Toctino 30 mg soft capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Toctino 30 mg soft capsules

alitretinoin

Read the entire leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Toctino is and what it is used for
2. What you need to know before taking Toctino
3. How to take Toctino
4. Possible adverse 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 in Toctino is alitretinoin. It belongs to a group of medicines known as retinoids, which are derived from vitamin A. Toctino capsules are available in two strengths containing 10 mg or 30 mg of alitretinoin.

Toctino is used to treat chronic hand eczema in adult patients that has not improved with any other topical treatments, including corticosteroids. Treatment with Toctino must be supervised by a skin specialist (dermatologist).

2. What you need to know before starting Toctino

Do not take Toctino

• If you are pregnant or breastfeeding.

• If there is any possibility you could become pregnant, you must follow the precautions of the "Pregnancy Prevention Programme"; see the section "Warnings and precautions".

• If you have a liver disease.

• If you have a severe kidney disease.

• If you have high levels of fats in the blood (such as high cholesterol or elevated triglycerides).

• If you have an untreated thyroid disease.

• If you have very high levels of vitamin A in the body (hypervitaminosis A).

• If you are allergic to alitretinoin, to other retinoids (such as isotretinoin), to peanut, to soy, or to any of the other ingredients of this medicine (listed in section 6).

• If you are taking tetracyclines (a type of antibiotic).

• If any of the above conditions apply to you, consult your doctor.

Do not take Toctino.

Warnings and precautions

Pregnancy Prevention Programme

Pregnant women must not take Toctino.

This medicine can seriously harm the unborn baby (the medicine is considered "teratogenic") – it may cause severe abnormalities in the baby's brain, face, ears, eyes, heart, and certain glands (thymus and parathyroid). It also increases the risk of miscarriage. This can occur even if Toctino is taken for only a short time during pregnancy.

• Do not take Toctino if you are pregnant or think you might be pregnant.
• Do not take Toctino if you are breastfeeding. The medicine is likely to pass into your milk and may harm your baby.
• Do not take Toctino if you are able to become pregnant during treatment.
• Do not become pregnant within one month after stopping treatment, as medicine may still remain in your body.

Women who could become pregnant must be prescribed Toctino under strict rules due to the risk of serious harm to the unborn baby.

These rules are:

• Your doctor must explain the risk of harm to the unborn baby – you must understand why you must not become pregnant and what you need to do to prevent pregnancy.
• You must have discussed contraception (birth control) with your doctor. Your doctor will provide information on how to avoid pregnancy. Your doctor may refer you to a specialist for contraceptive advice.
• Before starting treatment, your doctor will require you to take a pregnancy test. The test must confirm that you are not pregnant when starting Toctino treatment.

Women must use effective contraception before, during, and after taking Toctino

• You must agree to use at least one highly reliable contraceptive method (e.g., an intrauterine device or contraceptive implant) or two effective methods that work in different ways (e.g., a hormonal contraceptive pill and a condom). Discuss with your doctor which methods are suitable for you.
• You must use contraception for one month before starting Toctino, during treatment, and for one month after stopping treatment.
• You must use contraception even if you do not have periods or are not sexually active (unless your doctor determines it is not necessary).

Women must agree to undergo pregnancy tests before, during, and after taking Toctino

• You must agree to regular follow-up visits, ideally every month.
• You must agree to regular pregnancy testing, ideally every month during treatment and for one month after stopping Toctino (due to possible remaining medicine in your body), unless your doctor determines it is not necessary in your case.
• You must agree to additional pregnancy tests if requested by your doctor.
• You must not become pregnant during treatment or within one month after stopping treatment, as medicine may still remain in your body.
• Your doctor will discuss all these points with you using a checklist and will ask you (or a parent/guardian) to sign it. This checklist confirms that you have been informed of the risks and will follow the above rules.

If you become pregnant while taking Toctino, stop taking the medicine immediately and contact your doctor. Your doctor may refer you to a specialist for advice.

Additionally, if you become pregnant within one month after stopping Toctino, you must contact your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

Levels of oral retinoids in semen of men taking Toctino are too low to harm a partner's unborn baby. However, you must never share your medicine with anyone.

Additional precautions

Never give this medicine to another person. Please return any unused capsules to your pharmacist at the end of treatment.

Do not donate blood during treatment with this medicine or for one month after stopping Toctino, as harm to an unborn baby could occur if a pregnant woman receives your blood.

Talk to your doctor before starting Toctino:

• If you have ever had any mental health problems. This includes depression, aggressive tendencies, or mood changes. Also included are thoughts of self-harm or ending your life. This is because your mood may be affected while taking Toctino.
• If you have a kidney disease. Toctino is not recommended for people with moderate kidney disease. If you have kidney disease, discuss with your doctor whether Toctino is suitable for you.
• If you have high levels of fats in your blood, you may need more frequent blood tests. Toctino generally increases blood fats such as cholesterol or triglycerides. If your blood fat levels remain high, your doctor may reduce your dose or stop your Toctino treatment.
• If you have high blood sugar levels (diabetes), you may need to monitor your blood sugar levels more frequently, and your doctor may reduce your Toctino dose.
• If you have had a thyroid disease. Toctino may reduce thyroid hormone levels. If your thyroid hormone level is low, your doctor may prescribe supplements.

Take special care during treatment with Toctino:

• If you experience any vision problems, inform your doctor immediately. Use of Toctino may need to be stopped, and your vision monitored.
• If you have persistent headache, nausea or vomiting (feeling sick or actually vomiting), and blurred vision, as these may be signs of a condition called benign intracranial hypertension.

Stop taking the capsules immediately and contact your doctor as soon as possible.

• If you have bloody diarrhoea. Stop taking the capsules immediately and contact your doctor as soon as possible.
• Reduce exposure to sunlight and avoid sunlamps. Your skin may become more sensitive to sunlight. Before sun exposure, use a high-protection sunscreen (SPF 15 or higher). If you experience dry skin and lips during treatment, use moisturizing creams or ointments and lip balm.
• Reduce intense physical activity. Alitretinoin may cause muscle and joint pain.
• If you develop dry eyes, you can relieve this by using lubricating eye ointment or artificial tears. If you wear contact lenses and experience dry eyes, you may need to wear glasses during alitretinoin treatment. Dry eyes and vision problems usually resolve when treatment is stopped.
• Toctino may increase liver enzyme levels. Your doctor will perform blood tests during treatment to monitor these levels. If they remain high, your doctor may reduce your dose or stop your Toctino treatment.

Mental health problems

• You may not notice some changes in your mood and behavior, so it is very important to inform your friends and family that you are taking this medicine. They may notice these changes and help you quickly identify any problems that need to be discussed with your doctor.
• If you develop any mental health problems, including depression, aggressive tendencies, mood changes, or thoughts of self-harm or ending your life, you must stop taking Toctino immediately and contact your doctor as soon as possible.

Children and adolescents

Toctino is not recommended for use in individuals under 18 years of age. Efficacy in this age group is unknown.

Taking Toctino with other medicines

Do not take other medicines containing retinoids (e.g., isotretinoin), vitamin A supplements, or tetracyclines (a type of antibiotic) while taking Toctino, as they increase the risk of adverse effects.

Inform your doctor or pharmacist:

• If you are taking amiodarone (a medicine used to regulate heart rhythm). Taking amiodarone with Toctino is not recommended.
• If you are taking ketoconazole, fluconazole, or miconazole (medicines used to treat infections). Your doctor may decide to reduce your Toctino dose.
• If you are taking simvastatin (a medicine used to lower cholesterol levels). Toctino may reduce the amount of this medicine in your body.
• If you are taking gemfibrozil (another medicine used to lower cholesterol) or oxandrolone (an anabolic steroid). Your doctor may decide to reduce your Toctino dose.
• If you are receiving paclitaxel (used to treat cancer), taking rosiglitazone or repaglinide (used to treat diabetes). Toctino may increase the amount of these medicines in your body.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This also includes herbal medicines.

Pregnancy and breastfeeding

Do not take Toctino while breastfeeding.

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

Do not take Toctino if you are pregnant.

Toctino is likely to cause congenital malformations (in medical terms, it is teratogenic). It also increases the risk of miscarriage.

• Do not take Toctino if you are pregnant.
• Do not become pregnant during Toctino treatment or within one month after treatment ends.

For more information about pregnancy and contraception, refer to the "Pregnancy Prevention Programme" in section 2.

Driving and using machines

Your vision may be reduced at night during treatment. If this occurs, you must not drive or operate machinery.

Toctino contains soya oil and sorbitol

Do not use if you are allergic to peanuts or soya. If your doctor has told you that you have an intolerance to certain sugars, consult with your doctor before taking Toctino. This medicine contains 25.66 mg of sorbitol in each capsule.

3. How to take Toctino

When to take the capsules

The capsule should be taken with a main meal, preferably at the same time each day. The capsules must be swallowed whole and not chewed.

How much to take

The dose is 10 mg or 30 mg daily. If your body cannot tolerate the recommended dose of 30 mg, your doctor may prescribe the lower dose of 10 mg.

Always follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

How long to take the capsules

A treatment cycle usually lasts between 12 and 24 weeks, depending on how your condition improves. If your first treatment has been successful, your doctor may prescribe another treatment cycle if symptoms reappear.

If you take more Toctino than you should

If you take too many capsules or if someone accidentally takes your medicine, contact your doctor, pharmacist, or go to the nearest hospital immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone: 91 562 04 20. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Toctino

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Do not take a double dose to make up for a missed dose.

• If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• Headache.
• Increase in blood fats: higher levels of fats (triglycerides) and cholesterol in the blood.

Common adverse effects (may affect up to 1 in 10 people)

• Blood cell disorders: increase in the number of blood platelets (cells that help with clotting), decrease in the number of red and white blood cells observed in blood tests.

• Thyroid problems: decrease in thyroid hormone levels.

• Eye problems: eye inflammation (conjunctivitis), and eyelid area feeling dry and irritated eyes.

• Ask a pharmacist for a suitable eye drop. If you wear contact lenses and experience dry eyes, you may need to wear glasses instead.

• Ear problems: persistent noise in the ears (tinnitus).

• Dizziness.

• Blood and circulation disorders: hot flushes, high blood pressure (hypertension).

• Intestinal and stomach problems: nausea, vomiting, dry mouth.

• Muscle and joint pain: muscle pain, joint pain, lack of energy (tiredness). High levels of muscle breakdown products in the blood if you exercise vigorously.

• Skin and hair problems: dry skin, especially on the face, dryness and inflammation of the lips, skin redness, itchy skin rash, inflamed skin, hair loss.

• Liver problems: elevated liver enzymes observed in blood tests.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Vision problems, including blurred vision, distorted vision, cloudy surface on the eye (corneal opacity, cataracts).

• If your vision is affected**, stop taking Toctino immediately** and contact your doctor.

• Skin problems: itchy skin, skin peeling, skin rash, eczema with dry skin.

• Ear, nose and throat problems: nosebleeds.

• Intestinal and stomach problems: indigestion (dyspepsia).

• Bone disorders: extra bone growth, including the spinal disorder called ankylosing spondylitis.

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

• Persistent headache, with general discomfort (nausea), vomiting, and changes in vision, including blurred vision. These may be signs of benign intracranial hypertension.

• If you experience these symptoms, stop taking Toctino immediately and contact your doctor.

• Blood and circulation disorders: inflammation of blood vessels.

• Skin, hair and nail problems: nail disorders, increased sensitivity of the skin to sunlight, changes in hair texture.

Mental health problems

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

• Depression or related disorders. These signs include sad or changed mood, anxiety, feelings of emotional distress.
• Worsening of existing depression.
• Becoming violent or aggressive.

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

• Some people have had feelings or thoughts about harming themselves or ending their lives (suicidal thoughts), have attempted to end their lives (suicide attempt), or have ended their lives (suicide). These people may not appear to be depressed.
• Unusual behaviour.
• Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that are not there.

Contact your doctor immediately if you experience any signs of these mental health problems. Your doctor may advise you to stop taking Toctino. This may not be enough to stop the effects: you may need further help, which your doctor can manage.

Other adverse effects

In a very small number of people, other adverse effects have occurred, the exact frequency of which is not known (cannot be estimated from available data):

Serious allergic reactions. Signs include:

• Raised, itchy skin rash (hives).

• Swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing.

• Collapse.

• If you have these symptoms, contact your doctor immediately. Stop taking Toctino.

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

• Stop taking Toctino immediately and contact your doctor. These may be signs of serious intestinal conditions.

Night vision problems. Vision problems usually return to normal once treatment is stopped.

Blood and circulation disorders. Swelling in the hands, lower legs and feet (peripheral oedema).

Adverse effects of other medicines in the same class as Toctino

These effects have not been observed with Toctino to date, but cannot be ruled out. They are very rare and may affect up to 1 in 10,000 people.

Diabetes. Excessive thirst, frequent need to urinate, blood tests showing increased blood sugar levels. All of these may be signs of diabetes.

Bone disorders. Arthritis, bone disorders (growth delay, changes in bone density). Growing bones may stop growing.

Eye and vision disturbances. Worsening of colour blindness and colour vision, intolerance to contact lenses.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Toctino

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Keep the blister in the outer packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Toctino

• The active substance is alitretinoin. Each soft capsule contains 30 mg of alitretinoin.
• The other components are: refined soybean oil, partially hydrogenated soybean oil, medium-chain triglycerides, yellow beeswax, DL-alpha-tocopherol, gelatin, glycerol, liquid sorbitol (non-crystallizable), purified water, iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the product and contents of the pack

Toctino 30 mg soft capsules are brownish-red, oval-shaped, approximately 13 mm long and 8 mm wide, printed with “A3”. The capsules are packed in blisters and available in cartons containing 30 capsules.

Marketing Authorization Holder

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer

SwissCaps GmbH

Grassingerstrasse 9

D-83043 Bad Aibling

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany Toctino
Austria Toctino
Denmark Toctino
Slovakia Toctino
Slovenia Toctino
Spain Toctino
Finland Toctino
France Toctino
Netherlands Toctino
Italy Toctino
Norway Toctino

Date of the most recent review of this leaflet: November 2024.

Detailed and up-to-date information on this product is available by scanning the QR code included in the leaflet using a smartphone. The same information is also available at the following link: http://www.aemps.gob.es