Isotretinoin Aristo

Leaflet accompanying the packaging: information for the user

Isotretinoin Aristo, 10 mg, soft capsules

Isotretinoin Aristo, 20 mg, soft capsules

Isotretinoin

WARNING

CAN CAUSE SERIOUS HARM TO AN UNBORN CHILD. Women must use effective methods of contraception. Do not use during pregnancy or suspected pregnancy.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so 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 them, even if their symptoms seem the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Isotretinoin Aristo and what is it used for
• 2. Important information before using Isotretinoin Aristo
• 3. How to use Isotretinoin Aristo
• 4. Possible side effects
• 5. How to store Isotretinoin Aristo
• 6. Package contents and other information

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

The active substance of Isotretinoin Aristo is isotretinoin, a substance similar in structure to vitamin A, belonging to the group of medicines called retinoids (used in the treatment of acne). Isotretinoin Aristo is used to treat severe forms of acne(such as nodular or conglobate acne, or acne with a risk of permanent scarring) in adult patients and adolescents over 12 years of age, but only after the puberty period. Isotretinoin Aristo is used when the symptoms of acne have not improved after treatment with other anti-acne medicines, including antibiotics and topical medicines. Isotretinoin treatment must be supervised by a dermatologist(a specialist in the treatment of skin diseases).

2. Important information before using Isotretinoin Aristo

When not to use Isotretinoin Aristo:

• if the patient is pregnant or breastfeeding,
• if there is any likelihood that the patient may become pregnant, it is necessary to follow the precautions listed in the Pregnancy Prevention Program, see "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 elevated lipid levels (cholesterol, triglycerides) in the blood,
• if the patient has a high level of vitamin A in the body (hypervitaminosis A),
• if the patient is taking tetracycline antibiotics at the same time (see "Isotretinoin Aristo and other medicines").

If any of the above situations apply to the patient, they should consult a doctor before starting to take Isotretinoin Aristo.

Warnings and precautions

Before starting to use Isotretinoin Aristo, the patient should discuss it with their doctor or pharmacist:

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

The patient should talk to their doctor if they experience persistent back pain or pain in the buttocks during treatment with Isotretinoin Aristo. These symptoms may indicate the presence of sacroiliitis, a type of inflammatory back pain. The doctor may stop the treatment with Isotretinoin Aristo and refer the patient to a specialist for treatment of inflammatory back pain. Further evaluation, including imaging tests such as MRI, may be necessary.

Pregnancy Prevention Program

Women who are pregnant must not take Isotretinoin Aristo

This medicine can seriously harm an unborn child (it has a teratogenic effect). It can cause serious damage to the brain, face, ear, eyes, heart, and some glands (thymus and parathyroid) of the fetus. It also increases the risk of miscarriage. These effects can occur even if Isotretinoin Aristo is taken for a short period during pregnancy.

• Do not take Isotretinoin Aristo if you are pregnant or think you may 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 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.

Isotretinoin Aristo may be prescribed to female patients of childbearing potential only under strict conditions

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 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 with the doctor. The doctor will provide information on contraception methods. The doctor may refer the patient to a specialist for advice on contraception.
• 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 Isotretinoin Aristo.

Female patients must use effective contraception before, during, and after treatment with Isotretinoin Aristo

• The patient must agree to use at least one highly effective method of contraception (e.g., an intrauterine device or contraceptive implant), or
• two effective methods that work in different ways (e.g., oral hormonal contraceptives and condoms). The patient should discuss with their doctor which methods are most suitable for them.
• The patient must use a contraceptive method for one month before taking Isotretinoin Aristo, during treatment, and for one month after stopping the medicine.
• 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 Isotretinoin Aristo

• The patient must agree to have regular check-ups with their doctor, ideally every month.
• The patient must agree to have regular pregnancy tests, ideally every month during treatment and one month after stopping Isotretinoin Aristo, 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 tests as advised by their 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 doctor will discuss all these 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 above rules.

If the patient becomes pregnant while taking Isotretinoin Aristo, they must stop taking the medicine immediatelyand contact their doctor. The doctor may refer the patient to a specialist for advice. Additionally, if the patient becomes pregnant within one month of stopping treatment with Isotretinoin Aristo, they should contact their doctor. The doctor may refer the patient to a specialist for advice. Prescriptions for women of childbearing potential are limited to a quantity sufficient for 30 days of treatment, to ensure regular check-ups, including pregnancy tests and monitoring. It is best if the pregnancy test, prescription, and dispensing of isotretinoin are done on the same day. The dispensing of isotretinoin should be done within a maximum of 7 days from the prescription.

Advice for men

The content of oral retinoids in the semen of men taking Isotretinoin Aristo is too small to harm an unborn child of their partner. However, this medicine should never be shared with anyone else, especially women.

Additional precautions

Never give this medicine to another person

All unused capsules should be returned to the pharmacist after treatment is finished.

Do not donate blood while taking this medicine or for one month after stopping Isotretinoin Aristo

If the patient's blood is given to a pregnant woman, it may cause birth defects.

Information for all patients

• Tell your doctor if you have ever had mental health problems(including depression, suicidal thoughts, and psychosis) or if you are taking medicines for any of these conditions. You may not notice certain changes in your mood or behavior, so it is very important to tell your friends and family that you are taking this medicine. They may notice these changes and help you identify problems that need to be discussed with your doctor.
• Severe skin reactions have been observed during isotretinoin treatment(e.g., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis). The rash can take the form of widespread blistering or peeling of the skin. You should also look out for ulcers in the mouth, throat, nose, and genitals, as well as conjunctivitis (redness and swelling of the eyes).

In rare cases, Isotretinoin Aristo may cause severe reactions

allergic reactionsthat can include skin reactions such as rash, hives, and bruising or red spots on the hands and feet. If an allergic reaction occurs, stop taking Isotretinoin Aristo and consult your doctor immediately.

• Limit intense exercise and physical activity. Isotretinoin Aristo may cause muscle and joint pain, especially in children and adolescents who engage in intense physical activity.
• Isotretinoin has been associated with non-specific inflammatory bowel disease. If a patient with no history of gastrointestinal disease develops severe bloody diarrhea, the doctor will stop treatment with Isotretinoin Aristo.

Isotretinoin Aristo may cause dry eye syndrome, intolerance to contact lenses

and vision disturbances, including impaired night vision. There have been cases of dry eye that did not improve after treatment was stopped. You should inform your doctor if you experience any of these symptoms. The doctor may recommend using moisturizing eye ointments or products that replace tears. If you experience intolerance to contact lenses, the doctor may recommend wearing glasses during treatment. If you experience vision disturbances, the doctor may refer you to a specialist for advice and may recommend stopping Isotretinoin Aristo.

• Isotretinoin has been associated with mild intracranial hypertension, especially when taken with tetracycline antibiotics (a type of antibiotic used, for example, in the treatment of acne). If symptoms such as headache, nausea, vomiting, and vision disturbances occur, stop taking Isotretinoin Aristo and consult your doctor immediately. The doctor may refer you to a specialist to check for papilledema (swelling of the optic disc in the eye).
• Isotretinoin Aristo may increase liver enzyme activity. The doctor will order blood tests to check liver enzyme activity before, during, and after treatment. If liver enzyme activity remains high, the doctor may reduce the dose or stop treatment with Isotretinoin Aristo.
• Isotretinoin often leads to increased blood lipid levels, such as cholesterol or triglycerides. The doctor will check blood lipid levels before starting treatment with Isotretinoin Aristo, as well as during and after treatment. During treatment, it is best to avoid drinking alcohol or reduce its consumption. You should inform your doctor if you have high blood lipid levels, diabetes (high blood glucose levels), or if you are overweight or drink large amounts of alcohol. More frequent blood tests may be necessary. If blood lipid levels remain high, the doctor may reduce the dose or stop treatment with Isotretinoin Aristo.

Tell your doctor if you have any kidney disease. The doctor may start treatment with a lower dose of Isotretinoin Aristo and 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 you already have diabetes or are overweight or drink large amounts of alcohol.
• It is likely that the skin will become dry. During treatment, you should use a moisturizing cream or lotion and lip balm. To avoid skin irritation, you should avoid using exfoliating products or anti-acne products.

Avoid excessive sun exposure and the use of sunlamps

The skin may become more sensitive to sunlight. Before going out in the sun, you should apply products containing UV filters with a high sun protection factor (at least SPF 15) to your skin.

• Do not have any cosmetic procedures on your skin. Isotretinoin Aristo can make your skin more sensitive. You should not wax, have dermabrasion, or have laser treatments (to remove rough skin or scars) during treatment and for at least 6 months after stopping treatment, as this can lead to scarring, skin irritation, and, in rare cases, skin discoloration.

Children and adolescents

Do not use Isotretinoin Aristo in children under 12 years of age. It is not known if the medicine is safe or effective in this age group.

Treatment with Isotretinoin Aristo in adolescents over 12 years of age is only possible after the puberty period

Isotretinoin Aristo and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• Do not take products containing vitamin A or tetracycline antibiotics(a type of antibiotic used, for example, in the treatment of acne) or use any anti-acne products on the skin while taking Isotretinoin Aristo. You can use moisturizing products and emollients (creams or products applied to the skin that prevent water loss and soften the skin).
• Do not use topical anti-acne keratolytic or exfoliating productswhile taking Isotretinoin Aristo.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. For more information on contraception, pregnancy, and breastfeeding, see section 2, "Pregnancy Prevention Program".

Driving and using machines

During isotretinoin treatment, you may experience impaired night vision. This can occur suddenly. Therefore, patients should be cautious when driving or operating machinery. Drowsiness, dizziness, and vision disturbances have been reported very rarely. If you experience any of these symptoms, do not drive, operate machinery, or engage in other activities that may put you or others at risk. Isotretinoin Aristo contains soybean oil(refined and hydrogenated) Do not use this medicine if you are allergic to peanuts or soy.

Isotretinoin Aristo contains glycerol

This medicine may cause headache, stomach upset, and diarrhea.

Isotretinoin Aristo contains sorbitol

Sorbitol is a source of fructose. Isotretinoin Aristo, 10 mg contains 7.22 mg of sorbitol per capsule. Isotretinoin Aristo, 20 mg contains 9.96 mg of sorbitol per capsule.

Isotretinoin Aristo, 10 mg contains cochineal red (E 124)

Isotretinoin Aristo, 20 mg contains orange yellow FCF (E 110)

This medicine may cause allergic reactions.

3. How to use Isotretinoin Aristo

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The usual starting dose of Isotretinoin Aristois 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day). This means that if your body weight is 60 kg, the starting dose will usually be 30 mg per day.

Take the capsules once or twice a day

Take the medicine with a full stomach. Swallow the capsules whole with water or with food. After a few weeks, your doctor may adjust the dose. This will depend on how you feel while taking the medicine. For most patients, the dose is between 0.5 mg/kg/day and 1 mg/kg/day. If you feel that the effect of Isotretinoin Aristo is too strong or too weak, talk to your doctor or pharmacist. If you have severe kidney disease, your doctor will start treatment with a lower dose (such as 10 mg per day) and increase it to the maximum tolerated dose. If you do not tolerate the recommended dose, your doctor may continue treatment with a lower dose, which will be associated with a longer treatment period and a higher risk of relapse. Treatment usually lasts for 16 to 24 weeks. For most patients, only one treatment cycle is necessary. Acne symptoms may improve for up to 8 weeks after stopping treatment. Therefore, you should not start another treatment cycle until this time has passed. In rare cases, acne symptoms may worsen during the first few weeks of treatment. Improvement should occur over time as treatment continues. After stopping treatment, return any unused capsules to the pharmacist. Only keep them if your doctor advises you to.

What to do if you take more Isotretinoin Aristo than you should

If you take more Isotretinoin Aristo than you should or if someone accidentally swallows the medicine, talk to a doctor, pharmacist, or hospital. If you forget to take a dose of Isotretinoin Aristo, take it as soon as possible. However, if it is almost time for your next dose, do not take the missed dose, just take the next dose at the normal time. Do not take a double dose to make up for a forgotten dose.

What to do if you stop taking Isotretinoin Aristo

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Isotretinoin Aristo can cause side effects, although not everybody gets them. Some side effects caused by isotretinoin are related to the dose. Side effects usually go away after changing the dose or stopping treatment, but some may persist after stopping treatment. Some side effects can be serious and require immediate medical attention.

Side effects that require immediate medical attention: skin disorders

Frequency not known(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 look like circular spots, often with centrally located blisters, usually located on the hands and feet or buttocks. More severe rashes can cover the chest and back. They can also be accompanied by additional symptoms such as eye infection (conjunctivitis) or ulcers in the mouth, throat, or nose. Some types of rash can take the form of widespread peeling of the skin, which can be life-threatening. The occurrence of these severe skin rashes is often preceded by symptoms such as headache, fever, and body aches (flu-like symptoms).

If you experience a severe rash or the above skin symptoms, stop taking Isotretinoin Aristo and consult your doctor immediately

Psychiatric disorders

Rare side effects(may affect up to 1 in 1000 people)

• Depression or depression-related disorders. Symptoms include: sadness, feeling empty, mood changes, anxiety, crying spells, irritability, loss of pleasure or interest in social or sports activities, too much or too little sleep, changes in weight or appetite, decreased performance at school or work, or difficulty concentrating.
• 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 (suicide attempts), 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 you experience any of the above psychiatric symptoms, consult your doctor immediately

Stop taking Isotretinoin Aristo and consult your doctor. Stopping the medicine may not be enough for these effects to go away; additional help may be necessary, and your doctor can provide it.

Allergic reactions

Rare side effects(may affect up to 1 in 1000 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 you have asthma.

If you experience a severe reaction, go to the emergency room immediately

If you experience any allergic reaction, stop taking Isotretinoin Aristo and consult your doctor.

Musculoskeletal and connective tissue disorders

Frequency not known(cannot be estimated from the available data)

• Muscle weakness that can be life-threatening, may be associated with difficulty moving arms or legs, pain, swelling, bruising, or discoloration of a body part, dark urine, decreased urine production, or dehydration. 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 Isotretinoin Aristo.

Liver and kidney disorders

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 liver inflammation.
• Difficulty urinating, swollen and puffy eyelids, feeling extremely tired. These may be symptoms of kidney inflammation.

Stop taking Isotretinoin Aristo and consult your doctor 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 Isotretinoin Aristo with tetracycline antibiotics.

Stop taking Isotretinoin Aristo and consult your doctor 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 bowel disease.

Stop taking Isotretinoin Aristo and consult your doctor immediately

Eye disorders

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

• Blurred vision.

If you experience blurred vision, stop taking Isotretinoin Aristo and consult your doctor immediately

If you experience any other changes in your vision, consult your doctor 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. You should use a moisturizing cream from the start of treatment.
• Skin more sensitive and redder than usual, especially on the face.
• Back pain, muscle pain, joint pain, especially in children and adolescents . To avoid worsening of any bone or muscle disorders, you should limit intense physical activity while taking Isotretinoin Aristo.
• Eye inflammation (conjunctivitis) and eyelid inflammation, feeling of dryness and irritation of the eyes. You should consult a pharmacist to get suitable eye drops. If you experience dry eye syndrome, you 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 medicine has affected the cells responsible for blood clotting.
• Anemia - weakness, dizziness, pale skin - if the medicine has affected red blood cells.

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

• Headache.
• High cholesterol levels in the blood.
• Protein or blood in the urine.
• Increased susceptibility to infections, if the medicine has affected 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 and itching. If you experience any allergic reaction, stop taking Isotretinoin Aristo and consult your doctor.

Rare side effects(may affect up to 1 in 1000 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)

• May cause impaired night vision, color blindness, and decreased color perception.
• May cause increased sensitivity to light; may need to wear sunglasses to protect the eyes from too much light.
• Other vision disturbances, including blurred vision, distorted vision, and clouding of the cornea (corneal clouding, cataract).
• May cause excessive thirst, need to urinate frequently, blood test results indicating high glucose levels in the blood. These may be symptoms of diabetes.
• May cause worsening of acne during the first few weeks of treatment, but symptoms should start to improve over time as treatment continues.
• Skin inflammation, swollen and darker than usual, especially on the face.
• Excessive sweating or itching.
• Arthritis; bone disorders (growth delay, excessive growth, and changes in bone density); may cause growth inhibition in growing bones.
• Calcification of soft tissues, pain in tendons, and high levels of muscle breakdown products in the blood in case of intense physical activity.
• Increased sensitivity to light.
• Bacterial infections at the base of the nails, changes in the nails.
• Swelling, discharge, or pus.
• Excessive scarring after surgery.
• Increased hair growth on the body.
• Seizures, drowsiness, dizziness.
• May cause swelling of the lymph nodes.
• Dryness of the throat, hoarseness.
• Worsening of hearing.
• General malaise.
• High levels of uric acid in the blood.
• Bacterial infections.
• Vasculitis (sometimes with bruising, red spots).

Frequency not known(cannot be estimated from the available data)

• Dark or dark brown urine.
• Difficulty achieving or maintaining an erection.
• Decreased sex drive.
• Breast tenderness or swelling, occurring in men.
• Vaginal dryness.
• Urethritis.
• Sacroiliitis, a type of inflammatory back pain, causing pain in the lower back or buttocks.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Isotretinoin Aristo

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date refers to the last day of that month. Store in a temperature not above 25°C. Store in the original package 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 unused capsules to the pharmacist. Only keep them if your doctor advises you to.

6. Package contents and other information

What Isotretinoin Aristo contains

• The active substance of Isotretinoin Aristo 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 (soybean, type II), soybean oil, hydrogenated, refined soybean oil, beeswax, yellow Capsule shell: gelatin, glycerol, sorbitol, liquid, partially dehydrated, titanium dioxide (E 171), patent blue V (E 131), cochineal red (E 124), purified water. Isotretinoin Aristo, 20 mg:all-rac-α-tocopheryl acetate (E 307), hydrogenated vegetable oil (soybean, type II), soybean oil, hydrogenated, refined soybean oil, beeswax, yellow Capsule shell: gelatin, glycerol, sorbitol, liquid, partially dehydrated, titanium dioxide (E 171), orange yellow FCF (E 110), purified water.

What Isotretinoin Aristo looks like and contents of the pack

Isotretinoin Aristo, 10 mg: purple, oval, soft capsules, size 3. Isotretinoin Aristo, 20 mg: almost white to cream-colored, oval, soft capsules, size 6. PVC/TE/PVDC/Aluminum blister, in a cardboard box. Package size:Isotretinoin Aristo, 10 mg: 30, 120 soft capsules Isotretinoin Aristo, 20 mg: 30, 60, 120 soft capsules

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o. ul. Baletowa 30 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 medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (urpl.gov.pl) Date of last revision of the leaflet:January 2024