NEOTIGASON 25 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Neotigason 25 mg Hard Capsules

Acitretin

WARNING

IF YOU ARE PREGNANT, IT CAN SERIOUSLY HARM YOUR BABY.

Women must use effective contraceptives during the entire treatment.

Do not use it if you are pregnant or think you may be pregnant.

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

• Keep this package leaflet, 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 only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Neotigason and what is it used for
2. What you need to know before taking Neotigason
3. How to take Neotigason
4. Possible side effects
5. Storage of Neotigason
6. Package Contents and Additional Information

1. What is Neotigason and what is it used for

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 where the skin has thickened, may have a scaly appearance, and does not respond satisfactorily to other conventional treatments.

Neotigason is indicated for the treatment of skin disorders such as psoriasis, ichthyosis (a skin condition characterized by dryness and formation of scale-like masses), and Darier's disease (a hereditary skin, nail, and mucous membrane disorder, characterized by the formation of brown spots on the face, chest, abdomen, and folds).

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

2. What you need to know before taking Neotigason

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", consult the "Warnings and Precautions" section.
• If you are allergic to acitretin or 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 "Other Medications and Neotigason" section.

• If you are taking medications called tetracyclines (a type of antibiotic to treat infections) or methotrexate (for skin problems, arthritis, or cancer), see the "Other Medications and Neotigason" section.
  • Acitretin is contraindicated in children.

Warnings and Precautions

Treatment with acitretin should be monitored by a doctor specializing in the treatment of skin diseases for which it is indicated.

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

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

Inform your doctor if you experience severe abdominal and back pain (these can be signs of pancreas 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 seriously harm the baby (the medication is considered "teratogenic") - it can cause severe brain, face, ear, eye, heart, and certain gland (thymus and parathyroid) abnormalities in the baby. It also increases the likelihood of spontaneous abortion. This can happen even if Neotigason is taken only for a short period during pregnancy.

• Do not take this medication if you are pregnant or think you may be pregnant.
• Do not take Neotigason if you are breastfeeding. It is likely that the medication will pass into your milk and may harm your baby.
• Do not take Neotigason if you may become pregnant during treatment.
• Do not become pregnant during the 3 years following the end of this treatment because the medication may still be present in your body.

Women who may become pregnant are prescribed Neotigason 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 contraceptive 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 Neotigason.

Women must use effective contraceptives before, during, and after taking Neotigason

• You must agree to use at least one very reliable contraceptive method (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 would be suitable for you.
• You must use contraceptives for 1 month before taking Neotigason, during treatment, and for 3 years after stopping the treatment.
• You must use contraceptives even if you do not have your period or are not sexually active (unless your doctor decides it is not necessary).

Women must accept to have pregnancy tests before, during, and after taking Neotigason

• 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 stopping Neotigason (unless your doctor decides it is not necessary in your case).
• 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 ask you (or a parent/guardian) to sign it. This checklist confirms that you have been informed about the risks and will follow the above rules.

If you become pregnant while taking Neotigason, 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 Neotigason, 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 Neotigason 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 take any unused capsules to your pharmacist at the end of treatment.

You must not donate blood during treatment with this medication or for 3 years after stopping Neotigason because a baby could be harmed if a pregnant patient 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 blood or if you are obese. Your doctor may need to perform blood tests while you are taking Neotigason to check your blood fat levels.
• If you have cardiovascular problems. Your doctor may need to monitor your blood pressure more closely.
• If you drink a lot of alcohol.
• If you have liver problems.
• If you notice a decrease in your night vision.
• If you experience severe headache, nausea, vomiting, and/or vision problems. These can be symptoms of increased pressure in your head, which should be reviewed by your doctor as soon as possible.
• If you are going to be exposed to the sun or use a sunlamp. Neotigason can enhance the effects of UV light on the skin. Before exposing yourself to intense sunlight, apply a sunscreen (with a sun protection factor of at least SPF 15) to the areas of skin that will be exposed. Uncontrolled use of sunlamps should be avoided.
• 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 may affect your mood and behavior. They may notice these changes and help you identify any problems you need to discuss with your doctor.

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

Patients treated with Neotigason may experience hair loss.

Children and Adolescents

The use of this medication is not recommended in children and adolescents. If, for exceptional reasons, it must be used, it is necessary to carefully monitor any possible abnormality in the development of the child's muscles and bones.

Other Medications and Neotigason

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

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

Vitamin A: While taking Neotigason, you should not take medications that contain high doses of vitamin A (see the "Do not take Neotigason" section). It is not recommended to exceed the recommended dose of 4000-5000 IU of vitamin A per day.

