Izotek 10 mg

Leaflet accompanying 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 MAY SERIOUSLY HARM THE UNBORN CHILD
Women must use effective methods of contraception.
Do not use during pregnancy or if you suspect you may be pregnant.
This medicinal product will be subject to additional monitoring. This will allow for quick identification of new safety information. You can help by reporting any side effects you may get. To find out how to report side effects, see the last paragraph of section 4.

You should carefully read the contents of the leaflet before taking 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 to treat acne).
Izotek 10 mg is used to treat severe forms of acne(such as nodular or conglobate acne, or acne with a risk of scarring) in adults and adolescents over 12 years of age, only after puberty. Izotek 10 mg will be used only if the acne has not responded to other anti-acne treatments, 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:

• If you are allergic to isotretinoin, peanuts, or soy, or any of the other ingredients of this medicine(listed in section 6),
• If you are pregnant or breastfeeding,
• If there is a risk that you may become pregnant, it is necessary to follow the precautions listed in the Pregnancy Prevention Program, see "Warnings and precautions",
• For women who may become pregnant but cannot or do not want to follow the necessary pregnancy prevention measureslisted in the Pregnancy Prevention Program for this 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 A in the body(hypervitaminosis A),
• During concurrent treatment with tetracyclines(an antibiotic used, for example, in the treatment of acne) (see "Other medicines and Izotek 10 mg").

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

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting treatment with Izotek 10 mg.

Pregnancy Prevention Program

IMPORTANT

Information for women

Women who are pregnant must not take Izotek 10 mg.

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

may occur even if Izotek 10 mg is taken for a short period of time during pregnancy.
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.
• You must not become pregnant for one month after stopping treatment with Izotek 10 mg, as the medicine may still be present in your body.

Izotek 10 mg may be prescribed to female patients of childbearing potential under strict conditions.

The following conditions must be met:

• The doctor must explain to the patient the risk of damage to the unborn child (birth defects); the patient must understand why she must not become pregnant and how to prevent it.
• The patient must discuss contraception with the doctor. The doctor will provide the patient with information on contraceptive methods. The doctor may refer the patient to a specialist for advice on contraception.
• 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.

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 the medicine

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 decides it is not necessary).

Female patients must agree to have pregnancy tests before, during, and after treatment with Izotek 10 mg.

• 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 patient).
• The patient must agree to have additional pregnancy testsas recommended 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 these 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 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 the unborn child of their partner. 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 has ended.

Do not donate blood during treatment with this medicine or for one month after stopping Izotek 10 mg. If your blood is given to a pregnant woman, it may cause birth defects.

Information for all patients

• Tell your doctor if you have ever had problems with your mental health, including depression, aggression, or mood swings. This is because Izotek 10 mg may affect your mood. You may not notice some 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 changes and help you identify problems that need to be discussed with your doctor.
• Severe skin reactions have been observed during treatment with isotretinoin(e.g. erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis). The rash may take the form of widespread blistering or peeling of the skin. You should also be aware of ulcers in the mouth, throat, nose, and genital areas, as well as conjunctivitis (redness and swelling of the eyes).
• Izotek 10 mg may cause severe allergic reactions, which can include skin reactions such as rash, urticaria, and angioedema, or red and purple spots on the hands and feet. If an allergic reaction occurs, you should stop taking Izotek 10 mg and contact 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 develops severe bloody diarrhea without a history of gastrointestinal disease, 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.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 treatment with Izotek 10 mg.

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, or have recently taken, and any medicines you plan to take, including those obtained without a prescription.

• Do not take vitamin A supplements or tetracyclines (a type of antibiotic used, for example, in the treatment of acne) while taking Izotek 10 mg, or use any anti-acne treatments 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 or 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 during treatment with Izotek 10 mg and for one month after stopping the medicine.
If you become pregnant while taking Izotek 10 mgor within one month of stopping treatment, 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(as the medicine has a teratogenic effect). It also increases the risk of miscarriage.

Izotek 10 mg may cause serious abnormalities in the brain, face, ears, eyes, heart, and some glands (thymus and parathyroid) of the fetus.

Do not take Izotek 10 mg during breastfeeding.The medicine is likely to pass into breast milk and may harm the breastfed baby.
More information on pregnancy and contraception can be found in section 2 "Pregnancy Prevention Program".

Driving and using machines

During treatment, your ability to see in the dark may be impaired. Such vision problems can appear suddenly. In rare cases, they can persist after treatment has stopped. Very rarely, drowsiness, dizziness, and vision problems have been reported. If you experience these symptoms, you must 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 and Izotek 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.

Take the capsules once or twice a day.

