LYSODREN 500 мг Коированная таблетка

Содержание инструкции

1. Lysodren 500 mg tablets
   1. What is Lysodren and what is it used for
   2. What you need to know before you take Lysodren
   3. How to take Lysodren
   4. Possible side effects
   5. How to store Lysodren
   6. Package contents and other information

Lysodren 500 mg tablets

mitotane

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Always keep the Lysodren patient card with you, which is located at the end of this leaflet.
Contents of this leaflet

• 1. What Lysodren is and what it is used for
• 2. What you need to know before you take Lysodren
• 3. How to take Lysodren
• 4. Possible side effects
• 5. How to store Lysodren
• 6. Contents of the pack and other information

1. What is Lysodren and what is it used for

Lysodren is an antineoplastic medicine, which contains the active ingredient mitotane.
This medicine is used for the treatment of symptoms of advanced, inoperable, metastatic or recurrent 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 breastfeeding. You must not breastfeed during treatment with Lysodren.
• if you are taking medicines that contain spironolactone (see “Other medicines and Lysodren”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lysodren.
Inform your doctor if any of the following circumstances exist:

• if you have a wound (shock, severe trauma), an infection or if you have any illness during treatment with Lysodren. Inform your doctor immediately, who may decide to temporarily suspend treatment.
• 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 eyes or skin, dark urine and pain or discomfort in the upper right area of the abdomen. The doctor must perform blood tests to check liver function before and during treatment with Lysodren, and when clinically indicated. The doctor may decide to stop treatment with Lysodren.
• if you have severe kidney problems.
• if you are using any of the medicines mentioned below (see “Other medicines and Lysodren”).
• in case of gynecological problems such as vaginal bleeding, menstrual disorders and/or pelvic pain.

This medicine should not be handled by anyone other than the patient and those assisting them,
especially not by pregnant women. Those assisting the patient must wear disposable gloves
when handling the tablets.

During treatment with Lysodren
Lysodren may temporarily reduce the amount of hormones produced by your adrenal gland
(cortisol) but the doctor will correct this using appropriate hormonal treatment (steroids).
Lysodren may cause bleeding that lasts longer than usual. If you need surgery
or dental procedures during treatment with Lysodren, the doctor will perform
blood tests to check for the risk of prolonged bleeding.

Other medicines and Lysodren
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.
Lysodren must not be administered in combination with medicines that contain
spironolactone, often used as a diuretic in the treatment of heart, liver or kidney disorders.
Lysodren may interfere with many medicines. Therefore, you must tell your doctor if you are using
medicines that contain the following active ingredients:

• warfarin or other anticoagulants (blood thinners), used to prevent blood clots from forming. The dose of anticoagulant you are taking may need to be adjusted.
• anticonvulsants
• rifabutin or rifampicin, used in the treatment of tuberculosis
• griseofulvin, used in the treatment of fungal infections
• herbal remedies containing St. John's Wort ( Hypericum perforatum).
• sunitinib, etoposide: for cancer treatment
• midazolam, used as a sedative

Lysodren with food and drink
Lysodren should be taken preferably during meals that contain foods rich in fats,
such as milk, chocolate, oil.

Pregnancy, breastfeeding and fertility
Lysodren may harm the fetus. Therefore, if you are pregnant, think you may be pregnant or
are planning a pregnancy, inform your doctor as soon as possible to know if you should stop or
continue treatment with Lysodren.
If you are a woman of childbearing potential, you must use an effective method of contraception during
the period of treatment with Lysodren and also after you have finished it. Ask your doctor for advice.

Due to the risk of serious adverse reactions for the baby, you must not breastfeed during
treatment with Lysodren and also after you have finished it. Ask your doctor for advice.
Driving and using machines
Lysodren has a significant influence on the ability to drive vehicles and use machines. Ask
your doctor for advice.

3. How to take Lysodren

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

Dosage, method and duration of administration
At the beginning of treatment, the usual dose for adults is 2-3 g (from 4 to 6 tablets) per day.
The doctor may decide to start treatment with higher doses such as 4-6 g (from 8 to 12 tablets).
To determine the best dose for you, the doctor will regularly monitor the amount of Lysodren
present in the blood. The doctor may decide to temporarily interrupt the treatment with Lysodren
or to lower the dose if you experience some undesirable effects.

Use in children and adolescents
The initial daily dose of Lysodren is 1.5 - 3.5 g per m of body surface area (this will be
calculated by the doctor according to the child's weight and height). Experience in patients belonging to
this age group is very limited.

Method of administration
Swallow the tablets with a glass of water during meals that include the consumption of
foods rich in fats. You can divide the total daily dose into two or three intakes.

If you take more Lysodren than you should
Immediately inform your doctor if you have accidentally taken more Lysodren than you should or if
a child has accidentally ingested some tablets.

