Eugastrol Reflux 20mg

Tablets

Composition :

Each gastro-resistant tablet contains: 20 mg of pantoprazole (as sodium sesquihydrate) Excipients: Each gastro-resistant tablet contains 38.425 mg of maltitol (see section 4.4) and 0.345 mg of soy lecithin. For the full list of excipients, see section 6.1.

Excipients

Tablet core maltitol (E 965) crospovidone type B carmellose sodium sodium carbonate anhydrous (E 500) calcium stearate Tablet coating polyvinyl alcohol talc (E 553b) titanium dioxide (E 171) macrogol 3350 soy lecithin (E 322) iron oxide yellow (E 172) anhydrous sodium carbonate (E 500) methacrylic acid - ethyl acrylate copolymer (1: 1) polysorbate 80 sodium lauryl sulfate triethyl citrate (E 1505)

Therapeutic indications

Short-term treatment of reflux disease symptoms (e.g. heartburn, acid regurgitation) in adults.

Contraindications

Hypersensitivity to the active substance, to soya, peanuts or to any of the excipients (see section 6.1). Concomitant administration of atazanavir (see section 4.5).

Dosage

Posology 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. Use in pediatric patients 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.

Warnings and Precautions

Patients should be advised to inform their physician if: • They have unintended restoration of silhouette, 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 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. This medicine contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Interactions

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 cause a substantial reduction in the bioavailability of atazanavir. 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 ethanol. 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. There was no evidence of interactions with concomitantly administered antacids.

Side effects

Approximately 5% of patients may experience adverse drug reactions (ADRs). The most commonly reported ADRs are diarrhea and headache, which occur in approximately 1% of patients. The following side effects have been reported with pantoprazole. In the table below, undesirable effects are listed according to the following frequency classification: Very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1,000 to <1/100); rare (≥1 / 10,000, <1 / 1,000); very rare (<1 / 10,000), not known (cannot be estimated from the available data). Within each frequency class, undesirable effects are reported in descending order of severity.

Frequency System Organ Uncommon Rare Very rare Not known
Blood and lymphatic system disorders Thrombocytopenia; Leukopenia
Nervous system disorders Headache; Dizziness
Eye disorders Visual disturbances / blurred vision
Gastrointestinal disorders Diarrhea; Nausea / vomiting; Abdominal distension and bloating; Constipation; Dry mouth Abdominal pain and discomfort
Renal and urinary disorders Interstitial nephritis
Skin and subcutaneous tissue disorders Rash / exanthema / eruption; Itching Urticaria; Angioedema; Steven – Johnson Syndrome; Lyell's syndrome; Erythema multiforme; Photosensitivity
Musculoskeletal and connective tissue disorders Arthralgia; Myalgia
Metabolism and nutrition disorders Hyperlipidemia and increased lipid levels (triglycerides, cholesterol); Weight changes Hyponatremia
General disorders and administration site conditions Asthenia, fatigue and malaise Increase in body temperature; Peripheral edema
Immune system disorders Hypersensitivity (including anaphylactic reactions and anaphylactic shock)
Hepatobiliary disorders Increase in the level of liver enzymes (transaminases, γ – GT) Increase in the level of bilirubin Hepatocellular lesion; Jaundice Hepatocellular insufficiency
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)

Soy lecithin can very rarely cause allergic reactions.

Pregnancy and breastfeeding

Pregnancy There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have shown reproductive toxicity. Non-clinical studies reveal no signs of impaired fertility or teratogenic effects (see section 5.3). The potential risk for humans is unknown. This medicine should not be used during pregnancy. Breastfeeding 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.