Izotek 10 mg

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Izotek 10 mg (A-Cnotren), soft capsules

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

WARNING

CAN CAUSE SERIOUS HARM TO THE UNBORN CHILD
Women must use effective methods of contraception.
Do not use during pregnancy or suspected pregnancy.

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 to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Izotek 10 mg and what is it used for
• 2. Important information before taking Izotek 10 mg
• 3. How to take Izotek 10 mg
• 4. Possible side effects
• 5. How to store Izotek 10 mg
• 6. Contents of the packaging 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 permanent scarring) in adults and adolescents over 12 years of age, only after puberty. Izotek 10 mg will be used only if the severity of acne cannot be alleviated with other anti-acne medications, including antibiotics and topical medications.
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 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 "Warnings and precautions" section
• 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 the medicine

Izotek 10 mg,

• In liver disease,
• In patients with very high levels of lipids in the blood(e.g., high cholesterol or triglycerides),
• In patients with very high levels of vitamin Ain the body (hypervitaminosis A),
• 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 a 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

Pregnant women must not take Izotek 10 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 10 mg is taken for a short period
of time during pregnancy.

• Do not take Izotek 10 mg if you are pregnant or think you may be pregnant.
• Do not take Izotek 10 mg during breastfeeding. The medicine is likely to pass into breast milk and may harm the breastfed baby.
• Do not take Izotek 10 mg if you may become pregnant during treatment.
• The patient must not become pregnant for one month after stopping treatment, because the medicine may still be present in the patient's body.

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

This is due to the risk of serious birth defects. The following conditions must be met:

• The doctor must explain to the patient the risk of birth defects; the patient must understand why she must not become pregnant and how to prevent it.
• The patient must discuss contraception with the doctor(methods of birth control). The doctor will provide the patient with information on contraception methods. The doctor may refer the patient to a specialist for contraception advice.
• Before starting treatment, the doctor will ask the patient to have a pregnancy test. The test must show that the patient is not pregnant at the start of treatment with Izotek 10 mg.

Female patients must use effective methods of contraception before, during, and after treatment with Izotek 10 mg

Izotek 10 mg.

• The patient 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). The patient should discuss with the doctor which methods are most suitable for them.
• 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, 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 10 mg, she must immediately

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

In addition, a patient who becomes pregnant within one month of 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 sperm 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

This medicinal product should never be given 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 the patient's 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 10 mg may affect your mood.

The patient may not notice certain changes in their mood and behavior, so it is very important to tell friends and family members that they are taking this medicine. These people may notice such changes and help the patient identify problems that need to be discussed with the doctor.

• During treatment with isotretinoin, severe skin reactions have been observed(e.g., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis). A rash may occur in 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 10 mg may cause severe allergic reactions, which can include skin reactions such as rash, urticaria, and angioedema or anaphylaxis. In case of an allergic reaction, you should stop taking Izotek 10 mg and immediately consult your doctor.
• Limit intense exercise and physical activity. Izotek 10 mg may cause muscle and joint pain, especially in children and adolescents engaging in intense physical activity.
• Isotretinoin has been associated with non-specific gastrointestinal inflammation. If a patient without a history of gastrointestinal disease develops severe bloody diarrhea, the doctor will stop treatment with Izotek 10 mg.
• Izotek 10 mg may lead to dry eye syndrome, intolerance to contact lenses, and vision problems, including decreased night vision. There have been cases of dry eye that did not resolve after treatment ended. You should inform your doctor if you experience any of these symptoms. The doctor may recommend using moisturizing eye ointments or artificial tears. If you experience intolerance to contact lenses, the doctor may recommend wearing glasses during treatment. If you experience vision problems, the doctor may refer you to a specialist for advice and may recommend stopping Izotek 10 mg.
• During treatment with isotretinoin, mild intracranial hypertension has been observed, in some cases during concurrent treatment with isotretinoin and tetracyclines (a type of antibiotic used, for example, in the treatment of acne). If symptoms such as headache, nausea, vomiting, and vision disturbances occur, you should stop taking Izotek 10 mg and immediately consult your doctor. The doctor may refer you to a specialist to check for papilledema (swelling of the optic disc in the eye).
• Izotek 10 mg may increase liver enzyme activity. The treating doctor will order blood tests to check liver enzyme activity before, during, and after treatment. If liver enzyme activity remains high, the treating doctor may reduce the dose or stop treatment with Izotek 10 mg.
• Isotretinoin often leads to increased blood lipid levels, such as cholesterol or triglycerides. The doctor will check blood lipid levels before starting treatment with Izotek 10 mg and during and after treatment. During treatment, it is best to avoid drinking alcohol or reduce its consumption. You should inform your doctor if you have high blood lipid levels, diabetes (high blood sugar levels), or if you are overweight or have a history of alcoholism. More frequent blood tests may be necessary.
• Tell your doctor if you have any kidney problems. The doctor may start treatment with a lower dose of Izotek 10 mg and then increase it to the maximum tolerated dose.
• Izotek 10 mg may increase blood sugar levels. In rare cases, diabetes has developed in patients. The doctor may monitor blood sugar levels during treatment, especially if you already have diabetes or are overweight or have a history of alcoholism.
• It is likely that the skin will become dry. During treatment, you should use a moisturizing cream or lotion and lip balm to prevent skin irritation and dryness.
• Avoid excessive sun exposure and the use of sunlamps and tanning beds. The skin may become more sensitive to sunlight. Before going out in the sun, apply a sunscreen with a high sun protection factor (at least SPF 15) to your skin.
• Do not have any cosmetic procedures on the skin. Izotek 10 mg may make the skin more sensitive. Do not wax, dermabrade, or have laser treatments (to remove rough skin or scars) during treatment and for at least 6 months after treatment ends, as this may lead to scarring, skin irritation, or changes in skin color.
• Talk to your doctor if you experience persistent back pain or pain in the buttocks during treatment. These symptoms may indicate inflammatory bowel disease, a type of back pain caused by inflammation. The doctor may stop treatment with Izotek 10 mg and refer you to a specialist for treatment of inflammatory back pain. Further evaluation, including imaging studies such as an MRI, may be necessary.

