Stieprox 15 mg/g shampoo

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

CICLOPIROX OLAMINE

Disponible desde:

PCO Manufacturing Ltd.

Código ATC:

D01AE14

Designación común internacional (DCI):

CICLOPIROX OLAMINE

formulario farmacéutico:

Shampoo

Área terapéutica:

ciclopirox

Fecha de autorización:

2022-01-21

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
STIEPROX
®
15 MG/G SHAMPOO
ciclopirox olamine
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 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.

In this leaflet, Stieprox 15 mg/g Shampoo will be called
Stieprox.
WHAT IS IN THIS LEAFLET
1.
What Stieprox is and what it is used for
2.
What you need to know before you use Stieprox
3.
How to use Stieprox
4.
Possible side effects
5.
How to store Stieprox
6.
Contents of the pack and other information
1.
WHAT STIEPROX IS AND WHAT IT IS USED FOR
Stieprox contains the active substance ciclopirox olamine. This
belongs to a group of medicines called ‘anti-fungals’. Stieprox is
used to treat scalp disorders such as dandruff and seborrhoeic
dermatitis (red, flaky, itchy scalps) in adults and adolescents
aged over 12 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE STIEPROX
DO NOT USE STIEPROX

If you are allergic to ciclopirox olamine or any of the other
ingredients in this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Stieprox

If you have grey, white or damaged hair. This is because
Stieprox may affect the colour of your hair.
Stieprox is for external use only.
Stieprox may cause stinging and irritation to the eyes. If you
accidentally get Stieprox in your eyes, wash the affected area
with water.
Stieprox may cause skin irritation. If irritation occurs and
persists, treatment should be discontinued.
If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using Stieprox.
CHILDREN
Do not use t

Ficha técnica

Health Products Regulatory Authority
24 January 2022
CRN00CPSS
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stieprox 15 mg/g shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of shampoo contains 15 mg ciclopirox olamine.
Excipients with known effect:
Fragrance AF17050 containing allergens (Linalool, Alpha-Isomethyl
ionone (3-Methyl-4-(2,6,6-trimethyl-2-
cyclohexen-1-yl)-3-buten-2-one), Citronellol, Hexyl cinnamal (Hexyl
cinnamaldehyde), Benzyl salicylate, Benzyl benzoate,
Coumarin, Eugenol, Geraniol, Hydroxycitronellal, Isoeugenol,
Butylphenyl methylpropional (Lilial), Limonene, Benzyl alcohol,
Amyl cinnamal, Amylcinnamyl alcohol, Anisyl alcohol (Anise alcohol),
Benzyl cinnamate, Cinnamal, Cinnamyl alcohol, Citral,
Farnesol).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Shampoo
_Product imported from Austria_
Clear, straw to light orange coloured, shampoo.
4 CLINICAL PARTICULARS
As per PA1077/130/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/130/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium lauryl ether sulphate
Cocamidopropyl betaine
Sodium monohydrogen phosphate dodecahydrate
Citric acid monohydrate
Coconut diethanolamide
Hexylene glycol
Oleyl alcohol
Polysorbate 80
Polyquaternium 10
Fragrance AF17050 (contains: Linalool, Alpha-Isomethyl ionone
(3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one),
Citronellol, Hexyl cinnamal (Hexyl cinnamaldehyde), Benzyl
salicylate, Benzyl benzoate, Coumarin, Eugenol, Geraniol,
Hydroxycitronellal, Isoeugenol, Butylphenyl methylpropional (Lilial),
Limonene, Benzyl alcohol, Amyl cinnamal, Amylcinnamyl alcohol, Anisyl
alcohol (Anise alcohol), Benzyl cinnamate, Cinnamal,
Cinnamyl alcohol, Citral, Farnesol and dipropylene glycol)
Sodium hydroxide
Purified water
6.2 INCOMPATIBILITIES
Health Products Regulatory Authority
24 January 2022
CRN00CPSS
Page 2 of 2
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
bottle and outer carton of the