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PACKAGE LEAFLET: INFORMATION FOR THE USER

DACARBAZINE MEDAC 500 MG

POWDER FOR SOLUTION FOR INFUSION

DACARBAZINE MEDAC 1000 MG

POWDER FOR SOLUTION FOR INFUSION

Dacarbazine (as dacarbazine citrate)

Read all of this leaflet carefully before you start using this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1.    What DACARBAZINE MEDAC is and what it is used for

2.    Before you are given DACARBAZINE MEDAC

3.    How to use DACARBAZINE MEDAC

4.    Possible side effects

5.    How to store DACARBAZINE MEDAC

6.    Further information

1. WHAT DACARBAZINE MEDAC IS AND WHAT IT IS USED FOR

Dacarbazine belongs to the group of medicines known as cytostatic agents. These agents influence the growth of cancer cells.

DACARBAZINE MEDAC has been prescribed by your doctor for the treatment of cancer, such as advanced malignant melanoma (skin cancer), Hodgkin’s disease (cancer of the lymph tissue) or soft tissue sarcoma (cancer of muscles, fat, fibrous tissue, blood vessels or other supporting tissue of the body). DACARBAZINE MEDAC can be used in combination with other cytostatic agents.

2. BEFORE YOU ARE GIVEN DACARBAZINE MEDAC

You should not be given DACARBAZINE MEDAC

•    if you are allergic (hypersensitive) to dacarbazine or any of the other ingredients of DACARBAZINE MEDAC (please refer to section 6 for more detailed information).

•    if the number of white blood cells and/or platelets in your blood is too low (leukopenia and/or thrombocytopenia).

•    if you have a severe liver or kidney disease.

•    if you are pregnant or breast-feeding.

Take special care with DACARBAZINE MEDAC in the following case:

During treatment with DACARBAZINE MEDAC men are advised to take contraceptive measures, but also for 6 months after cessation of therapy.

You will have blood tests to check that you have enough blood cells to receive DACARBAZINE MEDAC before each administration. Your liver and kidney function will also be monitored.

Taking other medicines

It is not advisable to use any medical treatment without telling your doctor as there may be interactions between DACARBAZINE MEDAC and other medicines.

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

During chemotherapy you should avoid medicines that can cause liver damage (e.g. diazepam, imipramin, ketoconazole or carbamazepin).

Using DACARBAZINE MEDAC with food and drink

During chemotherapy you should not drink alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

DACARBAZINE MEDAC must NOT be administered if you are pregnant or if you are planning to become pregnant. You must take adequate contraceptive precautions during therapy.

You must NOT breast-feed while you are treated with DACARBAZINE MEDAC.

If you are thinking of becoming pregnant or of breast-feeding, discuss it with your doctor first.

Driving and using machines

Your ability to drive or operate machines may be influenced because of central nervous side effects (undesired effects on the brain and nerves) or feeling sick and being sick; but there is no reason why you cannot drive or use machines between courses of therapy with DACARBAZINE MEDAC unless you feel dizzy or unsure of yourself.

3. HOW TO USE DACARBAZINE MEDAC

This medicine will be given to you under the direction of a physician specialised in oncology (cancer treatment), having the facilities for regular monitoring of all clinical effects, during and after your therapy.

Dacarbazine is a substance sensitive to light exposure. The doctor or nurse giving you this medicine will make sure that dacarbazine will be protected from exposure to daylight during administration.

Immediately before use, DACARBAZINE MEDAC powder will be dissolved in 50 ml of water for injection. The resulting solution will be further diluted with 200 - 300 ml isotonic sodium chloride or glucose 5 % infusion solution and will be given to you by intravenous infusion (infusion into a vein) within 20 - 30 minutes.

The dose will depend on your blood counts and concurrent chemotherapy. Your doctor will calculate your dose taking into consideration your body surface area (m²), blood counts and other anticancer medicines or therapies given.

Your doctor may change the dose and frequency of dosing

depending on your blood test, your general condition, further therapies and your response to DACARBAZINE MEdAc. If you have any questions about your treatment, ask your doctor, nurse or pharmacist.

No special recommendations for the use of DACARBAZINE MEDAC in children can be given to your doctor until further data become available.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, DACARBAZINE MEDAC can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the risks and benefits of your treatment.

Tell your doctor immediately, if you notice anything of the following:

•    Signs of infection, such as sore throat and high temperature

•    Abnormal bruising or bleeding

•    Extreme tiredness

•    Persistent or severe vomiting or diarrhoea

•    Severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint

•    Yellowing of the skin and eyes because of liver problems

•    Signs of brain-related or nerve-related problems, such as headaches, impaired vision, fits, confusion, lethargy (state of being apathetic) or numbness and tingling of your face

These are all serious side effects. You may need urgent medical attention.

In the following all undesirable effects are listed that have been described:

Common side effects (more than 1 in 100 patients, but less than 1 in 10 patients)

•    Anaemia (decreased number of red blood cells)

•    Leukopenia (decreased number of white blood cells)

•    Thrombocytopenia (decreased number of platelets in the blood) The changes in blood counts are dose-dependent and delayed, with the lowest values often only occurring

after 3 to 4 weeks.

•    Anorexia (loss of appetite), feeling sick and being sick (all of which may be severe)

Uncommon side effects (more than 1 in 1,000 patients, but less than 1 in 100 patients)

•    Alopecia (hair loss)

•    Hyperpigmentation (increased skin colouring)

•    Photosensitivity (sensitivity to light) of the skin

•    Flu-like symptoms with exhaustion, chills, fever and muscular pain, occasionally during or often only days after dacarbazine administration. These disturbances may recur with the next infusion.

Rare side effects (more than 1 in 10,000 patients, but less than 1 in 1,000 patients)

•    Pancytopenia (decreased number of all cells in the blood)

•    Agranulocytosis (severely decreased number of granulocytes, a special type of white blood cells)

•    Anaphylactic reactions (severe allergic reaction resulting in e.g. drop in blood pressure, swelling of the hands, feet, ankles, face, lips, mouth and throat which may cause difficulty in swallowing or breathing, rapid pulse, hives and generalised itching or skin redness)

•    Headaches

•    Impaired vision

•    Confusion

•    Lethargy (state of being apathetic)

•    Convulsions (fits)

•    Facial paraesthesia (abnormal sensations of the face), numbness and flushing of the face shortly after injection

•    Diarrhoea

•    Veno-occlusive disease (VOD) (severe disease of the liver due to obstruction of the liver blood vessels) with hepatic necrosis (destruction of liver cells) which can be life-threatening. If this complication is suspected, your doctor will consider appropriate treatment.

•    Elevation of liver enzymes

•    Impaired kidney function

•    Erythema (red skin)

•    Maculopapular exanthema (skin eruptions)

•    Urticaria (hives)

•    Application site irritation

You may experience one or several of these symptoms, be sure to inform your doctor if you do.

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 www.mhra.gov. uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DACARBAZINE MEDAC

Do not store above 25 °C. Keep the vial in the outer carton in order to protect from light.

The shelf-life under these conditions is 3 years.

Keep out of the reach and sight of children.

Do not use DACARBAZINE MEDAC after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Freshly prepared (reconstituted) and further diluted solutions of DaCArBaZINE MEDAC should also be protected from light and must be used immediately.

DACARBAZINE MEDAC is for single use only.

Any portion of the contents remaining after use should be discarded by your doctor as well as solutions where the visual appearance of the product has changed. The diluted solution for infusion should be visually inspected by your doctor and only clear solutions practically free from particles should be used.

6. FURTHER INFORMATION

What DACARBAZINE MEDAC contains

•    The active substance is dacarbazine (as dacarbazine citrate).

•    The other ingredients are citric acid, anhydrous, and mannitol.

What DACARBAZINE MEDAC looks like and contents of the pack

The pharmaceutical DACARBAZINE MEDAC is a white or pale-yellow powder which is supplied in amber glass vials (Type I, Ph.Eur.).

Each single-dose vial of DACARBAZINE MEDAC 500 MG contains 500 mg dacarbazine, as dacarbazine citrate.

After reconstitution and final dilution DACARBAZINE MEDAC 500 MG contains 1.4 - 2.0 mg/ml dacarbazine.

Each single-dose vial of DACARBAZINE MEDAC 1000 MG contains 1000 mg dacarbazine, as dacarbazine citrate.

After reconstitution and final dilution DACARBAZINE MEDAC 1000 MG contains 2.8 - 4.0 mg/ml dacarbazine.

III

Marketing Authorisation Holder and Manufacturer

medac

Gesellschaft fur klinische Spezialpraparate mbH Theaterstr. 6 22880 Wedel Germany

Phone: +49 (0)4103 8006-0 Fax:    +49 (0)4103 8006-100

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This leaflet was last revised in 05/2014.

The following information is intended for medical or healthcare professionals only:

Dacarbazine is an antineoplastic agent. Before commencing, local cytotoxic guidelines should be referred to.

Dacarbazine should only be opened by trained staff and as with all cytotoxic agents precautions should be taken to avoid exposing staff. Handling of cytotoxic drugs should be generally avoided during pregnancy. Preparation of solution for administration should be carried out in a designated handling area and working over a washable tray or disposable plastic-backed absorbent paper.

Suitable eye protection, disposable gloves, face mask and disposable apron should be worn. Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is recommended).

On completion, any exposed surface should be thoroughly cleaned and hands and face washed.

In the event of spillage, operators should put on gloves, face masks, eye-protection and disposable apron and mop up the spilled material with an absorbent material tapped in the area for that purpose. The area should then be cleaned and all contaminated material transferred to a cytotoxic spillage bag or bin or sealed for incineration.

All reconstituted solutions should be suitably protected from light also during administration (light-resistant infusion set).

Vials of DACARBAZINE MEDAC are packed in boxes each containing 1 vial.