Izotek 10 mg

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. 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

IT CAN SERIOUSLY HARM AN UNBORN CHILD
Women must use effective methods of contraception.
Do not use during pregnancy or if pregnancy is suspected.
▼ This medicinal product will be subject to additional monitoring. This will allow for the rapid
identification of new safety information. Users of the medicinal product can also help by reporting
any adverse reactions they experience while taking the medicinal product. To find out how to report
adverse reactions, see the last paragraph of section 4.

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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 acne does not improve after treatment with other anti-acne medicines, including antibiotics and topical medicines.
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 followthe necessary pregnancy prevention measures, which are listed in the Pregnancy Prevention Program for 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 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, the patient should consult a doctor before starting treatment with Izotek 10 mg.

Warnings and precautions

Before starting treatment with Izotek 10 mg, the patient should discuss it with their doctor or pharmacist.

Pregnancy Prevention Program

IMPORTANT

Information for women

Pregnant women must not take Izotek 10 mg.

This medicine can seriously harm an unborn child (it has a teratogenic effect). It can cause serious damage to the brain, face, ear, eye, heart, and certain 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 while 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, as the medicine may still be present in the patient's body.

Izotek 10 mg may only be prescribed to women who are able to become pregnant if they strictly follow the specified rules. 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(birth control methods) with the doctor. The doctor will provide 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 contraception before, during, and after treatment with Izotek 10 mg.

Izotek 10 mg.

• ●

The patient must agree to use at least one highly effective method of contraception (such as an intrauterine device or contraceptive implant), or two effective methods that work in different ways (such as 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 Izotek 10 mg, during treatment, and for one month after stopping treatment.

Izotek 10 mg.

• ●

The patient must use contraception, even if they do not menstruate or are 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 follow-up visits 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,as 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,

as 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 risks and agrees to follow the rules mentioned above.

If the patient becomes pregnant while taking Izotek 10 mg, they must

stop taking the medicine immediatelyand contact their 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, they

should contact their 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 small to harm an unborn child. 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 while taking this medicine or for one month after stopping treatment with Izotek 10 mg. If the patient's blood is given to a pregnant woman, it may cause birth defects in the baby.

Information for all patients

• ●

The patient should discuss with their doctor if they have ever had

mental health problems,including depression, aggression, or mood swings. This is because Izotek 10 mg may affect the patient's mood. The patient may not notice certain changes in their mood and behavior, so it is very important to tell friends and family members about taking this medicine. They 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(such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been observed. The rash can take the form of widespread blistering or peeling of the skin. It is also necessary to pay attention to ulcers in the mouth, throat, nose, and genital areas, as well as conjunctivitis (redness and swelling of the eyes).
• ●

In rare cases, Izotek 10 mg may cause severe allergic reactions,

which can include skin reactions such as rash, hives, and bruising or red spots on the hands and feet. In case of an allergic reaction, the patient should stop taking Izotek 10 mg, seek medical attention immediately, and inform the doctor about taking the medicine.

• ●The patient should limit intense exercise and physical activity.Izotek 10 mg may cause muscle and joint pain, especially in children and adolescents who engage in intense physical activity.
• ●The use of isotretinoin has been associated with non-specific enteritis.If a patient experiences severe bloody diarrhea without a history of gastrointestinal disease, 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 impaired night vision.The patient should inform their doctor if they experience any of these symptoms. There have been cases of dry eye that did not improve after treatment was stopped. The doctor may recommend using moisturizing eye ointments or artificial tears. If the patient experiences intolerance to contact lenses, the doctor may recommend wearing glasses during treatment. If the patient experiences vision problems, the doctor may refer them to a specialist for advice and may recommend stopping treatment with Izotek 10 mg.

• ●

During treatment with isotretinoin, mild hypertension

has been observed,sometimes during concurrent treatment with isotretinoin and tetracyclines (a type of antibiotic used, for example, in the treatment of acne). In case of symptoms such as headache, nausea, vomiting, and vision disturbances, the patient should stop taking Izotek 10 mg and seek medical attention immediately. The doctor may refer the patient 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 liver function tests before, during, and after treatment to check liver enzyme activity. 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 levels of lipids in the blood,such as cholesterol or triglycerides. The doctor will check lipid levels before starting treatment with Izotek 10 mg, as well as during and after treatment. During treatment, it is best to avoid drinking alcohol or reduce its consumption. The patient should inform their doctor if they have high lipid levels, diabetes (high blood sugar), or if they 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.
• ●

The patient should inform their doctor if they 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 lead to increased blood sugar levels.In rare cases, patients have developed diabetes. The doctor may monitor blood sugar levels during treatment, especially if the patient already has diabetes or is overweight or has a history of alcoholism.

