Toctino

Package Leaflet: Information for the User

TOCTINO Soft Capsules 10 mg

TOCTINO Soft Capsules 30 mg

Alitretinoin

WARNING

CAN CAUSE SERIOUS HARM TO AN UNBORN CHILD.
Women must use effective methods of contraception.
Do not use during pregnancy or suspected pregnancy.
This medicinal product will be subject to additional monitoring. This will allow for quick identification of new safety information. Users of the medicinal product can also help by reporting any adverse reactions they experience after using the medicinal product. To find out how to report adverse reactions, see the last paragraph of section 4.

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 only. 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 package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents:

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

1. What TOCTINO is and what it is used for

The active substance of TOCTINO is alitretinoin. It belongs to a group of medicines called retinoids, which are derived from vitamin A. TOCTINO capsules are available in two strengths and contain 10 mg or 30 mg of alitretinoin.
TOCTINO is used in adults with severe chronic hand eczema that has not improved with other topical medicines, including steroids. Treatment with TOCTINO should be supervised by a doctor specializing in skin diseases (dermatologist).

2. Important information before taking TOCTINO

When not to take TOCTINO:

• 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 section "Warnings and precautions",

• if you have liver disease,
• if you have severe kidney disease,
• if you have high levels of fats in the blood (e.g. high cholesterol or triglycerides),
• if you have untreated thyroid disease,
• if you have very high levels of vitamin A in your body (vitamin A overdose),
• if you are allergic to alitretinoin, other retinoids (e.g. isotretinoin), peanuts, or soy, or any of the other ingredients of this medicine (listed in section 6),
• if you are taking tetracycline (an antibiotic).
• If any of the above warnings apply to you, you must consult your doctor again. In such a case, do not take TOCTINO

TOCTINO.

Warnings and precautions

Pregnancy Prevention Program

Women who are pregnant must not take TOCTINO.

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 TOCTINO is taken for a short period during pregnancy.

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

TOCTINO may be prescribed to women of childbearing potential only if they strictly follow certain rules. This is due to the risk of serious birth defects.

The following conditions must be met:

• Your doctor must explain the risk of harm to the unborn child (birth defects); you must understand why you must not become pregnant and how to prevent it.
• You must discuss contraception (birth control methods) with your doctor. Your doctor will provide you with information on birth control methods. Your doctor may refer you to a specialist for birth control advice.
• Before starting treatment, your doctor will ask you to have a pregnancy test. The test must show that you are not pregnant at the start of treatment with TOCTINO.

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

TOCTINO

• You 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). You should discuss with your doctor which methods are most suitable for you.

You must use a contraceptive during the month before taking TOCTINO, during treatment, and for one month after stopping treatment. You must use contraception even if you do not menstruate or are not currently sexually active (unless your doctor decides it is not necessary).

• You must agree to have regular pregnancy tests before, during, and after treatment with TOCTINO.
• You must agree to have regular check-ups with your doctor, ideally every month.
• You must agree to have regular pregnancy tests, ideally every month during treatment and one month after stopping treatment with TOCTINO, as the medicine may still be present in your body (unless your doctor decides it is not necessary for you).
• You must agree to have additional pregnancy tests as advised by your doctor.
• You must not become pregnant during and for one month after stopping treatment, as the medicine may still be present in your body.
• Your doctor will discuss all these issues with you, using a checklist, and ask you (or your parent or legal guardian) to sign it. This form confirms that you have been informed of the risks and agree to follow the rules mentioned above.

If you become pregnant while taking TOCTINO, you must stop takingthe medicine immediatelyand contact your doctor. Your doctor may refer you to a specialist for advice.
Additionally, if you become pregnant within one month of stopping treatment with TOCTINO, you should contact your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

The amount of oral retinoids in the semen of men taking TOCTINO is too small to harm an unborn child. However, you should never share this medicine with anyone else.

Additional precautions

Never give this medicine to anyone else. All unused capsules should be returned to the pharmacist after treatment has stopped.

