Solacutan 3% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac sodium

Available from:

Mibe Pharma UK Ltd

ATC code:

M02AA15

INN (International Name):

Diclofenac sodium

Dosage:

30mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13080100; GTIN: 5060608410019

Patient Information leaflet

MIBE PHARMA UK LTD
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLACUTAN
® 3% GEL
diclofenac sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE 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 signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT SOLACUTAN GEL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOLACUTAN GEL
3. HOW TO USE SOLACUTAN GEL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE SOLACUTAN GEL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SOLACUTAN GEL IS AND
WHAT IT IS USED FOR
Solacutan gel is a non-steroidal antiinflammatory
dermatological gel. Solacutan gel is applied to the
skin to treat a skin problem known as actinic or
solar keratosis that is caused by long-term
extensive sun exposure.
2. WHAT YOU NEED TO KNOW
BEFORE YOU USE SOLACUTAN GEL
DO NOT USE SOLACUTAN GEL
• if you are allergic to diclofenac or any of the
other ingredients of this medicine (listed in
section 6).
• if you have ever experienced an allergic reaction
such as skin rash (nettle rash), breathing
problems (wheezing) or runny nose (allergic
rhinitis) after taking aspirin or any other non-
steroidal anti-inflammatory medicinal products.
• if you are in the final 3 months of your pregnan-
cy.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
Solacutan gel.
• The possibility of systemic adverse reactions
following application of Solacutan gel cannot be
excluded when the medicinal product is used on
large areas of skin and for a prolonged period of
time. Consult your doctor if you:
– have, or have had in the past, a stomach ulcer
or bleeding from the

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
SOLACUTAN 3% GEL
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of gel contains 30 mg diclofenac sodium.
Excipient with known effect:
Each gram of gel contains 15 mg benzyl alcohol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gel
Clear, transparent, colourless to yellowish
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of actinic keratoses (AKs).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
Solacutan gel should be applied to the affected skin areas twice daily
and smoothed
into the skin gently. The amount used depends on the size of the area
to be treated.
Usually 0.5 g of gel (about the size of a pea) is applied to a 5x5 cm
lesion site. The
maximum daily amount of 8 grams of product allows simultaneous
treatment of up to
200 cm² skin surface area. The usual duration of treatment is 60 to
90 days.
Maximum effect has been observed with treatment durations at the upper
end of this
time range.
Complete healing of the lesion(s) or optimal therapeutic effect may
not be seen for up
to 30 days after completion of therapy.
Elderly people:
The normal dosage can be used.
Children and adolescent:
AK is a condition not generally seen within the paediatric population
and was not
studied. Therefore, dosage recommendations and indications for the use
of have not been established for use in children and adolescent.
Method of administration
Cutaneous use
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Because of the potential for cross-reactions, the gel should not be
used in patients
who have experienced hypersensitivity reactions such as symptoms as
asthma,
allergic rhinitis or urticaria to 2-acetoxybenzoic acid
(acetylsalicylic acid) or any
other non-steroidal anti-inflammatory medicinal products (NSAIDs).
The use of Solacutan gel is contraindicated in the third trimester of
pregnancy (see
section 4.6).
4.4
SPE