affecting the
joints, muscles and tendons including:
-
Rheumatoid arthritis, osteoarthritis, acute gout, ankylosing
spondylitis.
-
Backache, sprains and strains, soft tissue sports injuries, frozen
shoulder, dislocations and
fractures.
-
Tendonitis, tenosynovitis, bursitis.
They are also used to treat pain and inflammation associated with
dental and minor surgery.
PILdicltabsMT3.2
ALMIRAL 25MG TABLETS
CHILDREN (AGED 1-12 YEARS):
-
Treatment of juvenile chronic arthritis.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALMIRAL
DO NOT TAKE ALMIRAL
:
•
If you are allergic to diclofenac sodium, aspirin, ibuprofen or any
other NSAID or any of the
other ingredients of this medicine (listed in section 6). Signs of a
hypersensitivity reaction
include swelling of the face and mouth (angioedema), breathing
problems, c

Fachinformation

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Almiral 25mg gastro-resistant tablets
Almiral 50mg gastro resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Almiral tablets contain either 25mg or 50mg of diclofenac sodium
Excipients with known effect: lactose, sunset yellow (FCF) aluminium
lake (E110), tartrazine
aluminium lake (E102).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro resistant tablets
Almiral tablets are orange, round, convex, for oral administration.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
_ _
_Adults and Elderly _
Relief of all grades of pain and inflammation in a wide range of
conditions, including:
-
Arthritic conditions, rheumatoid arthritis, osteoarthritis, ankylosing
spondylitis, acute gout
-
Acute musculo-skeletal disorders, such as periarthritis (e.g. frozen
shoulder), tendinitis,
tenosynovitis, bursitis
-
Other painful conditions as a result of trauma, such as fracture, low
back pain, sprains and
strains, dislocations, orthopaedic, dental and other minor surgical
procedures.
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_Children (aged 1 - 12 years): _
Almiral
_25mg tablets: _
-
Treatment of juvenile chronic arthritis
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).
Posology
_Adults _
75mg - 150mg daily in two or three divided doses.
The recommended maximum daily dose of diclofenac is 150mg.
_Elderly _
Although the pharmacokinetics of diclofenac are not impaired to any
clinically relevant extent in elderly
patients, non steroidal anti-inflammatory drugs should be used with
particular caution in such patients
who generally are more prone to adverse reactions. In particular it is
recommended that the lowest
effective dosage should be used, in frail elderly patients or those
with a low body weight (see also
section 4.4) and the patient should be monitored for GI bleeding
during NSAID therapy.
_Pae