Package leaflet: Information for the user

Warning! Keep the leaflet, information on the outer packaging in a foreign language!
Izotek 20 mg (A-CNOTREN)
20 mg, soft capsules
Isotretinoinum
Izotek 20 mg and A-CNOTREN are different brand names of the same medicine.
WARNING
CAN CAUSE SEVERE HARM TO THE UNBORN CHILD
Women must use effective methods of contraception.
Do not use during pregnancy or if pregnancy is suspected.
This medicinal product will be subject to additional monitoring. This will allow for rapid
identification of new safety information. Patients can also help by reporting any adverse reactions
that occur after using the medicine. For information on how to report adverse reactions – see the last paragraph of section 4.
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Izotek 20 mg is and what it is used for
Important information before taking Izotek 20 mg
How to take Izotek 20 mg
Possible side effects
How to store Izotek 20 mg
Contents of the pack and other information

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

Izotek 20 mg contains the active substance isotretinoin – a substance related to vitamin A and
belonging to a group of medicines known as retinoids (used in the treatment of acne).
Izotek 20 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 the age of 12, only after puberty has begun.
Izotek 20 mg will be used only if the severity of acne has not been reduced by treatment with other anti-acne medicines, including antibiotics and topical treatments.
Treatment with Izotek 20 mg must be supervised by a dermatologist (a doctor specializing in the treatment of skin diseases).

2. Important information before using Izotek 20 mg

When not to use Izotek 20 mg:

if the patient is allergic to isotretinoin, peanuts or soy, or to any of the other ingredients of this medicine (listed in section 6),
if the patient is pregnant or breastfeeding,
if there is any risk that the patient could become pregnant, it is necessary to follow the precautions outlined in the Pregnancy Prevention Programme, see section “Warnings and precautions”,
in women who could become pregnant but are unable or unwilling to comply with the necessary measures to prevent pregnancy as specified in the Pregnancy Prevention Programme for Izotek 20 mg,
in liver disease,
in patients with very high levels of lipids in the blood (e.g. high cholesterol or triglyceride levels),
in patients with very high levels of vitamin A in the body (hypervitaminosis A),
during concomitant treatment with tetracyclines (an antibiotic used, among others, in the treatment of acne) (see “Other medicines and Izotek 20 mg”).

If any of the above situations apply, consult a doctor before starting to take Izotek 20 mg.
Warnings and precautions
Discuss this medicine with your doctor or pharmacist before starting treatment with Izotek 20 mg.
Pregnancy Prevention Programme
IMPORTANT
Information for women
Women who are pregnant must not take Izotek 20 mg.
This medicine may severely harm the unborn child (the medicine has a “teratogenic” effect). It may
cause severe malformations of the brain, face, ears, eyes, heart and certain glands (thymus and parathyroid glands) of the foetus. It also increases the risk of miscarriage. These effects may occur
even if Izotek 20 mg is taken for only a short 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 infant.
Do not take Izotek 20 mg if you could become pregnant during treatment.
You must not become pregnant for one month after stopping treatment, as the medicine may still be present in your body.

Izotek 20 mg may be prescribed to women of childbearing potential only if strict rules are followed.
This is due to the risk of severe birth defects in the unborn child.
The following conditions must be met:

The doctor must explain to you the risk of harm to the unborn child (birth defects); you must understand why you must not become pregnant and how to prevent it.
You must discuss contraception (birth control methods) with your doctor. Your doctor will provide information on contraceptive methods. Your doctor may refer you to a specialist for advice on contraception.
Before starting treatment, your doctor will ask you to take a pregnancy test. The test must confirm that you are not pregnant at the start of treatment with Izotek 20 mg.

Women must use effective contraceptive methods before, during and after treatment with
Izotek 20 mg.

You must agree to use at least one highly reliable 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). Discuss with your doctor which methods are most suitable for you.
You must use a contraceptive method for one month before starting Izotek 20 mg, during treatment, and for one month after stopping the medicine.
You must use contraception even if you are not having periods or are not currently sexually active (unless your doctor determines it is not necessary).

Women must agree to undergo pregnancy tests before, during and after treatment with
Izotek 20 mg.

