CLINDAHEXAL capsules can have side effects. Not all side effects reported for CLINDAHEXAL capsules are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CLINDAHEXAL capsules, please consult your doctor, pharmacist or other health care provider for advice.
If any of the following happens, stop taking CLINDAHEXAL capsules and tell your doctor immediately or go to the casualty department at your nearest hospital:
- Signs of severe allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eye lids, face or lips, rash or itching (especially affecting the whole body). These are all very serious side effects. If you have them, you may have had a serious allergic reaction to CLINDAHEXAL capsules. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately if you notice any of the following:
- Severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This may occur with some antibiotics and can be a sign of a serious bowel inflammation.
- 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 rash with small puss-containing blisters (exfoliative dermatitis bullous).
- Fever, swollen lymph nodes or skin rash, these may be symptoms of a condition known as DRESS (Drug reaction with eosinophilia and systemic symptoms) can be severe and life-threatening. The symptoms of DRESS usually begins several weeks after exposure to CLINDAHEXAL.
- A rare skin eruption that is characterised by the rapid appearance of areas of red skin studded with small blisters filled with white/yellow fluid (Acute Generalised Exanthematous Pustulosis (AGEP)).
- Yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems.
- Acute Kidney Injury.
These are all serious side effects. You may need urgent medical attention.
Frequent side effects:
- Stomach pain.
- Diarrhoea.
- Inflammation of the lining of the intestine (pseudomembranous colitis).
- Liver function shown by blood tests test may be affected.
Less frequent side effects:
- Nausea and/or vomiting.
- Rash characterised by a flat, red area on the skin that is covered with small bumps (rash maculopapular).
The frequency of the following side effects are unknown:
- Infection inside and around the vagina.
- Decrease in the number of blood cells which may cause bruising or bleeding or weaken the immune system (agranulocytosis).
- Decrease in the number of white blood cells (leukopenia, neutropenia) (seen in a blood test).
- Decrease in the number of blood platelets (thrombocytopenia) (seen in a blood test).
- Increase in the number of white blood cells (eosinophilia) (seen in a blood test).
- Severe allergic reactions which can be life-threatening.
- Impaired sense of taste.
- Inflammation or ulcers in the oesophagus (tube leading from the mouth to the stomach).
- Widespread rash with red flat spots that look like measles (rash morbilliform).
- 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).
- Itching.
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 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 effects, you can help provide more information on the safety of CLINDAHEXAL. Suspected side effects can also be reported directly to the HCR via [email protected].
