Izotek 20 mg

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Izotek 20 mg (A-Cnotren)
20 mg, soft capsules
Isotretinoinum
Izotek 20 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.
Do not use during pregnancy or if pregnancy is suspected.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Izotek 20 mg is and what it is used for
2. Important information before taking Izotek 20 mg
3. How to take Izotek 20 mg
4. Possible side effects
5. How to store Izotek 20 mg
6. 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 a risk of permanent scarring) in adults and adolescents over the age of 12, only after puberty.
Izotek 20 mg will be used only if the severity of acne has not improved with other anti-acne treatments, including antibiotics and topical medicines.
Treatment with Izotek 20 mg must be supervised by a dermatologist
(a doctor specializing in skin disorders).

2. Important information before using Izotek 20 mg

When not to use Izotek 20 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 may become pregnant, it is necessary to follow the precautions outlined in the Pregnancy Prevention Programme, see section "Warnings and precautions",
• in women who may become pregnant but are unable or unwilling to comply with the necessary pregnancy prevention measures outlined 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 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 20 mg is taken for only a short period of time during pregnancy.

• Do not take Izotek 20 mg if you are pregnant or suspect 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 nursing 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 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 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. intrauterine device or contraceptive implant), or two effective methods acting in different ways (e.g. oral hormonal contraceptives and condoms). Discuss with the doctor which methods are most suitable for the patient.
• The patient must use a contraceptive method 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 menstrual periods or is not currently sexually active (unless the doctor determines this is not necessary).

Women must agree to undergo pregnancy tests before, during and after
treatment with Izotek 20 mg.

• The patient must agree to attend regular follow-up visits with the doctor, ideally every month.
• The patient must agree to undergo regular pregnancy tests, ideally every month during treatment and one month after stopping treatment with 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 or within one month after stopping 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 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 another person, especially women.
Additional precautions
Never give this medicine to another person. All unused
capsules must be returned to the pharmacist after treatment ends.
Do not donate blood while taking this medicine or within one month after
stopping treatment with Izotek 20 mg. If a pregnant woman receives the patient's blood,
she may give birth to a child with congenital malformations.
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 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 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 bruises or red spots on the hands and feet. If an allergic reaction occurs, stop taking Izotek 20 mg immediately, contact your doctor and inform him/her 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 has been associated with non-specific inflammatory bowel disease. In case of severe bloody diarrhoea in a patient without a history of gastrointestinal disorders, 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, not resolving after treatment ends, have been reported. Inform your doctor if any of these symptoms occur. The doctor may recommend using moisturising eye ointments or artificial tears. In case of contact lens intolerance, 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 recommend discontinuing treatment with Izotek 20 mg.
• Benign intracranial hypertension has been observed during isotretinoin treatment, in some cases when isotretinoin was taken concomitantly with tetracyclines (a class of antibiotics used, for example, in acne treatment). If symptoms such as headache, nausea, vomiting and visual disturbances occur, stop taking Izotek 20 mg and contact your doctor immediately. 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. 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 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. The 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 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 and anti-acne products.
• Avoid excessive sun exposure and using sunlamps or tanning beds.

The skin may become more sensitive to sunlight. Before going outdoors, apply sunscreen products with high UV protection factor (at least SPF 15).

• Do not undergo any cosmetic skin procedures. Izotek 20 mg may make the skin more sensitive. Do not use waxing, dermabrasion or laser treatments (removing 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 discoloration.
• 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 management 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, as well as any medicines you plan to take, including those available without a prescription.

• While taking Izotek 20 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 on the skin. You may use moisturisers and emollients (creams or skin products that prevent water loss and soften the skin).
• Avoid topical use of keratolytic and exfoliating anti-acne products while taking Izotek 20 mg.

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 20 mg must not be used during pregnancy. If a woman is of childbearing potential, she should use an effective contraceptive method during treatment with Izotek 20 mg and for one month after stopping the medicine.
If pregnancy occurs while taking Izotek 20 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 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 nursing infant.
More information on pregnancy and contraception can be found in section 2 "Pregnancy Prevention Programme".
Driving and operating machinery
During therapy, night vision may deteriorate. These visual disturbances may appear suddenly. In rare cases, they persist after therapy ends.
Very rarely, drowsiness, dizziness and visual disturbances have been 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 exactly as directed 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's weight is 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 a full stomach. Capsules must be swallowed whole, taken with food or water.
After several weeks, your doctor may adjust the dose. This depends on how well the patient tolerates the treatment and on the therapeutic response. 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, 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 completion of treatment. Usually, a new 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, they may receive a lower dose, which may mean that treatment needs to be prolonged and that acne recurrence is more likely.
Taking more than the recommended dose of Izotek 20 mg
If a patient has taken too many capsules or if someone else accidentally ingests this medicine, contact a doctor, pharmacist, or 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.
If a dose of Izotek 20 mg is missed
If a dose has been 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 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 the 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 may 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 the patient develops a severe rash or any of the skin symptoms listed above, the use of Izotek 20 mg must be discontinued immediately and medical advice must 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 feelings of 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 experienced thoughts or images of self-harm or suicide (suicidal thoughts), attempted suicide, or died by suicide. These individuals may not have shown symptoms of depression.
• Unusual behaviour.
• Psychotic symptoms: loss of contact with reality, e.g. the patient hears voices or sees things that do not exist.

If any of the psychiatric symptoms described above occur, immediate medical advice must be sought. 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 required, 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, and mouth. Also sudden swelling of the 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, particularly if the patient suffers from asthma.

In the event of a severe allergic reaction, immediate attendance at an emergency department is required.
If any allergic reaction occurs, the use of Izotek 20 mg must be discontinued and the prescribing doctor must be contacted.
Musculoskeletal system
Frequency unknown (frequency cannot be estimated from the available data)

• Muscle weakness, which may potentially be life-threatening, may be associated with difficulty moving arms or legs, pain, swelling, bruising, dark 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. The use of Izotek 20 mg must be discontinued immediately and a doctor must be contacted.
• Problems with urination, swollen and puffy eyelids, feeling extremely tired. These may be symptoms of kidney inflammation. The use of Izotek 20 mg must be discontinued immediately and a doctor must 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 20 mg is taken concomitantly with tetracycline antibiotics. The use of Izotek 20 mg must be discontinued immediately and the prescribing doctor must 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 diarrhoea, nausea, and vomiting. These may be symptoms of severe intestinal diseases. The use of Izotek 20 mg must be discontinued immediately and the prescribing doctor must be contacted.

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

• Blurred vision.

If blurred vision occurs, the use of Izotek 20 mg must be discontinued immediately and medical advice must be sought. In case of any other changes in vision, medical advice should be sought 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 moisturising 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 any musculoskeletal 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. Advice should be sought from a pharmacist regarding 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. If any allergic reaction occurs, the use of Izotek 20 mg must be discontinued and the doctor must be contacted.
  Rare adverse effects (may occur in less than 1 in 1,000 patients)
• Hair loss (alopecia). Usually temporary. Should resolve after completion of treatment.

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

• Night vision impairment, colour blindness, and reduced colour perception may occur.
• 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 begin to 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 of developing bones may occur.
• Calcium deposition in soft tissues, tendon pain, and elevated levels of muscle breakdown products in blood during intense physical activity.
• Increased sensitivity to light.
• Bacterial infections at the base of 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, red spots).
  Frequency unknown (frequency cannot be estimated from the available data)
• Dark or dark brown urine.
• Difficulty achieving or maintaining erection.
• Reduced libido.
• Breast swelling with or without tenderness in men.
• Vaginal dryness.
• Sacroiliitis, a type of inflammatory back pain causing lower back or buttock pain.
• Urethritis.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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.
Adverse effects can also be reported to the marketing authorisation holder or parallel importer.
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 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.
Return any unused capsules to the pharmacist. Keep them only if instructed by a doctor.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This helps 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. 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 soft capsules (size 6).
The medicine is available in cardboard boxes containing PVC/PE/PVDC/Al blisters.
Pack sizes containing 10, 30, 50, 60 or 100 soft capsules are available.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Greece, the country of export:
Pharmathen Investments Group Limited
Kritis 32, Papachristoforou Building, 4th floor
3087 Limassol, Cyprus

Manufacturer:
Pharmathen S.A.
6, Dervenakion Str.
153 51 Pallini
Athens, Greece
Pharmathen International S.A.
Sapes Industrial Park Block 5
69300 Rodopi
Greece

Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw, Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Marketing Authorisation Number in Greece, the country of export: 45047/10/18-04-2012
Parallel Import Licence Number: 267/25

This medicinal product is authorised for marketing in the European Economic Area (EEA) under the following names:
Denmark: Isotretinoin Orion
Finland: Isotretinoin Orion
Poland: Izotek
Greece: A-Cnotren