Side Effects

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they occur, they are likely to be temporary, and not serious. However, some may be serious and need medical attention. Prolonged treatment with Flucloxacillin may result 1. 2. 3. 4. Customer: Kent Originated by: DOB (AWG) Product: Flucloxacillin JNT Capsules PIL Item Code: CP.FLU.JNT.C.V12P1 (P217/20) Proof No and Date: 1 24/02/2021 Revision: PRAC update Supersedes: ARTWORK FOR SUBMISSION CP.FLU.JNT.C.V11P1 (P217/19) Dimensions: 148mm x 450mm Colours Pantone Blue 280 in increased growth of resistant organisms. STOP taking Flucloxacillin Capsules and contact your doctor immediately if you experience: • allergy or hypersensitivity including itchy rash, itching, sore mouth or eyes, swelling of the face, lips, throat or tongue or breathing problems • severe, bloody diarrhoea (pseudomembranous colitis). If bloody diarrhoea develops, flucloxacillin treatment should be discontinued and appropriate therapy, e.g. oral vancomycin should be initiated. • jaundice (yellow colour in the skin and whites of the eyes), hepatitis (liver inflammation) – sometimes these effects on the liver can be delayed for up to 2 months after finishing treatment • skin rash with circular, red patches (Erythema multiforme) • severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome) • severe rash with reddening, peeling and swelling of the skin that looks like a burn (toxic epidermal necrolysis). These are all very rare side effects (may affect up to 1 in 10,000 people) Tell your doctor if you notice any of the following effects: Common (may affect up to 1 in 10 people): • diarrhoea, stomach upset and feeling sick – should be mild and wear off after a few days. • heartburn and indigestion Uncommon (may affect up to 1 in 100 people): • rash, itching, red/purple discolourations on the skin. • hives Very rare (may affect up to 1 in 10,000 people): • kidney problems including inflammation (may result in difficulty passing water or blood in the urine) • unexplained bleeding or bruising, or skin discolouration (may be caused by changes in the numbers of blood cells) • joint or muscle pains or fever (may develop 2 days after starting treatment) • abnormal breakdown of red blood cells (haemolytic anaemia) • seizures (convulsions) • changes in liver function test results (reversible when treatment is discontinued). • blood and lymphatic system disorders like neutropenia (reduction in white blood cells) including agranulocytosis (serious low level of white blood cells). People with this condition are at very high risk of serious infections due to their suppressed immune system. Patients are advised to report any signs and symptoms of infection to their doctor. Thrombocytopenia (low platelet count) and Eosinophilia (an increased number of eosinophils in the blood) • cases of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, generally in the presence of risk factors (see section 2). Not known (cannot be estimated from the available data): • Serious skin reactions A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). • Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythm. • Pain in oesophagus (the tube that connects mouth with stomach) and other related symptoms, such as difficulties in swallowing, heartburn, throat irritation or chest pain. Contact a doctor immediately if you get any of these symptoms. Some of these reactions can be delayed for up to two months after finishing the treatment. Check with your doctor if you have any problems while taking this medicine, even if you think the problems are not connected with the medicine, or are not listed in this leaflet. 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. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.