Patient Information Leaflet

Warning! Keep this leaflet! The packaging information in a foreign language.
Izotek 10 mg (A-Cnotren), capsules, soft
Isotretinoinum
Izotek 10 mg and A-Cnotren are different brand names for the same medicine.
WARNING
CAN CAUSE SEVERE HARM TO AN UNBORN CHILD
Women must use effective contraception.
Do not use during pregnancy or if pregnancy is suspected.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Izotek 10 mg is and what it is used for
Important information before taking Izotek 10 mg
How to take Izotek 10 mg
Possible side effects
How to store Izotek 10 mg
Contents of the pack and other information

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

Izotek 10 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 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 the age of 12, only after puberty.
Izotek 10 mg will be used only if the severity of acne has not improved with other anti-acne treatments, including antibiotics and topical medications.
Treatment with Izotek 10 mg must be supervised by a dermatologist (a doctor specializing in skin disorders).

2. Important information before using Izotek 10 mg

When not to use Izotek 10 mg:

if the patient is allergic to isotretinoin, peanuts or soya, or 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 pregnancy prevention measures outlined in the Pregnancy Prevention Programme for Izotek 10 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),
when undergoing concomitant treatment with tetracyclines (an antibiotic used, among others, in the treatment of acne) (see “Other medicines and Izotek 10 mg”).

If any of the above situations apply, consult a doctor before starting treatment with Izotek 10 mg.
Warnings and precautions
Before starting treatment with Izotek 10 mg, discuss this with your doctor or pharmacist.
Pregnancy Prevention Programme
IMPORTANT
Information for women
Women who are pregnant must not take Izotek 10 mg.
This medicine can 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). It also increases the risk of miscarriage. These effects
may occur even if Izotek 10 mg is taken for only a short period during pregnancy.

Do not take Izotek 10 mg if you are pregnant or think you might be pregnant.
Do not take Izotek 10 mg during breastfeeding. The medicine is likely to pass into breast milk and may harm the nursing infant.
Do not take Izotek 10 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 10 mg may be prescribed to women of childbearing potential only if strict adherence to
specific requirements is ensured. 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 the patient the risk of fetal harm (birth defects); the patient must understand why pregnancy must be avoided and how to prevent it.
The patient must discuss contraception (birth control methods) with the doctor. The doctor will provide information on contraceptive methods. The doctor may refer the patient to a specialist for contraceptive advice.
Before starting treatment, the doctor will request a pregnancy test. The test must confirm that the patient is not pregnant at the time treatment with Izotek 10 mg is initiated.

Women must use effective contraceptive methods before, during, and after treatment with
Izotek 10 mg.

The patient must agree to use at least one highly reliable method of contraception (e.g. intrauterine device or contraceptive implant), or two effective methods acting in different ways (e.g. oral hormonal contraceptives and condoms). Discuss with your doctor which methods are most suitable for you.
The patient must use contraception for one month before starting 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 determines this is unnecessary).

Women must agree to undergo pregnancy testing before, during, and after treatment with
Izotek 10 mg.

The patient must agree to regular follow-up visits with the doctor, ideally every month.
The patient must agree to regular pregnancy tests, ideally monthly during treatment and one month after stopping Izotek 10 mg, as the medicine may still be present in the body (unless the doctor determines this is unnecessary for a particular patient).
The patient must agree to additional pregnancy tests as recommended by the treating doctor.
The patient must not become pregnant during treatment or for one month after stopping treatment, as the medicine may still be present in the body.
The treating doctor will discuss all issues with the patient using a checklist and will ask the patient (or her parent or legal guardian) to sign it. This form confirms that the patient has been informed of the risks and agrees to follow the above requirements.

