Side Effects

Side Effects of Fleming 457  Suspension

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects below may happen with this medicine. Conditions you need to look out for Allergic reactions: • skin rash • inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body • fever, joint pain, swollen glands in the neck, armpit or groin • swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing • collapse. ➔ Contact a doctor immediately if your child gets any of these symptoms. Stop taking Fleming. Inflammation of large intestine Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever. ➔ Contact your doctor as soon as possible for advice if your child gets these symptoms. Common side effects These may affect up to 1 in 10 people • thrush (candida – a yeast infection of the vagina, mouth or skin folds) • feeling sick (nausea), especially when taking high doses → if affected take Fleming before food • vomiting • diarrhoea (in children). Uncommon side effects These may affect up to 1 in 100 people • skin rash, itching • raised itchy rash (hives) • indigestion • dizziness • headache. Uncommon side effects that may show up in blood tests: • increase in some substances (enzymes) produced by the liver. Rare side effects These may affect up to 1 in 1000 people • skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge – erythema multiforme) ➔ if you notice any of these symptoms contact a doctor urgently. Rare side effects that may show up in blood tests: • low number of cells involved in blood clotting • low number of white blood cells. 5 Frequency not known Frequency cannot be estimated from the available data. • Allergic reactions (see above) • Inflammation of the large intestine (see above) • Inflammation of the protective membrane surrounding the brain (aseptic meningitis) • Serious skin reactions: – a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis) – widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis) – a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis) – 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)). ➔ Contact a doctor immediately if your child gets any of these symptoms. • inflammation of the liver (hepatitis) • jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your child’s skin and whites of the eyes appear yellow • inflammation of tubes in the kidney • blood takes longer to clot • hyperactivity • convulsions (in people taking high doses of Fleming or who have kidney problems) • black tongue which looks hairy • stained teeth (in children), usually removed by brushing. Side effects that may show up in blood or urine tests: • severe reduction in the number of white blood cells • low number of red blood cells (haemolytic anaemia) • crystals in urine. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet