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 contraception methods.
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 that occur after taking the medicinal product. To learn how to report adverse reactions, see the last paragraph of section 4.

You should carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicinal product has been prescribed to a specific person. Do not pass it on to others. The medicinal product may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is TOCTINO and what is it used for

The active substance of TOCTINO is alitretinoin. It belongs to a group of medicinal products called retinoids, which are derivatives of 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 medicinal products, 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 the patient is pregnant or breastfeeding,
• if there is a risk that the patient may become pregnant, it is necessary to follow the precautions listed in the "Pregnancy Prevention Program",

see the "Warnings and Precautions" section,

• if the patient has liver disease,
• in patients with severe kidney disease,
• in patients with high levels of fats in the blood(e.g. high cholesterol or triglycerides),
• in patients with untreated thyroid disease,
• if the patient has very high levels of vitamin A(vitamin A overdose),
• if the patient is allergicto alitretinoin, other retinoids (e.g. isotretinoin), peanuts, or soy, or any of the other ingredients of this medicinal product (listed in section 6),
• if the patient is taking tetracycline(antibiotic).
• If any of the above warnings apply, you should consult your doctor again. In such cases, do not take TOCTINO

TOCTINO.

Warnings and Precautions

Pregnancy Prevention Program

Women who are pregnant must not take TOCTINO.

This medicinal product may seriously harm an unborn child (it has a "teratogenic" effect). It may 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 medicinal product 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 medicinal product may still be present in your body.

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

The following conditions must be met:

• The doctor must explain to the patient the risk of harm to the unborn child (birth defects); the patient must understand why she must not become pregnant and how to prevent it.
• The patient must discuss contraception (birth control methods) with the doctor. The doctor will provide information on methods to prevent pregnancy. 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 TOCTINO.

Female patients must use effective contraception methods before, during, and after treatment with TOCTINO

TOCTINO

• 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 them.

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

• The patient must agree to have regular pregnancy tests before, during, and after treatment with TOCTINO.
• 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 TOCTINO, as the medicinal product 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 and for one month after stopping treatment, as the medicinal product may still be present in the patient's body.
• The treating doctor will discuss all issues with the patient using a checklist and ask the patient (or their parent or legal guardian) to sign it. This form confirms that the patient has been informed of the risks and agrees to follow the rules outlined above.

If the patient becomes pregnant while taking TOCTINO, they must stop taking the medicinal product immediatelyand contact their doctor. The doctor may refer the patient to a specialist for advice.
Additionally, if the patient becomes pregnant within one month of stopping treatment with TOCTINO, they should contact their treating doctor. The doctor may refer the patient 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, this medicinal product should never be shared with anyone else.

Additional Precautions

Never give this medicinal product to another person. All unused capsules should be returned to the pharmacist after treatment is completed.

Do not donate blood while taking this medicinal product or for one month after stopping TOCTINO. If the patient's blood is given to a pregnant woman, she may give birth to a child with birth defects.

Before starting treatment with TOCTINO, the patient should discuss the following with their doctor:

• 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 TOCTINO may affect the patient's mood.
• If the patient has kidney disease. It is not recommended to take TOCTINO in patients with moderate kidney impairment. If the patient has kidney disease before taking TOCTINO, they should ask their doctor if this medicinal product is suitable for them.
• If the patient has high levels of fats in the blood, more frequent blood tests may be necessary. TOCTINO usually increases the levels of fats in the blood, such as cholesterol or triglycerides. If high levels of fats in the blood persist, the doctor may reduce the dose or stop TOCTINO.

If the patient has high blood sugar (diabetes), it may be necessary to monitor blood sugar levels more frequently, and the doctor may start with a lower dose of TOCTINO.

• If the patient has thyroid disease. TOCTINO may decrease thyroid hormone levels. If thyroid hormone levels are low, the doctor may prescribe supplements to replace them.

When to be particularly careful when taking this medicinal product:

• If the patient experiences any vision problems, they should contact their doctor immediately. It may be necessary to stop taking TOCTINO and have their vision checked.
• If the patient has persistent headaches, nausea, or vomiting (nausea), or blurred vision, these may be symptoms of benign intracranial hypertension. In such cases, the patient should stop taking TOCTINO immediatelyand contact their doctor as soon as possible.
• If the patient experiences bloody diarrhea, they should stop taking TOCTINO immediatelyand contact their doctor as soon as possible.
• The patient should limit their exposure to sunlightand avoid using sunlamps. The patient's skin may become more sensitive to sunlight. Before going out in the sun, the patient should apply a protective preparation with a high sun protection factor (SPF 15 or higher). If the patient experiences dry skin and mouth during treatment, they should use a moisturizing cream or ointment and lip balm.
• The patient should limit intense physical exercise: alitretinoin may cause muscle and joint pain.
• If the patient experiences dry eyes, using eye ointment or artificial tears may be helpful. If the patient wears contact lenses, they may need to be replaced with glasses during treatment with alitretinoin. Dry eyes and vision problems usually resolve after treatment is stopped.
• TOCTINO may increase liver enzyme activity. The doctor will order blood tests during treatment to measure liver enzyme activity. If the values are high, the doctor may reduce the dose or stop TOCTINO.

Mental Health Problems

• The patient may not notice certain changes in their mood and behavior, so it is very important to tell friends and family members about taking this medicinal product. These people may notice such changes and help the patient identify problems that need to be discussed with the doctor.
• If the patient has ever had mental health problems, including depression, aggression, or mood swings, as well as thoughts of self-harm or suicide, they should stop taking TOCTINO immediatelyand contact their doctor as soon as possible.

Children and Adolescents

TOCTINO is not indicated for use in people under 18 years of age. The efficacy of this medicinal product is not known in this age group.

TOCTINO and Other Medicinal Products

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

Tell your doctor or pharmacist if you:

• are taking amiodarone(a heart rhythm regulator), as it is not recommended to take amiodarone with TOCTINO;
• are taking ketokonazole, fluconazole, miconazole(antifungal medicinal products) or simvastatin(a cholesterol-lowering medicinal product) - the doctor will decide whether to reduce the dose of TOCTINO;
• are taking simvastatin(a cholesterol-lowering medicinal product), as TOCTINO may decrease the levels of this medicinal product in the body;
• are taking gemfibrozil(a cholesterol-lowering medicinal product) or oxandrolone(an anabolic steroid) - the doctor will decide whether to reduce the dose of TOCTINO;
• are taking paclitaxel(a cancer treatment) rosiglitazoneor repaglinide(diabetes treatments), as TOCTINO may increase the levels of these medicinal products in the body.

Tell your doctor or pharmacistabout all medicinal products you are currently taking or have recently taken, as well as any medicinal products you plan to take. This includes medicinal products that are available without a prescription and herbal products.

Pregnancy and Breastfeeding

Do not take TOCTINO while breastfeeding

• The medicinal product 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 effects). 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.

More information on pregnancy and contraception can be found in section 2 "Pregnancy Prevention Program".

Driving and Using Machines

During treatment, the patient may not see well enough at night. In such cases, they should not drive or operate machinery.
TOCTINO contains soybean oil and sorbitol.
If the patient is allergic to peanuts or soy, they should not take this medicinal product. If the doctor has informed the patient of intolerance to certain sugars, they should contact their 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

The capsules should be taken with the main meal, preferably at the same time of day. The capsules should be swallowed whole; do not chew them.

What Dose to Take

The dose should be 10 mg or 30 mg once a day. If the patient's body does not tolerate the recommended dose of 30 mg, the doctor may prescribe a lower dose of 10 mg. This medicinal product should always be taken as directed by the doctor. If you have any doubts, consult your doctor or pharmacist.

How Long to Take the Capsules

The treatment cycle usually lasts from 12 to 24 weeks, depending on the improvement achieved. If the first treatment is effective, in case of relapse, the doctor may prescribe another treatment cycle.

