Patient Information Leaflet

Azacitidine Sandoz, 200 mg, coated tablets
Azacitidine Sandoz, 300 mg, coated tablets
Azacitidinum
Please read all of this leaflet carefully before taking 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, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

What Azacitidine Sandoz is and what it is used for
What you need to know before taking Azacitidine Sandoz
How to take Azacitidine Sandoz
Possible side effects
How to store Azacitidine Sandoz
Contents of the pack and other information

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

What Azacitidine Sandoz is
Azacitidine Sandoz is an anticancer medicine belonging to a group of medicines called
antimetabolites. Azacitidine Sandoz contains an active substance called "azacitidine".
What Azacitidine Sandoz is used for
Azacitidine Sandoz is used to treat adults with acute myeloid leukaemia (AML). This is a type of cancer that affects the bone marrow and can cause problems with the normal production of blood cells.
Azacitidine Sandoz is used to help maintain control of the disease (to maintain remission, which is the period when the disease is less active or inactive).
How Azacitidine Sandoz works
Azacitidine Sandoz works by preventing the growth of cancer cells. The active substance in Azacitidine Sandoz, azacitidine, acts by altering the way genes in the cell are activated or deactivated. It also interferes with the production of new genetic material (RNA and DNA). This action is believed to inhibit the growth of leukaemia cancer cells.
If you have any questions about how Azacitidine Sandoz works or why it has been prescribed for you, please ask your doctor or nurse.

2. Important information before taking Azacitidine Sandoz

When not to take Azacitidine Sandoz

if the patient is allergic to azacitidine or any of the other ingredients of this medicine (listed in section 6);
if the patient is breastfeeding.

Warnings and precautions
Blood tests
Blood tests will be carried out before and during treatment with Azacitidine Sandoz to check whether the patient has an adequate number of blood cells and to assess whether the liver and kidneys are functioning properly. The doctor will decide how often the patient needs blood tests.
Immediately inform the doctor, pharmacist, or nurse if any of the following symptoms occur during treatment with Azacitidine Sandoz:

bruising or bleeding – may be due to a low number of blood cells called platelets;
fever – may be due to infection caused by a low number of white blood cells, which can be life-threatening;
diarrhoea, vomiting, or nausea.

Azacitidine may cause a severe immune reaction known as “differentiation syndrome” (see section 4 “Possible side effects”).
The doctor may decide to adjust the dose or temporarily or permanently discontinue treatment with Azacitidine Sandoz. The doctor may prescribe other medicines to help relieve these symptoms.
Children and adolescents
Azacitidine Sandoz is not recommended for use in children and adolescents under 18 years of age.
Azacitidine Sandoz with other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Azacitidine Sandoz may affect the way some other medicines work. Likewise, some other medicines may affect the way Azacitidine Sandoz works.
Pregnancy, contraception, and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine. Men should not father a child during treatment with Azacitidine Sandoz.
Pregnancy
Do not use Azacitidine Sandoz during pregnancy, as it may be harmful to the unborn child. Immediately inform the doctor if pregnancy occurs during treatment.
Contraception
Women of childbearing potential must use an effective method of contraception during treatment with Azacitidine Sandoz and for 6 months after stopping treatment with this medicine.
Men must use an effective method of contraception during treatment with Azacitidine Sandoz and for 3 months after stopping treatment with this medicine.
The doctor will discuss the most appropriate method of contraception with the patient.
Breastfeeding
Do not breastfeed during treatment with Azacitidine Sandoz, as it may harm the baby.
Fertility
Azacitidine Sandoz may affect the ability to have children. Consult the doctor before using this medicine.
Driving and operating machines or tools
The patient may feel tired, weak, or have difficulty concentrating. In such cases, or if other side effects occur, the patient should not drive or operate machinery or tools.
Azacitidine Sandoz contains lactose and sodium
Azacitidine Sandoz contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to take Azacitidine Sandoz

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure,
consult your doctor.
How much medicine to take

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

Azacitidine Sandoz is administered in treatment cycles of 28 days.

Azacitidine Sandoz is taken daily for the first 14 days of each 28-day cycle.
After this period, a 14-day break follows until the end of the cycle.

