DOSANLOC * 14CPR GASTRORES 20MG

DOSANLOC * 14CPR GASTRORES 20MG

Therapeutic indications

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

Dosage and method of use

DosageThe 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 recovery from symptoms is achieved, treatment should be stopped. Treatment should not exceed 4 weeks without prior medical advice. If no improvement in symptoms is noted within 2 weeks of continuous treatment, the patient should be instructed to seek medical attention.Special populationsNo dose adjustment is required in elderly patients or in patients with impaired renal or hepatic function. Pediatric population Dosanloc is not recommended for use in children and adolescents below 18 years due to insufficient data on its safety and efficacy.Method of administrationDosanloc tablets should not be chewed or crushed and should be swallowed whole with liquid before a meal.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration with atazanavir (see section 4.5).

Side effects

Summary of the safety profile.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.Table of adverse reactionsThe following adverse reactions have been observed with pantoprazole. Adverse reactions are ranked under the MedDRA convention of frequency within the following table: very common (≥1 / 10); common (≥1 / 100 to

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 at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

Patients should be instructed to contact their doctor if they: • suffer from 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 disorder. In these cases, a malignant form must be excluded • have previously suffered from gastric ulcers or have undergone gastrointestinal surgery • are on continuous symptomatic treatment for indigestion or heartburn for 4 weeks or more • suffer from jaundice, hepatic impairment or liver disease • have any other serious illness that affects general well-being • are over 55 and have new or recently changed symptoms. Patients with chronic recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals. In particular, patients over 55 who take any over-the-counter 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 H antagonists at the same time₂. 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.Gastrointestinal infections caused by bacteriaA decrease in gastric acidity for any reason, including the use of proton pump inhibitors, increases the gastric count of bacteria normally found in the gastrointestinal tract. Treatment with acid-reducing medicinal products causes a slightly increased risk of gastrointestinal infections such asSalmonella, Campylobacter or Clostridium difficile. This medicinal product contains the coloring agent Ponceau 4R aluminum lake (E 124), which may cause allergic reactions.

Pregnancy and breastfeeding

PregnancyThere are no adequate data from the use of pantoprazole in pregnant women. Animal studies have shown reproductive toxicity. Non-clinical studies revealed 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 in pregnancy.BreastfeedingIt is not known whether or not pantoprazole is excreted in human milk. Animal studies have shown the excretion of pantoprazole in breast milk. This medicine should not be used during breastfeeding.FertilityThere is no evidence of impaired fertility following administration of pantoprazole in animal studies (see section 5.3).

Expiry and retention

This medicinal product does not require any special storage precautions.

Interactions with other drugs

Dosanloc may reduce the absorption of active substances whose bioavailability depends on the 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) to healthy volunteers has been shown to result in a substantial reduction in the bioavailability of atazanavir. . Absorption of atazanavir is pH-dependent, therefore pantoprazole should not be administered concomitantly with atazanavir (see section 4.3). Pantoprazole is metabolised in the liver by the cytochrome P450 enzyme system. Interaction studies with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl estradiol did not reveal clinically significant interactions. However, an interaction of pantoprazole with other substances which are metabolised by the same enzyme system cannot be excluded. Although no interactions were observed during concomitant treatment with phenprocoumon or warfarin in clinical pharmacokinetic studies, a few isolated cases of changes in International Normalized Ratio (INR) have been detected during concomitant treatment in the post-marketing period. Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), it is recommended to monitor the prothrombin time / INR when pantoprazole treatment is initiated, when it is discontinued or when administered intermittently. Concomitant use of a high dose of methotrexate (e.g. 300 mg) and proton pump inhibitors has been reported to increase methotrexate levels in some patients. Therefore, in therapies where high-dose methotrexate is used, for example, cancer and psoriasis, temporary withdrawal of pantoprazole may need to be considered. No interactions with concomitantly administered antacids were noted.

Overdose

Doses up to 240 mg administered intravenously over 2 minutes were well tolerated. Since pantoprazole binds extensively to proteins, it is not readily dialyzable. In case of overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.

Active principles

Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of sodium sesquihydrate). Excipients with known effect: Contains 1 mcg of the coloring agent Ponceau 4R aluminum lake for each gastro-resistant tablet. For the full list of excipients, see section 6.1.

Excipients

NucleusCalcium stearate Microcrystalline cellulose Crospovidone (type A) Hydroxypropylcellulose (type EXF) Sodium carbonate, anhydrous Silica, colloidal anhydrousCoatingHypromellose Yellow iron oxide (E 172) Macrogol 400 Methacrylic acid – ethyl acrylate copolymer (1: 1) Polysorbate 80 Ponceau 4R aluminum lake (E 124) Quinoline yellow aluminum lake (E 104) Sodium laurilsulfate Titanium dioxide (E 171 ) Triethyl citrate