Izotek 20 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 20 mg(A-CNOTREN)

20 mg, soft capsules

Isotretinoin
Izotek 20 mg and A-CNOTREN are different trade names for the same medicine.

WARNING

IT CAN SERIOUSLY HARM THE UNBORN CHILD
Women must use effective methods of contraception.
Do not use during pregnancy or if you suspect you are pregnant.
This medicinal product will be subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, 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 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 adverse reactions, including any adverse reactions 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 20 mg and what is it used for
• 2. Important information before taking Izotek 20 mg
• 3. How to take Izotek 20 mg
• 4. Possible side effects
• 5. How to store Izotek 20 mg
• 6. Contents of the packaging and other information

1. What is Izotek 20 mg and what is it used for

Izotek 20 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 20 mg is used to treat severe forms of acne(such as nodular acne or conglobate acne or acne with a risk of permanent scarring) in adults and adolescents over 12 years of age, only after puberty. Izotek 20 mg will be used only if the severity of acne cannot be alleviated with other anti-acne medications, including antibiotics and topical medications.
Treatment with Izotek 20 mg must be supervised by a dermatologist(a doctor specializing in the treatment of skin diseases).

2. Important information before taking Izotek 20 mg

When not to take Izotek 20 mg:

• If the patient is allergic to isotretinoin, peanuts, or soy or any of the other ingredientsof this medicine (listed in section 6),
• If the patient is pregnant or breastfeeding,
• If there is a risk that the patient may become pregnant, it is necessary to follow the precautions listed in the Pregnancy Prevention Program,see the section "Warnings and precautions",
• For women who may become pregnant but cannot or do not want to followthe necessary pregnancy prevention measures that are listed in the Pregnancy Prevention Program for the medicine

Izotek 20 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 the case of concurrent treatment with tetracyclines(an antibiotic used, among other things, in the treatment of acne) (see "Other medicines and Izotek 20 mg").

In the event of any of the above situations, you should consult a doctor before starting treatment with Izotek 20 mg.

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting treatment with Izotek 20 mg.

Pregnancy Prevention Program

IMPORTANT

Information for women

Pregnant women must not take Izotek 20 mg.

This medicine can seriously harm the 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 20 mg is taken for a short period of time during pregnancy.

• Do not take Izotek 20 mg if you are pregnant or think you may be pregnant.
• Do not take Izotek 20 mg during breastfeeding.The medicine is likely to pass into breast milk and may harm the breastfed child.
• Do not take Izotek 20 mg if you may become pregnant during treatment.
• The patient must not become pregnant for one month after the end of treatment, because the medicine may still be present in the patient's body.

Izotek 20 mg may be prescribed to female patients of childbearing potential under strict conditions.

These 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 who will provide 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 20 mg.

Female patients must use effective methods of contraception before, during, and after treatment with Izotek 20 mg.

Izotek 20 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 them.
• The patient must use a contraceptive method for one month before taking the medicine

Izotek 20 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 20 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 20 mg, because 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, because 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 their 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 20 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 20 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 sperm of men taking Izotek 20 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

This medicinal product should never be given to another person. All unused capsules should be returned to the pharmacist after treatment has ended.

You must not donate blood during treatment with this medicine or for one month after stopping Izotek 20 mg. If your blood is given to a pregnant woman, she may have a baby with birth defects.

Information for all patients

• Tell your doctor if you have ever had mental health problems,including depression, aggression, or mood swings. This is because Izotek 20 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 these 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 can take the form of widespread blistering or peeling of the skin. You should also be aware of ulcers in the mouth, throat, nose, and genitals, as well as conjunctivitis (redness and swelling of the eyes).
• Izotek 20 mg may cause severe allergic reactions, which can include skin reactions such as rash, urticaria, and angioedema or red and blue spots on the hands and feet. In case of an allergic reaction, you should stop taking Izotek 20 mg, seek immediate medical attention, and inform your doctor that you are taking this medicine.
• You should limit intense exercise and physical activity.Izotek 20 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 has severe diarrhea with blood, and no history of gastrointestinal disease, the doctor will stop treatment with Izotek 20 mg.
• Izotek 20 mg may lead to dry eye syndrome, intolerance to contact lenses, and vision problems,including decreased 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. In case of contact lens intolerance, the doctor may recommend wearing glasses during treatment. In case of vision problems, the doctor may refer the patient to a specialist for advice and may recommend stopping treatment with Izotek 20 mg.

Children and adolescents

Izotek 20 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 20 mg in adolescents over 12 years of age is only possible after puberty.

Other medicines and Izotek 20 mg

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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 20 mg, or use any anti-acne medicines 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 20 mg, you should avoid using local anti-acne keratolytic and exfoliating agents.