If a patient becomes pregnant while taking Izotek 10 mg, she must immediately stop taking the
medicine and contact her doctor. The doctor may refer the patient to a specialist for advice.
Furthermore, a patient who becomes pregnant within one month after stopping treatment with
Izotek 10 mg 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 low to harm the unborn child of their partner. However, this medicine must never be shared 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.
Do not donate blood while taking this medicine or within one month after stopping
Izotek 10 mg. If a pregnant woman receives the patient's 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, aggressive tendencies, or mood swings. This is because Izotek 10 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 promptly.

Severe skin reactions (e.g. erythema multiforme [EM], Stevens-Johnson syndrome [SJS], and toxic epidermal necrolysis [TEN]) have been observed during isotretinoin treatment. Skin rash may present as widespread blistering or peeling of the skin. Be alert for mouth, throat, nose, or genital ulcers, as well as conjunctivitis (redness and swelling of the eyes).
In rare cases, Izotek 10 mg may cause severe allergic reactions, which may include skin rash, hives, or bruises or red spots on the hands and feet. If an allergic reaction occurs, stop taking Izotek 10 mg immediately, contact your doctor, and inform them that you are taking this medicine.
Reduce intense physical exertion and activity. Izotek 10 mg may cause muscle and joint pain, especially in children and adolescents engaging in intense physical activity.
Isotretinoin use has been associated with non-specific inflammatory bowel disease. If a patient without prior gastrointestinal disorders develops severe bloody diarrhoea, the doctor will discontinue treatment with Izotek 10 mg.
Izotek 10 mg may cause dry eye syndrome, intolerance to contact lenses, and vision problems, including night vision impairment. Cases of persistent dry eye that did not resolve after treatment ended have been reported. Inform your doctor if any of these symptoms occur. The doctor may recommend lubricating eye ointments or artificial tears. If contact lens intolerance occurs, the doctor may recommend wearing glasses during treatment. If vision problems occur, the doctor may refer you to a specialist for advice and may consider discontinuing Izotek 10 mg.
Mild intracranial hypertension has been observed during isotretinoin use, sometimes when isotretinoin is taken concurrently with tetracyclines (a class of antibiotics used, for example, in acne treatment). If symptoms such as headache, nausea, vomiting, or visual disturbances occur, stop taking Izotek 10 mg immediately and contact your doctor. The doctor may refer you to a specialist to check for papilledema (optic disc swelling).
Izotek 10 mg may increase liver enzyme activity. Your doctor will order blood tests before, during, and after treatment to monitor liver enzyme activity. If enzyme levels remain elevated, your doctor may reduce the dose or discontinue treatment with Izotek 10 mg.
Isotretinoin often increases blood lipid levels, such as cholesterol or triglycerides. Your doctor will check lipid levels before starting treatment with Izotek 10 mg, during treatment, and after treatment 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), 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 10 mg.
Inform your doctor if you have any kidney problems. Your 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 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 are overweight or have alcoholism.
Skin dryness is very likely to occur. During treatment, use a moisturising cream or ointment and lip balm. To avoid skin irritation, avoid using peeling or anti-acne products.
Avoid excessive sun exposure and do not use sunlamps or tanning beds. The skin may become more sensitive to sunlight. Before going out in the sun, apply a sunscreen with a high UV protection factor (at least SPF 15).
Do not undergo any cosmetic skin procedures. Izotek 10 mg may make the skin more sensitive. Do not wax, undergo 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, skin discoloration.
Discuss with your doctor if you experience persistent lower back or buttock pain during treatment with Izotek 10 mg. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. The doctor may discontinue treatment with Izotek 10 mg and refer you to a specialist for management of inflammatory back pain. Further evaluation, including imaging such as MRI, may be necessary.

Children and adolescents
Izotek 10 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 10 mg
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines.

