TOCTINO 10 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Toctino10mg soft capsules

alitretinoin

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Toctino and what is it used for
2. What you need to know before taking Toctino
3. How to take Toctino
4. Possible side effects
5. Storage of Toctino

Contents of the pack and further information

1. What is Toctino and what is it used for

The active substance of Toctino is alitretinoin. It belongs to a group of medicines known as retinoids, which are derived from vitamin A. Toctino capsules are marketed in two doses containing 10 mg or 30 mg of alitretinoin.

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

2. What you need to know before taking Toctino

Do not take Toctino

• If you are pregnant or breastfeeding.
• If there is a possibility that you may become pregnant, you must follow the precautions of the "Pregnancy Prevention Plan", see the 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(such as high cholesterol or elevated triglycerides).
• If you have an untreated thyroid disease.
• If you have very high levels of vitamin Ain the body (hypervitaminosis A).
• If you are allergicto alitretinoin, to other retinoids (such as isotretinoin), to peanuts, to soy, or to any of the other components of this medication (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 Plan

Pregnant women should not take Toctino.

This medication can seriously harm the baby (the medication is considered "teratogenic") - it can cause serious abnormalities of the brain, face, ear, eyes, heart, and certain glands of the baby (thymus and parathyroid). It also increases the likelihood of spontaneous abortion. This can happen even if Toctino is taken for only a short period during pregnancy.

• Do not take Toctino if you are pregnant or if you think you may be pregnant.
• Do not take Toctino if you are breastfeeding. It is likely that the medication will pass into your milk and may harm your baby.
• Do not take Toctino if you may become pregnant during treatment.
• Do not become pregnant during the month following the interruption of this treatment because the medication may still be present in your body.

Women who may become pregnant are prescribed Toctino under strict rules. This is due to the risk of serious harm to the baby.

These are the rules:

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

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

• You must agree to use at least one very reliable contraceptive method (such as an intrauterine device or contraceptive implant) or two effective methods that work in different ways (such as a hormonal contraceptive pill and a condom). Discuss with your doctor which methods would be suitable for you.
• You must use contraceptives for one month before taking Toctino, during treatment, and for one month after finishing treatment.
• You must use contraceptives even if you do not have your period or if you are not sexually active (unless your doctor decides it is not necessary).

Women must accept to have pregnancy tests before, during, and after taking Toctino

• You must agree to have regular follow-up visits, ideally every month.
• You must agree to have regular pregnancy tests, ideally every month during treatment and, because the medication may still be present in your body, one month after finishing treatment with Toctino (unless your doctor decides it is not necessary in your case).
• You must agree to have additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or during the month following treatment, as it is possible that the medication may still be present 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 about the risks and that you will follow the above rules.

If you become pregnant while taking Toctino, stop taking the medication immediatelyand consult 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 consult your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

The levels of oral retinoids in the semen of men taking Toctino are too low to harm the baby of their partners. However, you should never share your medication with anyone.

Additional precautions

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

Do not donate blood during treatment with this medication, nor during one month after stopping Toctino, as a baby could be harmed if a pregnant patient receives your blood.

Consult your doctor before starting to take Toctino:

• If you have ever had any mental health problems. This includes depression, aggressive tendencies, or mood changes. It also includes thoughts of self-harm or ending your life. This is because your mood may be affected while taking Toctino.
• If you have kidney disease. Toctino is not recommended in people with moderate renal disease. If you have kidney disease, consult your doctor if Toctino is suitable for you.
• If you have high levels of fats in the blood, you may need to have blood tests more often. Toctino generally increases blood fats, such as cholesterol or triglycerides. If your blood fats remain high, your doctor may reduce your dose or stop your treatment with Toctino.
• If you have high blood sugar levels (diabetes), you may need to check your blood sugar levels more frequently, and your doctor may reduce the dose of Toctino.
• 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.

Be careful during treatment with Toctino:

• If you experience any vision problems, inform your doctor immediately. You may need to stop taking Toctino and have your vision monitored.
• If you experience persistent headache, nausea, or vomiting (feel like vomiting or vomit), and blurred vision, as it may be signs of a condition called benign intracranial hypertension.

Stop taking the capsulesimmediately and contact your doctor as soon as possible.

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

Mental health problems

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

Children and adolescents

Toctino is not recommended for use in children under 18 years of age. Its efficacy in this age group is unknown.

Taking Toctino with other medicines

Do not take other medicines that contain retinoids (such as isotretinoin), vitamin A supplements, or tetracyclines(a type of antibiotic) while taking Toctino, as they increase the risk of side effects.

Tell your doctor or pharmacist:

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

Tell your doctor or pharmacistif you are using, have recently used, or may need to use any other medication, including those obtained without a prescription. This also includes herbal medicines.

Pregnancy and breastfeeding

Do not take Toctino during breastfeeding.

