Nizax activ

Package leaflet: Information for the patient

NIZAX ACTIV
20 mg/g, medicated shampoo
Ketoconazolum
Please read the entire leaflet carefully before using the medicine, as 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 physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the physician or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse, contact the physician.

Table of contents of the leaflet:

1. What Nizax Activ is and what it is 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 package and other information

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

Nizax Activ medicated shampoo is an antifungal shampoo intended for topical application
to the skin. The active substance is ketoconazole.
Indications
Nizax Activ medicated shampoo is indicated for the treatment and prevention of skin disorders caused by Malassezia (formerly Pityrosporum) yeasts, such as:
dandruff of the scalp (desquamation of the scalp skin 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 white spots on the skin of the chest) caused by Pityriasis versicolor infection.

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 treatment with Nizax Activ, discuss it with your doctor or pharmacist.
If the patient has previously undergone prolonged topical corticosteroid therapy, to avoid worsening of disease symptoms after discontinuation, the doctor will recommend gradually tapering off corticosteroid treatment over a period of 2 to 3 weeks. Skin may react to too rapid withdrawal of corticosteroids with redness and itching.
Any doubts should be clarified with a doctor.
Avoid contact of the product with eyes; if contact occurs, rinse eyes thoroughly with water.
Seborrhoeic dermatitis and dandruff are often associated with increased hair loss, which may also occur, although rarely, during treatment with Nizax Activ.

Children and adolescents
Do not use in children under 12 years of age.

Nizax Activ and other medicines
Tell your doctor about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
There is no data available regarding the use of Nizax Activ with other medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Nizax Activ medicated shampoo may be used during pregnancy and breastfeeding only if, in the opinion of the doctor, it is clearly necessary.

Nizax Activ contains fragrance composition Green Tea D878/L
The medicine contains a fragrance composition including, among others: benzyl alcohol, citral, isoeugenol, benzyl salicylate, geraniol, linalool, citronellol, hexyl cinnamal, d-limonene, dipropylene glycol. These substances may cause allergic reactions. The product contains 0.00006 mg of benzyl alcohol and 0.88 mg of dipropylene glycol per 1 g of medicated shampoo.

Nizax Activ contains carmine - may cause allergic reactions.

3. How to use Nizax Activ

This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicated shampoo is intended for topical application to the skin.
Adults and adolescents (aged over 12 years)
Unless otherwise directed by a doctor, the medicated shampoo Nizax Activ should be used according to the instructions described below.

1. Apply a small amount of shampoo to the affected skin. Usually, an amount the size of a palm or the contents of one sachet (6 ml) is sufficient for a single application. Before using Nizax Activ, hair may be previously washed with a regular shampoo.
2. Using a small amount of water, spread the medicated shampoo evenly over the skin. In the case of long hair, only the scalp needs to be washed.
3. Massage the medicated shampoo into the skin until foam is formed.
4. Leave the foam on the skin for 3 to 5 minutes, then rinse thoroughly.
5. A regular shampoo may be used daily.

Treatment:
Pityriasis versicolor: apply once daily for 5 consecutive days.
Seborrhoeic dermatitis and dandruff: apply twice a week for 2 to 4 weeks.
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Prophylaxis:
Pityriasis versicolor: apply once daily for 3 consecutive days per treatment cycle, prior to the summer season.
Seborrhoeic dermatitis and dandruff: apply once a week or once every two weeks.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Use of a higher than recommended dose of Nizax Activ
Topical use of the medicated shampoo Nizax Activ according to the indications and described method of use does not pose a risk of overdose.
In case of accidental ingestion, seek medical advice immediately.
Overdose may lead to an increase in adverse effects.
In case of accidental ingestion, the doctor will provide supportive and symptomatic treatment. To avoid aspiration of gastric contents, do not induce vomiting or perform gastric lavage.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everybody gets them.
Not very common (in 1 to 10 patients out of 1,000):
taste disturbances
inflammation of hair follicles
eye irritation, increased tearing, local site sensitivity
skin burning sensation, acne, hair loss, dry skin, changes in hair structure,
rash, skin changes, skin peeling, contact dermatitis or
reactions at the application site (redness, irritation, hypersensitivity reactions, itching, blisters).
Very rare (occurring in less than 1 patient out of 10,000) or frequency not known (frequency cannot be estimated from the available data):
angioedema
urticaria
hair discoloration.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, please inform your doctor or pharmacist. Adverse effects 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
Tel.: +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 Nizax Activ

Do not store at temperatures above 25°C.
Keep the medicine in a place out of sight and reach of children.
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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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nizax Activ contains

• The active substance is ketoconazole. 1 g of medicinal shampoo contains 20 mg of ketoconazole.
• Other components (excipients) are: ethoxylated sodium lauryl sulfate, disodium laureth sulfosuccinate, cocofatty acid diethanolamide, macrogol 120 methyl glucose dioleate, concentrated hydrochloric acid, sodium chloride, sodium hydroxide 30% solution, hydrolyzed collagen hydroxypropyl-laurildimethylammonium chloride, fragrance composition Green Tea D878/L (contains among others: benzyl alcohol, citral, isoeugenol, benzyl salicylate, geraniol, linalool, citronellol, hexyl cinnamal, d-limonene, dipropylene glycol), RRR-α-tocopherol (E 306), quinoline yellow (E 104), carmine red (E 124), purified water.

What Nizax Activ looks like and contents of the pack
Nizax Activ medicinal shampoo is a thick, clear solution ranging in colour from orange to orange-red, with a characteristic odour.
Packaging of Nizax Activ:
bottles made of high-density polyethylene (HDPE) with polypropylene "flip-top" caps, containing 100 ml of medicinal shampoo, placed in a cardboard box;
laminated sachets (PET/Aluminium/PE), containing 6 ml of medicinal shampoo, packed 6 units per cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal Product Information
tel.: 22 742 00 22
e-mail: [email protected]
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