Taking a Higher Dose of the Medicinal Product Than Recommended

If the patient takes too many capsules or the medicinal product is accidentally taken by another person, they should contact their doctor, pharmacist, or the nearest hospital immediately.

Missing a Dose of the Medicinal Product

If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped, and the next dose should be taken as scheduled. Do not take a double dose to make up for the missed capsule.

• If you have any doubts about taking the medicinal product, consult your doctor or pharmacist.

4. Possible Adverse Reactions

Like all medicinal products, TOCTINO can cause adverse reactions, although not everybody gets them.
very common: occur in more than 1 in 10 patients
common: occur in 1 to 10 in 100 patients
uncommon: occur in 1 to 10 in 1,000 patients
rare: occur in 1 to 10 in 10,000 patients
Very common adverse reactions:

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

Common adverse reactions:

• Blood cell 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
• The patient should ask their pharmacist for suitable eye drops; if the patient wears contact lenses and experiences dry eyes, they may need to be replaced with glasses.
• Ear problems:persistent ringing in the ears (tinnitus).
• Dizziness.
• Blood and circulation:hot flashes, high blood pressure (hypertension).
• Stomach and intestine problems:nausea, vomiting reflex, dry mouth.
• Muscle and joint pain:muscle pain, joint pain, lack of energy (fatigue). During 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, itching rash on the skin, skin inflammation, hair loss.
• Liver problems:increased liver enzyme activity observed in blood tests.

Uncommon adverse reactions:

• Vision problems, including blurred vision, disturbed vision, cloudy vision (corneal clouding, cataract)
• If vision problems occur, stop taking TOCTINO immediatelyand contact your doctor.
• Skin problems:itching of the 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 inhibited.

Rare adverse reactions:

• Persistent headachewith accompanying nausea (nausea), vomiting, and vision disturbances, including blurred vision. These may be symptoms of benign intracranial hypertension.
• If such symptoms occur, stop taking TOCTINO immediatelyand 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 adverse reactions(may affect up to 1 in 1,000 patients)

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

Very rare adverse reactions(may affect up to 1 in 10,000 patients)

• Some people have had thoughts or fantasies about self-harm or suicide (suicidal thoughts), attempted suicide (suicide attempts), or committed suicide. These people do not have to 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 actually exist.

If the patient experiences any of the above psychiatric disorders, they should

contact their doctor immediately. The doctor may advise stopping TOCTINO.
Stopping the medicinal product may not be enough for the adverse reactions to resolve; additional help may be necessary, and the doctor can provide it.

Other Adverse Reactions:

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

• itching rash protruding above the skin surface (hives),
• swelling, sometimes affecting the face or lips (angioedema), which can make breathing difficult,
• fainting.

If the patient experiences any of the above symptoms, they should contact their doctor immediately. They should stop taking TOCTINO.

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

• Stop taking TOCTINO immediatelyand 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).

Adverse Reactions of Other Medicinal Products in the Same Class as TOCTINO

The following adverse reactions have not been observed with TOCTINO, but they cannot be ruled out.
They are very rare and may occur in 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 inhibited.
Eye and vision disorders.Color blindness or impaired color vision, as well as intolerance to contact lenses.

Reporting Adverse Reactions

If the patient experiences any adverse reactions, including those not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, more information can be collected on the safety of the medicinal product.

5. How to Store TOCTINO

The medicinal product should be stored out of sight and reach of children.

Do not use this medicinal product after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month.
The "Lot" abbreviation 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.
Medicinal products should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicinal products they no longer use. 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:

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:

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 medicinal product 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, please contact the local representative of the marketing authorization holder:
GSK Services Sp. z o. o.
ul. Rzymowskiego 53
02-697 Warsaw
phone: (22) 576-90-00

This Medicinal Product 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 Leaflet:April 2022

Detailed and up-to-date information on this medicinal product is available by scanning the QR code on the 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 Biocidal Products - www.urpl.gov.pl

{QR Code}