Picato 150microgramsg gel

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Ingenol mebutate

Disponible depuis:

LEO Pharma

DCI (Dénomination commune internationale):

Ingenol mebutate

Dosage:

150microgram/1gram

forme pharmaceutique:

Gel

Mode d'administration:

Cutaneous

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 13080100; GTIN: 5702191009071

Notice patient

420 mm
297 mm
WHAT IS IN THIS LEAFLET
1.
What Picato
®
is and what it is used for
2.
What you need to know before you use Picato
®
3. How to use Picato
®
4. Possible side effects
5. How to store Picato
®
6. Contents of the pack and other information
1. WHAT PICATO
®
IS AND WHAT IT IS USED FOR
Picato contains the active substance ingenol mebutate.
This medicine is used for topical (on the skin) treatment of
actinic keratosis, also called solar keratosis, in adults. Actinic
keratoses are rough areas of skin found in people who have
been exposed to too much sunshine over the course of their
lifetime. Picato 150 micrograms/gram gel is used for actinic
keratosis on the face and scalp.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PICATO
®
DO NOT USE PICATO
-
If you are allergic to ingenol mebutate or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Picato.
- Do not get Picato in your eyes. Wash your hands thoroughly
after you have applied the gel. Wash your hands again if you
happen to touch the area where you applied the gel. Take
care not to transfer gel from the treatment area into your
eyes. In the event of accidental contact, remove the gel by
rinsing with plenty of water and seek medical assistance as
soon as possible.
- Do not swallow this medicine. Drink plenty of water if you
accidentally swallow this medicine and seek medical
assistance.
- Make sure that your skin has healed from any other
treatments or surgery before using this medicine. Do not
apply Picato on open wounds or damaged skin.
- Do not apply this medicine internally, to the area near the
eyes, to the inside of the nostrils, the inside of the ear or on
the lips.
- Avoid sunlight as much as possible (including sunlamps and
tanning beds).
- Be vigilant for any new scaly red patches, open sores,
elevated or warty growths within the treatment area.
Should any occur
, talk to your doctor immediately.
- This medicine is intended to treat one area of 25 cm
2
for

Résumé des caractéristiques du produit

OBJECT 1
PICATO 150 MCG/G GEL
Summary of Product Characteristics Updated 21-Jul-2017 | Leo
Laboratories Limited
1. Name of the medicinal product
Picato 150 micrograms/gram gel
2. Qualitative and quantitative composition
Each gram of gel contains 150 mcg of ingenol mebutate. Each tube
contains 70 mcg of ingenol mebutate
in 0.47 g of gel.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gel.
Clear colourless gel.
4. Clinical particulars
4.1 Therapeutic indications
Picato is indicated for the cutaneous treatment of non-hyperkeratotic,
non-hypertrophic actinic keratosis
in adults.
4.2 Posology and method of administration
Posology
_Actinic keratosis on the face and scalp in adults_
One tube of Picato 150 mcg/g gel (containing 70 mcg ingenol mebutate)
should be applied once daily to
the affected area for 3 consecutive days.
Optimal therapeutic effect can be assessed approximately 8 weeks after
treatment.
A repeat treatment course of Picato can be given if an incomplete
response is seen at a follow-up
examination after 8 weeks or if lesions that are cleared at this
examination recur in subsequent
examinations.
_Paediatric population_
There is no relevant use of Picato in the paediatric population.
_Elderly population_
No dose adjustment is required (see section 5.1).
_Immunocompromised patients_
Clinical data on treatment in immunocompromised patients is not
available, but systemic risks are not
expected since ingenol mebutate is not absorbed systemically.
Method of administration
The content of one tube covers a treatment area of 25 cm
2
(e.g. 5 cm x 5 cm). The tube is for single use
only and should be discarded after use (see section 6.6).
The gel from the tube should be squeezed onto a fingertip and spread
evenly over the entire treatment
area, allowing it to dry for 15 minutes. The content of one tube
should be used for one treatment area of
25 cm
2
.
For single use only.
_For treatment of the neck:_
If more than half of the treatment area is located in the upper part
of the neck, Picato 150