SEBIPROX 1.5% Shampoo

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CICLOPIROX OLAMINE

Available from:

Stiefel Laboratories (Ireland) Ltd Finisklin Business Park, Sligo, Famar Nederland BV, INdustrieweg 1,5531 AD BLADEL, Ireland

ATC code:

D01AE14

INN (International Name):

CICLOPIROX OLAMINE 1.5 % (W/W)

Pharmaceutical form:

CUTANEOUS LIQUID

Composition:

CICLOPIROX OLAMINE 1.5 % (W/W)

Prescription type:

POM

Therapeutic area:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Authorization status:

Withdrawn

Authorization date:

2011-03-16

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEBIPROX 1.5% SHAMPOO
Ciclopirox olamine
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Sebiprox Shampoo carefully
to get the best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
You must contact a doctor if your symptoms worsen or do not improve
after 4 weeks.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Sebiprox Shampoo is and what it is used for
2.
Before you use Sebiprox Shampoo
3.
How to use Sebiprox Shampoo
4.
Possible side effects
5.
How to store Sebiprox Shampoo
6.
Further information
1.
WHAT SEBIPROX SHAMPOO IS AND WHAT IT IS USED FOR
Sebiprox Shampoo contains a medicine called ciclopirox olamine. This
belongs to a group of medicines
called ‘anti-fungals’. Sebiprox Shampoo is used for red, scaly
itchy scalps (called seborrhoeic dermatitis).
2.
BEFORE YOU USE SEBIPROX SHAMPOO
DO NOT USE SEBIPROX SHAMPOO
-
if you are
ALLERGIC
(hypersensitive) to cicloprox olamine or any of the other ingredients
in Sebiprox
Shampoo (listed in Section 6).
If you are not sure, talk to your doctor or pharmacist before using
Sebiprox Shampoo.
TAKE SPECIAL CARE WITH SEBIPROX SHAMPOO

Sebiprox Shampoo is for external use only.

Check with your doctor or pharmacist before using this shampoo if you
have grey, white or chemically
damaged hair (for example, due to hair dye). This is because Sebiprox
Shampoo may, in rare instances,
affect the colour of your hair.

SEBRIPROX SHAMPOO IS NOT RECOMMENDED FOR CHILDREN
AGED UNDER 12
. This is because its safety and
effectiveness are not known in this age group.

TRY NOT TO GET SEBIPROX SHAMPOO IN YOUR EYES. IT MAY CAUSE STINGING
AND IRRITATION
. If you accidently
get Sebiprox Shampoo in your

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SEBIPROX 1.5% shampoo
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ciclopirox olamine……………………….1.50 g (1.5 % w/w)
for 100 g of shampoo
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Shampoo
A clear straw to light orange coloured viscous liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of seborrhoeic dermatitis of the scalp.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Only for cutaneous use.
Ciclopirox olamine shampoo 1.5% should be used two to three times
weekly. The hair should be
wetted and sufficient shampoo applied to produce an abundant lather.
The scalp and adjacent areas
should be vigorously massaged with the fingertips. The hair should
then be thoroughly rinsed and
the procedure repeated. The shampoo should remain in contact with the
scalp for a total contact
time of 3-5 minutes over the two applications.
_ _
The recommended treatment period is 4 weeks.
A mild shampoo may be used in between applications of ciclopirox
olamine 1.5% shampoo.
_ _
_Paediatric population _
The safety and efficacy of Sebiprox ciclopirox olamine 1.5% shampoo in
children aged under 12
years have not yet been established. No data are available.
4.3
CONTRAINDICATIONS
Hypersensitivity to ciclopirox olamine or to any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ciclopirox olamine shampoo 1.5% is for external use only.
Page 2 of 5
Avoid contact with eyes. Sebiprox Shampoo may cause eye irritation. In
case of accidental contact
with the eyes, rinse with water.
Ciclopirox olamine 1.5% shampoo may cause skin irritation. If
irritation occurs and persists,
treatment should be discontinued.
In rare instances, mainly in patients with chemically damaged (for
example, due to hair dye), grey
or white hair, a discolouration of the hair has been observed.
Sebiprox Shampoo contains dipropylene glycol (contained in fragrance
AF 17050), which may
cause skin irritation.
4.5
INTERACTION WITH OTHER MEDICINAL