Azacitidine Accord

Package leaflet: Information for the user

Azacitidine Accord 25 mg/mL powder for injectable suspension

azacitidine
Please 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 questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Azacitidine Accord is and what it is used for
2. What you need to know before using Azacitidine Accord
3. How to use Azacitidine Accord
4. Possible side effects
5. How to store Azacitidine Accord
6. Contents of the pack and other information

1. What Azacitidina Accord is and what it is used for

What Azacitidina Accord is
Azacitidina Accord is an anticancer agent belonging to a group of medicines called
"antimetabolites". Azacitidina Accord contains the active substance "azacitidine".
What Azacitidina Accord is used for
Azacitidina Accord is used in adults who are not eligible for stem cell transplantation to treat:

• high-risk myelodysplastic syndromes (MDS);
• chronic myelomonocytic leukaemia (CMML);
• acute myeloid leukaemia (AML).

These diseases affect the bone marrow and can cause problems with the normal production of blood cells.
How Azacitidina Accord works
Azacitidina Accord works by preventing cancer cells from growing. Azacitidine is incorporated into the genetic material of cells (ribonucleic acid (RNA) and deoxyribonucleic acid (DNA)).
It is believed to act by altering the way cells switch genes on and off, and by interfering with the production of new RNA and DNA. These actions are thought to correct the abnormalities in the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancer cells in leukaemia.
If you have any questions about how Azacitidina Accord works or why it has been prescribed for you, speak to your doctor or nurse.

2. What you need to know before using Azacitidine Accord

Do not use Azacitidine Accord

• if you are allergic to azacitidine or to any of the other ingredients of this medicine (listed in section 6);
• if you have advanced liver cancer;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Azacitidine Accord:

• if you have low platelet counts, red blood cells, or white blood cells;
• if you have kidney disease;
• if you have liver disease;
• if you have previously had heart disease or a heart attack, or if you have a history of lung disease.

Azacitidine Accord may cause a serious immune reaction called 'differentiation syndrome' (see section 4).
Blood tests
Before starting treatment with Azacitidine Accord and at the beginning of each treatment cycle, blood tests will be performed to check whether you have an adequate number of blood cells and to ensure that your liver and kidneys are functioning normally.
Children and adolescents
The use of Azacitidine Accord is not recommended in children and adolescents under 18 years of age.
Other medicines and Azacitidine Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Azacitidine Accord may affect how other medicines work.
Other medicines may also affect how Azacitidine Accord works.
Pregnancy, breastfeeding and fertility
Pregnancy
You must not use Azacitidine Accord during pregnancy, as it may harm the unborn child.
If you are a woman of childbearing potential, you must use an effective method of contraception during treatment with Azacitidine Accord and for 6 months after stopping treatment with Azacitidine Accord.
Inform your doctor immediately if you become pregnant during treatment with Azacitidine Accord.
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Breastfeeding
You must not breastfeed while using Azacitidine Accord. It is not known whether this medicine passes into breast milk.
Fertility
Men should not father a child during treatment with Azacitidine Accord. Men must use an effective method of contraception while taking Azacitidine Accord and for 3 months after stopping treatment with Azacitidine Accord.
Talk to your doctor if you wish to store sperm before starting this treatment.
Driving and using machines
Do not drive or operate tools or machinery if you experience side effects such as fatigue.

3. How to use Azacitidina Accord

Before administering Azacitidina Accord, your doctor will give you another medicine to prevent nausea and vomiting at the beginning of each treatment cycle.

• The recommended dose is 75 mg per m² of body surface area. Your doctor will determine the dose of this medicine based on your general condition, height, and body weight. Your doctor will monitor your progress and, if necessary, adjust the dose.

• Azacitidina Accord is administered daily for one week, followed by a 3-week break. This “treatment cycle” will be repeated every 4 weeks. Generally, at least 6 treatment cycles are administered.

This medicine will be administered by a doctor or nurse via subcutaneous injection (under the skin). The injection may be given in the skin of the thigh, abdomen, or upper arm.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice any of the following side effects:

• Drowsiness, tremor, jaundice, abdominal swelling and easy bruising. These may be symptoms of liver failure and can be life-threatening.
• Swollen legs and feet, back pain, reduced urine output, increased thirst, rapid pulse, dizziness, nausea, reduced appetite, confusion, restlessness or fatigue. These may be symptoms of kidney failure and can be life-threatening.
• Fever. This could be due to an infection caused by a low white blood cell count, which can be life-threatening.
• Chest pain or shortness of breath, possibly accompanied by fever. This may be due to a lung infection called "pneumonia" and can be life-threatening.
• Bleeding. For example, blood in the stool due to gastrointestinal bleeding, or bleeding inside the head. These may be symptoms of low platelet levels in the blood.
• Difficulty breathing, swollen lips, itching or skin rash. These may be due to an allergic reaction (hypersensitivity).

Other side effects include:
Very common side effects (may affect more than 1 in 10 people)

• Low red blood cell count (anaemia). You may feel tired and weak.
• Low white blood cell count. This may be accompanied by fever. Also, you may be more prone to infections.
• Low platelet count in the blood (thrombocytopenia). You may be more prone to bleeding and bruising.
• Constipation, diarrhoea, nausea, vomiting.
• Pneumonia.
• Chest pain, shortness of breath.
• Tiredness (fatigue).
• Reaction at the injection site, with redness, pain or skin reaction.
• Loss of appetite.
• Joint pain.
• Bruising.
• Rash.
• Small red or purple spots under the skin.
• Abdominal pain (stomach ache).
• Itching.
• Fever.
• Irritation of the nose and throat.
• Dizziness.
• Headache.
• Difficulty sleeping (insomnia).
• Nosebleeds (epistaxis).
• Muscle pain.
• Weakness (asthenia).
• Weight loss.
• Low levels of potassium in the blood.

Common side effects (may affect up to 1 in 10 people)

• Bleeding inside the head.
• Blood infection due to bacteria (sepsis), which may be caused by a low white blood cell count.
• Bone marrow failure, which may cause a reduction in red blood cells, white blood cells and platelets.
• A type of anaemia with reduced red blood cells, white blood cells and platelets.
• Urinary tract infection.
• Viral infection causing sores (herpes).
• Bleeding gums, gastrointestinal bleeding, bleeding from the anus due to haemorrhoids (haemorrhoidal bleeding), bleeding in the eye, bleeding under or into the skin (haematoma).
• Blood in the urine.
• Mouth or tongue ulcers.
• Skin changes at the injection site, including swelling, hard lump, bruising, bleeding into the skin (haematoma), rash, itching and skin colour changes.
• Skin redness.
• Skin infection (cellulitis).
• Infection of the nose and throat, or sore throat.
• Irritated or runny nose or sinuses (sinusitis).
• High or low blood pressure (hypertension or hypotension).
• Shortness of breath during physical activity.
• Sore throat and larynx.
• Indigestion.
• Lethargy.
• General feeling of being unwell.
• Anxiety.
• Confusion.
• Hair loss.
• Kidney failure.
• Dehydration.
• White coating covering the tongue, inside of cheeks, and sometimes the palate, gums and tonsils (fungal infection of the mouth).
• Fainting.
• Drop in blood pressure when standing up (orthostatic hypotension), causing dizziness upon standing or sitting up.
• Drowsiness, drowsiness (somnolence).
• Bleeding due to catheter.
• Disease affecting the intestine that may cause fever, vomiting and stomach pain (diverticulitis).
• Fluid around the lungs (pleural effusion).
• Chills (shivering).
• Muscle spasms.
• Raised, itchy skin rash (urticaria).
• Fluid accumulation around the heart (pericardial effusion).

Uncommon side effects (may affect up to 1 in 100 people)

• Allergic reaction (hypersensitivity).
• Tremor.
• Liver failure.
• Appearance of large, painful, raised, purple skin patches with fever.
• Painful skin ulceration (pyoderma gangrenosum).
• Inflammation of the lining around the heart (pericarditis).

Rare side effects (may affect up to 1 in 1,000 people)

• Dry cough.
• Painless swelling of the fingertips (drumstick fingers).
• Tumour lysis syndrome – metabolic complications that may occur during cancer treatment and sometimes even without treatment. These complications are caused by the breakdown products of dying tumour cells and may include the following: changes in haematological parameters; high levels of potassium, phosphate and uric acid; and low calcium levels, leading consequently to changes in kidney function, heart rhythm, seizures and sometimes death.

Not known (frequency cannot be estimated from the available data)

• Infection of the deeper layers of the skin, spreading rapidly and damaging skin and tissues, which may be fatal (necrotising fasciitis).
• Severe immune reaction (differentiation syndrome) which may cause fever, cough, breathing difficulties, rash, reduced urine output, low blood pressure (hypotension), swelling of arms or legs and rapid weight gain.
• Inflammation of blood vessels in the skin which may cause skin rashes (cutaneous vasculitis).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azacitidine Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the
carton. The expiry date refers to the last day of that month.
The doctor, pharmacist or nurse is responsible for the storage of Azacitidine Accord,
the preparation and the proper disposal of unused medicine.
For unopened vials of this medicine – no special storage conditions
are required.
For immediate use
Once reconstituted, the suspension must be administered within 60 minutes.
For subsequent use
If the Azacitidine Accord suspension is reconstituted with unrefrigerated water for injectable preparations, the suspension must be placed in a refrigerator (2 °C − 8 °C) immediately after preparation and stored in the refrigerator for a maximum of 8 hours.
If the Azacitidine Accord suspension is reconstituted with refrigerated water for injectable preparations (2 °C − 8 °C), the reconstituted suspension must be placed in a refrigerator (2 °C − 8 °C) immediately after preparation and stored in the refrigerator for a maximum of 22 hours.
Before administration, allow up to 30 minutes for the suspension to reach room temperature (20 °C − 25 °C).
The suspension must be discarded if large particles are present.

6. Package contents and other information

What Azacitidina Accord contains

• The active substance is azacitidine. One vial contains 100 mg or 150 mg of azacitidine. After reconstitution with 4 mL or 6 mL of water for injections, the reconstituted suspension contains 25 mg/mL of azacitidine.
• The other component is mannitol (E421).

Description of the appearance of Azacitidina Accord and contents of the pack
Azacitidina Accord is a white powder for injectable suspension, supplied in a glass vial containing 100 mg or 150 mg of azacitidine.
Packs:
1 vial containing 100 mg of Azacitidine.
1 vial containing 150 mg of Azacitidine.

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 Polska Sp.z o.o.
ul. Lutomierska 50,
95-200 Pabianice
Poland
Or
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind.
Zona Franca, Barcelona, 08040,
Spain
Or
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Or
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009,
Greece

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL /
NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Pharmaceutical S.A.
Tel: +30 210 7488 821

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/. In addition, links to other websites on rare diseases and related therapeutic treatments are provided.

The following information is intended exclusively for healthcare professionals:

Recommendations for safe handling
Azacitidine Accord is a cytotoxic medicinal product; therefore, as with other potentially toxic compounds, caution must be exercised during handling and preparation of azacitidine suspensions. Appropriate procedures for handling and disposal of antineoplastic medicinal products should be used.
In case of skin contact with reconstituted azacitidine, immediately and thoroughly wash with soap and water. In case of mucous membrane contact, thoroughly rinse with water.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned below (see section “Reconstitution procedure”).
Reconstitution procedure
Azacitidine Accord must be reconstituted with water for injections. The shelf life of the reconstituted medicinal product can be extended if reconstitution is performed using refrigerated (2 °C–8 °C) water for injections. Details on the storage of the reconstituted medicinal product are provided below.

1. Prepare the following items: vial(s) of azacitidine; vial(s) of water for injections; non-sterile surgical gloves; alcohol swabs; 5 mL syringe(s) with needle(s).
2. Draw into the syringe the appropriate volume of water for injections, ensuring that any air bubbles present in the syringe are expelled.

