Stieprox 15 mg/g Shampoo

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

CICLOPIROX OLAMINE

Tilgjengelig fra:

Lexon Pharmaceuticals (Ireland) Limited

ATC-kode:

D01AE; D01AE14

INN (International Name):

CICLOPIROX OLAMINE

Legemiddelform:

Shampoo

Terapeutisk område:

Other antifungals for topical use; ciclopirox

Autorisasjon dato:

2022-10-14

Informasjon til brukeren

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:
What Stieprox is and what it is used for
What you need to know before you use Stieprox
How to use Stieprox
Possible side effects
How to store Stieprox
Contents of the pack and other information
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.
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 this medicine on children under 12 years of age because the
safety and efficacy hav

Preparatomtale

Health Products Regulatory Authority
19 October 2022
CRN00D3RS
Page 1 of 2
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 of 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 and dipropylene glycol).
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
19 October 2022
CRN00D3RS
Page 2 of 2
Not applicable
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
bot