Prospecto:Information for the User

Acitretina IFC 25 mg Hard Capsules EFG

Read the entire prospectus carefully before starting to take the medication 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 medication has been prescribed to you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. See section 4.

1.What Acitretina IFC is and for what it is used

2.What you need to know before starting to take Acitretina IFC

3. How to take Acitretina IFC

4. Possible adverse effects

5. Storage of Acitretina IFC

6. Contents of the package and additional information

Acitretin belongs to a group of medications known as retinoids.Retinoids are derivatives of vitamin A.

This medication is used to treat severe skin problems in which the skin has thickened and may appear scaly and does not respond satisfactorily to conventional treatments.

Acitretina IFC is used for the treatment of:

• generalized and severe forms of various skin disorders,resulting from alterations of the outer layer of the skin (the epidermis), such as psoriasis, accompanied by dry, scaly, and waxy-like eruption.
• specific skin disorders characterized by dry scales,as a result of pronounced keratinization(ichthyosis, an organic process in which keratin deposits in cells and they become cornified like nails and hair) and similar disorders in which skin eruption (pityriasis) or small skin and mucous membrane swellings (erythema multiforme) occur.

Do not take Acitretina IFC

• If you are pregnant or breastfeeding
• If there is a possibility that you may become pregnant, you must follow the precautions outlined in “Pregnancy and Prevention of Pregnancy Plan”, see the section “Warnings and Precautions”.
• If your liver does not function correctly
• If your kidneys do not function correctly
• If you have very high levels of fat or cholesterol in your blood (also known as “hyperlipidemia”).
• If you are taking other retinoid medications, or medications, vitamin supplements, or foods that contain high levels of vitamin A. (See section “Do not take Acitretina IFC with”).
• If you are taking an antibiotic called tetracycline (for an infection).
• If you are being treated with methotrexate (a medication used for cancer, psoriasis, and rheumatic diseases). See section “Do not take Acitretina IFC with”.
• If you are taking a low-progesterone oral contraceptive pill. The contraceptive effect of the progesterone pill may be reduced by Acitretina IFC, and therefore the protection against pregnancy cannot be guaranteed. See section “Do not take Acitretina IFC with”.
• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medication (including those listed in section 6: “Contents of the pack and additional information”) or other retinoids. Hypersensitivity is generally manifested through skin reactions, such as rashes, itching, and/or hives.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take acitretin.

Recommendations for all patients

Acitretin usually increases levels of fats in the blood, such as cholesterol or triglycerides, which has been associated with pancreatitis.

Inform your doctor if you experience intense pain in the abdomen and back (these may be signs of pancreatitis).

Pregnancy and Prevention of Pregnancy Plan

Pregnant women should not take Acitretina IFC

This medication can severely harm the baby (the medication is considered “teratogenic”) - it can cause severe abnormalities of the brain, face, ear, eyes, heart, and certain glands of the baby (thyroid and parathyroid). It also increases the likelihood of spontaneous abortion. This can occur even if Acitretina IFC is taken only for a short period of time during pregnancy.

• Do not take Acitretina IFC if you are pregnant or think you may be pregnant.
• Do not take Acitretina IFC if you are breastfeeding. It is likely that the medication will pass into your milk and may harm your baby.
• Do not become pregnant during treatment.
• Do not become pregnant during the 3 years following the end of treatment due to the fact that there may still be medication in your body.

Pregnant women who may become pregnant are prescribed Acitretina 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. The doctor will give you information on how to avoid becoming pregnant. The 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 Acitretina IFC.

Pregnant women must use effective contraception before, during, and after taking Acitretina 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 for 1 month before taking Acitretina IFC, during treatment, and for 3 years 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 Acitretina 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, every 1-3 months for 3 years after stopping treatment with Acitretina IFC (unless your doctor decides that it is not necessary).
• You must agree to have additional pregnancy tests if your doctor requests them.
• You must not become pregnant during treatment or during the 3 years following the end of treatment due to the fact 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 Acitretina IFC, stop taking the medication immediately and consult your doctor. Your doctor may refer you to a specialist for advice.

