Zoxin-med

Patient Information Leaflet

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Zoxin-med is and what it is used for
2. What you need to know before using Zoxin-med
3. How to use Zoxin-med
4. Possible side effects
5. How to store Zoxin-med
6. Contents of the pack and other information

1. What Zoxin-med is and what it is used for

Zoxin-med is a medicated shampoo containing the active substance ketoconazole.
It is an antifungal medicine intended for topical application to the skin.

Indications
Zoxin-med is indicated for the prophylaxis and local treatment of fungal skin infections caused by Malassezia yeasts:

• Pityriasis capitis (dandruff) (scaling of the scalp in the form of white, easily detachable flakes);
• Seborrheic dermatitis (brownish-red patches on the chest and face, shedding in the form of white or yellowish scales);
• Pityriasis versicolor (small pink-beige or white spots).

2. Important information before using Zoxin-med

When not to use Zoxin-med

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Zoxin-med, discuss this with your doctor or pharmacist:

• if the patient has previously been treated long-term with topical corticosteroids, to avoid worsening of symptoms after stopping corticosteroid treatment, the doctor will recommend gradually discontinuing corticosteroid therapy over a period of 2 to 3 weeks. If corticosteroids are stopped too quickly, the skin may react with redness and itching. Zoxin-med should only be used 2 weeks after ending topical corticosteroid treatment.
• If a hypersensitivity reaction occurs, manifesting for example as redness and itching of the skin at the site of contact with the shampoo, use of the medicine should be discontinued and the patient should consult a doctor.
• Avoid contact of the medicine with the eyes. If the medicine gets into the eyes, rinse them thoroughly with plenty of water.
• Seborrheic dermatitis and dandruff are often accompanied by increased hair loss. During treatment with Zoxin-med, hair loss may worsen.

Children
The safety and efficacy of Zoxin-med in children have not been established.

Zoxin-med and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No data available.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Zoxin-med may be used during pregnancy and breastfeeding only if, in the opinion of the doctor, it is clearly necessary.

Driving and operating machinery
This medicine has no influence on the ability to drive and operate machinery.

Zoxin-med contains carmine (E 124)
Carmine may cause allergic reactions.

3. How to use Zoxin-med

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Method of administration and dosage
The medicine is intended for topical use.
Apply an appropriate amount of the medicinal shampoo to wet hair and scalp, massaging gently until foam forms. Rinse after 5 minutes.
Hair may first be washed with a regular shampoo.

For dandruff and seborrhoeic dermatitis of the scalp:

• Therapeutically – twice a week for 2 to 4 weeks;
• Prophylactically – once every 2 weeks.

For pityriasis versicolor:

• Therapeutically – once daily for 5 consecutive days;
• Prophylactically – before the summer season, once daily for 3 consecutive days.

Children
The safety and efficacy of this medicine in children have not been established.
If the effect of the medicine seems too strong or too weak, consult a doctor.

Use of more than the recommended dose of Zoxin-med
There are no data regarding overdose. In case of accidental ingestion, contact a doctor immediately for appropriate treatment.

Missed dose of Zoxin-med
Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Rarely (occurs in 1 to 10 people per 10,000):

• local itching, burning, contact dermatitis, irritation;
• greasiness or dryness of hair.

Very rarely (occurs in less than 1 person per 10,000):

• change in hair colour, mainly hair damage and hair whitening.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Zoxin-med

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging.
Do not use Zoxin-med if a change in colour of the liquid from red to brown is visible.
Do not use this medicine after the expiry date stated on the label or tube and on the
carton. The expiry date refers to the last day of the stated month.
Markings on the packaging:
Lot: Batch number.
EXP: Expiry date.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the pack and other information

What Zoxin-med contains

• The active substance is ketoconazole. 1 ml of medicinal shampoo contains 20 mg of ketoconazole.
• The other ingredients are: sodium lauryl ether sulfate, cocobetaine, diethanolamide of coconut oil fatty acids, glycosides of coconut and oleic acids and glycerol oleate, all-rac-α-tocopherol, polysorbate 20, imidocarbamide, carmine red (E 124), fragrance composition 60910, sodium chloride, hydrochloric acid, purified water.

What Zoxin-med looks like and contents of the pack
Zoxin-med is a medicinal shampoo.
The medicine is packaged as:

• a polyethylene bottle closed with a polypropylene "flip-top" cap containing 60 ml of medicinal shampoo, in a cardboard box, or
• a polyethylene tube closed with a polypropylene "flip-top" cap containing 60 ml or 100 ml of medicinal shampoo, in a cardboard box, or
• sachets containing 6 ml each, in a cardboard box. The pack contains 6 sachets.

Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel: (42) 22-53-100