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• ●It is likely that the skin will dry out.During treatment, the patient should use a moisturizing cream or ointment and lip balm. To avoid skin irritation, the patient should avoid using exfoliating products and anti-acne products.
• ●

The patient should avoid excessive sun exposure and the use of sunlamps and sunbeds.

The skin may become more sensitive to sunlight. Before going out in the sun, the patient should apply sunscreens with a high sun protection factor (at least SPF 15) to their skin.

• ●The patient should not have any cosmetic procedures on their skin.Izotek 10 mg may make the skin more sensitive. The patient should not wax, dermabrade, or have laser treatments (to remove rough skin or scars) during treatment and for at least six months after stopping treatment, as this may lead to scarring, skin irritation, or changes in skin color.
• The patient should discuss with their doctor if they 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 the patient 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 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those that are available without a prescription.

• ●

During treatment with Izotek 10 mg, the patient should not take

products containing vitamin A or tetracyclines(an antibiotic used, for example, in the treatment of acne), or use any anti-acne products on the skin. The patient may use moisturizing products and emollients (creams or preparations applied to the skin that prevent water loss and soften the skin).

• ●During treatment with Izotek 10 mg, the patient should avoid using topical anti-acne keratolytic and exfoliating agents.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Izotek 10 mg should not be used during pregnancy. If the woman is able to become pregnant, she should use effective contraception during treatment with Izotek 10 mg and for one month after stopping treatment.
If the patient becomes pregnant while taking Izotek 10 mgor within one month of stopping treatment, they should stop taking the medicine immediately and contact their doctor. The doctor may refer the patient 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 birth defects in the brain, face, ear, eye, heart, and certain glands (thymus and parathyroid) of the fetus.

Breastfeeding
The patient should not take Izotek 10 mg while breastfeeding.The medicine is likely to pass into breast milk and may harm the breastfed baby.
More information on pregnancy and contraception can be found in section 2 "Pregnancy Prevention Program".

Driving and using machines

During treatment, the patient's night vision may deteriorate. Such vision disturbances can occur suddenly. In rare cases, they may persist after treatment has stopped. Very rarely, drowsiness, dizziness, and vision disturbances have been reported. If the patient experiences these symptoms, they should not drive or operate machinery.
Izotek 10 mg contains soybean oil.The patient should not take Izotek 10 mg if they are allergic to peanuts or soy.

3. How to take Izotek 10 mg

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their 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 the patient weighs 60 kg, treatment will usually start with a dose of 30 mg per day.

Capsules should be taken once or twice a day.

The medicine should be taken with a full stomach. The capsules should be swallowed whole, with a drink of water or food.
After a few weeks, the doctor may change the dose.This depends on how the patient tolerates 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 the patient feels that the effect of Izotek 10 mg is too weak or too strong, they should inform their 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 treatment has stopped. Usually, a new treatment cycle is not started 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 cases of severe kidney disease, treatment should start with a lower dose (e.g., 10 mg/day), which can then be increased to the maximum tolerated dose. If the patient does not tolerate the recommended dose, they may receive a lower dose, which may mean that treatment will be longer and that relapse of acne is more likely.

Taking more than the recommended dose of Izotek 10 mg

If the patient has taken too many capsules or if someone else has taken the medicine by mistake, they should contact their doctor, pharmacist, or the nearest hospital immediately.
Isotretinoin is a derivative of vitamin A. Symptoms of overdose with Izotek 10 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

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they should not take the missed dose, but continue treatment as prescribed. The patient should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Izotek 10 mg can cause side effects, although not everyone gets them.
These symptoms often disappear or improve after treatment is stopped. Others may be severe 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 on the hands and feet or on the chest and back. More severe rashes may spread to the chest and back. Additional symptoms may include eye infections (conjunctivitis) or ulcers in the mouth, throat, or nose. Some types of rash may take the form of widespread peeling of the skin, which can 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 experiences a severe rash or the mentioned skin symptoms, they should stop taking Izotek 10 mg and seek medical attention immediately.

Psychiatric disorders

Rare side effects(may affect up to 1 in 1,000 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 about self-harm or suicide (suicidal thoughts), attempted suicide, or committed suicide. These people may not show 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 the patient experiences any of the above psychiatric symptoms, they should

seek medical attention immediately.The doctor may recommend stopping treatment with Izotek 10 mg. Stopping treatment may not be enough for these effects to improve; additional help may be necessary, and the doctor can provide it.

Allergic reactions

Rare side effects(may affect up to 1 in 1,000 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 the patient has asthma.

If the patient experiences a severe reaction, they should seek emergency medical attention.

If the patient experiences any allergic reaction, they should stop taking Izotek 10 mg and contact their 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.

Disorders of the liver and kidney

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.

The patient should stop taking Izotek 10 mg and seek medical attention immediately.

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

The patient should stop taking Izotek 10 mg and seek medical attention 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 antibiotics from the tetracycline group.

The patient should stop taking Izotek 10 mg and seek medical attention 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.

The patient should stop taking Izotek 10 mg and seek medical attention immediately.

Eye disorders

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

• ●Blurred vision.

If the patient experiences blurred vision, they should stop taking Izotek 10 mg and seek medical attention immediately.

If the patient experiences any other changes in their vision, they should seek medical attention 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, the patient should use a moisturizing cream.
• ●Skin more sensitive and reddened than usual, especially on the face.
• ●Back pain, muscle pain, joint pain, especially in children and adolescents. To avoid worsening of musculoskeletal or muscle disorders, the patient should limit intense physical activity while taking Izotek 10 mg.
• ●Eye inflammation (conjunctivitis) and eyelid inflammation, feeling of dryness and irritation of the eyes. The patient should consult their pharmacist for suitable eye drops. If the patient experiences dry eye syndrome, they 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, pale skin - if the problem affects red blood cells.

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

• ●Headache.
• ●Higher 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 the patient experiences any allergic reaction, they should stop taking Izotek 10 mg and seek medical attention.

Rare side effects(may affect up to 1 in 1,000 people)

• ●Hair loss (alopecia). This is usually temporary and should stop after treatment is finished.

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

• ●The patient may experience impaired night vision, color blindness, or decreased color perception.
• ●The patient may experience increased sensitivity to light; they may need to wear sunglasses to protect their eyes from too much light.
• ●Other vision problems, including blurred vision, distorted vision, or clouding of the cornea (corneal opacity).
• ●The patient may experience excessive thirst, need to urinate frequently, or blood test results showing high blood sugar levels. These may be symptoms of diabetes.
• ●During the first few weeks of treatment, the patient may experience worsening of acne, but symptoms should start to improve as time passes.
• ●The skin may become inflamed, 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); the patient's growing bones may stop growing.
• ●Calcification of soft tissues; muscle pain; and high levels of muscle breakdown products in the blood, especially with intense physical activity.
• ●Increased sensitivity to light.
• ●Bacterial infections under the fingernails, changes in the fingernails.
• ●Edema, discharge, or pus.
• ●Excessive scarring after surgery.
• ●Increased hair growth on the body.
• ●Seizures, drowsiness, dizziness.
• ●The patient may experience swelling of the lymph nodes.
• ●Dry throat, hoarseness.
• ●Hearing problems.
• ●General malaise.
• ●High uric acid levels in the blood.
• ●Bacterial infections.
• ●Vasculitis (inflammation of blood vessels), 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 libido.
• Breast tenderness or swelling, with or without pain, in men.
• Dry vagina.
• Sacroiliitis, a type of back pain caused by inflammation, causing pain in the lower back or buttocks.
• Urethritis.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, it is possible to gather more information on the safety of this medicine.

5. How to store Izotek 10 mg

The medicine should be kept out of 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.
The patient should return any leftover capsules to the pharmacist.The patient should only keep them if the doctor advises them to do so.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. 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.
• 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 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/Aluminum foil.
Packaging containing 10, 30, 60, or 100 soft capsules is available.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Pharmathen Investments Group Limited
Kritis 32
Papachristoforou Building, 4 floor
3087 Limassol
Cyprus

Manufacturer:

Pharmathen ABEE
6, Dervenakion str.
15351 Pallini, Greece
Pharmathen International SA
Sapes, Industrial Park Rodopi Perfecture
Block No 5, Rodopi 69300, Greece

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Greece, the country of export: 45/16-01-2012

Parallel import authorization number: 543/13

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
Date of revision of the leaflet:27.11.2023
[Information about the trademark]
Detailed and up-to-date information about this medicine is available by scanning the QR code on the leaflet using a smartphone. The same information is also available on the website [website address].
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