Voltarol Gel Patch 1% medicated plasters

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac epolamine

Available from:

Novartis Consumer Health UK Ltd

ATC code:

M02AA15

INN (International Name):

Diclofenac epolamine

Dosage:

10mg/1gram

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10030200

Summary of Product characteristics

OBJECT 1
VOLTAROL GEL PATCH
Summary of Product Characteristics Updated 02-Apr-2014 |
GlaxoSmithKline Consumer Healthcare
1. Name of the medicinal product
Voltarol
®
Gel Patch 1 %, medicated plaster
2. Qualitative and quantitative composition
Each 10 cm x 14 cm medicated plaster contains diclofenac epolamine
corresponding to 140 mg of
diclofenac sodium (1% w/w).
Excipients with known effect:
methyl parahydroxybenzoate (E218 _):_ 14 mg
propyl parahydroxybenzoate (E216): 7 mg
propylene glycol: 420 mg
Referred to amount per plaster.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Medicated plaster.
White to pale yellow paste spread as a uniform layer onto unwoven
support.
4. Clinical particulars
4.1 Therapeutic indications
Local symptomatic treatment of pain in epicondylitis and ankle sprain.
4.2 Posology and method of administration
Cutaneous use only
_Posology_
Adults and adolescents 16 years and older
• Symptomatic treatment of ankle sprains: 1 application a day
• Symptomatic treatment of epicondylitis: 1 application morning and
evening
_Duration of administration_
Voltarol Gel Patch is to be used for as short as possible depending on
the indication:
• Symptomatic treatment of ankle sprains : 3 days
• Symptomatic treatment of epicondylitis : max. 14 days.
If there is no improvement, during the recommended duration of
treatment or symptoms worsen, a doctor
should be consulted.
_Elderly_
This medication should be used with caution in elderly patients who
are more prone to adverse events.
See also Section 4.4.
_Children and adolescents below the age of 16 years_
There are insufficient data on efficacy and safety available for
children and adolescents below 16 years of
age (see also contraindication section 4.3).
In children aged 16 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 adolescents is/are advised
to consult a doctor.
_Patients with hepatic or renal insufficiency_
For the use of Voltarol Gel