Izotek 20 mg
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Izotek 20 mg (A-CNOTREN), capsules, soft
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 contraceptive methods.
Do not use during pregnancy or if pregnancy is suspected.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any questions, 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, 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 to treat severe forms of acne (such as nodular or conglobate acne, or acne with a risk of permanent scarring) in adults and adolescents above the age of 12, only after puberty has begun. Izotek 20 mg will be used only if previous treatments with other anti-acne medicines, including antibiotics and topical treatments, have failed to reduce the severity of acne.
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 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 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 who are unable or unwilling to comply with the necessary pregnancy prevention measures specified in the Pregnancy Prevention Programme for Izotek,
- 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),
- if taking 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, you should consult your doctor before starting to take Izotek 20 mg.
Warnings and precautions
Before starting to take 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 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). 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 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 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 she must not become pregnant and how to prevent it.
- The patient must discuss contraception (birth control methods) with her 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.
- You must agree to use at least one highly reliable method of contraception (e.g. an intrauterine device or contraceptive implant), or two effective methods with different mechanisms (e.g. oral hormonal contraceptives and condoms). Discuss with your doctor which methods are most suitable for you.
- You must use contraception for one month before starting Izotek 20 mg, during treatment, and for one month after stopping the medicine.
- You must use contraception even if you are not menstruating or are not currently sexually active (unless your doctor determines this is unnecessary).
Women must agree to undergo pregnancy testing before, during and after treatment with
Izotek 20 mg.
- You must agree to regular follow-up visits with your doctor, ideally monthly.
- You must agree to regular pregnancy tests, ideally monthly during treatment and one month after stopping Izotek 20 mg, as the medicine may still be present in your body (unless your doctor determines this is unnecessary for you).
- You must agree to additional pregnancy tests as recommended by your treating doctor.
- You must not become pregnant during treatment or for one month after stopping treatment, as the medicine may still be present in your body.
- Your treating doctor will discuss all issues with you using a checklist and will ask you (or your parent or legal guardian) to sign it. This form confirms that you have been informed of the risks and agree to comply with the above requirements.
If you become pregnant while taking Izotek 20 mg, you must stop taking the medicine immediately
and contact your doctor. Your doctor may refer you to a specialist for advice.
Furthermore, if you become pregnant within one month after stopping treatment with Izotek 20 mg,
you should contact your doctor.
Your doctor may refer you 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, you must never share this medicinal product with anyone else, especially women.
Additional precautions
Never pass this medicinal product 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 for one month after stopping Izotek 20 mg. If your blood is received by a pregnant woman, it may result in a baby with congenital malformations.
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 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 (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 be alert for ulcers in the mouth, throat, nose and genital organs, and for 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 him/her that you are taking this medicine.
-
Limit intense physical exertion and exercise. 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 severe bloody diarrhoea occurs in a patient without a history of gastrointestinal disorders, the doctor will discontinue treatment with Izotek 20 mg.
-
Izotek 20 mg may cause 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. Your doctor may recommend using moisturising eye ointments or artificial tears. If you experience intolerance to contact lenses, your doctor may recommend wearing glasses during treatment. If vision problems occur, your doctor may refer you to a specialist for advice and may consider discontinuing treatment with Izotek 10 mg or Izotek 20 mg.
-
Mild intracranial hypertension has been observed during isotretinoin treatment, sometimes when isotretinoin was taken concurrently with tetracyclines (a type of antibiotic used, for example, in acne treatment). If symptoms such as headache, nausea, vomiting or visual disturbances occur, stop taking Izotek 20 mg and contact your doctor immediately. Your doctor may refer you 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 causes increased blood lipid levels, such as cholesterol or triglycerides. Your doctor will check lipid levels before starting treatment with Izotek 20 mg, during treatment and after its completion. 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. 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 increase 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 peeling or anti-acne products.
-
Avoid excessive sun exposure and do not use sunlamps or sunbeds. Skin may become more sensitive to sunlight. Before going outdoors, apply sunscreen with a high sun protection factor (SPF 15 or higher).
-
Do not undergo any cosmetic skin procedures. Izotek 20 mg may make your 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, skin pigmentation changes.
-
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. Your doctor may discontinue treatment with Izotek 10 mg and 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), and do not use any topical anti-acne products on the skin. You may use moisturisers and emollients (creams or skin preparations that prevent water loss and soften the skin).
- While taking Izotek 20 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 20 mg must not be used during pregnancy. If you are of childbearing potential, you must use an effective contraceptive method during treatment with Izotek 20 mg and for one month after stopping treatment.
If you become pregnant while taking Izotek 20 mg or within one month after stopping treatment, stop taking the medicine immediately and contact your doctor. Your doctor may refer you to a specialist for advice.
Taking Izotek 20 mg during pregnancy may harm the unborn child (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) in the unborn child.
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 using machines
During therapy, night vision may deteriorate. Such visual disturbances may appear suddenly. In rare cases, they persist after therapy ends. Drowsiness, dizziness and visual disturbances have been reported very rarely. If you experience any of these symptoms, you 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 used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
The following products are available on the market: Izotek 10 mg and Izotek 20 mg.
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 body 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 should 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 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, 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 required. 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 impaired kidney function
In cases of severe kidney disease, treatment should be initiated at 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 result in a longer duration of treatment and a higher likelihood of acne recurrence.
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 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 may include: headache, nausea, vomiting, dizziness, irritability, and itching.
Missing a dose of Izotek 20 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 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 assistance. Initially, they appear as circular lesions, often with centrally located blisters, usually on 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 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 above skin symptoms, 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 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 completed suicide. These individuals may not 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, 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 necessary, which the doctor 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 mouth. Sudden swelling of 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 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, may be associated with difficulty 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 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 very 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 diarrhea, 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 vision changes 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 beginning 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 any musculoskeletal or muscular complaints, intense physical activity should be limited during treatment with Izotek 20 mg.
- Eye inflammation (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 clotting.
- Anemia—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, 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 temporary. Should resolve after completion of treatment.
Very rare adverse effects (may occur in less than 1 in 10,000 patients)
- May lead to worsening night vision, color blindness, and poorer color perception.
- May lead to increased light sensitivity; wearing sunglasses may be necessary to protect 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); may lead to inhibition of growing bone development.
- 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 nails, nail changes.
- Swelling, discharge, pus.
- Excessive scarring after surgical procedures.
- Increased body hair growth.
- Seizures, drowsiness, dizziness.
- May lead to swollen lymph nodes.
- Dry throat, hoarseness.
- Hearing problems.
- General malaise.
- High uric acid levels in blood.
- Bacterial infections.
- Blood vessel inflammation (sometimes with bruising, red spots).
Frequency unknown (frequency cannot be estimated from available data)
- Dark or dark brown urine.
- Difficulty achieving or maintaining erection.
- Reduced sexual drive.
- Breast swelling with tenderness or without, occurring 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 or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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 gather 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 stated month.
Return any unused capsules to the pharmacist. Keep them only 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 measures will 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.
- Each soft capsule contains 20 mg of isotretinoin.
- The other ingredients are: purified soybean oil, yellow wax, hydrogenated soybean oil, partially hydrogenated soybean oil, gelatin, glycerol, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).
What Izotek 20 mg looks like and contents of the pack
Izotek 20 mg are red-orange oval capsules (size 6).
The medicine is available in cardboard boxes containing PVC/PE/PVDC/Al blisters.
Pack sizes containing 10, 30, 60 and 100 soft capsules are available.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Greece, country of export:
Pharmathen Investments Group Limited
Kritis 32
Papachristoforou Building
4 floor, Limassol
Cyprus
Manufacturer:
Pharmathen SA, 6, Dervenakion str., 153 51 Pallini, Greece
Pharmathen International SA, Sapes, Industrial Park Block No 5, TK 69300, N. Rodopi, Greece
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Relabeled by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Greece, country of export: 45047/10/18-04-2012
Parallel Import Licence Number: 716/15
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Denmark: Isotretinoin Orion
Finland: Isotretinoin Orion
Poland: Izotek 20 mg
Greece: A-Cnotren 20 mg
Detailed and up-to-date information about this medicine is available by scanning with a smartphone the QR code on the package leaflet. The same information is also available on the website: http://inpharm.pl/do_pobrania/Retinoidy-karta-przypominajaca.doc.
QR Code