INVABEX can have side effects. Not all side effects reported for INVABEX are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using INVABEX, please consult your doctor, pharmacist or other healthcare professional for advice.
If any of the following happens, stop using INVABEX and tell your doctor immediately or go to the casualty department at your nearest hospital:
- swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
- fainting
- DRESS (drug rash with eosinophilia and systemic symptoms): This is a serious or life-threatening allergic reaction that may affect your skin or other parts of your body, such as your liver or blood cells. You may have fever, tender swollen glands in the neck, armpits and groin and a rash
- serious skin disorders, such as blistering or peeling of the skin, Stevens-Johnson syndrome (a complex allergic reaction, with skin and mucous membrane lesions, which may become severe and may be fatal)
- severely upset stomach (pseudomembranous colitis). You may have inflammation of the bowels, that could be life-threatening. The symptoms may include severe abdominal pain and diarrhoea, or diarrhoea tinged with blood, vomiting and fever.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to INVABEX. 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:
Adults 18 years of age and older:
- yellowing of the eyes and skin (jaundice or a liver disorder)
- seizure, tremor
- slow heart rate, irregular heartbeat, quick heartbeat
- low or high blood pressure
- an allergic reaction called Kounis syndrome (you may experience symptoms such as chest discomfort, acute chest pain, faintness, headache, nausea and dyspnoea)
- kidney function affected. Problems to urinate or to pass adequate urine (acute renal insufficiency)
- hallucinations (hearing and seeing things that do not exist)
- altered mental state (including aggression, disturbance of mental abilities, disorientation, confusion, memory loss, personality changes)
- decreased level of consciousness.
Children and adolescents (3 months to 17 years of age):
- hallucinations
- altered mental status (including aggression)
- high blood pressure.
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:
Adults 18 years of age and older:
- headache
- problems with the vein into which the medicine is given (including inflammation, formation of a lump, swelling at the injection site)
- diarrhoea, nausea, vomiting
- rash, itching
- increase in various liver enzymes. Some of the signs may be yellowing of the skin, whites of the eyes, pain or swelling in the abdomen, nausea and vomiting, dark urine, pale-coloured stools
- increased blood platelet count. Some of the signs may be headache, numbness of hands or feet, weakness, bleeding in mouth or gums, bloody stool, easy bleeding or bruising, nosebleeds
- muscle cramp, shoulder pain.
Children and adolescents (3 months to 17 years of age):
- diarrhoea, vomiting
- nappy rash, rash
- pain at the infusion site
- changes in white blood cell count, changes in liver function tests.
Less frequent side effects:
Adults 18 years of age and older:
- infections, such as oral thrush, vaginal thrush, yeast and fungal infections, wound infection after an operation, urinary tract infection
- laboratory tests may show very low white cell or blood platelet counts (which may lead to more infections or bleeding)
- anorexia (eating disorder)
- low blood sugar
- sleepiness, sleeplessness
- anxiety, depression
- altered taste sensation
- changes to the white part of the eye
- bleeding
- shortness of breath, sore throat, nasal congestion, cough, abnormal breathing sounds, wheezing
- nose bleeds
- constipation
- abdominal pain, inflammation of the membrane that lines the abdomen in the pelvic area
- acid regurgitation, indigestion, dry mouth, difficulty swallowing
- faecal incontinence
- inflammation of the liver and/or the gallbladder
- skin redness, inflammation
- skin blisters in a clustered arrangement on the face and possibly perineum, that may spread to the limbs, trunk, hands, feet and scalp (linear IgA bullous disease)
- miscarriage, genital bleeding
- fatigue
- leaking of fluid into the tissue and skin around the injection site
- fever, feeling unwell, swelling, chest pain
- changes in various laboratory blood and urine tests, indicating for example effects on the liver, kidneys, sugar, blood chemistry, cholesterol.
Children and adolescents (3 months to 17 years of age):
- headache
- hot flush
- discoloured faeces, black tar-like faeces
- skin redness, skin rash, tiny purple, red, or brown spots on the skin
- burning, itching, redness and warmth at infusion site, redness at injection site
- increase in platelet count and changes in other blood clotting tests.
The following side effects have been reported but the frequency for them to occur is not known:
Adults 18 years of age and older:
- uncontrolled, involuntary movement, spasmodic, jerky contractions
- unsteady walking
- stained teeth
- weak muscles.
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 INVABEX. You can also send an email directly to the company, [email protected], to ensure safety of the product.
