Prospecto:Information for the User

Alitretinoína IFC 30 mg Soft Gelatin Capsules EFG

?This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

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

• Keep this prospectus, as you may need to read it again. If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you, and you should not give it to others even if they have the same symptomsas you,as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

1.What is Alitretinoína IFC 30 mg Soft Gelatin Capsules EFG and for what it is used

2.What you need to knowbeforestarting totake Alitretinoína IFC 30 mg Soft Gelatin Capsules EFG

3.How to take Alitretinoína IFC 30 mg Soft Gelatin Capsules EFG

4.Possible adverse effects

5Storage of Alitretinoína IFC 30 mg Soft Gelatin Capsules EFG

6.Contents of the package and additional information

The active ingredient of Alitretinoína IFC is alitretinoína. It belongs to a group of medicines known asretinoids, which are derived from Vitamin A. Alitretinoína IFC is available in two doses, which contain 10 mg or 30 mg of alitretinoína.

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

Do not take Alitretinoína IFC:

• If you arepregnantorbreastfeeding.
• 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 aliver disease
• If you have aserious kidney disease
• If you have ahigh level of fats in the blood(such as high cholesterol or elevated triglycerides).
• If you have anuntreated thyroid disease
• If you havevery high levels of vitamin Ain 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).
• Ifyou are taking tetracyclines(a type ofantibiotic).

If you apply any of the above conditions,consult your doctor. Do not take Alitretinoína IFC.

Warnings and precautions

Pregnancy Prevention Plan

Pregnant women should not take Alitretinoína IFC

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 likelihood of miscarriage. This can occur even if Alitretinoína IFC is taken only for a short period of time during pregnancy.

•Do not take Alitretinoína IFC if you are pregnant or think you may be pregnant.

•Do not take Alitretinoína IFC if you are breastfeeding. It is likely that the medication will pass into your milk and harm your baby.

•Do not become pregnant during treatment.

•Do not become pregnant during the month after stopping treatment due to the fact that there may still be medication in your body.

Pregnant women who may become pregnant are prescribed Alitretinoína IFC 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 should 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 refer you to a specialist for advice 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 treatment with Alitretinoína IFC.

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

• 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 Alitretinoína IFC, 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 Alitretinoína IFC

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, due to the fact that there may still be medication in your body, 1 month after stopping treatment with Alitretinoína IFC (unless your doctor decides that 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 Alitretinoína IFC,stop taking the medication immediatelyand consult your doctor. Your doctor may refer you to a specialist for advice.

Additionally, if you become pregnant within a month of stopping Alitretinoína IFC, 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 Alitretinoína IFC are too low to harm the baby of their partners. However, you should 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 Alitretinoína IFC because a baby could be harmed if a pregnant woman receives your blood.

Consult your doctor before starting to take Alitretinoína IFC:

• 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 suicide. This is because your mood may be affected while taking Alitretinoína IFC.
• If you have a kidney disease.Alitretinoína IFC is not recommended for people with moderate kidney disease. If you have kidney disease, consult your doctor if Alitretinoína IFC is suitable for you.
• If you have a high level of fats in the blood;You may need to have blood tests more frequently. Alitretinoína IFC generally increases blood fats, such as cholesterol or triglycerides. If blood fats remain high, your doctor may reduce the dose or suspend treatment with Alitretinoína IFC.
• If you have high levels of sugar in the blood (diabetes);You are likely to need to check your blood sugar levels more frequently and your doctor may reduce the dose of Alitretinoína IFC.
• If you have been suffering from a thyroid disease.Alitretinoína IFCmay reduce thyroid hormone levels. If the thyroid hormone level is low, your doctor may prescribe supplements.

Be extra careful during treatment:

• If you experience any vision problems; inform your doctor immediately.You may need to stop taking Alitretinoína IFC and have your vision monitored.
• If you experience persistent headaches,nausea or vomiting (feel like vomiting or vomit) and blurred vision, as they may be signs of a condition called benign intracranial hypertension.Stop taking the capsules immediatelyand 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, you may need to wear glasses during treatment with alitretinoína. Dry eyes and vision problems usually return to normal when treatment is stopped.
• Alitretinoína IFC 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 the dose or suspend treatment with Alitretinoína IFC.

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 Alitretinoína IFC immediatelyand contact your doctor as soon as possible.

Children and adolescents

Alitretinoína IFC is not recommended for use in children under 18 years of age. Its effectiveness in this age group is unknown.

Alitretinoína IFC with other medications

Do not take other medications that contain retinoids(e.g., isotretinoína), vitamin A supplements or tetracyclines(a type of antibiotic) while taking Alitretinoína IFC, as it increases the risk of adverse effects.

