Pantoloc Control Special Precautions

Before taking PANTOLOC Control, caution should be exercised by: Patients who have been treated for heartburn or indigestion continuously for 4 or more weeks; Patients who are over 55 years old and taking non-prescription indigestion treatment on a daily basis; Patients who are over 55 years old with any new or recently changed reflux symptoms: Patients who have previously had a gastric ulcer or stomach surgery; Patients who have liver problems or jaundice (yellowing of skin or eyes); Patients who regularly see the doctor for serious complaints or conditions; Patients who are due to have an endoscopy or a breath test called a C-urea test; Patients who have ever had a skin reaction after treatment with a medicine similar to PANTOLOC Control that reduces stomach acid; Patients who are due to have a specific blood test (Chromogranin A); Patients taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection) at the same time as pantoprazole. Patients must be specifically advised.
This product should not be used for longer than 4 weeks unless prescribed. If the reflux symptoms (heartburn or acid regurgitation) persist for longer than 2 weeks, patients must be advised about the need for long-term intake of this medicine.
Taking PANTOLOC Control for longer periods may cause additional risks, such as: reduced absorption of Vitamin B12, and Vitamin B12 deficiency in patients who already have low body stores of Vitamin B12; fracture of the hip, wrist or spine, especially in patients who already have osteoporosis (reduced bone density) or at risk of getting osteoporosis (for example, patients taking steroids); falling magnesium levels in the blood (potential symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate). Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Patients must be advised if this product is being used for more than 4 weeks. Regular blood tests may be performed to monitor the levels of magnesium.
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs 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 requires magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs 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 PPI treatment and periodically.
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.
Concomitant use of Proton Pump Inhibitors (PPIs) with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. A temporary withdrawal of the PPI may be considered in some patients receiving treatments with high dose methotrexate.
Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.
Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk for 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 PANTOLOC Control. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Patients should seek medical attention immediately in case of any of the following symptoms, which could be a sign of another, more serious, disease: an unintentional loss of weight (not related to a diet or an exercise programme); vomiting (particularly if repeated); vomiting blood (this may appear as dark coffee grounds in the vomit); blood in the stools which may be black or tarry in appearance; difficulty in swallowing or pain when swallowing; looking pale and feeling weak (anaemia); chest pain; stomach pain; severe and/or persistent diarrhoea (because this medicine has been associated with a small increase in infectious diarrhoea); presence of a rash on the skin especially in areas exposed to the sun. Patients must be advised to inform the doctor as soon as possible, as there may be a need to stop the treatment with PANTOLOC Control. Patients must also be advised to mention any other ill-effects like pain in the joints.
Some tests may need to be performed.
Patients must be advised to inform the doctor that this medicine is being taken if the patient is due to have a blood test.
Relief from acid reflux and heartburn symptoms may be experienced after just one day of treatment with PANTOLOC Control, but this medicine is not meant to bring immediate relief. This should not be taken as a preventive measure.
Patients must be advised to have regular checkups if they have been suffering from repetitive heartburn or indigestion symptoms for some time.
The following recommendations for lifestyle and dietary changes may also help to relieve heartburn or acid-related symptoms: Avoid large meals; Eat slowly; Stop smoking; Reduce alcohol and caffeine consumption; Reduce weight (if overweight); Avoid tight-fitting clothing or belts; Avoid eating less than three hours before bedtime; Elevate bedhead (if the patient suffers from nocturnal symptoms); Reduce intake of food that can cause heartburn. These might include: Chocolate, peppermint, spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes.
Driving and using machines: PANTOLOC Control may cause side effects like dizziness or disturbed vision. Patients must be advised not to drive or use machines.
Use in Children: PANTOLOC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.