EUGASTROL REFLUSSO 14CPR 20MG

EUGASTROL REFLUSSO 20 MG COMPRESENT

active ingredients

Each gastrorous tablet contains 20 mg of pantoprazole (as sodium sesquidrate) Excipients with known effects: Each gastrorous tablet contains 38.4 mg of malt and 0.35 mg of soy lecithin. For the full list of excipients, see paragraph 6.1.

Excellent

Compressed core: maltitol (E965), crospovidone type B, carmellosa sodica, sodium carbonate (E500), calcium stearate. Coating of the tablet: polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol 3350, soy lecithin (E322), yellow iron oxide (E172), carbonated sodium (E500), metacrilic-copolymer ethlacrilate acid (1:1), polysorbed 80, laurilsulphate sodium, trietyl citrate (E1505).

Therapeutic indications

Eugastrol reflux is indicated for short-term treatment of symptoms of reflux disease (e.g. pyrosis, acid regurgitation) in adults.

Contraindications

Hypersensitivity to the active ingredient, substituted benzimidazoles of soy, peanuts or any of the excipients listed in the paragraph 6.1. Concurrent administration of pantoprazole with HIV protease inhibitors for which absorption depends on intragastric acid pH, such as atazanavir and nelfinavir, is not recommended due to the significant reduction of their bioavailability (see paragraph 4.5).

Population

Population: The recommended dose is 20 mg of pantoprazole (one tablet) per day. It may be necessary to take tablets for 2-3 consecutive days to obtain better symptoms. Once the complete remission of symptomatology is achieved, the treatment must be stopped. The duration of treatment must not exceed 4 weeks without medical advice. If you do not get a relief from symptoms within 2 weeks of continued treatment, the patient should be warned to inform the doctor. Special popularity: No dosage adjustment is required in elderly patients or patients with impairment of kidney or liver function. Pediatric population: Eugastrol reflux is not recommended for use in children and adolescents under 18 years of age due to data failure on safety and effectiveness. Method of administration: Eugastrol reflux tablets should not be chewed or crushed, but should be swallowed whole with liquid before a meal.

Conservation

This medicine does not require any special precaution for conservation.

