Voltaren 100 mg suppositories for adults

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Disponibil de la:

NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta

Codul ATC:

M01AB05

INN (nume internaţional):

DICLOFENAC SODIUM 100 mg

Forma farmaceutică:

SUPPOSITORY

Compoziție:

DICLOFENAC SODIUM 100 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Rezumat produs:

Licence number in the source country: Austria - 1-16308

Statutul autorizaţiei:

Authorised

Data de autorizare:

2023-12-20

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VOLTAREN 100 MG SUPPOSITORIES FOR ADULTS
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 menstrual periods.
•
They are also used for painful inflammatory in

Caracteristicilor produsului

VOLTAREN
(DICLOFENAC SODIUM)
Suppositories
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
VOLTAREN 100 mg suppositories for
adults
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is diclofenac sodium.
One suppository contains 100 mg of diclofenac sodium. Excipients
Hard fat.
3
PHARMACEUTICAL FORM
Suppositories. White to yellowish, torpedo-shaped suppositories with a
smooth surface
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).
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 should generally be divided into 2 to 3 doses. To
suppress nocturnal pain
and morning stiffness, treatment with tablets during t