Voltarol 1.16% Emulgel

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Diclofenac diethylammonium

थमां उपलब्ध:

Waymade Healthcare Plc

ए.टी.सी कोड:

M02AA15

INN (इंटरनेशनल नाम):

Diclofenac diethylammonium

डोज़:

11.6mg/1gram

फार्मास्यूटिकल फॉर्म:

Cutaneous gel

प्रशासन का मार्ग:

Cutaneous

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 10030200

सूचना पत्रक

1500
24.04.20[13]
VOLTAROL
®
1.16 % EMULGEL
®
DICLOFENAC DIETHYLAMMONIUM
1.16% W/W GEL
(diclofenac diethylammonium)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY 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 pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
-
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.
Your medicine is available using the above name but will be referred
to as
Voltarol Emulgel throughout this leaflet.
IN THIS LEAFLET
1. What Voltarol Emulgel is and what it is used for
2. What you need to know before you use Voltarol Emulgel
3. How to use Voltarol Emulgel
4. Possible side effects
5. How to store Voltarol Emulgel
6. Contents of the pack and other information
1. WHAT VOLTAROL EMULGEL IS AND WHAT IT IS USED FOR
Voltarol Emulgel contains the active substance diclofenac which
belongs to
a group of medicines called non-steroidal antiinflammatory drugs
(NSAIDs).
It is specially formulated for rubbing into the skin and used to
relieve pain
and reduce inflammation and swelling in painful conditions affecting
the
joints and muscles. Voltarol Emulgel can be used to treat:
-
muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
-
tendonitis (e.g. tennis elbow)
-
osteoarthritis.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VOLTAROL
EMULGEL
DO NOT USE VOLTAROL EMULGEL IF YOU:
-
are in the last 3 months of your pregnancy (see also pregnancy and
lactation section)
-
have an allergy (hypersensitivity) to any of the ingredients in the
product
(see Section 6 ‘What Voltarol Emulgel contains’).
-
have ever had an allergic reaction to diclofenac or other medicines
used
to treat pain, fever or inflammation, such as aspirin (acetylsalicylic
acid) o

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Voltarol 1.16% Emulgel, gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diethylammonium-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate.
1g of Voltarol Emulgel contains 11.6mg of the active substance
diclofenac
diethylammonium, which corresponds to 10mg diclofenac sodium.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Gel for topical administration
Oil emulsion in an aqueous gel. White to off white, soft, homogeneous,
cream
like
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the local symptomatic relief of pain and inflammation in:
-
trauma of the tendons, ligaments, muscles and joints, eg due to
sprains, strains
and bruises
-
localised forms of soft tissue rheumatism
It is recommended that the treatment be reviewed after 14 days in
these indications.
For the treatment of osteoarthritis of superficial joints such as the
knee. In the
treatment of osteoarthritis, therapy should be reviewed after 4 weeks.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only
_Adults and children 14 years and over_: Voltarol Emulgel 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) of
gel
should be applied 3 - 4 times a day.
After application, the hands should be washed unless they are the site
being treated.
_ _
_Use in the elderly_: The usual adult dosage may be
used.
_Children _
_and _
_adolescents: _
There
are
insufficient
data
on
efficacy
and
safety available for the children and adolescents below 14 years of
age (see
also contraindications section 4.3). In children aged 14 years and
over, if this
product is required for more than 7 days for pain relief or if the
symptoms
worsen the patient/parents of the adolescent is/are advised to consult
a
doctor.
Voltarol Emulgel is suitable for the transmission of ultrasound and
may
be used as a couplant in combination with ultrasound therapy.
If large
areas of the body are co