Inform your doctor or pharmacist if:

• You are takingamiodarone(a medication that helps regulate heart rhythm). Alitretinoína IFC and amiodarone should not be taken together.
• You are takingketoconazole,fluconazole,miconazole(medications used to treat infections). Your doctor may decide to reduce the dose of Alitretinoína IFC.
• You are takingsimvastatin(a medication used to lower cholesterol levels). Alitretinoína IFC may reduce the amount of this medication in your body.
• You are takinggemfibrozil(another medication used to lower cholesterol levels) oroxandrolone(an anabolic steroid). Your doctor may decide to reduce the dose of Alitretinoína IFC.
• You are receivingpaclitaxel(used to treat cancer), takingrosiglitazoneorrepaglinide(used to treat diabetes). Alitretinoína IFC 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 over-the-counter medications. This includes also herbal medications.

Pregnancy, breastfeeding and fertility

For more information on pregnancy and contraception, see the section “Pregnancy Prevention Plan” in the section “Warnings and precautions”.

Driving and using machines

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

Alitretinoína IFC contains soy oil

You should not use this medication if you are allergic to peanuts or soy.

Alitretinoína IFC contains sorbitol

This medication contains 25.55 mg of sorbitol in each Alitretinoína IFC 30 mg capsule.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

How long to take the capsules

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

If you take more capsules 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, contact the Toxicological Information Service, phone: 91 562 04 20. It is recommended to bring the packaging and the leaflet for this medication to the healthcare professional.

If you forgot to take Alitretinoína IFC

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, do not take 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 product, ask your doctor or pharmacist.

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

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

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

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

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

?Ask your pharmacist for an appropriate eye drop.If you wear contact lenses and experience dry eye, you may need to wear glasses instead.

• Ear problems:persistent ringing in the ears (tinnitus).
• Dizziness.
• Blood and circulation disorders:headaches, high blood pressure (hypertension).
• Intestine and stomach problems:nausea, vomiting, dry mouth.
• Muscle and joint pain:muscle pain, joint pain, 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(may affect up to 1 in 100 people)

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

??If your vision is affected, stop taking Alitretinoína IFC immediatelyand contact your doctor.

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

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

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

??If you experience these symptoms,stop taking Alitretinoína IFC immediatelyand contact your doctor.

• Blood and circulation disorders:inflammation of blood vessels.
• Skin and hair problems:changes innails, increased skin sensitivity to sunlight, changes in hair texture.

Mental problems

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

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

Very rare side effects(may 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 problems.Your doctor may advise you to stop taking Alitretinoína IFC. This may not be enough to stop the effects: you may need more help, and your doctor can 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 rash (hives).
• Inflammation, sometimes of the face or mouth (angioedema), causing difficulty breathing.
• swelling.

??If you have these symptoms, contact your doctor immediately. Stop taking Alitretinoína IFC.

Intestine and stomach problems

Severe stomach pain (abdominal), with or without bloody diarrhea, general discomfort (nausea), and vomiting.

??Stop taking Alitretinoína IFC immediatelyand contact your doctor. It may be a sign of serious intestinal problems.

Night vision problems

The vision problems usually return to normal after stopping treatment.

Blood and circulation disorders

Swelling of the hands, lower legs, and feet (peripheral edema).

Side effects of other medicines in the same class as Alitretinoína IFC

These side effects have not been observed with Alitretinoína IFC so far, 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.

They 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 of color blindness and color vision, intolerance to contact lenses.

In rare cases, soy oil may cause severe allergic reactions.

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 the Spanish System for the Vigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Alitretinoína IFC

-The active ingredient is alitretinoína.

Each soft capsule contains 30 mg of alitretinoína.

-The other components are:

Soft capsule content: refined soybean oil, partially hydrogenated soybean oil, hydrogenated vegetable oil, monoestearate of glyceryl, medium-chain triglycerides, all-rac-αtocopherol.

Soft capsule coating: gelatin, glycerol, liquid sorbitol (non-crystallized) (E420), titanium dioxide (E171), purified water, and yellow iron oxide (E172).

Appearance of the product and content of the container

Alitretinoína IFC 30 mg soft capsules are oval-shaped, yellow in color, 13 mm x 8 mm in size, and contain a viscous, opaque, yellow-orange suspension.

The soft capsules are packaged in PVC/PVDC/Aluminum blisters.

Container size: 30 capsules.

Marketing Authorization Holder

Industrial Farmacéutica Cantabria, S.A.

Ctra. Cazoña-Adarzo, s/n

39011 Santander

Spain

Responsible for manufacturing

Industrial Farmacéutica Cantabria, S.A.

C/ Pirita, 9

28850 Torrejón de Ardoz (Madrid)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands: ALITRETINOÏNE IFC 30 mg capsules, zacht

Spain: Alitretinoína IFC 30 mg soft capsules EFG

Italy: ALITRECARE

Portugal: ALITRETINOÍNA CANTABRIA 30 mg soft capsules

Last review date of this prospectus:April 2021

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