Izotziaia

Package Leaflet: Information for the Patient

Izotziaja, 0.5 mg/g, Gel

Isotretinoin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• The medicine is absolutely contraindicated in pregnancy.

Table of Contents of the Leaflet

• 1. What is Izotziaja and what is it used for
• 2. Important information before using Izotziaja
• 3. How to use Izotziaja
• 4. Possible side effects
• 5. How to store Izotziaja
• 6. Package contents and other information

1. What is Izotziaja and what is it used for

Izotziaja contains the active substance isotretinoin, a retinoid that regulates the growth and differentiation of the epidermis. Isotretinoin applied to acne-affected skin probably works similarly to tretinoin, which stimulates epidermal renewal by reducing intercellular cohesion in the stratum corneum. This prevents the formation of comedones and facilitates the removal of existing comedones.

Indications

Treatment of mild to moderate common acne.

2. Important information before using Izotziaja

When not to use Izotziaja:

• if the patient is hypersensitive to isotretinoin or any of the other ingredients of this medicine (listed in section 6),
• in pregnant women,
• in women planning to become pregnant,
• in breastfeeding women.

Warnings and precautions

Before starting treatment with Izotziaja, discuss it with your doctor or pharmacist. Avoid contact with the eyes, mouth, mucous membranes, and irritated skin, as well as areas of the skin with cuts, scratches, burns, or eczema. Be careful not to accumulate the medicine in skin folds (especially on the neck) or on the wings of the nose, as it may cause irritation to sensitive areas. The medicine should not be used by people with a history of cutaneous epithelioma. The skin area treated with Izotziaja should be protected from sunlight. If strong sunlight cannot be avoided, use UV filters and protect the skin with protective clothing. The medicine should not be used by people with sunburn, as the skin may be more sensitive to sunlight. Avoid artificial sources of UV radiation, such as quartz lamps and sunbeds.

Children

The safety and efficacy of Izotziaja in children have not been established, as acne is rare in this age group.

Izotziaja and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Be cautious when using other topical medicines. During treatment with Izotziaja, avoid using exfoliating agents (benzoyl peroxide) and abrasive cleansers, as they may enhance the irritating effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. DO NOT USE Izotziaja during pregnancy or if you are planning to become pregnant. For more information, consult your doctor. If you become pregnant during treatment with Izotziaja, stop the treatment immediately. In humans, systemic isotretinoin has been shown to cause fetal harm. Izotziaja should not be used in breastfeeding women.

Driving and using machines

There is no data on the effect of Izotziaja on the ability to drive and use machines.

Izotziaja contains butylhydroxytoluene (E 321)

The medicine may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

Izotziaja contains ethanol 96%

This medicine contains 922.5 mg of ethanol per gram of gel. It may cause a burning sensation on damaged skin. The medicine is flammable. Do not use near open flames, lit cigarettes, or certain appliances (e.g., hair dryers).

3. How to use Izotziaja

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The medicine is for topical use on the skin. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Use in adults

Apply a small amount of Izotziaja to the affected areas of the skin once or twice a day. Before applying the medicine, wash and dry the skin. After contact with the medicine, wash your hands thoroughly. The effectiveness of the treatment can usually be observed after 6-8 weeks.

Use in children

Izotziaja is not intended for use in children. Common acne is rare in children before puberty, and therefore, dosing in this age group has not been established.

Use in the elderly

The use of Izotziaja is not recommended in this age group, as common acne does not occur in the elderly.

Overdose of Izotziaja

No symptoms of isotretinoin overdose have been reported in the gel form. Accidental ingestion of a large dose of Izotziaja may cause symptoms similar to hypervitaminosis A, such as headaches, nausea, vomiting, drowsiness, irritation, and itching.

Missed dose of Izotziaja

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Izotziaja can cause side effects, although not everybody gets them. Izotziaja may cause burning, redness, itching of the skin, erythema, and desquamation. These are usually transient symptoms; however, if they worsen, the medicine should be used less frequently or the treatment should be interrupted for a few days and then resumed. If the symptoms of irritation worsen, the treatment should not be continued.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, ul. 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Izotziaja

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Shelf life after first opening the tube: 2 months. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month. Medicines should 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. Package contents and other information

What Izotziaja contains

• The active substance is isotretinoin. One gram of gel contains 0.5 mg of isotretinoin.
• The other ingredients are butylhydroxytoluene (E 321), hydroxypropylcellulose, ethanol 96%.

What Izotziaja looks like and contents of the pack

Izotziaja is a gel. The package is an aluminum tube with a screw cap, containing 20 g of gel, placed in a cardboard box.

Marketing authorization holder and manufacturer

ZIAJA Ltd, ul. Jesienna 9, 80-298 Gdańsk, Tel.: +48 58 521 34 00, Date of last revision of the leaflet:07/2023