While taking Izotek 10 mg, do not take vitamin A supplements or tetracyclines (an antibiotic used, for example, in acne treatment), or any topical anti-acne products. Moisturisers and emollients (creams or skin products that prevent water loss and soften the skin) may be used.
While taking Izotek 10 mg, avoid topical use of keratolytic or peeling anti-acne agents.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Pregnancy
Izotek 10 mg must not be used during pregnancy. If a woman is capable of becoming pregnant, she must use an effective contraceptive method during treatment with Izotek 10 mg and for one month after stopping treatment.
If pregnancy occurs while taking Izotek 10 mg or within one month after stopping treatment, stop taking the medicine immediately and 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 certain glands (thymus and parathyroid glands) in the fetus.
Breastfeeding
Do not take Izotek 10 mg while breastfeeding. This medicine is likely to pass into breast milk and may harm the nursing 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 deteriorate. These visual disturbances may appear suddenly. In rare cases, they persist after therapy ends. Drowsiness, dizziness, and visual disturbances have been very rarely reported. If these symptoms occur, the patient must not drive or operate machinery.
Izotek 10 mg contains soya oil. Do not take Izotek 10 mg if you are allergic to peanuts or soya.

3. How to use Izotek 10 mg

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
The following products are available on the market: Izotek 10 mg and Izotek 20 mg.
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 initiated 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
with liquid.
After a few weeks, the doctor may adjust the dose. This depends on how well the patient tolerates the treatment and on the therapeutic response. 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 10 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 necessary. Acne symptoms may continue to improve for up to 8 weeks after completion of treatment. Usually, a new treatment cycle is not started during this period.
Some individuals may notice a worsening of acne during the first weeks of treatment. These symptoms usually improve with continued therapy.
Patients with renal function disorders
In cases of severe kidney disease, treatment should start at a lower dose (e.g., 10 mg/day), which may then be gradually increased to the maximum dose tolerated by the patient.
If the patient cannot tolerate the recommended dose, a lower dose may be administered, which may mean that treatment will need to be prolonged and recurrence of acne may be more likely.
Taking more than the recommended dose of Izotek 10 mg
If the patient has taken too many capsules or if someone else accidentally ingests this medicine, contact a doctor, pharmacist, or nearest hospital immediately.
Isotretinoin is a derivative of vitamin A. Symptoms of poisoning with Izotek 10 mg are similar to those of vitamin A toxicity. These include: headache, nausea, vomiting, dizziness, irritability, and itching.
Missed dose of Izotek 10 mg
If a dose 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; continue treatment according to the prescribed 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 adverse effects

Like all medicines, this medicine can cause adverse 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.
Adverse effects requiring immediate medical assistance:
Skin problems
Frequency unknown (frequency 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 central blisters, usually located on the hands and palms or feet and soles. More severe rashes may involve blistering on the chest and back. Additional symptoms may also occur, such as eye infection (conjunctivitis) or ulceration in the mouth, throat, or nose. Some types of rash may progress to extensive skin peeling, which may be life-threatening. The onset of these severe skin reactions is often preceded by headache, fever, and body aches (flu-like symptoms).

If a patient develops a severe rash or any of the above skin symptoms, discontinue
treatment with Izotek 10 mg immediately and contact a doctor without delay.
Psychiatric disorders
Rare adverse 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 pre-existing depression.
Tendency towards violence or aggression.

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

Some individuals experienced thoughts or images of self-harm or suicide (suicidal ideation), attempted suicide, or died by suicide. These individuals did not necessarily show 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 10 mg.
Stopping the medicine may not be sufficient for these effects to resolve; additional support may be required, which the doctor can provide.
Allergic reactions
Rare adverse 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 the hands, feet, and ankles.

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

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

In case of a severe reaction, seek emergency medical care immediately.
If any allergic reaction occurs, discontinue taking Izotek 10 mg and contact your doctor.
Musculoskeletal system
Frequency unknown (frequency 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 10 mg.

Liver and kidney function disorders
Very rare adverse 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 10 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 10 mg immediately and contact a doctor.

Nervous system disorders
Very rare adverse 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 10 mg is taken concomitantly with tetracycline antibiotics. Discontinue Izotek 10 mg immediately and contact your doctor.

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

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

Discontinue Izotek 10 mg immediately and contact your doctor.
Eye disorders
Very rare adverse effects (may occur in less than 1 in 10,000 patients)

Blurred vision.

If blurred vision occurs, discontinue Izotek 10 mg immediately and contact a doctor.
If any other changes in vision occur, contact a doctor as soon as possible.
Other adverse effects
Very common adverse 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 muscular problems, reduce intense physical activity during treatment with Izotek 10 mg.
Inflammation of the eyes (conjunctivitis) and eyelids, dryness, and eye irritation. 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 clotting.
Anemia—weakness, dizziness, pale skin—if the problem involves red blood cells.

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

Headache.
Higher cholesterol levels in the blood.
Presence of protein or blood in the urine.
Increased susceptibility to infections—if the problem involves white blood cells.
Drying of the nasal cavity and formation of crusts leading to mild nosebleeds.
Soreness or inflammation of the throat and nasal cavity.
Allergic reactions such as rash, itching. If any allergic reaction occurs, discontinue taking Izotek 10 mg and contact your doctor.

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

Hair loss (alopecia). Usually temporary. Should resolve after treatment ends.

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

Night vision deterioration, color blindness, and reduced color perception may occur.
Increased sensitivity to light may occur; wearing sunglasses may be necessary to protect the eyes from excessive light.
Other vision problems, including blurred vision, image distortion, clouding of the eye surface (corneal clouding, 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 gradually improve over time.
Skin inflamed, swollen, and darker than usual, especially on the face.
Excessive sweating or itching.
Joint inflammation; bone system problems (growth delay, excessive growth, and changes in bone density); may lead to inhibition of growing bone development.
Calcium deposition in soft tissues, tendon pain, and high levels of muscle breakdown products in the 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 surgery.
Increased body hair growth.
Seizures, drowsiness, dizziness.
Lymph node swelling may occur.
Dry throat, hoarseness.
Hearing problems.
General malaise.
High uric acid levels in the blood.
Bacterial infections.
Blood vessel inflammation (sometimes with bruising or red spots).

Frequency unknown (frequency cannot be estimated from available data)

Dark or dark brown urine.
Difficulty achieving or maintaining an erection.
Reduced sexual drive.
Breast swelling with or without tenderness in men.
Vaginal dryness.
Sacroiliitis, a type of inflammatory back pain causing pain in the lower back or buttocks.
Urethritis.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Izotek 10 mg

Keep the medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Return any remaining capsules to the pharmacist. Keep them only if instructed by a doctor.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the package and other information

What Izotek 10 mg contains

The active substance in Izotek 10 mg is isotretinoin. Each soft capsule contains 10 mg of isotretinoin.
The other components are: purified soybean oil, yellow wax, hydrogenated soybean oil, partially hydrogenated soybean oil, capsule shell: gelatin, glycerol, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (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 PVC/PE/PVDC/Al blisters.
Packages containing 10, 30, 60 and 100 soft capsules are available.
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, 4th floor
3087 Limassol, Cyprus
Manufacturer:
Pharmathen SA, 6, Dervenakion str., 153 51 Pallini, Greece
Pharmathen International SA, Sapes, Industrial Park Block No 5, TK 69300, N. Rodopi, Greece
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in Greece, country of export: 45/16-01-2012
Parallel Import Licence number: 412/14
This medicinal product is authorised for marketing in the European Economic Area under the following names:
Denmark: Isotretinoin Orion
Finland: Isotretinoin Orion
Poland: Izotek 10 mg
Greece: A-Cnotren 10 mg
Detailed and up-to-date information about this medicinal product is available by scanning with a smartphone the QR code located on the package leaflet. The same information is also available on the website: http://inpharm.pl/do_pobrania/Retinoidy-karta-przypominajaca.doc.
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