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  • 039487020

Indicated for gastroesophageal reflux.

Indicated in case of heartburn.

Deductible over-the-counter drug.

Antacid action.

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[su_spoiler title = "MEDICINAL NAME"style =" fancy "icon =" chevron-circle "]

Xantrazol 20 mg gastro-resistant tablets

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[su_spoiler title = "QUALITATIVE AND QUANTITATIVE COMPOSITION"style =" fancy "icon =" chevron-circle "]

Each gastro-resistant tablet contains 20.6 mg of omeprazole magnesium salt corresponding to 20 mg of omeprazole.

Excipient: Each gastro-resistant tablet contains 19-20 mg of sucrose.

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[su_spoiler title = "PHARMACEUTICAL FORM"style =" fancy "icon =" chevron-circle "]

Gastro-resistant tablet.

Pink, oblong, biconvex, film-coated tablets, debossed on one side and 20 mg on the other side, containing gastro-resistant granules.

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[su_spoiler title = "THERAPEUTIC INDICATIONS"style =" fancy "icon =" chevron-circle "]

Xantrazol gastro-resistant tablets are indicated for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.

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[su_spoiler title = "DOSAGE AND METHOD OF ADMINISTRATION"style =" fancy "icon =" chevron-circle "]

Dosage in adults

The recommended dose is 20 mg, once a day, for 14 days.

It may be necessary to take the tablets for 2-3 consecutive days to improve symptoms.

Most patients have complete resolution of heartburn within 7 days. Once complete resolution of symptoms has been achieved, treatment should be stopped.

Special populations

Impaired renal function

No dosage adjustment is necessary in patients with impaired renal function.

Impaired liver function

Patients with impaired liver function should take Xantrazol under medical advice.

Elderly (> 65 years)

Dosage adjustment is not necessary in elderly patients.

Method of administration

It is recommended to take Xantrazol tablets in the morning, preferably on an empty stomach, swallowed whole with half a glass of water. The tablets should not be chewed or crushed.

Patients with swallowing difficulties

Break the tablet and disperse it in a tablespoon of still water or, if you prefer, mix it with fruit juice or apple puree. The dispersion must be swallowed immediately (or within 30 minutes). The dispersion must be mixed before drinking it. Rinse the bottom with half a glass of water. DO NOT USE milk or sparkling water. The gastro-resistant granules must not be chewed.

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[su_spoiler title = "CONTRAINDICATIONS"style =" fancy "icon =" chevron-circle "]

Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients.

Omeprazole, like other proton pump inhibitors, should not be administered concomitantly with nelfinavir.

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[su_spoiler title = "WARNINGS AND PRECAUTIONS FOR USE"style =" fancy "icon =" chevron-circle "] In the presence of alarm symptoms (eg significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when the presence of a gastric ulcer, the malignant nature of the ulcer should be excluded as the symptomatic response to therapy could alleviate symptoms and delay a correct diagnosis.

Co-administration of atazanavir and proton pump inhibitors is not recommended. If the combination of atazanavir and proton pump inhibitor is judged unavoidable, close clinical monitoring (eg viral load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; the dose of omeprazole should not exceed 20 mg.

Omeprazole is a CYP2C19 inhibitor. Potential interaction with drugs metabolised by CYP2C19 should be considered at the start or end of treatment with omeprazole. An interaction was observed between clopidogrel and omeprazole. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of clopidogrel and omeprazole should be discouraged.

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 seek medical attention and the healthcare professional should evaluate the advisability of stopping treatment with Xantrazol. SCLE following treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Xantrazol gastro-resistant tablets contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency should not take this medicine.

Treatment with proton pump inhibitors may cause a slightly increased risk of Salmonella and Campylobacter gastrointestinal infections.

Patients with long-term recurrent symptoms of dyspepsia or heartburn should see their doctor at regular intervals. In particular, patients over 55 who are taking daily over-the-counter (OTC, non-prescription) medicines for dyspepsia or heartburn should inform their pharmacist or doctor.

Patients should be advised to consult a physician if:

Have had previous gastric ulcer or have undergone gastrointestinal surgery

Have been on continuous symptomatic treatment for dyspepsia or heartburn for 4 or more weeks

Have jaundice or have severe liver disease

They are over the age of 55 and their symptoms are new or have recently changed.

Patients should not take omeprazole as a preventative treatment.

Interference with laboratory tests

An increased level of Chromogranin A (CgA) can interfere with diagnostic tests for neuroendocrine tumors. To avoid this interference, Xantrazol treatment should be stopped for at least 5 days before CgA measurements. 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. [/ Su_spoiler]

[su_spoiler title = "INTERACTIONS"style =" fancy "icon =" chevron-circle "]

Effects of omeprazole on the pharmacokinetics of other active substances

Active ingredients with pH-dependent absorption

Gastric pH-dependent absorption of active substances may be increased or reduced by decreased intragastric acidity during treatment with omeprazole.

Nelfinavir, atazanavir

Plasma levels of nelfinavir and atazanavir decrease when omeprazole is co-administered.

Concomitant administration of omeprazole and nelfinavir is contraindicated. Co-administration of omeprazole (40 mg once daily) reduced the mean nelfinavir exposure by approximately 40% and reduced the mean exposure of the pharmacologically active metabolite M8 by approximately 75-90%. The interaction may also involve CYP2C19 inhibition.

Concomitant administration of omeprazole and atazanavir is not recommended. Co-administration of omeprazole (40 mg once daily) and atazanavir 300 mg / ritonavir 100 mg to healthy volunteers resulted in a reduction of 75% of atazanavir exposure. Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. Co-administration of omeprazole (20 mg once daily) and atazanavir 400 mg / ritonavir 100 mg to healthy volunteers resulted in a reduction of approximately 30% exposure of atazanavir compared to atazanavir 300 mg / ritonavir 100 mg once daily.


Concomitant treatment with omeprazole (20 mg / day) and digoxin in healthy subjects resulted in an increase of 10% the bioavailability of digoxin. Digoxin toxicity has rarely been reported. However, caution is advised when using high-dose omeprazole in elderly patients. Therapeutic monitoring of digoxin should therefore be increased.


In a cross-over clinical study, clopidogrel (300 mg loading dose followed by 75 mg / day) was administered for 5 days as monotherapy and with omeprazole (80 mg given together with clopidogrel). Exposure to the active metabolite of clopidogrel decreased by 46% (day 1) and 42% (day 5) when clopidogrel and omeprazole were co-administered. When clopidogrel and omeprazole were co-administered there was a decrease of 47% (24 hours) and 30% (day 5) of the mean inhibition of platelet aggregation. In another study it was shown that administering clopidogrel and omeprazole at different times does not prevent their interaction, which appears to be driven by the inhibitory action of omeprazole on CYP2C19. Inconsistent data from observational and clinical studies have been reported on the clinical implications of this pharmacokinetic / pharmacodynamic interaction in terms of increased major cardiovascular events.

Other active ingredients

Absorption of posaconazole, erlotinib, ketoconazole and itraconazole is significantly reduced and therefore clinical efficacy may be compromised. Concomitant use of posaconazole and erlotinib should be avoided.

Active substances metabolised by CYP2C19

Omeprazole is a moderate inhibitor of its main metabolising enzyme, CYP2C19. Therefore, the metabolism of concomitant active substances also metabolised by CYP2C19 may be decreased and systemic exposure to these substances increased. Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.


Omeprazole, given as 40 mg to healthy volunteers in a cross-over study, increased cilostazol Cmax and AUC by 18, respectively.% and of 26% and one of its active metabolites respectively of 29% and 69%.


Monitoring of phenytoin plasma concentration is recommended during the first two weeks after initiation of omeprazole treatment and, if a phenytoin dose adjustment is required, monitoring and further dose adjustment is recommended when ending treatment. with omeprazole.

Mechanism unknown


Concomitant administration of omeprazole and saquinavir / ritonavir resulted in an increase in plasma levels of saquinavir up to approximately 70% with good tolerability in HIV-positive patients.


Concomitant administration of omeprazole has been reported to increase the serum levels of tacrolimus. Monitoring of tacrolimus concentrations and renal function (creatinine clearance) should be increased and, if necessary, the tacrolimus dosage should be adjusted.


When given together with proton pump inhibitors, an increase in methotrexate levels has been reported in some patients.

When methotrexate is administered in high doses, a temporary withdrawal of omeprazole should be considered.

Influence of other active substances on the pharmacokinetics of omeprazole

CYP2C19 and / or CYP3A4 inhibitors

As omeprazole is metabolised by CYP2C19 and CYP3A4, the active substances inhibiting CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may increase the serum levels of omeprazole, decreasing its rate of metabolism. Co-administration of voriconazole results in more than double exposure to omeprazole. Since the administration of high doses of omeprazole was well tolerated, no dose adjustment of omeprazole is generally necessary. However, dose adjustment should be considered in patients with severe hepatic impairment and in the case of long-term treatment.

Inducers of CYP2C19 and / or CYP3A4

Active substances inducing CYP2C19 or CYP3A4 or both (such as rifampicin and St. John's wort) may lead to a decrease in the serum levels of omeprazole, increasing the metabolism of omeprazole.

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[su_spoiler title = "FERTILITY, PREGNANCY AND BREASTFEEDING"style =" fancy "icon =" chevron-circle "]

The results of three prospective epidemiological studies (more than 1000 outcomes of exposed patients) indicate no adverse effects of omeprazole on pregnancy or on the health of the fetus / newborn. Omeprazole can be used during pregnancy.

Omeprazole is excreted in breast milk but is unlikely to affect the infant when administered in therapeutic doses.

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[su_spoiler title = "EFFECTS ON THE ABILITY TO DRIVE VEHICLES"style =" fancy "icon =" chevron-circle "]

It is unlikely that Xantrazol will affect the ability to drive or use machines. Adverse drug reactions such as dizziness and visual disturbances may occur. If they suffer from it, patients should not drive or operate machinery.

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[su_spoiler title = "SIDE EFFECTS"style =" fancy "icon =" chevron-circle "]

The most common side effects (1 - 10% of patients) are headache, abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting and fundic gland polyps (benign).

The following adverse reactions, identified or suspected, have been identified during clinical trials with omeprazole and post-marketing. In no case was a correlation with the administered drug dose established. Undesirable effects are classified by frequency and Organ Classification System (SOC). Frequency categories are defined using the following convention: Very common (≥1 / 10), Common (≥1 / 100 to

SOC / frequency

Side effects

Disorders of the blood and lymphatic system


Leukopenia, thrombocytopenia

Very rare:

Agranulocytosis, pancytopenia

Disorders of the immune system


Hypersensitivity reactions, eg. fever, angioedema and anaphylactic reaction / shock

Metabolism and nutrition disorders



Very rare:


Psychiatric disorders




Agitation, confusion, depression

Very rare:

Aggression, hallucinations

Nervous system disorders




Dizziness, paraesthesia, somnolence


Changes in taste

Eye disorders


Blurred vision

Ear and labyrinth disorders



Respiratory, thoracic and mediastinal disorders



Gastrointestinal disorders


Abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting, fundic gland polyps (benign)


Dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis

Hepatobiliary disorders


Elevation of liver enzyme values


Hepatitis with or without jaundice

Very rare:

Hepatic failure, encephalopathy in patients with pre-existing liver disease

Skin and subcutaneous tissue disorders


Dermatitis, itching, rash, urticaria


Alopecia, photosensitization

Very rare:

Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)

Not known:

Subacute cutaneous lupus erythematosus

Musculoskeletal and connective tissue disorders


Arthralgia, myalgia

Very rare:

Muscle weakness

Renal and urinary disorders


Interstitial nephritis

Reproductive system and breast disorders

Very rare:


General disorders and administration site conditions


Malaise, peripheral edema


Increased sweating

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 http://www.agenziafarmaco.gov.it/it/responsabili.

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[su_spoiler title = "OVERDOSE"style =" fancy "icon =" chevron-circle "]

There is limited information available regarding overdose with omeprazole in humans. Doses up to 560 mg are reported in the literature and there have been occasional reports of single oral doses up to 2,400 mg of omeprazole (120 times the usually recommended clinical dose). Nausea, vomiting, dizziness, abdominal pain, diarrhea and headache have been reported. In individual cases, apathy, depression and confusion were also observed.

The symptoms described were transient and no serious consequences were reported. With increasing doses the elimination rate did not change (first order kinetics). Treatment, if necessary, is symptomatic. [/ Su_spoiler]

[su_spoiler title = "LIST OF EXCIPIENTS"style =" fancy "icon =" chevron-circle "]

Microcrystalline cellulose,

Glycerol monostearate 40-55,



Macrogol 6000

Magnesium stearate

Copolymer of methacrylic acid - ethyl acrylate (1: 1) dispersion at 30%

Polysorbate 80

Crospovidone (Type A)

Sodium hydroxide (for pH adjustment)

Sodium stearyl fumarate

Sugar balls (containing sucrose and corn starch)

Synthetic paraffin


Triethyl citrate

Reddish brown iron oxide (E172)

Titanium dioxide (E171)

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[su_spoiler title = "STORAGE"style =" fancy "icon =" chevron-circle "]

Do not store above 25 ° C

Store in the original package in order to protect from moisture.

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[su_spoiler title = "MARKETING AUTHORIZATION HOLDER"style =" fancy "icon =" chevron-circle "] Bayer Spa - Viale Certosa 130 - Milan

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[su_spoiler title = "AUTHORIZATION NUMBER - MINSAN"style =" fancy "icon =" chevron-circle "]

14 gastro-resistant tablets AIC 039487020

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