Izotek 10 mg

Package Leaflet: Information for the User

Izotek, 10 mg, Soft Capsules

Izotek, 20 mg, Soft Capsules

Isotretinoin

WARNING

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

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet to be able to read it again if needed.
• In case of 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.
• 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 Izotek 10 mg and Izotek 20 mg are and what they are used for
• 2. Important information before taking Izotek 10 mg and Izotek 20 mg
• 3. How to take Izotek 10 mg and Izotek 20 mg
• 4. Possible side effects
• 5. How to store Izotek 10 mg and Izotek 20 mg
• 6. Contents of the pack and other information

1. What Izotek 10 mg and Izotek 20 mg are and what they are used for

Izotek 10 mg and Izotek 20 mg contain 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 and Izotek 20 mg are 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 and Izotek 20 mg will be used only if the acne has not responded to other anti-acne medicines, including antibiotics and topical medicines.

Treatment with Izotek 10 mg and Izotek 20 mg must be supervised by a dermatologist

(a doctor specializing in the treatment of skin diseases).

2. Important information before taking Izotek 10 mg and Izotek 20 mg

When not to take Izotek 10 mg and Izotek 20 mg:

• If the patient is allergic to isotretinoin, peanuts, or soy, or any of the other ingredients of 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 section "Warnings and precautions".
• For women who may become pregnant but cannot or do not want to follow the necessary pregnancy prevention measureslisted in the Pregnancy Prevention Program for Izotek.

Izotek,

• In liver disease,
• In patients with very high levels of lipids in the blood(e.g., high cholesterol or triglycerides),
• In patients with very high levels of vitamin A in the body(hypervitaminosis A),
• In case of concurrent treatment with tetracyclines(an antibiotic used, for example, in the treatment of acne) (see "Other medicines and Izotek 10 mg and Izotek 20 mg").

In case of any of the above situations, you should consult a doctor before starting treatment with Izotek 10 mg and Izotek 20 mg.

Warnings and precautions

Before starting treatment with Izotek 10 mg and Izotek 20 mg, you should discuss it with your doctor or pharmacist.

Pregnancy Prevention Program

IMPORTANT

Information for Women

Pregnant women must not take Izotek 10 mg and Izotek 20 mg.

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

can occur even if Izotek 10 mg or Izotek 20 mg is taken for a short period during pregnancy.

• Do not take Izotek 10 mg or Izotek 20 mg if you are pregnant or think you may be pregnant.
• Do not take Izotek 10 mg or Izotek 20 mg during breastfeeding.The medicine is likely to pass into breast milk and may harm the breastfed baby.
• Do not take Izotek 10 mg or Izotek 20 mg if you may become pregnant.
• 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 or Izotek 20 mg may be prescribed to female patients of childbearing age only under strict conditions.

The following conditions must be met:

• The doctor must explain the risk of birth defects to the patient; 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 information on contraception methods. The doctor may refer the patient to a specialist for advice on contraception.
• Before starting treatment, the doctor will ask the patient to have a pregnancy test.The test must show that the patient is not pregnant at the start of treatment with Izotek 10 mg or Izotek 20 mg.

Female patients must use effective contraception methods before, during, and after treatment with Izotek 10 mg or Izotek 20 mg.

Izotek 10 mg or Izotek 20 mg.

• The patient must agree to use at least one highly effective method of contraception (e.g., an intrauterine device or a contraceptive implant), or two effective methods that work in different ways (e.g., oral hormonal contraceptives and condoms).The patient should discuss with the doctor which methods are most suitable for her.
• The patient must use a contraceptive method for one month before taking Izotek 10 mg or Izotek 20 mg, during treatment, and for one month after stopping treatment.

Izotek 10 mg or Izotek 20 mg, and for one month after stopping treatment.

• 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 and 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 treatment with Izotek 10 mg or 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 these issues with the patient using a checklist and ask the patient (or her parent or legal guardian) to sign it.This form confirms that the patient has been informed of the risks and agrees to follow the above rules.

If the patient becomes pregnant while taking Izotek 10 mg or 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 10 mg or Izotek 20 mg, she should contact her doctor.

The doctor may refer the patient to a specialist for advice.

Advice for Men

The amount of oral retinoids in the semen of men taking Izotek 10 mg or Izotek 20 mg is too small to harm an unborn child. However, this medicinal product should never be shared with anyone else, especially women.

