GEMCITABINE OETHMAAN can have side effects. Not all side effects reported for GEMCITABINE OETHMAAN are included in this leaflet. Should your general health worsen while taking GEMCITABINE OETHMAAN, please consult your doctor, pharmacist or other health care professional for advice.
If any of the following happens, stop receiving GEMCITABINE OETHMAAN and tell your doctor immediately or go to the casualty department at your nearest hospital:
- an allergic reaction, symptoms of which includes rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue
These are very serious side effects. If you have them, you may have had a serious reaction to GEMCITABINE OETHMAAN. 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:
- Fever or infection (frequent): if you have a temperature of 38 ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very frequent).
- Irregular heart rate (arrhythmia) (less frequent)
- Pain, redness, swelling or sores in your mouth (frequent).
Allergic reactions: if you develop skin rash (very frequent) / itching (frequent), or fever (very frequent).
Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very frequent).
Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very frequent).
Difficulty breathing (it is very frequent to have mild breathing difficulty soon after the GEMCITABINE OETHMAAN infusion which soon passes, however less frequently there can be more severe lung problems).
Headache with changes in vision, confusion, seizures or fits (posterior reversible encephalopathy syndrome).
Generalised swelling, shortness of breath or weight gain, as you might have fluid leakage from small blood vessels into the tissues (capillary leak syndrome).
Extreme tiredness and weakness, purpura or small areas of bleeding in the skin (bruises), acute renal failure (low urine output /or no urine output), and signs of infection (haemolytic uraemic syndrome). It may be fatal (less frequent).
Severe skin rash with flushing, fever, blisters or ulcers (Stevens - Johnson syndrome) (less frequent).
Severe rash with reddening, peeling and swelling of the skin that looks like a burn (toxic epidermal necrolysis) (less frequent).
A red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever (Acute Generalized Exanthematous Pustulosis (AGEP) (frequency not known).
These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following: Side effects with GEMCITABINE OETHMAAN may include:
- Frequent side effects
- Low haemoglobin level (anaemia), Low white blood cells, Low platelet count
- Difficulty breathing
- Vomiting, nausea
- Skin rash- allergic skin rash, frequently itchy, hair loss
- Liver problems: found through abnormal blood test results
- Blood in urine, abnormal urine tests: protein in urine
- Flu like symptoms including fever
- Oedema (swelling of ankles, fingers, feet, face)
- Infections
- Fever accompanied by low white blood cell count (febrile neutropenia)
- Anorexia (poor appetite)
- Headache, insomnia, sleepiness
- Cough, runny nose
- Constipation, diarrhoea
- Pain, redness, swelling or sores in the mouth
Itching, sweating
Muscle pain, back pain
Fever, weakness, chills
Less frequent side effects
Clots forming in small blood vessels (thrombotic microangiopathy).
Interstitial pneumonitis (scarring of the air sacs of the lung)
Spasm of the airways (wheeze)
Abnormal chest X ray/scan (scarring of the lungs)
Irregular heart beat (dysrrhythmia), heart failure
Kidney failure
Serious liver damage, including liver failure
Stroke
Heart attack (myocardial infarction)
Low blood pressure
Inflammation of the blood vessels (peripheral vasculitis).
Skin scaling, ulceration or blister formation
Injection site reactions
Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)
Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy.
Fluid in the lungs
Radiation toxicity - scarring of the air sacs of the lung associated with radiation therapy
Gangrene of fingers or toes
Increased platelet count
Anaphylactic reaction (severe hypersensitivity/ allergic reaction)
Sloughing of skin and severe skin blistering, skin redness with swelling (pseudocellulitis)
Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)
Frequency unknown: Sepsis: when bacteria and their toxins circulate in the blood and start to damage the organs
Lyell’s syndrome - rash where the skin is itchy, red, swollen, blistered or peeling
You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.
If you are concerned about any side effects, talk to your doctor. If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of GEMCITABINE OETHMAAN.