3. Insert the needle of the syringe containing water for injections into the rubber stopper of the azacitidine vial and then inject the water for injections into the vial.
4. After removing the syringe and needle, shake the vial vigorously until a uniform, opaque suspension is formed. After reconstitution, each mL of the suspension contains 25 mg of azacitidine (100 mg/4 mL or 150 mg/6 mL). The reconstituted product is a homogeneous, opaque suspension free of aggregates. The suspension must be discarded if it contains large particles or aggregates. Do not filter the suspension after reconstitution, as this may remove the active substance. Note that some adapters, needles, and closed systems contain filters; therefore, such systems must not be used for administration of the medicinal product after reconstitution.
5. Clean the rubber stopper and insert a new syringe with an attached needle into the vial. Invert the vial, ensuring that the tip of the needle is below the liquid level. Then pull back the plunger to withdraw the required amount of medication for the correct dose, making sure to remove any air bubbles remaining in the syringe. Afterwards, remove the syringe with the needle from the vial and dispose of the needle.
6. At this point, firmly attach a new subcutaneous injection needle to the syringe (use of 25 gauge needles is recommended). The suspension should not be pushed into the needle prior to injection in order to reduce the incidence of local reactions at the injection site.
7. When more than one vial is required, repeat the steps described for the preparation of the suspension. For doses requiring more than one vial, divide the dose equally (e.g., a 150 mg dose = 6 mL, 2 syringes with 3 mL each). Due to retention in the vial and needle, it may not be possible to withdraw all of the suspension from the vial.
8. The contents of the dosing syringe must be resuspended immediately before administration. The temperature of the suspension at the time of injection should be approximately 20 °C–25 °C. To resuspend, roll the syringe vigorously between the palms of the hands until a uniform, opaque suspension is obtained. The suspension must be discarded if it contains large particles or aggregates.

Storage of the reconstituted medicinal product
For immediate use
The suspension of Azacitidine Accord may be prepared immediately before use, and the reconstituted suspension must be administered within 60 minutes. If the elapsed time exceeds 60 minutes, the reconstituted suspension must be properly discarded and a new dose must be prepared.
For later use
When reconstitution is performed using non-refrigerated water for injections, the reconstituted suspension must be stored immediately in a refrigerator (2 °C–8 °C) after reconstitution and kept refrigerated for a maximum of 8 hours. If the storage time in the refrigerator exceeds 8 hours, the suspension must be properly discarded and a new dose must be prepared.
When reconstitution is performed using refrigerated water for injections (2 °C–8 °C), the reconstituted suspension must be stored immediately in a refrigerator (2 °C–8 °C) after reconstitution and kept refrigerated for a maximum of 22 hours. If the storage time in the refrigerator exceeds 22 hours, the suspension must be properly discarded and a new dose must be prepared.
Before administration, allow up to 30 minutes for the syringe filled with the reconstituted suspension to reach a temperature of approximately 20 °C–25 °C. If the elapsed time exceeds 30 minutes, the suspension must be discarded and properly disposed of, and a new dose must be prepared.

Calculation of individual dose
The total dose based on body surface area (BSA) can be calculated as follows:
Total dose (mg) = Dose (mg/m²) × BSA (m²)
The table below is only an example of how to calculate individual doses of azacitidine based on an average BSA of 1.8 m².

Administration method
Do not filter the suspension after reconstitution.
The reconstituted solution of Azacitidina Accord must be injected subcutaneously (insert the needle at an angle of 45–90°) into the upper arm, thigh, or abdomen, using a 25 gauge needle.
Doses exceeding 4 mL must be administered at two different injection sites.
Rotate injection sites systematically. Subsequent injections should be administered at least 2.5 cm away from the previous site and never into sensitive, bruised, reddened, or hardened areas.
Disposal
Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.

Package leaflet: Information for the user

Azacitidina Accord 200 mg film-coated tablets, 300 mg film-coated tablets

azacitidine
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Azacitidina Accord is and what it is used for
2. What you need to know before taking Azacitidina Accord
3. How to take Azacitidina Accord
4. Possible side effects
5. How to store Azacitidina Accord
6. Contents of the pack and other information

1. What Azacitidine Accord is and what it is used for

What Azacitidine Accord is
Azacitidine Accord is an antineoplastic medicine belonging to a group of medicines called antimetabolites. Azacitidine Accord contains the active substance azacitidine.
What Azacitidine Accord is used for
Azacitidine Accord is used to treat adults with acute myeloid leukaemia (AML). This is a type of cancer affecting the bone marrow, which can cause problems with the normal production of blood cells.
Azacitidine Accord is used to control the disease (remission, when the disease is less severe or not active).
How Azacitidine Accord works
Azacitidine Accord works by preventing cancer cells from growing. Azacitidine, the active substance in Azacitidine Accord, acts by altering the way cells switch genes on and off. It also reduces the production of new genetic material (RNA and DNA). These effects are believed to block the growth of cancer cells in leukaemia.
If you have any questions about how Azacitidine Accord works or why it has been prescribed for you, please speak to your doctor or nurse.

2. What you need to know before taking Azacitidina Accord

Do not take Azacitidina Accord

• if you are allergic to azacitidine or to any of the other ingredients of this medicine (listed in section 6)
• if you are breastfeeding.

Warnings and precautions
Blood tests
Before and during treatment with Azacitidina Accord, you will undergo blood tests to check whether you have an adequate number of blood cells and to assess whether your liver and kidneys are functioning normally. Your doctor will determine how often these blood tests should be performed.
Immediately inform your doctor, pharmacist, or nurse if you experience any of the following symptoms during treatment with Azacitidina Accord:

• bruising or bleeding – which could be due to a low number of blood cells called platelets;
• fever – which could be due to an infection caused by a reduced number of white blood cells, which may be life-threatening;
• diarrhea, vomiting, or nausea (feeling unwell).

Your doctor may need to adjust the dose, temporarily suspend, or permanently discontinue treatment with Azacitidina Accord. Your doctor may also prescribe additional medicines to manage these symptoms.
Children and adolescents
Azacitidina Accord is not recommended for children and adolescents under 18 years of age.
Other medicines and Azacitidina Accord
Inform your doctor if you are taking, have recently taken, or might take any other medicines. This is because Azacitidina Accord may affect how other medicines work. Likewise, other medicines may affect how Azacitidina Accord works.
Pregnancy, contraception, and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine. Men should not father a child while receiving treatment with Azacitidina Accord.
Pregnancy
Do not use Azacitidina Accord during pregnancy, as it may harm the unborn baby. Inform your doctor immediately if you become pregnant during treatment with Azacitidina Accord.
Contraception
Women of childbearing potential must use an effective method of contraception during treatment with Azacitidina Accord and for 6 months after stopping treatment with Azacitidina Accord. Men must use an effective method of contraception during treatment with Azacitidina Accord and for 3 months after stopping treatment with Azacitidina Accord.
Your doctor will discuss with you the most appropriate contraceptive method to use.
Breastfeeding
Do not breastfeed while taking Azacitidina Accord, as it may harm the baby.
Fertility
Azacitidina Accord may affect your ability to have children. Speak with your doctor before using this medicine.
Driving and using machines
You may feel tired, weak, or have difficulty concentrating. If this occurs or if you experience other adverse effects, do not drive or operate tools or machinery.
Azacitidina Accord contains lactose
Azacitidina Accord contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Azacitidina Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Azacitidine Accord

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.

How much Azacitidine Accord to take

• The recommended dose is 300 mg, taken orally once daily.
• Your doctor may reduce the dose to 200 mg once daily.

Azacitidine Accord is administered in treatment cycles of 28 days.

• You must take Azacitidine Accord every day for the first 14 days of each 28-day cycle.
• You will then have a 14-day treatment-free period for the remainder of the cycle.

Your doctor will determine the dose of Azacitidine Accord you should take. Your doctor may decide to:

• extend the treatment period beyond 14 days in each treatment cycle
• reduce the dose or temporarily interrupt treatment
• reduce the duration of treatment to 7 days.

Always take Azacitidine Accord exactly as prescribed by your doctor.
Your doctor will prescribe a medicine to help reduce nausea (feeling unwell) and vomiting.
Take this medicine 30 minutes before each tablet of Azacitidine Accord during the first and second treatment cycles. Your doctor will inform you if you need to continue taking it for a longer period, if necessary.

How to take this medicine

• Take Azacitidine Accord once daily, every day at the same time.
• Swallow the tablets whole with a glass of water.
• To ensure you take the correct dose, do not break, crush, dissolve, or chew the tablets.
• You may take the medicine with food or between meals.

If you vomit after taking a tablet, do not take another one on the same day. Instead, wait until the next day and take the next scheduled dose. Do not take a double dose on the same day.
If powder from a broken tablet comes into contact with your skin, wash the skin immediately and thoroughly with soap and water. If the powder gets into your eyes, nose, or mouth, rinse the affected area thoroughly with water.

If you take more Azacitidine Accord than you should
If you take more tablets than prescribed, contact your doctor or go to the hospital immediately. If possible, bring the medicine pack and this leaflet with you.

If you forget to take Azacitidine Accord
If you forget to take Azacitidine Accord at your usual time, take the usual dose as soon as you remember on the same day, and take the next dose at the usual time the following day. Do not take a double dose to make up for a forgotten tablet or for vomiting.

If you stop taking Azacitidine Accord
Do not stop taking Azacitidine Accord unless your doctor tells you to.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Immediately inform your doctor, pharmacist or nurse if you experience any of the
following symptoms during treatment with Azacitidine Accord:

• bruising or bleeding – which could be due to a low number of blood cells called platelets;
• fever – which could be due to an infection caused by a reduced number of white blood cells, which can be life-threatening;
• diarrhoea, vomiting or nausea (feeling unwell).

Other side effects include:
Very common side effects (may affect more than 1 in 10 people):

• constipation
• stomach pain
• infection of nose, sinuses and throat
• lung infection
• feeling tired or weak
• loss of appetite
• pain affecting various parts of the body which may range from sharp to dull
• joint stiffness
• back pain.

Common side effects (may affect up to 1 in 10 people):

• influenza
• urinary tract infection
• hay fever
• anxiety
• weight loss.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azacitidina Accord

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 blister and the carton after
Exp/EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Azacitidina Accord contains

• The active substance is azacitidine. Each film-coated tablet contains 200 mg or 300 mg of azacitidine.
• The other components are mannitol, silicified microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
• Coating of 200 mg tablets: hypromellose (E464), lactose monohydrate, polyethylene glycol (E1521), triacetin (E1518), titanium dioxide (E171), iron oxide red (E172). See section 2 “Azacitidina Accord contains sodium”.
• Coating of 300 mg tablets: hypromellose (E464), lactose monohydrate, polyethylene glycol (E1521), triacetin (E1518), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172). See section 2 “Azacitidina Accord contains sodium”.

Description of the appearance of Azacitidina Accord and contents of the pack
Azacitidina Accord 200 mg film-coated tablets are oval-shaped, pink tablets, approximately 17 x 7.6 mm, with “MA1” engraved on one side and smooth on the other side.
Azacitidina Accord 300 mg film-coated tablets are oval-shaped, brown tablets, approximately 19 x 9 mm, with “MA2” engraved on one side and smooth on the other side.
The 200 mg and 300 mg film-coated tablets of Azacitidina Accord are available in cartons containing 7 and 14 film-coated tablets in alu-alu blisters or alu/PVC/PCTFE blisters with perforated aluminum foil, and in cartons containing 7 x 1 and 14 x 1 film-coated tablets in unit-dose blisters with transverse perforations.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n
Edifici Est, 6 Planta
08039 Barcelona
Spain

Manufacturer
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
Pabianice, 95-200
Poland
Accord Healthcare B.V.
3528 BD Winthontlaan 200
Utrecht, 3526 KV
The Netherlands
Accord Healthcare Single Member S.A.
64 Km National Road Athens
Lamia, 32009
Greece

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu