Acitretin IFC 25 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acitretin IFC 25 mg hard capsules EFG

WARNING

IF USED DURING PREGNANCY, MAY CAUSE SERIOUS HARM TO THE BABY.

Women must use effective contraception throughout treatment.

Do not use if pregnant or suspect you may be pregnant.

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

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you; do 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 are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Acitretina IFC is and what it is used for
What you need to know before taking Acitretina IFC
How to take Acitretina IFC
Possible adverse effects
Storage of Acitretina IFC
Package contents and additional information

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

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

This medicine is used to treat severe skin disorders in which the skin has become thickened and may appear scaly, and which do 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 abnormalities of the outer layer of the skin (the epidermis), such as psoriasis, accompanied by dry, scaly, wax-like eruptions.
Specific skin disorders characterized by dry scaling, resulting from marked keratinization (ichthyosis, a condition in which keratin deposits in skin cells, causing them to become horny like nails and hair), and similar disorders associated with skin eruptions (pityriasis) or small skin and mucosal papules (lichen ruber).

2. What you need to know before taking Acitretina IFC

Do not take Acitretina IFC

If you are pregnant or breastfeeding.
If there is any possibility you could become pregnant, you must follow the precautions outlined in “Pregnancy and Pregnancy Prevention Plan”; see the section “Warnings and precautions”.
If your liver is not functioning properly.
If your kidneys are not functioning properly.
If you have very high levels of fat or cholesterol in your blood (also known as "hyperlipidemia").
If you are taking other retinoid medicines, or any medicines, vitamin supplements, or foods containing high levels of vitamin A. (See section “Do not take Acitretina IFC with”).
If you are taking an antibiotic called tetracycline (used to treat infection). See section “Do not take Acitretina IFC with”.
If you are being treated with methotrexate (a medicine used to treat cancer, psoriasis, and rheumatic diseases). See section “Do not take Acitretina IFC with”.
If you are taking a contraceptive pill with very low progesterone content (progesterone-only pills). The contraceptive effect of progesterone-only pills 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 substance or to any of the other components of this medicine (listed in section 6: “Contents of the pack and other information”) or to other retinoids. Hypersensitivity usually manifests as skin reactions such as rash, hives, and/or itching.

Warnings and precautions

Talk to your doctor or pharmacist before starting acitretin.

Recommendations for all patients

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

Inform your doctor if you experience severe abdominal or back pain (these may be signs of inflammation of the pancreas).

Pregnancy and Pregnancy Prevention Plan

Pregnant women must not take Acitretina IFC

This medicine can seriously harm the unborn baby (the medicine is considered “teratogenic”) – it may cause severe abnormalities in the baby’s brain, face, ears, eyes, heart, and certain glands (thymus and parathyroid). It also increases the risk of spontaneous abortion. This can occur even if Acitretina IFC is taken for only a short time during pregnancy.

Do not take Acitretina IFC if you are pregnant or think you might be pregnant.
Do not take Acitretina IFC if you are breastfeeding. The medicine is likely to pass into your milk and may harm your baby.
Do not take Acitretina IFC if you could become pregnant during treatment.
Do not become pregnant within 3 years after stopping treatment because the medicine may still remain in your body.

Women who could become pregnant are prescribed Acitretina IFC under strict rules due to the risk of serious harm to the unborn baby

These rules are:

Your doctor must explain the risk of harm to the unborn baby – you must understand why you must not become pregnant and what you need to do to prevent pregnancy.
You must have discussed contraception (birth control) with your doctor. Your doctor will provide information on how to avoid pregnancy. Your doctor may refer you to a specialist for contraceptive advice.
Before starting treatment, your doctor will require you to take a pregnancy test. The test must confirm that you are not pregnant when starting Acitretina IFC treatment.

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

You must agree to use at least one highly reliable method of contraception (e.g., an intrauterine device or 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 are suitable for you.
You must use contraception for one month before starting Acitretina IFC, throughout treatment, and for 3 years after stopping treatment.
You must use contraception even if you do not have periods or are not sexually active (unless your doctor decides otherwise).

Women must agree to undergo pregnancy testing before, during, and after taking Acitretina IFC

You must agree to regular follow-up visits, ideally every month.
You must agree to regular pregnancy testing, ideally every month during treatment and, because the medicine may still remain in your body, every 1–3 months for 3 years after stopping Acitretina IFC (unless your doctor decides otherwise).
You must agree to additional pregnancy tests if requested by your doctor.
You must not become pregnant during treatment or within 3 years after stopping treatment because the medicine may still remain 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 of the risks and will follow the above rules.

If you become pregnant while taking Acitretina IFC, stop taking the medicine immediately and contact your doctor. Your doctor may refer you to a specialist for advice.

Additionally, if you become pregnant within 3 years after stopping Acitretina IFC, contact your doctor immediately. Your doctor may refer you to a specialist for advice.

Advice for men

Levels of oral retinoids in semen of men taking Acitretina IFC are too low to harm a partner’s unborn baby. However, you must never share your medicine with anyone.

Additional precautions

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

You must not donate blood during treatment with this medicine, or for 3 years after stopping Acitretina IFC, because an unborn baby could be harmed if a pregnant woman receives your blood.

Talk to your doctor before starting Acitretina IFC:

If you have ever had any mental health problems, such as depression, aggressive tendencies, 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 certain changes in your mood or behavior, so it is very important to inform your friends and family that this medicine could affect your mood and behavior. They may notice these changes and help you identify any issues that need to be discussed with your doctor.

Take special care with Acitretina IFC

If you have high blood sugar (diabetes), drink large amounts of alcohol, are overweight, or have lipid metabolism disorders or high blood pressure. Your blood values will be monitored more frequently when you start this medicine.
If you notice problems with your vision, especially in the dark (see "Driving and use of machines").
If you wear contact lenses. Acitretina IFC causes dry eyes, so you will need to wear glasses throughout the treatment period.
If Acitretina IFC is used to treat children. Bone growth and development must be checked regularly. In cases of long-term treatment in children, the doctor must carefully weigh the potential serious side effects against the benefits of treatment.
If you are exposed to sunlight or use a sunbed. Acitretina IFC may increase the effects of UV light. In such cases, avoid excessive sun exposure and do not use a sunbed. Before sun exposure, ensure you use adequate sun protection (at least SPF 15).
If you experience severe headache, nausea, vomiting, or vision changes, as rare cases of benign increased intracranial pressure have been reported.

Tests and analyses before starting treatment:

Your doctor must perform a blood test before starting treatment to check liver function. Blood tests will also be performed every 1–2 weeks during the first 2 months of treatment. Afterwards, at least once every 3 months during treatment. If liver function appears abnormal, weekly monitoring will be required. If abnormal liver function leads to premature discontinuation of treatment, liver function must be monitored for at least 3 months after stopping Acitretina IFC.
Before starting treatment, cholesterol and triglyceride levels (fasting values) must be tested, then once a month after starting treatment, and subsequently every 3 months during treatment.
In diabetic patients, retinoids may either improve or worsen glucose tolerance. Therefore, blood sugar tests should be performed more frequently than usual during the initial stages of treatment.
In high-risk patients where cardiovascular risk indicators do not return to normal or remain altered, a reduction in dose or discontinuation of acitretin treatment should be considered.
Your doctor may monitor your blood pressure.
Before starting Acitretina IFC and during long-term treatment, your doctor will periodically examine your bones (e.g., once a year) because this medicine may cause bone changes (see "4. Possible side effects"). If any of these occur, your doctor will discuss the benefits and risks of continuing treatment with you.

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

Cases of bone changes have occasionally been reported in children after long-term treatment with etretinate (another “retinoid” medicine). Therefore, growth parameters and bone development must be closely monitored in children.

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

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

Other medicines and Acitretina IFC

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

The effects of phenytoin (a medicine for epilepsy) may be increased if you take Acitretina IFC. The dosage of phenytoin may need to be adjusted.

