Vurdon tablets slow release film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

diclofenac (diclofenac sodium)

Available from:

Help S.A.

ATC code:

M01AB05

INN (International Name):

diclofenac (diclofenac sodium)

Dosage:

100mg

Pharmaceutical form:

tablets slow release film-coated

Units in package:

(10/1x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-08-04

Patient Information leaflet

VURDON
®
100 MG SLOW RELEASE FILM-COATED TABLETS
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 phar
-
macist.
•
This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of ill
-
ness 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 leaf
-
let. See section 4.
This medicine will be referred to as Vurdon 100mg tablets
throughout this leaflet.
IN THIS LEAFLET:
1. What Vurdon 100mg tablets are and what they are used for
2. What you need to know before you take Vurdon 100mg
tablets
3. How to take Vurdon 100mg tablets
4. Possible side effects
5. How to store Vurdon 100mg tablets
6. Contents of the pack and other information
1. WHAT VURDON 100MG TABLETS ARE AND WHAT THEY
ARE USED FOR
Diclofenac sodium, the active ingredient in Vurdon 100mg tab
-
lets, is one of a group of medicines called non-steroidal anti-
inflammatory drugs (NSAIDs) (ATC code: M01AB05). NSAIDs
reduce pain and inflammation. Vurdon 100mg tablets are
especially formulated to release the diclofenac sodium slowly.
Vurdon 100mg tablets relieve pain, reduce swelling and ease
inflammation in conditions affecting the joints, muscles and
tendons including:
•
Rheumatoid arthritis, osteoarthritis, acute gout (painful in
-
flammation of the joints especially in the feet and hands),
ankylosing spondylitis (form of spinal arthritis).
•
Backache, sprains and strains, soft tissue sports injuries, fro
-
zen shoulder, dislocations and fractures.
•
Conditions affecting the tendons for example, tendonitis,
tenosynovitis, bursitis.
They are also used to treat pain and inflammation associated
with dental and minor surgery.
Vurdon 100mg tablets are not suitable for children.
2. WHAT YOU NEED TO KNOW BEFORE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Vurdon Slow release film-coated tablets 100 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Diclofenac sodium 100 mg
Excipients(s) with known effect
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Slow release film-coated tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS AND ELDERLY
Relief of all grades of pain and inflammation in a wide range of
conditions, including:
(i) arthritic conditions: rheumatoid arthritis, osteoarthritis,
ankylosing spondylitis,
acute gout,
(ii) acute musculo-skeletal disorders such as periarthritis (for
example frozen
shoulder), tendinitis, tenosynovitis, bursitis,
(iii) other painful conditions resulting from trauma, including
fracture, low back pain,
sprains, strains, dislocations, orthopaedic, dental and other minor
surgery.
CHILDREN
Vurdon 100mg S.R.F.C. tablets are not suitable for children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see section 4.4).
_ADULTS:_ One 100 mg Vurdon S.R.F.C. tablet daily. If necessary, the
daily dosage can
be increased to 150 mg by supplementation with the conventional dosage
forms
containing diclofenac sodium 25 mg or 50 mg.
The recommended maximum daily dose of diclofenac sodium is 150mg.
_SPECIAL POPULATIONS_
_ELDERLY:_ Although the pharmacokinetics of Diclofenac sodium are not
impaired to any
clinically relevant extent in elderly patients, nonsteroidal
anti-inflammatory drugs
should be used with particular caution in such patients who generally
are more prone
to adverse reactions. In particular it is recommended that the lowest
effective dosage
be used in frail elderly patients or those with a low body weight (see
also
precautions) and the patient should be monitored for GI bleeding
during NSAID
therapy.
_RENAL IMPAIRMENT: _Diclofenac is contraindicated in patients with
severe renal
impairment (see section