Voltaren Retard 100 Modified-release Tablets 100mg

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

DICLOFENAC SODIUM

Saadav alates:

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

ATC kood:

M01AB05

INN (Rahvusvaheline Nimetus):

DICLOFENAC SODIUM 100 mg

Ravimvorm:

MODIFIED-RELEASE TABLET

Koostis:

DICLOFENAC SODIUM 100 mg

Retsepti tüüp:

POM

Terapeutiline ala:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Volitamisolek:

Authorised

Loa andmise kuupäev:

2005-10-25

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VOLTAREN
® SR 75 AND
VOLTAREN
® RETARD 100MG
DICLOFENAC SODIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR
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 affects 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
SR Tablets and Voltaren Retard Tablets are specially formulated to
release the diclofenac
sodium slowly.
•
Voltaren Tablets relieve pain, reduce swelling, reduce fever and ease
inflammation in
conditions affecting the joints, muscles and tendons including:
•
Rheumatoid arthritis, osteoarthritis and spondyolarthritis, 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

Toote omadused

VOLTAREN
®
(DICLOFENAC SODIUM)
Modified-release tablets
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2
1
TRADE NAME OF THE MEDICINAL PRODUCT
VOLTAREN SR 75
VOLTAREN Retard 100
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is diclofenac sodium.
One modified-release tablet contains 75 mg or 100 mg of diclofenac
sodium.
EXCIPIENTS
Silica
aerogel,
cetyl
alcohol,
povidone,
magnesium
stearate,
sucrose,
hydroxypropyl
methylcellulose, polysorbate 80, talc, titanium dioxide, red iron
oxide (E 172), macrogol 8000
purified water, ethanol with 5% isopropyl.
3
PHARMACEUTICAL FORM
Modified-release tablets with prolonged release of the active
substance.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of:
•
Inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis, ankylosing
spondylitis, osteoarthritis and spondylarthritis, painful syndromes of
the vertebral column,
non-articular rheumatism.
•
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.
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 with
meals and must not be
divided or chewed.
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).
Page 3
GENERAL TARGET POPULATION: ADULTS
The recommended initial daily dose is 100 to 150 mg, administered as 1
tablet of Voltaren
Retard 100 mg or as 2 tablets of Voltaren SR 75 mg.
In milder cases, as well as for long-term therapy, 75 to 100 mg daily
is usually sufficient.
Where the symptoms are most pronounced during the night or in the
morning, Voltaren SR 75
mg and Voltaren Retard 100 mg should preferably be taken in the
evening.
The t