Eugastrol Reflux 20mg Pantoprazole 14 Gastro-resistant Tablets

Each gastro-resistant tablet contains:

20 mg of pantoprazole (as sodium sesquihydrate)

Excipients with known effect: Each gastro-resistant tablet contains 38.4 mg of maltitol and 0.35 mg of soy lecithin.

Dosage

The recommended dose is 20 mg of pantoprazole (one tablet) per day.

It may be necessary to take the tablets for 2-3 consecutive days to improve symptoms. Once complete remission of symptoms is achieved, treatment should be discontinued.

The duration of treatment should not exceed 4 weeks without prior medical consultation.

If symptom relief is not achieved within 2 weeks of continued treatment, the patient should be advised to notify the physician.

Special populations

No dosage adjustment is required in elderly patients or in patients with impaired renal or hepatic function.

Pediatric population

The use of Eugastrol reflux is not recommended in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.

Method of administration

Eugastrol Reflux tablets should not be chewed or crushed, but should be swallowed whole with liquid before a meal.

Hypersensitivity to the active substance, substituted benzimidazoles in soy, peanuts or any of the excipients

Patients should be advised to inform their physician if:

They have unintentional weight loss, anemia, gastrointestinal bleeding, dysphagia, persistent vomiting or bloody vomiting, as treatment with pantoprazole can relieve symptoms and delay the diagnosis of serious conditions. In these cases it is necessary to exclude the presence of a malignant pathology.

They have previously suffered from gastric ulcer or have undergone gastrointestinal surgery.

I have been on continuous symptomatic treatment for indigestion or heartburn for 4 or more weeks.

They suffer from jaundice, impaired liver function or liver disease.

They suffer from any other serious pathology with repercussions on general well-being.

They are over the age of 55 and have new symptoms or recent changes in pre-existing symptoms.

Patients with chronic relapsing symptoms of indigestion or heartburn should see their doctor at regular intervals. In particular, patients over the age of 55 who take non-prescription remedies for indigestion or heartburn on a daily basis should inform their pharmacist or doctor.

Patients should not take pantoprazole and another proton pump inhibitor or H2 receptor antagonist at the same time.

Patients should consult their doctor before taking this medicine if they are to undergo an endoscopy or breath test for urea.

Patients should be advised that the tablets are not intended to provide immediate relief of symptoms.

Symptomatic relief may begin to be felt after approximately one day of treatment with pantoprazole, but may need to be taken for 7 days before full heartburn control is achieved. Patients should not take pantoprazole as a preventive medicine.

Decreased gastric acidity following any treatment - including proton pump inhibitors - increases the bacterial load normally present in the gastrointestinal tract.

Therefore, treatment with acid-reducing drugs may slightly increase the risk of gastrointestinal infections such as those caused by Salmonella, Campylobacter, or C. difficile.

Subacute cutaneous lupus erythematosus (SCLE)

Proton pump inhibitors are associated with extremely infrequent cases of SCLE. In the presence of lesions, especially on the skin parts exposed to sunlight, and if accompanied by arthralgia, the patient should immediately consult a doctor and the healthcare professional should evaluate the opportunity to stop treatment with Eugastrol reflux 20 mg gastro-resistant tablets.

SCLE following treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests

An increased level of Chromogranin A (CgA) can interfere with diagnostic tests for neuroendocrine tumors. To avoid this interference, treatment with Eugastrol Reflux 20 mg gastro-resistant tablets should be stopped for at least 5 days before CgA measurements (see section 5.1). If the CgA and gastrin levels have not returned to the reference range after the initial measurement, measurements should be repeated 14 days after stopping the proton pump inhibitor treatment.

This medicine contains maltitol.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Eugastrol reflux can reduce the absorption of active ingredients whose bioavailability is dependent on gastric pH (eg ketoconazole).

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) has been shown to result in a substantial reduction in the bioavailability of atazanavir in healthy volunteers. . Absorption of atazanavir is pH dependent. Therefore, pantoprazole should not be co-administered with atazanavir (see section 4.3).

Pantoprazole is metabolised in the liver via the cytochrome P450 enzyme system. An interaction of pantoprazole with other compounds metabolised through 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 estradi.

Although no interaction was observed during concomitant administration of pantoprazole and phenprocoumon or warfarin in pharmacokinetic studies, isolated cases of changes in the International Normalized Ratio (INR) value have been reported post-marketing during concomitant treatment with these substances. . Therefore, in patients being treated with coumarin-type anticoagulants (e.g. phenprocoumon or warfarin), it is recommended that prothrombin time / INR checks be performed after initiation or discontinuation of pantoprazole therapy and in the event of its irregular use.

Increased methotrexate levels have been reported in some patients with concomitant use of high dose methotrexate (e.g. 300 mg) and proton pump inhibitors. Therefore, in settings where high dose methotrexate is used, for example, cancer and psoriasis, temporary withdrawal of pantoprazole may need to be considered.

There was no evidence of interactions with concomitantly administered antacids.

Pregnancy

There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have shown reproductive toxicity. Preclinical studies reveal no signs of impaired fertility or teratogenic effects. The potential risk for humans is unknown. This medicine should not be used during pregnancy.

Feeding time

It is not known whether pantoprazole is excreted in human breast milk. Studies in animals have shown excretion of pantoprazole in breast milk. This medicine should not be used during breastfeeding.

Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If this occurs, the patient should not drive or operate machinery.

Soy lecithin can very rarely cause allergic reactions.

Reporting of suspected adverse reactions.

There are no known symptoms of overdose in humans.

Doses up to 240 mg administered intravenously over 2 minutes were well tolerated

Since pantoprazole binds extensively to plasma proteins, it is not readily dialyzable.

In the event of an overdose with clinical signs of intoxication, no specific therapeutic recommendations are provided, apart from the adoption of the usual symptomatic and supportive measures.