Toctino: detailed information

Package leaflet: Information for the user

TOCTINO 10 mg soft capsules
TOCTINO 30 mg soft capsules
Alitretinoin
WARNING
CAN CAUSE SEVERE HARM TO AN UNBORN CHILD.
Women must use effective contraception.
Do not use during pregnancy or if pregnancy is suspected.
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you may experience. For information on how to report side effects, see the last paragraph of section 4.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

What TOCTINO is and what it is used for
What you need to know before taking TOCTINO
How to take TOCTINO
Possible side effects
How to store TOCTINO
Contents of the pack and other information

1. What TOCTINO is and what it is used for

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

2. Important information before using TOCTINO

When not to use TOCTINO:

if the patient is pregnant or breastfeeding,
if there is any risk that the patient may become pregnant, it is necessary to follow the precautions listed under the "Pregnancy Prevention Programme", see section "Warnings and precautions",
if the patient has liver disease,
in patients with severe kidney disease,
in patients with elevated blood lipid levels (e.g. increased cholesterol or triglycerides),
in patients with untreated thyroid disease,
if the patient has very high levels of vitamin A in the body ( hypervitaminosis A ),
if the patient is allergic to alitretinoin, to other retinoids (e.g. isotretinoin), peanuts or soya, or to any of the other ingredients of this medicine (listed in section 6),
if the patient is taking tetracycline ( antibiotic ).
- If any of the above warnings apply, the patient should contact their doctor again. In such cases, TOCTINO must not be used.

Warnings and precautions
Pregnancy Prevention Programme
Women who are pregnant must not take TOCTINO.
This medicine may severely harm the unborn child (the medicine has a "teratogenic" effect). It may
cause severe malformations of the brain, face, ear, eyes, heart, and certain glands (thymus and
parathyroid glands) of the foetus. It also increases the risk of miscarriage. These effects may occur
even if TOCTINO is taken for only a short time during pregnancy.

Do not take TOCTINO if the patient is pregnant or suspects she may be pregnant.
Do not take TOCTINO during breastfeeding. The medicine is likely to pass into breast milk and may harm the baby.
Do not take TOCTINO if the patient could become pregnant during treatment.
The patient must not become pregnant for one month after stopping treatment, as the medicine may still be present in her body.

TOCTINO may be prescribed to women of childbearing potential only if they strictly comply
with specific requirements. This is due to the risk of severe birth defects in the unborn child.
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 her doctor. The doctor will provide information on methods of preventing pregnancy. The doctor may refer the patient to a specialist for contraceptive advice.
Before starting treatment, the doctor will ask the patient to take a pregnancy test. The test must confirm that the patient is not pregnant at the start of TOCTINO treatment.

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

The patient must agree to use at least one highly reliable method of contraception (e.g. intrauterine device or contraceptive implant), or two effective methods acting in different ways (e.g. oral hormonal contraceptives and condoms). The most suitable methods for the patient should be discussed with the doctor.
The patient must use contraception for one month before taking TOCTINO, during treatment, and for one month after stopping the medicine.
The patient must use contraception even if she is not menstruating or is not currently sexually active (unless the doctor determines it is unnecessary).

Women must agree to undergo pregnancy tests before, during, and after treatment with
TOCTINO

The patient must agree to attend regular follow-up visits with her doctor, ideally every month.
The patient must agree to undergo regular pregnancy tests, ideally every month during treatment and one month after stopping TOCTINO, as the medicine may still be present in her body (unless the doctor decides testing is unnecessary for that patient).
The patient must agree to additional pregnancy tests as recommended by her doctor.
The patient must not become pregnant during or within one month 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 will 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 rules listed above.

If a patient becomes pregnant while taking TOCTINO, she must stop taking the medicine immediately
and contact her doctor. The doctor may refer the patient to a specialist for advice.
Additionally, a patient who becomes pregnant within one month after stopping TOCTINO should contact her doctor. The doctor may refer her to a specialist for advice.
Advice for men
The amount of oral retinoids in the semen of men taking TOCTINO is too low to harm their partner's unborn child. However, this medicine must never be shared with anyone else.
Additional precautions
Never pass this medicine on to another person. All unused capsules must be returned to the
pharmacist after treatment is completed.
Do not donate blood while taking this medicine or for one month after stopping TOCTINO. If a
pregnant woman receives the patient's blood, she may give birth to a child with birth defects.
Before starting TOCTINO, discuss the following with your doctor:

If the patient has ever had mental health problems, including depression, aggression, mood swings, or thoughts of self-harm or suicide. This is because TOCTINO may affect the patient's mood.
If the patient has kidney disease. TOCTINO is not recommended in patients with moderate kidney impairment. If the patient has kidney disease before starting TOCTINO, ask the doctor whether this medicine is suitable.
If the patient has elevated blood lipid levels, more frequent blood tests may be needed. TOCTINO usually increases blood lipid levels such as cholesterol or triglycerides. If high lipid levels persist, the doctor may reduce the dose or discontinue TOCTINO.
If the patient has high blood sugar (diabetes), more frequent blood sugar monitoring may be needed, and the doctor may start treatment with a lower dose of TOCTINO.
If the patient has thyroid disease. TOCTINO may reduce thyroid hormone levels. If thyroid hormone levels are low, the doctor may prescribe replacement therapy.

When to exercise special caution when using this medicine:

If any eye problems occur, contact the doctor immediately. Treatment with TOCTINO may need to be stopped and vision checked.
If the patient has persistent headache, nausea or vomiting, or blurred vision, these may be symptoms of benign intracranial hypertension. In such cases, the capsules must be stopped immediately and the doctor contacted as soon as possible.
If the patient develops bloody diarrhoea, stop taking the capsules immediately and contact the doctor as soon as possible.
Sunlight exposure should be limited and use of sunbeds avoided. The patient's skin may become more sensitive to sunlight. Before going outdoors, apply a high-protection sunscreen (SPF 15 or higher). If the patient develops dry skin and lips during treatment, a moisturising cream or ointment and a protective lip balm should be used.
Intense physical exercise should be limited: alitretinoin may cause muscle and joint pain.
If the patient experiences dry eyes, eye ointment or artificial tear drops may help. 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 stopping treatment.
TOCTINO may increase liver enzyme activity. The doctor will order blood tests during treatment to monitor liver enzyme levels. If levels are elevated, the doctor may reduce the dose or discontinue TOCTINO.

Mental health problems

The patient may not notice certain changes in mood or behaviour, so it is very important to inform friends and family members that the patient is taking this medicine. These people may notice such changes and help the patient identify problems quickly for discussion with the doctor.
If the patient has ever had mental health problems, including depression, aggression, mood swings, or thoughts of self-harm or suicide, TOCTINO must be stopped immediately and the doctor contacted as soon as possible.

Children and adolescents
TOCTINO is not indicated for use in individuals under 18 years of age. The efficacy of this medicine is not known in this age group.
TOCTINO and other medicines
While taking TOCTINO, do not take other retinoids (e.g. isotretinoin), vitamin A supplements, or tetracyclines (antibiotics). These increase the risk of adverse effects.
Tell your doctor or pharmacist if the patient:

is taking amiodarone (a medicine for heart rhythm disorders), as amiodarone is not recommended with TOCTINO;
is taking ketoconazole, fluconazole, miconazole (medicines for infections) or simvastatin (a medicine to lower cholesterol) – the doctor will decide whether the dose of TOCTINO should be reduced;
is taking simvastatin (a medicine to lower cholesterol), as TOCTINO may reduce the level of this medicine in the body;
is taking gemfibrozil (a medicine to lower cholesterol) or oxandrolone (an anabolic steroid) – the doctor will decide whether the dose of TOCTINO should be reduced;
is taking paclitaxel (a cancer medicine), rosiglitazone, or repaglinide (medicines for diabetes), as TOCTINO may increase the levels of these medicines in the body.

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This includes over-the-counter and herbal medicines.
Pregnancy and breastfeeding
Do not use TOCTINO during breastfeeding

The medicine is likely to pass into breast milk and may harm the baby. Do not use TOCTINO during pregnancy. TOCTINO is likely to cause severe birth defects (medically termed "teratogenic"). It also increases the risk of miscarriage.
Do not use TOCTINO during pregnancy.
During treatment with TOCTINO and for one month after stopping treatment, pregnancy must be avoided.

More information on pregnancy and contraception can be found in section 2 "Pregnancy Prevention Programme".
Driving and operating machinery
During treatment, the patient may have poor night vision. In such cases, driving or operating machinery should be avoided.
TOCTINO contains soya oil and sorbitol.
If the patient is allergic to peanuts or soya, this medicine should not be used. If the doctor has informed the patient of an intolerance to certain sugars, consult the doctor before using 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 use TOCTINO

When to take the capsules
The capsules should be taken with a main meal, preferably at the same time each day. The capsules must be swallowed whole; they must not be chewed.
What dose should be taken
The dose should be 10 mg or 30 mg once daily. 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 medicine should always be taken according to the doctor's instructions. In case of doubt, consult the doctor or pharmacist.
How long to take the capsules
The treatment course usually lasts from 12 to 24 weeks, depending on the improvement achieved. If the first treatment was effective, the doctor may prescribe another treatment course in case of symptom recurrence.
Taking more than the recommended dose
If the patient takes too many capsules or if this medicine is accidentally taken by someone else, contact a doctor, pharmacist or the nearest hospital immediately.
Missing a dose of the medicine
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 completely omitted and the next dose taken according to the prescribed schedule. Do not take a double dose to make up for a missed capsule.