You must not donate blood while taking this medicine or for one month after stopping treatment with TOCTINO. If a pregnant woman receives your blood, she may have a baby with birth defects.

Before taking TOCTINO, you should discuss the following with your doctor:

• 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 TOCTINO may affect your mood.
• If you have kidney disease. It is not recommended to take TOCTINO if you have moderate kidney failure. If you have kidney disease before taking TOCTINO, you should ask your doctor if this medicine is suitable for you.
• If you have high levels of fats in the blood, you may need to have more frequent blood tests. TOCTINO usually increases the levels of fats in the blood, such as cholesterol or triglycerides. If you have persistently high levels of fats in the blood, your doctor may reduce the dose or stop treatment with TOCTINO.

If you have high blood sugar (diabetes), you may need to have your blood sugar levels checked more frequently, and your doctor may start you on a lower dose of TOCTINO.

• If you have thyroid disease, TOCTINO may decrease thyroid hormone levels. If your thyroid hormone levels are low, your doctor may prescribe thyroid hormone replacement therapy.

When to be particularly careful when taking this medicine:

• If you experience any vision problems, you should contact your doctor immediately. You may need to stop taking TOCTINO and have your vision checked.
• If you have persistent headaches, nausea, or vomiting (nausea), these may be symptoms of benign intracranial hypertension. In this case, you must stop taking TOCTINOand contact your doctor immediately.
• If you experience bloody diarrhea, you must stop taking TOCTINOand contact your doctor immediately.
• Limit your exposure to sunlightand avoid using sunlamps. Your skin may become more sensitive to sunlight. Before going out in the sun, apply a sunscreen with a high sun protection factor (SPF 15 or higher). If you experience dry skin and mouth during treatment, you should use a moisturizing cream or ointment and lip balm.
• Limit intense physical exercise: alitretinoin may cause muscle and joint pain.
• If you experience dry eyes, you may need to use eye ointment or artificial tears. If you wear contact lenses, you may need to replace them with glasses during treatment with alitretinoin. Dry eyes and vision problems usually resolve after treatment is stopped.
• TOCTINO may increase liver enzyme activity. Your doctor will perform blood tests during treatment to check liver enzyme activity. If the levels are high, your doctor may reduce the dose or stop treatment with TOCTINO.

Mental health problems

• You may not notice certain 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 these changes and help you identify problems that need to be discussed with your doctor.
• If you have ever had mental health problems, including depression, aggression, or mood swings, as well as thoughts of self-harm or suicide, you must stop taking TOCTINOand contact your doctor immediately.

Children and adolescents

TOCTINO is not intended for use in people under 18 years of age. The efficacy of this medicine in this age group is not known.

TOCTINO and other medicines

While taking TOCTINO, do not take other retinoids (e.g. isotretinoin), vitamin A preparations, or tetracycline(an antibiotic). These increase the risk of side effects.

Tell your doctor or pharmacist if you:

• are taking amiodarone(a medicine that regulates heart rhythm), as it is not recommended to take amiodarone with TOCTINO;
• are taking ketokonazole, fluconazole, miconazole(medicines used to treat infections) or simvastatin(a medicine used to lower cholesterol levels); your doctor will decide whether to reduce the dose of TOCTINO;
• are taking simvastatin(a medicine used to lower cholesterol levels), as TOCTINO may decrease the levels of this medicine in your body;
• are taking gemfibrozil(a medicine used to lower cholesterol levels) or oxandrolone(an anabolic steroid); your doctor will decide whether to reduce the dose of TOCTINO;
• are taking paclitaxel(a medicine used to treat cancer), rosiglitazone, or repaglinide(medicines used to treat diabetes), as TOCTINO may increase the levels of these medicines in your body.

Tell your doctor or pharmacistabout all medicines you are taking, or have recently taken, and any you plan to take, including those obtained without a prescription and herbal medicines.

Pregnancy and breastfeeding

Do not take TOCTINO while breastfeeding

• The medicine is likely to pass into breast milk and may harm the baby.

Do not take TOCTINO during pregnancy

TOCTINO is likely to cause serious birth defects (teratogenic). It also increases the risk of miscarriage.

• Do not take TOCTINO during pregnancy.
• During treatment with TOCTINOand for one month after stopping treatment, do not become pregnant.

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

Driving and using machines

During treatment, you may not see well enough in the dark. In this case, do not drive or operate machinery.
TOCTINO contains soybean oil and sorbitol.
If you are allergic to peanuts or soy, do not take this medicine. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking TOCTINO.
Each 10 mg TOCTINO capsule contains 20.08 mg of sorbitol. Each 30 mg TOCTINO capsule contains 25.66 mg of sorbitol.

3. How to take TOCTINO

When to take the capsules

Take the capsules with your main meal, preferably at the same time each day. Swallow the capsules whole; do not chew them.

What dose to take

The dose should be 10 mg or 30 mg once daily. If you cannot tolerate the recommended dose of 30 mg, your doctor may prescribe a lower dose of 10 mg. Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

How long to take the capsules

Treatment usually lasts from 12 to 24 weeks, depending on the improvement achieved. If the first treatment is successful, your doctor may prescribe another treatment cycle if symptoms recur.

What to do if you take more TOCTINO than you should

If you take too many capsules or if someone else takes your medicine by mistake, you should contact your doctor, pharmacist, or the nearest hospital immediately.

What to do if you forget to take a dose

If you forget to take a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten capsule.

• If you are unsure about taking your medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, TOCTINO can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very common side effects:

• headache,
• increased levels of fats in the blood:increased levels of fats (triglycerides) and cholesterol in the blood.

Common side effects:

• Blood disorders:increased platelet count (cells that help blood clot), decreased red and white blood cell count, observed in blood tests.
• Thyroid problems:decreased thyroid hormone levels.
• Eye problems:eye inflammation (conjunctivitis) and eyelid area; feeling of dryness and irritation of the eyes
• You should ask your pharmacist for suitable eye drops; if you wear contact lenses and experience dry eyes, you may need to replace them with glasses.
• Ear problems:persistent ringing in the ears (tinnitus).
• Dizziness.
• Blood and circulation:hot flushes, high blood pressure (hypertension).
• Stomach and intestine problems:nausea, vomiting, dry mouth.
• Muscle and joint pain:muscle pain, joint pain, lack of energy (fatigue). With intense exercise, high levels of substances produced by muscle breakdown may appear in the blood.
• Skin and hair problems:dry skin, especially on the face, dry and irritated mouth, redness of the skin, itchy rash on the skin, skin inflammation, hair loss.
• Liver problems:increased liver enzyme activity observed in blood tests.

Uncommon side effects:

• Vision problems, including blurred vision, disturbed vision, cloudy vision (corneal clouding, cataract)
• If you experience vision problems, stop taking TOCTINOand contact your doctor.
• Skin problems:itchy skin, skin peeling, rash, dry skin, eczema.
• Ear, nose, and throat problems:nosebleeds.
• Stomach and intestine problems:indigestion (dyspepsia).
• Bone disorders:excessive bone growth, including ankylosing spondylitis; bone growth may be slowed down.

Rare side effects:

• Persistent headachewith accompanying nausea (nausea), vomiting, and vision problems, including blurred vision. These may be symptoms of benign intracranial hypertension.
• If you experience these symptoms, stop taking TOCTINOand contact your doctor.
• Blood and circulation:blood vessel inflammation.
• Skin, hair, and nail problems:nail disorders, increased sensitivity of the skin to sunlight, changes in hair structure.

Psychiatric disorders

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

• Depression or related disorders. Symptoms include sadness or mood changes, anxiety, feeling of emotional discomfort.
• Worsening of existing depression.
• Aggression or violence.

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. hearing voices or seeing things that do not exist.

