Izotek 10 mg: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms appear identical.
If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

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 similar to vitamin A and belonging to a group of medicines called 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 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 has not been reduced with other anti-acne treatments, including antibiotics and topical medicines.
Treatment with Izotek 10 mg must be supervised by a dermatologist (a doctor specializing in skin disease treatment).

2. Important Information Before Using Izotek 10 mg

When not to use Izotek 10 mg:

if the patient is allergic to isotretinoin, peanuts, soy, 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 essential 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 specified 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),
during 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 conditions apply, consult your doctor before starting treatment with Izotek 10 mg.
Warnings and precautions
Discuss this with your doctor or pharmacist before starting treatment with Izotek 10 mg.
Pregnancy Prevention Programme
IMPORTANT
Information for women
Women who are pregnant must not take Izotek 10 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 10 mg is taken for only a short period during pregnancy.

Do not take Izotek 10 mg if you are pregnant or suspect 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 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 capable of becoming pregnant only if strict adherence to specific rules 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 harm to the unborn child (birth defects); the patient must understand why she must not become pregnant and how to prevent it.
The patient must discuss contraception (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 start of treatment with Izotek 10 mg.

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. 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.
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 have menstrual periods or is not currently sexually active (unless the doctor determines it is not necessary).

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

The patient must agree to attend regular follow-up visits with the doctor, ideally once a month.
The patient must agree to undergo regular pregnancy tests, ideally once a month during treatment and one month after stopping Izotek 10 mg, as the medicine may still be present in the body (unless the doctor decides it is not necessary for a particular patient).
The patient must agree to undergo 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 her 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 rules outlined above.

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 for one month after stopping Izotek 10 mg. If a pregnant woman receives blood from the patient, the child may be born with birth defects.
Information for all patients

Discuss with your doctor if you have ever had any mental health problems, including depression, aggression, or mood swings. This is because Izotek 10 mg may affect your mood.

You may not notice certain changes in your mood and 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 quickly that need to be discussed with your doctor.

Severe skin reactions have been observed during isotretinoin treatment (e.g. erythema multiforme [EM], Stevens-Johnson syndrome [SJS], and toxic epidermal necrolysis [TEN]). Skin rash may present as widespread blistering or peeling of the skin. Also watch for ulcers in the mouth, throat, nose, and genital organs, as well as conjunctivitis (redness and swelling of the eyes).
In rare cases, Izotek 10 mg may cause severe allergic reactions, which may affect the skin in the form of rash, hives, or bruising, 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.
Limit intense physical effort and activity. Izotek 10 mg may cause muscle and joint pain, particularly in children and adolescents who engage in intense physical activity.
Isotretinoin use has been associated with non-specific inflammatory bowel disease. If a patient without a history of gastrointestinal disorders develops severe bloody diarrhoea, the doctor will discontinue treatment with Izotek 10 mg.
Izotek 10 mg may lead to 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 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 the patient to a specialist for advice and may also recommend discontinuing Izotek 10 mg.
Mild intracranial hypertension has been observed during isotretinoin use, sometimes during concomitant use of isotretinoin and 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 and contact your doctor immediately. The doctor may refer the patient to a specialist to check for papilledema (optic disc swelling).
Izotek 10 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 elevated, your doctor may reduce the dose or discontinue treatment with Izotek 10 mg.
Isotretinoin often leads to increased 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 lead to increased 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 likely to occur. During treatment, use a moisturising cream or ointment and lip balm. To prevent 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 outdoors, apply 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 hair, perform dermabrasion, or undergo laser treatments (to remove keratinised skin or scars) during treatment and for at least 6 months after treatment ends, as this may lead to scarring, skin irritation, or, in rare cases, skin pigmentation changes.
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 the patient to a specialist for treatment of inflammatory back pain. Further evaluation, including imaging tests such as MRI, may be required.

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
Tell 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), 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).
During treatment with Izotek 10 mg, avoid topical use of keratolytic or peeling anti-acne products.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect 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 should use an effective contraceptive method during treatment with Izotek 10 mg and for one month after stopping the medicine.
If pregnancy occurs during treatment with 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 foetus (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) of the foetus.
Breastfeeding
Do not take Izotek 10 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
Treatment may impair night vision. These visual disturbances may occur suddenly. In rare cases, they persist after treatment ends. Drowsiness, dizziness, and visual disturbances have been reported very rarely. 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.
Izotek 10 mg (10 mg) and Izotek 20 mg (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 b.w./day).
If the patient's body 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 must be swallowed whole, taken with food or
swallowed together with a meal.
After several weeks, the doctor may adjust the dose. This depends on how well the patient tolerates the treatment and the therapeutic response. For most patients, the dose ranges from 0.5 mg/kg b.w./day to 1 mg/kg b.w./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. In most patients, only one treatment cycle is necessary. Acne symptoms may continue to improve for up to 8 weeks after completing treatment. Usually, a new 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 impaired kidney function
In cases of severe kidney disease, treatment should begin with 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; however, this may require a longer treatment duration and may increase the likelihood of acne recurrence.
Taking more than the recommended dose of Izotek 10 mg
If a patient takes too many capsules or if someone accidentally ingests this medicine, contact a doctor, pharmacist, or the 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 may include: headache, nausea, vomiting, dizziness, irritability, and itching.
Missing a dose of Izotek 10 mg
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should not be made up; instead, 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 upon discontinuation of treatment. Others may be severe and
require immediate medical attention.
Adverse effects requiring immediate medical assistance:
Skin problems
Frequency unknown (frequency which cannot be estimated from the available data)

Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which may be life-threatening and require immediate medical assistance. 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 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 present as widespread 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 above skin symptoms, treatment with Izotek 10 mg must be discontinued immediately and medical advice should be sought 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 emotional discomfort.
Worsening of existing depression.
Tendency towards violence or aggression.

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

Some individuals have experienced thoughts or images related to self-harm or suicide (suicidal thoughts), attempted suicide, or completed suicide. These individuals may 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, immediate contact with a physician is required. The doctor may recommend discontinuation of Izotek 10 mg.
Stopping the medication may not be sufficient for these effects to resolve; additional support may be necessary, which the physician 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 oral cavity. Also sudden swelling of 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, immediate attendance at an emergency department is required.
In case of any allergic reaction, treatment with Izotek 10 mg should be discontinued and the treating physician should be contacted.
Musculoskeletal system
Frequency unknown (frequency which cannot be estimated from the available data)

Muscle weakness, which may potentially be life-threatening, possibly associated with difficulties in 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. Treatment with Izotek 10 mg must be discontinued immediately and a physician should be contacted.
Problems with urination, swollen and puffy eyelids, feeling extremely tired. These may be symptoms of kidney inflammation. Treatment with Izotek 10 mg must be discontinued immediately and a physician should be contacted.

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.

Treatment with Izotek 10 mg must be discontinued immediately and the treating physician should be contacted.
Gastrointestinal disorders
Very rare adverse effects (may occur in less than 1 in 10,000 patients)

Severe abdominal pain with or without bloody diarrhea, nausea, and vomiting. These may be symptoms of severe intestinal diseases. Treatment with Izotek 10 mg must be discontinued immediately and the treating physician should be contacted.

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

Blurred vision.

If blurred vision occurs, treatment with Izotek 10 mg must be discontinued immediately and a physician should be contacted. In case of any other vision changes, contact a physician 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, chapping and inflammation of the lips, rash, mild itching, and slight peeling. A moisturizing cream should be used from the beginning of treatment.
Skin more sensitive and reddened than usual, especially on the face.
Back pain, muscle pain, joint pain, particularly in children and adolescents. To avoid worsening of any musculoskeletal or muscular complaints, intense physical activity should be limited during treatment with Izotek 10 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 adverse 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. In case of any allergic reaction, treatment with Izotek 10 mg should be discontinued and a physician should be contacted.

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

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

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

May lead to worsening of night vision, color blindness, and impaired color perception.
May lead to increased light sensitivity; 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.
During the first few weeks, acne may worsen, 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; problems with the skeletal system (growth delay, excessive growth, and changes in bone density); may lead to inhibition of growth in growing bones.
Calcium deposition in soft tissues, tendon pain, and high levels of muscle breakdown products in blood during intense physical activity.
Increased light sensitivity.
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.
May lead to swelling of lymph nodes.
Dry throat, hoarseness.
Hearing problems.
General malaise.
High blood uric acid levels.
Bacterial infections.
Vasculitis (sometimes with bruising or red spots).

Frequency unknown (frequency which cannot be estimated from the available data)

Dark or dark brown urine.
Difficulty achieving or maintaining erection.
Reduced sexual drive.
Breast swelling with or without tenderness, occurring 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 Adverse Drug Reactions of the 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
Reporting adverse effects helps to provide more information on the safety of the 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. Keep the container tightly closed 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 stated month.
Any remaining capsules should be returned to the pharmacist. Keep them only if advised by a doctor.
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 pack 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/Aluminium blisters.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Greece, the country of export:
Pharmathen Investments Group Limited
Kritis 32, Papachristoforou Building, 4 floor
Limassol
Cyprus

Manufacturer:
Pharmathen Pharmaceuticals SA
6, Dervenakion str.
15351 Pallini, Attica
Greece
Pharmathen International SA
Sapes, Industrial Park Rodopi Prefecture, Block No 5
Rodopi 69300
Greece

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Marketing Authorisation number in Greece, the country of export: 45/16-01-2012
Parallel Import Licence number: 192/20

This medicinal product is authorised in the European Economic Area under the following names:
Denmark: Isotretinoin Orion
Finland: Isotretinoin Orion
Poland: Izotek
Greece: A-Cnotren 10 mg

Detailed and up-to-date information on this medicine is available by scanning with a smartphone the QR code located on the leaflet. The same information is also available on the website: http://sirpl.org/Retinoidy .
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