Voltaren D Tablets Dispersible 50

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DICLOFENAC SODIUM

Available from:

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

ATC code:

M01AB05

INN (International Name):

DICLOFENAC SODIUM 50 mg

Pharmaceutical form:

DISPERSIBLE TABLET

Composition:

DICLOFENAC SODIUM 50 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2005-10-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VOLTAREN® D DISPERSIBLE TABLETS 50MG
(DICLOFENAC FREE ACID)
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR
MEDICINE. 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. 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.
WHAT IS IN THIS LEAFLET
1
WHAT VOLTAREN D ARE, AND WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOLATREN D
3
HOW TO TAKE VOLTAREN D
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE VOLTAREN D
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT VOLTAREN D DISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR
Diclofenac sodium, the active ingredient of Voltaren D, 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. Voltaren D act quickly and so are used
to treat short-term
painful conditions affecting the joints and muscles. They are
especially useful for the
treatment of sprains, strains and back pain and also reduce fever.
They should not be taken
for more than three months. They have no effect on the causes of
inflammation or fever.
Voltaren D can be used for short-term treatment of the following
conditions:
•
Pain and swelling after surgery.
•
Sprains, strains or other injuries.
•
Flare-ups of degenerative pain (arthritis).
•
Gout attacks.
•
Back pain, frozen shoulder, tennis elbow, and other types of
rheumatism.
•
Painful
inflammatory
conditions
in
gynaecology,
including
painful
menstrual
periods.
•
Infections of the ear, nose, or throat.
2
MONITORING DURING YOUR TREATMENT WITH VOLTAREN D
If you have establi

Summary of Product characteristics

VOLTAREN
® D
(DICLOFENAC SODIUM)
Dispersible tablets
SUMMARY OF PRODUCT CHARACTERISTICS
Novartis
Page 2
Voltaren
®
D 50mg Dispersable Tablets
1
NAME OF THE MEDICINAL PRODUCT
VOLTAREN
D
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is diclofenac free acid.
One Voltaren D dispersible tablet contains 46.5 mg of diclofenac free
acid, which is
equivalent to 50 mg of diclofenac sodium.
EXCIPIENTS
Cellulose microcrystalline; sodium carboxymethyl starch;
croscarmellose sodium; silica
aerogel; hydrogenated castor oil; talc.
3
PHARMACEUTICAL FORM
Dispersible tablets, specifically designed to disintegrate quickly in
water, yielding a
tasteless suspension of diclofenac free acid. The suspension is to be
taken orally.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of the following acute conditions:
•
Symptomatic, short-term treatment of post-operative inflammation and
pain (POP),
e.g. following dental or orthopedic surgery.
•
Painful post-traumatic inflammatory states, e.g. due to sprains.
•
Flare-up of osteoarthritis.
•
Acute attacks of gout.
•
Non-articular rheumatism.
•
Painful syndromes of the vertebral column.
•
Painful and/or inflammatory conditions in gynaecology, e.g. primary
dysmenorrhea 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
and the lowest
effective dose given for the shortest possible duration.
Novartis
Page 3
Voltaren
®
D 50mg Dispersable Tablets
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 an