VOLTAREN EMULGEL 1%

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DICLOFENAC SODIUM

Available from:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC code:

M02AA15

Pharmaceutical form:

GEL

Composition:

DICLOFENAC SODIUM 1 %

Administration route:

TOPICAL

Prescription type:

Not required

Manufactured by:

NOVARTIS CONSUMER HEALTH SA, SWITZERLAND

Therapeutic area:

DICLOFENAC

Therapeutic indications:

Self medication for the following indications: Local treatment of pain, inflammation and swelling due to: • 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 Physicians order :• Pain caused by osteoarthrosis of the peripheral joints, as of the knee or fingers

Authorization date:

2018-03-12

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed without a doctor’s prescription
VOLTAREN EMULGEL 1%
ACTIVE INGREDIENT AND ITS QUANTITY IN A DOSE UNIT:
Diclofenac Sodium (as Diclofenac Diethylamine) 1%
Additional ingredients are listed in 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.
You should use the medicine properly. Consult the pharmacist if you
have further questions. 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?
Self-treatment for the following indications:
Local treatment of pain, inflammation and swelling due to:
•
Pain, inflammation and swelling due to injury to: tendons, ligaments,
muscles and joints, e.g. due
to sprains, strains, bruises and/or back pain (such as: sports
injuries).
•
Localized forms of soft tissue rheumatism, such as tendinitis (e.g.
tennis elbow), bursitis.
According to a doctor’s order:
Pain due to osteoarthritis of the peripheral joints, such as the knee
or fingers.
THERAPEUTIC CLASS
Voltaren emulgel contains the active ingredient diclofenac, which
belongs to a group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs).
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or any of the
additional components the
medicine contains (See section 6).
•
You are in the last trimester of your pregnancy (see also the
pregnancy and breastfeeding
section).
•
You have previously had an allergic reaction to diclofenac or to other
medicines for treatment of
pain, fever or inflammation, such as: aspirin (acetylsalicylic acid)
or ibuprofen.
Symptoms of an allergic reaction to these medicines may include:
asthma, wheezing or
shortness of breath; skin rash or urticaria; swelling of the face or
tongue; ru

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Voltaren Emulgel 1 % gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of Voltaren Emulgel contains 11.6 mg of the active substance
diclofenac diethylamine, which
corresponds to 10 mg of diclofenac sodium. For a full list of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel for topical administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Self medication for the following indications:
Local treatment of pain, inflammation and swelling due to:

Pain and inflammation and swelling in trauma of the tendons,
ligaments, muscles and joints,
e.g. due to sprains, strains and/or bruises and/or backache (e.g.
sports injuries);

Localized forms of soft tissue rheumatism such as tendonitis (e.g.
tennis elbow), bursitis.
By Physicians order:

Pain caused by osteoarthritis of the peripheral joints, as of the knee
or fingers.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS AGED 12 YEARS AND OVER:
Voltaren Emulgel should be applied over the affected area 3 or 4 times
daily and rubbed gently into
the skin. 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.
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 unless recommended
by a doctor, or 21 days for arthritis pain
When used without medical prescription, patients should consult their
doctor if the condition does
not improve within 7 days, or if it gets worse.
CHILDREN:
Voltaren Emulgel is not recommended for use in children below 12 years
of age.
THE ELDERLY:
The usual adult dosage may be used.
4.3.
CONTRAINDICATIONS

Patients with or without chronic asthma in whom attacks of asthma,
urticaria, or acute rhinitis
are precipitated by acetylsalicy