Label: information for the user

Toctino10mg soft capsules

alitretinoína

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

Contents of the package andadditional information

The active ingredient of Toctino is alitretinoin. It belongs to a group of medications known asretinoids, which are derived from vitamin A. Toctino capsules are marketed in two doses containing 10mg or 30mg 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).

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 a liver disease.
• If you have a severe kidney disease.
• If you have a high level of fats in your 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 your body (hypervitaminosis A).
• If you are allergicto alitretinoína, to other retinoids (such as isotretinoína), to peanuts, to soy or to any of the other components of this medication (including in section 6).
• If you are taking tetracyclines(a type ofantibiotic).

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

You must not take Toctino.

Warnings and Precautions

Pregnancy Prevention Plan

Pregnant women must not take Toctino.

This medication can severely harm the baby (the medication is considered "teratogenic") - it can cause severe brain, face, ear, eye, heart and certain gland abnormalities in the baby (thyroid and parathyroid glands). It also increases the risk of spontaneous abortion. This can happen even if Toctino is taken only for a short period of time during pregnancy.

• You must not take Toctino if you are pregnant or if you think you might be pregnant.
• You must not take Toctino if you are breastfeeding. It is likely that the medication will pass to your milk and can harm your baby.
• You must not take Toctino if you may become pregnant during treatment.
• You must not become pregnant during the month following the interruption of this treatment because it is possible that there may still be medication in your body.

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

These are the rules:

• Your doctor must explain the risk of harm to the baby - you must understand why you must not become pregnant and what you must do to avoid becoming pregnant.
• You must have discussed contraception (birth control) with your doctor. Your doctor will give you information on how to avoid becoming pregnant. Your doctor may send you to a specialist to advise you on contraception.
• 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 taking Toctino.

Pregnant women must use effective contraception before, during and after taking Toctino

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

Pregnant women must agree 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 it is possible that there may still be medication in your body, 1 month after stopping treatment with Toctino (unless your doctor decides that in your case it is not necessary).
• You must agree to have additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or during a month after, because it is possible that there may still be medication 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 send you to a specialist to advise you.

Additionally, if you become pregnant within a month after stopping Toctino, you must consult your doctor. Your doctor may send you to a specialist to advise you.

Advice for men

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

Additional precautions

You must never give this medication to anyone else. Please take any unused capsules to your pharmacist at the end of treatment.

You must not donate blood during treatment with this medication, nor during 1 month after stopping Toctino because a baby could be harmed if a pregnant woman receives your blood.

Consult your doctor before starting to take Toctino:

• If you have ever had any mental health problems.Thisincludes depression, aggressive tendencies or mood changes. It also includes thoughts of self-harm or suicide. 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, consult your doctor if Toctino is suitable for you.
• If you have a high level of fats in your blood,you may need to have blood tests more often. Toctino generally increases fats in the blood, 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 levels of sugar in your blood (diabetes),it is likely that you will need to check your blood sugar levels more frequently and your doctor may reduce your 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.

You must be careful during treatment with Toctino:

• If you experience any vision problems, inform your doctor immediately.You may need to stop taking Toctino and monitor your vision.
• If you experience persistent headaches,nausea or vomiting (you feel like vomiting or vomit) and blurred vision, as it may be a sign 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 immediatelyand contact your doctor as soon as possible.
• Reduce your exposure to sunlightand avoid exposure to sunlamps. Your skin may become more sensitive to sunlight. Before exposing yourself to the sun, use a high-protection sunscreen (SPF 15 or higher).If during treatment you experience dry skin and lips, use moisturizing creams or ointments and lip balm.
• Reduce intense physical activity.Alitretinoína may cause muscle and joint pain.
• If you develop dry eyes, you can relieve it by applying an eye lubricating ointment or artificial tears. If you wear contact lenses and experience dry eyes, you may need to wear glasses during treatment with alitretinoína. 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 to 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 problemsincluding depression, aggressive tendencies, mood changes, thoughts of self-harm or suicide,stop taking Toctino immediatelyand contact your doctor as soon as possible.

Children and adolescents

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

Taking Toctino with other medications

Do not take other medications that contain retinoids (such as isotretinoína), vitamin A supplements or tetracyclines(a type ofantibiotic).while taking Toctino, as they increase the risk of adverse effects.

