Product Information for the User

Lysodren 500 mg Tablets

mitotane

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

• Keep this product information, 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 should not be given 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 product information. See section 4.

Always carry the Lysodren Patient Card that is attached at the end of this product information with you.

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

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

Lysodren is a medication for cancer treatment that contains the active ingredient mitotane.

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

Do not take Lysodren

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

• if you are breastfeeding. Do not breastfeed while taking Lysodren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lysodren.

You must inform your doctor if you are in any of the following cases:

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

• if you suffer liver problems: Inform your doctor if you develop any of the following signs and symptoms of liver problems during treatment with Lysodren: itching, yellowish color 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 the treatment with Lysodren.

• if you suffer severe kidney disorders.

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

You must not handle this medication except by the patient and the people who take care of them, and especially not by pregnant women. People who take 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 hormone 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 medications and Lysodren

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

You must not take Lysodren with medications that contain spironolactone, a medication that is often used as a diuretic to treat heart, liver, or kidney diseases.

Lysodren may also interfere with other medications. Therefore, if you take any medication that contains any of the following active substances, you must 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 medications
• rifabutin or rifampicin in tuberculosis treatments.

• griseofulvin in fungal infections treatments.

• herbal preparations containing St. John's Wort or hypericum (Hypericum perforatum).
• sunitinib, etoposide: for cancer treatment.
• 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, breastfeeding, and fertility

Lysodren may harm the fetus. If you are pregnant, think you may be pregnant, or intend to become pregnant, inform your doctor as soon as possible to know if 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 interrupted. You must consult your doctor.

Due to the potential for severe adverse reactions in your baby, do not breastfeed your child if you take Lysodren, even after treatment has been interrupted. Consult your doctor.

Driving and operating machinery

The influence of Lysodren on your ability to drive and operate machinery is important. Consult your doctor.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage and Administration

The usual starting 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).

To select the optimal dose to treat your condition, your doctor will regularly monitor the amount of Lysodren in your blood. Your doctor may decide to temporarily stop or reduce the Lysodren treatment if you experience certain adverse effects.

Use in Children and Adolescents

The starting daily dose of Lysodren is 1.5 to 3.5 g/m2of body surface area (your doctor will calculate this based on the child's weight and size). Experience in patients of this age group is very limited.

Administration Form

You should take the tablets with a glass of water during meals that contain high-fat 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 a tablet.

If You Forget to Take Lysodren

If you accidentally forget to take a dose, take the next dose according to the established dosage. Do not take a double dose to compensate for the missed dose.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform 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 abnormalities: yellowing of the skin and eyes (jaundice), itching, nausea, diarrhea, fatigue, dark urine

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

These symptoms may indicate complications, for which it may be appropriate to use a specific medication.

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

• Very frequent: may affect more than 1 in 10 people

• Frequent: may affect up to 1 in 10 people

• Unknown frequency: cannot be estimated from available data

Very frequent side effects

• Vomiting, nausea (dizziness), diarrhea, abdominal pain
• Loss of appetite
• Strange sensations such as pins and needles or muscle cramps
• Disorders affecting movement and coordination, dizziness, confused state
• Drowsiness, fatigue, muscle fatigue (fatigue in muscles when exerting effort)
• Inflammation (swelling, heat, pain) of mucous membranes, skin irritations
• Circulatory disorders (increased bleeding time)
• Increase in cholesterol, triglycerides (fats) and liver enzymes (in blood tests)

• Decrease in white blood cell count
• Development of breast tissue in men
• Adrenal insufficiency (may cause fatigue, abdominal pain, nausea, vomiting, diarrhea, confusion)

Frequent side effects

• Dizziness, headaches

• Peripheral nervous system disorders (collection 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 bruises and bleeding)
• Autoimmune hepatitis (may cause yellowing of the skin and eyes, dark urine)
• Difficulty coordinating muscles

Unknown frequency

• Fever
• Generalized pain
• Flushing, high or low blood pressure, dizziness/dizziness when standing up quickly

Increased salivation

• Eye disorders: deterioration of vision, blurred vision, double vision, distorted images, photophobia
• Oportunistic infection

• Decrease in uric acid in blood tests
• Inflammation of the bladder with bleeding
• Presence of blood in urine, presence of proteins in urine

• Balance disorder
• Distortion of taste
• Poor digestion

• Ovarian cysts (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
• Increased globulin binding to sex hormones (a protein that binds to sex hormones) in blood tests
• Increased globulin binding to corticosteroids in blood tests
• Increased globulin binding to thyroxine 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.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.

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

Do not use this medication after the expiration date that appears on the box and on the bottle after CAD.

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of medications that you no longer need. This will help protect the environment.

Lysodren Composition

• The active ingredient is mitotane. Each tablet contains 500 mg of mitotane.
• The other components are cornstarch, microcrystalline cellulose (E460),

macrogol 3350 and anhydrous colloidal silica.

Appearance of the product and contents of the package

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

Lysodren is presented in plastic bottles of 100 tablets

Marketing Authorization Holder:

Esteve RD France SAS

25 Boulevard Romain Rolland

92120 Montrouge

France

Responsible for manufacturing:

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

Last review date of this leaflet: 11.2024

Other sources of information

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

On the website of the European Medicines Agency, this leaflet can be found in all languages of the European Union/European Economic Area.

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LYSODREN: PATIENT CARD