Voltaren 100mg suppositories

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

DICLOFENAC SODIUM

थमां उपलब्ध:

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

ए.टी.सी कोड:

M01AB05

INN (इंटरनेशनल नाम):

DICLOFENAC SODIUM 100 mg

फार्मास्यूटिकल फॉर्म:

SUPPOSITORY

रचना:

DICLOFENAC SODIUM 100 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2005-10-25

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VOLTAREN
® 12.5 MG SUPPOSITORIES.
VOLTAREN
® 50 MG SUPPOSITORIES.
VOLTAREN
® 100 MG SUPPOSITORIES.
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 Voltaren suppositories are, and what they are used for
2
What you need to know before you take Voltaren Suppositories
3
How to take Voltaren Suppositories
4
Possible side effects
5
How to store Voltaren Suppositories
6
Contents of the pack and other information
1
WHAT VOLTAREN SUPPOSITORIES ARE, AND WHAT THEY ARE USED FOR
Diclofenac sodium, the active ingredient in Voltaren Suppositories, 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 Suppositories relieve pain, reduce swelling, reduce fever and
ease inflammation
in conditions affecting the joins, 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 Suppositories are used in painful inflammatory conditions in
gynaecology,
including menstrua

उत्पाद विशेषताएं

VOLTAREN
®
(DICLOFENAC SODIUM)
Suppositories
SUMMARY OF PRODUCT CHARACTERISTICS
Novartis
Page 2
Voltaren® 12.5mg, 50mg & 100mg suppositories
1
NAME OF THE MEDICINAL PRODUCT
VOLTAREN12.5 mg suppositories.
VOLTAREN 50 mg suppositories.
VOLTAREN
100 mg suppositories.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is diclofenac sodium.
One suppository contains 12.5 mg, 50 mg, or 100 mg of diclofenac
sodium.
Excipients
Hard fat.
3
PHARMACEUTICAL FORM
Suppositories.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of:
•
Inflammatory
and
degenerative
forms
of
rheumatism:
rheumatoid
arthritis
(JRA),
juvenile
rheumatoid
arthritis,
ankylosing
spondylitis,
osteoarthritis
and
spondyloarthritis, 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.
•
Migraine attacks.
•
Symptomatic short-term treatment of pain related to painful
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.
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).
Novartis
Page 3
Voltaren® 12.5mg, 50mg & 100mg suppositories
GENERAL TARGET POPULATION: ADULTS
The recommended initial daily dose is 100 to 150 mg. In milder cases,
as well as for long-
term therapy, 75 to 100 mg daily is usually sufficient.
The total daily dose sh