Eugastrol Reflux 20 Mg Pantoprazole 7 Gastro-resistant Tablets

Pantoprazole-based tablets.

Therapeutic indications

Eugastrol Reflux is used for the short-term treatment of reflux symptoms (eg heartburn, acid regurgitation) in adults.

Dosage and Posology

The drug should be taken according to the following doses and methods: 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 achieve an improvement in symptoms. Once complete healing of symptoms is achieved, treatment should be stopped. Treatment should not exceed 4 weeks without consulting a doctor. If no improvement in symptoms is noted within 2 weeks of continuous treatment, the patient should seek medical attention.

No dose adjustment is necessary in elderly patients or in patients with renal or hepatic impairment. Eugastrol Reflux Control is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.

Eugastrol Reflux Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.

Overdose

Doses up to 240 mg administered intravenously over 2 minutes were well tolerated. Since pantoprazole is extensively protein bound, it is not readily dialyzable. In the event of an overdose with clinical signs of intoxication, other than symptomatic and supportive treatment, no specific therapeutic recommendations can be made.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Simultaneous administration with atazanavir

Side effects

Approximately 5% of patients can be expected to experience adverse reactions. The most commonly reported adverse reactions are diarrhea and headache, both occurring in approximately 1% of patients. The following adverse reactions have been observed with pantoprazole. Within the table below, adverse reactions are ranked under MedDRA 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, adverse reactions are reported in order of decreasing severity.

- Disorders of the blood and lymphatic system

• Rare: Agranulocytosis
• Very rare: Thrombocytopenia; Leukopenia; Pancytopenia

- Disorders of the immune system

• Rare: Hypersensitivity (including anaphylactic reactions and anaphylactic shock)

- Metabolism and nutrition disorders

• Rare: Hyperlipidemias and increased lipids (triglycerides, cholesterol); Weight changes
• Not known: Hyponatremia; Hypomagnesemia

- Psychiatric disorders

• Uncommon: Sleep disturbances
• Rare: Depression (and all aggravations of this symptom)
• Very rare: Disorientation (and all aggravations of this symptom)
• Not known: Hallucinations; Confusion (especially in predisposed patients, as well as aggravation of these symptoms in case of pre-existence)

- Nervous system disorders

• Uncommon: Headache; Dizziness
• Rare: Changes in taste

- Eye disorders

• Rare: Disturbance in vision / blurred vision

- Gastrointestinal disorders

• Uncommon: Diarrhea; Nausea / vomiting; Abdominal distension and bloating; Constipation; Dry mouth Abdominal pain and discomfort

- Hepatobiliary disorders

• Uncommon: Increased levels of liver enzymes (transaminases, -GT)
• Rare: Increased bilirubin
• Not known: Hepatocellular injury; Jaundice Hepatocellular insufficiency

- Skin and subcutaneous tissue disorders

• Uncommon: Rash / rash / eruption; Itching
• Rare: Hives; Angioedema
• Not known: Steven-Johnson syndrome; Lyell's syndrome; Erythema multiforme; Photosensitivity

- Musculoskeletal and connective tissue disorders

• Uncommon: Arthralgia; Myalgia

- Renal and urinary disorders

• Not known: Interstitial nephritis

Reproductive system and breast disorders

• Rare: Gynecomastia

- General disorders and administration site conditions

• Uncommon: Asthenia, fatigue and malaise
• Rare: Increased body temperature; Peripheral edema

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Special warnings

Patients should be instructed to contact their physician if: - They have unintentional weight loss, anemia, gastrointestinal bleeding, dysphagia, persistent vomiting or bloody vomiting, as the medicine may relieve symptoms and delay the diagnosis of a serious condition . In these cases, a malignant form must be excluded. - Have had previous stomach ulcers or gastrointestinal surgery. - I have been on continuous symptomatic treatment for indigestion or heartburn for 4 weeks or more. - Have jaundice, liver impairment, or liver disease. - Have any other serious pathology that impairs general well-being. - Are over 55 with new or recently changed symptoms.

Patients with chronic recurring symptoms of indigestion or heartburn should see their doctor at regular intervals. Especially, patients over 55 who take any non-prescription medicine for indigestion or heartburn on a daily basis should inform their pharmacist or doctor. Patients should not take any other proton pump inhibitors or H2 antagonists at the same time. Patients undergoing endoscopy or breath testing (UBT) should consult their doctor before taking this medicine. Patients should be advised that the tablets are not intended to provide immediate relief. Patients may begin to experience improvement in symptoms after approximately one day of treatment with pantoprazole, but it may be necessary to take it for 7 days to achieve complete control of heartburn. Patients should not take pantoprazole as a preventative drug.

Decreased gastric acidity for any reason - including proton pump inhibitors - increases the gastric counts of bacteria normally found in the gastrointestinal tract. Treatment with acid-reducing medicinal products leads to a slightly increased risk of gastrointestinal infections such as Salmonella, Campylobacter, or Clostridium difficile.

This medicine contains lecithin derived from soybean oil. If the patient is allergic to peanut or soy, he should not use this medicine. This medicine contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. This medicinal product does not require any special storage conditions.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

Each Eugastrol Reflux tablet contains:

Active principle

Pantoprazole 20 mg (as sodium sesquihydrate).

Excipients

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