Axotret

Leaflet accompanying the packaging: information for the user

Axotret, 5 mg, soft capsules

Axotret, 40 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 that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Axotret and what is it used for
• 2. Important information before taking Axotret
• 3. How to take Axotret
• 4. Possible side effects
• 5. How to store Axotret
• 6. Contents of the packaging and other information

1. What is Axotret and what is it used for

The active substance of Axotret is isotretinoin, a substance similar in structure to vitamin A, belonging to a group of medicines called retinoids (used in the treatment of acne). Axotret 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 puberty. Axotret is used when the symptoms of acne have not improved after treatment with other anti-acne medicines, including antibiotics and topical medicines.

2. Important information before taking Axotret

When not to take Axotret:

• 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 soybeans) 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 high levels of vitamin A in the body (hypervitaminosis A),
• if the patient is taking tetracycline antibiotics at the same time (see "Axotret and other medicines").

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

Warnings and precautions

Before starting Axotret, the patient should discuss the following 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 Axotret 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 Axotret. These symptoms may indicate inflammatory back pain. The doctor may stop Axotret treatment and refer the patient to a specialist for back pain treatment. Further evaluation, including imaging tests such as MRI, may be necessary.

Pregnancy Prevention Program

Women who are pregnant must not take Axotret

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

• Do not take Axotret if you are pregnant or think you may be pregnant.
• Do not take Axotret during breastfeeding. The medicine is likely to pass into breast milk and may harm the baby.
• Do not take Axotret if you may become pregnant during treatment.
• The patient should not become pregnant for one month after stopping Axotret, as the medicine may still be present in the patient's body.

Axotret may be prescribed to female patients of childbearing age only under strict conditions

The following conditions must be met:

• The doctor must explain the risk of birth defects to the patient; the patient must understand why she must not become pregnant and how to prevent it.
• The patient must discuss contraception 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 ask the patient to have a pregnancy test. The test must show that the patient is not pregnant at the start of Axotret treatment.

Female patients must use effective methods of contraception before, during, and after Axotret treatment

• 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 Axotret, during treatment, and for one month after stopping Axotret.
• The patient must use contraception, even if she does not menstruate or is not currently sexually active (unless the doctor decides it is not necessary).

Female patients must agree to have pregnancy tests before, during, and after Axotret treatment

• The patient must agree to have regular check-ups with her doctor, ideally every month.
• The patient must agree to have regular pregnancy tests, ideally every month during treatment and one month after stopping Axotret, 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 recommended by her doctor.
• The patient should not become pregnant during and for one month after stopping Axotret, 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 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 rules.

If the patient becomes pregnant while taking Axotret, she must stop taking the medicine immediatelyand contact her doctor. The doctor may refer the patient to a specialist for advice. Additionally, if the patient becomes pregnant within one month of stopping Axotret, she should contact her doctor. The doctor may refer the patient to a specialist for advice. Prescriptions for women of childbearing age are limited to a 30-day supply, 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. Isotretinoin should be dispensed within a maximum of 7 days of the prescription being written.

Advice for men

The amount of oral retinoids in the semen of men taking Axotret is too small to harm an unborn child. However, Axotret should never be shared with anyone, especially women.

Additional precautions

Never give this medicine to another person

All unused capsules should be returned to the pharmacist after treatment

Do not donate blood during treatment with Axotret or for one month after stopping Axotret

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 some changes in your mood and behavior, so it is very important to tell your friends and family that you are taking this medicine. They may notice 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).
• Axotret can cause severe allergic reactionsthat may include skin reactions such as rash, hives, and bruising or red spots on the hands and feet. If an allergic reaction occurs, stop taking Axotret and consult your doctor immediately.
• Limit intense exercise and physical activity. Axotret can 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 experiences severe bloody diarrhea without a history of gastrointestinal disease, the doctor may stop Axotret treatment.

Axotret may cause dry eye syndrome, intolerance to contact lenses

and vision problems, including decreased night vision. There have been cases of dry eye that did not improve after treatment was stopped. If any of these symptoms occur, you should inform your doctor. The doctor may recommend using moisturizing eye ointments or tear substitutes. If contact lens intolerance occurs, 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 stopping Axotret treatment.

• Isotretinoin has been associated with mild intracranial hypertension, especially when taken with tetracycline antibiotics. If symptoms such as headache, nausea, vomiting, and vision problems occur, stop taking Axotret and consult your doctor immediately. The doctor may refer the patient to a specialist to check for papilledema (swelling of the optic disc).
• Axotret may increase liver enzyme activity. The doctor will monitor liver enzyme activity with blood tests before, during, and after treatment. If liver enzyme activity remains high, the doctor may reduce the dose or stop Axotret treatment.
• Isotretinoin often leads to increased blood lipid levelssuch as cholesterol or triglycerides. The doctor will check lipid levels before starting Axotret, during treatment, and after stopping 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 sugar), 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 Axotret treatment.

Tell your doctor if you have any kidney problems

The doctor may start Axotret treatment at a lower dose (e.g., 10 mg per day) and increase it to the maximum tolerated dose.

• Axotret may increase blood sugar levels. In rare cases, diabetes has developed in patients. The doctor may monitor blood sugar levels during treatment, especially if the patient already has diabetes or is overweight or drinks 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 prevent dryness and irritation. To avoid skin irritation, you should avoid using exfoliating products or anti-acne products.

Avoid excessive sun exposure and the use of sunlamps or tanning beds

Your skin may become more sensitive to sunlight. Before going out in the sun, apply a sunscreen with a high sun protection factor (at least SPF 15) to your skin.

• Do not have any cosmetic procedures on your skin. Axotret can make your skin more sensitive. Do not wax, dermabrade, or have laser treatments (to remove rough skin or scars) during treatment and for at least 6 months after stopping Axotret, as this can lead to scarring, skin irritation, or changes in skin color.

Children and adolescents

Axotret should not be used in children under 12 years of age. It is not known if the medicine is safe or effective in this age group.

Treatment with Axotret in adolescents over 12 years of age is only possible after puberty

Axotret 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 antibioticswhile taking Axotret, or use any anti-acne products on your skin. You can use moisturizing products and emollients (creams or products applied to the skin to prevent water loss and soften the skin).
• Do not use topical anti-acne keratolytic or exfoliating productswhile taking Axotret.

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 decreased night vision. This can occur suddenly. Therefore, patients should be cautious when driving or operating machinery. Drowsiness, dizziness, and vision problems have been reported very rarely. If these symptoms occur, do not drive, operate machinery, or engage in activities that may put yourself or others at risk. Axotret contains soybean oil(refined and hydrogenated) Do not use this medicine if you are allergic to peanuts or soybeans.

Axotret contains glycerol

This may cause headache, stomach upset, and diarrhea.

Axotret contains sorbitol

Sorbitol is a source of fructose. Axotret, 5 mg contains 5.85 mg of sorbitol per capsule. Axotret, 40 mg contains 14.43 mg of sorbitol per capsule.

Axotret (only 40 mg) contains cochineal red (E 124)

This may cause allergic reactions.

3. How to take Axotret

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The usual starting dose of Axotretis 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day). This means that if the patient weighs 60 kg, the usual starting dose will 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 Axotret is too strong or too weak, you should consult your doctor or pharmacist. If you have severe kidney disease, your doctor will start Axotret treatment at a lower dose (e.g., 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. The treatment cycle 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 with continued treatment. 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 Axotret than you should

If you take more Axotret than you should or accidentally swallow the medicine, consult your doctor, pharmacist, or the nearest hospital.

What to do if you forget to take Axotret

If you forget to take a dose of Axotret, 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 usual time. Do not take a double dose to make up for a missed dose.

What to do if you stop taking Axotret

If you have any further questions about taking this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Axotret can cause side effects, although not everybody gets them. Some side effects of isotretinoin are dose-related. 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 available data)

• Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) that can be life-threatening and require immediate medical attention. Initially, they may look like circular patches, often with central blisters, usually located on the hands and feet or buttocks. More severe rashes can cover the chest and back. Additional symptoms may include eye infections (conjunctivitis) or ulcers in the mouth, throat, or nose. Some types of rashes can take the form of widespread peeling of the skin, which can be life-threatening. The onset of these severe skin rashes is often preceded by headache, fever, and flu-like symptoms.

If you experience a severe rash or the above skin symptoms, stop taking Axotret 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.
• Increased aggression or violence.

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

• Some people have had thoughts or fantasies 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, you should

consult your doctor immediately. The doctor may recommend stopping Axotret treatment. Stopping the medicine may not be enough to make these effects go away; additional help may be necessary, and the 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 the patient has asthma.

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

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

Musculoskeletal and connective tissue disorders

Frequency not known(cannot be estimated from available data)

• Muscle weakness that can be life-threatening, which may be associated with difficulty moving arms or legs, pain, swelling, bruising, dark urine, decreased urine production, or feelings of confusion 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 Axotret.

Disorders of the liver and kidney

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

• Yellowing of the skin or whites of the eyes and feeling tired. These may be symptoms of liver inflammation.
• Difficulty urinating, swollen and puffy eyes, feeling extremely tired. These may be symptoms of kidney inflammation.

Stop taking Axotret 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 problems, including blurred vision. These may be symptoms of mild intracranial hypertension, especially when taking Axotret with tetracycline antibiotics.

Stop taking Axotret 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 Axotret 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 Axotret and consult your doctor immediately

If you experience any other changes in your vision, you should 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 bone or muscle disorders, you should limit intense physical activity while taking Axotret.
• Eye inflammation (conjunctivitis) and eyelid inflammation, feeling of dryness and irritation of the eyes. You should ask your pharmacist for suitable eye drops. If you experience dry eye syndrome, you may need to wear glasses instead of contact lenses during treatment.
• 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 Axotret 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 stopped.

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

• Decreased night vision, color blindness, and decreased color perception.
• Increased sensitivity to light; you may need to wear sunglasses to protect your eyes from too much light.
• Other vision problems, including blurred vision, distorted vision, and clouding of the cornea (corneal opacity).
• Excessive thirst, need to urinate frequently, and blood test results showing high blood sugar levels. These may be symptoms of diabetes.
• During the first few weeks, acne symptoms may worsen, but they should improve over time with continued treatment.
• Skin inflammation, swollen and darker than usual, especially on the face.
• Excessive sweating or itching.
• Arthritis; bone disorders (delayed growth, excessive growth, and changes in bone density); growth retardation may occur in growing bones.
• Calcification of soft tissues; pain and tenderness of tendons; high levels of muscle breakdown products in the blood in the 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.
• Swollen lymph nodes.
• Dry throat, hoarseness.
• Hearing impairment.
• General feeling of being unwell.
• High levels of uric acid in the blood.
• Bacterial infections.
• Vasculitis (sometimes with bruising, red spots).

Frequency not known(cannot be estimated from 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 back pain with an inflammatory cause, causing pain in the lower back or buttocks.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring, 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 Axotret

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 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. This will help protect the environment. Return any unused capsules to the pharmacist. Only keep them if your doctor advises you to.

6. Contents of the packaging and other information

What Axotret contains

• The active substance of Axotret is isotretinoin. Axotret, 5 mg:One soft capsule contains 5 mg of isotretinoin. Axotret, 40 mg:One soft capsule contains 40 mg of isotretinoin.

The other ingredients are: Axotret, 5 mg:all-rac-α-tocopheryl acetate (E 307), hydrogenated vegetable oil (soybean, type II), soybean oil, hydrogenated soybean oil, yellow beeswax, capsule shell: gelatin, glycerol, sorbitol liquid, partially dehydrated, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), purified water; Axotret, 40 mg:all-rac-α-tocopheryl acetate (E 307), hydrogenated vegetable oil (soybean, type II), soybean oil, hydrogenated soybean oil, yellow beeswax, capsule shell: gelatin, glycerol, sorbitol liquid, partially dehydrated, titanium dioxide (E 171), patent blue V (E 131), cochineal red (E 124), purified water.

What Axotret looks like and contents of the pack

Axotret, 5 mg:light orange, oval, soft capsules, size 2. Axotret, 40 mg:purple, oval, soft capsules, size 12. PVC/TE/PVDC/Aluminum blister, in a cardboard box. Package size:Axotret, 5 mg:30 soft capsules Axotret, 40 mg:30 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