Your doctor will inform you of the dose of Azacitidine Sandoz you should take. Your doctor may
decide to:

extend treatment beyond 14 days in each treatment cycle;
reduce the dose or temporarily interrupt treatment;
shorten treatment to 7 days. Azacitidine Sandoz should always be taken exactly as prescribed by your doctor.

Your doctor will prescribe a medicine to help prevent nausea and vomiting. This medicine should be taken
30 minutes before each dose of Azacitidine Sandoz tablets during the first and second
treatment cycles. If needed, your doctor may recommend continuing this medicine for a longer period.
How to take the medicine

Azacitidine Sandoz should be taken once daily, at the same time each day.
Tablets should be swallowed whole with a glass of water.
To ensure the correct dose is administered, tablets must not be broken, crushed, dissolved, or chewed.
The medicine may be taken with food or between meals. If the patient vomits after taking a tablet, do not take another dose 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 the skin, wash the skin immediately and thoroughly
with soap and water. If the powder gets into the eyes, nose, or mouth, rinse the area thoroughly with water.
Taking more Azacitidine Sandoz than prescribed
If you take more tablets than prescribed, contact your doctor immediately or go to a hospital. If possible, bring
the medicine packaging and this leaflet with you.
Missing a dose of Azacitidine Sandoz
If you forget to take your dose of Azacitidine Sandoz at the usual time, take the usual dose as soon as you
remember that 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 missed or vomited tablet.
Stopping Azacitidine Sandoz
Do not stop taking Azacitidine Sandoz unless your doctor advises otherwise.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Serious side effects
Contact your doctor, pharmacist, or nurse immediately if you experience any of the following symptoms while being treated with Azacitidine Sandoz:

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

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

constipation;
abdominal pain;
infections of the nose, sinuses and throat;
lung infection;
feeling tired or weak;
loss of appetite;
pain in various parts of the body – may range from sharp to dull pain;
joint stiffness;
back pain.

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

influenza (flu);
urinary tract infection;
hay fever;
anxiety;
weight loss.

Frequency not known (frequency cannot be estimated from the available data):

severe immune reaction (differentiation syndrome), which may cause fever, cough, difficulty breathing, rash, reduced urine output, low blood pressure (hypotension), swelling of the hands or feet, and rapid weight gain.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301; Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Azacitidine Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Azacitidine Sandoz contains

The active substance is azacitidine. Each coated tablet contains 200 mg or 300 mg of azacitidine.
The other ingredients are: sodium croscarmellose, magnesium stearate, mannitol, microcrystalline cellulose, colloidal anhydrous silica.
The 200 mg tablet coating contains: hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol, triacetin, and iron oxide red (E 172). See section 2, "Azacitidine Sandoz contains lactose and sodium".
The 300 mg tablet coating contains: hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol, triacetin (E 1518), iron oxide red (E 172), iron oxide yellow (E 172), and iron oxide black (E 172). See section 2, "Azacitidine Sandoz contains lactose and sodium".

What Azacitidine Sandoz looks like and contents of the pack
Azacitidine Sandoz coated tablets are pink, oval-shaped, measuring 17.2 mm × 7.7 mm,
with the engraved mark "753" on one side and smooth on the other side.
Azacitidine Sandoz coated tablets are brown, oval-shaped, measuring 19.2 mm × 9.2 mm,
with the engraved mark "754" on one side and smooth on the other side.
The coated tablets are packed in single-dose perforated blisters made of
OPA/Aluminum/PVC/Aluminum foil, placed in a cardboard box.
Each pack contains 7 x 1 or 14 x 1 coated tablet(s).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
+48 22 209 70 00

Importer
Qualimetrix S.A.
Mesogeion Avenue 579
Agia Paraskevi
153 43 Athens, Greece
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann SGN 3000, Malta
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
Paola, PLA 3000, Malta
KeVaRo Group EOOD
Ulitsa Tsaritsa Eleonora 9, Office 23, Floor 5
1618 Sofia, Bulgaria

This medicinal product is authorised in the European Economic Area under the following names:
Denmark: Azacitidin Hexal
Austria: Azacitidin Sandoz 200 mg – Filmtabletten
Azacitidin Sandoz 300 mg – Filmtabletten
France: Azacitidine Sandoz
Italy: Azacitidina Sandoz GmbH
Poland: Azacitidine Sandoz