Additional Precautions

Never give this medicinal product to another person. All unused capsules should be returned to the pharmacist after treatment is stopped.

You must not donate blood during treatment with this medicine or for one month after stopping Izotek 10 mg or Izotek 20 mg. If your blood is given to a pregnant woman, it may cause birth defects.

Information for All Patients

• Tell your doctor if you have ever had mental health problems, including depression, aggression, or mood swings. This is because Izotek 10 mg or 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 changes and help you identify problems that need to be discussed with your doctor.
• Severe skin reactions have been observed during isotretinoin treatment(e.g., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis). The rash can look like circular patches, often with central blisters, usually on the hands and feet or buttocks. More severe rashes can cover larger areas of the body. You should also look out for ulcers in the mouth, throat, nose, and genitals, and conjunctivitis (redness and swelling of the eyes).
• Izotek 10 mg and Izotek 20 mg may cause severe allergic reactions, which can include skin reactions such as rash, urticaria, and angioedema, or red spots on the hands and feet. If you experience an allergic reaction, you should stop taking Izotek 10 mg or Izotek 20 mg and contact your doctor immediately.
• Limit intense exercise and physical activity.Izotek 10 mg and Izotek 20 mg may cause muscle and joint pain, especially in children and adolescents who are physically active.
• Isotretinoin has been associated with non-specific gastrointestinal inflammation.If a patient experiences severe bloody diarrhea without a history of gastrointestinal disease, the doctor will stop treatment with Izotek 10 mg or Izotek 20 mg.
• Izotek 10 mg and Izotek 20 mg may cause dry eye syndrome, intolerance to contact lenses, and vision problems, including decreased night vision. There have been cases of dry eye that did not improve after treatment was stopped. You should tell your doctor if you experience any of these symptoms. The doctor may recommend using lubricating eye ointments or artificial tears. If you experience intolerance to contact lenses, the doctor may recommend wearing glasses during treatment. If you experience vision problems, the doctor may refer you to a specialist for advice and may recommend stopping treatment with Izotek 10 mg or Izotek 20 mg.
• Mild pseudotumor cerebri has been observed during isotretinoin treatment, sometimes in combination with tetracyclines (a type of antibiotic used, for example, in the treatment of acne). If you experience symptoms such as headache, nausea, vomiting, and vision disturbances, you should stop taking Izotek 10 mg or Izotek 20 mg and contact your doctor immediately. The doctor may refer you to a specialist to check for papilledema (swelling of the optic disc in the eye).
• Izotek 10 mg and Izotek 20 mg may increase liver enzyme activity.The treating doctor will order liver function tests before, during, and after treatment to check liver enzyme activity. If enzyme activity remains high, the doctor may reduce the dose or stop treatment with Izotek 10 mg or Izotek 20 mg.
• Isotretinoin often leads to increased blood lipid levels, such as cholesterol or triglycerides. The doctor will check lipid levels before starting treatment with Izotek 10 mg and Izotek 20 mg, during treatment, and after stopping treatment. During treatment, it is best to avoid drinking alcohol or reduce its consumption. You should tell your doctor if you have high lipid levels, diabetes (high blood sugar), or if you are overweight or have a history of alcoholism. More frequent blood tests may be necessary. If lipid levels remain high, the doctor may reduce the dose or stop treatment with Izotek 10 mg or Izotek 20 mg.
• Tell your doctor if you have any kidney problems.The doctor may start treatment with a lower dose of Izotek 10 mg and Izotek 20 mg and increase it to the maximum tolerated dose.
• Izotek 10 mg and Izotek 20 mg may cause increased blood sugar levels.In rare cases, patients have developed diabetes. 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 avoid skin irritation, you should avoid using exfoliating products and anti-acne products.
• 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, you should apply a sunscreen with a high sun protection factor (at least SPF 15) to your skin.
• Do not have any cosmetic procedures on your skin.Izotek 10 mg or Izotek 20 mg may make your skin more sensitive. You should not wax, have dermabrasion, or have laser treatments (to remove rough skin or scars) during treatment and for at least 6 months after stopping treatment, as this may lead to scarring, skin irritation, or changes in skin color.
• Tell your doctor if you experience persistent back pain or pain in the buttocks. These symptoms may indicate inflammatory bowel disease, a type of back pain caused by inflammation. The doctor may stop treatment with Izotek 10 mg or Izotek 20 mg and refer you to a specialist for treatment of inflammatory back pain. Further evaluation, including imaging tests such as MRI, may be necessary.

Children and Adolescents

Izotek 10 mg and Izotek 20 mg are 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 and Izotek 20 mg in adolescents over 12 years of age is only possible after puberty.

Other Medicines and Izotek 10 mg 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 tetracycline antibiotics(used, for example, in the treatment of acne) or use any anti-acne products on the skin while taking Izotek 10 mg and Izotek 20 mg. You can use moisturizing products and emollients (creams or lotions applied to the skin to prevent water loss and soften the skin).

skin.

• Do not use local anti-acne keratolytic or exfoliating productswhile taking Izotek 10 mg and Izotek 20 mg.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Izotek 10 mg and Izotek 20 mg must not be taken during pregnancy. If you are able to become pregnant, you must use effective contraception during treatment with Izotek 10 mg or Izotek 20 mg and for one month after stopping treatment.
If you become pregnant while taking Izotek 10 mg or Izotek 20 mgor within one month of stopping treatment, you must stop taking the medicine immediatelyand contact your doctor. The doctor may refer you to a specialist for advice.

Taking Izotek 10 mg or Izotek 20 mg during pregnancy may harm the fetus (because the medicine has a teratogenic effect). It also increases the risk of miscarriage.

Izotek 10 mg or Izotek 20 mg may cause serious birth defects in the fetus, including

brain, face, ear, eye, heart, and some glands (thymus and parathyroid).

Driving and Using Machines

During treatment, your night vision may be impaired. Such visual disturbances may occur suddenly. In rare cases, they may persist after treatment has stopped. Very rarely, drowsiness, dizziness, and visual disturbances have been reported. If you experience these symptoms, you must not drive or operate machinery.
Izotek 10 mg and Izotek 20 mg contain soybean oil. Do not take Izotek 10 mg or Izotek 20 mg if you are allergic to peanuts or soy.

3. How to Take Izotek 10 mg and Izotek 20 mg

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose:

The initial dose is usually 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day).
If your weight is 60 kg, treatment will usually start with a dose of 30 mg per day.

Take the capsules once or twice a day.

Take the medicine with a full stomach. Swallow the capsules whole with water or food.
After a few weeks, your doctor may change your dose.This depends on how you tolerate the treatment and the results. 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 or Izotek 20 mg is too weak or too strong, you should tell your doctor or pharmacist.
Treatment usually lasts from 16 to 24 weeks.For most patients, only one treatment cycle is necessary. Acne symptoms may improve for up to 8 weeks after treatment is stopped. Treatment is usually not started again until then. Some people may experience worsening of acne during the first few weeks of treatment. These symptoms usually improve as treatment continues.

Patients with Kidney Problems

In case of severe kidney disease, treatment should start with a lower dose (e.g., 10 mg/day), and the dose may be increased to the maximum tolerated dose. If you do not tolerate the recommended dose, you may receive a lower dose, which may mean that treatment will be longer and that acne may be more likely to come back.

Taking More Than the Recommended Dose of Izotek 10 mg or Izotek 20 mg

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 with Izotek 10 mg and Izotek 20 mg are similar to those of vitamin A overdose. These include headache, nausea, vomiting, dizziness, irritability, and itching.

Missing a Dose of Izotek 10 mg or 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, and continue with your regular dosing schedule. 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 and Izotek 20 mg can cause side effects, although not everybody gets them.
These symptoms usually disappear or decrease after stopping treatment. Others may be serious and require immediate medical attention.

Side Effects Requiring 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 central blisters, usually on the hands and feet or buttocks. More severe rashes can cover larger areas of the body. They can also be accompanied by other symptoms, such as eye infections (conjunctivitis) or ulcers in the mouth, throat, or nose.

Some types of rash can look like widespread peeling of the skin, which can be life-threatening. The onset of these severe skin rashes is often preceded by headache, fever, and flu-like symptoms.

If you experience a severe rash or the above skin symptoms, you must stop taking Izotek 10 mg or Izotek 20 mg and contact your doctor immediately.

Psychiatric Disorders

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

• Depression or related disorders. Symptoms include sadness, mood changes, anxiety, and emotional discomfort.
• Worsening of existing depression.
• Aggression or violent behavior.

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

• Some people have had thoughts or ideas of self-harm or suicide (suicidal thoughts), attempted suicide (suicide attempts), or committed suicide. These people may not have shown signs of depression.
• Abnormal behavior.
• Psychotic symptoms: loss of contact with reality, e.g., the patient hears voices or sees things that do not exist.

If you experience any of the above psychiatric symptoms, you must

contact your doctor immediately.The doctor may recommend stopping treatment with Izotek 10 mg or Izotek 20 mg. Stopping treatment 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: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and mouth. Also, sudden swelling of the hands, feet, and ankles. Very rare side effects(may affect up to 1 in 10,000 people)
• Sudden chest tightness, shortness of breath, and wheezing, especially if you have asthma.

If you experience a severe reaction, you must go to the emergency room immediately.

If you experience any allergic reaction, you must stop taking Izotek 10 mg or Izotek 20 mg and contact your doctor.

Musculoskeletal System

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 confusion. These are symptoms of rhabdomyolysis, a breakdown of muscle tissue that can lead to kidney failure. This can happen if you engage in intense physical activity while taking Izotek 10 mg or Izotek 20 mg.

Liver and Kidney Disorders

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

• Jaundice (yellowing of the skin or eyes) and fatigue. These may be symptoms of hepatitis.

You must stop taking Izotek 10 mg or Izotek 20 mg and contact your doctor immediately.

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

You must stop taking Izotek 10 mg or 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 10 mg or Izotek 20 mg with tetracycline antibiotics.

You must stop taking Izotek 10 mg or 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 gastrointestinal disease.

You must stop taking Izotek 10 mg or 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 must stop taking Izotek 10 mg or 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 red than usual, especially on the face.
• Back pain, muscle pain, joint pain, especially in children and adolescents who are physically active. To avoid worsening of any bone or muscle problems, you should limit intense physical activity while taking Izotek 10 mg and 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. If you experience dry eye syndrome, you may need to wear glasses instead of contact lenses.
• Increased liver enzyme activity in blood tests.
• Changes in lipid levels in the blood (including HDL or triglycerides).
• Bruising, bleeding, or faster blood clotting - if the problem affects the cells responsible for blood clotting.
• Anemia - weakness, dizziness, paleness - 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 nasal passages and formation of crusts, 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 must stop taking Izotek 10 mg or 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 and should stop after treatment is stopped.

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

• Impaired night vision, color blindness, and decreased color perception.
• Increased sensitivity to light; you may need to wear sunglasses to protect your eyes from too much light.
• Other eye problems, including blurred vision, distorted vision, and clouding of the cornea (corneal opacity).
• Excessive thirst, need to urinate frequently, and 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, tendon 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, 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 libido.
• Breast tenderness or swelling, occurring in men.
• Vaginal dryness.
• Sacroiliitis, 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 Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Izotek 10 mg and Izotek 20 mg

Keep this medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Return any leftover capsules to the pharmacist.You should 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. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Izotek 10 mg and Izotek 20 mg Contain

• The active substance of Izotek 10 mg and Izotek 20 mg is isotretinoin. Izotek 10 mg: each soft capsule contains 10 mg of isotretinoin. Izotek 20 mg: each soft capsule contains 20 mg of isotretinoin.
• Other ingredients are purified soybean oil, yellow wax, hydrogenated soybean oil, partially hydrogenated soybean oil, gelatin, glycerol, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

What Izotek 10 mg and Izotek 20 mg Look Like and Contents of the Pack

Izotek 10 mg are oval, red-orange capsules (size 3).
Izotek 20 mg are oval, red-orange capsules (size 6).
The medicine is available in cardboard boxes containing PVC/PE/PVDC/Aluminum blisters.
Available pack sizes are 10, 30, 50, 60, or 100 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

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

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Denmark:
Isotretinoin Orion
Finland: Isotretinoin Orion
Poland:
Izotek
Greece:
A-Cnotren 10 mg
Date of Last Revision of the Leaflet:January 2024
Detailed and up-to-date information on this medicinal product is available by scanning the QR code on the leaflet with a smartphone. The same information is also available on the website www.izotek.pl
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