Take the medicine with a full stomach. Swallow the capsules whole, with a drink of water or with food.
After a few weeks, your doctor may change your dose.This depends on how you tolerate the treatment and the results of the treatment. 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, tell your doctor or pharmacist.
Treatment usually lasts from 16 to 24 weeks.In most patients, only one treatment cycle is needed. Acne symptoms may continue to improve for up to 8 weeks after treatment has 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 cases 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 relapse of acne is more likely.

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, contact your doctor, pharmacist, or the nearest hospital immediately.
Isotretinoin is a derivative of vitamin A. Symptoms of overdose of Izotek 10 mg are similar to those of vitamin A overdose. These include 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These symptoms usually disappear or improve after stopping treatment. Others may be serious 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 appear as circular patches, often with centrally located blisters, usually located on the hands and feet or on the chest and back. More severe rashes may spread to the chest and back and may also include additional symptoms such as eye infection (conjunctivitis) or ulcers in the mouth, throat, or nose. Some types of rash may take the form of 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, 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 of self-harm or suicide (suicidal thoughts), attempted suicide (suicide attempts), or committed suicide. These people may not have shown signs of depression.
• Abnormal behavior.
• Psychotic symptoms: loss of contact with reality, e.g. the patient hears voices or sees things that do not exist.

If you experience any of the above psychiatric symptoms, contact your doctor immediately.

Your doctor may recommend stopping treatment with Izotek 10 mg.Stopping treatment may not be enough to make these effects go away; additional help may be needed, and your 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, go to the emergency room immediately.

If you experience any allergic reaction, 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 kidneys

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 hepatitis.

Stop taking Izotek 10 mg immediately and contact your doctor.

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

Stop taking Izotek 10 mg immediately and contact your doctor.

Nervous system disorders

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

• Persistent headache with nausea, vomiting, and vision problems, including blurred vision. These may be symptoms of benign intracranial hypertension, especially when taking Izotek 10 mg with antibiotics from the tetracycline group.

Stop taking Izotek 10 mg immediately and contact your doctor.

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.

Stop taking Izotek 10 mg immediately and contact your doctor.

Eye disorders

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

• Blurred vision.

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

If you experience any other changes in your vision, 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. You should use a moisturizing cream from the start of treatment.
• Skin more sensitive and red 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 disorders, you should limit intense physical activity while taking Izotek 10 mg.
• Inflammation of the eyes (conjunctivitis) and eyelids, 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 lipid levels in the blood (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 in the nose, 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, stop taking Izotek 10 mg and contact your doctor.

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

• Hair loss (alopecia). This is usually temporary and should stop after treatment has finished.

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

• Impaired night vision, color blindness, and impaired 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 (corneal clouding, 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 as treatment continues.
• Skin inflammation, swollen and darker than usual, especially on the face.
• Excessive sweating or itching.
• Arthritis; bone disorders (delayed growth, excessive growth, and changes in bone density); growth retardation may occur in growing bones.
• Calcification of soft tissues; pain and inflammation of tendons; high levels of muscle breakdown products in the blood in case of 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.
• Dry throat, hoarseness.
• Hearing problems.
• General feeling of being unwell.
• High levels of uric acid in the blood.
• Bacterial infections.
• Vasculitis (sometimes with bruising, red and purple spots).

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

• Dark or dark brown urine.
• Difficulty achieving or maintaining an erection.
• Decreased libido.
• Breast tenderness or swelling, occurring in men.
• Vaginal dryness.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please 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, tel.: +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 which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Return any unused capsules to the pharmacist.Only keep them if your doctor tells 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 capsules (size 3).
The medicine is available in cardboard boxes containing blisters of PVC/PE/PVDC/Aluminum.
Available in packs of 100 soft capsules.
For more information, 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
3087 Lemesos, Cyprus

Manufacturer:

Pharmathen S.A.
6, Dervenakion Str.
153 51 Pallini
Athens, Greece
Pharmathen International S.A.
Industrial Park Sapes, Block No 5
Rodopi Prefecture 69300, Greece

Parallel Importer:

ProCarePlus Pharma S.A.
ul. Bobrzyńskiego 14, 30-348 Kraków

Repackaged by:

CanPoland S.A.
ul. Beskidzka 190, 91-610 Łódź
Chemiczno-Farmaceutyczna Spółdzielnia Pracy "ESPEFA"
ul. Juliusza Lea 208, 30-133 Kraków
Marketing Authorization Number in Greece, the country of export: 45/16-01-2012

Parallel Import Authorization Number: 37/22

This medicinal product 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: 14.01.2022
[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 https://pcp-izotek.pl/
QR code