ACITRETIN IFC 25 mg HARD CAPSULES

Introduction

Package Leaflet:information for the user

Acitretina IFC 25 mg hard capsules EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Acitretina IFC and what is it used for
2. What you need to know before taking Acitretina IFC
3. How to take Acitretina IFC
4. Possible side effects
5. Storage of Acitretina IFC
6. Package contents and additional information

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

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

This medication is used to treat severe skin problems where the skin has thickened and may have a scaly appearance and does not respond satisfactorily to other 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, along with dry, scaly, and waxy-like eruptions.
• specific skin disorders characterized by dry scales,as a result of pronounced keratinization (ichthyosis, an organic process in which keratin is deposited in cells and they become horny like nails and hair) and similar disorders in which skin eruptions (pityriasis) or small bumps on the skin and mucous membranes (lichen ruber) occur.

2. What you need to know before taking Acitretina IFC

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 of "Pregnancy and Pregnancy Prevention Plan", see the section "Warnings and precautions".
• If your liveris not working properly.
• If your kidneysare not working properly.
• If you have very high levels of fat or cholesterolin 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).See section "Do not take Acitretina IFC with".
• If you are being treated with methotrexate(a medication used to treat cancer, psoriasis, and rheumatic diseases). See section "Do not take Acitretina IFC with".
• If you are taking a low-dose progestin-only contraceptive pill. The contraceptive effect of the progestin-only pill may be reduced by Acitretina IFC, and therefore, contraceptive protection 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 (included in section 6: "Package contents and additional information") or other retinoids. Hypersensitivity is usually manifested through skin reactions, such as rash, hives, and/or itching.

Warnings and precautions

Consult your doctor or pharmacist before starting to take acitretina.

Recommendations for all patients

Acitretina usually increases blood fat levels, such as cholesterol or triglycerides, which has been associated with pancreatitis.

Tell your doctor if you experience severe abdominal and back pain (these can be signs of pancreas inflammation).

Pregnancy and Pregnancy Prevention Plan

Pregnant women should not take Acitretina IFC

This medication can seriously harm the baby (the medication is considered "teratogenic") - it can cause serious brain, face, ear, eye, heart, and certain gland abnormalities (thymus and parathyroid) in the baby. It also increases the likelihood of spontaneous abortion. This can happen even if Acitretina IFC is taken only for a short period 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 take Acitretina IFC if you may become pregnant during treatment.
• Do not become pregnant during the 3 years following the interruption of this treatment because the medication may still be present in your body.

Women who may become pregnant are prescribed Acitretina IFC 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 contraception 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 Acitretina IFC.

Women must use effective contraceptives before, during, and after taking Acitretina IFC

• You must agree to use at least one very reliable contraceptive method (e.g., an intrauterine device or a 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 would be suitable for you.
• You must use contraceptives for 1 month before taking Acitretina IFC, during treatment, and for 3 years 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 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, because the medication may still be present in your body, every 1-3 months for 3 years after finishing treatment with Acitretina IFC (unless your doctor decides 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 treatment because 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 Acitretina 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 3 years after stopping Acitretina 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 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 another person. Please return 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 patient 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 may 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 that you 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 that you need to discuss with your doctor.

Be careful with Acitretina IFC

• If you have high blood sugar levels(diabetes), if you drink a lot of alcohol, if you are overweight, if you have lipid metabolism disorders or high blood pressure. Your blood values will be checked more frequently when you start taking this medication.
• If you notice that you have vision problems, especially in the dark (see "Driving and using machines").
• If you wear contact lenses. Acitretina IFC causes dry eyes, and therefore, you will need to wear glasses during the entire treatment period.
• If Acitretina IFC is used to treat children. Bone growth and development must be checked periodically. In the case of prolonged treatment in children, the doctor must carefully weigh the potential serious side effects against the benefits of treatment with this medication.
• If you are going to be exposed to a lot of sunlightor use a tanning bed. Acitretina IFC may increase the effects of UV light. In this case, avoid excessive sun exposure and do not use a tanning bed. Before exposing yourself to the sun, make sure you wear adequate sun protection (at least a sun protection factor of 15).
• If you experience severe headache, nausea, vomiting, and vision changes, as there have been rare cases of benign increased pressure in the brain.

Tests and analyses before starting treatment:

• Your doctor must perform a blood test before starting treatment to check liver function. They will also perform 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 examined every week. If abnormal liver function leads to premature interruption of treatment, liver function will be examined for at least 3 months after stopping Acitretina IFC.
• Before starting treatment, cholesterol and triglyceride tests (fasting values) must be performed, once a month after starting treatment, and subsequently every 3 months during treatment.
• In diabetics, retinoids may improve or worsen glucose tolerance. Therefore, blood sugar tests must be performed more frequently than usual during the initial stages of treatment.
• In all patients at high risk, where cardiovascular risk indicators do not return to normal or remain altered, a reduction in dose or interruption of treatment with acitretina should be considered.
• Your doctor may check your blood pressure.
• Before treatment with Acitretina IFC and during prolonged treatment, your doctor will examine your bones at regular intervals (e.g., once a year) because this medication may cause changes in bones (see "4. Possible side effects"). If any of these changes occur in your case, your doctor will discuss the advantages and disadvantages of continuing treatment with you.

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

• There have been occasional reports of changes in bones in children after prolonged treatment with etretinate (another "retinoid" medication). Therefore, it is necessary to closely monitor growth and bone development parameters in children.

Very rare cases of a serious condition (Capillary Leak Syndrome/Retinoic Acid Syndrome) that causes blood to leak from small blood vessels (capillaries) have been reported. This can cause severe low blood pressure, edema (fluid accumulation causing swelling), and shock (collapse).

