Axotret

Package Leaflet: Information for the User

Axotret, 10 mg, Soft Capsules

Axotret, 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 this leaflet before taking 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 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 pack and other information

1. What is Axotret and what is it used for

The active substance of Axotret is isotretinoin, which belongs to a group of medicines called retinoids.

Indications

Axotret is used to treat severe forms of acne (such as nodular or conglobate acne, or acne with a risk of permanent scarring) that have not responded to treatment with oral antibiotics and topical medicines.
Treatment with isotretinoin must be supervised by a dermatologist with experience in treating severe forms of acne with retinoids. Axotret is not used to treat acne before puberty or in children under 12 years of age.

2. Important information before taking Axotret

When not to take Axotret:

• if you are pregnant or breastfeeding,
• if there is a risk that you may become pregnant, it is necessary to follow the precautions listed in the Pregnancy Prevention Program, see "Warnings and precautions",
• if you are 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 failure,
• in patients with significantly elevated blood lipid levels (cholesterol, triglycerides),
• if you have high levels of vitamin A in your body (hypervitaminosis A),
• if you are taking tetracycline antibiotics.

Warnings and precautions

Before starting treatment with Axotret, you should discuss it with your doctor or pharmacist:

• -If you have 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 your mood.

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.
• You must not become pregnant for one month after stopping treatment with Axotret, as the medicine may still be present in your body.

Axotret may be prescribed to women of childbearing potential only under strict conditions due to the risk of serious birth defects.

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 (birth control methods) with the doctor. The doctor will provide information on birth control 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 Axotret.

Women must use effective methods of contraception before, during, and after treatment with Axotret

• 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 the doctor which methods are most suitable for her.
• The patient must use a contraceptive method for one month before taking Axotret, during treatment, and for one month after stopping treatment with this medicine.
• 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).

Women must agree to have pregnancy tests before, during, and after treatment with Axotret

• The patient must agree to have regular check-ups with the doctor, ideally every month.
• The patient must agree to have regular pregnancy tests, ideally every month during treatment and one month after stopping treatment with 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 the treating doctor.
• The patient must not become pregnant during and for one month after stopping treatment, as the medicine may still be present in her body.
• The treating 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 a 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 a patient becomes pregnant within one month of stopping treatment with Axotret, she should contact her 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.
Continuation of treatment requires a new prescription, and each prescription is valid for only seven days.

Advice for Men

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

Additional Precautions

This medicinal product should never be given to another person. All unused capsules should be returned to the pharmacist after treatment is completed.

You should not donate blood during treatment with this medicine or for one month after stopping Axotret. If your blood is given to a pregnant woman, she may have a baby with birth defects.

Axotret may increase the levels of certain fats, such as triglycerides or cholesterol, in the blood. Before, during, and after treatment, the doctor will monitor the levels of these fats in the blood. You should inform your doctor if you have had high levels of lipids in the blood, diabetes, overweight, or alcoholism, as more frequent blood tests may be necessary.
Axotret may increase liver enzyme activity. Before, during, and after treatment, the doctor will perform blood tests to monitor this. If elevated liver enzyme levels persist, the doctor may reduce the dose of Axotret or stop treatment with isotretinoin.
Axotret may increase blood sugar levels and, in rare cases, cause diabetes. The doctor may monitor blood sugar levels during treatment, especially if you have diabetes, are overweight, or are an alcoholic.
During treatment, you should use a moisturizing cream or balm for dry skin, as dry skin or lips may occur during treatment with isotretinoin.
Mental health problems
There have been reports of depression, worsening of depressive symptoms, anxiety, aggression, mood changes, behavioral disorders, psychotic symptoms, and, rarely, suicidal thoughts, attempted suicide, and suicide.
You should inform your doctor if you have had mental health problems, including depression, behavioral disorders, or psychosis.
You may not notice certain changes in your mood or behavior, so it is essential 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.
If you experience an allergic reaction (skin redness, itching) or a severe anaphylactic reaction, you should stop treatment immediately and contact your doctor as soon as possible.
There have been very rare reports of mild intracranial hypertension associated with Axotret. If you experience persistent headache, nausea, vomiting, and vision disturbances, you should stop treatment immediately and contact your doctor as soon as possible.
In very rare cases, Axotret has been associated with inflammatory bowel disease. If you experience severe bloody diarrhea (e.g., blood in the stool), you should stop treatment immediately and contact your doctor as soon as possible.
Taking Axotret may cause night vision problems. This effect can occur suddenly. Therefore, patients should be cautious when driving or operating machinery at night.
Somnolence, dizziness, and vision disturbances have been reported very rarely. If these symptoms occur, you should not drive or engage in other activities that may put yourself or others at risk.
Axotret contains a small amount of ethanol (alcohol), less than 100 mg per dose.
Axotret contains soybean oil. You should not take this medicine if you are allergic to peanuts or soy.

3. How to take Axotret

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor.
The usual dose of Axotret is 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day).
After a few weeks, your doctor may adjust the dose. This will depend on how you feel while taking the medicine. In most patients, the dose is between 0.5 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.
The capsules should be taken with food, once or twice a day. The capsules should be swallowed whole, not chewed or sucked.
If you have severe kidney disease, your doctor will start treatment with a lower dose, such as 10 mg per day, and then 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 duration and a higher risk of relapse of the disease.
In some cases, the symptoms of acne may worsen during the first few weeks of treatment. Improvement should occur over time during continued treatment.
The treatment cycle usually lasts for 16 to 24 weeks. The symptoms of acne may take up to 8 weeks to improve after stopping treatment. Therefore, you should not start another treatment cycle until this time has passed. In most patients, only one treatment cycle is necessary.
After stopping treatment, you should return any unused capsules to the pharmacy. You should only keep them if your doctor advises you to do so. Remember that the 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.

What to do if you take more Axotret than you should

In case of overdose, you should consult your doctor, pharmacist, or the nearest hospital.

What to do if you miss a dose of Axotret

If you miss a dose of Axotret, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

What to do if you stop taking Axotret

Stopping treatment may cause the symptoms to return.
If you have any further doubts about taking this medicine, you should consult your doctor.

4. Possible side effects

Like all medicines, Axotret can cause side effects, although not everybody gets them.
These effects often disappear during continued treatment or after stopping treatment. Your doctor can help you deal with them.

Very common (may affect more than 1 in 10 people):

• Blood disorders that affect various types of blood cells. There may be disorders of cells responsible for blood clotting, which means that bleeding or bruising may occur more easily. If red blood cell disorders occur, anemia may develop. During treatment, blood will be regularly monitored.
• Inflammation of the eye (conjunctivitis) and eyelid area (blepharitis).
• Dryness and mild irritation of the eyes. You should ask your pharmacist to recommend suitable eye drops that can help.
• Dry skin, particularly on the lips and face. There may be inflammatory skin conditions (dermatitis), flaking, and inflammation of the lips (cheilitis), rash, itching, and skin peeling. This dryness can be reduced by regularly using good moisturizing creams from the start of treatment. In very common cases, the skin may become more delicate and redder than usual, especially on the face.
• Back pain. Due to the fact that muscle and joint pain are very common during treatment with isotretinoin, especially in children and adolescents, you should be careful to reduce the intensity of physical exercise during treatment.
• Increased liver enzyme activity, detected in blood tests performed throughout the treatment period.
• Increased levels of triglycerides in the blood, decreased levels of high-density lipoproteins.

Common (may affect up to 1 in 10 people):

• Neutropenia (reduced number of white blood cells - granulocytes, responsible for fighting infections).
• Headache.
• Dryness inside the nose, nosebleeds, and inflammation of the nasal passages.
• Increased levels of cholesterol in the blood, increased levels of glucose in the blood.
• Hematuria, proteinuria.

Rare (may affect up to 1 in 1,000 people):

• Depression or related disorders. Symptoms include sadness, mood changes, anxiety, and emotional discomfort.
• Worsening of existing depression.
• Aggression or violent behavior.
• Allergic skin reactions such as skin rash and itching, anaphylactic reactions, hypersensitivity. Severe allergic reactions (anaphylactic reactions) can cause chest tightness and breathing difficulties. If you experience an allergic reaction, you should stop taking Axotret and contact your doctor.
• Hair loss. Hair should return to normal after stopping treatment.
• Alopecia.

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

• Some people have had thoughts or ideas about self-harmor suicide (suicidal thoughts), attempted suicide, or committed suicide. These people do not have to show symptoms of depression.
• Abnormal behavior.
• Psychotic symptoms: loss of contact with reality, e.g., hearing voices or seeing things that do not exist.

If you experience any of the above-mentioned mental health disorders, you should

contact your doctor immediately. The doctor may advise you to stop taking Axotret.
Stopping treatment may not be enough to make these effects disappear; additional help may be necessary, and your doctor can provide it.

• Seizures, somnolence, dizziness.
• Vasculitis.
• Lymphadenopathy (enlarged lymph nodes).
• Mild intracranial hypertension, especially when isotretinoin is used with certain antibiotics (tetracyclines). If you experience persistent headache, nausea, vomiting, and vision disturbances, you should stop taking Axotret and contact your doctor immediately.
• Due to dry eyes during treatment, people wearing contact lenses may need to wear glasses.
• Night vision problems caused by the medicine, making it harder to see in the dark. The medicine may also cause color blindness and some patients may have reduced ability to distinguish colors. Sensitivity to light may increase, and you may need to wear sunglasses to protect your eyes from too much sunlight.
• Vision disturbances such as blurred vision, corneal clouding, and cataracts (clouding of the eye surface). If you notice any effect of Axotret on your vision, you should contact your doctor immediately.
• Hearing problems (worsening of hearing).
• Severe gastrointestinal disorders, such as pancreatitis, gastrointestinal bleeding, colitis, ileitis, and inflammatory bowel disease. If you experience severe abdominal pain with bloody diarrhea or without, nausea, and vomiting, you should stop taking isotretinoin and contact your doctor immediately.
• Kidney inflammation. Symptoms include excessive fatigue, difficulty urinating, and swollen and puffy eyelids. If you experience these symptoms, you should stop taking the medicine and contact your doctor.
• Bacterial infections of the skin and mucous membranes. Localized bacterial infections of the tissue around the nail, with swelling and pus discharge, nail changes, and increased body hair.
• Diabetes, with symptoms such as excessive thirst and frequent urination. Blood tests often showed elevated blood sugar levels.
• Increased levels of uric acid in the blood (hyperuricemia).
• Excessive sweating.
• Bronchospasm, especially in patients with asthma, hoarseness.
• Worsening of acne symptoms.
• The skin may appear inflamed and swollen, with increased pigmentation on the face, and there may be skin rashes, hair disorders.
• Arthritis, bone disorders (including delayed bone growth, bone spurs, and decreased bone density), calcification of tendons and ligaments, and rare cases of tendon and ligament pain, and abnormal levels of muscle breakdown products in the blood, if the patient engages in intense physical exercise while taking the medicine. Bones that have not yet finished growing may stop growing prematurely.
• Severe liver disorders (hepatitis). If you experience yellowing of the skin or eyes with fatigue, you should stop taking the medicine and contact your doctor immediately.
• Increased activity of creatine phosphokinase in the blood.
• Excessive granulation, malaise.

Frequency not known (frequency 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 appear as round spots, often with centrally located blisters, usually on the arms and hands or legs and feet, and more severe rashes may be accompanied by blisters on the chest and back. Additional symptoms may include eye inflammation (conjunctivitis) or ulcers in the mouth, throat, or nose. Severe skin rashes can cause widespread skin peeling, which can be life-threatening. These severe skin rashes are often preceded by headache, fever, and flu-like symptoms. If a rash develops or the above skin changes occur, you should stop treatment with Axotret and contact your doctor immediately.
• Difficulty achieving or maintaining an erection.
• Decreased libido.
• Breast tenderness or swelling in men,
• Vaginal dryness.
• Sacroiliitis, a type of back pain with an inflammatory cause, causing pain in the lower back or buttocks.
• Urethritis.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported 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

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Store in a temperature below 25°C.
Store in the original package.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Axotret contains

• The active substance of Axotret is isotretinoin. One soft capsule contains 10 mg or 20 mg of isotretinoin.
• The other ingredients are: hydrogenated soybean oil, hydrogenated vegetable oil, white beeswax, disodium edetate, butylhydroxyanisole, refined soybean oil. Coating(only for Axotret, 10 mg): gelatin, glycerol, iron oxide red (E 172), titanium dioxide (E 171), purified water. Coating(only for Axotret, 20 mg): gelatin, glycerol, allura red (E 129), brilliant blue (E 133), titanium dioxide (E 171), purified water. Printing ink: shellac, iron oxide black (E 172), n-butanol, propylene glycol, isopropanol, ammonium hydroxide.

What Axotret looks like and contents of the pack

Axotret is a soft capsule.
Axotret, 10 mg: light pink opaque gelatin capsules of oval shape, with 'RR' printed in ink, containing an orange-yellow oily liquid.
Axotret, 20 mg: brown opaque gelatin capsules of oval shape, with 'RR' printed in ink, containing an orange-yellow oily liquid.
Axotret is available in blisters containing 30 or 60 soft capsules, packaged in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands
GAP SA
46, Agissilaou str.
Agios Dimitrios Attiki, 173 41
Athens
Greece
Date of last revision of the leaflet:January 2024

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