Izotek 20 mg: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the outer packaging in a foreign language!
Izotek 20 mg (A-CNOTREN)
20 mg, soft capsules
Isotretinoinum
Izotek 20 mg and A-CNOTREN are different brand names of the same medicine.
WARNING
CAN CAUSE SEVERE HARM TO THE UNBORN CHILD
Women must use effective methods of contraception.
Do not use during pregnancy or if pregnancy is suspected.
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

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

Contents of the leaflet

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

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

Izotek 20 mg contains the active substance isotretinoin – a substance related to vitamin A and belonging to a group of medicines known as retinoids (used in the treatment of acne).
Izotek 20 mg is used in the treatment of severe forms of acne (such as nodular or conglobate acne, or acne with risk of permanent scarring) in adults and adolescents above the age of 12 years, only after puberty. Izotek 20 mg should be used only if the severity of acne has not been reduced by treatment with other anti-acne medicines, including antibiotics and topical treatments.
Treatment with Izotek 20 mg must be supervised by a dermatologist (a doctor specialized in treating skin diseases).

2. Important information before using Izotek 20 mg

When not to use Izotek 20 mg:

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

If any of the above situations apply,
consult a doctor before starting treatment with Izotek 20 mg.
Warnings and precautions
Before starting treatment with Izotek 20 mg, discuss this with your doctor or
pharmacist.
Pregnancy Prevention Programme
IMPORTANT
Information for women
Women who are pregnant must not take Izotek 20 mg.
This medicine can severely harm the unborn child (the medicine has a "teratogenic effect"). It
can cause serious damage to the brain, face, ears, eyes, heart and certain glands (thymus and parathyroid glands) of the foetus. It also increases the risk of miscarriage. These effects may
occur even if Izotek 20 mg is taken for only a short period during pregnancy.

Do not take Izotek 20 mg if you are pregnant or think you may be pregnant.
Do not take Izotek 20 mg while breastfeeding. The medicine is likely to pass into breast milk and may harm the breastfed infant.
Do not take Izotek 20 mg if you could become pregnant during treatment.
You must not become pregnant for one month after stopping treatment, as the medicine may still be present in your body.

Izotek 20 mg may be prescribed to women of childbearing potential only if strict 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 harm to the unborn child (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 ask the patient to undergo a pregnancy test. The test must confirm that the patient is not pregnant at the start of treatment with Izotek 20 mg.

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

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 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 20 mg, during treatment and for one month after stopping the medicine.
The patient must use contraception even if she does not have 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 20 mg.

The patient must agree to regular follow-up visits to the doctor, ideally every month.
The patient must agree to undergo regular pregnancy tests, ideally every month during treatment and one month after stopping Izotek 20 mg, as the medicine may still be present in the body (unless the doctor decides otherwise 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 and for one month after 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-mentioned requirements.

If a patient becomes pregnant while taking Izotek 20 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 20 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 20 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 medicine to another person. All unused capsules must be returned to the
pharmacist after treatment is completed.
You must not donate blood while taking this medicine or within one month after stopping
Izotek 20 mg. If a pregnant woman receives your blood, she may give birth to a child with
birth defects.
Information for all patients

