Voltaren Emulgel 11.6 mg/g emulsion-gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DICLOFENAC SODIUM

Available from:

Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece

ATC code:

M02AA15

INN (International Name):

DICLOFENAC SODIUM 10 mg/g

Pharmaceutical form:

GEL

Composition:

DICLOFENAC SODIUM 10 mg/g

Prescription type:

OTC

Therapeutic area:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Authorization status:

Authorised

Authorization date:

2007-04-20

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VOLTAREN EMULGEL
GEL
DICLOFENAC DIETHYLAMINE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Voltaren
Emulgel carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 14 days.
•
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Voltaren Emulgel is and what it is used for
2
What you need to know before you use Voltaren Emulgel
3
How to use Voltaren Emulgel
4
Possible side effects
5
How to store Voltaren Emulgel
6
Further information
1
WHAT VOLTAREN EMULGEL IS AND WHAT IT IS USED FOR
Voltaren Emulgel is specially formulated for topical dermatological
use. The active substance
is diclofenac which belongs to a group of medicines called
non-steroidal anti-inflammatory
drugs (NSAIDs).
Voltaren Emulgel provides relief from the symptoms of inflammation,
such as swelling and
pain.
IT CAN BE USED FOR:
Symptomatic treatment of:
•
Post-traumatic inflammation of tendons, ligaments, muscles and joints,
due to
sprains, strains, joint dislocations and contusions;
•
Localised forms of soft-tissue rheumatism (tendosynovitis,
shoulder-hand syndrome,
bursitis, and periarthritis)
•
Localised forms of degenerative rheumatism (osteoarthritis of the
peripheral joints
and vertebral column)
Treatment should not be continued beyond 2 weeks.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE VOLTAREN EMULGEL
DO NOT USE VOLTAREN EMULGEL
•
If you are allergic (hypersensitive) to diclofenac, acetylsalicylic
acid and other non-
steroidal anti-inflammatory drugs, propylene glycol, isopropanol or
any of the other
ingredients of this medicine (listed at the end of th

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Voltaren Emulgel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gr of Voltaren Emulgel contains 11.6 mg of diclofenac diethylamine,
which corresponds to 10 mg
diclofenac sodium (1%).
Excipient(s): Propylene glycol.
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Emulsion-gel
White to practically white, homogeneous, cream-like gel.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of:
- Post-traumatic inflammation of the tendons, ligaments, muscles and
joints, e.g. due to
sprains, strains, joint dislocations, contusions;
- Localised forms of soft tissue rheumatism (tenosynovinitis,
shoulder-hand syndrome,
bursitis and periarthropathy);
- Localised forms of degenerative rheumatism (osteoarthritis of the
peripheral joints and of
the vertebral column)
Therapy should be discontinued after two weeks of drug administration
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS AND ADOLESCENTS AGED 14 YEARS AND OVER: _
• DOSAGE
Voltaren Emulgel 1.16% should be applied locally to the skin 3 or 4
times daily and should be rubbed
gently. The amount needed depends on the size of the painful area: 2 g
to 4 g Voltaren Emulgel (a
quantity ranging in size from a cherry to a walnut) is sufficient to
treat an area of about 400-800 cm².
After application, the hands should be washed, unless they are the
site being treated.
• TREATMENT DURATION
The duration of treatment depends on the indication and clinical
response.
2
IT IS RECOMMENDED THAT TREATMENT SHOULD NOT BE CONTINUED BEYOND 2
WEEKS
When used without medical prescription for any of the above
indications, patients should consult their
doctor if the condition does not improve within 7 days, or if it gets
worse.
CHILDREN AND ADOLESCENTS BELOW 14 YEARS:
There are insufficient data on efficacy and safety available for
children and adolescents below 14 years
and it is not recommended to use this medicine (see also
contraindications section 4.3)
In adolescents aged 14