Warnings

Patients should be advised to inform the doctor if: • They have a non-intentional weight loss, anemia, gastrointestinal bleeding, dysphagia, persistent vomiting or vomiting with blood, since 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 been subjected to gastrointestinal surgery. • They are in continuous symptomatic treatment for indigestion or pyrosis from 4 or more weeks. • They suffer from jaundice, impairment of liver or hepatopathy. • They suffer from any other serious pathology with repercussions on general well-being. • They are older than 55 years old and have new symptoms or recent variations of existing symptoms. Patients with chronic relapse symptoms of indigestion or pyrosis should consult your doctor at regular intervals. In particular, patients over 55 years of age who take daily prescriptions for indigestion or pyrosis, must inform the pharmacist or physician. Patients should not simultaneously take pantoprazole and another protonic pump inhibitor or an antagonist of the H receptor₂. Patients should consult the doctor before taking this medicine if they must be subjected to endoscopy or breathing test for urea. Patients should be informed that tablets are not intended to provide immediate relief of symptomatology. The symptomatic relief can begin to be warned after about a day of treatment with pantoprazole, but it may be necessary to take it for 7 days before reaching a complete control of pyrosis. Patients should not take pantoprazole as a preventive medicine. Gastrointestinal infections caused by bacteria: The decreased gastric acidity, as a result of any treatment - including that with protonic pump inhibitors - increases the bacterial charge normally present in the gastrointestinal tract. Therefore treatment with acidity reducing drugs can slightly increase the risk of gastrointestinal infections such as those caused by Salmonella, , Campylobacter, o Clostridium difficult. . Subacute cutaneous erythematose lupus (LECS): Protonic pump inhibitors are associated with extremely infrequent cases of LECS. In the presence of injuries, especially on the skin parts exposed to the sun rays, and if accompanied by artralgia, the patient must immediately address to the doctor and the healthcare provider must assess the opportunity to stop treatment with Eugastrol reflux. The appearance of LECS following a treatment with a protonic pump inhibitor can increase the risk of LECS onset with other protonic pump inhibitors. Interference with laboratory exams: An increased level of Chromogranin A (CgA) can interfere with diagnostic tests for neuroendocrine tumors. To avoid such interference, the treatment with Eugastrol reflux must be suspended for at least 5 days before CgA measurements (see paragraph 5.1). If the levels of CgA and gastrin are not returned within the reference range after initial measurement, it is necessary to repeat the measurements 14 days after the interruption of treatment with protonic pump inhibitor. The following additional risks are considered relevant for long-term use: This medicine is intended only for short-term use (up to 4 weeks) (refer to paragraph 4.2). Patients should be warned about additional risks associated with long-term use of medicines and the need for prescription and regular surveillance. Influence on vitamin B12 absorption: Pantoprazol, like all medicines that block acid, can reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achloride. This should be taken into account in patients with reduced body reserves or risk factors for reduced absorption of vitamin B12 in long-term therapy, or if you observe their clinical symptoms. Fracture of the bone: Protonic pump inhibitors, especially when used in high doses and for long periods (> 1 year), can modestly increase the risk of hip fracture, wrist and spine fracture, mainly in the elderly or in the presence of other recognised risk factors. Observative studies suggest that protonic pump inhibitors can increase overall fracture risk by 10-40%. Some of these increases may be due to other risk factors. Patients at risk of osteoporosis should receive assistance based on current clinical guidelines and should take appropriate vitamin D and calcium intake. Hypomaginemia: In patients treated with protonic pump inhibitors (PPI) as pantoprazole, for at least three months, but in most cases for a year, the presence of severe hypomagnesiemia was rarely reported. Severe manifestations of hypomagnesia may occur as fatigue, tetania, delirium, seizures, dizziness and ventricular arrhythmia; however, these manifestations could be subdued and underestimated. Hypomagnesia may lead to hypocalcemia and/or hypokaliemia (see paragraph 4.8). In most affected patients, hypomagnesiaemia (and hypocalcemia associated with hypomagnesiaemia and/or hypokaliemia) improved after the reintegration of magnesium reserves and the suspension of PPI. For patients for whom prolonged treatment is foreseen or taking PPIs with digoxin or medicines that may cause hypomagnesiemia (e.g. diuretics), health professionals should consider measuring magnesium levels before starting treatment with PPI and periodically during treatment. Excipient. . Maltito: Patients with rare hereditary problems of fructose intolerance should not take this medicine. Sodium: This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “without sodium”.

Interactions

Medicines with pH-dependent absorption pharmacokinetics: Eugastrol reflux can reduce the absorption of active ingredients whose bioavailability is dependent on gastric pH (e.g. ketoconazole). HIV protease inhibitors: The co-administration of pantoprazole with HIV protease inhibitors such as atazanavir and nelfinavir, whose absorption depends on the pH of intragastric acid, is contraindicated due to the significant reduction of their bioavailability (see paragraph 4.3). Cucumin antiagulants (fenprocumone or warfarin): Although no interaction has been observed in pharmacokinetics studies during the concomitant administration of pantoprazole and phenprocumone or warfarin, after the marketing of the product, isolated cases of variations in the value related to the International Normalized Report (INR) were reported during concomitant treatment with such substances. Therefore, in patients in treatment with cumarinic anticoagulants (e.g. fenprocumone or warfarin), it is recommended to carry out protrombine/valori time controls of INR after the start or interruption of pantoprazol therapy and in case of irregular use. Methodology: In some patients an increase in metotrexate levels has been reported with the concomitant use of high dose metotrexate (e.g. 300 mg) and protonic pump inhibitors. Therefore, in contexts where high dose metotrexate is used, for example, cancer and psoriasis, it may be necessary to consider the temporary suspension of pantoprazole. Other interaction studies: Pantoprazol is metabolized in the liver through the enzyme system of the P450 cytochrome. No clinically significant interactions have been observed in interaction studies with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glybenclamide, metoprolol, naprossene, nifedipine, phenytoin, pyroxicam, theophylline and an oral contraceptive containing levonorgestrel and etylestradiol. However, an interaction of pantoprazole cannot be excluded with other metabolized compounds through the same enzymatic system. Interactions with antacids were not highlighted at the same time.

