Pantoloc Control Tablets 20mg Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate).
Excipient: contains 1.06 microgram soya lecithin per gastro-resistant tablet
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
The recommended dose is 20 mg pantoprazole (one tablet) per day.
It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Once complete relief of symptoms has occurred, treatment should be discontinued.
The treatment should not exceed 4 weeks without consulting a doctor.
If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor.
No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function.
Pantoloc Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Method of administration
Pantoloc Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
Patients should be instructed to consult a doctor if:
• They have unintentional weight loss, anaemia, gastrointestinal bleeding, dysphagia, persistent vomiting or vomiting with blood, since it may alleviate symptoms and delay diagnosis of a severe condition. In these cases, malignancy should be excluded.
• They have had previous gastric ulcer or gastrointestinal surgery.
• They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
• They have jaundice, hepatic impairment, or liver disease.
• They have any other serious disease affecting general well-being.
• They are aged over 55 years with new or recently changed symptoms.
Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals. Especially, patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.
Patients should not take another proton pump inhibitor or H2 antagonist concomitantly.
Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test.
Patients should be advised that the tablets are not intended to provide immediate relief.
Patients may start to experience symptomatic relief after approximately one day of treatment with pantoprazole, but it might be necessary to take it for 7 days to achieve complete heartburn control.
Patients should not take pantoprazole as a preventive medicinal product.
Decreased gastric acidity, due to any means - including proton pump inhibitors - increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with acid-reducing medicinal products leads to a slightly increased risk of gastrointestinal infections such as Salmonella, Campylobacter, or C. difficile.
There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have shown reproductive toxicity. Preclinical studies revealed no evidence of impaired fertility or teratogenic effects (see section 5.3). The potential risk for humans is unknown. This medicinal product should not be used during pregnancy.
It is unknown whether pantoprazole is excreted in human breast milk. Animal studies have shown excretion of pantoprazole in breast milk. This medicinal product should not be used during breast-feeding.
Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients should not drive or operate machines.
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