• It is likely that the medication will pass into your milk and may harm your baby.

Do not take Toctino if you are pregnant

Toctino can cause congenital malformations (it is teratogenic). It also increases the risk of spontaneous abortion.

• Do not take Toctino if you are pregnant
• Do not become pregnant during treatment with Toctino or during the month following treatment.

For more information on pregnancy and contraception, see the "Pregnancy Prevention Plan" in section 2.

Driving and using machines

Your vision may not be as good at nightduring treatment. If this happens, do not drive or operate machinery.

Toctino contains soybean oil and sorbitol

It should not be used in case of peanut or soy allergy. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking Toctino. This medication contains 20.08 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 should be swallowed whole and not chewed.

How much to take

The dose is 10 mg or 30 mg per day. If your body cannot tolerate the recommended dose of 30 mg, you may be prescribed the lower dose of 10 mg.

Follow your doctor's instructions for taking this medication exactly. 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 the disease improves. If your first treatment is successful, your doctor may prescribe another treatment cycle if symptoms recur.

If you take more Toctino than you should

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone: 91 562 04 20. It is recommended to take the packaging and package leaflet of this medication to the healthcare professional.

If you forget to take Toctino

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

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very frequent adverse effects

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

Frequent adverse effects

• 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, noticing dryness and irritation in the eyes.

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

• Ear problems: persistent ringing in the ears (tinnitus).
• Dizziness.
• Blood and circulation disorders: hot flashes, high blood pressure (hypertension).
• Intestinal and stomach problems: nausea, vomiting, dry mouth.
• Muscle and joint pain: muscle pain, joint pain, lack of energy (fatigue). High levels of muscle breakdown products in the blood if you engage in strenuous exercise.
• Skin and hair problems: dry skin, especially on the face, dry and inflamed lips, skin redness, itchy rash, inflamed skin, hair loss.
• Liver problems: elevated liver enzymes observed in blood tests.

Infrequent adverse effects

• Vision problemsincluding blurred vision, distorted vision, cloudy surface in the eye (corneal opacity, cataracts).

• If your vision is affected stop taking Toctino immediatelyand contact your doctor.

• Skin problems:skin itching, skin peeling, rash, dry skin eczema.
• Ear, nose, and throat problems:nosebleeds.
• Intestinal and stomach problems:indigestion (dyspepsia).
• Bone disorders:excessive bone growth, including a spinal disorder called ankylosing spondylitis.

Rare adverse effects

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

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

• Blood and circulation disorders:inflammation of blood vessels.
• Skin, hair, and nail problems: nail disorders, increased skin sensitivity 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 altered 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 self-harm or ending their own lives (suicidal thoughts), have attempted to end their own lives (suicide attempt), or have ended their own lives (suicide). These people may not seem to be depressed.
• Unusual behavior.
• 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 signs of any 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 more help and your doctor can manage it.

Other adverse effects

In a very small number of people, other adverse effects have occurred, whose exact frequency is not known:

Severe allergic reactions.The signs include:

• Raised itchy skin rash (hives).
• Inflammation, 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 pain (abdominal) with or without bloody diarrhea, nausea, and vomiting.

• Stop taking Toctino immediatelyand contact your doctor. This may be a sign of serious intestinal conditions.

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

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

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 less than 1 in 10,000 people.

Diabetes.Excessive thirst, frequent need to urinate, blood tests showing an increase in blood sugar levels. All of these can be signs of diabetes.

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

Eye and vision disorders.Worsening of color blindness and color vision, intolerance to contact lenses.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: 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 expiration date that appears on the packaging and blister after CAD. The expiration date is 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 should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Toctino composition

• The active ingredient isalitretinoin. Each soft capsule contains 10mgof alitretinoin.
• The other ingredients are:refined soybean oil, partially hydrogenated soybean oil, medium-chain triglycerides, yellow beeswax, DL-alpha-tocopherol, gelatin, glycerol, non-crystallizable sorbitol liquid, purified water, red iron oxide (E172) and black iron oxide (E172).

Product appearance and package contents

The Toctino 10 mg soft capsules are brown, oval, approximately 11 mm long and 7 mm wide, printed with “A1”. The capsules are packaged in blisters and presented in boxes of 30 capsules.

Marketing authorization holder

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: + 34 900 202 700

es-ci@gsk.com

Manufacturer

SwissCaps GmbH

Grassingerstrasse 9

D-83043 Bad Aibling

Germany

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

Germany Toctino

Austria Toctino

Denmark Toctino

Slovakia Toctino

Slovenia Toctino

Spain Toctino

Finland Toctino

France Toctino

Greece Cehado

Netherlands Toctino

Iceland Toctino

Italy Toctino

Norway Toctino

Poland Toctino

United Kingdom (Northern Ireland): Toctino

Date of the last revision of this leaflet:January 2024.

Detailed and updated 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