Additionally, if you become pregnant within 3 years of stopping Acitretina IFC, 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 Acitretina IFC 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 anyone else. Please take any unused capsules to your pharmacist at the end of treatment.

Do not donate blood during treatment with this medication, or during the 3 years after stopping Acitretina IFC because a baby could be harmed if a pregnant woman receives your blood.

Consult your doctor before starting to take Acitretina IFC:

• If you have ever had any mental health problems, such as depression, aggressive tendencies, or mood changes, or signs of psychosis (altered perception of reality, such as hearing voices or seeing things that are not there). This is because taking Acitretina IFC can affect your mood and mental health.

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 this medication may affect your mood and behavior. They may notice these changes and help you identify any problems you need to discuss with your doctor.

Be extra careful with Acitretina IFC

• If you have high levels of sugar in your blood (diabetes), if you drink a lot of alcohol, if you are overweight, if you have lipid metabolism disorders or high blood pressure.
• If you notice problems with your vision, especially in the dark (see “Driving and using machines”).
• If you wear contact lenses.Acitretina IFC causes dry eyes, and therefore you will have to wear glasses throughout the treatment period.
• If Acitretina IFC is used to treat children. The growth and development of bones must be checked periodically. In the case of prolonged treatment in children, the doctor must carefully weigh the possible serious side effects against the benefits of treatment with this medication.
• If you are going to receive a lot of sunlight or use a sunbed.Acitretina IFC can cause an increase in the effects of UV light. In this case, avoid excessive exposure to sunlight and do not use a sunbed. Before exposing yourself to the sun, make sure you are wearing adequate sun protection (at least SPF 15).
• If you experience intense headaches, nausea, vomiting, and vision changes, as there have been rare cases of benign intracranial hypertension.

Tests and analyses before starting treatment:

• Your doctor must perform a blood test before starting treatment tocheck liver function. They will also do blood tests every 1-2 weeks during the first 2 months after starting treatment.Later, at least once every 3 months during treatment.If liver function appears abnormal, it will be checked every week.If abnormal liver function leads to premature discontinuation of treatment, liver function will be checked for at least 3 months after stopping treatment with Acitretina IFC.
• Before starting treatment, blood tests for cholesterol and triglycerides (fasting values) must be performed, once a month after starting treatment, and then every 3 months during treatment.
• In diabetics, retinoids can both improve and worsen glucose tolerance.Therefore, blood glucose tests must be performed more frequently than usual during the initial stages of treatment.
• In all high-risk patients in whom cardiovascular risk indicators do not return to normal or continue to be abnormal, consideration should be given to reducing the dose or discontinuing treatment with acitretin.
• Your doctor may monitor your blood pressure.
• Your doctor may check your bones periodically (for example, once a year) because this medication can cause changes in bones (see “4. Possible side effects”).If this occurs in your case, the doctor will discuss the advantages and disadvantages of continuing treatment with you.

Inform your doctor if you notice the following possible signs of bone changes:bone pain, joint or muscle pain, limited mobility.

• Rare cases of bone changes have been reported in children after prolonged treatment with etretinate (another “retinoid” medication). Therefore, it is necessary to closely monitor growth and bone development in children.

Rare cases of a severe condition (capillary extravasation syndrome/retinoic acid syndrome) have been reported, which causes the leakage of blood from small blood vessels (capillaries). This can cause severe hypotension (low blood pressure), edema (fluid accumulation causing swelling), and shock (collapse).

Rare cases of a severe skin reaction with symptoms such as rashes, blistering, or skin peeling (dermatitis exfoliativa) have been reported.

Other medications and Acitretina IFC

Inform your doctor or pharmacist if you are taking/using or have taken/used any other medication, even those purchased without a prescription.

The effects of phenytoin (an epilepsy medication) may be increased if you take Acitretina IFC. It may be necessary to adjust the dosage of phenytoin.

Do not take Acitretina IFC with:

• tetracycline antibiotic, as this may cause increased intracranial pressure.
• metotrexate (a medication used for cancer, psoriasis, and rheumatic diseases), as this combination may cause liver inflammation.
• a low-progesterone oral contraceptive pill. The contraceptive effect of the progesterone pill may be reduced by Acitretina IFC, and therefore the protection against pregnancy cannot be guaranteed.
• medications or vitamin supplements that contain high levels of vitamin A (more than 5000 IU per day).
• other retinoid medications, such as isotretinoin.

