Proton Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Patients must be advised in case of any side effects. This includes any possible side effects not listed in this monograph.
If the patient notices any of the following rare but serious side effects, Proton should be stopped and patient must be advised to seek medical advice 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.
Common side effects (may affect up to 1 in 10 people): Headache; Effects on the stomach or gut: diarrhoea, stomach pain, constipation, flatulence; Feeling sick (nausea) or being sick (vomiting); Benign polyps in the stomach.
Uncommon side effects (may affect up to 1 in 100 people): Swelling of the feet and ankles; Insomnia (disturbed sleep); Dizziness, tingling feelings such as "pins and needles", feeling sleepy; Spinning feeling (vertigo); Changes in blood tests that check how the liver is working; Skin rash, lumpy rash (hives) and itchy skin; Generally feeling unwell and lacking energy.
Rare side effects (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.
Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
Feeling agitation, confusion or depressed.
Taste changes.
Eyesight problems such as blurred vision.
Suddenly feeling wheezy or short of breath (bronchospasm).
Dry mouth.
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).
Severe kidney problems (interstitial nephritis).
Increased sweating.
Very rare side effects (may affect up to 1 in 10,000 people): Change 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.
Enlarged breasts in men.
Not known (frequency cannot be estimated from the available data): Inflammation in the gut (leading to diarrhoea).
If the patient is on Proton 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 the patient gets any of these symptoms, advise the patient to seek medical advice promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Regular blood tests may be performed to monitor the levels of magnesium. Rash, possibly with pain in the joints.
Proton may in very rare cases affect the white blood cells leading to immune deficiency. If the 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 the patient to consult the 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 the medicine at this time.