BETACIN ® can have side effects. Not all side effects reported for BETACIN ® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this BETACIN ®, please consult your health care provider for advice.
If any of the following happens, stop taking BETACIN ® capsules and tell your doctor immediately or go to the casualty department at your nearest hospital:
- signs of bleeding in the stomach:
- Pass blood in your faeces (stools/motions)
- Pass black tarry stools
- Vomit any blood or dark particles that look like coffee grounds
- signs of an allergic reaction:
- difficulty breathing or swallowing, asthma, sudden decrease in blood pressure
- swelling of the face, lips, tongue or throat.
- A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
These are all very serious side effects. If you have them, 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:
- abdominal pain (pains in your stomach) or other abnormal stomach symptoms
- effects on the stomach such as feeling or being sick, inflammation of the stomach lining, small intestine or mouth, constipation, diarrhoea, wind, perforation of previous intestinal damage, narrowing of or blockage in the intestine
- abnormal liver function (as seen in blood tests)
- liver disease: yellowing of the skin or whites of the eyes (jaundice), inflammation of the liver (hepatitis), causing fatigue, weakness, loss of appetite, weight loss, abdominal pain, fever
- skin reactions such as itching, pale or red irregular raised patches with severe itching (hives), disorder characterised by blood spots, bruising and discolouring of the skin (purpura), blisters or skin that is red, flaky or peeling such as severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis), circular, irregular red patches on the skin of the hands and arms (erythema multiforme), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome)
- aseptic meningitis (stiff neck, headache, feeling or being sick, fever, disorientation) especially in those who already have an auto - immune disease such as systemic lupus erythematosus or mixed connective tissue disease.
These are serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
- Eyes:
- blurred and double vision
- inflammation of the optic nerve (which may cause eye pain and loss of vision)
- eye pain
- changes in your sight.
- Ear:
- ringing or buzzing in the ears
- hearing disturbances including deafness.
- Blood:
- small purple red spots, nosebleeds, bruising, disorder characterised by blood spots, blood clotting throughout the body, disturbance of blood count, reduction in blood cell production by the bone marrow. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion, or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.
- Metabolism:
- high blood sugar
- sugar in the urine
- high blood levels of potassium (muscle cramps or pain, irregular heartbeat, unusual tiredness or weakness).
- Nervous system:
- headache, dizziness, lightheadedness, spinning sensation (vertigo), tiredness, fainting, a feeling of general discomfort and illness, drowsiness, coma, fluid in the brain causing swelling
- depression, nervousness, confusion, hallucinations, anxiety and other mental health problems, a feeling of unreality (that the mind is separated from the body), difficulty sleeping speech disorder, fits or seizures, worsening of epilepsy, disorder of the nerves causing tingling and numbness, pins and needles
- uncontrolled movements, worsening of parkinsonism (tremor, stiffness and shuffling).
- Heart:
- fluid retention causing swelling, chest pain, heart failure (symptoms include shortness of breath, tiredness, increased heart rate, flushing, swelling - especially of the ankles)
- high and low blood pressure (symptoms include dizziness, fainting, light-headedness, nausea, heart attack)
- racing heartbeat, irregular heartbeat, palpitations.
- Blood vessels:
- Breathing:
- increase in the number of white blood cells in the lungs
- narrowing of the airways in those who have a history of asthma or allergic disease.
- Stomach and intestines:
- loss of appetite
- development or worsening of ulcerative colitis or Crohn’s disease
- inflammation of the pancreas causing pain and tenderness in the abdomen and back (pancreatitis).
- Skin:
- inflammation of blood vessels
- sensitivity to sunlight or artificial light (e.g. sunbeds)
- tender red lumps usually on the legs (erythema nodosum)
- hair loss, sweating
- worsening of psoriasis (itchy scaly pink patches on the elbows, knees, scalp and other parts of the body).
- Liver:
- blocked bile flow (pale coloured stools, dark urine, itching).
- Muscle and bone:
- muscle weakness, increased breakdown of cartilage.
- Kidneys:
- blood in the urine
- nephrotic syndrome (increased protein in urine and fluid retention)
- too much protein in the urine
- inflammation of the kidneys, reduced kidney function or kidney failure.
- Reproductive system:
- bleeding from the vagina
- breast enlargement or tenderness, enlarged breasts in men.
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 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 effect you can help provide more information on the safety of BETACIN ®.
