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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Docetaxel 20 mg/1 ml, 80 mg/4 ml, 160 mg/8 ml Concentrate For Solution For Infusion

Docetaxel

Read all of this leaflet carefully before you start using 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, hospital 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. See section 4.

What is in this leaflet    Other medicines and Docetaxel

1.    What Docetaxel is and what it is used for    Please tell your doctor or hospital pharmacist if you are

2.    What you need to know before you use Docetaxel taking or have recently taken any other medicine,

3.    How to use Docetaxel    including medicines obtained without a prescription. This

4.    Possible side effects    is because Docetaxel or the other medicine may not work

5.    How to store Docetaxel    as well as expected and you may be more likely to get a

6.    Contents of the pack and other information    _sid_{e e}ff_ect.

1. What Docetaxel is and what it is used for

Docetaxel is a substance derived from the needles of yew trees. Docetaxel belongs to the group of anti-cancer medicines called taxoids.

Docetaxel 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 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 could be administered in combination with doxorubicin and cyclophosphamide.

•    For the treatment of lung cancer, docetaxel could be administered either alone or in combination with cisplatin.

•    For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone.

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

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

2. What you need to know before you use Docetaxel

You must not be given Docetaxel

•    if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel concentrate

•    if the number of white blood cells is too low

•    if you have a severe liver disease.

Warnings and precautions

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

Tell your doctor, hospital pharmacist or nurse if you have vision problems. In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.

If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately. Your doctor may stop your treatment immediately.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel 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; 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.

Docetaxel concentrate contains alcohol. Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment. See also section "Docetaxel concentrate contains ethanol (alcohol)" below.

Pregnancy, breastfeeding and fertility

Ask your doctor for advice before being given any medicine.

Docetaxel 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 may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

You must not breastfeed while you are treated with Docetaxel.

If you are a man being treated with Docetaxel, 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.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. The amount of alcohol in this medicine may impair your ability to drive or use machines (see below).

Docetaxel concentrate contains ethanol (alcohol)

Docetaxel 20 mg/1 ml contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg Ethanol per vial, equivalent to 10 ml of beer or 4 ml wine per vial.

Docetaxel 80 mg/4 ml contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g Ethanol per vial, equivalent to 40 ml of beer or 17 ml wine per vial. Docetaxel 160 mg/8 ml contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g Ethanol per vial, equivalent to 80 ml of beer or 33 ml wine per vial.

Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are breastfeeding, in children and high-risk groups such as patients with liver disease, or epilepsy.

The amount of alcohol in this medicinal product may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).

The amount of alcohol in this medicinal product may alter the effects of other medicines.

3. How to use Docetaxel

Docetaxel 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 metres (m²) and will determine the dose you should receive.

Method and route of administration

Docetaxel 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. 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.

The amount of alcohol in this medicine may impair your ability to drive or use machines.

4. Possible side effects

Like all medicines, this medicine 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 alone are: decrease in the number of red blood cells or white blood cells, hair loss (alopecia), nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

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

During the infusion at the hospital the following allergic reactions (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 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 or 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 colour 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 up to 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 up to 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.

Frequency unknown:

•    interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing. Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)

•    pneumonia (infection of the lungs)

•    pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)

•    blurred vision due to swelling of the retina within the eye (cystoid macular oedema)

•    decrease of the sodium in your blood.

Reporting of side effects

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. You can also report side effects directly via the Yellow Card Scheme, website: 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 Docetaxel

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

Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP. The expiry date refers to the last day of that month.

Docetaxel 20 mg/ml and 80 mg/4 ml: Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light.

Docetaxel 160 mg/8 ml: Do not store above 25°C. Do not freeze.

Use the vials immediately after opening. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Chemical and physical in-use stability has been demonstrated in non-PVC bags for 6 hours at 25°C and for 48 hours at 2° to 8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2° to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and should be discarded.

Do not throw away any medicines via wastewater. 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 Docetaxel concentrate contains

The active substance is docetaxel. Each ml of concentrate for solution for infusion contains 20 mg docetaxel (anhydrous).

One vial of 20 mg/1 ml concentrate contains 20 mg docetaxel.

One vial of 80 mg/4 ml concentrate contains 80 mg docetaxel.

One vial of 160 mg/8 ml concentrate contains 160 mg docetaxel.

The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid anhydrous.

What Docetaxel concentrate looks like and contents of the pack

Docetaxel concentrate for solution for infusion is a pale yellow to brownish-yellow solution.

The 20 mg/1 ml concentrate is supplied in a 2 ml glass vial with a rubber stopper and a green flip-off seal. Each vial contains 1 ml concentrate.

The 80 mg/4 ml concentrate is supplied in a 5 ml glass vial with a rubber stopper and a pink flip-off seal. Each vial contains 4 ml concentrate.

The 160 mg/8 ml concentrate is supplied in a 10 ml glass vial with a rubber stopper and a blue flip-off seal. Each vial contains 8 ml concentrate.

Each box contains 1 vial.

Marketing Authorisation Holder and Manufacturer

Dr. Reddy's Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom

This leaflet was last revised in 12/2015