If you forget to take Lysodren
If you have accidentally forgotten to take a dose, take the next dose as prescribed.
Do not take a double dose to make up for the missed dose.
If you have any doubts 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 everyone will experience them.

Immediately inform your doctorif any of the following side effects occur:

• Adrenal insufficiency: fatigue, abdominal pain, nausea, vomiting, diarrhea, confusion
• Anemia: paleness of the skin, muscle fatigue, breathing problems, dizziness, especially when standing up
• Liver alterations: yellowing of the skin and eyes, itching, nausea, diarrhea, fatigue, dark urine
• Neurological disorders: movement and coordination disorders, abnormal sensations such as tingling, memory loss, difficulty concentrating, difficulty speaking, dizziness

These symptoms may reveal complications that require specific treatments.
Based on how often they occur, a side effect is defined as follows:

• very common: may affect more than 1 in 10 people
• common: may affect up to 1 in 10 people
• not known: the frequency cannot be estimated based on available data

Very common side effects

• vomiting, nausea (feeling of vomiting), diarrhea, stomach pain
• loss of appetite
• abnormal sensations such as tingling
• movement and coordination disorders, dizziness, confusion
• drowsiness, fatigue, muscle weakness (muscle fatigue under strain)
• inflammation (swelling, burning, pain) of the mucous membranes, skin rash
• blood alterations (increased bleeding time)
• increased cholesterol, triglycerides (fats) and liver enzymes (in blood tests)
• decreased white blood cell count
• excessive breast development in men
• adrenal insufficiency (can cause fatigue, abdominal pain, nausea, vomiting, diarrhea, confusion)

Common side effects

• dizziness, headache
• peripheral nervous system disorders (combination of sensory disturbances, muscle atrophy and weakness, decreased tendon reflex and vasomotor symptoms such as a feeling of warmth in the face, sweating and sleep disturbances)
• mental alterations (such as memory loss, difficulty concentrating)
• movement disorders
• decreased red blood cells (anemia accompanied by symptoms such as paleness of the skin and fatigue), decreased platelets (may make you more prone to bruising and bleeding)
• autoimmune hepatitis (can cause yellowing of the skin and eyes, dark urine)
• difficulty coordinating muscles

Frequency not known

• fever
• generalized pain
• feeling of warmth in the face, high or low blood pressure, dizziness/vertigo when getting up quickly
• increased salivation
• eye disorders: altered vision, blurred vision, double vision, distorted images, glare
• opportunistic infections
• liver injury (can cause yellowing of the skin and eyes, dark urine)
• decreased uric acid value 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
• altered digestion
• ovarian macrocysts (with or without symptoms, such as pelvic pain, vaginal bleeding, menstrual disorders)
• reduced androstenedione (precursor to sex hormones) in blood tests in women
• reduced testosterone (sex hormone) in blood tests in women
• increased sex hormone-binding globulin (a protein that binds to sex hormones) in blood tests
• increased levels of corticosteroid-binding globulin in blood tests increase in thyroxine-binding globulin in blood tests
• reduced free testosterone (sex hormone) in blood tests in men
• hypogonadism in men (with symptoms such as excessive breast development, decreased libido, erectile dysfunction, fertility problems)
• allergic reactions, itching

Additional side effects in children and adolescents
Problems with the thyroid gland, mental and growth retardation, and one case of encephalopathy have been observed in children and adolescents. In addition, some signs of hormonal changes have been observed
(such as breast enlargement in males and vaginal bleeding and/or early breast development in
females).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the national reporting system
described in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lysodren

Keep this medicine out of the sight and reach of children.
Store in the original package. After opening: 1 year.
Do not use this medicine after the expiry date which is stated on the pack and vial after
Exp.
Medicines no longer used and waste materials from such medicines should be disposed of in accordance with
current local regulations on cytotoxic medicines.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lysodren contains

• The active ingredient is mitotane. Each tablet contains 500 mg of mitotane.
• The other ingredients are corn starch, microcrystalline cellulose (E 460), macrogol 3350 and anhydrous colloidal silica.

Description of the appearance of Lysodren and package contents
Lysodren tablets are white, biconvex, round and notched.
Lysodren is sold in plastic bottles containing 100 tablets.

Marketing Authorisation 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
o

Centre Specialites Pharmaceutiques
76-78, avenue du Midi
63800 Cournon d’Auvergne
France

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu. Additionally, links to other websites on rare diseases
and related therapeutic treatments are provided.
This leaflet is available in all languages of the European Union/European Economic Area on the
website of the European Medicines Agency.
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PATIENT CARD LYSODREN
I am undergoing treatment with Lysodren (mitotane)My doctor's name is:
I am predisposed to adrenal insufficiency
………………………………………..
Telephone: ……………………………….
For product information,
acute
If I need emergency care,
appropriate precautions
must be taken
contact:
Esteve Pharmaceuticals S.A.
Tel: + 34 93 446 60 00
[email protected]