Package leaflet: Information for the patient

Azacitidine MSN, 200 mg, film-coated tablets
Azacitidine MSN, 300 mg, film-coated tablets
Azacitidinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

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

What Azacitidine MSN is
Azacitidine MSN is an anticancer medicine belonging to a group of medicines called
antimetabolites.
Azacitidine MSN contains the active substance azacitidine.

What Azacitidine MSN is used for
Azacitidine MSN is used in the treatment of adults with acute myeloid leukaemia (AML). This is a type of cancer that affects the bone marrow and can cause difficulties in the normal production of blood cells.
Azacitidine MSN is used to maintain control over the disease (to sustain remission, i.e. the period when the disease is less severe or inactive).

How Azacitidine MSN works
Azacitidine MSN works by preventing the growth of cancer cells. The active substance in Azacitidine MSN, azacitidine, acts by altering the way genes in the cell are activated and deactivated, as well as interfering 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 MSN works or why it has been prescribed, please consult your doctor or nurse.

2. Important information before using Azacitidine MSN

When not to use Azacitidine MSN

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

Warnings and precautions
Blood tests
Before starting treatment and during treatment with Azacitidine MSN, blood tests will be performed to check whether the patient has an adequate number of blood cells and whether the liver and kidneys are functioning properly. The doctor will decide how often the patient should have blood tests.
The patient should immediately inform the doctor, pharmacist or nurse if any of the following symptoms occur during treatment with Azacitidine MSN:

Bruising or bleeding – may be caused by a low number of blood cells called platelets;
Fever – may be due to infection resulting from a low number of white blood cells, which can be life-threatening;
Diarrhea, vomiting or nausea.

The doctor may decide to change the dose or temporarily or permanently discontinue treatment with Azacitidine MSN. The doctor may also prescribe other medicines to relieve these symptoms.
Children and adolescents
Azacitidine MSN is not recommended for use in children and adolescents under 18 years of age.
Azacitidine MSN and other medicines
The patient should tell the doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Azacitidine MSN may affect the way some other medicines work. Likewise, some other medicines may affect the way Azacitidine MSN works.
Pregnancy, contraception and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. Men should not father a child during treatment with Azacitidine MSN.
Pregnancy
Azacitidine MSN must not be used during pregnancy, as it may be harmful to the unborn child. The patient must immediately inform the doctor if she becomes pregnant during treatment.
Contraception
Women of childbearing potential must use an effective method of contraception during treatment with Azacitidine MSN and for 6 months after stopping treatment with this medicine. Men must use an effective method of contraception during treatment with Azacitidine MSN and for 3 months after stopping treatment with this medicine.
The doctor will discuss with the patient the most appropriate method of contraception.
Breastfeeding
Breastfeeding must not be undertaken during treatment with Azacitidine MSN, as it may harm the child.
Fertility
Azacitidine MSN may affect the ability to have children. The patient should consult the doctor before using this medicine.
Driving and operating machinery or tools
The patient may feel tired, weak or have difficulty concentrating. In such a case, or if other adverse effects occur, the patient should not drive or operate machinery or tools.
Azacitidine MSN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to take Azacitidine MSN

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Dosage

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

Azacitidine MSN is administered in treatment cycles of 28 days.

Azacitidine MSN 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 MSN to 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 MSN should always be taken as directed 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 MSN 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

Take Azacitidine MSN once daily – at the same time each day.
Swallow the tablets whole with a glass of water.
To ensure the correct dose is given, do not break, crush, dissolve, or chew the tablets.
The medicine may be taken with food or between meals. If vomiting occurs 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 MSN than prescribed
If more tablets are taken than prescribed, contact your doctor immediately or go to the hospital. If possible, bring the medicine pack and this leaflet with you.
Missing a dose of Azacitidine MSN
If you forget to take your usual dose of Azacitidine MSN, 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 missed or vomited tablet.
Stopping Azacitidine MSN
Do not stop taking Azacitidine MSN unless your doctor advises otherwise.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Immediately tell your doctor, pharmacist or nurse if any of the following symptoms occur during treatment with Azacitidine MSN:

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

Other adverse reactions include:
Very common adverse reactions (may occur in more than 1 in 10 people):

constipation
abdominal pain
nose, sinus and throat infections
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 adverse reactions (may occur in up to 1 in 10 people):

influenza (flu)
urinary tract infection
allergic rhinitis (hay fever)
anxiety
weight loss

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Azacitidine MSN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton box: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Azacitidine MSN contains
The active substance is azacitidine.
Each coated tablet contains 200 mg of azacitidine.
Each coated tablet contains 300 mg of azacitidine.

The other ingredients are:
Tablet core: Silicified microcrystalline cellulose (containing microcrystalline cellulose (E 460)
and silicon dioxide (E 551)), mannitol (E 421), sodium croscarmellose (E 468), and magnesium stearate
(E 470b).

Tablet coating:
[200 mg]: Macrogol – 8000 (E 1521), hypromellose (E 464), titanium dioxide (E 171), macrogol
(E 1521), triacetin (E 1518), and iron oxide red (E 172).
[300 mg]: Macrogol – 8000 (E 1521), hypromellose (E 464), titanium dioxide (E 171), macrogol
(E 1521), triacetin (E 1518), iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172).

What Azacitidine MSN looks like and contents of the pack
Azacitidine MSN 200 mg, coated tablets are pink, oval, biconvex, film-coated tablets, embossed with "MA" on one side and "24" on the other.
Azacitidine MSN 300 mg, coated tablets are brown, oval, biconvex, film-coated tablets, embossed with "MA" on one side and "25" on the other.
The coated tablets are packed in blisters.
Each cardboard carton contains 7 or 14 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
Tel.: (+48) 699 711 147
(logo of the marketing authorisation holder)

Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area under the following names:
Netherlands: Azacitidine MSN 200 mg filmomhulde tabletten
Azacitidine MSN 300 mg filmomhulde tabletten
Poland: Azacitidine MSN