Acitretina IFC with food and drinks

Do not drink alcohol during treatment with Acitretina IFC, as this may increase the risk of side effects.

Women of childbearing age should not consume any alcohol during treatment with acitretin and for 2 months after stopping treatment (see “Instructions for women of childbearing age”). The combined use of Acitretina IFC and alcohol may produce a substance (etretinate), which can be harmful to the fetus, and once formed, this substance takes time to be completely eliminated from the body.

Pregnancy, breastfeeding, and fertility

Pregnancy

Do not take Acitretina IFC if you are pregnant or may become pregnant at any time during treatment and for 3 years after stopping treatment.

If you become pregnant during treatment with Acitretina IFC, stop taking it immediately and consult your doctor; if you become pregnant within 3 years of stopping treatment, consult your doctor immediately.

It is likely that acitretin, the active ingredient in this medication, will cause fetal malformations.If you become pregnant during treatment with this medication, despite the precautions outlined in the leaflet (see “Instructions for women of childbearing age”, below, and “Pregnancy and Prevention of Pregnancy Plan” in the section “Warnings and Precautions”), or within 3 years of stopping treatment, there is a high likelihood that the baby will be born with severe malformations.

For more information on pregnancy and contraception, see the section “Pregnancy and Prevention of Pregnancy Plan”

Breastfeeding

Do not take Acitretina IFC if you are breastfeeding, as acitretin passes into breast milk and may harm the baby.

Driving and using machines

Your vision may deteriorate during treatment. This could happen suddenly. In rare cases, this effect has continued after treatment has stopped. Be careful if you drive or use tools or machines at night or in a tunnel. (See “Be extra careful with Acitretina IFC”)

Acitretina IFC should only be prescribed by doctors, preferably specialists, who have experience in treating systemic retinoids and correctly assess the risk of acitretina in case of pregnancy.

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

• Take Acitretina IFC with meals or with milk.
• Swallow the capsules whole.

The dose is different for each patient. Your doctor will indicate the correct dose for you.

To allow for individualized treatment, Acitretina IFC capsules are available in doses of 10 or 25 mg of acitretina.

Adults and Seniors

• The usual starting dose for adults and seniors is 25 mg or 30 mg once a day.
• Your doctor may increase or decrease the dose after 2-4 weeks. This will depend on the degree of treatment effectiveness and the effect it has on you.
• The maximum dose is 75 mg per day.
• Most patients take Acitretina IFC for a maximum of 3 months. However, your doctor may decide that you take it for a longer period.

If you take more Acitretina IFC than you should

If you take more Acitretina IFC than you should, you may experience headaches, nausea, vomiting, drowsiness, irritability, and itching. Stop taking the medication and consult your doctor immediately or go to the hospital.

If you forget to take Acitretina IFC

Do not take a double dose of Acitretina IFC to make up for the missed dose. If you forget to take a dose, take it as soon as you remember and continue with the established treatment regimen. However, if there is not much time left before the next dose, do not take the missed dose.

If you interrupt treatment with Acitretina IFC

Your doctor is best qualified to decide whether to interrupt treatment with Acitretina IFC and how to do it. If you want to stop taking the medication, consult your doctor first.

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

Like all medications, Acitretina IFC can cause side effects, although not everyone will experience them.

• Acitretina IFC side effects are related to the dose. The higher the daily dose, the greater the risk of side effects.
• Treatment with high doses can cause mood changes, including irritability, aggression, and depression.
• Most side effects occur at the beginning of treatment, when the dose has not yet been fully adjusted. Most side effects are reversible after adjusting the dose or discontinuing treatment.
• It is possible that skin symptoms may worsen at the beginning of treatment.
• Since Acitretina IFC is a derivative of vitamin A, most of its side effects are similar to those that occur in people who have taken too much vitamin A.

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

Using moisturizers or 'emollients' from the start of treatment may help reduce skin dryness and lip problems.

