Side Effects

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause some side effects, although not everybody gets them. Stop taking Amoxicillin Suspension and see a doctor straight away, if you notice any of the following serious side effects – you may need urgent medical treatment: The following are very rare (may affect up to 1 in 10,000 people) • allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or breathing difficulties. These can be serious and occasionally deaths have occurred • rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems • a delayed allergic reaction can occur usually 7 to 12 days after having Amoxicillin Suspension, some signs include: rashes, fever, joint pains and enlargement of the lymph nodes especially under the arms • a skin reaction known as ‘erythema multiforme’ where you may develop: itchy reddish-purple patches on the skin especially on the palms of the hands or soles of the feet, ‘hive-like’ raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and genitals. You may have a fever and be very tired • other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches • 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)). • fever, chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a problem with your blood cells • the Jarisch-Herxheimer reaction which occurs during treatment with Amoxicillin Suspension for Lyme disease and causes fever, chills, headache, muscle pain and skin rash. • inflammation of the large bowel (colon) with diarrhoea (sometimes containing blood), pain and fever • serious liver side effects may occur. They are mainly associated with people having treatment over a long period, males and the elderly. You must tell your doctor urgently if you get: – severe diarrhoea with bleeding – blisters, redness or bruising of the skin – darker urine or paler stools – yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice. These can happen when having the medicine or for up to several weeks after. If any of the above happens stop taking the medicine and see your doctor straight away. Sometimes you may get less severe skin reactions such as: • a mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms, legs, palms, hands or feet. This is uncommon (may affect up to 1 in 100 people) If you have any of these talk to your doctor as Amoxicillin Suspension will need to be stopped. The other possible side effects are: Common (may affect up to 1 in 10 people): • nausea (feeling of sickness) • diarrhoea • skin rash Uncommon (may affect up to1 in 100 people): • being sick (vomiting).

Very rare side effects (may affect up to 1 in 10,000 people):

• thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist • kidney problems • fits (convulsions), seen in patients on high doses or with kidney problems • dizziness • hyperactivity • teeth may appear stained, usually returning to normal with brushing (this has been reported in children) • the tongue may change to yellow, brown or black and it may have a hairy appearance • an excessive breakdown of red blood cells causing a type of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes • low number of white blood cells • low number of cells involved with blood clotting • the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself. Frequency not known (cannot be estimated from the available data) • chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome) • Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a certain kind of allergic reaction with the leading symptom of repetitive vomiting (1-4 hours after drug intake). Further symptoms could comprise abdominal pain, lethargy, diarrhoea, and low blood pressure. • crystals in the urine leading to acute renal injury, which may be seen as cloudy urine, or difficulty or discomfort in passing urine. Make sure you drink plenty of fluids to reduce the chance of these symptoms. • rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease) • inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis) Reporting of side effects If you get any 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 directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or by searching 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