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 20 mg must not be used during pregnancy. If you are able to become pregnant, you should use effective contraception while taking Izotek 20 mg and for one month after stopping it.
If you become pregnant while taking Izotek 20 mgor 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 20 mg during pregnancy may harm the fetus(because the medicine has a teratogenic effect). It also increases the risk of miscarriage.

Izotek 20 mg may cause serious malformations in the brain, face, ears, eyes, heart, and some glands (thymus and parathyroid) of the fetus.

Do not take Izotek 20 mg during breastfeeding.It is likely that the medicine will pass into breast milk and may harm the breastfed child.
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 decrease. Such vision disturbances can appear suddenly. In rare cases, they may persist after treatment has stopped. Very rarely, drowsiness, dizziness, and vision disturbances have been reported. If you experience these symptoms, you should not drive or operate machinery.
Izotek 20 mg contains soybean oil. Do not take Izotek 20 mg if you are allergic to peanuts or soy.

3. How to take Izotek 20 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 the patient weighs 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 a full stomach. The capsules should be swallowed whole, with a drink of water or with food.
After a few weeks, the doctor may change the dose.This depends on how the patient tolerates 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 the patient feels that the effect of Izotek 20 mg is too weak or too strong, they should inform their 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 the end of treatment. Usually, a new treatment cycle is not started 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 the 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 the patient does not tolerate the recommended dose, they may receive a lower dose, which may mean that treatment will be longer and that relapse of acne is more likely.

Taking a higher dose of Izotek 20 mg than recommended

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 of Izotek 20 mg are similar to symptoms of vitamin A overdose. These include: headache, nausea, vomiting, dizziness, irritability, and itching.

Missing a dose of Izotek 20 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 the 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 20 mg can cause side effects, although not everybody gets them.
These symptoms often disappear or decrease after stopping treatment. 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 centrally located blisters, usually located on the hands and feet or arms and legs. More severe rashes may cover the chest and back. They may also be accompanied by other symptoms, such as eye infections (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, body aches (flu-like symptoms).

If you experience a severe rash or the above skin symptoms, you should stop taking Izotek 20 mg and seek immediate medical attention.

Psychiatric disorders

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

• Depression or related disorders. Symptoms include sadness, mood changes, anxiety, feeling uncomfortable.
• 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 show symptoms 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, you should

seek immediate medical attention.The doctor may recommend stopping treatment with Izotek 20 mg. Stopping treatment may not be enough for these effects to resolve; 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 the patient has asthma.

If you experience a severe reaction, you should seek immediate medical attention.

If you experience any allergic reaction, you should stop taking Izotek 20 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 20 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 hepatitis.

You should stop taking Izotek 20 mg and contact your doctor immediately.

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

You should stop taking Izotek 20 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 benign intracranial hypertension, especially when taking Izotek 20 mg with antibiotics from the tetracycline group.

You should stop taking Izotek 20 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 20 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 20 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 redder than usual, especially on the face.
• Back pain, muscle pain, joint pain, especially in children and adolescents. To avoid worsening any bone or muscle disorders, you should limit intense physical activity while taking Izotek 20 mg.
• Eye inflammation (conjunctivitis) and eyelid inflammation, feeling of dryness and irritation of the eyes. You should ask your pharmacist for suitable eye drops. In case of dry eye syndrome, it may be necessary 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, you should stop taking Izotek 20 mg and contact your doctor.

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

• Hair loss (alopecia). This is usually temporary. It should stop after the end of treatment.

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; it may be necessary to wear sunglasses to protect the eyes from too much light.
• Other vision problems, including blurred vision, distorted vision, 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 problems (delayed growth, excessive growth, and changes in bone density); growth retardation may occur in growing bones.
• Calcification of soft tissues; pain in 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, 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 blue 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 swelling with tenderness, occurring in men.
• Vaginal dryness.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Adverse Reaction 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 20 mg

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Keep the packaging tightly closed to protect from light.
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 stated.
You should return any remaining capsules to the pharmacist.You should 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 packaging and other information

What Izotek 20 mg contains

• The active substance of Izotek 20 mg is isotretinoin. Each soft capsule contains 20 mg of isotretinoin.
• The other ingredients are: purified soybean oil, yellow wax, hydrogenated soybean oil, partially hydrogenated vegetable oil, capsule shell: gelatin, glycerol, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

What Izotek 20 mg looks like and contents of the pack

Izotek 20 mg are oval, red-orange capsules (size 6).
The medicine is available in cardboard boxes containing PVC/PE/PVDC/Aluminum blisters.
A pack containing 100 soft capsules is available.
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
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
Licence number in Greece, the country of export: 45047/10/18-04-2012

Parallel import licence number: 38/22

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 20 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/
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