Actikerall 5mg/g / 100mg/g cutaneous solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluorouracil; Salicylic acid

Available from:

Almirall Ltd

ATC code:

L01BC52

INN (International Name):

Fluorouracil; Salicylic acid

Dosage:

5mg/1gram ; 100mg/1gram

Pharmaceutical form:

Cutaneous solution

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13080100; GTIN: 4042762012620

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTIKERALL 5 MG/G + 100 MG/G CUTANEOUS SOLUTION
Fluorouracil + Salicylic acid
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.
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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 of the 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 Actikerall is and what it is used for
2.
What you need to know before you use Actikerall
3.
How to use Actikerall
4.
Possible side effects
5.
How to store Actikerall
6.
Content of the pack and other information
1.
WHAT ACTIKERALL IS AND WHAT IT IS USED FOR
Actikerall contains two active substances, fluorouracil and salicylic
acid.
Fluorouracil belongs to a group of medicines known as antimetabolites,
which inhibit the growth of cells
(cytostatic agent). Salicylic acid is a substance to soften hard skin.
Actikerall is a solution to treat actinic keratosis (grade I/II) in
adult patients with a healthy immune system.
Actinic keratoses are small crusty, scaly or crumbly patches of skin.
They may be red or light brown or have
the same colour as your skin. They may be dry or rough to touch and
they are sometimes easier to feel than
see.
These skin changes commonly occur in people that have had a lot of sun
exposure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ACTIKERALL
DO NOT USE ACTIKERALL
-
if you are allergic to fluorouracil, salicylic acid or any of the
other ingredients of this medicine (listed
in section 6).
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while breast-feeding.
-
during pregnancy, and if there is a possibility that you might be
pregnant.
-
if you have kidney problems.
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if it could come into contact with the eyes, the inside of the m

Summary of Product characteristics

OBJECT 1
ACTIKERALL 5MG/G + 100MG/G CUTANEOUS SOLUTION
Summary of Product Characteristics Updated 18-Apr-2017 | Almirall
Limited
1. Name of the medicinal product
Actikerall 5 mg/g + 100 mg/g Cutaneous Solution
2. Qualitative and quantitative composition
1 g (= 1.05 ml) cutaneous solution contains 5 mg of fluorouracil and
100 mg of salicylic acid.
Excipient with known effect:
80 mg of dimethyl sulfoxide/g of solution.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Cutaneous solution.
Actikerall is a clear, colourless to slightly orange-white solution.
4. Clinical particulars
4.1 Therapeutic indications
Actikerall is indicated for the topical treatment of slightly palpable
and/or moderately thick hyperkeratotic
actinic keratosis (grade I/II) in immunocompetent adult patients.
Grade I/II intensity is based on the 4-point scale of Olsen et al.
(1991), see section 5.1.
4.2 Posology and method of administration
Posology
_Adults_
Actikerall should be applied once daily to the affected area (up to 25
cm²) until the lesions have
completely cleared or for up to a maximum of 12 weeks. If severe side
effects occur, reduce the
frequency of drug application to three times per week until the side
effects improve. If areas of skin with
a thin epidermis are treated, the solution should be applied less
frequently and the course of the therapy
monitored more often.
Response can be seen as early as in four weeks (see section 5.1).
Response increases over time and data
are available for treatment up to 12 weeks. Complete healing of the
lesion(s) or optimal therapeutic effect
may not be evident for up to eight weeks after treatment cessation.
Treatment should be continued,
although response is not apparent after the first four weeks.
When assessing options to treat recurrent lesions, the physician
should consider that the efficacy of
retreatment with Actikerall has not been formally measured in clinical
trials.
_Paediatric population_
There is no relevant use of Actikerall in the paediatric population
for th