EUGASTROL REFLUX * 14CPR 20MG
Eugastrol reflux is indicated for the short-term treatment of reflux disease symptoms (e.g. heartburn, acid regurgitation) in adults.
Dosage and method of use
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 Eugastrol reflux 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 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 soya, peanuts or to any of the excipients listed in section 6.1. Co-administration of pantoprazole with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH, such as atazanavir and nelfinavir, is not recommended due to the significant reduction in their bioavailability (see section 4.5).
Summary of the safety profile About 5% of patients may experience adverse reactions. The most commonly reported adverse reactions are diarrhea and headache, occurring in approximately 1% of patients. Tabulated list of adverse reactions The following adverse reactions have been reported with pantoprazole. In the table below, adverse reactions are listed by MedDRA frequency classification: Very common (≥1 / 10); common (≥1 / 100,
|Frequency||Common||Uncommon||Rare||Very rare||Not known|
|Disorders of the blood and lymphatic system|| || ||Agranulocytosis||Thrombocytopenia; Leukopenia; Pancytopenia|| |
|Disorders of the immune system|| || ||Hypersensitivity (including anaphylactic reactions and anaphylactic shock)|| || |
|Metabolism and nutrition disorders|| || ||Hyperlipidemia and increased lipid levels (triglycerides, cholesterol); Weight changes|| ||Hyponatremia; Hypomagnesemia, Hypocalcemia (1); Hypokalemia|
|Psychiatric disorders|| ||Sleep disorders||Depression (and all stages of exacerbation)||Disorientation (and all stages of exacerbation)||Hallucinations; Confusion (especially in predisposed patients, and worsening of these symptoms if pre-existing)|
|Nervous system disorders|| ||Headache Dizziness||Disorders of taste|| ||Paresthesia|
|Eye disorders|| || ||Disturbed vision / blurred vision|| || |
|Gastrointestinal disorders||Fundic gland polyps (benign)||Diarrhea; Nausea / vomiting; Abdominal distension and bloating; Constipation; Dry mouth Abdominal pain and discomfort|| || ||Microscopic colitis|
|Hepatobiliary disorders|| ||Increased liver enzymes (γ-GT transaminases)||Increased bilirubin|| ||Hepatocellular damage, Jaundice; Hepatocellular insufficiency|
|Skin and subcutaneous tissue disorders|| ||Rash / exanthema / eruption; itch||Urticaria; Angioedema;|| ||Steven-Johnson Syndrome; Lyell's syndrome; Erythema multiforme; Photosensitivity, Subacute cutaneous lupus erythematosus (see section 4.4)|
|Musculoskeletal and connective tissue disorders|| ||Fracture of the wrist, hip and spine.||Arthralgia; Myalgia|| ||Muscle spasm(2)|
|Renal and urinary disorders|| || || || ||Interstitial nephritis (with possible progression to renal failure)|
|Reproductive system and breast disorders|| || ||Gynecomastia|| || |
|General disorders and administration site conditions|| ||Asthenia, fatigue and malaise||Increased body temperature; Peripheral edema|| || |
(1) Hypocalcemia in association with hypomagnesaemia (2) Muscle spasm as a consequence of electrolyte disturbances Soy lecithin can very rarely cause allergic reactions. Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Patients should be advised to inform their physician if: • They have unintended weight loss, anemia, gastrointestinal bleeding, dysphagia, persistent vomiting or bloody vomiting, as treatment with pantoprazole may relieve symptoms and delay the diagnosis of serious conditions. . In these cases it is necessary to exclude the presence of a malignant pathology. • 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. • Suffering from jaundice, impaired liver function or liver disease. • Suffer from any other serious pathology with repercussions on general well-being. • 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 H-receptor antagonist at the same time2. 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. Gastrointestinal infections caused by bacteria 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 Clostridium 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. 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, Eugastrol reflux treatment 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 discontinuation of the proton pump inhibitor treatment. This medicinal product is intended for short-term use only (up to 4 weeks) (see section 4.2). Patients should be warned of additional risks associated with long-term use of medicinal products and the need for regular prescribing and surveillance. The following additional risks are considered relevant for long-term use: Influence on the absorption of vitamin B12: Pantoprazole, like all acid-blocking medicines, can reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy, or if respective clinical symptoms are observed. Fracture of the bone: Proton pump inhibitors, especially when used in high doses and for long periods (> 1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in older people or in the presence of others. recognized risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%. Some of these increases could be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and should get adequate intake of vitamin D and calcium. HypomagnesemiaSevere hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) such as pantoprazole for at least three months, and in most cases in patients treated for one year. Severe manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia may occur; however, these manifestations could arise subtly and be underestimated. In most affected patients, hypomagnesaemia improved after replenishment of magnesium stores and discontinuation of the PPI. For patients who are anticipated on prolonged treatment or who are taking PPIs with digoxin or medicines that can cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment. This medicine contains maltitol and sodium Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, ie essentially 'sodium-free'.
Pregnancy and breastfeeding
Pregnancy A moderate amount of data from pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or fetus / neonatal toxicity. Studies in animals have shown reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of pantoprazole during pregnancy. Feeding time Studies in animals have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk, but excretion in human milk has been reported. A risk to the newborns / infants cannot be excluded. Therefore, the decision to discontinue breast-feeding or to discontinue / abstain from pantoprazole therapy must take into account the benefit of breast-feeding for the child and the benefit of pantoprazole therapy for the woman. Fertility There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).
Expiry and retention
This medicinal product does not require any special storage conditions.
Interactions with other drugs
Eugastrol reflux can reduce the absorption of active ingredients whose bioavailability is dependent on gastric pH (eg ketoconazole). HIV protease inhibitors Co-administration of pantoprazole with HIV protease inhibitors such as atazanavir and nelfinavir, the absorption of which depends on the pH of the intragastric acid, is contraindicated due to the significant reduction in their bioavailability (see section 4.3). 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 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. Pantoprazole is metabolised in the liver via the cytochrome P450 enzyme system. No clinically significant interactions were observed in interaction studies with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl estradi. However, an interaction of pantoprazole with other compounds metabolised through the same enzyme system cannot be excluded. There was no evidence of interactions with concomitantly administered antacids.
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 case of overdose with clinical signs of intoxication, no specific therapeutic recommendations are provided, apart from the adoption of the usual symptomatic and supportive measures.
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 (see section 4.4) and 0.35 mg of soy lecithin. For the full list of excipients, see section 6.1.
Core of the tablet maltitol (E965) crospovidone type B carmellose sodium sodium carbonate (E500) calcium stearate Tablet coating polyvinyl alcohol talc (E553b) titanium dioxide (E171) macrogol 3350 soy lecithin (E322) yellow iron oxide (E172) sodium carbonate (E500) methacrylic acid-ethyl acrylate copolymer (1: 1) polysorbate 80 sodium laurilsulfate triethyl citrate (E1505)