If you experience any of the above psychiatric disorders, you must

contact your doctor immediately.Your doctor may advise you to stop taking TOCTINO. Stopping treatment may not be enough to make the effects go away; additional help may be needed, and your doctor can provide it.

Other side effects:

Other side effects have occurred in a small number of people, and their exact frequency is not known:
Severe allergic reactions.Symptoms may include:

• itchy rash that stands out from the skin surface (hives),
• swelling, sometimes affecting the face or lips (angioedema), which can make breathing difficult,
• fainting.

If you experience any of the above symptoms, you must contact your doctor immediately. You must stop taking TOCTINO.

Gastrointestinal and stomach disorders.Severe stomach pain (abdominal pain) with heavy bloody diarrhea or without, nausea (nausea) and vomiting.

• Stop taking TOCTINOand contact your doctor. These may be symptoms of serious gastrointestinal diseases.

Vision problems in the dark.Vision problems usually resolve after treatment is stopped.
Blood and circulation:swelling of the hands, lower limbs, and feet (peripheral edema).

Side effects of other medicines in the same group as TOCTINO

The following side effects have not been observed with TOCTINO, but they cannot be ruled out.
They are very rare and may affect less than 1 in 10,000 people.
Diabetes.Excessive thirst, need to urinate frequently, increased blood sugar levels observed in blood tests. Any of these symptoms may be a sign of diabetes.
Bone disorders.Arthritis, bone disorders (delayed growth, changes in bone density); bone growth may be slowed down.
Eye and vision disorders.Color blindness or impaired color vision, as well as intolerance to contact lenses.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.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 TOCTINO

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month stated.
The abbreviation "Lot" means the batch number of the product.
Do not store above 30°C. Store in the original package.
Store the blister in the outer carton 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.

6. Contents of the pack and other information

What TOCTINO contains

The active substance of TOCTINO is alitretinoin.

Other ingredients of TOCTINO 10 mg are:

purified soybean oil, partially hydrogenated soybean oil, medium-chain triglycerides, yellow wax, all-rac-α-tocopherol, gelatin, glycerol, non-crystallizing liquid sorbitol, purified water, iron oxide red (E 172), iron oxide black (E 172).

Other ingredients of TOCTINO 30 mg are:

purified soybean oil, partially hydrogenated soybean oil, medium-chain triglycerides, yellow wax, all-rac-α-tocopherol, gelatin, glycerol, non-crystallizing liquid sorbitol, purified water, iron oxide red (E 172), iron oxide yellow (E 172).

What TOCTINO looks like and contents of the pack

TOCTINO is a soft capsule.
TOCTINO 10 mg capsulesare 11 mm long and 7 mm wide, oval, brownin color, and marked with the symbol "A1".
TOCTINO 30 mg capsulesare 13 mm long and 8 mm wide, oval, red-brownin color, and marked with the symbol "A3".
The medicine is available in packs (blisters) containing 30 soft capsules.

Marketing authorization holder

Stiefel Laboratories Legacy (Ireland) Ltd
Finisklin Business Park, Sligo
Ireland

Manufacturer

SwissCaps GmbH, Grassingerstrasse. 9, D-83043 Bad Aibling, Germany
To obtain more detailed information, you should contact the local representative of the marketing authorization holder:
GSK Services Sp. z o. o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. (22) 576-90-00

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Toctino
Denmark
Toctino
Finland
Toctino
France
Toctino
Greece
Cehado
Spain
Toctino
Netherlands
Toctino
Iceland
Toctino
Germany
Toctino
Norway
Toctino
Poland
Toctino
Slovakia
Toctino
Slovenia
Toctino
Italy
Toctino
United Kingdom (Northern Ireland): Toctino
Date of last revision of the package leaflet:April 2022

Detailed and up-to-date information on this medicine is available by scanning the QR code on the package leaflet using a smartphone. The same information is also available on the website www.toctino.com/poland.html and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocides - www.urpl.gov.pl

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