Prospect: information for the user

Neotigason 25 mg hard capsules

Acitretin

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

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

1. What isNeotigasonand for what it is used

2. What you need to know before starting to takeNeotigason

3. How to takeNeotigason

4. Possible adverse effects

5. Storage ofNeotigason

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, may appear scaly, and does not respond satisfactorily to conventional treatments.

Neotigason is indicated for the treatment of skin alterations such as psoriasis, ichthyosis (skin alteration that manifests with dryness and formation of masses similar to scales) and Darier's disease (hereditary skin, nail, and mucous membrane disease, which manifests with brown-colored patches on the face, chest, abdomen, and folds).

Acitretin should only be prescribed by doctors, preferably dermatologists, who have experience in treating systemic retinoids and can correctly evaluate the risk caused by acitretin in case of pregnancy and the follow-up required.

Do not take Neotigason

• If you are pregnant or breastfeeding.
• If there is a possibility that you may become pregnant, you must follow the precautions of the “Pregnancy Prevention Plan”, see the section “Warnings and precautions”.
• If you are allergic to acitretin or to any of the other components of this medication (listed in section 6) or if you are taking other “retinoid” medications, such as isotretinoin and tazarotene.
• If you have severe liver or kidney problems.
• If you have high levels of fats (lipids) in your blood.
• If you are taking vitamin A, see the section “Other medications and Neotigason”.

-If you are taking medications called tetracyclines (a type of antibiotic for treating infections) or methotrexate (for skin problems, arthritis, or cancer), see the section “Other medications and Neotigason”.

• Acitretin is contraindicated in children.

Warnings and precautions

The treatment with acitretin must be monitored by a specialized doctor in the treatment of skin diseases for which it is indicated.

Acitretin should only be used as a last resort, that is, when other treatments have failed.

Acitretin habitually increases the 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 inflammation).

Due to the risk of fetal malformations, this medication should not be administered to others. Any unused or expired medication should be returned to the pharmacy for disposal.

Pregnancy Prevention Plan

Pregnant women should not take Neotigason.

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 Neotigason is taken for only a short period of time during pregnancy.

• You should not take this medication if you are pregnant or think you may be pregnant.
• You should not take Neotigason if you are breastfeeding. It is likely that the medication will pass into your milk and harm your baby.
• You should not take Neotigason if you may become pregnant during treatment.
• You should 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 have Neotigason prescribed 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 should do to avoid becoming pregnant.
• You must have discussed birth control (contraception) with your doctor. Your doctor will give you information on how to avoid becoming pregnant. Your doctor may send you to a specialist for advice on birth control.
• Before starting treatment, your doctor will ask you to undergo a pregnancy test. The test must show that you are not pregnant when you start treatment with Neotigason.

Pregnant women must use effective birth control before, during, and after taking Neotigason

• You must agree to use at least one very reliable method (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 birth control during a month before taking Neotigason, during treatment, and for 3 years after the end of treatment.
• You must use birth control 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 undergo pregnancy tests before, during, and after taking Neotigason

• You must agree to undergo regular follow-up visits, ideally every month.
• You must agree to undergo 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 the end of treatment with Neotigason (unless your doctor decides that it is not necessary).
• You must agree to undergo additional pregnancy tests if your doctor requests them.
• You should 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 Neotigason,stop taking the medication immediatelyand consult your doctor. Your doctor may send you to a specialist for advice.

Additionally, if you become pregnant within 3 years after stopping Neotigason, you must consult your doctor. Your doctor may send you to a specialist for advice.

Advice for men

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

Additional precautions

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

You should not donate blood during treatment with this medication, nor during 3 years after stopping Neotigason because a baby could be harmed if a pregnant woman receives your blood.

Consult your doctor before starting to take Neotigason:

-If you have diabetes.You will need to check your blood sugar levels more frequently when you start taking Neotigason.

-If you have high levels of fats in your bloodor if you are obese. Your doctor may need to do blood tests while you are taking Neotigason to check the level of fats in your blood.

-If you have cardiovascular problems.It is possible that your doctor will monitor your blood pressure, etc.

-If you drink a lot of alcohol.

-If you have liver problems.

-If you notice that your night vision is decreasing.

-If you have intense headaches, nausea, vomiting, and/or vision problems. These may be signs of increased pressure in your head, which should be checked as soon as possible by your doctor.