Do not take Acitretina IFC with:

the antibiotic tetracycline, because it may increase pressure in the brain.
methotrexate (a medicine used to treat cancer, psoriasis, and rheumatic diseases), because this combination may cause liver inflammation.
a contraceptive pill with very low progesterone content (progesterone-only pills). The contraceptive effect of progesterone-only pills may be reduced by Acitretina IFC, so reliable contraceptive protection is not guaranteed.
medicines or vitamin supplements containing high levels of vitamin A (more than 5000 IU per day).
other retinoid medicines, such as isotretinoin.

Taking Acitretina IFC with food and drink

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

Women of childbearing age must not consume any alcohol during treatment with acitretin and for up to 2 months after stopping treatment (see "Instructions for women of childbearing age"). The combined use of Acitretina IFC and alcohol may lead to the formation of a substance (etretinate), which may 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 could become pregnant at any time during treatment or within 3 years after stopping treatment.

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

The active substance in this medicine, acitretin, is likely to cause fetal malformations. If you become pregnant during treatment with this medicine, despite the precautions outlined in the leaflet (see "Instructions for women of childbearing age", below, and “Pregnancy and Pregnancy Prevention Plan” in the “Warnings and precautions” section), or within 3 years after treatment, there is a high probability that the child will be born with severe congenital malformations.

Instructions for women of childbearing potential

Acitretin IFC is highly teratogenic. This means that the fetus is likely to suffer severe harm.

Typical malformations associated with acitretin include, for example, damage to the central nervous system, heart and major blood vessels, skull and face, skeleton, and thymus gland.

The risk of malformations is high, even if the medicine is taken only briefly during pregnancy or if pregnancy occurs within 3 years after treatment has ended.

If you are a woman of childbearing potential, you may only take Acitretin IFC:

if you suffer from a very severe or disabling skin disease that has not improved with any other treatment.

if you strictly follow the following precautions to avoid pregnancy during treatment with Acitretin IFC and for 3 years after stopping treatment:

if your doctor has explained to you the teratogenic risk (severe fetal malformations) of Acitretin IFC and you understand why you must not become pregnant and how to prevent pregnancy.

you must use an effective method of contraception continuously, preferably two complementary methods (hormonal contraception or an intrauterine device, and use of a condom or diaphragm is also recommended), starting at least 1 month before beginning the medicine, throughout treatment, and for 3 years after stopping treatment. Consult your doctor about effective contraceptive methods. Contact your doctor immediately if pregnancy is suspected.

you have had a medically supervised pregnancy test (which must be negative) no more than 3 days before starting the first dose of Acitretin IFC, to ensure you are not pregnant. You may also be required to have regular pregnancy tests while taking this medicine. After treatment ends, pregnancy tests should be performed every 1–3 months for 3 years following the last dose of Acitretin IFC.

you start taking Acitretin IFC after a negative pregnancy test, on the second or third day of your next menstrual period.

you understand and accept the need for monthly follow-up visits and possibly additional pregnancy tests, as determined by your doctor.

you strictly follow these precautions if you ever need to repeat treatment with Acitretin IFC.

you do not consume alcohol (in beverages, food, or medicines) while taking Acitretin IFC and for 2 months after stopping treatment, because alcohol can increase the risk of birth defects.

Women of childbearing potential must not receive blood donations from patients being treated with acitretin.

Your doctor may ask you (or your legal guardian) to sign a declaration confirming that you have been informed of the risks of treatment with Acitretin IFC and that you accept the necessary precautionary measures.

If you have any questions about these instructions, consult your doctor or pharmacist before taking this medicine.

For more information about pregnancy and contraception, see the section “Pregnancy and Pregnancy Prevention Program”.

Lactation

You must not take Acitretin IFC if you are breastfeeding, because acitretin passes into breast milk and may harm your baby.

Driving and use of machines

Your night vision may be impaired during treatment. This may occur suddenly. In rare cases, this effect has persisted after treatment has ended. Exercise caution if driving or operating tools or machinery at night or in a tunnel. (See "Take special care with Acitretin IFC")

3. How to take Acitretina IFC

Acitretina IFC should only be prescribed by physicians, preferably specialists, who have experience in treating with systemic retinoids and who can properly assess the risk of acitretin during pregnancy.

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Take Acitretina IFC with food or milk.
Swallow the capsules whole.

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

To allow individualized treatment, Acitretina IFC capsules are available in strengths of 10 mg or 25 mg of acitretin.

Adults and elderly

The usual starting dose for adults and elderly patients is 25 mg or 30 mg once daily.
After 2–4 weeks, your doctor may increase or reduce the dose, depending on the treatment's effectiveness and how it affects you.
The maximum dose is 75 mg per day.
Most patients take Acitretina IFC for up to 3 months. However, your doctor may decide that you should 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 medicine and consult your doctor immediately or go to a hospital.

If you forget to take Acitretina IFC

Do not take a double dose of Acitretina IFC to make up for a missed dose. If you forget to take a dose, take it as soon as you remember and then continue with your regular dosing schedule. However, if it is almost time for your next dose, skip the missed dose.

If you stop taking Acitretina IFC

Your doctor is best qualified to decide whether treatment with Acitretina IFC should be stopped, and how. If you wish to stop taking the medicine, always consult your doctor first.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Acitretin IFC may cause adverse effects, although not everyone experiences them.

The adverse effects of Acitretin IFC are dose-related. The higher the daily dose, the greater the risk of adverse effects.
Treatment with high doses may cause mood changes including irritability, aggression, and depression.
Most adverse effects occur at the beginning of treatment, when the dose has not yet been fully adjusted. Most adverse effects are reversible after modifying the dose or discontinuing treatment.
It is possible that skin symptoms may worsen initially during treatment.
Since Acitretin IFC is a derivative of vitamin A, most of its adverse effects resemble symptoms seen in people who have taken excessive amounts of vitamin A.

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

dryness or inflammation of the lips
dry, irritated nose, runny nose, nosebleeds
skin peeling, 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 blood test)
increased levels of fats (triglycerides, cholesterol) in the blood (confirmed by blood test)
dryness, irritation, or swelling of the eyes, which may make contact lenses intolerable

The use of moisturizers or emollients from the start of treatment may help reduce problems with dry skin and lips.

Adverse effects on the skin and mucous membranes occur relatively early (within a few days) after starting treatment; hair loss may be expected several weeks later.

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

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

headache
muscle and joint pain
swelling of hands, ankles, and feet
inflammation of the mouth mucosa
gastrointestinal disorders (e.g., nausea, vomiting, abdominal pain, diarrhea, indigestion)
fragile skin, sticky sensation, rash, skin inflammation, changes in hair texture, brittle nails, nail fold infection, skin redness

Uncommon adverse 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, for example around the mouth (cheilitis), blisters and skin inflammation (bullous dermatitis)
increased skin sensitivity to sunlight

Rare adverse 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, stabbing, or sudden pain

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

increased blood pressure in the brain
night vision disturbances, eye cornea inflammation (ulcerative keratitis)
yellow discoloration of 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 Candida or candidiasis)
intensely itchy rash with irregular, raised, pale or red patches (hives)
hearing disturbances, ringing in the ears (tinnitus)
redness
serious condition causing leakage of blood from small blood vessels (capillaries) (Capillary Leak Syndrome/Rétinoic 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 bumps or nodules on the skin that may 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 may range from mild to severe.
Changes in voice tone (dysphonia)
Mood disturbances
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:

Glucose tolerance may improve or worsen.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acitretin IFC

Keep out of the sight and reach of children.

Do not use the medicine after the expiry date, which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Return any unused capsules to the pharmacist.

"Medicines must not be disposed of via wastewater or household waste. Deposit unused medicines and their packaging at the SIGRE POINT at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment."

6. Contents of the pack and other information

Composition of Acitretin IFC

The active substance is acitretin. Each hard capsule contains 25 mg of acitretin.
The other components are:

Capsule filling: maltodextrin (corn), sodium ascorbate, microcrystalline cellulose.

Capsule coating: 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 contents of the container

Acitretin 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 body of the capsule.

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

Pack sizes:

20, 30 and 50 hard capsules.

Only some pack sizes may be commercially available.

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

Industrial Farmacéutica Cantabria, S.A.

Pirita, 9

28850 Torrejón de Ardoz

Madrid, Spain

This medicinal product 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: Acitretin IFC 25 mg capsules

Date of the most recent review of this leaflet: December 2024

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