Stieprox

Package Leaflet: Information for the User

Stieprox, 15 mg/g (1.5%), Medicinal Shampoo

Ciclopirox Olamine

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have any Further Questions, Ask Your Doctor or Pharmacist.
• This Medicinal Product has been Prescribed for You. Do not Pass it on to Others. It may Harm them, even if their Symptoms are the Same as Yours.
• If You Experience any Side Effects, including any not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Stieprox and What is it Used for
• 2. Important Information Before Using Stieprox
• 3. How to Use Stieprox
• 4. Possible Side Effects
• 5. How to Store Stieprox
• 6. Package Contents and Other Information

1. What is Stieprox and What is it Used for

Stieprox is a Medicinal Shampoo that Contains the Active Substance with Antifungal Action

• Ciclopirox Olamine. Ciclopirox Olamine Acts on Fungi of the Mallasseziaspp (also Called Pityrosporum) Type, which are the Main Cause of such Diseases as Dandruff and Seborrhoeic Dermatitis. Additionally, Ciclopirox Olamine has Anti-inflammatory Properties.

Stieprox is Indicated for Local Treatment and Relief of Symptoms of Scalp Disorders, such as Dandruff and Seborrhoeic Dermatitis.

2. Important Information Before Using Stieprox

When Not to Use Stieprox

• If You are Allergic to Ciclopirox Olamine or any of the Other Ingredients of this Medicinal Product Listed in Section 6.
• In Children and Adolescents Under 18 Years of Age.

Warnings and Precautions

Before Starting to Use Stieprox, Discuss it with Your Doctor or Pharmacist. Stieprox is Intended for Use Only on the Scalp. In Rare Cases, Mainly in Patients with Chemically Damaged Hair and in Patients with Grey and Light Hair, Hair Discoloration has been Observed. Stieprox may Cause Eye Irritation. As with the Use of Other Shampoos, Avoid Contact of Stieprox with the Eyes. If Stieprox Comes into Contact with the Eyes, Rinse them with a Large Amount of Warm Water. Stieprox may Cause Skin Irritation. If the Irritation Persists, Stop Using it and Consult Your Doctor.

Children and Adolescents Under 18 Years of Age

No Studies have been Conducted on the Safety of Using Stieprox in Children and Adolescents Under 18 Years of Age.

Stieprox and Other Medicinal Products

Tell Your Doctor or Pharmacist About all Medicinal Products You are Currently Taking or Have Recently Taken, as well as any Medicinal Products You Plan to Take. No Interactions have been Reported Between Stieprox and Other Medicinal Products. In Case of 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, Ask Your Doctor or Pharmacist for Advice Before Using this Medicinal Product. There are no Data on the Safety of Using Stieprox in Pregnant or Breastfeeding Women. If Your Doctor Decides that You can Use Stieprox During Breastfeeding, Before Starting to Breastfeed, Make Sure that any Residues of Stieprox have been Thoroughly Rinsed from the Breast.

Driving and Using Machines

Using Stieprox does not Affect the Ability to Drive and Use Machines.

Stieprox Contains a Fragrance Composition with Allergens

Stieprox Contains the 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 Cinnamal, Benzyl Salicylate, Benzyl Benzoate, Coumarin, Eugenol, Geraniol, Hydroxycitronellal, Isoeugenol, Lilial (2-(4-tert-Butylbenzyl)propionaldehyde), d-Limonene, Benzyl Alcohol, Amyl Cinnamal, Pentyl Cinnamal, Anisaldehyde, Benzyl Cinnamate, Cinnamal, Cinnamyl Alcohol, Citral, Farnesol. These Allergens may Cause Allergic Reactions.

3. How to Use Stieprox

This Medicinal Product Should be Used as Directed by Your Doctor or Pharmacist. If You are in any Doubt, Consult Your Doctor or Pharmacist. Stieprox is Intended for Use on the Scalp.

Use in Adults

It is Usually Recommended to Use the Medicinal Product Two or Three Times a Week.

