Vurdon tablets gastro-resistant

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

diclofenac (diclofenac sodium)

Διαθέσιμο από:

Help S.A.

Φαρμακολογική κατηγορία (ATC):

M01AB05

INN (Διεθνής Όνομα):

diclofenac (diclofenac sodium)

Δοσολογία:

50mg

Φαρμακοτεχνική μορφή:

tablets gastro-resistant

Μονάδες σε πακέτο:

(20/2x10/) in blister

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-08-04

Φύλλο οδηγιών χρήσης

VURDON
®
50 MG GASTRO-RESISTANT 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 50mg tablets
throughout this leaflet.
IN THIS LEAFLET:
1. What Vurdon 50mg tablets are and what they are used for
2. What you need to know before you take Vurdon 50mg tab
-
lets
3. How to take Vurdon 50mg tablets
4. Possible side effects
5. How to store Vurdon 50mg tablets
6. Contents of the pack and other information
1. WHAT VURDON 50MG TABLETS ARE AND WHAT THEY
ARE USED FOR
Diclofenac sodium, the active ingredient in Vurdon 50mg tab
-
lets, is one of a group of medicines called non-steroidal anti-
inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflam
-
mation.
Vurdon 50mg 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VURDON
50MG TABLETS
DO NOT TAKE VURDON 50MG TABLETS IF:
•
you are allergic to diclofenac sodium, aspirin, ibuprofen or
any other NSAID, or to any of the other ing

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Vurdon 50mg Gastro-resistant tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Diclofenac sodium 50 mg
Excipients(s) with known effect
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gastro-resistant 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 50 mg tablets are not suitable for children aged under 18.
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_: 75 mg to 150 mg daily in two or three divided doses.
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 4.3). No specific studies have been carried
out in patients
with renal impairment, therefore, no specific dose adjustment
recommendations can
be made. Caution