LYSODREN 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lysodren 500 mg Tablets

mitotane

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Always carry the Lysodren Patient Card that is attached to the end of this leaflet with you.

Contents of the pack

1. What is Lysodren and what is it used for

1. What you need to know before you take Lysodren
2. How to take Lysodren
3. Possible side effects

1. Storage of Lysodren
2. Contents of the pack and other information

1. What is Lysodren and what is it used for

Lysodren is a medicine for the treatment of cancer that contains the active substance mitotane.

This medicine is used for the symptomatic treatment of advanced, inoperable, recurrent or metastatic malignant tumors of the adrenal glands.

2. What you need to know before you take Lysodren

Do not take Lysodren

• if you are allergic to mitotane or any of the other ingredients of this medicine (listed in section 6).

• if you are breast-feeding. You must not breast-feed while taking Lysodren.

• if you are taking medicines that contain spironolactone (see “Taking Lysodren with other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Lysodren.

You should inform your doctor if you are in any of the following situations:

• if you suffer any injury (shock, severe trauma), have an infection or suffer any disease while taking Lysodren. Inform your doctor immediately, who may recommend that you interrupt treatment temporarily.

• if you have liver problems: Inform your doctor if you develop any of the following signs and symptoms of liver problems during treatment with Lysodren: itching, yellowing of the skin or eyes, dark urine, and pain or discomfort in the upper right part of the stomach. Your doctor should perform blood tests to check your liver function before treatment, during treatment with Lysodren, and when clinically indicated. Your doctor may decide to interrupt treatment with Lysodren.

• if you have severe kidney disorders.

• if you are taking any of the medicines listed below (see “Other medicines and Lysodren”).
• if you have gynecological problems such as vaginal bleeding, menstrual disorders, and/or pelvic pain.

No one except the patient and the people taking care of them should handle this medicine, especially not pregnant women. The people taking care of the patient should use disposable gloves when handling the tablets.

During treatment with Lysodren

Lysodren may temporarily decrease the amount of hormones produced by your adrenal gland (cortisol), but your doctor will correct this using the appropriate hormonal medication (steroids).

Lysodren may cause bleeding that lasts longer than usual. If you need to undergo surgery or dental procedures during treatment with Lysodren, your healthcare professional will perform blood tests to check the risk of prolonged bleeding.

Always carry the Lysodren Patient Card that is attached to the end of this leaflet with you.

Other medicines and Lysodren

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

Do not take Lysodren with medicines that contain spironolactone, a medicine that is often used as a diuretic to treat heart, liver, or kidney diseases.

Lysodren may also interfere with other medicines. Therefore, if you are taking any medicine that contains any of the following active substances, you should tell your doctor:

• warfarin or other anticoagulants (blood thinners) used to prevent blood clots. The dose of the anticoagulant may need to be adjusted.
• antiepileptic medicines
• rifabutin or rifampicin in tuberculosis treatments.

• griseofulvin in fungal infection treatments.

• herbal preparations that contain St. John's Wort or hypericum (Hypericum perforatum).
• sunitinib, etoposide: to treat cancer.
• midazolam, used as a sedative.

Taking Lysodren with food and drinks

Lysodren should be taken preferably during meals, with fatty foods such as milk, chocolate, or oil.

Pregnancy, breast-feeding, and fertility

Lysodren may harm the fetus. If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor as soon as possible to determine whether you should interrupt or continue treatment with Lysodren.

Women of childbearing age should use an effective contraceptive method during treatment with Lysodren, even after treatment has been discontinued. You should consult your doctor.

Due to the potential for serious adverse reactions in your baby, you should not breast-feed your child if you are taking Lysodren, even after treatment has been discontinued. Consult your doctor.

Driving and using machines

The influence of Lysodren on the ability to drive and use machines is significant. Consult your doctor.

3. How to take Lysodren

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

Dosage and administration

The normal initial dose is 2 to 3 g (4 to 6 tablets) per day.

Your doctor may start treatment with higher doses, such as 4 to 6 g (8 to 12 tablets).

In order to select the optimal dose to treat your disease, your doctor will regularly monitor the amount of Lysodren in your blood. Your doctor may decide to interrupt treatment with Lysodren temporarily or reduce the dose if you experience certain side effects.

Use in children and adolescents

The daily initial dose of Lysodren is 1.5 to 3.5 g/m2 of body surface area (your doctor will calculate it based on the child's weight and size). Experience in patients of this age is very limited.

Method of administration

You should take the tablets with a glass of water, during meals that contain fatty foods. The total daily dose can be administered in two or three doses.

