Proton Special Precautions

Patients must be advised before taking Proton.
Proton may hide the symptoms of other diseases. Therefore, if any of the following happens to the patient before starting Proton or while taking it, patients must be advised to seek medical advice straight away: Patient loses a lot of weight for no reason and have problems swallowing; gets stomach pain or indigestion; begins to vomit food or blood; passes black stools (blood-stained faeces); experiences severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infections diarrhoea; has severe liver problems; has ever had a skin reaction after treatment with medicine similar to Proton that reduces stomach acid; due to have specific blood test (Chromogranin A).
If the patient takes Proton on a long-term basis (longer than 1 year), the patient would probably be kept under regular surveillance. Advise the patient to report any new and exceptional symptoms and circumstances.
Taking a proton pump inhibitor like Proton, especially over a period of more than one year, may slightly increase the patient's risk of fracture in the hip, wrist or spine. Advise the patient to inform the doctor if the patient has osteoporosis or if the patient is taking corticosteroids (which can increase the risk of osteoporosis).
If the patients gets a rash on the skin, especially in areas exposed to the sun, advise the patient to inform the doctor as soon as the patient can (as the treatment may need to be stopped with Proton). Advise the patient to also mention any other ill-effects like pain in the joints.
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients treatment of hypomagnesemia required magnesium replacement and discontinuation of the proton pump inhibitors.
For patients expected to be on prolonged treatment or who take proton pump inhibitors with medications such as digoxin or drugs that may cause hypomagnesemia (e.g. diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of proton pump inhibitors treatment and periodically.
Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Subacute cutaneous lupus erythematosus (SCLE), proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Proton. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Proton capsule contain lactose: Proton capsule contain lactose. If the patient has been told by the doctor that he/she has an intolerance to some sugars, advise the patient to contact the doctor before taking this medicinal product.
Driving or operate machinery: Treatment with omeprazole is not likely to affect the ability to drive or operate machinery. Side effects such as dizziness and visual disturbance may occur, if affected, the patient should not drive or operate machinery.
Use in Children: Some children with chronic illnesses may require long-term treatment although it is not recommended. This medicine should not be given to children under 1 year of age or <10 kg.
Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
In long term use, especially for more than 1 year, the treatment must be reviewed regularly and assess the risk benefit ratio periodically.