Methotrexate (a medication used to treat psoriasis or certain types of cancer): It should be avoided to take methotrexate and Neotigason together, as there is a risk of hepatitis (liver inflammation) (see the "Do not take Neotigason" section).

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

Oral contraceptives (medications used to prevent unwanted pregnancies): The contraceptive effect of progestogen microdose preparations may be reduced by interaction with Neotigason. Therefore, progestogen microdose preparations or "minipills" should not be used, as retinoids interfere with their contraceptive effect.

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

Taking Neotigason with Food, Drinks, and Alcohol

Women of childbearing age should not consume alcohol (in beverages, food, or medications) during treatment with Neotigason or for 2 months after stopping the treatment. The ingestion of acitretin and alcohol can result in the formation of a compound (etretinate), which can be harmful to the fetus and 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

To obtain more information about pregnancy and contraception, consult the "Pregnancy Prevention Plan" section in the "Warnings and Precautions" section.

Driving and Using Machines

Neotigason can cause a decrease in night vision in some cases, which disappears when treatment is stopped. Therefore, precautions should be taken when driving vehicles or operating 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; this is essentially "sodium-free".

3. How to take Neotigason

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

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

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

Use in Adults and Elderly

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

It is possible that after 2-4 weeks the doctor will increase or decrease the dose. This will depend on the degree of efficacy of the treatment and its effect 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, the doctor may decide that you should take it for a longer period. Long-term treatment is not recommended in 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

The use of this medication is not recommended in children and adolescents unless, in the doctor's judgment, the benefits significantly outweigh the risks.

The dose will be determined 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 taken.

If you forget to take Neotigason

Do not take a double dose to make up for forgotten doses. 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 stop taking Neotigason

It is your doctor who is best qualified to decide whether you should stop treatment with acitretin and how. 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.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Most of the adverse effects of Neotigason depend on the dose, and for this reason, most patients experience some adverse effects during the initial period, while the dose is being adjusted. These effects are generally well-tolerated at the recommended doses and usually disappear when the dose is reduced or treatment is interrupted.

The most frequent occurrence is that the skin and mucous membranes are the most affected parts, with dryness, sometimes with erosion, in the 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 have the following adverse effects at the same time:

• severe headache;
• nausea or vomiting;
• vision problems.

The following adverse effects have been observed during treatment with Neotigason:

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

• dry, irritated, or swollen eyes, which can cause intolerance to contact lenses;
• dry, irritated, or runny nose, nasal bleeding;
• dry mouth, thirst;
• dryness or inflammation of the lips, which can be relieved by applying a greasy ointment. Itching, hair loss, peeling of the skin 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 blood fat levels (shown in a blood test;
• elevation of uric acid (shown in a blood test).

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

• headache;
• inflammation of the mouth mucosa, abdominal pain, diarrhea, nausea, vomiting;
• fragile skin, sticky sensation on the skin or rash, skin inflammation, changes in hair texture, brittle nails, infection of the skin 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 (rhagades), blisters, and skin inflammation (bullous dermatitis), skin more sensitive to sun (photosensitivity reaction).

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

• damage to the peripheral nervous system, which can 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):

• increase in blood pressure inside the skull;
• night blindness, inflammation of the cornea of the eye (ulcerative keratitis;
• yellowish skin, yellowish color in the white of the eyes (jaundice;
• bony pain, changes in bone growth.

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

• vaginal infection (also known as Candida or thrush;
• hearing problems, sounds in the ear (tinnitus;
• redness, decreased resistance of the blood vessel walls, retinoic acid syndrome;
• changes in taste;
• rectal bleeding;
• small red bumps on the skin that can 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 alteration;
• signs of psychosis: altered perception of reality, such as hearing voices or seeing things that are not there.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Neotigason

Keep this medicine out of sight and reach of children.

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

Do not use this medicine 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.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Neotigason

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

Capsule content:glucose, sodium ascorbate (E-301), microcrystalline cellulose (E-460i), gelatin.

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

Printing ink components:shellac, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, black iron oxide (E-172).

Appearance of Neotigason and Packaging Content

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 packs of 30 capsules.

Other presentations:

Neotigason 10 mg hard capsules: Pack of 30 capsules.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Cenexi

52, Rue Marcel et Jacques Gaucher

94120 Fontenay-Sous-Bois

France

O

Cenexi

17, Rue de Pontoise

95520 Osny

France

Date of the Last Revision of this Prospectus:January 2025

Detailed and updated information on this product is available by scanning the QR code included in the prospectus using a smartphone. The same information is also available at the following link: https://cima.aemps.es/info/60302 and the website http://www.aemps.gob.es/.