Package leaflet: Information for the user

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

 What is in this leaflet: 

1.  What Mytanne is and what it is used for

2.  What you need to know before you take Mytanne

3.  How to take Mytanne

4.  Possible side effects

5.  How to store Mytanne

6.  Contents of the pack and other information

 1.  What Mytanne is and what it is used for

Mytanne 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.

 2.  What you need to know before you take Mytanne

 Do not take Mytanne

-  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 Mytanne.

-  if you are being treated with medicines containing spironolactone (see "Other medicines and Mytanne").

Warnings and precautions

Talk to your doctor or pharmacist before taking Mytanne.

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 Mytanne. Tell your doctor immediately, who may decide to temporarily stop treatment.

-  if you have liver problems: Tell your doctor if you develop any of the following signs and symptoms of liver problems during Mytanne treatment: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area. Your doctor should do blood tests to check your liver function before and during treatment with Mytanne, and as clinically indicated.

-  if you have severe kidney problems

-  if you are using any medicines mentioned below (see "Other medicines and Mytanne").

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 Mytanne.

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

Other medicines and Mytanne

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 Mytanne with medicines containing spironolactone, often used as a diuretic for heart, liver or kidney diseases.

Mytanne 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)

-  Sunitinib:  to treat cancer

 Mytanne with food and drink

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

Pregnancy, breast-feeding and fertility

Mytanne 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 Mytanne and even after stopping it. Ask your doctor for advice.

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

Driving and using machines

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

 3.  How to take Mytanne

Always take this medicine exactly as your doctor has told you. 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 Mytanne in your blood. Your doctor may decide to stop treatment with Mytanne temporarily or to lower the dose if you experience certain side effects.

Use in children and adolescents The starting daily dose of Mytanne is 1.5 to 3.5 g/m2 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 a glass of water during meals containing fat-rich food. You can divide the total daily dose in two or three intakes.

If you take more Mytanne than you should

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

If you forget to take Mytanne

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.

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

 4.  Possible side effects

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

Tell your doctor immediately if 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: may affect more than 1 in 10 people

-  common: may affect up to 1 in 10 people 

-  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 

l   dizziness, headache

l   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)

l   mental impairment (such as memory loss, concentration difficulty)

l   movement disorder

l   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)

l   hepatitis (auto-immune) (may cause yellowing of the skin and eyes, dark coloured urine)

l   difficulty of coordinating muscles

 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, distortion of images, complain of glare

-  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

-  balance disorder

-  distortion of the sense of taste

-  impaired digestion

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

Reporting of side effects

If you get 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the medicine.

5.  How to store Mytanne

Keep out of the sight and reach of children.

 Store in the original packaging. 

 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

 6.  Contents of the pack and other information

What Mytanne 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 Mytanne looks like and contents of the pack

Mytanne tablets are white, biconvex, round and with “TLPH” on one side. Mytanne is available in plastic bottles of 100 tablets.

Marketing Authorisation Holder

Tongmeng(Lao) Pharmaceutical and Food Co., Ltd

Rd13 South,31km,Ban Naphasuk,Saithany District

Vientiane

Lao PDR

Manufacturer

Tongmeng(Lao) Pharmaceutical and Food Co., Ltd

Rd13 South,31km,Ban Naphasuk,Saithany District

Vientiane

Lao PDR

Mytanne 500 mg tablets

Mitotane

Mytanne is available in plastic bottles of 100 tablets