Izotek 10 mg

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Izotek 10 mg(A-CNOTREN)

10 mg, soft capsules

Isotretinoin
Izotek 10 mg and A-CNOTREN are different trade names for the same medicine.

WARNING

IT CAN SERIOUSLY HARM AN UNBORN CHILD
Women must use effective methods of contraception.
Do not use during pregnancy or if you suspect you are pregnant.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Izotek 10 mg and what is it used for
• 2. Important information before taking Izotek 10 mg
• 3. How to take Izotek 10 mg
• 4. Possible side effects
• 5. How to store Izotek 10 mg
• 6. Contents of the pack and other information

1. What is Izotek 10 mg and what is it used for

Izotek 10 mg contains the active substance isotretinoin, a substance similar to vitamin A and belonging to a group of medicines called retinoids (used in the treatment of acne).
Izotek 10 mg is used to treat severe forms of acne(such as nodular or conglobate acne or acne with a risk of permanent scarring) in adults and adolescents over 12 years of age, only after puberty. Izotek 10 mg will be used only if the severity of acne cannot be alleviated with other anti-acne medications, including antibiotics and topical treatments.
Treatment with Izotek 10 mg must be supervised by a dermatologist(a doctor specializing in the treatment of skin diseases).

2. Important information before taking Izotek 10 mg

When not to take Izotek 10 mg:

• of this medicine (listed in section 6),
• see "Warnings and precautions" section
• in women who may become pregnant but cannot or do not want to followthe necessary pregnancy prevention measures, which are listed in the Pregnancy Prevention Program for the medicine

Izotek 10 mg,

• in liver disease,
• in patients with very high levels of lipids in the blood(e.g., high cholesterol or triglycerides),
• in patients with very high levels of vitamin Ain the body (hypervitaminosis A),
• in case of concurrent treatment with tetracyclines(an antibiotic used, for example, in the treatment of acne) (see "Other medicines and Izotek 10 mg").

In case of any of the above situations, you should consult a doctor before starting treatment with Izotek 10 mg.

Warnings and precautions

Before starting treatment with Izotek 10 mg, you should discuss it with your doctor or pharmacist.

Pregnancy Prevention Program

IMPORTANT

Information for women

Pregnant women must not take Izotek 10 mg.

This medicine can seriously harm an unborn child (the medicine has a teratogenic effect). It can cause serious damage to the brain, face, ear, eyes, heart, and some glands (thymus and parathyroid) of the fetus. It also increases the risk of miscarriage. These effects

can occur even if Izotek 10 mg is taken for a short period of time during pregnancy.

Do not take Izotek 10 mg if you are pregnant or think you may be pregnant.

• Do not take Izotek 10 mg during breastfeeding.The medicine is likely to pass into breast milk and may harm the breastfed baby.

Do not take Izotek 10 mg if you may become pregnant during treatment.

The patient must not become pregnant for one month after stopping treatment, as the medicine may still be present in the patient's body.

Izotek 10 mg may only be prescribed to female patients of childbearing potential under strict conditions. This is due to the risk of serious birth defects.

The following conditions must be met:

The doctor must explain to the patient the risk of birth defects

(congenital anomalies); the patient must understand why she must not become pregnant and how to prevent it.

• The patient must discuss contraception with the doctor(methods of birth control). The doctor will provide the patient with information about contraceptive methods. The doctor may refer the patient to a specialist for contraceptive advice.
• Before starting treatment, the doctor will ask the patient to have a pregnancy test.The test must show that the patient is not pregnant at the start of treatment with Izotek 10 mg.

Female patients must use effective methods of contraception before, during, and after treatment

with Izotek 10 mg.

The patient must agree to use at least one highly effective method of contraception (e.g., an intrauterine device or contraceptive implant), or two effective methods that work in different ways (e.g., oral hormonal contraceptives and condoms).The patient should discuss with the doctor which methods are most suitable for her.

The patient must use a contraceptive for one month before taking Izotek 10 mg, during

treatment, and for one month after stopping the medicine.

The patient must use contraception, even if she does not menstruate or is not currently

sexually active(unless the doctor considers it unnecessary).

Female patients must agree to have pregnancy tests before, during, and after treatment

The patient must agree to have regular check-ups with the doctor, ideally every month.

The patient must agree to have regular pregnancy tests,

ideally every month during treatment and one month after stopping Izotek 10 mg, as the medicine may still be present in the patient's body (unless the doctor decides it is not necessary for the individual patient).

• The patient must agree to have additional pregnancy testsas advised by the treating doctor.

The patient must not become pregnant during and for one month after stopping treatment,

as the medicine may still be present in the patient's body.

The treating doctor will discuss all issues with the patient using a checklist and

ask the patient (or her parent or legal guardian) to sign it.This form confirms that the patient has been informed of the risk and agrees to follow the above rules.

If the patient becomes pregnant while taking Izotek 10 mg, she must

stop taking the medicine immediatelyand contact her doctor. The doctor may refer the patient to a specialist for advice.

In addition, if the patient becomes pregnant within one month of stopping treatment

with Izotek 10 mg, she should contact her treating doctor.The doctor may refer the patient to a specialist for advice.

Advice for men

The amount of oral retinoids in the semen of men taking Izotek 10 mg is too small to harm an unborn child. However, this medicinal product should never be shared with anyone else, especially women.

Additional precautions

Never give this medicinal product to another person. All unused capsules should be returned to the pharmacist after treatment is completed.

Do not donate blood while taking this medicine or for one month after stopping Izotek 10 mg.

Information for all patients

Discuss with your doctor if you have ever had problems

related to mental health,including depression, aggression, or mood swings. This is because Izotek 10 mg may affect your mood. You may not notice certain changes in your mood and behavior, so it is very important to tell your friends and family that you are taking this medicine. They may notice such changes and help you identify problems that need to be discussed with your doctor.

• During isotretinoin treatment, severe skin reactions(e.g., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been observed. The rash can look like circular patches, often with central blisters, usually on the hands and feet or buttocks. More severe rashes can cover larger areas of the body. They can also cause additional symptoms such as eye infections (conjunctivitis) or sores in the mouth, throat, or genitals. Some types of rash can lead to widespread peeling of the skin, which can be life-threatening. The onset of these severe skin rashes is often preceded by headache, fever, and flu-like symptoms.

In rare cases, Izotek 10 mg may cause severe allergic reactions,

which can include skin reactions such as rash, hives, and bruising or red spots on the hands and feet. If an allergic reaction occurs, you should stop taking Izotek 10 mg and consult your doctor immediately.

• Limit intense exercise and physical activity.Izotek 10 mg may cause muscle and joint pain, especially in children and adolescents who engage in intense physical activity.
• Isotretinoin has been associated with non-specific inflammatory bowel disease.If a patient with no history of gastrointestinal disease develops severe bloody diarrhea, the doctor will stop treatment with Izotek 10 mg.

Izotek 10 mg may lead to dry eye syndrome, intolerance to contact lenses

and vision problems, including impaired night vision.There have been cases of dry eye that did not improve after treatment was stopped. You should inform your doctor if you experience any of these symptoms. The doctor may recommend using moisturizing eye ointments or artificial tears. If you experience intolerance to contact lenses, the doctor may recommend wearing glasses during treatment. If you experience vision problems, the doctor may refer you to a specialist for advice and may recommend stopping Izotek 10 mg.

During isotretinoin treatment, mild intracranial hypertension has been observed,

in some cases during concurrent treatment with isotretinoin and tetracyclines (a type of antibiotic used, for example, in the treatment of acne). If symptoms such as headache, nausea, vomiting, and vision disturbances occur, you should stop taking Izotek 10 mg and consult your doctor immediately. The doctor may refer you to a specialist to check for papilledema (swelling of the optic disc).

• Izotek 10 mg may increase liver enzyme activity.The treating doctor will order blood tests to check liver enzyme activity before, during, and after treatment. If liver enzyme activity remains high, the treating doctor may reduce the dose or stop treatment with Izotek 10 mg.
• Isotretinoin often leads to increased blood lipid levels,such as cholesterol or triglycerides. The doctor will check blood lipid levels before starting treatment with Izotek 10 mg, as well as during and after treatment. During treatment, it is best to avoid drinking alcohol or reduce its consumption. You should inform your doctor if you have high blood lipid levels, diabetes (high blood sugar levels), or if you are overweight or have a history of alcoholism. More frequent blood tests may be necessary. If blood lipid levels remain high, the doctor may reduce the dose or stop treatment with Izotek 10 mg.

Tell your doctor if you have any kidney problems.

The doctor may start treatment with a lower dose of Izotek 10 mg and then increase it to the maximum tolerated dose.

• Izotek 10 mg may increase blood sugar levels.In rare cases, patients have developed diabetes. The doctor may monitor blood sugar levels during treatment, especially if you already have diabetes or are overweight or have a history of alcoholism.
• It is likely that the skin will become dry.During treatment, you should use a moisturizing cream or lotion and lip balm to prevent skin irritation and dryness.

Avoid excessive sun exposure and the use of sunlamps and tanning beds.

Your skin may become more sensitive to sunlight. Before going out in the sun, apply a sunscreen with a high sun protection factor (at least SPF 15) to your skin.

• Do not have any cosmetic procedures on your skin.Izotek 10 mg can make your skin more sensitive. Do not wax, dermabrade, or have laser treatments (to remove rough skin or scars) during treatment and for at least 6 months after stopping treatment, as this can lead to scarring, skin irritation, and changes in skin color.
• Tell your doctor if you experience persistent back pain or pain in the buttocks. These symptoms may indicate inflammatory bowel disease, a type of back pain caused by inflammation. The doctor may stop treatment with Izotek 10 mg and refer you to a specialist for treatment of inflammatory back pain. Further evaluation, including imaging studies such as MRI, may be necessary.

Children and adolescents

Izotek 10 mg should not be used in children under 12 years of age. It is not known whether the medicine is safe or effective in this age group.

Treatment with Izotek 10 mg in adolescents over 12 years of age is only possible after puberty.

Other medicines and Izotek 10 mg

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.

While taking Izotek 10 mg, do not take

products containing vitamin A or tetracycline(an antibiotic used, for example, in the treatment of acne) or use any anti-acne products on the skin. You can use moisturizing products and emollients (creams or preparations applied to the skin that prevent water loss and soften the skin).

• While taking Izotek 10 mg, avoid using topical anti-acne keratolytic or exfoliating products.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Izotek 10 mg must not be used during pregnancy. If you are able to become pregnant, you must use effective contraception while taking Izotek 10 mg and for one month after stopping the medicine.
If you become pregnant while taking Izotek 10 mg or within one month of stopping treatment, you should stop taking the medicine immediatelyand contact your doctor. The doctor may refer you to a specialist for advice.
Taking Izotek 10 mg during pregnancy may harm the fetus(because the medicine has a teratogenic effect). It also increases the risk of miscarriage.

Izotek 10 mg may cause serious birth defects in the fetus, including

brain, face, ear, eye, heart, and some gland (thymus and parathyroid) defects.

Do not take Izotek 10 mg during breastfeeding.

Izotek 10 mg is likely to pass into breast milk and may harm the breastfed baby.
For more information on pregnancy and contraception, see section 2 "Pregnancy Prevention Program".

Driving and using machines

During treatment, your ability to see in the dark may decrease. Such vision disturbances can occur suddenly. In rare cases, they can persist after treatment is stopped. Very rarely, drowsiness, dizziness, and vision disturbances have been reported. If you experience these symptoms, you should not drive or operate machinery.
Izotek 10 mg contains soybean oil.Do not take Izotek 10 mg if you are allergic to peanuts or soy.

3. How to take Izotek 10 mg

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Izotek 10 mg (10 mg) and Izotek 20 mg (20 mg) are available.

Recommended dose:

The initial dose is usually 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day).
If your weight is 60 kg, treatment will usually start with a dose of 30 mg per day.

Capsules should be taken once or twice a day.

The medicine should be taken with food. Swallow the capsules whole with water or food.
After a few weeks, your doctor may change the dose.This depends on how you tolerate the treatment and the results of the therapy. For most patients, the dose is between 0.5 mg/kg/day and 1 mg/kg/day. If you feel that the effect of Izotek 10 mg is too weak or too strong, you should inform your doctor or pharmacist.
Treatment usually lasts from 16 to 24 weeks.In most patients, only one treatment cycle is necessary. Acne symptoms may continue to improve for up to 8 weeks after treatment is stopped. Treatment is usually not started again until then. Some people may experience worsening of acne during the first few weeks of treatment. These symptoms usually improve as treatment continues.

Patients with kidney problems

In case of severe kidney disease, treatment should start with a lower dose (e.g., 10 mg/day), which can then be increased to the maximum tolerated dose.
If you do not tolerate the recommended dose, you may receive a lower dose, which may mean that treatment will be longer and that acne is more likely to recur.

Taking more than the recommended dose of Izotek 10 mg

If you have taken too many capsules or if someone else has taken your medicine by mistake, you should contact your doctor, pharmacist, or the nearest hospital immediately.
Isotretinoin is a derivative of vitamin A. Symptoms of overdose with Izotek 10 mg are similar to those of vitamin A overdose, such as headache, nausea, vomiting, dizziness, irritability, and itching.

Missing a dose of Izotek 10 mg

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, do not take the missed dose, but continue treatment as prescribed. Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Izotek 10 mg can cause side effects, although not everybody gets them.
These symptoms usually disappear or decrease after treatment is stopped. Others may be severe and require immediate medical attention.

Side effects that require immediate medical attention:

Skin problems

Frequency not known(frequency cannot be estimated from the available data)

• Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which can be life-threatening and require immediate medical attention. Initially, they may look like circular patches, often with central blisters, usually on the hands and feet or buttocks. More severe rashes can cover larger areas of the body. They can also cause additional symptoms such as eye infections (conjunctivitis) or sores in the mouth, throat, or genitals. Some types of rash can lead to widespread peeling of the skin, which can be life-threatening. The onset of these severe skin rashes is often preceded by headache, fever, and flu-like symptoms.

If you experience a severe rash or the above skin symptoms, you should stop taking Izotek 10 mg and contact your doctor immediately.

Psychiatric disorders

Rare side effects(may affect up to 1 in 1000 people)

• Depression or related disorders. Symptoms include sadness, mood changes, anxiety, and emotional discomfort.
• Worsening of existing depression.
• Aggression or violent behavior.

Very rare side effects(may affect up to 1 in 10,000 people)

• Some people have had thoughts or ideas about self-harm or suicide (suicidal thoughts), attempted suicide (suicide attempts), or committed suicide. These people may not have shown symptoms of depression.
• Abnormal behavior.
• Psychotic symptoms: loss of contact with reality, e.g., hearing voices or seeing things that do not exist.

If you experience any of the above psychiatric symptoms, you should

contact your doctor immediately.The doctor may recommend stopping Izotek 10 mg. Stopping the medicine may not be enough to make these effects go away; additional help may be necessary, and the doctor can provide it.

Allergic reactions

Rare side effects(may affect up to 1 in 1000 people)

• Severe (anaphylactic) reactions: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and mouth. Also, sudden swelling of the hands, feet, and ankles.

Very rare side effects(may affect up to 1 in 10,000 people)

• Sudden chest tightness, shortness of breath, and wheezing, especially if you have asthma.

If you experience a severe allergic reaction, you should go to the emergency room immediately.

If you experience any allergic reaction, you should stop taking Izotek 10 mg and contact your doctor.

Musculoskeletal and connective tissue disorders

Frequency not known(frequency cannot be estimated from the available data)

• Muscle weakness, which can be life-threatening, may be associated with problems moving arms or legs, pain, swelling, bruising, dark urine, decreased urine production, or kidney failure. These are symptoms of rhabdomyolysis, a breakdown of muscle tissue that can lead to kidney failure. This can occur with intense physical activity while taking Izotek 10 mg.

Disorders of the liver and kidney

Very rare side effects(may affect up to 1 in 10,000 people)

• Yellowing of the skin or whites of the eyes and feeling tired. These may be symptoms of liver inflammation.

You should stop taking Izotek 10 mg and contact your doctor immediately.

• Problems urinating, swollen and bruised eyelids, feeling very tired. These may be symptoms of kidney inflammation.

You should stop taking Izotek 10 mg and contact your doctor immediately.

Nervous system disorders

Very rare side effects(may affect up to 1 in 10,000 people)

• Persistent headache with nausea, vomiting, and vision disturbances, including blurred vision. These may be symptoms of mild intracranial hypertension, especially when taking Izotek 10 mg with tetracycline antibiotics.

You should stop taking Izotek 10 mg and contact your doctor immediately.

Gastrointestinal disorders

Very rare side effects(may affect up to 1 in 10,000 people)

• Severe abdominal pain with bloody diarrhea, nausea, and vomiting, or without these symptoms. These may be symptoms of severe bowel disease.

You should stop taking Izotek 10 mg and contact your doctor immediately.

Eye disorders

Very rare side effects(may affect up to 1 in 10,000 people)

• Blurred vision.

If you experience blurred vision, you should stop taking Izotek 10 mg and contact your doctor immediately.

If you experience any other changes in your vision, you should contact your doctor as soon as possible.

Other side effects

Very common side effects(may affect more than 1 in 10 people)

• Dry skin, especially on the lips and face, skin inflammation, peeling, and inflammation of the lips, rash, mild itching, and mild peeling. From the start of treatment, you should use a moisturizing cream.
• Skin more sensitive and reddened than usual, especially on the face.
• Back pain, muscle pain, joint pain, especially in children and adolescents . To avoid worsening of any bone or muscle problems, you should limit intense physical activity while taking Izotek 10 mg.
• Eyelid inflammation (conjunctivitis) and inflammation of the eyes, feeling of dryness and irritation of the eyes. You should ask your pharmacist for suitable eye drops. If you experience dry eye syndrome, you may need to wear glasses instead of contact lenses.
• Increased liver enzyme activity in blood tests.
• Changes in blood lipid levels (including HDL or triglycerides).
• Bruising, bleeding, or faster blood clotting - if the problem affects the cells responsible for blood clotting.
• Anemia - weakness, dizziness, pale skin - if the problem affects red blood cells.

Common side effects(may affect up to 1 in 10 people)

• Headache.
• High cholesterol levels in the blood.
• Presence of protein or blood in the urine.
• Increased susceptibility to infections, if the problem affects white blood cells.
• Dryness of the nasal passages and formation of crusts, leading to mild nosebleeds.
• Pain or inflammation of the throat and nasal passages.
• Allergic reactions, such as rash, itching. If you experience any allergic reaction, you should stop taking Izotek 10 mg and contact your doctor.

Rare side effects(may affect up to 1 in 1000 people)

• Hair loss (alopecia). It is usually temporary and should stop after treatment is completed.

Very rare side effects(may affect up to 1 in 10,000 people)

• Decreased ability to see in the dark, color blindness, and decreased color perception.
• Increased sensitivity to light; you may need to wear sunglasses to protect your eyes from too much light.
• Other vision problems, including blurred vision, distorted vision, and clouding of the cornea (cataract).
• Excessive thirst, need to urinate frequently, blood test results indicating high blood sugar levels. These may be symptoms of diabetes.
• During the first few weeks, acne may worsen, but symptoms should start to improve over time.
• Skin inflammation, swollen, and darker than usual, especially on the face.
• Excessive sweating or itching.
• Arthritis; bone problems (delayed growth, excessive growth, and changes in bone density); growth retardation may occur in growing bones.
• Calcification of soft tissues; pain and high levels of muscle breakdown products in the blood, especially with intense physical activity.
• Increased sensitivity to light.
• Bacterial infections at the base of the nails, changes in the nails.
• Swelling, discharge, or pus.
• Excessive scarring after surgery.
• Increased hair growth on the body.
• Seizures, drowsiness, dizziness.
• Swollen lymph nodes may occur.
• Dryness of the throat, hoarseness.
• Hearing problems.
• General feeling of being unwell.
• High levels of uric acid in the blood.
• Bacterial infections.
• Vasculitis (sometimes with bruising or red spots).

Frequency not known(frequency cannot be estimated from the available data)

• Dark or dark brown urine.
• Difficulty achieving or maintaining an erection.
• Decreased sex drive.
• Breast tenderness or swelling, occurring in men
• Vaginal dryness
• Sacroiliitis, a type of back pain caused by inflammation, causing pain in the lower back or buttocks.
• Urethritis.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Izotek 10 mg

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original package. Keep the package tightly closed to protect from light.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
Return any remaining capsules to the pharmacist.Only keep them if your doctor advises you to.
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. Contents of the pack and other information

What Izotek 10 mg contains

• The active substance of Izotek 10 mg is isotretinoin. Each soft capsule contains 10 mg of isotretinoin.
• The other ingredients are: purified soybean oil, yellow wax, hydrogenated soybean oil, partially hydrogenated soybean oil, capsule shell: gelatin, glycerol, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

What Izotek 10 mg looks like and contents of the pack

Izotek 10 mg are oval, red-orange (size 3) capsules.
The medicine is available in cardboard boxes containing PVC/PE/PVDC/Aluminum blisters.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Pharmathen Investments Group Limited
Kritis 32, Papachristoforou Building, 4 floor
Limassol
Cyprus

Manufacturer:

Pharmathen Pharmaceuticals SA
6, Dervenakion str.
15351 Pallini, Attica
Greece
Pharmathen International SA
Sapes, Industrial Park Rodopi Perfecture, Block No 5
Rodopi 69300
Greece

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Greece, the country of export: 45/16-01-2012
Parallel import authorization number: 192/20

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Isotretinoin Orion
Finland:
Isotretinoin Orion
Poland:
Izotek
Greece:
A-Cnotren 10 mg

Date of revision of the leaflet: 01.07.2025

[Information about the trademark]
Detailed and up-to-date information about this medicine is available by scanning the QR code on the leaflet using a smartphone. The same information is also available on the website http://sirpl.org/Retinoidy .
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