-If you are going to be exposed to a lot of sunlight or use a sunbed. Neotigason can enhance the effects of UV light on your skin. Before exposing yourself to intense sunlight, apply asunscreen (with a protection factor of at least SPF 15) to the areas of your skin that will be exposed. You should avoid the uncontrolled use of sunbeds.

-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 Neotigason 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 that you tell your friends and family that this medication could affect your mood and behavior. They may notice these changes and help you identify any problems that you need to discuss with your doctor.

Your liver function and the levels of fats (lipids) in your blood should be checked before starting treatment and regularly during treatment. Your doctor may also check your bones periodically, as Neotigason can cause changes in your bones, especially in children and older adults receiving long-term treatment.

Patients treated with Neotigason may experience hair loss.

Children and adolescents

This medication is not recommended for use in children and adolescents. If, for exceptional reasons, it must be used, it is essential to closely monitor any possible abnormalities in the development of the child's muscles and bones.

Other medications and Neotigason

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Tetracyclines(a type of antibiotic): It is contraindicated to treat Neotigason with antibiotics such as tetracyclines (see the section “Do not take Neotigason”) at the same time, as it may cause an increase in pressure within the skull (benign intracranial hypertension).

Vitamin A:While taking Neotigason, you should not take medications that contain high doses of vitamin A (see the section “Do not take Neotigason”). Do not exceed the recommended daily dose of 4000-5000 IU of vitamin A.

Methotrexate(a medication used to treat psoriasis or certain types of cancer): You should avoid administering methotrexate and Neotigason together, as there is a risk of hepatitis (liver inflammation) (see the section “Do not take Neotigason”).

Phenobarbital(a medication for epilepsy): Neotigason partially reduces the binding of phenobarbital to plasma proteins. The clinical significance of this is not yet known, but it should be remembered in the case of administering both medications at the same time.

Oral contraceptives(medications used to prevent unwanted pregnancies): The contraceptive effect of microdose progesterone preparations may be reduced by interaction with Neotigason. Therefore, microdose progesterone preparations or “mini-pills” should not be used, as retinoids interfere with their contraceptive effect.

Until now, no interactions have been observed between Neotigason and other substances (e.g., digoxin, cimetidine).

Neotigason with food, drinks, and alcohol

Pregnant women cannot consume alcohol (in drinks, foods, or medications) during treatment with Neotigasonor for 2 months after the end of treatment.The ingestion of acitretin and alcohol can result in the formation of a compound (etretinato), which can be harmful to the fetus, and once formed, it takes a long time to be completely eliminated from the body.

The capsules should be taken with some food or milk.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Neotigason can cause, in some cases, a decrease in night vision, which disappears when treatment is stopped. Therefore, you should exercise extreme caution if you need to drive vehicles or operate hazardous machinery during treatment.

Neotigason contains glucose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Neotigason contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially “sodium-free”.

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

The capsules should be taken whole once a day, accompanied by some food or milk.

The required doses of Neotigason vary from person to person, so your doctor will prescribe an appropriate dose for you. This medication is administered orally.

Use in adults and elderly people

For psoriasis, the recommended starting dose is 25 mg (1 capsule of 25 mg) or 30 mg (3 capsules of 10 mg).

Your doctor may increase or decrease the dose after 2-4 weeks, depending on the degree of treatment efficacy and the effect it has on you.

The maximum dose is 75 mg (3 capsules of 25 mg) per day. This maximum dose should not be exceeded. The capsule should be taken, preferably once a day with food.

Most patients take acitretin for a maximum of 3 months. However, your doctor may decide that you take it for a longer period. Long-term treatment is not recommended for patients with psoriasis.

In patients with Darier's disease, the usual starting dose is 10 mg, which may be increased by your doctor.

Use in children and adolescents

This medication is not recommended for use in children and adolescents unless, in the doctor's opinion, the benefits outweigh the risks.

The dose will be established based on weight.

Before starting treatment with this medication, consult the "Pregnancy Prevention Plan" section in the "Warnings and Precautions" section.

If you take more Neotigason than you should

If you take more acitretin than you should, you may experience severe headache, dizziness, nausea or vomiting, drowsiness, irritability, and itching. Stop treatment with the medication and consult your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Neotigason

Do not take a double dose to compensate for the missed doses. 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 little time left before the next dose, do not take the missed dose.

If you interrupt treatment with Neotigason

It is the doctor who is best qualified to decide whether to interrupt treatment with acitretin 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 medicines, this medicine can cause side effects, although not everyone will experience them.

