Remethan 25mg Gastro-Resistant Tablets

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

DICLOFENAC SODIUM

Dostupné s:

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

ATC kód:

M01AB05

INN (Mezinárodní Name):

DICLOFENAC SODIUM 25 mg

Léková forma:

GASTRO-RESISTANT TABLET

Složení:

DICLOFENAC SODIUM 25 mg

Druh předpisu:

POM

Terapeutické oblasti:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Stav Autorizace:

Authorised

Datum autorizace:

2006-11-02

Informace pro uživatele

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REMETHAN 25 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 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 Remethan is and what it is used for
2.
What you need to know before you take Remethan
3.
How to take Remethan
4.
Possible side effects
5.
How to store Remethan
6.
Contents of the pack and other information
1.
WHAT REMETHAN IS AND WHAT IT IS USED FOR
Diclofenac sodium, the active substance of Remethan, is a
Non-steroidal Anti-inflammatory
Drug (NSAID), belonging to the group of phenylacetic acid.
NSAID’s are drugs used for the relief from the symptoms caused by
arthritis (rheumatism),
such as inflammation, oedema (swelling), rigidity and pain in the
arthroses (joints). The action
of the NSAID’s is due mainly to the inhibition of the composition of
prostaglandins.
These drugs do not cure arthritis. They only help for as long as they
are taken.
Remethan is used in painful conditions of the joints and the muscles.
It is indicated in rheumatoid arthritis, ankylosing spondylitis,
tendinitis (inflammation of one
tendon), synovial tendinitis (inflammation of the sheath of a tendon),
bursitis (inflammation of
one sheath), sprains, and in acute uric arthritis (gout).
Remethan is also indicated in treating pain and inflammation in
surgery (orthopedic, dental and
other operations). In children, Remethan is indica

Charakteristika produktu

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICAL PRODUCT
Remethan 25 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 25 mg diclofenac sodium.
Excipient(s) with known effect
Each gastro-resistant tablet contains 52.8 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow, round, enteric-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Remethan is indicated for the treatment of rheumatoid arthritis,
ankylosing spondylitis,
osteoarthrosis, low back pain, frozen shoulder, tendinitis,
tenosynovitis, bursitis, strains, sprains
and acute gout. Remethan is also indicated for the control of pain and
inflammation in
orthopaedic, dental and other minor surgery.
In children it is indicated for the 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 Special
warnings and precautions for
use).
Posology
_Adults: _
The recommended adult dose of Remethan is 75-150 mg daily given in two
or three divided
doses. The maximum daily dose is 150 mg.
_Children: _
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Children should be given 1-3 mg/kg per day in divided doses.
_Elderly: _
Although the pharmacokinetics of Remethan 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 be used in frail elderly
patients or those with a
low body weight (see also Precautions) and the patient should be
monitored for GI bleeding for
4 weeks following initiation of NSAID therapy.
Method of administration
Oral administration.
4.3
CONTRAINDICATIONS
Hyper