Stieprox

Package leaflet: Information for the user

Stieprox, 15 mg/g (1.5%) medicinal shampoo
Ciclopirox olamine
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Stieprox is and what it is used for
2. Important information before using 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 is a medicinal shampoo containing the active substance with antifungal properties,
ciclopirox olamine. Ciclopirox olamine acts against fungi of the genus Mallassezia spp (also known as Pityrosporum), which are the main cause of conditions such as pityriasis (dandruff) and seborrhoeic dermatitis. Additionally, ciclopirox olamine exhibits anti-inflammatory activity.

Stieprox is indicated for the topical treatment and relief of symptoms of scalp skin disorders,
such as dandruff and seborrhoeic dermatitis.

2. Important information before using Stieprox

When not to use Stieprox

• if the patient is allergic to ciclopirox olamine or to any of the other ingredients of this medicine listed in section 6,
• in children and adolescents under 18 years of age.

Warnings and precautions
Before starting to use Stieprox, discuss this with your doctor or pharmacist.
Stieprox is intended for use on the hairy scalp only.
In rare cases, mainly in patients with hair damaged by chemical treatments and in patients with grey or light-coloured hair, discolouration of hair has been observed.
Stieprox may cause eye irritation. As with other shampoos, avoid contact of Stieprox with the eyes. If Stieprox comes into contact with the eyes, rinse thoroughly with plenty of lukewarm water.
Stieprox may cause skin irritation. If irritation persists, discontinue use and consult your doctor.

Children and adolescents under 18 years of age
Studies on the safety of Stieprox in children and adolescents under 18 years of age have not been conducted.

Stieprox and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions between Stieprox and other medicines have been reported.
If in doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
There is no data available on the safety of Stieprox in pregnant or breastfeeding women.
If your doctor decides that Stieprox may be used during breastfeeding, you should ensure that any residue of Stieprox has been thoroughly rinsed off the breasts before breastfeeding.

Driving and operating machinery
Use of Stieprox does not affect the ability to drive or operate machinery.

Stieprox contains a fragrance composition with allergens
Stieprox contains the fragrance composition Fruitier Timotei AF 17050 containing the following allergens:
linalool, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)but-3-en-2-one, citronellol, hexyl cinnamaldehyde, benzyl salicylate, benzyl benzoate, coumarin, eugenol, geraniol, hydroxycitronellal, isoeugenol, lilial (2-(4-tert-butylbenzyl)propionaldehyde), d-limonene, benzyl alcohol, amyl cinnamaldehyde, pentyl cinnamyl alcohol, anisyl alcohol, benzyl cinnamate, cinnamaldehyde, cinnamyl alcohol, citral, farnesol.
These allergens may cause allergic reactions.

3. How to use Stieprox

This medicine should be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Stieprox is intended for use on the hairy scalp.

Use in adults
The usual recommendation is to use the medicine two or three times a week.

• Wet the hair and apply a sufficient amount of Stieprox to produce a rich lather.
• Massage the scalp and adjacent skin areas thoroughly with the fingertips.
• Rinse the hair thoroughly and then repeat the above steps. The medicine should remain in contact with the scalp for 3 to 5 minutes. The recommended duration of treatment is 4 weeks. Between applications of Stieprox, a different mild shampoo may be used.

Dose adjustment is not necessary in elderly patients or in patients with renal or hepatic impairment.

Use in children and adolescents under 18 years of age
Do not use Stieprox in children and adolescents under 18 years of age.
There is a lack of data on the safety and efficacy of Stieprox in children and adolescents under 18 years of age.

If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Use of more than the recommended dose of Stieprox
After application to the scalp, the medicine should be thoroughly rinsed off.
In case of accidental oral ingestion, contact a doctor immediately.

Missed dose of Stieprox
Do not use a double dose to make up for a missed dose.

Stopping treatment with Stieprox
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everybody gets them.
Data from clinical trials
Common adverse reactions
May occur in no more than 1 in 10 patients:

• irritation at the site of application, with symptoms such as itching, burning, redness, rash.

Data obtained after marketing authorization
Rare adverse reactions
May occur in no more than 1 in 1,000 patients:

• hypersensitivity at the site of application,
• skin peeling,
• rash,
• hair loss,
• hair discoloration,
• change in hair structure.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Stieprox

No special requirements.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: „EXP”.
The code „Lot” refers to the product batch number. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Stieprox contains
The active substance is ciclopirox olamine.
1 g of medicinal shampoo contains 15 mg of ciclopirox olamine.
Other ingredients are: sodium lauryl sulfate, cocamidopropyl betaine, disodium phosphate dodecahydrate, citric acid monohydrate, cocodiethanolamide, hexylene glycol, oleic alcohol, polysorbate 80, polyquaternium 10, fragrance composition Fruitier Timotei AF 17050*, purified water, sodium hydroxide.
*Stieprox contains fragrance composition Fruitier Timotei AF 17050 with the following allergens: linalool, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, citronellol, hexyl cinnamic aldehyde, benzyl salicylate, benzyl benzoate, coumarin, eugenol, geraniol, hydroxycitronellal, isoeugenol, lilial (2-(4-tert-butylbenzyl)propionaldehyde), d-limonene, benzyl alcohol, amyl cinnamic aldehyde, pentyl cinnamic alcohol, anisyl alcohol, cinnamyl benzoate, cinnamaldehyde, cinnamyl alcohol, citral, farnesol.

What Stieprox looks like and contents of the pack
Stieprox is a medicinal shampoo.
Pack
A bottle containing 100 ml of medicinal shampoo, placed in a cardboard carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Manufacturer
Delpharm Bladel B.V.
Industrieweg 1
5531 AD Bladel
The Netherlands

For further information, please contact the local representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
tel. (22) 576-90-00