VOLTAREN EMULGEL FORTE 2%

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

DICLOFENAC SODIUM

Saadav alates:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC kood:

M02AA15

Ravimvorm:

GEL

Koostis:

DICLOFENAC SODIUM 2 %

Manustamisviis:

TOPICAL

Retsepti tüüp:

Not required

Valmistatud:

GSK CONSUMER HEALTHCARE SARL, SWITZERLAND

Terapeutiline ala:

DICLOFENAC

Näidustused:

Local treatment of pain, inflammation and swelling in adults and adolescents aged 12 years and over due to:• Soft tissue injuries: Pain and inflammation and swelling in trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises and/or backache (e.g. sports injuries).• Localized forms of soft tissue rheumatism such as tendonitis (e.g.tennis elbow), bursitis.• By physician's order - Pain caused by osteoarthrosis of the peripheral joints, as of the knee or fingersThe gel should not be used for more than 14 days

Loa andmise kuupäev:

2019-08-31

Infovoldik

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This preparation is dispensed without a doctor's prescription
VOLTAREN EMULGEL FORTE 2%
Active ingredient and its quantity in a dose unit:
Diclofenac diethylamine 2.32%
(Corresponds to Diclofenac sodium 2.0%)
For a list of inactive ingredients and allergens in the preparation
– see section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any other questions, refer to
the doctor or the pharmacist. Use the preparation according to the
instructions in section 3 – “How
should you use the medicine?” in this leaflet. You should use the
medicine properly. Consult the
pharmacist if you need more information. Refer to the doctor if signs
of the ailment (symptoms)
worsen or do not improve after 7 days.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for use without a doctor’s order for the
following indications:
Local treatment of pain, inflammation and swelling in adults and
adolescents over 12 years of age, in
the following cases:
Trauma of the tendons, ligaments, muscles and joints due to sprain,
strain, bruise and/or back pain
(e.g., sports injuries).
Local soft tissue rheumatic diseases, such as tendonitis (e.g., tennis
elbow) and bursitis.
DO NOT USE FOR MORE THAN 14 DAYS.
According to a doctor’s order, the medicine is intended for
treatment of pain due to osteoarthritis of
the joints, such as the knee or fingers.
THERAPEUTIC CLASS:
Voltaren Emulgel Forte 2% contains the active ingredient diclofenac,
which belongs to the class of
non-steroidal anti-inflammatory drugs (NSAIDs). It has a special
formulation which enables it to be
rubbed into the skin.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE PREPARATION IF:
•
You are sensitive (allergic) to the active ingredient (diclofenac
diethylamine) or to other medicines
for treatment of pain, fever or inflammation, such as ibuprofen or
aspirin (a medicine used to treat
blo

Toote omadused

VOLTAREN EMULGEL FORTE 2%
1 NAME OF THE MEDICINAL PRODUCT
Voltaren Emulgel Forte 2%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of Voltaren Emulgel Forte 2% contains 23.2 mg of diclofenac
diethylamine,
which corresponds to 20 mg of diclofenac sodium.
Excipients:
Propylene glycol (50 mg/g gel)
Butyl hydroxytoluene (0.2 mg/g gel).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
White to practically white, soft, homogeneous, cream-like gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local treatment of pain, inflammation and swelling in adults and
adolescents aged 12
years and over due to:
• Soft tissue injuries: pain and inflammation and swelling in trauma
of the tendons,
ligaments, muscles and joints, e.g. due to sprains, strains and
bruises and/or
backache (e.g. sports injuries).
• Localized forms of soft tissue rheumatism such as tendonitis (e.g.
tennis elbow),
bursitis.
• By physician's order - pain caused by osteoarthrosis of the
peripheral joints, as of
the knee or fingers.
The gel should not be used for more than 14 days
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS AGED 12 YEARS AND OVER:
Voltaren Emulgel Forte 2% provides lasting pain relief of up to 12
hours (applied 2
times daily - morning and evening). It should be rubbed gently into
the skin at the
affected area.
The amount needed depends on the size of the painful area: 2 g to 4 g
(a quantity
ranging in size from a cherry to a walnut) of gel 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. The duration of treatment depends on the indication and
clinical
response. The gel should not to be used for more than 14 days for
soft-tissue injuries
or soft tissue rheumatism, or 21 days for arthritis pain, unless
recommended by a
doctor.
When used without medical prescription, patients should consult their
doctor if the
condition does not improve within 7 days, or if it gets worse.
2
PAEDIATRIC PATIENTS (