Patient Information Leaflet

Izotziaja, 0.5 mg/g, gel
Isotretinoinum
Please read this leaflet carefully before using the medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
This medicine is absolutely contraindicated during pregnancy.

Table of Contents

What Izotziaja is and what it is used for
Important information before using Izotziaja
How to use Izotziaja
Possible side effects
How to store Izotziaja
Contents of the pack and other information

1. What Izotziaja is and what it is used for

Izotziaja contains the active substance isotretinoin, a member of the retinoid group, which regulates the growth and differentiation of the epidermis. When applied to acne-affected skin, isotretinoin likely acts similarly to tretinoin, stimulating epidermal renewal by reducing intercellular cohesion in the stratum corneum. Thus, it prevents the formation of comedones and facilitates the removal of existing ones.
Indications
Treatment of mild to moderate acne vulgaris.

2. Important information before using Izotziaja

When not to use Izotziaja:

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

Warnings and precautions
Before starting treatment with Izotziaja, discuss this with your doctor or pharmacist.
Avoid contact of the medicine with eyes, mouth, mucous membranes, irritated skin, and areas of skin with cuts, abrasions, burns, or rash.
Care should be taken to prevent the medicine from accumulating in skin folds (especially on the neck) or on the nasal alae, as it may cause irritation of sensitive areas.
Izotziaja should not be used by patients with a history of cutaneous epithelioma (cutaneous epithelioma).
Skin areas treated with Izotziaja should be protected from sunlight. If exposure to strong sunlight cannot be avoided, UV filters and protective clothing should be used. Izotziaja should not be used by patients with sunburn, as the skin may be more sensitive to sunlight in such cases.
Avoid artificial sources of UV radiation, such as quartz lamps or visits to solariums.

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

Izotziaja and other medicines
Inform your doctor about all medicines currently or recently used, as well as any medicines you plan to use.
Exercise caution when using other topical treatments simultaneously. During treatment with Izotziaja, avoid using keratolytic agents (e.g. benzoyl peroxide) and abrasive-cleansing products, as they may increase irritant effects.

Pregnancy, breastfeeding, and effects on fertility
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.
DO NOT use Izotziaja during pregnancy or if the patient plans to become pregnant.
Further information is available from the attending physician. If pregnancy occurs during treatment with Izotziaja, treatment must be stopped immediately.
In humans, isotretinoin administered systemically is known to cause fetal damage.
Izotziaja should not be used in women who are breastfeeding.

Driving and operating machinery
There is no data available on the effects of Izotziaja on the ability to drive vehicles or operate machinery.

Izotziaja contains butylhydroxytoluene (E 321)
This medicine may cause local skin reactions (e.g. contact dermatitis) or irritation of eyes and mucous membranes.

Izotziaja contains 96% ethanol
This medicine contains 922.5 mg of ethanol per gram of gel. It may cause stinging on damaged skin. The product is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

3. How to use Izotziaja

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
This medicine is intended for topical application to the skin.
If you feel the effect of the medicine is too strong or too weak, consult a doctor.

Use in adults
A small amount of Izotziaja should be applied to the affected areas of the skin once or twice daily.
Before application, the skin should be washed and thoroughly dried. Hands should be washed thoroughly
after contact with the medicine. Treatment effectiveness is usually observed after 6–8 weeks.

Use in children
Izotziaja is not intended for use in children. Acne vulgaris rarely occurs in children before puberty,
and therefore the dosage in this age group has not been established.

Use in elderly patients
The use of Izotziaja is not recommended in this age group, as acne vulgaris does not occur in elderly individuals.

Use of a higher than recommended dose of Izotziaja
Symptoms of overdose with isotretinoin in gel form have not been reported. Accidental ingestion of a large dose of Izotziaja may cause symptoms similar to hypervitaminosis A, such as headache, nausea, vomiting, drowsiness, irritation, and itching.

Missed dose of Izotziaja
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone will experience them.
Izotziaja may cause burning, redness, itching, erythematous changes, and peeling of the skin. These symptoms are usually transient. If they intensify, the frequency of application should be reduced or treatment may need to be interrupted for several days, after which the medicinal product can be reapplied. However, if skin irritation symptoms worsen, treatment should not be continued.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Izotziaja

Keep the medicine out of sight and reach of children.
Store below 25°C.
Period of validity 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What the medicine 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.
Pack: an aluminum tube with a cap containing 20 g of gel, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
Jesienna 9 Street, 80-298 Gdańsk
Tel.: +48 58 521 34 00