FLENODIC can have side effects. Not all side effects reported for FLENODIC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FLENODIC, please consult your healthcare provider for advice.
If any of the following happens, stop taking / using FLENODIC and tell your doctor immediately or go to the casualty department at your nearest hospital:
- swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing ore breathing,
- rash or itching,
- fainting.
FLENODIC, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood. This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.
These are all very serious side effects. If you have them, you may have had a serious reaction to FLENODIC. 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:
- sudden and crushing chest pain
- angina
- breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
- changes in the way your heart beats, for example, if you notice it beating faster
- sudden weakness or numbness in the face, arm or leg especially on one side of the body, sudden loss or disturbance of vision; sudden difficulty in speaking or ability to understand speech; sudden migraine-like headaches which happen for the first time, with or without disturbed vision. These symptoms can be an early sign of a stroke
- yellowing of your skin or the whites of your eyes
- signs of recurrent infections such as fever or sore throat
- Stevens Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals)
- less urine than is normal to you
- mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with FLENODIC and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain
- flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
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:
- nausea
- vomiting
- diarrhoea
- abdominal pain
- flatulence
- anorexia
- abdominal cramps and discomfort
- local irritation
- headache
- dizziness
- feeling of off balance
- liver function abnormal
Less frequent side effects:
- inflammation of the lining of the stomach
- bleeding in the gastrointestinal tract
- stomach ulcers with or without a rupture in the gastrointestinal tract
- vomiting of blood
- bright red or black blood in stool
- inflammation of the inner lining of the colon
- constipation
- small sores in the inside of the mouth
- inflammation of the mouth
- inflammation of the pancreas
- loss of blood because of the vomiting of blood or the loss of blood after a stool
- blood disorders such as deficiency of red blood cells, low number of platelets, a low level of white blood cells in the blood, which can interfere with the ability to fight infection
- a rare condition in which the body stops producing enough new blood cells, an abnormally low count of a type of white blood cell
- a high level of disease-fighting white blood cells known as eosinophils in the blood, a disorder in which red blood cells are destroyed faster than they can be made
- asthma, inflammation of lung tissue
- disorientation
- depression
- nightmares
- irritability
- pins and needles
- anxiety
- impaired concentration
- tremor
- sweating
- memory disturbance
- fits, an illness characterised by serous inflammation of the linings of the brain (i.e., meninges)
- taste alterations, tiredness
- sleeplessness or sleepiness
- blurred vision, double vision
- changes in the colour, damage to the optic nerve
- loss of hearing, ringing of ears
- high/low blood pressure fluctuations, inflammation of blood vessels
- liver disorders including liver failure and liver, acute toxic injury of the liver, increase in liver enzymes
- Lyell’s syndrome and other skin rashes which may be made worse by exposure to other skin rashes which may be made worse by exposure to sunlight
- loss of hair, hives
- kidney failure, presence of blood or protein in the urine, is order of the kidneys in which all or part of the renal papillae die
- kidney disorder that causes the body to excrete too much protein in the urine
- kidney disorder in which the spaces between the kidney tubules become swollen (inflamed), inflammation of the bladder
- impotence
- swelling and swelling of your lower legs and arms
Side effects with unknown frequency
- occurs when blood flow to part of the large intestine (colon) is temporarily reduced, usually due to constriction of the blood vessels supplying the colon or lower flow of blood through the vessels due to low pressures
- confusion, hallucinations, malaise (general feeling of discomfort), disturbances of sensation
- inflammation of the nerves in the eye
- symptoms such as chest pain (relating to reduced blood flow to the heart) caused by an allergic reaction or a strong immune reaction to a drug or other substance.
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 FLENODIC.
