CYTARABINE FRESENIUS can have side effects. Not all side effects reported for CYTARABINE FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CYTARABINE FRESENIUS, please consult your healthcare provider for advice.
If any of the following happens, stop using CYTARABINE FRESENIUS and tell your doctor immediately or go to the casualty department at your nearest hospital:
- • an allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body), and you may feel you are going to faint.
- • infection to the whole body (sepsis), with symptoms of fever and chills, very low body temperature, urinating less than normal, rapid pulse, rapid breathing, nausea and vomiting, diarrhea, body aches.
- • unexpected bleeding e.g. bleeding gums, blood in urine or vomit.
- • unexpected bruises. These are the symptoms of low numbers of blood cells.
- • blood in vomit or in stools (gastrointestinal necrosis or ulcer).
- • severe pain in the chest and difficulty breathing (this may be a symptom of pericarditis).
- • loss of vision, loss of sense of touch, mental disturbance or loss of ability to move normally, paralysis (this medicine may cause side effects to the nervous system, brain and eyes which are usually reversible but may be very serious).
These are all very serious side effects. If you have them, you may have had a serious reaction to CYTARABINE FRESENIUS. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
- • pneumonia (which can become serious and lead to organ failure).
- • insufficient production or decrease in numbers of red blood cells, white blood cells or platelets, production of red blood cells larger than normal (will be determined by blood tests conducted by your doctor).
- • liver damage.
- • “cytarabine syndrome”, which is characterised by the following side effects that usually, occurs 6 to 12 hours after receiving CYTARABINE FRESENIUS. Feeling generally unwell with a high temperature, pain in bone, muscle pain and sometimes chest pain, blistery rash, swollen and sore eyes.
- • abnormal bone marrow results from a biopsy, or blood results from a smear test.
- • abdominal pain, chills, vomiting, fever, dark-coloured urine, diarrhoea (this may be symptoms of liver abscess, a pus-filled mass inside the liver).
- • inflammation to your veins (caused by a blood clot).
- • shortness of breath, sore throat, pain or difficulty swallowing.
- • jaundice (seen as yellowing of the skin and whites of the eye).
- • blood in your urine and impaired kidney function.
- • chest pain.
The following side effects have been reported with high dose therapy:
- • paralysis caused by cerebral disorder, experience problems in walking, speech problems, involuntary muscle movement caused by cerebellar disorder, tiredness, weakness, fainting.
- • short or stabbing chest pain, build-up of fluid in the lungs.
- • infection and inflammation of the intestines.
- • prolonged state of unconsciousness (coma), fit, poor balance caused by damage to nerves.
- • fast heartbeat, reduced function of the heart, shortness of breath, dizziness, swelling of legs, ankles, feet and veins in the neck (cardiomyopathy), which can be fatal.
These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
Frequent side effects:
- • inflammation or appearance of sores in the mouth, lips, or on the anus, feeling sick (nausea), being sick (vomiting), diarrhoea, abdominal pain.
- • hair loss is common and may be quite severe (hair normally re-grows when your treatment course ends), skin rash, ulceration on your skin.
- • feeling hot and feverish.
Frequency of side effects not known:
- • you may get an infection, including infection or inflammation at the site of your injection.
- • loss of appetite.
- • headaches or feeling dizzy.
- • sore and swollen eyes (conjunctivitis).
- • slower than usual heart rate or heartbeat.
- • severe pain in the abdomen, feeling sick or vomiting, inflammation or ulcers in the gullet, causing heartburn (this may be a symptom of inflammation of the pancreas).
- • skin redness (similar to sunburn), pain and numbness in joints, fingers, toes or face, swelling of the abdomen, legs, ankles and feet, a sensation of tingling or burning, tenderness and tightness of the skin, thick calluses on the palms and hands, itchy skin rash, itching or increased freckles.
- • difficulty or pain when passing urine.
The following side effects have been reported with high dose therapy:
Frequent side effects:
- • eye infection, irritation, pain and blurred vision.
- • peeling of the skin.
Frequency of side effects not known:
- • changes in your personality.
- • slower than usual heart rate or heartbeat.
- • stomach pain or tenderness (peritonitis), burning stomach pain (gastrointestinal ulcer).
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of CYTARABINE FRESENIUS. Patients are asked to report any suspected adverse drug reactions to their healthcare provider or Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed.
