Sinazol

Package Leaflet: Information for the Patient

Sinazol, 20 mg/g, Medicinal Shampoo

Ketoconazole

Read the Leaflet Carefully Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be contacted.

Table of Contents of the Leaflet:

• 1. What Sinazol is and what it is used for
• 2. Important information before using Sinazol
• 3. How to use Sinazol
• 4. Possible side effects
• 5. How to store Sinazol
• 6. Contents of the pack and other information

1. What Sinazol is and what it is used for

Sinazol is a medicinal shampoo for use on the skin with an antifungal effect. The active substance of the medication is ketoconazole. When applied to the skin, it penetrates the body in negligible amounts.

Indications

Seborrhoeic dermatitis of the scalp. Dandruff of the scalp.

2. Important information before using Sinazol

When not to use Sinazol

• if the patient is allergic to ketoconazole or any of the other ingredients of the medication (listed in section 6).

Warnings and precautions

Before starting to use Sinazol, the doctor or pharmacist should be consulted.
Contact with the eyes should be avoided. However, if this occurs, the eyes should be rinsed immediately with water.
In the case of previous long-term local corticosteroid treatment, to avoid exacerbation of disease symptoms after discontinuation, the doctor will recommend gradual (over 2 to 3 weeks) withdrawal of corticosteroid treatment. The skin may react with redness and itching if corticosteroids are stopped too quickly. Sinazol can be used only after 2 weeks from the end of local corticosteroid treatment.
Any doubts should be clarified with the doctor.
Dandruff and seborrhoeic dermatitis of the scalp, for which Sinazol is used, are often accompanied by hair loss, which can also rarely occur during the use of Sinazol.

Children and adolescents

This medication should not be used in children and adolescents, as experience with its use in this age group is limited.

Sinazol and other medications

No data available.
The doctor or pharmacist should be informed about all medications currently or recently taken, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if pregnancy is suspected or planned, the doctor or pharmacist should be consulted before using this medication.
Sinazol may be used during pregnancy and breastfeeding if, in the doctor's opinion, it is absolutely necessary.

Driving and using machines

The effect of the medication on driving and using machines is not significant.

Sinazol contains the dye azorubine

Azorubine (E 122) may cause allergic reactions.

3. How to use Sinazol

This medication should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.
In case of doubts, the doctor or pharmacist should be consulted.
For skin use.

Adults

Unless the doctor advises otherwise, for the treatment of seborrhoeic dermatitis of the scalp and dandruff of the scalp, it should be used twice a week for 2 to 4 weeks.
As a preventive measure, it should be used once a week or once every two weeks.
The scalp should be washed with 5 ml to 6 ml (1 teaspoon) of the medicinal shampoo diluted in a small amount of water. The diluted medicinal shampoo should be rubbed thoroughly into the scalp and hair, then left on for 3 to 5 minutes, and finally rinsed off.

Use in children and adolescents

This medication should not be used in children and adolescents.
If the effect of Sinazol is too strong or too weak, the doctor or pharmacist should be contacted.

Using more than the recommended dose of Sinazol

Local use of Sinazol in accordance with the indications and recommended method of use does not pose a risk of overdose. In case of accidental ingestion, the doctor should be contacted immediately.
To avoid the medication entering the respiratory tract, vomiting should not be induced, and stomach lavage should not be performed.
In case of any further doubts related to the use of the medication, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, Sinazol can cause side effects, although not everybody gets them.
Rarely (occurring in 1 to 10 out of 10,000 patients), local irritation, itching, burning, dryness, or oiliness of the hair may occur.
Very rarely (in less than 1 out of 10,000 patients), a change in hair color, mainly chemical damage and graying of the hair, has been observed.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.:

• (22) 49 21 301, fax: (22) 49 21309, e-mail: ndl@urpl.gov.pl.

Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to store Sinazol

Do not store above 25°C.
Do not store in the refrigerator or freeze.
The medication should be stored in a place inaccessible and invisible to children.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medications should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Sinazol contains

• The active substance is ketoconazole. 1 g of the medication contains 20 mg of ketoconazole.
• The other ingredients of the medication are: sodium lauryl ether sulfate, disodium lauryl sulfosuccinate, diethanolamide of fatty acids of coconut oil (Cocomide DEA), hydrolyzed collagen hydroxypropyl - lauryldimethylammonium chloride, macrogol 120 methyl glucose dioleate, sodium chloride, sodium hydroxide, concentrated hydrochloric acid, imidurea, azorubine (Acid Red 2C) E 122, purified water.

What Sinazol looks like and contents of the pack

Sinazol, medicinal shampoo, is a liquid.
Packaging:
A white HDPE plastic bottle containing 60 g or 100 g of the medicinal shampoo, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
110 00 Prague
Czech Republic
Manufacturer
Tallinna Farmaatsiatehase AS
Tondi 33, 11316 Tallinn, Estonia
Phone: +372 612 0201
Fax: +372 612 0330
To obtain further information on the medication, the marketing authorization holder should be contacted.
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
110 00 Prague
Czech Republic

Date of the last revision of the leaflet: