CLAMENTIN can have side effects. Not all side effects reported for CLAMENTIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CLAMENTIN, please consult your healthcare provider for advice.
If any of the following happens, stop taking CLAMENTIN and tell your doctor immediately or go to the casualty department at your nearest hospital:
- Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
- rash or itching;
- fainting;
- inflammation of the protective membrane surrounding the brain (aseptic meningitis);
- chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome).
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);
- a 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));
- a 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);
- rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease).
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to CLAMENTIN. 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:
- 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;
- inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever;
- jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your skin and whites of the eyes appear yellow;
- inflammation of the liver (hepatitis);
- convulsions (in people taking high doses of CLAMENTIN or who have kidney problems);
- black tongue which looks hairy.
Acute inflammation of the pancreas (acute pancreatitis): If you have severe and on-going pain in the stomach area this could be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin/clavulanate. It is a certain kind of allergic reaction with the leading symptom of repetitive vomiting (1-4 hours after medicine intake). Further symptoms could comprise abdominal pain, lethargy, diarrhoea and low blood pressure. These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
The following side effects have been reported frequently:
- Nausea;
- vomiting;
- diarrhoea;
- thrush (Candida - a yeast infection of the vagina, mouth or skin folds);
- indigestion;
- dizziness;
- easy bruising, bleeding and pinpoint-sized reddish-purple spots on the lower legs;
- inflammation of the lining of the stomach;
- painful swelling and sores inside the mouth;
- soreness of the tongue.
The following side effects have been reported less frequently:
- Increase in some substances (enzymes) produced by the liver;
- dizziness;
- headache;
- upper abdominal discomfort with symptoms such as a burning sensation, bloating or gassiness, nausea or feeling full too quickly after starting to eat;
- severe reduction in the number of white blood cells.
The following side effects have been reported but the frequency is unknown:
- Tooth discolouration;
- inflammation of tubes in the kidney;
- severe reduction in the number of white blood cells;
- low number of red blood cells (haemolytic anaemia);
- crystals in urine leading to acute kidney injury;
- a state of excessive restlessness;
- low number of cells involved in blood clotting;
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 on the SAHPRA website at: https://medsafety.sahpra.org.za/#download, via email at: [email protected] or via telephone at: 0125010311. By reporting side effects, you can help provide more information on the safety of CLAMENTIN.
