Lysodren 500 mg tablets

Lysodren is an antitumoral medicine.

This medicine is used for the treatment of symptoms of advanced non operable, metastatic or recurrent malignant tumours of the adrenal glands.

Do not take Lysodren

• if you are allergic (hypersensitive) to mitotane or any of the other ingredients of Lysodren
• if you are breast-feeding. You must not breast-feed while taking Lysodren.
• if you are being treated with medicines containing spironolactone (see "Using other medicines").

Take special care with Lysodren

You should tell your doctor if any of the following applies to you:

• if you have an injury (shock, severe trauma), an infection or if you have any illness while you are taking Lysodren. Tell your doctor immediately, who may decide to temporarily stop treatment.
• if you have severe liver or kidney problems.
• if you are using any medicines mentioned below (see "Using other medicines").

This medicine should not be handled by persons other than the patient and his/her caregivers, and especially not by pregnant women. Caregivers should wear disposable gloves when handling the tablets.

Your doctor may prescribe you some hormonal treatment (steroids) while you are taking Lysodren.

Always keep with you the Lysodren Patient Card included at the end of this leaflet.

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

You must not use Lysodren with medicines containing spironolactone, often used as a diuretic for heart, liver or kidney diseases.

Lysodren may interfere with several medicines. Therefore, you should tell your doctor if you are using medicines containing any of the following active substances:

• warfarin or other anticoagulants (blood thinners), used to prevent blood clots. The dose of your anticoagulant may need adjustment.
• antiepileptics
• rifabutin or rifampicin, used to treat tuberculosis
• griseofulvin, used in the treatment of fungal infections
• herbal preparations containing St. John?s wort ( Hypericum perforatum)

Taking Lysodren with food and drink

Lysodren should preferably be taken during meals containing fat-rich food such as milk, chocolate, oil.

Pregnancy and breast-feeding

Lysodren may harm the foetus. If you are pregnant or planning to become pregnant, tell your doctor. If you may become pregnant, you should use effective contraception during treatment with Lysodren and even after stopping it. Ask your doctor for advice.

You must not breast-feed while taking Lysodren and even after stopping it. Ask your doctor for advice.

Driving and using machines
Lysodren has a major influence on your ability to drive and use machines. Ask your doctor for advice.

Always take Lysodren exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dose and schedule

The usual starting dose for adults is 2 to 3 g (4 to 6 tablets) per day.
Your doctor may start treatment at higher doses such as 4 to 6 g (8 to 12 tablets).

In order to find the optimal dose for you, your doctor will monitor regularly the levels of Lysodren in your blood. Your doctor may decide to stop treatment with Lysodren temporarily or to lower the dose if you experience certain side effects.

Children and adolescents

The starting daily dose of Lysodren is 1.5 to 3.5 g/m 2 body surface (this will be calculated by your doctor according to the weight and the size of the child). The experience in patients in this age group is very limited.

Method of administration

You should swallow the tablets with water during meals containing fat-rich food. You can divide the total daily dose in two or three intakes.

If you take more Lysodren than you should

Tell your doctor immediately if you have taken accidentally more Lysodren than you should or if a child has accidentally swallowed some.

If you forget to take Lysodren

If you accidentally miss a dose, just take the next dose as scheduled. Do not take a double dose to make up for the forgotten one.

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

Tellyour doctor immediatelyif you experience any of the following side effects:

• Adrenal insufficiency: fatigue, abdominal pain, nausea, vomiting, diarrhoea, confusion
• Anaemia: cutaneous pallor, muscular fatigability, feeling breathless, vertigo especially when standing up
• Liver damage: yellowing of the skin and eyes, itching, nausea, diarrhoea, fatigue, dark coloured urine
• Neurological disorders: movement and coordination disorders, abnormal sensations like pins and needles, memory loss, concentration difficulty, difficulty to talk, vertigo

These symptoms may reveal complications for which specific medication could be appropriate.

Side effects may occur with certain frequencies, which are defined as follows:

• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency cannot be estimated from the available data

Very common side effects

• vomiting, nausea (feeling sick), diarrhoea, belly pain
• lack of appetite
• abnormal sensations like pins and needles
• movement and coordination disorders, vertigo, confusion
• feeling sleepy, fatigue, muscle weakness (fatigue of muscle during effort)
• inflammation (swelling, heat, pain) of mucosa, skin rash
• blood disorders (bleeding time prolonged)
• increase of cholesterol, triglycerides (fats) and liver enzymes (in blood tests)
• decrease in white blood cells count
• breast overdevelopment in men
• adrenal insufficiency