Discuss with your doctor if you have ever had mental health problems, including depression, aggression or mood swings. This is because Izotek 20 mg may affect your mood. You may not notice certain changes in your mood or behaviour, so it is important to inform your friends and family members that you are taking this medicine. They may notice such changes and help you identify problems that need to be discussed with your doctor.
Severe skin reactions (e.g. erythema multiforme [EM], Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]) have been observed during isotretinoin treatment. Skin rash may present as widespread blistering or skin peeling. Also watch for mouth, throat, nose and genital ulcers, as well as conjunctivitis (redness and swelling of the eyes).
In rare cases, Izotek 20 mg may cause severe allergic reactions, which may affect the skin in the form of rash, hives and bruising or red spots on the hands and feet. If an allergic reaction occurs, stop taking Izotek 20 mg immediately, contact your doctor without delay and inform them that you are taking this medicine.
Limit intense physical exertion and activity. Izotek 20 mg may cause muscle and joint pain, particularly in children and adolescents engaging 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 20 mg.
Izotek 20 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 using moisturising 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 20 mg.
Mild intracranial hypertension has been observed during isotretinoin use, in some cases while concomitantly taking 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 20 mg immediately and contact your doctor without delay. The doctor may refer the patient to a specialist to check for papilledema (optic disc swelling).
Izotek 20 mg may increase liver enzyme activity. Your doctor will order appropriate blood tests before, during and after treatment to monitor liver enzyme activity. If enzyme activity remains elevated, your doctor may reduce the dose or discontinue treatment with Izotek 20 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 20 mg, as well as during and after treatment. It is best to avoid alcohol or at least reduce alcohol consumption during treatment. Inform your doctor if you have high blood lipid levels, diabetes (high blood glucose levels), or if you are overweight or have alcoholism. More frequent blood tests may be necessary. If blood lipid levels remain high, your doctor may reduce the dose or discontinue treatment with Izotek 20 mg.
Inform your doctor if you have any kidney problems. Your doctor may start treatment with a lower dose of Izotek 20 mg and then increase it to the maximum tolerated dose.
Izotek 20 mg may 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 if you are overweight or have alcoholism.
Skin dryness is likely to occur. During treatment, use a moisturising cream or ointment and lip balm. To prevent skin irritation, avoid using exfoliating 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 sunscreen with a high sun protection factor (SPF 15 or higher).
Do not undergo any cosmetic skin procedures. Izotek 20 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, rarely, changes in skin pigmentation.
Discuss with your doctor if you experience persistent lower back or buttock pain during treatment with Izotek 20 mg. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. The doctor may discontinue treatment with 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 20 mg is not recommended for children under 12 years of age. It is not known whether the medicine is safe or effective in this age group.
Use in adolescents over 12 years of age is only possible after puberty.
Other medicines and Izotek 20 mg
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including medicines obtained without a prescription.

While taking Izotek 20 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 20 mg, avoid topical use of keratolytic and exfoliating anti-acne products.

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 20 mg must not be used during pregnancy. If a woman is of childbearing potential, she must use an effective method of contraception during treatment with Izotek 20 mg and for one month after treatment ends.
If pregnancy occurs while taking Izotek 20 mg or within one month after treatment ends, stop taking the medicine immediately and contact your doctor. The doctor may refer you to a specialist for advice.
Taking Izotek 20 mg during pregnancy may harm the foetus (as the medicine has a teratogenic effect). It also increases the risk of miscarriage.
Izotek 20 mg may cause serious abnormalities in the brain, face, ears, eyes, heart and certain glands (thymus and parathyroid glands) of the foetus.
Breastfeeding
Do not take Izotek 20 mg while breastfeeding. This medicine is likely to pass into breast milk and may harm the breastfed infant.
More information on pregnancy and contraception can be found in section 2 "Pregnancy Prevention Programme".
Driving and operating machinery
During treatment, night vision may be impaired. Such visual disturbances may appear suddenly. In rare cases, they persist after treatment ends.
Drowsiness, dizziness and visual disturbances have been very rarely reported. If these symptoms occur, the patient must not drive or operate machinery.
Izotek 20 mg contains soya oil. Do not take Izotek 20 mg if you are allergic to peanuts or soya.

3. How to use Izotek 20 mg

This medicine should always be taken as prescribed by your doctor. If in doubt, consult 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 bw/day).
If the patient weighs 60 kg, treatment is usually started at a dose of 30 mg per day.
Capsules should be taken once or twice daily.
The medicine should be taken with food. Capsules must be swallowed whole, taken with liquid or
swallowed together with food.
After several weeks, your doctor may adjust the dose. This depends on how well the patient tolerates the treatment and the therapy results. For most patients, the dose ranges from 0.5 mg/kg bw/day to 1 mg/kg bw/day.
If the patient feels that the effect of Izotek 20 mg is too weak or too strong, this should be reported to the doctor or pharmacist.
Treatment usually lasts from 16 to 24 weeks. For most patients, only one treatment cycle is necessary. Acne symptoms may continue to improve for up to 8 weeks after treatment ends. Usually, another treatment cycle is not started during this time.
Some individuals may notice a worsening of acne during the first weeks of treatment. These symptoms usually improve as treatment continues.
Patients with kidney function disorders
In cases of severe kidney disease, treatment should start with a lower dose (e.g., 10 mg/day), which may then be gradually increased to the maximum dose tolerated by the patient.
If the patient cannot tolerate the recommended dose, a lower dose may be prescribed, which may mean that treatment needs to be prolonged and the risk of acne recurrence may be higher.
Taking more than the recommended dose of Izotek 20 mg
If a patient has taken too many capsules or if someone else accidentally takes this medicine, contact a doctor, pharmacist, or the nearest hospital immediately.
Isotretinoin is a derivative of vitamin A. Symptoms of poisoning with Izotek 20 mg are similar to those of vitamin A toxicity. These include, for example: headache, nausea, vomiting, dizziness, irritability, and itching.
Missed dose of Izotek 20 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; 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 resolve or disappear 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, typically 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 ulcers 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 rashes is often preceded by headache, fever, and body aches (flu-like symptoms).

If a patient develops a severe rash or any of the skin symptoms listed above, discontinue
treatment with Izotek 20 mg immediately and contact a doctor without delay.

Psychiatric disorders

Rare 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 pre-existing depression.
Tendency towards violence or aggression.

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

Some individuals have had thoughts or fantasies about self-harm or suicide (suicidal ideation), attempted suicide, or died by suicide. These individuals may not necessarily show symptoms of depression.
Unusual behaviour.
Psychotic symptoms: loss of contact with reality, e.g. hearing voices or seeing things that are not really there.

If any of the psychiatric symptoms described above occur, contact a doctor immediately.
The doctor may recommend discontinuation of Izotek 20 mg. Stopping the medicine may not be sufficient for these effects to resolve; additional support may be needed, which the doctor can provide.

Allergic reactions

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

Severe (anaphylactic) reactions: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, or mouth. Sudden swelling of the hands, feet, and ankles may also occur.

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

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

In case of a severe allergic reaction, go immediately to the emergency department.
If any allergic reaction occurs, discontinue taking Izotek 20 mg and contact your doctor.

Musculoskeletal system

Frequency unknown (frequency cannot be estimated from available data)

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

Liver and kidney function disorders

Very rare 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 20 mg immediately and contact a doctor.

Problems with urination, swollen and puffy eyelids, feeling extremely tired. These may be symptoms of kidney inflammation.

Discontinue Izotek 20 mg immediately and contact a doctor.

Nervous system disorders

Very rare 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 20 mg is taken concomitantly with tetracycline antibiotics.

Discontinue Izotek 20 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 diarrhoea, nausea, and vomiting, or without these symptoms. These may be symptoms of severe intestinal diseases.

Discontinue Izotek 20 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 20 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 start 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 of any musculoskeletal or joint symptoms, intense physical activity should be limited during treatment with Izotek 20 mg.
Inflammation of the eyes (conjunctivitis) and eyelids, dryness and irritation of the eyes. Consult a pharmacist for appropriate eye drops. If dry eye syndrome occurs, 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.
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.
Drying of the nasal cavity and formation of crusts leading to mild nosebleeds.
Pain or inflammation of the throat and nasal cavity.
Allergic reactions such as rash, itching. If any allergic reaction occurs, discontinue taking Izotek 20 mg and contact a doctor.

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

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

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

Night vision may deteriorate, colour blindness may occur, and colour perception may worsen.
Increased sensitivity to light may occur; wearing sunglasses may be necessary to protect the eyes from bright 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, changes in bone density); growth inhibition in growing bones may occur.
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 surgery.
Increased body hair growth.
Seizures, drowsiness, dizziness.
Lymph node swelling may occur.
Dry throat, hoarseness.
Hearing problems.
General malaise.
High blood uric acid levels.
Bacterial infections.
Vasculitis (sometimes with bruising or red spots).

Frequency unknown (frequency 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 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 20 mg

Keep the medicine out of the sight and reach of children.
Do not store above 25°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 specified month.
Any remaining capsules should be returned to the pharmacist. They should only be kept if advised 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. Such practices help protect the environment.

6. Contents of the pack and other information

What Izotek 20 mg contains

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

What Izotek 20 mg looks like and contents of the pack
Izotek 20 mg are oval, red-orange capsules (size 6).
The medicine is available in cardboard boxes containing PVC/PE/PVDC/Aluminium blisters.
For more detailed information, please contact the responsible party or parallel importer.

Responsible party in Greece, country of export:
Pharmathen Investments Group Limited
Kritis 32, Papachristoforou Building, 4th floor
3087 Lemesos
Cyprus

Manufacturer:
Pharmathen S.A.
6, Dervenakion Str.
153 51 Pallini
Athens, Greece
Pharmathen International S.A.
Industrial Park Sapes, Block No 5
Rodopi Prefecture 69300, Greece

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorisation Number in Greece, country of export: 45047/10/18-04-2012
Parallel Import Authorisation Number: 240/22

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Isotretinoin Orion
Finland: Isotretinoin Orion
Poland: Izotek
Greece: A-Cnotren 20 mg

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