Very rare cases of a severe skin reaction with symptoms such as rash, blisters, or skin peeling (exfoliative dermatitis) have been reported.

Other medications and Acitretina IFC

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

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

Do not take Acitretina IFC with:

• the antibiotic tetracycline, because it may cause an increase in brain pressure.
• methotrexate(a medication for the treatment of cancer, psoriasis, and rheumatic diseases), because this combination may cause liver inflammation.
• a low-dose progestin-only contraceptive pill. The contraceptive effect of the progestin-only pill may be reduced by Acitretina IFC, and therefore, reliable contraceptive protection 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.

Taking 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 acitretina and up to 2 months after finishing treatment (see "Instructions for women of childbearing age"). The combined use of Acitretina IFC and alcohol may produce a substance (etretinate) that 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 up to 3 years after stopping the medication.

If you become pregnant during treatment with Acitretina IFC, stop taking it immediately and contact your doctor; if you become pregnant during the 3 years following treatment, contact your doctor immediately.

It is likely that acitretina, the active ingredient of this medication, will cause birth defects. If you become pregnant during treatment with this medication, despite the precautions outlined in the prospectus (see "Instructions for women of childbearing age" and "Pregnancy and Pregnancy Prevention Plan" in the section "Warnings and precautions"), or in the 3 years following treatment, there is a high probability that the child will be born with serious birth defects.

To obtain more information about pregnancy and contraception, see the section "Pregnancy and Pregnancy Prevention Plan"

Breastfeeding

Do not take Acitretina IFC if you are breastfeeding, because acitretina passes into breast milk and may harm your baby.

Driving and using machines

Your night vision may deteriorate during treatment. This can happen suddenly. In rare cases, this effect can be severe.

3. How to take Acitretina IFC

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

Follow exactly the administration instructions of 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 individualized treatment, Acitretina IFC capsules are available in doses of 10 or 25 mg of acitretina.

Adults and elderly

• The usual starting dose for adults and elderly is 25 mg or 30 mg once a day.
• It is possible that after 2 - 4 weeks your doctor may increase or decrease the dose. It will depend on the degree of effectiveness of the treatment and its effect 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 headache, nausea or vomiting, drowsiness, irritability, and itching. Stop taking the medication and consult your doctor or go to a hospital immediately.

If you forget to take Acitretina IFC

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

If you interrupt treatment with Acitretina IFC

It is your doctor who is best qualified to decide whether treatment with Acitretina IFC should be interrupted, and how. If you want to stop taking the medication, always consult your doctor first.

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

4. Possible side effects

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

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

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

• dryness or inflammation of the lips
• dry, irritated, runny, or bleeding nose
• peeling of the skin, especially on the palms of the hands and soles of the feet
• inflammation of the nasal mucosa
• itching
• hair loss
• dry mouth, feeling more thirsty than usual
• changes in liver function (confirmed by a blood test)
• increase in blood fat levels (triglycerides, cholesterol) (confirmed by a blood test)
• dryness, irritation, or swelling of the eyes, which may cause intolerance to contact lenses.

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

Side effects on the skin and mucous membranes occur relatively soon (a few days) after starting treatment; hair loss can be expected several weeks later.

These side effects are reversible after modifying the dose or interrupting 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
• pain in the muscles and joints
• swelling of hands, ankles, and feet
• inflammation of the mouth mucosa
• gastrointestinal disorders (e.g., nausea, vomiting, abdominal pain, diarrhea, digestive disorders)
• fragile skin, sticky skin sensation or rash, skin inflammation, changes in hair texture, fragile nails, infection around the nail, skin redness

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

• dizziness
• blurred vision
• gum inflammation
• liver inflammation (hepatitis)
• fissures, cracks, or fine linear scars on the skin, e.g., around the mouth (rhagades), blisters, and skin inflammation (bullous dermatitis)
• increased skin sensitivity 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, and tingling in the feet and hands, or burning, pain, or sudden stinging.

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

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

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

• vaginal infection (also known as Candidaor candidiasis)
• intense itching rash with irregular, raised, pale, or red patches (hives)
• hearing disorders, ringing in the ears (tinnitus)
• redness
• severe condition that causes blood to leak from small vessels (capillaries) (Capillary Leak Syndrome/Retinoic Acid Syndrome). This can cause severe hypotension (low blood pressure), edema (fluid accumulation), and shock (collapse).
• changes in taste; rectal bleeding
• small red bumps or nodules on the skin that can bleed easily (pyogenic granuloma)
• loss of eyelashes or eyebrows (madarosis)
• severe skin reaction with symptoms such as rash, blisters, or skin peeling (exfoliative dermatitis)
• sudden allergic reaction with symptoms such as rash, swelling, or itching of the skin, red and inflamed eyes, severe nasal congestion, asthma, or wheezing. The reaction can range from mild to severe.
• Changes in voice tone (dysphonia)
• Mood alteration
• Signs of psychosis: altered perception of reality, such as hearing voices or seeing things that are not there.

Children:

Occasional changes in bones may occur. Growth and bone development parameters should be monitored.

Diabetics:

There may be an improvement or worsening of glucose tolerance.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use, website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Acitretina IFC

Keep out of sight and reach of children.

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

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

Return unused capsules to the pharmacist.

"Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment."

6. Package contents and additional information

Composition of Acitretina IFC

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

• Other components are:

Filler: maltodextrin (corn), sodium ascorbate, microcrystalline cellulose.

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

Appearance of the product and package contents

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

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

Package sizes:

20, 30, and 50 hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Manufacturer

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 medication is authorized in the Member States of the European Economic Area under the following names:

ES: Acitretina IFC 25 mg hard capsules EFG

IT: Zorias 25 mg

NL: Acitretine IFC 25 mg capsules

Date of the last revision of this leaflet: December 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/