Voltaren Retard 75 mg Modified-release tablet

Country: Malta

Language: English

Source: Medicines Authority

Available from:

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

ATC code:

M01AB05

INN (International Name):

DICLOFENAC SODIUM 75 mg

Pharmaceutical form:

MODIFIED-RELEASE TABLET

Composition:

DICLOFENAC SODIUM 75 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Product summary:

Licence number in the source country: Greece - 8546-2-2007

Authorization status:

Authorised

Authorization date:

2023-12-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VOLTAREN RETARD 75
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 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,
including menstrual periods.
Monitoring during you

Summary of Product characteristics

VOLTAREN
(DICLOFENAC SODIUM)
Modified-release tablets
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2
1
TRADE NAME OF THE MEDICINAL PRODUCT
VOLTAREN RETARD 75 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is diclofenac sodium.
One modified-release tablet contains 75 mg of diclofenac sodium.
The active ingredient of these forms of Voltaren is
sodium-[o[(2,6-dichlorophenyl)-amino]-
phenyl]-acetate (=diclofenac sodium).
EXCIPIENTS
Cetyl
alcohol;
Magnesium
stearate;
polyvidone;
silicon
dioxide
(aerosil®
200);
sucrose;
hypromellose; iron oxide red (E172); macrogol
®
8000; polysorbate 80; sucrose; Talc purified;
titanium dioxide (E171); iron oxide black (E172) Shellac (Opacode
®
S-1-17823), propylene
glycol (E1520) Ammonium hydroxide 28%
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 RETARD 75 mg.
In milder cases, as well as for long-term therapy, 75 to 100 mg