Voltarol 1.16% Emulgel P

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:

11.6mg/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: 5012131741801 5012131742600 5051562015808 5051562017208

Patient Information leaflet

Nyon Leaflet
Pharma code XXXX
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 Voltarol Osteoarthritis Joint Pain
Relief 1.16% Gel carefully to get the best results from it.
•
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 symptoms worsen or do not
improve within 7 days.
•
If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET
1.
What Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel is and
what it is used for
2.
Before you use Voltarol Osteoarthritis Joint Pain Relief
1.16% Gel
3.
How to use Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel
4.
Possible side effects
5.
How to store Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel
6.
Further information
1. WHAT VOLTAROL OSTEOARTHRITIS JOINT PAIN RELIEF
1.16% GEL IS AND WHAT IT IS USED FOR
Voltarol Osteoarthritis Joint Pain Relief 1.16% 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 and is used to relieve pain and
reduce inflammation and swelling in painful conditions affecting
the joints and muscles. Voltarol Osteoarthritis Joint Pain Relief
1.16% Gel can be used to treat:
•
muscle and joint injuries (e.g. sprains, strains, bruises,
backache, sports injuries)
•
tendonitis (e.g. tennis elbow)
•
mild arthritis (symptoms of mild arthritis include joint pain at
rest, joint pain on movement, joint swelling or stiffness (after
sleep or long rest)).
2. BEFORE YOU USE VOLTAROL OSTEOARTHRITIS JOINT
PAIN RELIEF 1.16% GEL
DO NOT use Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel
if you:
•
have an allergy (hypersensitivity) to any of the ingredients in the
product (see Section 6 ‘What Voltar

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Voltarol Emulgel P or Voltarol Osteoarthritis Joint Pain Relief 1.16%
Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diethylammonium-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate.
100g of Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel contains
1.16g of the
active substance diclofenac diethylammonium, which corresponds to 1g
diclofenac
sodium.
For excipients, see section 6.1
3
PHARMACEUTICAL FORM
Gel for topical administration.
White to practically 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, e.g. due to
sprains,
strains and bruises
-
localised forms of soft tissue rheumatism
For the relief of pain of non-serious arthritic conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only
_ _
_Adults and children 14 years and over_: The gel should be rubbed
gently into the skin 3-4
times daily. 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. The
maximum daily dose is 16g. Therefore the maximum weekly dose is 112g.
For arthritis pain it may be necessary to apply the gel for up to 7
days (to allow its effect to
build up on the joint) before an improvement in pain is noticed. 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. Consultation with a doctor is
recommended if more than two
major joints in the body are affected. 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 ye