Nizax Activ

Package Leaflet: Information for the Patient

NIZAX ACTIV

20 mg/g, medicinal shampoo
Ketoconazole

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

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

1. What is Nizax Activ and what is it used for

Nizax Activ, a medicinal shampoo with antifungal action, is intended for local use on the skin. The active substance of the medicine is ketoconazole.

Indications for Use

Nizax Activ, a medicinal shampoo, is indicated for the treatment and prevention of skin diseases caused by yeast of the genus Malassezia(Pityrosporum), such as:
scalp dandruff (flaking of the scalp in the form of white, easily removable flakes);
seborrhoeic dermatitis (brown-red patches on the chest and face, which flake off in the form of white or yellow flakes);
pityriasis versicolor (small, white patches on the skin of the chest) caused by Pityriasis versicolorinfection.

2. Important Information Before Using Nizax Activ

When Not to Use Nizax Activ

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

Warnings and Precautions

Before starting to use Nizax Activ, the patient should discuss it with their doctor or pharmacist.
In the case of previous long-term local corticosteroid treatment, in order 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.
Any doubts should be clarified with the doctor.
Contact with the eyes should be avoided, if this happens, the eyes should be rinsed with water.
Seborrhoeic dermatitis and dandruff are often accompanied by increased hair loss, which may also occur, although rarely, during the use of Nizax Activ.

Children and Adolescents

Do not use in children under 12 years of age.

Nizax Activ and Other Medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
There is no data on the use of Nizax Activ with other medicines.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Nizax Activ, a medicinal shampoo, may be used during pregnancy and breastfeeding only if, in the doctor's opinion, it is absolutely necessary.

Nizax Activ Contains a Fragrance Composition Green Tea D878/L

The medicine contains a fragrance composition containing, among other things: benzyl alcohol, citral, isoeugenol, benzyl salicylate, geraniol, linalool, citronellol, hexylcinnamaldehyde, d-limonene, dipropylene glycol. These substances may cause allergic reactions. The medicine contains 0.00006 mg of benzyl alcohol and 0.88 mg of dipropylene glycol per 1 g of medicinal shampoo.
Nizax Activ contains cochineal red -may cause allergic reactions.

3. How to Use Nizax Activ

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The medicinal shampoo is intended for local use on the skin.
Adults and adolescents (over 12 years of age)
Unless the doctor recommends otherwise, Nizax Activ shampoo is used according to the rules described below.

• 1. Apply a small amount of shampoo to the infected skin, usually an amount that fits in the palm of the hand or the contents of one sachet (6 ml) is sufficient for a single application. Before using Nizax Activ, the hair can be washed with a regular shampoo.
• 2. Using a small amount of water, spread the medicinal shampoo evenly over the skin. In the case of long hair, it is enough to wash only the scalp.
• 3. Massage the medicinal shampoo into the skin until a lather is obtained.
• 4. Leave the lather on the skin for 3 to 5 minutes, then rinse.
• 5. A regular shampoo can be used for everyday washing.

Treatment:
Pityriasis versicolor: use once a day for 5 consecutive days.
Seborrhoeic dermatitis and scalp dandruff: use twice a week for 2 to 4 weeks.
Prevention:
Pityriasis versicolor: use once a day for 3 consecutive days per treatment cycle, before the summer season.
Seborrhoeic dermatitis and scalp dandruff: use once a week or once every two weeks.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

Using a Higher Than Recommended Dose of Nizax Activ

Local use of Nizax Activ shampoo in accordance with the indications and the method of use described does not pose a risk of overdose.
In case of accidental ingestion of the medicine, the patient should immediately contact their doctor.
Overdose of the medicine may cause an increase in side effects.
In case of accidental ingestion of the medicine, the doctor will use supportive and symptomatic treatment. To avoid aspiration of gastric contents, the patient should not be made to vomit or have their stomach pumped.

4. Possible Side Effects

Like all medicines, Nizax Activ can cause side effects, although not everybody gets them.
Uncommon(in 1 to 10 patients out of 1000):
taste disorders
folliculitis
eye irritation, increased tearing, hypersensitivity at the application site
burning sensation of the skin, acne, hair loss, dry skin, changes in hair structure, rash, skin changes, flaking of the skin, contact dermatitis or reactions at the application site (redness, irritation, hypersensitivity reactions, itching, pustules).
Rare(in less than 1 patient out of 10,000) or of unknown frequency(frequency cannot be estimated from the available data):
angioedema
urticaria
hair discoloration.

Reporting Side Effects

If any side effects occur, including any possible side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of 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.
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 medicine.

5. How to Store Nizax Activ

Do not store above 25°C.
The medicine should be stored out of sight and reach of children.
Shelf life after first opening the bottle: 6 months.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Nizax Activ Contains

• The active substance of the medicine is ketoconazole. 1 g of medicinal shampoo contains 20 mg of ketoconazole.
• The other ingredients (excipients) are: sodium lauryl ether sulfate, disodium laureth sulfosuccinate, diethanolamide of fatty acids of coconut oil, macrogol 120 methyl glucose dioleate, hydrochloric acid, sodium chloride, sodium hydroxide, 30% solution, hydroxypropyl-lauryldimethylammonium chloride of hydrolyzed collagen, fragrance composition Green Tea D878/L (contains, among other things: benzyl alcohol, citral, isoeugenol, benzyl salicylate, geraniol, linalool, citronellol, hexylcinnamaldehyde, d-limonene, dipropylene glycol), RRR-α-tocopherol (E 306), quinoline yellow (E 104), cochineal red (E 124), purified water.

What Nizax Activ Looks Like and What the Pack Contains

Nizax Activ, a medicinal shampoo, is a thick, clear solution with an orange to orange-red color and a characteristic odor.
The packaging of Nizax Activ:
HDPE bottles with a flip-top polypropylene cap, containing 100 ml of medicinal shampoo, placed in a cardboard box;
laminated sachets (PET/Aluminum/PE), containing 6 ml of medicinal shampoo, placed 6 pieces in a cardboard box.

Marketing Authorization Holder and Manufacturer

"HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information on the Medicine

tel.: 22 742 00 22
e-mail: [email protected]

Date of Last Revision of the Leaflet: 07/2023

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