PANTOLOC CONTROL 20MG
Pantoprazole
Pack quantity: 7 Tabs
PANTOLOC CONTROL 20MG 7 TABS: Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults
Therapeutic indications
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults
Posology and method of administration
Posology
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.
Special populations
No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function.
Paediatric use
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.
Contraindications
Hypersensitivity to the active substance, to soya or to any of the other excipients (see section 6.1).
Co-administration with atazanavir
Special warnings and precautions for use
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.
Interaction with other medicinal products and other forms of interaction
Pantoloc Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
It has been shown that co-administration of atazanavir 300 mg/ritonavir 100 mg with omeprazole (40 mg once daily) or atazanavir 400 mg with lansoprazole (60 mg single dose) to healthy volunteers resulted in a substantial reduction in the bioavailability of atazanavir. The absorption of atazanavir is pH-dependent. Therefore, pantoprazole must not be co-administered with atazanavir (see section 4.3).
Pantoprazole is metabolized in the liver via the cytochrome P450 enzyme system. An interaction of pantoprazole with other substances which are metabolized by the same enzyme system cannot be excluded. However, no clinically significant interactions were observed in specific tests with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl oestradiol.
Although no interaction during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in International Normalised Ratio (INR) have been reported during concomitant treatment in the post-marketing period. Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.
There were no interactions with concomitantly administered antacids.
Pregnancy and lactation
Pregnancy
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.
Lactation
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
Effects on ability to drive and use machines
Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients should not drive or operate machines
Undesirable effects
Approximately 5% of patients can be expected to experience adverse drug reactions (ADRs). The most commonly reported ADRs are diarrhoea and headache, both occuring in approximately 1% of patients
