Enstilar 50micrograms/g / 0.5 mg/g cutaneous foam

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betamethasone dipropionate; Calcipotriol monohydrate

Available from:

LEO Pharma

ATC code:

D05AX52

INN (International Name):

Betamethasone dipropionate; Calcipotriol monohydrate

Dosage:

500microgram/1gram ; 50microgram/1gram

Pharmaceutical form:

Cutaneous foam

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13050200; GTIN: 5702191012125 5702191015799

Patient Information leaflet

BACK
FRONT
000000-00
420 mm
287 mm
NO VISION CONTROL UNTIL FURTHER NOTICE!
JUG 27.06.2014
WHAT IS IN THIS LEAFLET
1. What Enstilar
®
is and what it is used for
2. What you need to know before you use Enstilar
®
3. How to use Enstilar
®
4. Possible side effects
5. How to store Enstilar
®
6. Contents of the pack and other information
1. WHAT ENSTILAR
®
IS AND WHAT IT IS USED FOR
Enstilar is used on the skin to treat psoriasis vulgaris in
adults. Psoriasis is caused by your skin cells being produced
too quickly. This causes redness, scaling and thickness of
your skin.
Enstilar contains calcipotriol and betamethasone.
Calcipotriol helps to bring the rate of skin cell growth back to
normal and betamethasone helps to reduce the inflammation.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ENSTILAR
®
DO NOT USE ENSTILAR:
• if you are allergic to calcipotriol, betamethasone or any of
the other ingredients of this medicine (listed in section 6)
• if you have problems with calcium levels in your blood
(ask your doctor)
• if you have certain types of psoriasis called: erythrodermic
psoriasis or pustular psoriasis (ask your doctor if you are
unsure).
AS ENSTILAR CONTAINS A STRONG STEROID, DO NOT USE ENSTILAR
ON SKIN AREAS AFFECTED BY:
• skin infections caused by viruses (e.g. cold sores or
chicken pox)
• skin infections caused by a fungus (e.g. athlete’s foot and
ringworm)
• skin infections caused by bacteria
• skin infections caused by parasites (e.g. scabies)
• tuberculosis (TB)
• perioral dermatitis (red rash around the mouth)
• thin skin, easily damaged veins, stretch marks
• ichthyosis (dry skin with fish-like scales)
• acne (pimples)
• rosacea (severe flushing or redness of the skin on the face)
• ulcers and wounds.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE USING
ENSTILAR IF:
• you have diabetes mellitus (diabetes), as your blood sugar
level may be affected by the steroid
• you are using other medicines that contain steroids, as
you may get side effects
•

Summary of Product characteristics

OBJECT 1
ENSTILAR CUTANEOUS FOAM
Summary of Product Characteristics Updated 10-May-2016 | Leo
Laboratories Limited
1. Name of the medicinal product
Enstilar 50 micrograms/g + 0.5 mg/g cutaneous foam
2. Qualitative and quantitative composition
One gram of cutaneous foam contains 50 micrograms of calcipotriol (as
monohydrate) and 0.5 mg of
betamethasone (as dipropionate).
Excipient with known effect:
Butylhydroxytoluene (E321) 50 micrograms/g cutaneous foam.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Cutaneous foam.
After spraying, a white to off-white foam is formed.
4. Clinical particulars
4.1 Therapeutic indications
Topical treatment of psoriasis vulgaris in adults.
4.2 Posology and method of administration
Posology
Enstilar foam should be applied to the affected area once daily. The
recommended treatment period is 4
weeks. The daily maximum dose of Enstilar should not exceed 15 g, i.e.
one 60 g can should last for at
least 4 days. 15 g corresponds to the amount administered from the can
if the actuator is fully depressed
for approximately one minute. A two-second application delivers
approximately 0.5 g. As a guide, 0.5 g
of foam should cover an area of skin roughly corresponding to the
surface area of an adult hand.
If using other topical products containing calcipotriol in addition to
Enstilar, the total dose of all
calcipotriol containing products should not exceed 15 g per day.
The total body surface area treated should not exceed 30%.
Special populations
_Renal and hepatic impairment_
The safety and efficacy of Enstilar foam in patients with severe renal
insufficiency or severe hepatic
disorders have not been evaluated.
_Paediatric population_
The safety and efficacy of Enstilar foam in children below 18 years
have not been established. No data
are available.
Method of administration
For cutaneous use.
The can should be shaken for a few seconds before use. Enstilar should
be applied by spraying holding
the can at least 3 cm from the skin. The foam can be sprayed holding
the ca