Like all medicines, Esomeprazole NORMON can cause side effects, although not everybody gets them.
If any of the following serious side effects is noticed, advise patient to stop taking Esomeprazole NORMON and to contact a doctor immediately: Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be 'Stevens-Johnson syndrome' or 'toxic epidermal necrolysis'.
Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
These effects are rare, affecting 1 to 10 patients in 10,000.
Other side effects include: Common (may affect up to 1 in 10 people): Headache.
Effects on the stomach or gut: stomach pain, constipation, diarrhoea, wind (flatulence).
Feeling sick (nausea) or being sick (vomiting).
Injection site reaction.
Uncommon (may affect up to 1 in 100 people): Swelling of the feet and ankles.
Disturbed sleep (insomnia).
Dizziness, tingling feelings such as "pins and needles", feeling sleepy.
Spinning feeling (vertigo).
Eyesight problems such as blurred vision.
Dry mouth.
Changes in blood tests that check how the liver is working.
Skin rash, lumpy rash (hives) and itchy skin.
Fracture of the hip, wrist or spine (if Esomeprazole NORMON is used in high doses and over long duration).
Rare (may affect up to 1 in 1,000 people): Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
Feeling agitated, confused or depressed.
Taste changes.
Suddenly feeling wheezy or short of breath (bronchospasm).
An inflammation of the inside of the mouth.
An infection called "thrush" which can affect the gut and is caused by a fungus.
Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
Hair loss (alopecia).
Skin rash on exposure to sunshine.
Joint pains (arthralgia) or muscle pains (myalgia).
Generally feeling unwell and lacking energy.
Increased sweating.
Very rare (may affect up to 1 in 10,000 people): Changes in blood count including agranulocytosis (lack of white blood cells).
Aggression.
Seeing, feeling or hearing things that are not there (hallucinations).
Severe liver problems leading to liver failure and inflammation of the brain.
Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Muscle weakness.
Severe kidney problems.
Enlarged breasts in men.
Not known (frequency cannot be estimated from the available data): If patient is on Esomeprazole NORMON for more than three months it is possible that the levels of magnesium in the blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If patient gets any of these symptoms, advise patient to tell the doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Regular blood tests can be performed to monitor the levels of magnesium.
Inflammation in the gut (leading to diarrhoea).
Rash, possible with pain in the joints.
Esomeprazole NORMON may in very rare cases affect the white blood cells leading to immune deficiency. If patient has an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, advise patient to consult a doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for the patient to give information about his/her medication at this time.
Do not be concerned by this list of possible side effects. Patient may not get any of them. If any of the side effects get serious, or in case of any side effects not listed in this monograph, advise patient to tell a doctor or pharmacist.