Leaflet: information for the user

Docetaxel Accord 20 mg/1 ml concentrate for infusion EFG

Docetaxel Accord 80 mg/4 ml concentrate for infusion EFG

Docetaxel Accord 160 mg/8 ml concentrate for infusion EFG

docetaxel

Read this leaflet carefully before starting to use this medicine, because

it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, hospital pharmacist or nurse.
• If you experience any side effects, consult your doctor, hospital pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

The name of this medicine is Docetaxel Accord. Its common name is docetaxel. The

docetaxel is a substance derived from the needles (leaves) of the yew tree.

Docetaxel belongs to the group of anticancer drugs called taxoids.

Docetaxel Accord has been prescribed by your doctor for the treatment of breast cancer, certain types of lung cancer (non-small cell lung cancer), prostate cancer, stomach cancer or head and neck cancer:

• For the treatment of advanced breast cancer, docetaxel may be administered either alone or in combination with doxorubicin, or trastuzumab or capecitabina.
• For the treatment of early breast cancer with or without lymph node involvement, docetaxel may be administered in combination with doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, docetaxel may 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.

You should not be given Docetaxel Accord:

• if your white blood cell count is too low.
• if you have severe liver disease.

Warnings and precautions

Before each treatment with Docetaxel Accord, a blood test will be performed to check that you have a sufficient number of blood cells and sufficient liver function to receive Docetaxel Accord. If your white blood cell count is altered, you may experience fever or associated infections.

Inform your doctor, hospital pharmacist or nurse immediately if you have abdominal pain or tenderness, diarrhea, rectal bleeding, bloody stools or fever. These symptoms may be the first signs of severe gastrointestinal toxicity, which can be fatal. Your doctor must address this immediately.

Inform your doctor, hospital pharmacist or nurse if you have vision problems. In the event of vision problems, particularly blurred vision, an immediate eye and vision examination must be performed.

Inform your doctor, hospital pharmacist or nurse if you have previously experienced

allergic reactions to paclitaxel.

Inform your doctor, hospital pharmacist or nurse if you have heart problems.

If you develop acute problems or worsening of the lungs (fever, difficulty breathing, cough), inform your doctor, hospital pharmacist or nurse immediately. Your doctor may interrupt your treatment immediately.

Your doctor will recommend taking premedication, consisting of an oral corticosteroid such as dexamethasone, one day before the administration of Docetaxel Accord and continuing for one or two days afterwards to minimize some adverse effects that may occur after the infusion of Docetaxel Accord, particularly allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

During treatment, you may receive other medications to maintain your

blood cell count.

Docetaxel Accord contains alcohol. Consult your doctor if you are dependent on alcohol or

liver disorders. See also the section “Docetaxel Accord contains ethanol

(alcohol)” below.

Use of Docetaxel Accord with other medications

Please inform your doctor or hospital pharmacist if you are using or have recently used another medication, even those purchased without a prescription. The reason is that Docetaxel Accord or the other medication may not work as expected and you may be more likely to experience an adverse effect.

The alcohol content of this medication may alter the effects of other medications.

Pregnancy, breastfeeding and fertility

Consult with your doctor before using any medication.

Docetaxel AccordSHOULD NOTbe administered if you are pregnant, unless clearly indicated by your doctor.

You should not become pregnant while undergoing treatment with this medication and you should use an effective contraceptive method during therapy, as docetaxel may be harmful to the fetus. If you become pregnant during your treatment, you must inform your doctor immediately.

You cannot breastfeed while being treated with docetaxel.

If you are a man undergoing treatment with docetaxel, it is recommended that you do not father a child during treatment and for 6 months after treatment, as well as informing about sperm conservation before treatment, as docetaxel may alter male fertility.

Driving and operating machinery

The alcohol content of this medication may affect your ability to drive and use machines.

You may experience adverse effects of this medication that may alter your ability to drive, use tools or operate machinery (see section 4 Possible adverse effects). If this happens, do not drive or use any tools or machinery before consulting with your doctor, nurse or hospital pharmacist.

Docetaxel Accord contains ethanol (alcohol)

Docetaxel Accord 20 ml/1 ml contains

a 50% volume of anhydrous ethanol (alcohol), corresponding to 395 mg anhydrous ethanol per vial, equivalent to 10 ml of beer or 4 ml of wine.

Docetaxel Accord 80 ml/4 ml contains

a 50% volume of anhydrous ethanol (alcohol) corresponding to 1.58 g anhydrous ethanol per vial, equivalent to 40 ml of beer or 17 ml of wine.

Docetaxel Accord 160 ml/8 ml contains

a 50% volume of anhydrous ethanol (alcohol) corresponding to 3.16 g anhydrous ethanol per vial, equivalent to 80 ml of beer or 33 ml of wine.

This medication is harmful to individuals with alcoholism.

The alcohol content must be taken into account in the case of pregnant women or breastfeeding women, children and high-risk populations, such as patients with liver disease or epilepsy.

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

Docetaxel Accord will be administered by a healthcare professional.

Recommended dose

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

Form and route of administration

Docetaxel Accord will be administered through intravenous infusion in one of your veins. The infusion will last approximately one hour during which you will be in the hospital.

Administration frequency

You will receive the treatment, through intravenous infusion, once every 3 weeks.

Your doctor may change the dose and frequency of administration based on your blood test results, overall condition, and response to Docetaxel Accord. In particular, inform your doctor if you experience diarrhea, mouth sores, numbness or tingling, fever, and provide your blood test results. This information will allow your doctor to decide if a dose reduction is necessary. If you have any other questions about the use of this medication, ask your doctor or the hospital pharmacist.

Like all medicines, Docetaxel can cause side effects, although not everyone will experience them.

Your doctor will discuss them with you and explain the possible risks and benefits of your treatment.

The most frequent side effects of Docetaxel, when administered alone, are: a decrease in the number of red or white blood cells, alopecia, nausea, vomiting, mouth sores, diarrhea, and fatigue.

The severity of the side effects of Docetaxel may increase when administered in combination with other chemotherapy agents.

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

• hives, skin reactions, itching,
• chest tightness, difficulty breathing,
• fever or chills,
• back pain,
• decreased blood pressure

Other more severe reactions may occur.

If you had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel, which may be more severe.

The hospital staff will closely monitor your health status during treatment. If you notice any of these side effects, report them immediately.

Between one infusion and another of docetaxel, the following may occur and their frequency may vary depending on the combination of medications you receive:

Very frequent(may affect more than 1 in 10 patients):

• infections, a decrease in the number of red blood cells (anemia) or white blood cells (which are important to fight infections) and platelets
• fever: if this happens, you must inform your doctor immediately.
• allergic reactions as described above
• loss of appetite (anorexia)
• insomnia
• numbness or tingling sensation or pain in the joints
• headache
• alteration of taste
• inflammation of the eye or excessive tearing
• swelling caused by defective lymphatic drainage
• shortness of breath
• nasal secretion; inflammation of the throat and nose; cough
• nasal bleeding
• mouth sores
• stomach discomfort including nausea, vomiting, and diarrhea, constipation
• abdominal pain

• indigestion
• hair loss: in most cases, your hair will grow back normally. In some cases (unknown frequency), permanent hair loss has been observed.
• redness and swelling of the palms of the hands or soles of the feet, which can cause skin peeling (this can also occur in arms, face, or body)
• change in nail color, which may fall off
• muscle pain; back or bone pain
• changes or absence of menstrual period
• swelling of hands, feet, legs
• fatigue; or catarrah symptoms
• weight gain or loss.

Frequent(may affect up to 1 in 10 patients):

• oral candidiasis
• dehydration
• dizziness
• hearing loss
• decreased blood pressure, irregular or rapid heartbeats
• heart failure
• esophagitis
• dry mouth
• difficulty or pain swallowing
• bleeding
• liver enzyme elevation (hence the need for regular blood tests).

Rare(may affect up to 1 in 1,000 patients):

• syncope
• skin reactions, phlebitis (inflammation of the vein) or swelling at the infusion site
• blood clot formation.

Rare(may affect up to 1 in 1,000 patients):

• inflammation of the colon, small intestine, which could be fatal (unknown frequency); intestinal perforation.

Unknown frequency(cannot be estimated from available data):

• pulmonary interstitial disease (inflammation of the lungs that produces cough and difficulty breathing. Lung inflammation may also occur when docetaxel treatment is used with radiation therapy)
• pneumonia (lung infection)
• pulmonary fibrosis (scarring and thickening of the lungs with difficulty breathing).
• blurred vision due to inflammation of the retina inside the eye (cystoid macular edema)
• decreased sodium, potassium, magnesium, and/or calcium in your blood (electrolyte imbalance)
• ventricular arrhythmia or ventricular tachycardia (which manifests as irregular or rapid heartbeats, severe shortness of breath, dizziness, or fainting). Some of these symptoms may be severe. If this happens, report it to your doctor immediately

• reactions at the injection site, at the site of a previous reaction.
• you may develop non-Hodgkin's lymphoma (cancer that affects the immune system) and other cancers in patients treated with docetaxel in combination with certain anticancer treatments.

Reporting side effects

If you experience any type of side effect, consult your doctor, the hospital pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendixV.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the outer packaging and on the vial label after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect it from light.

Use the vial immediately after opening. If not used immediately, the user is responsible for the storage time and conditions.

From a microbiological standpoint, it must be diluted in controlled, aseptic conditions.

The medication must be used immediately after adding it to the infusion bag. If not used immediately, the user is responsible for the storage time and conditions, and it should not normally exceed 6 hours below 25°C, including the infusion time to the patient.

The physical and chemical stability of the prepared infusion solution as recommended is demonstrated for up to 48 hours if stored between 2 and 8°C in non-PVC bags.

Prepare the infusion solution as recommended. Do not connect the infusion solution to the infusion set for more than 6 hours when stored at 25°C.

The docetaxel infusion solution is supersaturated, so it may crystallize over time. If crystals appear, the solution should not be used and should be discarded.

Do not dispose of medications through the drains. Ask your pharmacist where to dispose of unused medications. This will help protect the environment.

What Docetaxel Accord contains

• The active substance is docetaxel. Each ml of concentrate for solution for infusion contains

20 mg of docetaxel.

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

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

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

• The other components are polisorbate 80, anhydrous ethanol (see section 2) and anhydrous citric acid.

Appearance of Docetaxel Accord and contents of the pack

Docetaxel Accordconcentrate for solution for infusion is a pale yellow to yellowish transparent solution.

Docetaxel Accord 20 mg/1 ml is provided in a 5 ml transparent glass vial with a fluorotec plus rubber stopper, an aluminium seal and an orange flip-off cap.

Docetaxel Accord 80 mg/4 ml is provided in a 5 ml transparent glass vial with a fluorotec plus rubber stopper, an aluminium seal and a red flip-off cap.

Docetaxel Accord 160 mg/8 ml is provided in a 10 ml transparent glass vial with a fluorotec plus rubber stopper, an aluminium seal and a red flip-off cap.

Size of the pack:

Each pack contains one vial of 1 ml concentrate.

Each pack contains one vial of 4 ml concentrate.

Each pack contains one vial of 8 ml concentrate.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow, Middlesex HA1 4HF

UK

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Last update of the leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:

http://www.ema.europa.eu

This information is intended solely for healthcare professionals:

GUIDE FOR PREPARATION FOR USE OF DOCETAXEL ACCORD

CONCENTRATE FOR SOLUTION FOR INFUSION

Please read the contents of this guide carefully before preparing the Docetaxel Accord infusion solution.

Recommendations for safe handling

Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling and preparing its solutions. It is recommended to use gloves.

If the Docetaxel Accord concentrate or infusion solution comes into contact with the skin, the skin should be washed immediately and thoroughly with water and soap. If the concentrate or infusion solution enters the mucous membranes, it should be washed immediately and thoroughly with water.

Preparation for intravenous administration

Preparation of the infusion solution

DO NOT USE this medicine (Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion, in a single vial) with other medicines that contain docetaxel in 2 vials (concentrate and diluent).

DO NOT USE this medicine (Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion, in a single vial) with other medicines that contain docetaxel in 2 vials (concentrate and diluent).

DO NOT USE this medicine (Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion, in a single vial) with other medicines that contain docetaxel in 2 vials (concentrate and diluent).

Docetaxel Accord concentrate for solution for infusion does not require prior dilution with a diluent and is ready to be added to the infusion solution.

• Each vial is for single use and should be used immediately after opening. If not used immediately, the storage periods and conditions are the responsibility of the user. It may be necessary to use more than 1 vial of docetaxel concentrate for solution for infusion to obtain the required dose for the patient. For example, for a dose of 140 mg of docetaxel, 7 ml of docetaxel concentrate for solution would be required.
• Extract the required amount of concentrate for solution for infusion aseptically using a calibrated syringe with a 21G needle.

The concentration of docetaxel in the vial of Docetaxel Accord is 20 mg/ml.

• Then, inject it once (with a single injection) into a 250 ml infusion bag, which contains either a 5% glucose solution or a 9 mg/ml sodium chloride solution (0.9%). If a dose greater than 190 mg of docetaxel is required, use a larger volume of infusion solution, in order not to exceed the concentration of 0.74 mg/ml of docetaxel.
• Mix the infusion bag manually by rotating it.
• From a microbiological point of view, it should be diluted in controlled aseptic conditions and the medicine should be used immediately. If not used immediately, the storage periods and conditions are the responsibility of the user.

Once added to the infusion bag as recommended, the docetaxel infusion solution is stable for 6 hours if stored below 25°C. It should be used within this 6-hour period (including the hour of intravenous administration).

Additionally, the physical and chemical stability of the prepared infusion solution is demonstrated up to 48 hours if stored between 2 and 8°C in non-PVC bags.

The docetaxel infusion solution is supersaturated, and it may crystallize over time. If crystals appear, the solution should not be used and should be discarded.

• As with all parenteral products, the infusion solution should be visually inspected before use; solutions with precipitate should be discarded.

Elimination

The unused medicine and all materials that have come into contact with it should be disposed of in accordance with local regulations. Do not dispose of medicines by flushing them down the toilet. Ask your pharmacist where to dispose of medicines that are no longer needed. This will help protect the environment.