Voltarol Pain-eze 1.16% Emulgel

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Diclofenac diethylammonium

Tilgængelig fra:

Haleon UK Ltd

ATC-kode:

M02AA15

INN (International Name):

Diclofenac diethylammonium

Dosering:

11.6mg/1gram

Lægemiddelform:

Cutaneous gel

Indgivelsesvej:

Cutaneous

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 10030200; GTIN: 5012131743003 5051562005908 5051562032102 5051562032805 5051562032904

Indlægsseddel

Pharma code XXX
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 Back and Muscle 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 Back and Muscle Pain Relief 1.16% Gel
is and what it is used for
2.
Before you use Voltarol Back and Muscle Pain Relief
1.16% Gel
3.
How to use Voltarol Back and Muscle Pain Relief
1.16% Gel
4.
Possible side effects
5.
How to store Voltarol Back and Muscle Pain Relief
1.16% Gel
6.
Further information
1.
WHAT VOLTAROL BACK AND MUSCLE PAIN RELIEF
1.16% GEL IS AND WHAT IT IS USED FOR
Voltarol Back and Muscle 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 Back and
Muscle 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)
2.
BEFORE YOU USE VOLTAROL BACK AND MUSCLE PAIN
RELIEF 1.16% GEL
DO NOT USE VOLTAROL BACK AND MUSCLE PAIN RELIEF
1.16% GEL IF YOU:
• have an allergy (hypersensitivity) to any of the
ingredients in the product (see Section 6 ‘What Voltarol
Back and Muscle Pain Relief 1.16% Gel contains’).
• have ever had an allergic reaction to diclofenac or other
medicines used to treat pain, fever or inflammation, such
as aspirin (acetylsalicyclic acid) or ibupro

Produktets egenskaber

1
NAME OF THE MEDICINAL PRODUCT
Voltarol Pain-eze Emulgel
Voltarol Back and Muscle Pain Relief 1.16% Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diethylammonium-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate.
100g of this medicine 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.
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 For cutaneous use only
_ _
_Adults and children aged 14 years and over_: this medicine 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.
A period of at least 4 hours should be left between applications. The
dose should
not be applied more than 4 times in a 24 hour period.
If symptoms persist after 7 days or get worse at any time, medical
advice should
be sought.
Not to be used for more than 7 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 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.
4.3
CONTRAINDICATIONS
•
Patients with or without chronic asthma in whom attacks of asthma,
angioedema, urticaria
or acute rhinitis are precipitated by acetylsalicylic acid (aspirin)
or other non-steroidal
anti- infla