Zoxin-med

Package Leaflet: Information for the Patient

Zoxin-med,20 mg/ml, medicinal shampoo
Ketoconazolum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed 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 this 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 is Zoxin-med and what is it used for
• 2. Important information 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 is Zoxin-med and what is it used for

Zoxin-med is a medicinal shampoo containing the active substance ketoconazole.
This is an antifungal medicine for topical use on the skin.

Indications for Use

Zoxin-med is indicated for the prevention and treatment of local fungal skin infections caused by yeast of the genus Malassezia:

• in dandruff of the scalp (flaking of the epidermis in the form of white, easily removable scales);
• in seborrhoeic dermatitis (brown-red spots on the chest and face, which flake off in the form of white or yellow scales);
• in 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 hypersensitive to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Before starting to use Zoxin-med, the patient should discuss it with a doctor or pharmacist:

• if the patient has been treated locally with corticosteroids for a long time, in order to avoid exacerbation of the disease symptoms after stopping their use, the doctor will recommend gradual (over 2 to 3 weeks) withdrawal of corticosteroid therapy. The skin may react to too rapid withdrawal of corticosteroids with redness and itching. The medicine can be used only after 2 weeks from the end of local corticosteroid therapy.
• If a hypersensitivity reaction occurs, manifested by redness and itching of the skin at the site of contact with the shampoo, the use of the medicine should be stopped and a doctor consulted.
• Contact of the medicine with the eyes should be avoided. If the medicine gets into the eyes, they should be rinsed with a large amount of water.
• Seborrhoeic dermatitis and dandruff are often accompanied by increased hair loss. During the use of Zoxin-med, hair loss may worsen.

Children

The safety and efficacy of using the medicine in children have not been established.

Zoxin-med and Other Medicines

The patient should inform the doctor or pharmacist about all medicines being taken currently or recently, as well as about medicines planned to be taken.
No data available.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Zoxin-med can be used during pregnancy and breastfeeding only if, in the doctor's opinion, it is absolutely necessary.

Driving and Using Machines

The medicine does not affect the ability to drive or use machines.

Zoxin-med Contains Caramel Red (E 124)

Carmel red may cause allergic reactions.

3. How to Use Zoxin-med

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.

Method of Administration and Dosage

The medicine is intended for topical use.
Apply an appropriate amount of medicinal shampoo to wet hair and skin, massage to create a lather. Rinse after 5 minutes.
Hair can be washed beforehand with a regular shampoo.
In dandruff of the scalp and seborrhoeic dermatitis:

• therapeutically - 2 times a week for 2 to 4 weeks;
• prophylactically - once every 2 weeks.

In pityriasis versicolor:

• therapeutically - once a day for 5 days;
• prophylactically - before the summer period once a day for the next 3 days.

Children

The safety and efficacy of using the medicine in children have not been established.
In case of a feeling that the effect of the medicine is too strong or too weak, a doctor should be consulted.

Using More Than the Recommended Dose of Zoxin-med

No data on overdose of the medicine. In case of accidental ingestion of the medicine, a doctor should be contacted immediately to apply appropriate treatment.

Missing a Dose of Zoxin-med

A double dose should not be used to make up for a missed dose.
In case of any further doubts related to the use of the medicine, a doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely(occurring in 1 to 10 people out of 10,000):

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

Very rarely(occurring in less than 1 person out of 10,000):

• change in hair color, mainly damage and graying of hair.

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, a doctor or pharmacist should be consulted.
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.: + 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to Store Zoxin-med

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C. Store in the original packaging.
Do not use Zoxin-med if a change in the color 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 specified month.
Markings on the packaging:
Lot: Batch number.
EXP: Expiry date.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the Pack and Other Information

What Zoxin-med Contains

• The active substance of the medicine is ketoconazole. 1 ml of medicinal shampoo contains 20 mg of ketoconazole.
• The other ingredients are: sodium laureth sulfate, cocamidopropyl betaine, diethanolamide of coconut oil fatty acids, glycosides of coconut oil fatty acids and oleic acid glycerol ester, all-rac-α-tocopherol, polysorbate 20, imidurea, carmel red (E 124), fragrance composition 60910, sodium chloride, hydrochloric acid, purified water.

What Zoxin-med Looks Like and What the Pack Contains

Zoxin-med is a medicinal shampoo.
The packaging of the medicine is

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

Marketing Authorization Holder and Manufacturer

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

Date of Last Revision of the Leaflet: