Acitren

Package Leaflet: Information for the User

Acitren, 10 mg, hard capsules

Acitren, 25 mg, hard capsules

Acitretin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

WARNING

May cause serious harm to an unborn child. Women must use effective contraception. Do not take if pregnant or think you may be pregnant.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Acitren is and what it is used for
• 2. Before you take Acitren
• 3. How to take Acitren
• 4. Possible side effects
• 5. How to store Acitren
• 6. Contents of the pack and other information

1. What Acitren is and what it is used for

Acitretin, the active substance of Acitren, belongs to a group of substances called retinoids, which are derivatives of vitamin A. Acitren is used for the symptomatic treatment of very severe disorders of keratinization (dry, thickened, and scaly skin), resistant to other standard treatments, such as:

• psoriasis (common psoriasis, especially erythrodermic and pustular forms),
• abnormal thickening of the outer layer of skin on the palms and soles (palmar and plantar keratoderma),
• abnormal formation of pustules on the palms and soles (pustular psoriasis of the palms and soles),
• diseases from the group of ichthyosis (ichthyosis),
• Darier's disease,
• Devergie's disease (red pityriasis),
• lichen planus of the skin and mucous membranes.

Acitren should only be prescribed by a doctor, preferably a dermatologist, with experience in the use of systemic retinoids and full knowledge of the teratogenic risk associated with Acitren.

2. Before you take Acitren

When not to take Acitren

• if you are pregnant or breastfeeding;
• if there is any 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 acitretin, other retinoids, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver dysfunction;
• if you have severe kidney dysfunction;
• if you have very high levels of lipids (fats) in the blood;
• if you are taking medicines such as tetracyclines (medicines used to treat infections) or methotrexate (a medicine used to treat skin diseases, inflammatory joint diseases, or cancer) (see "Acitren and other medicines");
• if you are taking vitamin A or other retinoid medicines (e.g., isotretinoin) (see "Acitren and other medicines").

If any of the above points apply to you, you should contact your doctor before starting treatment with Acitren.

Warnings and precautions

Acitretin often causes an increase in blood lipid levels, such as cholesterol or triglycerides, which may be associated with pancreatitis. You should inform your doctor if you experience severe abdominal and back pain (which may be symptoms of pancreatitis). Before starting treatment with Acitren, you should discuss this with your doctor or pharmacist. Pregnancy Prevention Program

Women who are pregnant must not take Acitren.

This medicine can seriously harm an unborn child (it has a teratogenic effect). It may cause severe 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 Acitren is taken for a short period during pregnancy.

• You must not take Acitren if you are pregnant or think you may be pregnant.
• You must not take Acitren during breastfeeding. The medicine is likely to pass into breast milk and may harm the baby.
• You must not take Acitren if you may become pregnant during treatment.
• You must not become pregnant for 3 years after stopping treatment, as the medicine may still be present in your body.

Acitren may be prescribed to women of childbearing potential only under strict conditions due to the risk of severe 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 (birth control methods) 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 Acitren.

Women must use effective contraception before, during, and after treatment with Acitren

Acitren

• 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 for 1 month before taking Acitren, during treatment, and for 3 years 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 Acitren

• 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 ideally every 1 to 3 months for 3 years after stopping treatment with Acitren, as the medicine may still be present in the patient's body (unless the doctor decides it is not necessary for the individual patient).
• The patient must agree to have additional pregnancy tests as recommended by the treating doctor.
• The patient must not become pregnant during treatment and for 3 years 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 above rules.

If the patient becomes pregnant while taking Acitren, she must stop takingthe medicine immediatelyand contact her doctor. The doctor may refer the patient to a specialist for advice. Additionally, if the patient becomes pregnant within 3 years of stopping treatment with Acitren, she should contact her treating doctor. The doctor may refer the patient to a specialist for advice. The patient must not consume alcohol (contained in drinks, food, or medicines) during treatment with Acitren and for 2 months after stopping treatment, as alcohol may increase the risk of birth defects.

Advice for men

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

Additional precautions

You should never give this medicine to another person. All unused capsules should be returned to the pharmacist after treatment has ended.

You must not donate blood during treatment with this medicine or for 3 years after stopping treatment with Acitren. If your blood is given to a pregnant woman, she may have a baby with birth defects.

Baby with birth defects.

Pregnancy, breastfeeding, and fertility

For more information on pregnancy and contraception, see section 2 "Pregnancy Prevention Program".

Warnings and precautions

Before taking Acitren, you should discuss this with your doctor or pharmacist:

• if you have ever had problems with your mental health, including depression, aggression, mood swings, or symptoms of psychosis (altered perception of reality, such as hearing voices or seeing things that are not there). This is because Acitren may affect your mood and mental health.
• if you have diabetes. You should have your blood sugar levels checked more often at the start of treatment with Acitren.
• if you are overweight or have high levels of lipids in the blood. Your doctor may order blood tests during treatment with Acitren to monitor your lipid levels.
• if you have cardiovascular diseases. You may need to be monitored more closely, e.g., your doctor may check your blood pressure more often.
• if you drink a lot of alcohol.
• if you have liver dysfunction.

Additionally, while taking Acitren:

• your night vision may worsen (see also "Driving and using machines" and section 4);
• you may experience an increase in blood pressure in the brain. This will need to be confirmed as soon as possible by your doctor. For more information on symptoms, see section 4;
• the effect of UV radiation on the skin may be enhanced by Acitren. Before exposure to strong sunlight, you should apply a sunscreen with a high sun protection factor (at least SPF 15) to exposed skin. You should avoid using sunlamps and prolonged sun exposure;
• you should have your liver function and lipid levels checked regularly before and during treatment. Your doctor may also regularly check your bone condition, as Acitren may cause changes in bones, especially during long-term treatment in children and the elderly;
• high doses of Acitren may cause mood changes (including irritability, aggression, and depression);
• rarely, a severe condition (capillary leak syndrome/retinoic acid syndrome) has been observed, in which small blood vessels (capillaries) leak. This can lead to severe low blood pressure, swelling (fluid accumulation causing swelling), and shock. For more information, see section 4;
• rarely, a severe skin reaction with symptoms such as rash, blisters, or peeling of the skin (exfoliative dermatitis) has been observed. For more information, see section 4;
• due to the risk of harm to an unborn child, you should not give this medicine to anyone else. Unused or expired capsules should be returned to the pharmacy for disposal.

Mental health disorders The patient may not notice certain changes in their mood and behavior, so it is essential to tell friends and family members that this medicine may cause changes in behavior and mood. These people may notice such changes and help identify problems that need to be discussed with the doctor. Long-term treatment(see section 3 "How to take Acitren") The following precautions should be taken:

• You should have your lipid levelschecked at regular intervals, not exceeding 3 months.

Children

In children, growth and bone development should be closely monitored. Due to the possible severe side effects during long-term treatment, the benefit-risk ratio of using Acitren should be carefully considered.

Acitren and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Acitren should not be taken at the same time as the following medicines (see also "When not to take Acitren"):

• vitamin A, as there is a risk of vitamin A overdose,
• other retinoids (e.g., isotretinoin or tretinoin), as there is a risk of vitamin A overdose,
• methotrexate (a medicine used to treat skin diseases, inflammatory joint diseases, or cancer), as there is not only a risk of vitamin A overdose but also an increased risk of liver inflammation;
• tetracyclines (medicines used to treat bacterial infections), as they, like Acitren, increase intracranial pressure.

When taking phenytoin (a medicine used to treat epilepsy) with Acitren, remember that phenytoin is partially displaced from its binding sites by Acitren. However, such an effect on protein binding has not been observed when Acitren is given with anticoagulant medicines from the coumarin group (medicines that prevent blood clotting). The contraceptive effect of progestogen-only medicines may be reduced by interaction with Acitren. Therefore, you should not use progestogen-only medicines (so-called mini-pills) for contraception. No further interactions between Acitren and other substances or products are known, e.g., cimetidine, digoxin, oral contraceptives ("the pill") containing a combination of estrogens and progestogens.

Acitren with food and drink

Women of childbearing potential must not consume alcohol during treatment with Acitren and for 2 months after stopping treatment (in drinks, food, or medicines). Taking Acitren with alcohol may lead to the formation of a substance (etretinate) that can harm an unborn child. Since it cannot be excluded that this substance may also be formed without the influence of alcohol and that it may also remain in the body for a very long time before being completely eliminated, you should continue to use effective contraception for 3 years even after stopping treatment with Acitren.

Pregnancy and breastfeeding

Acitren causes birth defects in an unborn child. You must strictly followthe following instructions, even if you have difficulty becoming pregnant (impaired fertility): Do not take Acitrenif you are pregnant, think you may be pregnant, or may become pregnant during treatment with this medicine and for 3 years after stopping treatment. See section 2 "Pregnancy Prevention Program". Do not take Acitrenif you are breastfeeding. If you become pregnant or think you may be pregnantwhile taking Acitren or within 3 years of stopping treatment, you should contact your doctor immediately. If you have any further questions on these instructions, ask your doctor or pharmacist before taking Acitren.

Prescription

Prescriptions for women of childbearing potential are limited to a quantity sufficient for 30 days of treatment. Continued treatment requires a new prescription. The dispensing of isotretinoin should occur within a maximum of 7 days of the prescription being written. It is recommended that the pregnancy test, prescription writing, and dispensing of the medicine occur on the same day.

Driving and using machines

You should be careful when driving or operating machinery. During treatment, your night vision may worsen. This can happen suddenly. In rare cases, vision disturbances persisted after treatment ended (see also "Warnings and precautions" and section 4 "Possible side effects").

Acitren contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which is essentially "sodium-free".

Acitren contains glucose

This medicine contains glucose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Acitren

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is: The dose depends on the clinical symptoms of the disease and the patient's tolerance to the medicine. The dose should be determined individually for each patient by the treating doctor. The following information may serve as a guide only.

Adults

The recommended initial daily dose is 25 mg of acitretin (i.e., 1 capsule of 25 mg Acitren) or 30 mg of acitretin (i.e., 3 capsules of 10 mg Acitren) taken for 2 to 4 weeks. This dose may already provide satisfactory therapeutic results. The maintenance dose must be adjusted according to the therapeutic results and tolerance. In general, a daily dose of 25 mg to 50 mg of acitretin taken for the next 6 to 8 weeks allows for optimal therapeutic effect. However, in some cases, it may be necessary to increase the dose to a maximum of 75 mg of acitretin per day (i.e., 3 capsules of 25 mg Acitren). You must not exceed this maximum dose. In the case of keratinization disorders (dry, thickened, and scaly skin), the maintenance dose should be as low as possible (even lower than 20 mg of acitretin per day). In no case should you exceed 50 mg of acitretin per day.

Children and adolescents

Due to the possibility of severe side effects during long-term use, the benefit-risk ratio of using Acitren should be carefully considered. Acitren should only be used when all other treatment options have been found to be insufficient. The dose will be determined by the doctor based on the patient's body weight. The daily dose is approximately 0.5 mg of acitretin per kilogram of body weight. Higher doses of up to 1 mg of acitretin per kilogram of body weight per day may be required in some cases for a limited period. You must not exceed the maximum dose of 35 mg of acitretin per day. The maintenance dose should be kept as low as possible due to the possibility of long-term side effects. Administration The hard capsules should be swallowed whole with food, preferably with milk. You must strictly follow the dose of Acitren prescribed by your doctor. Additional local therapies, including nursing care, during treatment with Acitren should be discussed with the treating doctor. Duration of treatment The duration of treatment is determined by the doctor, depending on the type of disease and tolerance to the medicine.

Women of childbearing potential

You should start taking Acitren on the second or third day of your next menstrual period. You should have a pregnancy testwithin 3 days before starting treatment and at regular intervals during treatment and up to 3 years after stopping treatment. The test result must always be negative. You should use effective and reliable contraceptioncontinuously from at least 4 weeks before starting Acitren, during treatment, and for 3 years after stopping treatment; see also "Pregnancy and breastfeeding".

If you take more Acitren than you should

If you take more Acitren than you should or if someone else takes your medicine, you should contact the emergency department of your nearest hospital or your doctor immediately. In case of overdose, symptoms such as headache, malaise, drowsiness, irritability, and itching of the skin may occur.

If you forget to take Acitren

If you accidentally take less Acitren than you should or forget to take a dose, you should take the medicine as soon as possible. If it is almost time for your next dose, do not take the missed dose, but continue taking your medicine as scheduled.

If you stop taking Acitren

Before stopping treatment with Acitren or stopping it prematurely, you should always consult your doctor. If you have any further doubts about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Acitren can cause side effects, although not everybody gets them.

If you experience any of the following side effects, tell your doctor immediately and stop taking Acitren:

• extremely severe or prolonged headache, nausea, vomiting, and vision disturbances. These may be symptoms of increased blood pressure in the brain (very rare - may occur in fewer than 1 in 10,000 people);
• immediate allergic reaction with symptoms such as skin rash, swelling, or itching, red and swollen eyes, severe nasal congestion, asthma, or wheezing. This reaction can range from mild to life-threatening (frequency not known: cannot be estimated from the available data);
• yellowing of the skin and whites of the eyes, which may be symptoms of jaundice (very rare - may occur in fewer than 1 in 10,000 people) or liver inflammation (uncommon - may occur in fewer than 1 in 100 people). Other symptoms may include loss of appetite, fever, general malaise, nausea, dark urine, and abdominal pain;
• a severe condition in which small blood vessels (capillaries) leak (capillary leak syndrome/retinoic acid syndrome). This can lead to severe low blood pressure, swelling (fluid accumulation causing swelling), and shock. Symptoms include swelling or edema, difficulty breathing, stomach cramps, muscle pain, excessive thirst, and general feelings of fatigue and weakness (frequency not known);
• a severe skin reaction with symptoms such as rash, blisters, or peeling of the skin (exfoliative dermatitis) (frequency not known).

Other side effects include:

Very common side effects(may occur in more than 1 in 10 people):

• dry, irritated, or swollen eyes and related intolerance to contact lenses,
• dry, irritated nasal mucosa, cold, nosebleeds,
• dry mouth, thirst,
• dryness or inflammation of the lips, which can be alleviated by applying a greasy ointment. Itching, hair loss, peeling of the skin on the palms and soles or even the whole body,
• liver dysfunction (confirmed by blood tests),
• increased blood lipid levels (confirmed by blood tests).

Common side effects(may occur in fewer than 1 in 10 people):

• headache,
• inflammation of the oral mucosa, abdominal pain, diarrhea, nausea, vomiting,
• delicate skin, feeling of sticky skin, or rash, skin inflammation, change in hair structure, brittle nails, nail fold inflammation, redness of the skin,
• joint pain, muscle pain,
• swelling of the hands, feet, and ankles.

Uncommon side effects(may occur in fewer than 1 in 100 people):

• drowsiness,
• blurred vision,
• inflammation of the gums,
• fissures, cracks, or ulcers of the skin, e.g., around the mouth, blisters, or skin inflammation (bullous dermatitis), increased sensitivity of the skin to sunlight (photosensitivity).

Rare side effects(may occur in fewer than 1 in 1,000 people):

• damage to the peripheral nervous system, including symptoms such as muscle weakness, numbness, or tingling in the hands and feet, and even burning, stabbing, or sudden shooting pains.

Very rare side effects(may occur in fewer than 1 in 10,000 people):

• worsening of night vision, inflammation of the cornea (corneal ulceration),
• bone pain, changes in bones.

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

• vaginal infections (also known as thrush or yeast infection),
• hearing disorders, ringing in the ears (tinnitus),
• hot flashes,
• changes in taste, rectal bleeding,
• small, red bumps on the skin that bleed easily (pyogenic granuloma),
• loss of eyelashes and eyebrows (madarosis),
• painless (rarely itchy) swelling of the skin, mucous membranes, and surrounding tissues,
• hives,
• skin thinning,
• improvement or worsening of glucose tolerance in patients with diabetes,
• change in voice (dysphonia).
• mood changes
• psychotic symptoms: altered perception of reality, such as hearing voices or seeing things that are not there.

There may be an initial worsening of psoriasis symptoms at the start of treatment.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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.: +48 22 49 21 301 Fax: +48 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 Acitren

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 carton and blister after "EXP". The expiry date refers to the last day of that month. Do not store above 30°C. Store in the original package to protect from moisture. 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.

6. Contents of the pack and other information

What Acitren contains

The active substance is acitretin. One hard capsule of Acitren 10 mg contains 10 mg of acitretin. One hard capsule of Acitren 25 mg contains 25 mg of acitretin. The other ingredients are: Capsule contents: maltodextrin sodium ascorbate microcrystalline cellulose Capsule shell (10 mg): gelatin sodium lauryl sulfate titanium dioxide (E 171) iron oxide black (E 172) iron oxide red (E 172) purified water shellac propylene glycol Capsule shell (25 mg): gelatin sodium lauryl sulfate titanium dioxide (E 171) iron oxide yellow (E 172) iron oxide black (E 172) iron oxide red (E 172) purified water shellac propylene glycol

What Acitren looks like and contents of the pack

The 10 mg Acitren hard capsule consists of a white to off-white body and a brown cap, marked with black ink "A10" on the body. The capsules contain a yellow powder. The 25 mg Acitren hard capsule consists of a yellow to light yellow body and a brown cap, marked with black ink "A25" on the body. The capsules contain a yellow powder. The capsules are packed in PVC/PVDC/Aluminum blisters. Pack sizes: 30, 50, and 100 hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o. ul. Dolna 21 05-092 Łomianki tel. +48 22 350 66 69

Manufacturer

mibe GmbH Arzneimittel Münchener Straße 15 06796 Brehna Germany SUN-FARM Sp. z o.o. ul. Dolna 21 05-092 Łomianki

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Acicutan 10 mg Kapseln Acicutan 25 mg Kapseln Poland Acitren Acitren Date of last revision of the leaflet:06.2024 Detailed and up-to-date information on this medicine is available by scanning the QR code on the leaflet using a smartphone. The same information is also available on the website http://sunfarm.pl/library/2018/08/21/153483447808.pdf 'Insert QR code' + http://sunfarm.pl/library/2018/08/21/153483447808.pdf