• Wet Your Hair and Apply Stieprox in the Amount Necessary to Produce a Rich Lather.
• Massage the Scalp Vigorously with Your Fingertips and the Adjacent Skin Surface.
• Rinse Your Hair Thoroughly and Then Repeat the Above Steps. The Medicinal Product Should be in Contact with the Scalp for 3 to 5 Minutes. The Recommended Treatment Duration is 4 Weeks. Between Uses of Stieprox, a Different Mild Shampoo may be Used.

No Dose Adjustment is 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 are no Data on the Safety and Efficacy of Using Stieprox in Children and Adolescents Under 18 Years of Age. If You Feel that the Action of the Medicinal Product is too Strong or too Weak, Consult Your Doctor or Pharmacist.

Using More than the Recommended Dose of Stieprox

After Applying the Medicinal Product to the Scalp, Rinse it Thoroughly. In Case of Accidental Ingestion, Consult Your Doctor.

Missing a Dose of Stieprox

Do not Take a Double Dose to Make up for a Forgotten Dose.

Stopping Treatment with Stieprox

If You have any Further Questions on the Use of this Medicinal Product, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medicinal Products, Stieprox can Cause Side Effects, although not Everybody gets them. Data from Clinical Trials Common Side EffectsMay Occur in Less than 1 in 10 Patients:

• Irritation at the Application Site, with Symptoms such as Itching, Burning, Redness, Rash.

Data Obtained After the Medicinal Product has been Placed on the Market Rare Side EffectsMay Occur in Less than 1 in 1000 Patients:

• Hypersensitivity at the Application Site.
• Scaling of the Skin.
• Rash.
• Hair Loss.
• Discoloration of Hair.
• Change in Hair Structure.

Reporting Side Effects

If You Experience any Side Effects, including any not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist or Nurse. Side Effects can be Reported Directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side Effects can also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, You can Help Provide more Information on the Safety of this Medicinal Product.

5. How to Store Stieprox

No Special Precautions. Keep the Medicinal Product out of the Sight and Reach of Children. Do not Use this Medicinal Product After the Expiry Date Stated on the Packaging After "EXP". The Abbreviation "Lot" means the Batch Number of the Product. The Expiry Date Refers to the Last Day of the Specified Month. Medicinal Products Should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicinal Products that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Stieprox Contains

The Active Substance of the Medicinal Product is Ciclopirox Olamine. 1 g of Medicinal Shampoo Contains 15 mg of Ciclopirox Olamine; the Other Ingredients are: Sodium Lauryl Ether Sulfate, Cocamidopropyl Betaine, Disodium Phosphate Dodecahydrate, Citric Acid Monohydrate, Coconut Diethanolamide, Hexylene Glycol, Oleyl Alcohol, Polysorbate 80, Polyquaternium 10, Fragrance Composition Fruitier Timotei AF 17050*, Purified Water, Sodium Hydroxide. *Stieprox Contains the 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 Cinnamal, Benzyl Salicylate, Benzyl Benzoate, Coumarin, Eugenol, Geraniol, Hydroxycitronellal, Isoeugenol, Lilial (2-(4-tert-Butylbenzyl)propionaldehyde), d-Limonene, Benzyl Alcohol, Amyl Cinnamal, Pentyl Cinnamal, Anisaldehyde, Benzyl Cinnamate, Cinnamal, Cinnamyl Alcohol, Citral, Farnesol.

What Stieprox Looks Like and Contents of the Package

Stieprox is a Medicinal Shampoo.

Packaging

A Bottle Containing 100 ml of Medicinal Shampoo, Packaged in a Cardboard Box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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, Netherlands. For Further Information, Contact the Representative of the Marketing Authorization Holder: GSK Services Sp. z o.o., ul. Rzymowskiego 53, 02-697 Warsaw, tel. (22) 576-90-00 Date of Last Revision of the Package Leaflet:January 2025