PACKAGE LEAFLET: INFORMATION FOR THE USER

Docetaxel Regiomedica 40 mg/ ml concentrate and solvent for solution for infusion

docetaxel

Read all of this leaflet carefully before you are given 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, pharmacist or nurse.

-    If you get any side effects, talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

In this leaflet:

1.    What Docetaxel Regiomedica is and what it is used for

2.    What you need to know before you use Docetaxel Regiomedica

3.    How to use Docetaxel Regiomedica

4.    Possible side effects

5.    How to store Docetaxel Regiomedica

6.    Contents of the pack and other information

1. What Docetaxel Regiomedica is and what it is used for

The name of this medicine is Docetaxel Regiomedica. Its common name is docetaxel. Docetaxel is a

substance derived from the needles of yew trees.

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

Docetaxel Regiomedica has been prescribed by your doctor for the treatment of breast cancer, special

forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck

cancer:

-    For the treatment of advanced breast cancer, Docetaxel Regiomedica could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.

-    For the treatment of early breast cancer with or without lymph node involvement, Docetaxel Regiomedica could be administered in combination with doxorubicin and cyclophosphamide.

-    For the treatment of lung cancer, Docetaxel Regiomedica could be administered either alone or in combination with cisplatin.

-    For the treatment of prostate cancer, Docetaxel Regiomedica is administered in combination with prednisone or prednisolone.

-    For the treatment of metastatic gastric cancer, Docetaxel Regiomedica is administered in combination with cisplatin and 5-fluorouracil.

-    For the treatment of head and neck cancer, Docetaxel Regiomedica is administered in combination with cisplatin and 5-fluorouracil.

2. What you need to know before you use Docetaxel Regiomedica You must not be given Docetaxel Regiomedica

-    you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel Regiomedica

-    the number of white blood cells is too low

-    you have a severe liver disease.

Warnings and precautions

Before each treatment with Docetaxel Regiomedica, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Regiomedica. In case of white blood cell disturbances, you may experience associated fever or infections.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Regiomedica administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Regiomedica in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

During treatment, you may be given other medicines to maintain the number of your blood cells.

Other medicines and Docetaxel Regiomedicad

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Docetaxel Regiomedica or the other medicines may not work as well as expected and you may be more likely to get a side effect.

Pregnancy, breast-feeding and fertility

Ask your doctor for advice before being given any medicine.

Docetaxel Regiomedica must NOT be administered if you are pregnant unless clearly indicated by your doctor.

You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy because Docetaxel Regiomedica may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

You must not breast-feed while you are treated with Docetaxel Regiomedica.

If you are a man being treated with Docetaxel Regiomedica you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because docetaxel may alter male fertility.

Docetaxel Regiomedica

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Docetaxel Regiomedica concentrate and solvent for solution for infusion both contain small amounts of ethanol (alcohol), less than 100 mg per infusion.

3. How to use Docetaxel Regiomedica

Docetaxel Regiomedica will be administered to you by a healthcare professional.

Usual dose

The dose will depend on your weight and your general condition. Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.

Method and route of administration

Docetaxel Regiomedica will be given by infusion into one of your veins (intravenous use). The infusion will last approximately one hour during which you will be in the hospital.

Frequency of administration

You should usually receive your infusion once every 3 weeks.

Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Regiomedica. In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him results of your blood tests. Such information will allow her/him to decide whether a dose reduction is needed. If you have any further questions on the use of this medicine, ask your doctor or hospital pharmacist.

4. Possible side effects

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

Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.

The most commonly reported adverse reactions of Docetaxel Regiomedica alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of Docetaxel Regiomedica may be increased when Docetaxel Regiomedica is given in combination with other chemotherapeutic agents.

During the infusion at the hospital the following allergic reactions may occur (may affect more than 1 in 10 people):

-    flushing, skin reactions, itching

-    chest tightness; difficulty in breathing

-    fever or chills

-    back pain

-    low blood pressure.

More severe reactions may occur.

The hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of these effects.

Between infusions of Docetaxel Regiomedica the following may occur, and the frequency may vary with the combinations of medicines that are received:

Very common (may affect more than 1 in 10 people):

-    infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets

-    fever: if this happens you must tell your doctor immediately

-    allergic reactions as described above

-    loss of appetite (anorexia)

-    insomnia

-    feeling of numbness or pins and needles or pain in the joints of muscles

-    headache

-    alteration in sense of taste

-    inflammation of the eye or increased tearing of the eyes

-    swelling caused by faulty lymphatic drainage

-    shortness of breath

-    nasal drainage; inflammation of the throat and nose; cough

-    bleeding from the nose

-    sores in the mouth

-    stomach upsets including nausea, vomiting and diarrhoea, constipation

-    abdominal pain

-    indigestion

-    hair loss (in most cases normal hair growth should return)

-    redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)

-    change in the color of your nails, which may detach

-    muscle aches and pains; back pain or bone pain

-    change or absence of menstrual period

-    swelling of the hands, feet, legs

-    tiredness; or flu-like symptoms

-    weight gain or loss.

Common (may affect upto 1 in 10 people):

-    oral candidiasis

-    dehydration

-    dizziness

-    hearing impaired

-    decrease in blood pressure; irregular or rapid heart beat

-    heart failure

-    oesophagitis

-    dry mouth

-    difficulty or painful swallowing

-    haemorrhage

-    raised liver enzymes (hence the need for regular blood tests).

Uncommon (may affect upto 1 in 100 people):

-    fainting

-    at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling

-    inflammation of the colon, small intestine; intestinal perforation

-    blood clots

If you get any side effects, talk to your doctor, hospital pharmacist or nurse. This includes any side effects not listed in this leaflet.

5. How to store Docetaxel Regiomedica

Keep this medicine out of the sight and reach of children.

This medicine should not be used after the expiry date shown on the carton, blister pack and vials. Store below 25°C.

Store in the original package in order to protect from light.

The premix solution should be used immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).

The infusion solution should be used within 4 hours at room temperature (below 25°C).

Both, the premix solution and the infusion solution should not be stored below 2°C.

6. Contents of the pack and other information

What Docetaxel Regioemdica concentrate contains

-    The active substance is docetaxel.

Each ml of docetaxel concentrate for solution for infusion contains 40 mg of docetaxel (anhydrous).

One vial of concentrate contains 20 mg /0.5 ml docetaxel One vial of concentrate contains 80 mg/2 ml docetaxel.

-    The other ingredients are: polysorbat 80 (E433), citric acid anhydrous (E330), ethanol absolute and nitrogen.

What solvent vial contains

13% (w/w) ethanol 96% in water for injection.

What Docetaxel Regioemdica looks like and contents of the pack

The concentrate is a clear yellow to brownish-yellow, viscous solution.

The solvent is a clear, colourless solution.

Each carton contains a blister pack with one single dose vial of concentrate and one single dose vial of solvent.

Marketing Authorisation Holder and Manufacturer

Regiomedica GmbH Teichstr. 66 79539 Lorrach Germany

This medicinal product is authorised in the Member States of the EEA under the following

Docetaxel Regiomedica 40 mg/ml Docetaxel Regiomedica 40 mg/ml Docetaxel Regiomedica 40 mg/ml Docetaxel Regiomedica 20 mg/0.5 ml Docetaxel Regiomedica 80 mg/2 ml Docetaxel Regiomedica 40 mg/ml Docetaxel Regiomedica 40 mg/ml

This leaflet was approved in 09/2012