Gastroschoum Reflux Omeprazole 20 mg 14 Hard Capsules

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

Gastroschoum Reflux Omeprazole 20 mg 14 Hard Capsules it's a over-the-counter drug indicated for the treatment of gastric reflux symptoms in adults, as heartburn e acid regurgitation. Each hard capsule contains 20 mg omeprazole, active ingredient belonging to the category of proton pump inhibitors (PPIs), among the most used and clinically documented for reduce the production of gastric acid and quickly alleviate ailments related tostomach acidity.

Thanks to its targeted action on proton pump, Gastroschoum Reflux works directly at the source of the problem: most patients get a Complete relief from heartburn within 7 days with one single capsule per day, taken on an empty stomach at least 30 minutes before meals. The pack of 14 hard capsules it is ideal for a complete two-week treatment cycle, practical to store and simple to take.

Gastroschoum Reflux omeprazole 20 mg It is indicated for adults who suffer from gastroesophageal reflux, stomach acidity e occasional burning.

INDICATIONS

Why is Gastroschoum Reflux Omeprazole 20 mg 14 Hard Capsules used? What is it for?

GastroSchoum Reflux is indicated for treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.

ACTIVE INGREDIENTS AND EXCIPIENTS

What is the composition of Gastroschoum Reflux Omeprazole 20 mg 14 Hard Capsules?

Each capsule contains 20 mg omeprazole. Excipients with known effects: each hard capsule contains 225 mg sodium. For the full list of excipients, see section 6.1.

Capsule contents: sodium hydrogen carbonate (E500ii), sodium starch glycolate (Type A), sodium stearyl fumarate (E485). Capsule: gelatine (E441), red iron oxide (E172), titanium dioxide (E171).

DOSAGE

How is Gastroschoum Reflux Omeprazole 20 mg 14 Hard Capsules taken?

Adults: the recommended dose is 20 mg (one capsule) once a day for 14 days. You may need to take the capsules for 2-3 consecutive days to achieve improvement in symptoms. Most patients get a Complete relief from heartburn within 7 days. Once complete disappearance of symptoms has been achieved, treatment should be discontinued.

Particular populations.
Renal impairment: no dosage adjustment is necessary in patients with impaired renal function (see section 5.2).
Hepatic impairment: patients with impaired liver function should consult a doctor before taking omeprazole (see section 5.2).
Elderly: no dose adjustment is necessary in elderly patients (see section 5.2).
Pediatric population: The use of GastroSchoum Reflux is not recommended for children and adolescents under 18 years of age.

Method of administration: GastroSchoum Reflux must be taken on an empty stomach, at least 30 minutes before eating and at least two hours after the last meal. The capsule should be swallowed whole with half a glass of water and it should not be chewed or opened.

CONTRAINDICATIONS AND SIDE EFFECTS

When should Gastroschoum Reflux Omeprazole 20 mg 14 Hard Capsules not be used and what side effects can it cause?

Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients listed in section 6.1. Omeprazole like others proton pump inhibitors (PPIs) must not be used concomitantly with nelfinavir (see section 4.5).

The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhea, flatulence and nausea/vomiting. Below is the complete classification by frequency according to MedDRA.

Classification by systems and organs - Frequency - Adverse Reaction
Pathologies of the blood and lymphatic system - Rare - Leukopenia, thrombocytopenia
Pathologies of the blood and lymphatic system - Very rare - Agranulocytosis, pancytopenia
Immune system disorders - Rare - Hypersensitivity reactions such as fever, angioedema, anaphylactic reaction/shock
Metabolism and nutrition disorders - Rare - Hyponatremia
Metabolism and nutrition disorders - Not known - Hypomagnesemia, hypocalcaemia, hypokalaemia
Psychiatric disorders - Uncommon - Insomnia
Psychiatric disorders - Rare - Agitation, confusion, depression
Psychiatric disorders - Very rare - Aggression, hallucinations
Nervous system disorders - Common - Headache
Nervous system disorders - Uncommon - Dizziness, paraesthesia, drowsiness
Nervous system disorders - Rare - Taste disturbances
Eye pathologies - Rare - Blurred vision
Ear and labyrinth disorders - Uncommon - Dizziness
Respiratory, thoracic and mediastinal disorders - Rare - Bronchospasm
Gastrointestinal disorders - Common - Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign)
Gastrointestinal disorders - Rare - Dry mouth, stomatitis, gastrointestinal candidiasis
Gastrointestinal disorders - Not known - Microscopic colitis
Hepatobiliary disorders - Uncommon - Increased liver enzymes
Hepatobiliary disorders - Rare - Hepatitis with or without jaundice
Hepatobiliary disorders - Very rare - Hepatic failure, encephalopathy
Pathologies of the skin and subcutaneous tissue - Uncommon - Dermatitis, pruritus, rash, urticaria
Pathologies of the skin and subcutaneous tissue - Rare - Alopecia, photosensitivity, AGEP, DRESS
Pathologies of the skin and subcutaneous tissue - Very rare - Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)
Pathologies of the skin and subcutaneous tissue - Not known - Subacute cutaneous lupus erythematosus (SLE)
Pathologies of the musculoskeletal system - Rare - Arthralgia, myalgia
Pathologies of the musculoskeletal system - Very rare - Muscle weakness
Renal and urinary disorders - Rare - Tubulointerstitial nephritis (with possible progression to renal failure)
Pathologies of the reproductive system - Very rare - Gynecomastia
Systemic pathologies - Uncommon - Malaise, peripheral edema
Systemic pathologies - Rare - Increased sweating
Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