Common side effects

• dizziness, headache
• peripheral nervous system disorders: association of sensory disorders, muscular weakness and atrophy, decrease of tendon reflex and vasomotor symptoms such as hot flushes, sweat and sleep disorders)
• mental impairment (such as memory loss, concentration difficulty)
• movement disorder
• decrease of red blood cells (anaemia, with symptoms such as skin pallor and fatigue), decrease in blood platelets (may make you more prone to bruising and bleeding)
• hepatitis (auto-immune) (may cause yellowing of the skin and eyes, dark coloured urine)

Frequency Not Known

• fever
• general aching
• flushing, high or low blood pressure, feeling of dizziness/vertigo when you suddenly stand up
• increased production of saliva
• eye disorders: visual impairment, vision blurred, double vision
• fungal infection
• liver damage (may cause yellowing of the skin and eyes, dark coloured urine)
• decreased uric acid in blood tests
• bladder inflammation with bleeding
• presence of blood in urine, presence of proteins in urine,

In children and adolescents, thyroid problems, neuro-psychological and growth retardation have been observed.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or your pharmacist.

Keep out of the reach and sight of children.

Store in the original container.

Do not use after the expiry date which is stated on the carton and the bottle after EXP.

Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicines.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Lysodren contains

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

What Lysodren looks like and contents of the pack

Lysodren tablets are white, biconvex, round and scored.
Lysodren is available in plastic bottles of 100 tablets.

Marketing Authorisation Holder

Laboratoire HRA Pharma15 rue Béranger
F - 75003 Paris
France

Manufacturer

Corden Pharma Latina S.p.A.
Via del Murillo Km. 2.800
04010 Sermoneta (Latina)
Italy
or

CENTRE SPECIALITES PHARMACEUTIQUES
76-78, avenue du Midi
63800 COURNON D?AUVERGNE
FRANCE

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Laboratoire HRA Pharma TélTel 33 01 40 33 11 30 LuxembourgLuxemburg Laboratoire HRA Pharma TélTel 33 01 40 33 11 30

Laboratoire HRA Pharma Te. 33 01 40 33 11 30 Magyarország Laboratoire HRA Pharma Tel. 33 01 40 33 11 30

eská republika Laboratoire HRA Pharma Tel 33 01 40 33 11 30 Malta Laboratoire HRA Pharma Tel 33 01 40 33 11 30

Danmark Laboratoire HRA Pharma Tlf 33 01 40 33 11 30 Nederland Laboratoire HRA Pharma Tel 33 01 40 33 11 30

Deutschland HRA Pharma Deutschland GmbH Tel 49 0 234 516 592-0 Norge Laboratoire HRA Pharma Tlf 33 01 40 33 11 30

Eesti Laboratoire HRA Pharma Tel 33 01 40 33 11 30 Österreich Laboratoire HRA Pharma Tel 33 01 40 33 11 30

Laboratoire HRA Pharma 33 01 40 33 11 30 Polska Laboratoire HRA Pharma Tel 33 01 40 33 11 30

España Laboratorios HRA Pharma España SL Tel 34 902 107 428 Portugal Laboratoire HRA Pharma Tel 33 01 40 33 11 30

France Laboratoire HRA Pharma Tel 33 01 40 33 11 30 România Laboratoire HRA Pharma Tel 33 01 40 33 11 30

Ireland Laboratoire HRA Pharma Tel 33 01 40 33 11 30 Slovenija Laboratoire HRA Pharma Tel 33 01 40 33 11 30

Ísland Laboratoire HRA Pharma Sími 33 01 40 33 11 30 Slovenská republika Laboratoire HRA Pharma Tel 33 01 40 33 11 30

Italia HRA Pharma Italia srl Tel 39 06 541 44 60 SuomiFinland Laboratoire HRA Pharma PuhTel 33 01 40 33 11 30

Laboratoire HRA Pharma 33 01 40 33 11 30 Sverige Laboratoire HRA Pharma Tel 33 01 40 33 11 30

Latvija Laboratoire HRA Pharma Tel 33 01 40 33 11 30 United Kingdom HRA Pharma UK Ltd. Tel 44 0 800 917 9548

Lietuva
Laboratoire HRA Pharma
Tel: + 33 (0)1 40 33 11 30

This leaflet was last approved in

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

LYSODREN PATIENT CARD

I am on Lysodren mitotane treatment The name of my Doctor is I am prone to acute adrenal insufficiency .. Phone . In case I need emergency care, adequate precautionary measures should be taken For information on the product, please contact Laboratoire HRA Pharma Tel 33 1 40 33 11 30 lysodrenhra-pharma.com