You must agree to regular follow-up visits with your doctor, ideally every month.
You must agree to regular pregnancy tests, ideally every month during treatment and one month after stopping Izotek 20 mg, as the medicine may still be present in your body (unless your doctor decides it is not necessary for you).
You must agree to additional pregnancy tests as recommended by your doctor.
You must not become pregnant during treatment or for one month after stopping treatment, as the medicine may still be present in your body.
Your doctor will discuss all issues with you using a checklist and will ask you (or your parent or legal guardian) to sign it. This form confirms that you have been informed of the risks and agree to follow the rules outlined above.

If you become pregnant while taking Izotek 20 mg,
stop taking the medicine immediately and contact your doctor. Your doctor may refer you to a
specialist for advice.
Furthermore, if you become pregnant within one month after stopping treatment with
Izotek 20 mg, you should contact your doctor. Your doctor may refer you to a specialist for advice.
Advice for men
The amount of oral retinoids in the semen of men taking Izotek 20 mg is too low to harm the unborn child of their partner. However, you must never share this medicinal product with anyone else, especially women.
Additional precautions
Never give this medicinal product to another person. All unused capsules must be returned to the
pharmacist after treatment ends.
You must not donate blood while taking this medicine or for one month after stopping
Izotek 20 mg. If a pregnant woman receives your blood, she may give birth to a child with birth defects.
Information for all patients

Discuss with 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 certain changes in your mood or behaviour, so it is very important to inform your friends and family members that you are taking this medicine. They may notice such changes and help you identify problems that need to be discussed with your doctor.
Severe skin reactions (e.g. erythema multiforme [EM], Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]) have been observed during isotretinoin treatment. The rash may involve widespread blistering or peeling of the skin. Also watch for mouth, throat, nose and genital ulcers, as well as conjunctivitis (redness and swelling of the eyes).
In rare cases, Izotek 20 mg may cause severe allergic reactions, which may include skin rash, hives, bruising or red spots on the hands and feet. If an allergic reaction occurs, stop taking Izotek 20 mg immediately, contact your doctor without delay and inform them that you are taking this medicine.
Limit intense physical effort and exercise. Izotek 20 mg may cause muscle and joint pain, particularly in children and adolescents who engage in intense physical activity.
Isotretinoin use has been associated with idiopathic inflammatory bowel disease. If a patient develops severe bloody diarrhoea and has no history of gastrointestinal disease, the doctor will discontinue treatment with Izotek 20 mg.
Izotek 20 mg may cause dry eye syndrome, intolerance to contact lenses and vision problems, including night vision impairment. Inform your doctor if any of these symptoms occur. Your doctor may recommend lubricating eye ointments or artificial tears. If you experience intolerance to contact lenses, your doctor may recommend wearing glasses during treatment. If vision problems occur, your doctor may refer you to a specialist for advice and may also recommend stopping Izotek 20 mg.
Mild intracranial hypertension has been observed during isotretinoin treatment, in some cases when isotretinoin was taken concomitantly with tetracyclines (a type of antibiotic used, for example, in acne treatment). If symptoms such as headache, nausea, vomiting or visual disturbances occur, stop taking Izotek 20 mg and contact your doctor immediately. Your doctor may refer you to a specialist to check for papilloedema (swelling of the optic disc in the eye).
Izotek 20 mg may increase liver enzyme activity. Your doctor will order appropriate blood tests before, during and after treatment to monitor liver enzyme activity. If enzyme activity remains high, your doctor may reduce the dose or discontinue treatment with Izotek 20 mg.
Isotretinoin often causes increased blood lipid levels, such as cholesterol or triglycerides. Your doctor will check lipid levels before starting treatment with Izotek 20 mg, during treatment and after it ends. During treatment, it is best to avoid alcoholic beverages or at least reduce their consumption. Inform your doctor if you have high blood lipid levels, diabetes (high blood glucose levels), or if you are overweight or have alcoholism. More frequent blood tests may be necessary. If blood lipid levels remain high, your doctor may reduce the dose or discontinue treatment with Izotek 20 mg.
Inform your doctor if you have any kidney problems. Your doctor may start treatment with a lower dose of Izotek 20 mg and then increase it to the maximum tolerated dose.
Izotek 20 mg may increase blood glucose levels. In rare cases, diabetes has developed in patients. Your doctor may monitor blood glucose levels during treatment, especially if you already have diabetes or if you are overweight or have alcoholism.
Skin dryness is likely to occur. During treatment, use a moisturising cream or ointment and lip balm. To prevent skin irritation, avoid using peeling and anti-acne products.
Avoid excessive sun exposure and do not use sunlamps or sunbeds. Your skin may become more sensitive to sunlight. Before going outdoors, apply a sunscreen product with a high UV protection factor (at least SPF 15).
Do not undergo any cosmetic skin procedures. Izotek 20 mg may make your skin more sensitive. Do not use waxing, dermabrasion or laser treatments (to remove thickened skin or scars) during treatment or for at least 6 months after treatment ends, as this may lead to scarring, skin irritation or, in rare cases, changes in skin pigmentation.