If in doubt about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very common: occurs in more than 1 in 10 patients
Common: occurs in 1 to 10 in 100 patients
Uncommon: occurs in 1 to 10 in 1,000 patients
Rare: occurs 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 number of platelets (cells that help the blood to clot), decreased number of red and white blood cells, observed in blood tests.
Thyroid problems: decreased levels of thyroid hormones.
Eye problems: eye inflammation (conjunctivitis) and eyelid area; sensation of dryness and irritation of the eyes
- 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 or noise in the ears (tinnitus).
Dizziness.
Blood and cardiovascular system: hot flushes, high blood pressure (hypertension).
Abdominal and intestinal problems: nausea, vomiting reflex, dry mouth.
Muscle and joint pain: muscle pain, joint pain, lack of energy (fatigue). With intense physical exercise, high levels of substances resulting from muscle breakdown may appear in the blood.
Skin and hair problems: dry skin, especially on the face, dry and irritated lips, skin redness, itchy skin rash, 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 field of vision (corneal opacity, cataract)
- If vision disturbances occur, immediately stop taking TOCTINO and contact your doctor.
Skin problems: itching of the skin, skin peeling, rash, dry skin, skin eruptions.
Ear, nose and throat problems: nosebleeds.
Abdominal and intestinal problems: indigestion (dyspepsia).
Bone disorders: excessive bone growth, including ankylosing spondylitis.

Rare adverse reactions:

Persistent headache accompanied by nausea, vomiting and visual disturbances, including blurred vision. These may be symptoms of benign intracranial hypertension.
- If these symptoms occur, immediately stop taking TOCTINO and contact your doctor.
Blood and cardiovascular system: inflammation of blood vessels (vasculitis).
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 conditions. Symptoms include sadness or mood changes, anxiety, and feelings of emotional discomfort.
Worsening of existing depression.
Tendency towards violence or aggression.

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

Some individuals have experienced thoughts or images related to self-harm or suicide (suicidal thoughts), attempted suicide, or completed suicide. These individuals may not show symptoms of depression.
Unusual behaviour.
Psychotic symptoms: loss of contact with reality, e.g. the patient hears voices or sees things that do not exist in reality.

If any of the psychiatric symptoms described above occur,
contact your doctor immediately. Your doctor may recommend discontinuing TOCTINO.
Stopping the medication may not be sufficient for symptoms to resolve; additional support may be required, which your doctor can provide.

Other adverse reactions:
Other adverse reactions have occurred in a small number of people, and their exact frequency is unknown:
Severe allergic reactions. Symptoms may include:

Itchy rash raised above the skin surface (urticaria),
Swelling, sometimes affecting the face or lips (angioedema), causing difficulty breathing,
Fainting.
- If any of the above symptoms occur, contact your doctor immediately. Discontinue TOCTINO.

Intestinal and stomach problems. Severe stomach pain (abdominal pain) with or without severe bloody diarrhoea,
nausea and vomiting.

Immediately stop taking TOCTINO and contact your doctor. These may be symptoms of serious intestinal diseases.

Problems seeing in the dark. Vision problems usually resolve after stopping treatment.
Blood and cardiovascular system: swelling of the hands, lower legs and feet (peripheral oedema).

Adverse reactions of other medicines in the same class as TOCTINO
The following adverse reactions have not been observed with TOCTINO so far, but cannot be ruled out.
They are very rare and may occur in fewer 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 indicate diabetes.
Bone disorders. Joint inflammation, bone disorders (delayed growth, changes in bone density); bone growth may be inhibited.
Eye and vision disorders. Colour blindness or impaired colour vision may occur, as well as intolerance to contact lenses.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder. Reporting adverse reactions helps provide more information on the safety of the 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 cardboard box and
on the blister after: EXP. The expiry date refers to the last day of the specified month.
"Lot" is the batch number of the product.
Do not store above 30°C. Store in the original packaging.
Keep the blister in the outer cardboard package 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. These measures will help
protect the environment.

6. Contents of the pack and other information

What TOCTINO contains

The active substance is alitretinoin.

The other ingredients of TOCTINO 10 mg are:
purified soybean oil, partially hydrogenated soybean oil, medium-chain saturated 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).

The other ingredients of TOCTINO 30 mg are:
purified soybean oil, partially hydrogenated soybean oil, medium-chain saturated 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 available as soft capsules.

TOCTINO 10 mg capsules are 11 mm long and 7 mm wide, oval-shaped, brown in colour, and marked with the symbol "A1".

TOCTINO 30 mg capsules are 13 mm long and 8 mm wide, oval-shaped, red-brown in colour, and marked with the symbol "A3".

The medicine is available in packs (blister packs) containing 30 soft capsules.

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

Manufacturer
SwissCaps GmbH, Grassingerstrasse 9, D-83043 Bad Aibling, Germany

For further information, please contact the local representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. (22) 576-90-00

This medicine is authorised for sale in 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

Detailed and up-to-date information about this medicine is available by scanning the QR code
on the Package Leaflet with 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 and Biocidal Products - www.urpl.gov.pl
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