Voltarol 12 Hour Emulgel P 2.32% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac diethylammonium

Available from:

Haleon UK Ltd

ATC code:

M02AA15

INN (International Name):

Diclofenac diethylammonium

Dosage:

23.2mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10030200; GTIN: 5051562030603 5051562030702 5051562033802

Patient Information leaflet

Pharma code XXX
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use Voltarol 12 Hour Joint Pain Relief 2.32% Gel
exactly as described in this leaflet or as your pharmacist
has told you.
You should check with your doctor or pharmacist if you
are not sure.
• This medicine is available without prescription.
However, you still need to use Voltarol 12 Hour Joint
Pain Relief 2.32% Gel carefully to get the best results
from it. Note that this leaflet is revised on a regular
basis with the latest information on your medicine.
Please refer to the date at the end of the leaflet.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or
advice.
• You must contact a doctor if your signs of illness
worsen or do not improve after 7 days.
• If you get any side effects which worry you (even side
effects not listed in this leaflet), talk to your doctor or
pharmacist.
IN THIS LEAFLET
1.
What Voltarol 12 Hour Joint Pain Relief 2.32% Gel is
and what it is used for
2.
What you need to know about Voltarol 12 Hour Joint
Pain Relief 2.32% Gel
3.
How to use Voltarol 12 Hour Joint Pain Relief 2.32% Gel
4.
Possible side effects
5.
How to store Voltarol 12 Hour Joint Pain Relief 2.32% Gel
6.
What is in the pack and further information
1. WHAT VOLTAROL 12 HOUR JOINT PAIN RELIEF
2.32% GEL IS AND WHAT IT IS USED FOR
Voltarol 12 Hour Joint Pain Relief 2.32% Gel contains the
active substance diclofenac which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). It is specially formulated for rubbing into the
skin.
Voltarol 12 Hour Joint Pain Relief 2.32% Gel is used to
relieve pain and reduce inflammation and swelling in a
number of painful conditions affecting the joints and
muscles. Voltarol 12 Hour Joint Pain Relief 2.32% Gel
can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries), relieving pain and helping
recovery back to normal function;
• tendonit

Summary of Product characteristics

OBJECT 1
VOLTAROL 12 HOUR EMULGEL P
Summary of Product Characteristics Updated 02-Aug-2017 |
GlaxoSmithKline Consumer Healthcare
1. Name of the medicinal product
Voltarol® 12 Hour Emulgel® P 2.32% Gel
Voltarol® Extra Strength Emulgel® P 2.32% Gel
Voltarol 12 Hour Joint Pain Relief 2.32% Gel
2. Qualitative and quantitative composition
Diethylammonium-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate.
100g of this medicine contains 2.32g of the active substance
diclofenac diethylammonium, which
corresponds to 2g diclofenac sodium.
Excipients:
Propylene glycol (50 mg/g gel)
Buthylhydroxytoluene (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
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
4.2 Posology and method of administration
_Adults and children 14 years and over_: The gel 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 2 times a day (preferably morning and evening). The
maximum daily dose is 8g.
Therefore the maximum weekly dose is 56g.
The gel can be used for up to 14 days under pharmacy supervision.
After application, the hands should be washed unless they are the site
being treated.
If symptoms do not improve by day 7, or if they worsen within the
first 7 days, a consultation with a
doctor is recommended. Do not use for more than 14 days unless
recommended by a doctor.
_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 requ