Children and adolescents
Izotek 20 mg is not recommended for children under 12 years of age. It is not known whether the medicine is safe or effective in this age group.
Use 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 currently taking, have recently taken or plan to take, including medicines available without a prescription.

Do not take vitamin A supplements or tetracyclines (an antibiotic used, for example, in acne treatment) while taking Izotek 20 mg, and do not use any topical anti-acne products. You may use moisturisers and emollients (creams or skin products that prevent water loss and soften the skin).
While taking Izotek 20 mg, avoid topical use of keratolytic or peeling anti-acne products.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor before using this medicine.
Pregnancy
Izotek 20 mg must not be used during pregnancy. If you are of childbearing potential, you must use an effective method of contraception during treatment with Izotek 20 mg and for one month after stopping the medicine.
If you become pregnant while taking Izotek 20 mg or within one month after stopping treatment, stop taking the medicine immediately and contact your doctor. Your doctor may refer you to a specialist for advice.
Taking Izotek 20 mg during pregnancy may harm the foetus (as the medicine has a teratogenic effect). It also increases the risk of miscarriage.
Izotek 20 mg may cause serious abnormalities in the foetus’s brain, face, ears, eyes, heart and certain glands (thymus and parathyroid glands).
Breastfeeding
Do not take Izotek 20 mg while breastfeeding. This medicine is likely to pass into breast milk and may harm the breastfed infant.
More information on pregnancy and contraception can be found in section 2 “Pregnancy Prevention Programme”.
Driving and operating machinery
During therapy, night vision may be impaired. These visual disturbances may occur suddenly. In rare cases, they persist after therapy ends. Very rarely, drowsiness, dizziness and visual disturbances have been reported. If you experience any of these symptoms, you must 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 use the medicine Izotek 20 mg

This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult your
doctor or pharmacist.
The medicines Izotek 10 mg and Izotek 20 mg are available on the market.
Recommended dose:
The initial dose is usually 0.5 mg per kilogram of body weight per day (0.5 mg/kg bw/day).
If the patient's weight is 60 kg, treatment is usually started at a dose of 30 mg per day.
Capsules should be taken once or twice daily.
The medicine should be taken with a full stomach. Capsules should be swallowed whole, taken with food or
swallowed together with a meal.
After a few weeks, your doctor may change the dose. This depends on how well the patient tolerates the treatment and
on the results of therapy. For most patients, the dose ranges from 0.5 mg/kg bw/day to 1 mg/kg
bw/day. If the patient feels that the effect of Izotek 20 mg is too weak or too strong,
this should be reported to the doctor or pharmacist.
Treatment usually lasts from 16 to 24 weeks. For most patients, only one treatment cycle is required.
Acne symptoms may continue to improve for up to 8 weeks after completion of treatment. Usually, another treatment cycle is not started within this period.
Some individuals may notice a worsening of acne during the first weeks of treatment. These symptoms
usually improve as treatment continues.
Patients with kidney function disorders
In cases of severe kidney disease, treatment should start with a lower dose (e.g. 10
mg/day), which may then be increased to the maximum dose tolerated by the patient.
If the patient does not tolerate the recommended dose, a lower dose may be administered, which may mean
that treatment will need to be prolonged and recurrence of acne will be more likely.
Taking more than the recommended dose of Izotek 20 mg
If the patient has taken too many capsules or if another person accidentally ingests this medicine, contact your
doctor, pharmacist, or nearest hospital immediately.
Isotretinoin is a derivative of vitamin A. Symptoms of poisoning with Izotek 20 mg are similar to
those of vitamin A poisoning. These include: headache, nausea, vomiting, dizziness,
irritability, and itching.
Missed dose of Izotek 20 mg
If a dose of the medicine is missed, take it as soon as possible. However, if it is almost time for the next dose, do not
make up the missed dose, but continue treatment according to the prescribed dosing schedule. Do not take a double dose to
make up for a missed dose.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
These symptoms often diminish or resolve after discontinuation of treatment. Others may be severe and
require immediate medical attention.
Side effects requiring immediate medical assistance:
Skin problems
Frequency unknown (frequency that cannot be estimated from available data)

Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which may be life-threatening and require immediate medical attention. Initially, they appear as circular lesions, often with centrally located blisters, typically affecting hands and palms or feet and soles. More severe rashes may involve blister formation on the chest and back. Additional symptoms may also occur, such as eye infection (conjunctivitis) or ulcers in the mouth, throat, or nose. Some types of rashes may progress to extensive skin peeling, which may be life-threatening. The onset of these severe skin rashes is often preceded by headache, fever, and body aches (flu-like symptoms).

If the patient develops a severe rash or any of the skin symptoms listed above, discontinue
treatment with Izotek 20 mg immediately and contact a doctor without delay.
Psychiatric disorders
Rare side effects (may occur in less than 1 in 1,000 patients)

Depression or related disorders. Symptoms include sadness, mood changes, anxiety, and feelings of emotional discomfort.
Worsening of existing depression.
Tendency towards violence or aggression.

Very rare side effects (may occur in less than 1 in 10,000 patients)

Some individuals have experienced thoughts or images of self-harm or suicide (suicidal ideation), attempted suicide, or died by suicide. These individuals may not display symptoms of depression.
Unusual behavior.
Psychotic symptoms: loss of contact with reality, e.g., the patient hears voices or sees things that do not exist in reality.

If any of the psychiatric symptoms described above occur, contact a doctor immediately.
The doctor may recommend discontinuation of Izotek 20 mg. Stopping the medication may not be sufficient for these effects to resolve; additional support may be required, which the doctor can provide.
Allergic reactions
Rare side effects (may occur in less than 1 in 1,000 patients)

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

Very rare side effects (may occur in less than 1 in 10,000 patients)

Sudden chest tightness, shortness of breath, and wheezing, particularly if the patient suffers from asthma.

In case of a severe allergic reaction, seek emergency medical care immediately.
If any allergic reaction occurs, discontinue taking Izotek 20 mg and contact the treating physician.
Musculoskeletal system
Frequency unknown (frequency that cannot be estimated from available data)

Muscle weakness, which may potentially be life-threatening, may be associated with difficulty moving arms or legs, pain, swelling, bruising of body parts, dark-colored urine, reduced urine output or cessation of urine production, confusion, or dehydration. These are symptoms of rhabdomyolysis, i.e., breakdown of muscle tissue, which may lead to kidney failure. This may occur during intense physical activity while taking Izotek 20 mg.

Liver and kidney function disorders
Very rare side effects (may occur in less than 1 in 10,000 patients)

Yellowing of the skin or whites of the eyes and feeling tired. These may be symptoms of hepatitis. Discontinue Izotek 20 mg immediately and contact a doctor.
Problems with urination, swollen and puffy eyelids, feeling extremely tired. These may be symptoms of kidney inflammation. Discontinue Izotek 20 mg immediately and contact a doctor.

Nervous system disorders
Very rare side effects (may occur in less than 1 in 10,000 patients)

Persistent headache accompanied by nausea, vomiting, and visual disturbances, including blurred vision. These may be symptoms of benign intracranial hypertension, particularly when Izotek 20 mg is taken concomitantly with tetracycline antibiotics. Discontinue Izotek 20 mg immediately and contact the treating physician.

Gastrointestinal disorders
Very rare side effects (may occur in less than 1 in 10,000 patients)

Severe abdominal pain accompanied by bloody diarrhea, nausea, and vomiting, or without these symptoms. These may be symptoms of severe intestinal diseases.

Discontinue Izotek 20 mg immediately and contact the treating physician.
Eye disorders
Very rare side effects (may occur in less than 1 in 10,000 patients)

Blurred vision.

If blurred vision occurs, discontinue Izotek 20 mg immediately and contact a doctor.
In case of any other vision changes, contact a doctor as soon as possible.
Other side effects
Very common side effects (may occur in more than 1 in 10 patients)

Dry skin, especially around the lips and face, skin inflammation, chapped and inflamed lips, rash, mild itching, and slight peeling. A moisturizing cream should be used from the beginning of treatment.
Skin more sensitive and redder than usual, especially on the face.
Back pain, muscle pain, joint pain, particularly in children and adolescents. To avoid worsening any musculoskeletal or joint complaints, intense physical activity should be limited during treatment with Izotek 20 mg.
Inflammation of the eyes (conjunctivitis) and eyelids, dryness and irritation of the eyes. Consult a pharmacist for appropriate eye drops. In case of dry eye syndrome, wearing glasses instead of contact lenses may be necessary.
Increased liver enzyme activity in blood tests.
Altered blood lipid levels (including HDL or triglycerides).
Bruising, bleeding, or faster blood clotting – if the problem involves cells responsible for blood clotting.
Anaemia – weakness, dizziness, pale skin – if the problem involves red blood cells.

Common side effects (may occur in less than 1 in 10 patients)

Headache.
Higher blood cholesterol levels.
Presence of protein or blood in urine.
Increased susceptibility to infections – if the problem involves white blood cells.
Dryness inside the nasal cavity and formation of crusts leading to mild nosebleeds.
Pain or inflammation of the throat and nasal cavity.
Allergic reactions such as rash, itching. If any allergic reaction occurs, discontinue taking Izotek 20 mg and contact a doctor.

Rare side effects (may occur in less than 1 in 1,000 patients)

Hair loss (alopecia). Usually transient. Should resolve after completion of treatment.

Very rare side effects (may occur in less than 1 in 10,000 patients)

Night vision impairment, color blindness, and reduced color perception may occur.
Increased sensitivity to light may occur; wearing sunglasses may be necessary to protect the eyes from excessively bright light.
Other eye problems, including blurred vision, image distortion, clouding of the eye surface (corneal opacity, cataract).
Excessive thirst, frequent urination, blood test results indicating increased blood glucose levels. These may be symptoms of diabetes.
Acne may worsen during the first few weeks, but symptoms should begin to improve over time.
Skin inflamed, swollen, and darker than usual, especially on the face.
Excessive sweating or itching.
Joint inflammation; bone-related problems (growth delay, excessive growth, changes in bone density); may lead to inhibition of growth in developing bones.
Calcium deposition in soft tissues, tendon pain, and high levels of muscle breakdown products in blood during intense physical activity.
Increased sensitivity to light.
Bacterial infections at the base of the nails, nail changes.
Swelling, discharge, pus.
Excessive scarring after surgical procedures.
Increased body hair growth.
Seizures, drowsiness, dizziness.
Lymph node swelling may occur.
Dry throat, hoarseness.
Hearing problems.
General malaise.
High blood uric acid levels.
Bacterial infections.
Vasculitis (sometimes with bruising or red spots).

Frequency unknown (frequency that cannot be estimated from available data)

Dark or dark brown urine.
Difficulty achieving or maintaining erection.
Reduced libido.
Breast swelling with or without tenderness in men.
Vaginal dryness.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Izotek 20 mg

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging.
Store the container 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 stated month.
Return any unused capsules to the pharmacist. Keep them only if
your doctor advises you to do so.
Medicines must not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. Such measures help
protect the environment.

6. Contents of the pack and other information

What Izotek 20 mg contains

The active substance in 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), red iron oxide (E 172), yellow iron oxide (E 172).

What Izotek 20 mg looks like and contents of the pack
Izotek 20 mg are oval, red-orange soft capsules (size 6).
The medicine is available in cardboard boxes containing PVC/PE/PVDC/Aluminium blisters.
Pack size: 100 soft capsules.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Greece, 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 in:
CanPoland S.A.
ul. Beskidzka 190, 91-610 Łódź
Chemiczno-Farmaceutyczna Spółdzielnia Pracy "ESPEFA"
ul. Juliusza Lea 208, 30-133 Kraków
Marketing Authorisation Number in Greece, country of export: 45047/10/18-04-2012
Parallel Import Licence Number: 38/22
This medicinal product is authorised for marketing in the European Economic Area under the following names:
Denmark: Isotretinoin Orion
Finland: Isotretinoin Orion
Poland: Izotek 20 mg
Detailed and up-to-date information about this medicine is available by scanning with a smartphone the QR code on the package leaflet. The same information is also available on the website
https://pcp-izotek.pl/
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