INTERACTIONS

Which medicines or foods can modify the effect of Gastroschoum Reflux Omeprazole 20 mg 14 Hard Capsules?

Nelfinavir, atazanavir: the concomitant administration of omeprazole with nelfinavir is contraindicated. Co-administration with atazanavir is not recommended.

Clopidogrel: coadministration reduces exposure to the active metabolite of clopidogrel. As a precaution, concomitant use should be discouraged.

Digoxin: Concomitant treatment with omeprazole may increase the bioavailability of digoxin. Therapeutic monitoring is recommended, especially in elderly patients at high doses.

Substances metabolised by CYP2C19: Omeprazole is a moderate inhibitor of CYP2C19. The metabolism of substances such as R-warfarin, cilostazol, diazepam and phenytoin may be reduced with increased systemic exposure.

Methotrexate: in the presence of high doses of methotrexate, it may be necessary to consider temporary discontinuation of omeprazole.

Voriconazole: concomitant treatment leads to a more than two-fold increase in omeprazole exposure. Dose adjustment is generally not required.

PREGNANCY AND BREASTFEEDING

Can Gastroschoum Reflux Omeprazole 20 mg 14 Hard Capsules be used during pregnancy and breastfeeding?

Pregnancy: The results of three prospective epidemiological studies (more than 1,000 exposed children) indicate that there are no adverse effects of omeprazole on pregnancy or on the health of the fetus/newborn. Omeprazole can be used during pregnancy.
Breastfeeding: Omeprazole is excreted in breast milk but is unlikely to affect the baby when used at therapeutic doses.
Fertility: Animal studies with orally administered omeprazole do not indicate effects on fertility.

WARNINGS

What are the warnings of Gastroschoum Reflux Omeprazole 20 mg 14 Hard Capsules?

In the presence of suspicious symptoms (e.g. significant and unwanted weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, the presence of a neoplasm should be excluded before instituting treatment.

Clopidogrel: as a precaution the concomitant use of omeprazole and clopidogrel should be avoided (see section 4.5).

Serious cutaneous adverse reactions (SCAR): including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), which may be life-threatening or fatal, have been reported very rarely in association with omeprazole treatment.

Subacute cutaneous lupus erythematosus (SLE): Proton pump inhibitors are associated with extremely infrequent cases of SCLE. In the presence of skin lesions, especially on the parts exposed to sunlight, the patient must immediately contact a doctor.

Renal impairment: Acute tubulointerstitial nephritis (TIN) has been observed in patients taking omeprazole. Omeprazole should be discontinued if TIN is suspected.

Interference with laboratory tests: an increased level of Chromogranin A (CgA) can interfere with diagnostic tests for neuroendocrine tumors. Omeprazole treatment should be discontinued for at least 5 days before CgA measurements.

Sodium: this medicine contains 225 mg sodium per capsule, equivalent to 11.2% of the maximum daily amount of 2 g recommended by the WHO for an adult.

Patients should be instructed to consult a doctor if: they have had a previous gastric ulcer or gastrointestinal surgery; have been on continuous symptomatic treatment for 4 or more weeks; have jaundice or severe liver disease; are over 55 years of age with new or recently changed symptoms.

Data on overdose in humans are limited. Symptoms described include nausea, vomiting, dizziness, abdominal pain, diarrhea and headache. In case of overdose it is advisable to resort to symptomatic treatment by adopting generic support measures.

GastroSchoum Reflux has negligible effects on the ability to drive or use machines. However, in case of dizziness or visual disturbances, caution is recommended.

CONSERVATION

How is Gastroschoum Reflux Omeprazole 20 mg 14 Hard Capsules stored?

Store at temperature below 25°C. Store in the original package in order to protect the medicine from moisture.

FORMAT

What is the format of Gastroschoum Reflux Omeprazole 20 mg 14 Hard Capsules?

14 Hard Capsules

DRUG LEGAL TEXT

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