Vilonit

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DICLOFENAC SODIUM

Available from:

Kleva S.A. 189 Parnithos Avenue, 13671 Acharnai, Attiki, Greece

ATC code:

M02AA15

INN (International Name):

DICLOFENAC SODIUM 1 % (W/W)

Pharmaceutical form:

GEL

Composition:

DICLOFENAC SODIUM 1 % (W/W)

Prescription type:

OTC

Therapeutic area:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Authorization status:

Authorised

Authorization date:

2006-03-29

Patient Information leaflet

VILONIT
GEL- Version 1-01/2012
1
PATIENT INFORMATION LEAFLET
VILONIT
® GEL 1%
DICLOFENAC DIETHYLAMMONIUM
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR
MEDICINE. IT CONTAINS
IMPORTANT INFORMATION.
VILONIT
®
can be given without a prescription from your Physician. You should
use VILONIT
®
carefully in order to have the best results.
-
Keep this leaflet in a safe place. You may need to read it again.
-
If you have any questions or if there is something you don’t
understand, please ask your
doctor or pharmacist.
-
You should contact your doctor if your symptoms get worse or do not
get better after 14
days.
-
If any of the side effects get serious or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1.
What VILONIT
®
is and what it is used for
2.
What you should know before you use VILONIT
®
3.
How to use VILONIT
®
4.
Possible side effects
5.
How to store VILONIT
®
6.
Other information
1
1
.
.
W
W
H
H
A
A
T
T VILONIT
®
®
I
I
S
S
A
A
N
N
D
D
W
W
H
H
A
A
T
T
I
I
T
T
I
I
S
S
U
U
S
S
E
E
D
D
F
F
O
O
R
R
VILONIT
® IS FORMULATED FOR TOPICAL ADMINISTRATION ONLY.
VILONIT
®
CONTAINS
DICLOFENAC,
AN
ACTIVE
SUBSTANCE
WHICH
BELONGS
TO
A
FAMILY
OF
MEDICINES CALLED NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS).
VILONIT
® CAN RELIEVE THE SYMPTOMS OF INFLAMMATION, SUCH AS SWELLING AND PAIN,
BUT IT
HAS NO EFFECT ON THE CAUSES OF THE INFLAMMATION.
It is used, as potentially effective, for the local symptomatic relief
of pain and inflammation in:

trauma of the tendons, ligaments, muscles and joints, e.g. due to
sprains, strains and bruises

localised forms of soft tissue rheumatism (tenosynovitis, scalenus
syndrome, thylacitis and
periarthritis)

For the treatment of osteoarthritis of superficial joints
It is recommended that the treatment should not be continued more than
14 days.
VILONIT
GEL- Version 1-01/2012
2
2.
WHAT YOU SHOULD KNOW BEFORE YOU USE VIILONIT
®
DO NOT USE VILONIT
®
:
If you have ever had allergy (hypers

Summary of Product characteristics

Page
1
of
8
1.
NAME OF THE MEDICINAL PRODUCT
VILONIT
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diethylammonium-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate.
1g of VILONIT
®
contains 11.6mg of the active substance diclofenac diethylammonium,
which corresponds to 10mg diclofenac sodium.
For full list of excipients, see section 6.1 “List of excipients”.
3.
PHARMACEUTICAL FORM
GEL
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
VILONIT
®
is indicated for the local symptomatic relief of pain and inflammation
in:
-
trauma of the tendons, ligaments, muscles and joints, e.g. due to
sprains, strains and
bruises
-
localised
forms
of
soft
tissue
rheumatism
(tenosynovitis,
scalenus
syndrome,
thylacitis and periarthritis)
-
localised indication of degenerated arthropathy (osteoarthritis of
peripheral joints
and spine).
Treatment should not be continued for more than two weeks.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
VILONIT
®
should be rubbed gently into the skin
.
Depending on the size of the affected
site to be treated 2-4g (a circular shaped mass approximately
2.0-2.5cm in diameter)
should be applied 3 - 4 times a daily
.
After application, the hands should be washed
unless they are the site being treated.
The duration of the treatment depends on the indications and the
patient’s response. It is
recommended not to continue the treatment after two weeks.
Page
2
of
8
Children
Dosing schemes and indications for the use of VILONIT
®
on children have not been
determined, therefore its use is not recommended.
4.3.
CONTRAINDICATIONS
Hypersensitivity
to
diclofenac,
acetylsalicylic
acid
and
other
non-steroidal
anti-
inflammatory agents, propylene glycol, isopropanol or any of the other
ingredients of
VILONIT
®
.
VILONIT
®
is also contra-indicated to patients with or without chronic asthma in
whom
attacks of asthma, urticaria or acute rhinitis are precipitated by
aspirin or other non-
steroidal anti-inflammatory agents.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS
Warnings
The likelihood of systemic side