Stieprox 15 mg/g Shampoo

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

CICLOPIROX OLAMINE

זמין מ:

GlaxoSmithKline (Ireland) Limited

קוד ATC:

D01AE; D01AE14

INN (שם בינלאומי):

CICLOPIROX OLAMINE

כמות:

15 milligram(s)/gram

טופס פרצבטיות:

Shampoo

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Other antifungals for topical use; ciclopirox

מצב אישור:

Marketed

תאריך אישור:

2001-10-05

עלון מידע

Reason for update:
EU Excipient guideline update. - RFI
Market: IE
Agency Approval Date:
Text Date: 18/08/2020
Text Issue and Draft No.: Issue 6 Draft 2
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 d

מאפייני מוצר

Health Products Regulatory Authority
23 June 2021
CRN009ZK5
Page 1 of 5
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/G CICLOPIROX OLAMINE.
EXCIPIENTS WITH KNOWN EFFECT:
Fruitier timotei AF17050 contains allergens (see section 6.1)
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1.
3 PHARMACEUTICAL FORM
Shampoo.
Clear, straw to light-orange coloured, viscous shampoo.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Stieprox is indicated in the treatment of scalp disorders such as
dandruff and seborrhoeic dermatitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS AGED OVER 12 YEARS:
Stieprox is only for topical application to the scalp and adjacent
areas.
The hair should be wetted and sufficient Stieprox 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.
Stieproxshould be used two to three times weekly or as often as
necessary for the treatment of scalp disorders. A mild
shampoo can be used in between applications of Stieprox.
The recommended treatment period is 4 weeks.
ELDERLY PATIENTS:
The dosage instructions given above are suitable for the elderly.
PAEDIATRIC POPULATION:
The safety and efficacy of Stieprox in children under 12 years of age
have not been established.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance,ciclopirox olamine,or to any
of the excipients listed in section 6.1.
Health Products Regulatory Authority
23 June 2021
CRN009ZK5
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Stieprox is for external use only.
As with all shampoo products avoid contact with eyes. Ciclopirox
olamine may cause eye irritation. In case of accidental contact
with the eyes, rinse with water.
Stieprox ma