Tacidine is an anticancer agent which belongs to a group of medicines called "antimetabolites".
Tacidine contains the active substance "Azacitidine".
Tacidine is used in adults who are not able to have a stem cell transplantation to treat
• higher-risk myelodysplastic syndromes (MDS)
• chronic myelomonocytic leukaemia (CMML)
• acute myeloid leukaemia (AML)
These are diseases which affect the bone marrow and can cause problems with normal blood cell
production.
How Tacidine works
Tacidine works by preventing cancer cells from growing. Azacitidine becomes incorporated into
the genetic material of cells (ribonucleic acid (RNA) and deoxyribonucleic acid (DNA)). It is
thought to work by altering the way the cell turns genes on and off and also by interfering with the
production of new RNA and DNA. These actions are thought to correct problems with the
maturation and growth of young blood cells in the bone marrow that cause myelodysplastic
disorders, and to kill cancerous cells in leukaemia.
Talk to your doctor or nurse if you have any questions about how Tacidine works or why this
medicine has been prescribed for you.

You must not be given Tacidine if
• you are allergic to Azacitidine or any of the other ingredients of this medicine
(listed in Section 6)
• you have advanced liver cancer
• you are pregnant
• you are breastfeeding
• you have severe problems with your kidney function
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before you are given Tacidine if
• you have decreased counts of platelets, red or white blood cells
• you have kidney disease
• you have liver disease
• you have ever had a heart condition or heart attack or any history of lung disease
Blood Test
You will have blood tests before you begin treatment with Tacidine and at the start of each period
of treatment (called a "cycle"). This is to check that you have enough blood cells and that your
liver and kidneys are working properly.
If you are older than 65 years, your doctor will give you the regular blood tests described above
but may also check your kidney function during your treatment with other tests.
Children and Adolescents
Tacidine is not recommended for use in children and adolescents below the age of 18.
Other medicines and Tacidine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines that you get without a prescription and herbal medicines. This
is because Tacidine may affect the way some other medicines work. Also, some other medicines
may affect the way Tacidine works.
Pregnancy, Breastfeeding and Fertility
Pregnancy
You should not use Tacidine during pregnancy as it may be harmful to the baby.
Use an effective method of contraception during and up to 3 months after treatment.
Tell your doctor straightaway if you become pregnant during treatment.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
You should not breastfeed when using Tacidine. It is not known if this medicine passes into
human milk.
Fertility
Men should not father a child while receiving treatment with Tacidine. Use an effective method of
contraception during and up to 3 months after treatment with this medicine.
Talk to your doctor if you wish to conserve your sperm before starting this treatment.
Female partners of male patients receiving Tacidine should not become pregnant.
Driving and using machines
Do not drive or use any tools or machines if you experience side effects, such as tiredness.

Before giving you Tacidine, your doctor will give you another medicine to prevent nausea and
vomiting at the start of each treatment cycle.
The recommended dose is 75mg per m2 body surface area. Your doctor will decide your dose of
this medicine, depending on your general condition, height and weight. Your doctor will check
your progress and may change your dose if necessary.
Tacidine is given every day for 7 days, followed by a rest period of 21 days. This "treatment
cycle" will be repeated every 28 days. You will usually receive at least 6 treatment cycles.
This medicine will be given to you as an injection under the skin (subcutaneously i.e. under the
skin on your thigh, abdomen or upper arm) or as an intravenous infusion by a doctor or a nurse.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straightaway if you notice any of the following side effects:
• Drowsiness, shaking, jaundice, abdominal bloating and easy bruising. These may be
symptoms of liver failure and can be life threatening.
• Swelling of the legs and feet, back pain, reduced passing of water, increased thirst, rapid
pulse, dizziness and nausea, vomiting or reduced appetite and feelings of confusion,
restlessness or fatigue. These may be symptoms of kidney failure and can be life threatening.
• A fever. This could be due to an infection as a result of having low levels of white blood cells,
which can be life threatening.
• Chest pain or shortness of breath which may be accompanied with a fever. This may be
due to an infection of the lung called "pneumonia", and can be life threatening.
• Bleeding. Such as blood in the stools due to bleeding in the stomach or gut, or such as bleeding
inside your head. These may be symptoms of having low levels of platelets in your blood.
• Difficulty breathing, swelling of the lips, itching or rash. This may be due to an allergic
(hypersensitivity) reaction.
Other side effects include
Very common (may affect more than 1 in 10 people)
• reduced red blood count (anaemia). You may feel tired and pale
• reduced white blood cell count. This may be accompanied by a fever. You are also more likely
to get infections
• a low blood platelet count (thrombocytopenia). You are more prone to bleeding and bruising
• constipation, diarrhoea, nausea, vomiting
• pneumonia
• chest pain, being short of breath
• tiredness (fatigue)
• injection site reaction including redness, pain or a skin reaction
• loss of appetite
• joint aches
• bruising
• rash
• red or purple spots under your skin
• pain in your belly (abdominal pain)
• itching
• fever
• sore nose and throat
• dizziness
• headache
• having trouble sleeping (insomnia)
• nosebleeds (epistaxis)
• muscle aches
• weakness (asthenia)
• weight loss
• low levels of potassium in your blood
Common (may affect up to 1 in 10 people)
• bleeding inside your head
• an infection of the blood caused by bacteria (sepsis). This may be due to low levels of white
cells in your blood
• bone marrow failure. This can cause low levels of red and white blood cells and platelets
• a type of anaemia where your red and white blood cells and platelets are reduced
• an infection in your urine
• a viral infection causing cold sores (herpes)
• bleeding gums, bleeding in the stomach or gut, bleeding from around your back passage due to
piles (haemorrhoidal haemorrhage), bleeding in your eye, bleeding under your skin, or into
your skin (haematoma)
• blood in your urine
• ulcers of your mouth or tongue
• changes to your skin at the injection site. These include swelling, a hard lump, bruising,
bleeding into your skin (haematoma), rash, itching and changes in the skin colour
• redness of your skin
• skin infection (cellulitis)
• an infection of the nose and throat, or sore throat
• sore or runny nose or sinuses (sinusitis)
• high or low blood pressure (hypertension or hypotension)
• being short of breath when you move
• pain in your throat and voice box
• indigestion
• lethargy
• feeling generally unwell
• anxiety
• being confused
• hair loss
• kidney failure
• dehydration
• white coating covering tongue, inner cheeks, and sometimes on the roof of your mouth, gums
and tonsils (oral fungal infection)
• fainting
• a fall in blood pressure when standing (orthostatic hypotension) leading to dizziness when
moving to a standing or sitting position
• sleepiness, drowsiness (somnolence)
• bleeding due to a catheter line
• a disease affecting the gut which can result in fever, vomiting and stomach pain (diverticulitis)
• fluid around the lungs (pleural effusion)
• shivering (chills)
• muscle spasms
• raised itchy rash on the skin (urticaria)
• collection of fluid around the heart (pericardial effusion)
Uncommon (may affect up to 1 in 100 people)
• allergic (hypersensitivity) reaction
• shaking
• liver failure
• large plum-coloured, raised painful patches on the skin with fever
• painful skin ulceration (pyoderma gangrenosum)
• inflammation of the lining around the heart (pericarditis)
Rare (may affect up to 1 in 1,000 people)
• dry cough
• painless swelling in the finger tips (clubbing)
• tumour lysis syndrome - metabolic complications that can occur during treatment of cancer and
sometimes even without treatment. These complications are caused by the product of dying
cancer cells and may include the following: changes to blood chemistry; high potassium,
phosphorus, uric acid, and low calcium consequently leading to changes in kidney function,
heartbeat, seizures, and sometimes death
Not known (frequency cannot be estimated from the available data)
• infection of the deeper layers of skin, which spreads quickly, damaging the skin and tissue,
which can be life threatening (necrotising fasciitis).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report the side effects directly to the National
Pharmacovigilance Centre (NPC) (see Section 6). By reporting side effects, you can help provide
more information on the safety of this medicine.

Keep out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the vial label and the carton. The
expiry date refers to the last day of that month.
Your doctor, pharmacist or nurse are responsible for storing Tacidine. They are also responsible
for preparing and disposing of any unused Tacidine correctly.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.
After reconstitution
When Tacidine is reconstituted using water for injection that has not been refrigerated, chemical
and physical in-use stability of the reconstituted medicinal product has been demonstrated at 25°C
for 1 hour and at 2°C to 8°C for 8 hours.
The shelf life of the reconstituted medicinal product can be extended by reconstituting with
refrigerated (2°C to 8°C) water for injection. When Tacidine is reconstituted using refrigerated
(2°C to 8°C) water for injection, the chemical and physical in-use stability of the reconstituted
medicinal product has been demonstrated at 2°C to 8°C for 22 hours.
From a microbiological point of view, the reconstituted 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 must not be longer than 8 hours at 2°C to 8°C when reconstituted using water for
injection that has not been refrigerated or not longer than 22 hours when reconstituted using
refrigerated (2°C to 8°C) water for injection.
The reconstituted medicinal product should be allowed up to 30 minutes prior to administration to
reach room temperature (20°C to 25°C).
If large particles are present in the reconstituted medicinal product it should be discarded.