The majority of Neotigason side effects depend on the dose and for this reason, most patients experience some side effects during the initial period while adjusting the dose. These side effects are generally well tolerated at recommended doses and usually disappear once the dose is reduced or treatment is discontinued.

The most common areas affected are the skin and mucous membranes, observing dryness, sometimes with erosion, in lips, mouth, and nasal or conjunctival mucous membranes. In rare cases, the patient's sensitivity to sunlight may increase.

Stop taking Neotigason and consult your doctor immediately if you experience the following side effects at the same time:

• Intense headache;
• Nausea or vomiting;
• Visual problems.

The following side effects have been observed during Neotigason treatment:

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

-Dry, irritated, or swollen eyes, which may cause intolerance to contact lenses;

-Runny, irritated, or bloody nose;

-Dry mouth, thirst;

-Dryness or inflammation of the lips, which may be alleviated by applying a greasy ointment. Itching, hair loss, skin peeling on the palms of the hands or soles of the feet, or even on the rest of the body;

-Changes in liver function (shown in a blood test);

-Increased levels of fats in the blood (shown in a blood test);

-Elevated uric acid levels (shown in a blood test).

Common(may affect up to 1 in 10 patients):

-Headache;

-Mouth mucosa inflammation, abdominal pain, diarrhea, nausea, vomiting;

-Fragile skin, sticky sensation on the skin or rash, skin inflammation, changes in hair texture, brittle nails, skin infection around a nail, redness of the skin, hair weakening;

-Joint pain, muscle pain;

-Swelling of hands, ankles, and feet.

Uncommon(may affect up to 1 in 100 patients):

-Dizziness;

-Blurred vision;

-Gum inflammation;

-Liver inflammation;

-Fissures, cracks, or fine scars on the skin, e.g. around the mouth (rágades), blisters, and skin inflammation (dermatitis bullosa), skin more sensitive to the sun (photosensitivity reaction).

Rare(may affect up to 1 in 1,000 patients):

-Damage to the peripheral nervous system, which may include symptoms such as muscle weakness, numbness, and tingling in the feet and hands or burning, stabbing pain.

Very rare(may affect up to 1 in 10,000 patients):

-Increased intracranial pressure;

-Night blindness, corneal inflammation of the eye (ulcerative keratitis);

-Yellowish skin, yellowish discoloration in the white of the eyes (jaundice);

-Bone pain, changes in bone growth.

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

-Vaginal infection (also known as Candida or aphthae);

-Problems with hearing, sounds in the ear (tinnitus);

-Redness,decreased resistance of the walls of blood vessels, retinoic acid syndrome;

-Changes in taste;

- Bleeding in the rectum;

-Small red bumps on the skin that may bleed easily(pyogenic granuloma), thinner skin, skin peeling (exfoliative dermatitis), skin atrophy, angioedema, partial or total loss of eyelashes or eyebrows (madarosis);

-Improvement or worsening of glucose tolerance in diabetic patients;

-Changes in voice tone, dysphonia;

-Allergic reaction;

-Mood changes;

-Psychosis symptoms: altered perception of reality, such as hearing voices or seeing things that are not there.

Reporting of 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 Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25°C. Store in the original packaging to protect it from humidity.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Return unused capsules to your pharmacist. Store them only if your doctor asks you to.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy.in case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Neotigason

• The active ingredient is acitretin. Each capsule contains 25 mg of acitretin.
• The other components are:

Contents of the capsule:sucrose, sodium ascorbate (E-301), microcrystalline cellulose (E-460i), gelatin.

Capsule coating:iron oxide black (E-172), iron oxide yellow (E-172), iron oxide red (E-172), titanium dioxide (E-171) and gelatin.

Components of the printing ink:shellac, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, iron oxide black (E-172).

Appearance of Neotigason and contents of the packaging

It is presented in the form of hard capsules with a yellow body and a brown cap, and the inscription “25” on the body, packaged in blisters, in containers of 30 capsules.

Other presentations:

Neotigason 10 mg hard capsules: Container of 30 capsules.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

Cenexi

52, Rue Marcel et Jacques Gaucher

94120 Fontenay-Sous-Bois

France

O

Cenexi

17, Rue de Pontoise

95520 Osny

France

Last review date of this leaflet:January 2025

Detailed and updated informationabout this product is available by scanning the QR code included in the leaflet through a smartphone. The same information is also available at the following link:https://cima.aemps.es/info/60302and the websitehttp://www.aemps.gob.es/.