Effects

Summary of security profile: About 5% of patients may experience adverse reactions. Tabulate list of adverse reactions: The following adverse reactions were reported with pantoprazole. In the table below, adverse reactions are listed according to the MedDRA frequency classification: Very common (≥1/10); common (≥1/100, Frequency Classification systems and organs Town Not common Rare Very rare Notable Emolinfopoietic system pathologies     Agranulocytes Trombocytopenia; Leucopenia; Pancitope   Immune system disorders     Hypersensitivity (including anaphylactic reactions and anaphylactic shock)     Disorders of metabolism and nutrition     Hyperlipidemias and increased lipid levels (triglycerides, cholesterol); Weight variations   Iponatremia; Hypomagnesiemia, Hypocalcemia ⁽¹⁾; Hypokaliemia⁽¹⁾ Psychiatric disorders   Sleep disturbances Depression (and all stages of exacerbation) Disorientation (and all stages of exacerbation) Hallucinations; Confusion (especially in patients prepared, and worsening of such symptoms if existing) Diseases of the nervous system   Cefalea; Capogiro Disorders of taste   Opinion Pathologies of the eye     Disorders of blurred vision/vision     Gastrointestinal diseases Fungus gland polyps (drinks) Diarrhea; Nausea/vomite; Abdominal distension and swelling; Stipsi; Dry mouth; Pain and abdominal disorder     Microscopy Colite Hepatobiliary diseases   Increased liver enzymes (transaminasis γ-GT) Bilirubin increased   Hepatocellular year, Ittero; Hepatocellular insufficiency Pathologies of skin and subcutaneous tissue   Rash / esantema / eruption; Prudence Orticaria; Angioedema;   Steven-Johnson syndrome; Lyell syndrome; Multiform erythema; Photosensitivity; Drug reaction with heosinophilia and systemic symptoms (DRESS); Subacute cutaneous erythematose lupus (see paragraph 4.4) Diseases of musculoskeletal system and connective tissue   Pulse fracture, hip and spine fracture. Artralgia; Mialgia   Muscle spasm⁽²⁾ Kidney and urinary pathologies         Interstitial nephritis (with possible progression to kidney failure) Pathologies of the reproductive apparatus and of the breast     Gynecomastia     Systemic pathologies and conditions for administration   Astenia, fatigue and malaise Increased body temperature; Peripheral edema     ⁽¹⁾ Hypocalcemia and/or hypokaliemia may be related to the occurrence of hypomagnesiemia (see paragraph 4.4). ⁽²⁾ Muscle spasm as a result of electrolytic disorder. Soy lecithin can cause very rarely allergic reactions. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Doses up to 240 mg administered intravenously in 2 minutes were well tolerated. Since pantoprazole is widely linked to plasma proteins, it is not readily dialysisable. In case of overdose with clinical signs of intoxication, specific therapeutic recommendations are not provided, apart from the adoption of the usual symptomatic and support measures.

Pregnancy

: A moderate amount of pregnant women's data (between 300-1000 pregnancy results) does not indicate any malformation or fetus/neonatal toxicity. Animal studies showed reproductive toxicity (see paragraph 5.3). As a precautionary measure, it is preferable to avoid the use of pantoprazole during pregnancy.

Nursing:

Studies in animals showed an excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk, but excretion in breast milk has been reported. A risk for infants or infants cannot be excluded. Therefore, the decision to stop breastfeeding or stop/ refrain from pantoprazole therapy should consider the benefit of breastfeeding for the child and the benefit of pantoprazole therapy for the woman.

Fertility

: There has been no evidence of fertility impairment following the administration of pantoprazole in animal studies (see paragraph 5.3).

Source: Farmadati