Isotretinoin aristo: detailed information

Package leaflet: Information for the user

Isotretinoin Aristo, 10 mg, capsules, soft
Isotretinoin Aristo, 20 mg, capsules, soft
Isotretinoinum
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 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 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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Isotretinoin Aristo is and what it is used for

The active substance in Isotretinoin Aristo is isotretinoin – a substance structurally similar to vitamin A, belonging to a group of medicines called retinoids (used in the treatment of acne).
Isotretinoin Aristo 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 adult patients and adolescents over the age of 12, but only after puberty has begun. Isotretinoin Aristo is used when acne symptoms have not improved after treatment with other anti-acne medicines, including antibiotics and topical treatments.
Treatment with isotretinoin must be supervised by a dermatologist (a doctor specialising in skin disorders).

2. Important information before using Isotretinoin Aristo

When not to use Isotretinoin Aristo:

if the patient is pregnant or breastfeeding,
if there is any possibility that the patient could become pregnant, it is essential to follow the precautions outlined in the Pregnancy Prevention Programme, see section "Warnings and precautions",
if the patient is allergic to isotretinoin, soybean oil (peanuts or soy), or any of the other ingredients of this medicine (listed in section 6),
in patients with liver disease,
in patients with significantly increased levels of lipids (cholesterol, triglycerides) in the blood,
if the patient has high levels of vitamin A in the body (hypervitaminosis A),
if the patient is taking tetracycline antibiotics at the same time (see section "Isotretinoin Aristo with other medicines").

If any of the above situations apply to the patient, consult a doctor before
starting treatment with Isotretinoin Aristo.
Warnings and precautions
Before starting treatment with Isotretinoin Aristo, discuss this with your doctor or pharmacist:

If the patient has ever had mental health problems, including depression, aggressive tendencies, mood swings, or thoughts of self-harm or suicide. This is because Isotretinoin Aristo may affect the patient's mood.

Talk to your doctor if the patient experiences persistent pain in the lower back or buttocks during treatment with Isotretinoin Aristo. These symptoms may indicate inflammation of the sacroiliac joints, a type of inflammatory back pain.
The doctor may discontinue treatment with Isotretinoin Aristo and refer the patient to a specialist for management of inflammatory back pain. Further evaluation may be necessary, including imaging studies such as magnetic resonance imaging (MRI).
Pregnancy Prevention Programme
Women who are pregnant must NOT take Isotretinoin Aristo
This medicine can severely harm the unborn child (it has a "teratogenic" effect). It may cause severe brain, facial, ear, eye, heart, and gland (thymus and parathyroid) abnormalities in the fetus. It also increases the risk of miscarriage. These effects may occur even if Isotretinoin Aristo is taken for only a short time during pregnancy.

Do NOT take Isotretinoin Aristo if the patient is pregnant or suspects she might be pregnant.
Do NOT take Isotretinoin Aristo during breastfeeding. The medicine is likely to pass into breast milk and may harm the baby.
Do NOT take Isotretinoin Aristo if the patient could become pregnant during treatment.
The patient must NOT become pregnant for one month after stopping treatment, as the medicine may still be present in her body.

Isotretinoin Aristo may be prescribed to women of childbearing potential only if strict rules are followed. 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 pregnancy prevention methods. The doctor may refer the patient to a specialist for contraceptive advice.
Before starting treatment, the doctor will ask the patient to take a pregnancy test. The test must confirm that the patient is not pregnant at the start of treatment with Isotretinoin Aristo.

Patients must use effective contraceptive methods before, during, and after treatment with Isotretinoin Aristo

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 that work 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 contraception for one month before starting Isotretinoin Aristo, throughout treatment, and for one month after stopping the medicine.
The patient must use contraception even if she is not menstruating or not currently sexually active (unless the doctor determines it is not necessary).

Patients must agree to undergo pregnancy tests before, during, and after treatment with Isotretinoin Aristo

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 Isotretinoin Aristo, as the medicine may still be present in her body (unless the doctor decides it is not necessary for a particular patient).
The patient must agree to undergo additional pregnancy tests as recommended by the treating doctor.
The patient must NOT become pregnant during or within one month after stopping treatment, as the medicine may still be present in her body.
The treating doctor will discuss all issues with the patient, using a checklist, and ask the patient (or her parent or legal guardian) to sign it. This form confirms that the patient has been informed of the risks and agrees to follow the rules outlined above.

If the patient becomes pregnant while taking Isotretinoin Aristo, she must IMMEDIATELY STOP
taking the medicine and contact her doctor. The doctor may refer the patient
to a specialist for advice.
Additionally, a patient who becomes pregnant within one month after stopping Isotretinoin Aristo should contact her treating doctor. The doctor may refer her to a specialist for advice.
Prescriptions for women of reproductive age are limited to a 30-day supply to ensure regular follow-up visits, including pregnancy testing and monitoring. Ideally, the pregnancy test, prescription, and dispensing of isotretinoin should occur on the same day. Dispensing of isotretinoin should occur within a maximum of 7 days of the prescription date.
Advice for men
The amount of oral retinoids in the semen of men taking Isotretinoin Aristo 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 ends.
Do NOT donate blood while taking this medicine or within one month after stopping Isotretinoin Aristo. If a pregnant woman receives the patient's blood, she may give birth to a child with birth defects.
Information for all patients

Discuss with the doctor if the patient has ever had mental health problems (including depression, suicidal behaviour, or psychosis) or if the patient is taking medicines for any of these conditions. The patient may not notice certain changes in mood or behaviour, so it is very important to inform friends and family members about taking this medicine. They may notice such changes and help the patient quickly identify problems that need to be discussed with the 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, or genital ulcers, and eye inflammation (redness and swelling of the eyes).
- In rare cases, Isotretinoin Aristo may cause severe allergic reactions, which may affect the skin in the form of rash, hives, or bruises, or red spots on the hands and feet. If an allergic reaction occurs, stop taking Isotretinoin Aristo immediately, contact a doctor, and inform them that you are taking this medicine.
- Limit intense physical exertion and activity. Isotretinoin Aristo may cause muscle and joint pain, particularly in children and adolescents engaging in intense physical activity.
- Isotretinoin use has been associated with inflammatory bowel disease. If the patient develops severe bloody diarrhoea without a history of gastrointestinal disorders, the doctor will discontinue treatment with Isotretinoin Aristo.
- Isotretinoin Aristo may cause dry eye syndrome, intolerance to contact lenses, and visual disturbances, including night vision impairment. Cases of persistent dry eye after treatment have been reported. Inform the doctor if any of these symptoms occur. The doctor may recommend lubricating eye ointments or artificial tears. If contact lens intolerance occurs, the doctor may recommend wearing glasses during treatment. If visual disturbances occur, the doctor may refer the patient to a specialist for advice and may recommend stopping Isotretinoin Aristo.
- Benign intracranial hypertension has been observed during isotretinoin treatment, sometimes when isotretinoin is 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 Isotretinoin Aristo immediately and contact a doctor. The doctor may refer the patient to a specialist to check for papilledema (optic disc swelling).
- Isotretinoin Aristo may increase liver enzyme activity. The treating doctor will order blood tests before, during, and after treatment to check liver enzyme activity. If enzyme activity remains elevated, the doctor may reduce the dose or discontinue treatment with Isotretinoin Aristo.
- Isotretinoin often leads to increased blood lipid levels, such as cholesterol or triglycerides. The doctor will check lipid levels before starting treatment with Isotretinoin Aristo, during treatment, and after it ends. During treatment, it is best to avoid alcoholic beverages or at least reduce their consumption. Inform the doctor if the patient has high blood lipid levels, diabetes (high blood glucose), is overweight, or consumes large amounts of alcohol. More frequent blood tests may be necessary. If blood lipid levels remain high, the doctor may reduce the dose or discontinue treatment with Isotretinoin Aristo.
Inform the doctor if the patient has any kidney disease. The doctor may start treatment with a lower dose of Isotretinoin Aristo and then increase it to the maximum tolerated dose.
Isotretinoin Aristo may increase blood glucose levels. In rare cases, diabetes has developed in patients. The doctor may monitor blood glucose levels during treatment, especially if the patient already has diabetes, is overweight, or consumes large amounts of alcohol.
Skin dryness is likely to occur. During treatment, use a moisturizing cream or ointment and lip balm. To prevent skin irritation, avoid using peeling or anti-acne products.
Avoid excessive sun exposure and the use of 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 at least 15).
Do not undergo any cosmetic skin procedures. Isotretinoin Aristo may make the skin more sensitive. Do not remove hair with wax, perform dermabrasion, or undergo laser treatments (to remove dead skin or scars) during treatment and for at least 6 months after it ends, as this may lead to scarring, skin irritation, or, in rare cases, skin discoloration.

Children and adolescents
Do not use Isotretinoin Aristo in 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.
Isotretinoin Aristo with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

While taking Isotretinoin Aristo, do NOT take products containing vitamin A or tetracycline antibiotics (an antibiotic used, for example, in acne treatment), or any topical anti-acne products. Moisturizers and emollients (creams or skin products that prevent water loss and soften the skin) may be used.
While taking Isotretinoin Aristo, avoid topical use of keratolytic or peeling anti-acne products.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
For more information on contraception, pregnancy, and breastfeeding, see section 2, "Pregnancy Prevention Programme".
Driving and operating machinery
During isotretinoin treatment, night vision may be impaired. This symptom may appear suddenly. Therefore, patients should exercise caution when driving or operating machinery.
Drowsiness, dizziness, and visual disturbances have been reported very rarely. If any of these symptoms occur, do not drive, operate machinery, or participate in other activities where you or others could be put at risk.
Isotretinoin Aristo contains soybean oil (refined and hydrogenated)
Do not use the medicine if a hypersensitivity to peanuts or soy has been diagnosed.
Isotretinoin Aristo contains glycerol
The medicine may cause headache, gastrointestinal disturbances, and diarrhoea.
Isotretinoin Aristo contains sorbitol
Sorbitol is a source of fructose.
Isotretinoin Aristo 10 mg contains 7.22 mg of sorbitol in each capsule.
Isotretinoin Aristo 20 mg contains 9.96 mg of sorbitol in each capsule.
Isotretinoin Aristo 10 mg contains cochineal red (E 124)
Isotretinoin Aristo 20 mg contains orange-yellow FCF (E 110)
The medicine may cause allergic reactions.

3. How to use Isotretinoin Aristo

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual starting dose of this medicine is 0.5 mg per kilogram of body weight per day (0.5 mg/kg bw per day). This means that if the patient's body weight is 60 kg, the usual starting dose will typically be 30 mg per day.
Capsules should be taken once or twice daily.
The medicine should be taken with food. Swallow the capsules whole, with water or together with food.
After several weeks, your doctor may adjust the dose. This will depend on how the patient feels while taking the medicine. In most patients, the dose ranges from 0.5 mg/kg bw per day to 1 mg/kg bw per day.
If the effect of Isotretinoin Aristo seems too strong or too weak, consult your doctor or pharmacist.
If the patient has severe kidney disease, treatment with Isotretinoin Aristo will be initiated by the doctor at a lower dose (such as 10 mg per day), which will then be increased to the highest tolerated dose.
If the patient cannot tolerate the recommended dose, the treating doctor may continue treatment with a lower dose, which may result in a longer treatment duration and a higher risk of disease recurrence.
The treatment course usually lasts from 16 to 24 weeks. Most patients will require only one treatment course. Acne symptoms may continue to improve for up to 8 weeks after completion of treatment. Therefore, do not start another treatment course before this period has elapsed.
In rare cases, acne symptoms may worsen during the first few weeks of treatment. Improvement should occur over time with continued therapy.
After completing treatment, return any unused capsules to the pharmacist. Only retain them if specifically instructed by your doctor. Remember that this medicine has been prescribed for a specific patient. Do not give it to others. It may harm them, even if their symptoms appear similar.
Taking more than the recommended dose of Isotretinoin Aristo
If more than the recommended dose of Isotretinoin Aristo is taken, or if the medicine is accidentally swallowed, seek advice from your doctor, pharmacist, or nearest hospital immediately.
Missing a dose of Isotretinoin Aristo
If a dose of Isotretinoin Aristo is missed, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose; instead, continue with the next dose according to the regular schedule. Do not take a double dose to make up for a missed dose.
Stopping Isotretinoin Aristo
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects associated with isotretinoin use are dose-dependent.
Adverse effects usually resolve after dose adjustment or discontinuation of treatment; however, some may persist after treatment has ended. Certain adverse effects may be severe and require immediate medical attention.

Adverse effects requiring immediate medical assistance: Skin disorders
Frequency unknown (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 intervention. These initially appear as circular lesions, often with centrally located blisters, typically affecting the hands and palms or feet and soles. More severe rashes may involve blister formation on the chest and back. Additional symptoms may include eye infection (conjunctivitis) or ulceration in the mouth, throat, or nose. Some types of rash may progress to extensive skin peeling, which can be life-threatening. The onset of these severe skin reactions is often preceded by headache, fever, and body aches (flu-like symptoms). If a patient develops a severe rash or any of the above skin symptoms, treatment with Isotretinoin Aristo must be discontinued immediately and medical advice should be sought without delay.

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

Depression or depression-related disorders. Symptoms include: sadness, feelings of emptiness, mood changes, anxiety, crying spells, irritability, loss of interest in pleasure, social or sports activities, sleeping too much or too little, changes in body weight or appetite, reduced performance at school or work, or difficulty concentrating.
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 mental imagery related to self-harm or suicide (suicidal ideation), 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. hearing voices or seeing things that are not actually present.

If any of the psychiatric symptoms described above occur, medical advice must be sought immediately.
The physician may recommend discontinuation of Isotretinoin Aristo. Discontinuing the medicine may not be sufficient for these symptoms to resolve; additional support may be required, which the physician 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, or 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 has asthma.

In case of a severe allergic reaction, immediate attendance at an emergency department is required.
If any allergic reaction occurs, treatment with Isotretinoin Aristo should be stopped and the prescribing physician should be contacted.

Musculoskeletal system
Frequency unknown (cannot be estimated from available data)

Muscle weakness, which may potentially be life-threatening, possibly 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 Isotretinoin Aristo.

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 unusually tired. These may be symptoms of hepatitis.
Difficulty urinating, swollen and puffy eyelids, feeling excessively tired. These may be symptoms of nephritis. Treatment with Isotretinoin Aristo must be stopped immediately and medical advice should be sought.

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 Isotretinoin Aristo is taken concomitantly with tetracycline antibiotics. Treatment with Isotretinoin Aristo must be stopped immediately and medical advice should be sought.

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

Severe abdominal pain accompanied by bloody diarrhoea, nausea, and vomiting, or occurring without these symptoms. These may be symptoms of serious intestinal diseases. Treatment with Isotretinoin Aristo must be stopped immediately and medical advice should be sought.

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

Blurred vision. If blurred vision occurs, treatment with Isotretinoin Aristo must be stopped immediately and medical advice should be sought. Any other changes in vision should prompt immediate contact with a physician.

Other adverse effects
Very common adverse effects (may occur in more than 1 in 10 patients)

Dry skin, particularly affecting the lips and face, skin inflammation, chapped and inflamed lips, skin rash, mild itching, and slight peeling. A moisturising 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 musculoskeletal symptoms, intense physical activity should be limited during treatment with Isotretinoin Aristo.
Eye inflammation (conjunctivitis) and eyelid inflammation, dryness and irritation of the eyes. A pharmacist should be consulted to select appropriate eye drops. If dry eye syndrome develops, wearing glasses instead of contact lenses may be necessary.
Elevated liver enzyme levels in blood tests.
Altered blood lipid levels (including HDL or triglycerides).
Bruising, bleeding, or faster blood clotting – if the medicine has affected cells responsible for blood clotting.
Anaemia – weakness, dizziness, pale skin – if the medicine has affected red blood cells.

Common adverse effects (may occur in less than 1 in 10 patients)

Headache.
Increased blood cholesterol levels.
Presence of protein or blood in urine.
Increased susceptibility to infections – if the medicine has affected white blood cells.
Drying of the nasal mucosa and formation of crusts leading to mild nosebleeds.
Pain or inflammation of the throat and nasal cavity.
Allergic reactions such as rash and itching. If any allergic reaction occurs, treatment with Isotretinoin Aristo should be discontinued and medical advice should be sought.

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

Hair loss (alopecia). This is usually temporary and should resolve after treatment ends.

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

Impaired night vision, colour blindness, and reduced colour perception.
Increased sensitivity to light; wearing sunglasses may be necessary to protect the eyes from bright light.
Other visual disturbances, including blurred vision, image distortion, clouding of the eye surface (corneal clouding, cataract).
Excessive thirst, frequent urination, blood test results indicating elevated blood glucose levels. These may be symptoms of diabetes.
Acne may worsen during the first few weeks of treatment, but symptoms should gradually improve over time.
Skin affected by inflammation, swollen and darker than usual, particularly on the face.
Excessive sweating or itching.
Joint inflammation; bone disorders (growth delay, excessive growth, changes in bone density); may lead to inhibition of growth in developing bones.
Calcium deposition in soft tissues, tendon pain, and elevated levels of muscle breakdown products in blood during intense physical activity.
Increased light sensitivity.
Bacterial infections at the base of the nails, nail changes.
Swelling, discharge, pus.
Excessive scarring after surgical procedures.
Increased body hair growth.
Seizures, drowsiness, dizziness.
Lymph node swelling may occur.
Dry throat, hoarseness.
Hearing impairment.
General malaise.
Elevated blood uric acid levels.
Bacterial infections.
Blood vessel inflammation (sometimes with bruising or red spots).

Frequency unknown (cannot be estimated from available data)

Dark or dark brown urine.
Difficulty achieving or maintaining erection.
Reduced sexual drive.
Breast swelling with or without tenderness in males.
Vaginal dryness.
Urethritis (inflammation of the urethra).
Sacroiliitis (inflammation of the sacroiliac joints), a type of inflammatory back pain causing lower back or buttock pain.

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 also be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Isotretinoin Aristo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following the word
"EXP". The expiry date refers to the last day of the stated month.
Store below 25 °C.
Keep in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Return any remaining capsules to the pharmacist. Keep only if instructed to do so by your doctor.

6. Contents of the package and other information

What Isotretinoin Aristo contains

The active substance is isotretinoin.
Isotretinoin Aristo, 10 mg: One soft capsule contains 10 mg of isotretinoin.
Isotretinoin Aristo, 20 mg: One soft capsule contains 20 mg of isotretinoin.
Other ingredients are:
Isotretinoin Aristo, 10 mg: all-rac-α-tocopheryl acetate (E 307), hydrogenated vegetable oil (soy, type II), hydrogenated soybean oil, refined soybean oil, beeswax, yellow capsule shell: gelatin, glycerol, sorbitol liquid, partially dehydrated, titanium dioxide (E 171), patent blue V (E 131), carmine red (E 124), purified water.
Isotretinoin Aristo, 20 mg: all-rac-α-tocopheryl acetate (E 307), hydrogenated vegetable oil (soy, type II), hydrogenated soybean oil, refined soybean oil, beeswax, yellow capsule shell: gelatin, glycerol, liquid sorbitol, partially dehydrated, titanium dioxide (E 171), sunset yellow FCF (E 110), purified water.

What Isotretinoin Aristo looks like and contents of the pack
Isotretinoin Aristo, 10 mg: violet, oval soft capsules, size 3.
Isotretinoin Aristo, 20 mg: almost white to cream-coloured, oval soft capsules, size 6.
PVC/TE/PVDC/Aluminium blister packs in a cardboard box.
Pack sizes:
Isotretinoin Aristo, 10 mg: 30, 120 soft capsules
Isotretinoin Aristo, 20 mg: 30, 60, 120 soft capsules

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Tel.: +48 22 855 40 93
Fax: +48 22 855 40 95

Manufacturer
GAP SA
Agissilaou str. 46
173 41 Agios Dimitrios Attiki
Greece

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (urpl.gov.pl)