Voltaren 50mg gastro-resistant Tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

DICLOFENAC SODIUM

Tillgänglig från:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC-kod:

M01AB05

INN (International namn):

DICLOFENAC SODIUM 50 mg

Läkemedelsform:

GASTRO-RESISTANT TABLET

Sammansättning:

DICLOFENAC SODIUM 50 mg

Receptbelagda typ:

POM

Terapiområde:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Bemyndigande status:

Authorised

Tillstånd datum:

2005-10-25

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VOLTAREN
® 25 MG GASTRO-RESISTANT TABLETS.
VOLTAREN
® 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 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 any of the 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 Voltaren Tablets are, and what they are used for
2
What you need to know before you take Voltaren Tablets
3
How to take Voltaren Tablets
4
Possible side effects
5
How to store Voltaren Tablets
6
Contents of the pack and other information
1
WHAT VOLTAREN TABLETS ARE, AND WHAT THEY ARE USED FOR
Diclofenac sodium, the active ingredient in Voltaren Tablets, is one
of a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs reduce pain
and inflammation, by blocking the synthesis of the molecules
(prostaglandins) responsible
for inflammation, pain and fever. It has no effect on the causes of
inflammation or fever.
Voltaren Tablets relieve pain, reduce swelling, reduce fever and ease
inflammation in
conditions affecting the joints, muscles and tendons including:
Rheumatoid
arthritis,
osteoarthritis
and
spondyloarthritis,
acute
gout,
ankylosing
spondylitis, and other types of rheumatism
Backache, frozen shoulder, soft tissue sports injuries, sprains and
strains, dislocations and
fractures
Tendonitis, tenosynovitis, bursitis
They are used to treat pain and inflammation associated with dental
and minor surgery.
Voltaren Tablets are used in painful inflammatory conditions in
gynaecology, including
menstrual periods.
They are also used for painful inflammatory infections of the ear,
nose and

Produktens egenskaper

VOLTAREN
(DICLOFENAC SODIUM)
25 mg and 50 mg Gastro-resistant tablets
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2
1
NAME OF THE MEDICINAL PRODUCT
VOLTAREN 25 mg gastro-resistant tablets.
VOLTAREN 50 mg gastro-resistant tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is diclofenac sodium.
One gastro-resistant tablet contains 25 mg or 50 mg of diclofenac
sodium.
EXCIPIENTS
Silica
aerogel,
cellulose
microcryst.,
lactose,
magnesium
stearate,
povidone
sodium
carboxymethyl starch, maize starch, hydroxypropyl methylcellulose,
glyceryl polyethylene
glycol oxystearate, yellow iron oxide (E 172), talc, titanium dioxide,
methacrylic acid
copolymer,
macrogol
8000,
simethicone
emulsion,
purified
water,
ethanol
with
5%
isopropyl alcohol. The 50mg tablets also contain red iron oxide (E
172).
3
PHARMACEUTICAL FORM
Gastro-resistant tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of:
•
Inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis, juvenile
rheumatoid arthritis (JRA), ankylosing spondylitis, osteoarthritis and
spondylarthritis,
painful syndromes of the vertebral column, non-articular rheumatism.
•
Acute attacks of gout.
•
Symptomatic, short-term treatment of post-traumatic and post-operative
pain (POP),
inflammation and swelling, e.g. following dental or orthopaedic
surgery.
•
Painful and/or inflammatory conditions in gynaecology, e.g. primary
dysmenorrhoea or
adnexitis.
•
Symptomatic short-term treatment of pain related to inflammatory
infections of the ear,
nose
or
throat,
e.g.
pharyngotonsillitis,
otitis
(ENT).
In
keeping
with
general
therapeutic principles, the underlying disease should be treated with
anti-infective
basic
therapy,
as
therapeutically
appropriate.
Fever
alone
without
inflammatory
component is not an indication.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
As a general recommendation, the dose should be individually adjusted.
The tablets should
be swallowed whole with liquid, preferably before meals, and must not
be divided or
chewed.