• ARIPIPRAZOLE ACCORD can have side effects.
• Not all side effects reported for ARIPIPRAZOLE ACCORD are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ARIPIPRAZOLE ACCORD, please consult your doctor, pharmacist or other healthcare professional for advice.
• If any of the following happens, stop taking ARIPIPRAZOLE ACCORD and tell your doctor immediately or go to the casualty department at your nearest hospital:
- o Swelling of face, tongue
- o Difficulty breathing
- o Severe skin rash or itching
These are all very serious side effects. If you have them, you may have had a serious reaction to ARIPIPRAZOLE ACCORD. 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:
- o You start having thoughts of hurting yourself.
- o You experience an increased urge to gamble, spend money excessively or other impulsive behaviour.
- o Muscle stiffness, a high fever, faster heartbeat or faster breathing – these could be signs of a serious condition called Neuroleptic malignant syndrome.
- o If you are agitated, restless, experience insomnia, confusion and a rapid heart rate and high blood pressure – these may be signs of serotonin syndrome.
- o Heart palpitations, dizziness, nausea, cold sweats and chest pain – these may be signs of a cardiac problem.
- o Leg pain or tenderness, accompanied by swelling and reddish, warm skin – these could indicate a clot in a vein.
- o Fever, rash and swollen lymph nodes could indicate a condition called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms).
These are all serious side effects. You may need urgent medical attention.
• Tell your doctor if you notice any of the following:
- o Frequent side effects
- ▪ Increased thirst, needing to urinate more often, especially at night – these could be signs of diabetes
- ▪ Difficulty sleeping, feeling anxious or restless
- ▪ Tremors, headache, feeling sleepy, dizziness
- ▪ Blurred vision
- ▪ Constipation, abdominal discomfort, nausea, vomiting, increased saliva production
- ▪ Fatigue, weakness or lack of energy
o Less frequent side effects
- ▪ Change in menstrual cycle, production of breast milk
- ▪ Increased thirst, dry mouth, needing to urinate often, fatigue may indicate increased blood sugar levels
- ▪ Depression
- ▪ Involuntary facial movements or repetitive twisting movements, uncontrollable urge to move your legs
- ▪ Double vision, sensitivity to light
- ▪ Increased heart rate
- ▪ Feeling light headed or dizzy when standing up from a sitting or lying down position
- ▪ swelling of hands and feet
o Side effects with unknown frequency
- ▪ Eating disorder
- ▪ Spasm of the eyeballs where they get into a fixed position
- ▪ Difficulty speaking, feeling of something being stuck in your throat
- ▪ Food, saliva or liquids are breathed into your lungs instead of being swallowed.
- ▪ Difficulty swallowing, abdominal pain, diarrhoea
- ▪ Yellowing skin and eyes – which may indicate liver problems
- ▪ Skin rash when exposed to sun, loss of hair, increased sweating
- ▪ Muscle stiffness, dark, reddish urine, weakness, muscle aches
- ▪ Difficulty urinating completely, leakage of urine
- ▪ Prolonged erection
- ▪ Problems with regulating temperature, chest pain, swelling of hands and feet
- ▪ Increase or decrease in your weight
- ▪ compulsive sexual behaviour or sexual addiction
- ▪ hiccups
• 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. 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 ARIPIPRAZOLE ACCORD.