Children and adolescents

Izotek 10 mg is not recommended for children under 12 years of age. It is not known if the medicine is safe or effective in this age group.

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

Other medicines and Izotek 10 mg

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

• Do not take vitamin A supplements or tetracyclines (an antibiotic used, for example, in the treatment of acne) while taking Izotek 10 mg, or use any anti-acne topical treatments. You can use moisturizing products and emollients (creams or preparations applied to the skin to prevent water loss and soften the skin).
• While taking Izotek 10 mg, avoid using topical anti-acne keratolytic or exfoliating treatments.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Izotek 10 mg must not be used during pregnancy. If you are able to become pregnant, you must use effective contraception while taking Izotek 10 mg and for one month after stopping the medicine.
If you become pregnant while taking Izotek 10 mg or within one month of stopping treatment, you must 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(because 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 while breastfeeding. It is likely that the medicine will pass into breast milk and may harm the breastfed baby.
For more information on pregnancy and contraception, see section 2 "Pregnancy Prevention Program".

Driving and using machines

During treatment, your ability to see in the dark may decrease. Such vision disturbances may appear suddenly. In rare cases, they may persist after treatment ends. Very rarely, drowsiness, dizziness, and vision disturbances have been reported. If you experience these symptoms, you 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 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 the patient weighs 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 therapy. For most patients, the dose is between 0.5 mg/kg/day and 1 mg/kg/day. If you feel that the effect of Izotek 10 mg is too weak or too strong, tell your doctor or pharmacist.
Treatment usually lasts from 16 to 24 weeks. In most patients, only one treatment cycle is necessary. Acne symptoms may continue to improve for up to 8 weeks after 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

However, these symptoms usually improve as treatment continues.

Patients with kidney function disorders

In case of severe kidney disease, treatment should start with a lower dose (e.g., 10 mg/day), which may then be increased to the maximum tolerated dose.

Taking a higher dose of Izotek 10 mg than recommended

If you have taken too many capsules or if someone else has taken your medicine by mistake, you should contact a doctor, pharmacist, or the nearest hospital immediately.

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, Izotek 10 mg can cause side effects, although not everybody gets them.
These symptoms often 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 arms and legs. More severe rashes may involve the chest and back. They may also be accompanied by additional symptoms, such as eye infections (conjunctivitis) or ulcers in the mouth, throat, or nose. Some types of rash may appear as 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, stop taking Izotek 10 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, 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, or committed suicide. These people may not have shown 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, seek immediate medical attention

Stop taking Izotek 10 mg and consult your doctor. Stopping the medicine may not be enough to make these effects go away; additional help may be necessary, and the doctor can provide it.

Allergic reactions

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

• Severe (anaphylactic) reactions: breathing or swallowing problems 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, seek immediate medical attention

If you experience any allergic reaction, stop taking Izotek 10 mg and consult 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.

Liver and kidney disorders

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 and consult your doctor immediately

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

Stop taking Izotek 10 mg and consult your doctor immediately

Nervous system disorders

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

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

Stop taking Izotek 10 mg and consult 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 gastrointestinal disease.

Stop taking Izotek 10 mg and consult 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, stop taking Izotek 10 mg and consult your doctor immediately

If you experience any other changes in your vision, you should consult 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, chapping, 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 any bone or muscle problems, you should limit intense physical activity while taking Izotek 10 mg.
• Eye inflammation (conjunctivitis) and eyelid inflammation, feeling of dryness and irritation of the eyes. You should ask your pharmacist for suitable eye drops. If you experience dry eye syndrome, you may need to wear glasses instead of contact lenses.
• Increased liver enzyme activity in blood tests.
• Changes in blood lipid levels (including HDL or triglycerides).
• Bruising, bleeding, or faster blood clotting - if the problem affects the cells responsible for blood clotting.
• Anemia - weakness, dizziness, pale skin - if the problem affects red blood cells.

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

• Headache.
• High cholesterol levels in the blood.
• Protein or blood in the urine.
• Increased susceptibility to infections, if the problem affects white blood cells.
• Dryness of the inside of the nose and formation of crusts, leading to mild nosebleeds.
• Pain or inflammation of the throat and nose.
• Allergic reactions, such as rash, itching. If you experience any allergic reaction, stop taking Izotek 10 mg and consult 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 ends.

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

• Decreased ability to see in the dark, color blindness, and impaired color vision.
• 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 opacity).
• Excessive thirst, need to urinate frequently, blood test results showing 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 and 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 or red spots).

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

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, 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 packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Return any leftover 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 packaging 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 soya oil, yellow wax, hydrogenated soya oil, partially hydrogenated soya 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/Al.
Packs of 10, 30, 60, and 100 soft capsules are available.
For more information, contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Greece, the 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.
Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Authorisation number in Greece, the country of export:45/16-01-2012
Parallel import authorisation number:412/14

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Dania:

Isotretinoin Orion

Finlandia:

Isotretinoin Orion

Polska:

Izotek 10 mg

Grecja:

A-Cnotren 10 mg

Date of revision of the leaflet: 12.12.2024

Detailed and up-to-date information on this medicine is available by scanning the QR code on the leaflet using a smartphone. The same information is also available on the website http://inpharm.pl/do_pobrania/Retinoidy-karta-przypominajaca.doc.
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