Inform your doctor or pharmacist:

• If you are takingamiodarona(a medication that helps regulate heart rhythm). It is not recommended to take amiodarona with Toctino.
• If you are takingketoconazol,fluconazol,miconazol(medications used to treat infections). Your doctor may decide to reduce your dose of Toctino.
• If you are takingsimvastatina(a medication used to reduce cholesterol levels). Toctino may reduce the amount of this medication in your body.
• If you are takinggemfibrozilo(another medication used to reduce cholesterol levels) oroxandrolona(an anabolic steroid). Your doctor may decide to reduce your dose of Toctino.
• If you are receivingpaclitaxel(used to treat cancer), takingrosiglitazonaorrepaglinida(used to treat diabetes). Toctino may increase the amount of these medications in your body.

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

Pregnancy and breastfeeding

Do not take Toctinoduring breastfeeding.

• It is likely that the medication will pass to your milk and can harm your baby.

Do not take Toctino if you are pregnant

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

• You must not take Toctino if you are pregnant
• You must not become pregnant during treatment with Toctinoor during a month after treatment.

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

Driving and using machines

Your vision may not be as good at nightduring treatment. If this happens, you must not drive or operate machines.

Toctino contains soy oil and sorbitol

You must not use it if you are allergic to peanuts or soy. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking Toctino.Toctino contains 20.08 mg of sorbitol in each capsule.

When to Take the Capsules

The capsule should be taken with a main meal, preferably at the same time every 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 exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult again with your doctor or pharmacist.

How Long to Take the Capsules

Treatment cycles usually last between 12 and 24 weeks, depending on how the disease improves. If your first treatment was 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 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 Toxicological Information Service, phone: 91 562 04 20. It is recommended to bring the packaging and the 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 to take the next dose, skip the missed dose and continue as usual.

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

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

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

Very common side effects

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

Common side effects

• Blood cell disorders:increase in the number of platelets in the blood (cells that help in clotting), decrease in the number of red and white blood cells observed in blood tests.
• Thyroid problems:decrease in thyroid hormone levels.
• Eye problems:inflammation of the eye (conjunctivitis) and the eyelid area, noting dryness and irritation in the eyes.

• Ask your pharmacist for an appropriate eye drop.If you use contact lenses andsuffer from dryeye, you may have to use glasses instead.

• Ear problems:persistent ringing in the ears (tinnitus).
• Dizziness..
• Blood and circulation disorders:hot flushes, high blood pressure (hypertension).
• Intestine 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, dryness and inflammation of the lips, redness of the skin, itchy skin rash, inflamed skin, hair loss.
• Liver problems:elevated liver enzymes observed in blood tests.

Uncommon side effects

• Eye problems:including 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:itching skin,skin peeling, skin rash, eczema dry skin.
• Ear, nose, and throat problems:nasal bleeding.
• Intestine and stomach problems:indigestion (dyspepsia).
• Bone disorders:excessive growth of bones, including the spinal disorder called ankylosing spondylitis.

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

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

Very rare side effects(can affect up to 1 in 10,000 people)

• Some people have had thoughts or feelings 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 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 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 more help and your doctor may manage it.

Other side effects

In a very small number of people, other side effects have occurred whose exact frequency is unknown:

Severe allergic reactions.The signs include:

• Raised, itchy skin rash (hives).
• Inflammation, sometimes of the face or mouth (angioedema), causing difficulty breathing.
• Collapsing.

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

Intestine 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 severe intestinal disorders.

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

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

Side effects of other medicines in the same class as Toctino

These side effects have not been observed with Toctino to date, but cannot be ruled out.They are very rare and may affect fewer 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 may be signs of diabetes.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication 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 at a temperature above30°C.Store the blister in the outer packaging to protect it from light.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Toctino

• The active ingredient isalitretinoin. Each soft capsule contains10mgof alitretinoin.
• The other components are:soybean oil (refined), partially hydrogenated soybean oil, medium-chain triglycerides, yellow beeswax, DL-alpha-tocopherol, gelatin, glycerol, liquid sorbitol (non-crystallizable), purified water, red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the package

Toctino 10mg soft capsules arebrown, oval, approximately11 mmin length and7 mmin width, 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

[email protected]

Responsible for manufacturing

SwissCaps GmbH

Grassingerstrasse9

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:

GermanyToctino

AustriaToctino

DenmarkToctino

SlovakiaToctino

SloveniaToctino

SpainToctino

FinlandToctino

FranceToctino

GreeceCehado

NetherlandsToctino

IcelandToctino

ItalyToctino

NorwayToctino

PolandToctino

United Kingdom (Northern Ireland):Toctino

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

Detailed and updated information about this product is available by scanning the QR code included in the leaflet through a smartphone. The same information is also available at the following link:http://www.aemps.gob.es