Side Effects

Side Effects of Cetroxol 500

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you have any of the below symptoms of a severe allergic reaction stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital.

Uncommon (may affect up to 1 in 100 people):

• swelling of the face, lips, tongue, throat, hands, feet or genitals • blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome). Rare (may affect up to 1 in 1,000 people): • skin rash accompanied by other symptoms such as fever, swollen glands and an increase in a type of white blood cell (eosinophilia). A rash appears as small, itchy red bumps (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)). Not known (frequency cannot be estimated from the available data): • sudden difficulty in breathing, speaking and swallowing • extreme dizziness or collapse • severe rash involving reddening, peeling and swelling of the skin (Toxic Epidermal Necrolysis). If you experience any of the following serious side effects, contact your doctor as soon as possible as you may need urgent medical attention. Uncommon (may affect up to 1 in 100 people): • inflammation of the liver (hepatitis) • signs of infection such as a sore throat and high temperature caused by a reduction in the number of white blood cells (leukopenia or neutropenia). Rare (may affect up to 1 in 1,000 people): • skin eruption that is characterised by the rapid appearance of red skin studded with small pustules (small blisters filled with white/yellow fluid) (Acute Generalised Exanthematous Pustulosis (AGEP)). Not known (frequency cannot be estimated from the available data): • severe or prolonged diarrhoea, which may have blood or mucus in it. This can be a sign of a serious bowel inflammation. This is something that can occasionally happen after taking antibiotics • reduced number of red blood cells due to destruction (haemolytic anaemia); unusual bruising or bleeding caused by a reduction in the number of platelets (thrombocytopenia) • yellowing of the skin or whites of the eyes (jaundice) or liver failure (rarely lifethreatening) • inflammation of the pancreas, which causes severe pain in the abdomen and back • inflammation of the kidney or kidney failure, increased or reduced urine output, or traces of blood in your urine • a skin rash that has raised patches or blisters and may be itchy (erythema multiforme) • rapid (ventricular tachycardia) or irregular heart beat, sometimes being lifethreatening, changes of the heart rhythm found by an electro-cardiogram (QT prolongation and torsade de pointes). Other side effects include: Very common (may affect more than 1 in 10 people): • diarrhoea • abdominal pain • feeling sick (nausea) • wind (flatulence). Common (may affect up to 1 in 10 people): • lack of appetite (anorexia) • feeling dizzy • headache • sensation of pins and needles or numbness (paraesthesia) • changes in your sense of taste • visual impairment • deafness • being sick (vomiting), stomach pain or cramps, loss of appetite, problems digesting your food • skin rashes and itching • joint pain (arthralgia) • fatigue • change in the quantity of the white blood cells and the concentration of bicarbonate in the blood. Uncommon (may affect up to 1 in 100 people): • yeast infection of the mouth or vagina (thrush) • nervousness • reduced sense of touch (hypoaesthesia) • feeling drowsy (somnolence)
• • having difficulty sleeping (insomnia)
  • hearing loss or ringing in your ears
  • palpitations
  • inflammation of the lining of the stomach
  (gastritis)
  • constipation
  • skin more sensitive to sunlight than normal
  • urticaria
  • chest pain
  • swelling (oedema)
  • general feeling of being unwell (malaise)
  • weakness (asthenia)
  • change in liver enzyme levels and blood
  levels.
  Rare (may affect up to 1 in 1,000 people):
  • feeling agitated
  • spinning sensation (vertigo)
  • abnormal liver function.
  Not known (frequency cannot be estimated
  from the available data):
  • aggression or anxiety
  • fainting (syncope)
  • fits (convulsions)
  • feeling hyperactive
  • change in your sense of smell (anosmia,
  parosmia)
  • change in your sense of taste (ageusia)
  • exacerbation or aggravation of muscle
  weakness (myasthenia gravis)
  • low blood pressure
  • your tongue changes colour.
  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