Package leaflet: Information for the patient

Sinazol, 20 mg/g, medicated shampoo
Ketoconazole
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Contents of the leaflet:

What Sinazol is and what it is used for
Important information before using Sinazol
How to use Sinazol
Possible side effects
How to store Sinazol
Contents of the pack and other information

1. What Sinazol is and what it is used for

Sinazol is a medicated shampoo for topical use with antifungal properties. The active substance
is ketoconazole. When applied to the skin, the medicine 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 medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Sinazol, consult your doctor or pharmacist.
Avoid contact of the medicine with the eyes. If contact occurs, rinse the eyes immediately with water.
If long-term topical corticosteroid treatment has been previously used, your doctor will recommend gradually discontinuing corticosteroids over 2 to 3 weeks to prevent worsening of symptoms after stopping their use. Skin may react to too rapid withdrawal of corticosteroids with redness and itching. Sinazol may only be used 2 weeks after completing topical corticosteroid treatment.
Consult your doctor if you have any doubts.
Seborrheic dermatitis and dandruff of the scalp, conditions for which Sinazol is used, are often accompanied by hair loss, which may rarely also occur during treatment with Sinazol.
Children and adolescents
Do not use this medicine in children and adolescents, as experience with its use in this age group is limited.
Sinazol with other medicines
No data available.
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.
Pregnancy, breastfeeding and fertility
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult your doctor or pharmacist before using this medicine.
Sinazol may be used during pregnancy and breastfeeding if, in the opinion of the doctor, it is clearly necessary.
Driving and operating machinery
The effect of the medicine on the ability to drive and operate machinery is not significant.
Sinazol contains the colouring agent azorubine
Azorubine (E 122) may cause allergic reactions.

3. How to use Sinazol
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
For topical application.
Adults
Unless otherwise directed by a doctor, for the treatment of seborrheic dermatitis of the scalp and dandruff of the scalp, use twice a week for 2 to 4 weeks.
For prophylaxis, use once a week or once every two weeks.
Wash the scalp with 5 ml to 6 ml (1 teaspoon) of the medicinal shampoo diluted in a small amount of water. Thoroughly massage the diluted medicinal shampoo into the scalp and hair, leave on for 3 to 5 minutes, then rinse off.
Use in children and adolescents
Do not use in children and adolescents.
If the effect of Sinazol is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Sinazol
Topical use of Sinazol according to the indications and recommended method of use does not pose a risk of overdose. In case of accidental ingestion, contact a doctor immediately.
To avoid the medicine entering the respiratory tract, do not induce vomiting and do not perform gastric lavage.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Local irritation, itching and burning sensation, dryness or greasiness of hair may occur rarely (in 1 to 10 out of 10,000 patients).
Very rarely (in less than 1 out of 10,000 patients), change in hair colour has been observed, particularly in chemically damaged hair and greying of hair.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
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: (22) 49 21 301, fax: (22) 49 21309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sinazol

Do not store above 25°C.
Do not store in the refrigerator or freeze.
Keep the medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the packaging and other information

What Sinazol contains

The active substance is ketoconazole. 1 g of the medicinal product contains 20 mg of ketoconazole.
The other components are: sodium lauryl ether sulfate, disodium lauryl sulfosuccinate, fatty acid diethanolamide of coconut oil (Cocomide DEA), hydroxypropyl hydrolyzed collagen - lauryldimethylammonium chloride, polyglycerol-120 methylglucose dioleate, sodium chloride, sodium hydroxide, concentrated hydrochloric acid, imidourea, azorubine (Acid Red 2C) E 122, purified water.

What Sinazol looks like and contents of the pack
Sinazol, medicinal shampoo, is a liquid.
Packaging:
White plastic HDPE bottle containing 60 g or 100 g of medicinal shampoo, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Tel.: +372 612 0201
Fax: +372 612 0330

For further information about this medicinal product, please contact the Marketing Authorisation Holder.
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
110 00 Prague
Czech Republic