If you take more Lysodren than you should

Contact your doctor immediately if you accidentally take more Lysodren than you should or if a child accidentally ingests any tablets.

If you forget to take Lysodren

If you accidentally miss a dose, take the next dose according to the established posology. Do not take a double dose to make up for the missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediatelyif you experience any of the following side effects:

• Adrenal insufficiency: fatigue, abdominal pain, nausea, vomiting, diarrhea, confusion
• Anemia: paleness, tendency to muscle fatigue, difficulty breathing, dizziness especially when standing up

• Liver disorders: yellowing of the skin and eyes (jaundice), itching, nausea, diarrhea, fatigue, dark urine

• Neurological disorders: disorders that affect movement and coordination, strange sensations such as pins and needles or cramps, memory loss, difficulty concentrating, difficulty walking, dizziness

These symptoms may indicate complications, for which specific medication may be appropriate.

These side effects may occur with certain frequencies, which are defined below:

• very common: may affect more than 1 in 10 people

• common: may affect up to 1 in 10 people

• frequency not known: cannot be estimated from the available data

Very common side effects

• vomiting, nausea (dizziness), diarrhea, abdominal pain
• loss of appetite
• strange sensations such as pins and needles or cramps
• disorders that affect movement and coordination, dizziness, confusion
• drowsiness, fatigue, muscle fatigue (fatigue in the muscles when making an effort)
• inflammation (swelling, heat, pain) of the mucous membranes, skin irritation
• circulatory disorders (increased bleeding time)
• increased cholesterol, triglycerides (fats), and liver enzymes (in blood tests)

Common side effects

• dizziness, headaches

• peripheral nervous system disorders (a set of sensory disorders, muscle weakness and atrophy, decreased reflexes, and vasomotor symptoms such as flushing, sweating, and sleep disorders)

• mental disability (such as memory loss and difficulty concentrating)
• motor disorders

• decrease in red blood cell count (anemia, with symptoms such as paleness and fatigue), decrease in platelet count (may increase your predisposition to bruising and bleeding)
• hepatitis (autoimmune) (may cause yellowing of the skin and eyes, dark urine)
• difficulty coordinating muscles

Frequency not known

• fever
• generalized pain
• flushing, high or low blood pressure, dizziness/vertigo when standing up quickly
• increased salivation
• eye disorders: vision loss, blurred vision, double vision, distorted images, glare
• opportunistic infection

• liver damage (may cause yellowing of the skin or eyes, dark urine)
• decrease in uric acid in blood tests
• bladder inflammation with bleeding
• presence of blood in the urine, presence of protein in the urine

• balance disorder
• distortion of the sense of taste
• indigestion

• ovarian macrocysts (with or without symptoms such as pelvic pain, vaginal bleeding, menstrual disorders)
• decrease in androstenedione (precursor of sex hormones) in blood tests in women
• decrease in testosterone (sex hormone) in blood tests in women
• increase in sex hormone-binding globulin (a protein that binds to sex hormones) in blood tests
• increase in corticosteroid-binding globulin in blood tests
• increase in thyroxine-binding globulin in blood tests
• decrease in free testosterone (sex hormone) in blood tests in men
• hypogonadism in men (with symptoms such as excessive breast development, decreased libido, erectile dysfunction, fertility disorders)
• allergic reactions, itching

In children and adolescents, thyroid problems, neuropsychological problems, growth retardation, and a case of encephalopathy have been observed. Additionally, some signs of hormonal changes (such as excessive breast development in men and vaginal bleeding and/or early breast development in women) have been observed.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lysodren

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

Store in the original packaging. Once opened: 1 year.

Do not use this medicine after the expiry date that appears on the carton and on the bottle after EXP.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations for cytotoxic medicines.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lysodren

• The active substance is mitotane. Each tablet contains 500 mg of mitotane.
• The other ingredients are cornstarch, microcrystalline cellulose (E460), macrogol 3350, and colloidal anhydrous silica.

Appearance and packaging of the product

Lysodren tablets are white, biconvex, round, and scored.

Lysodren is available in plastic bottles of 100 tablets.

Marketing authorization holder:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca 109 Planta 4

08038 Barcelona

Spain

+ 34 93 446 60 00

Manufacturer:

Latina Pharma S.p.A.

Via Murillo, 7

04013 Sermoneta (LT)

Italy

or

Centre Specialites Pharmaceutiques

76-78, avenue du Midi

63800 Cournon d’Auvergne

France

Date of last revision of this leaflet: 04.2025

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.

This leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.

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LYSODREN: PATIENT CARD