Skin and mucous membrane side effects occur relatively quickly (a few days) after starting treatment; hair loss can be expected several weeks later.

These side effects are reversible after adjusting the dose or discontinuing treatment.However, due to the hair growth cycle, hair recovery will take several months.

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

• headache
• muscle and joint pain
• swelling of hands, ankles, and feet
• inflammation of the oral mucosa
• gastrointestinal disturbances (e.g., nausea, vomiting, abdominal pain, diarrhea, digestive disorders)
• fragile skin, feeling of sticky or itchy skin, inflammation of the skin, changes in hair texture, brittle nails, skin infection around the nails, skin redness

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

• dizziness
• blurred vision
• inflammation of the gums
• inflammation of the liver (hepatitis)
• fine, linear, or thread-like skin cracks or fissures, for example around the mouth (rhabdomyoma), blisters, or inflammation of the skin (dermatitis bullosa)
• increased sensitivity of the skin to sunlight

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

• damage to the peripheral nervous system, including symptoms such as muscle weakness, numbness, or tingling in the feet and hands, or burning, stabbing, or sudden pain.

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

• increased blood pressure in the brain
• alteration in night vision, inflammation of the cornea of the eye (ulcerative keratitis)
• yellow discoloration of the skin and eyes (jaundice)
• bone pain, changes in bone growth

Frequency not known(frequency that cannot be estimated from available data)

• vaginal infection (also known asCandidaor candidiasis)
• intense itching with irregular, raised, pale, or red patches (rashes)
• alterations in hearing, ringing in the ears (tinnitus)
• redness
• severe condition causing bleeding from small blood vessels (capillaries) (capillary extravasation syndrome/retinoid acid syndrome). This may cause severe hypotension (low blood pressure), edema (fluid accumulation causing swelling), and shock (collapse).
• changes in taste sensation; rectal bleeding
• small, red, or nodular skin bumps that may bleed easily (pyogenic granuloma)
• loss of eyelashes or eyebrows (madarosis)
• severe skin reaction with symptoms such as itching, blisters, or skin peeling (exfoliative dermatitis)
• sudden allergic reaction with symptoms such as itching, swelling, or redness of the skin, red, inflamed eyes, severe nasal congestion, asthma, or wheezing. The reaction may range from mild to severe.
• changes in voice tone (dysphonia)
• mood changes
• psychosis symptoms: altered perception of reality, such as hearing voices or seeing things that are not there.

Children:

Occasional changes in bones may occur. Bone growth and development parameters should be monitored.

Diabetics:

There may be improvement or worsening of glucose tolerance.

Reporting side effects

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

Keep out of sight and reach of children.

Do not use the medication after the expiration date, which appears on the packaging afterCAD.The expiration date is the last day of the month indicated.

Do not store the medication above 86°F (30°C). Store it in the original packaging to protect it from moisture.

Return unused capsules to the pharmacist.

“Medications should not be thrown away through drains or in the trash. Dispose of packaging and medications you no longer need at the PHARMACY TAKE-BACK POINT. 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 Acitretina IFC

• The active ingredient is acitretin.Each hard capsule contains 25 mg of acitretin.

• The other components are:

Filling of the capsule: maltodextrin (corn), sodium ascorbate, microcrystalline cellulose.

Capsule coating: gelatin, propylene glycol, sodium lauryl sulfate, titanium dioxide (E171), iron oxide yellow (E172),iron oxide black (E172), iron oxide red (E172), shellac, purified water.

Appearance of the product and content of the container

Acitretina IFC 25 mg capsules contain a yellow powder and consist of a yellow to slightly yellow body and a brown cap, with the characters "A25" printed in black on the capsule body.

The capsules are packaged in PVC/PVDC/aluminum blisters.

Container sizes:

20, 30, and 50 hard capsules.

Only some container sizes may be marketed.

Holder of the Marketing Authorization

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Responsible for manufacturing

Laboratorio Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante

Valencia, Spain

Or

Industrial Farmacéutica Cantabria, S.A.

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:

ES: Acitretina IFC 25 mg hard capsules EFG

IT: Zorias 25 mg

NL: Acitretine IFC 25 mg capsules

Last review date of this leaflet: December 2024

Further detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/