Maalox Reflux 7 Tablets 20mg,Maalox Reflusso 7 Compresse 20mg,SofAR SPA

“ACTIVE Ingredients: Pantoprazole (as sodium sesquidrato).
Excipients: Core: maltitol (E965); crospovidone type B; sodium carmellosa; sodium carbonate anhydrous; calcium stearate. Coating: poly(vinilalcool); t alco; titanium dioxide (E 171); macrogol 3350; soy lecithin; iron oxide yellow (E 172); sodium carbonate anhydrous; metal acid copolymer produced by ethyl acrylate (1:1); sodium lauryl sulfate; polysorbate 80; trireme ilcitrato.
INDICATIONS: Short-term treatment of reflux symptoms (eg, heartburn, acid reflux) in adults.
CONTRAINDICATIONS/EFF.SECONDARY: Hypersensitivity to the active substance, benzimidazole replaced by ecitina (derived from soybean oil), or to any of the other ingredients; simultaneous administration with atazanavir.
DOSAGE: The recommended dose is 20 mg pantoprazole (one tablet) per day. It may be necessary to take the tablets for 2-3 days in a row to get an improvement in symptoms.
STORAGE: This drug does not require special storage conditions.
Special INSTRUCTIONS: Patients should be instructed to consult a physician
INTERACTIONS: Effect of pantoprazole on the absorption of other drugs: f arm may reduce the absorption of active ingredients whose bioavailability depends on gastric pH (eg ketoconazole). Medicines for HIV (atazanavir): and it has been proven that administration of contemp orani atazanavir 300 mg/ritonavir 100 mg with omeprazole (40 mg once daily) or atazanavir 400 mg with lansoprazole (60 mg in a single dose) in healthy volunteers resulted in to a significant decrease in the bioavailability of atazanavir. Absorption of atazanavir and pHdipendente. Therefore, pantoprazole should not be coadministered with atazanavir. Coumarin anticoagulants (fenprocumone and or warfarin): Although no interactions were observed during treatment concomitantly with fenprocumone or warfarin in clinical pharmacokinetic studies, some isolated cases of changes in the Intrinsic Normalized Ratio (INR) have been reported during treatment with concomitant nt in the post-marketing period. Therefore, in patients treated with coumarin anticoagulants (eg, fenprocumone or warfarin), it is recommended that prothrombin time/INR be monitored when treatment with pantoprazole is started, when stopped, or when administered intermittently. Methotrexate: In some patients, concomitant use of high dose methotrexate (eg, 300 mg) and a proton pump inhibitor has been reported to increase their methotrexate levels. Therefore, in cases where methotrexate is used in high doses, for example in the treatment of tumors and psoriasis, temporary suspension of pantoprazole therapy should be evaluated. Other interaction studies with: Pantoprazole is metabolized in the liver by the cytochrome P450 enzyme system. Interaction studies with carbamazepine, caffeine, diazepam, diclofena C, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedip inna, phenytoin, piroxicam, theophylline and oral contraceptives containing the bodies levonorgestrel and ethinyl estradiol did not reveal clinically significant interactions. In any case, interaction of pantoprazole with other substances that are metabolized by the same enzyme system cannot be excluded. There were no interactions with antacids administered concomitantly.
SIDE EFFECTS: About 5% of patients can be expected to experience adverse drug reactions (ADR). Adverse reactions are most often indicated by diarrhea and headache, which occur in about 1% of patients. The following table lists the adverse reactions of pantoprazole, arranged according to the following frequency classification: very common (>=1/10); general (>=1/100, =1/1000, =1/10.000, adverse reactions with pantoprazole in clinical trials, and my post-marketing experience. Diseases of the emolinfopoietico system. Rarely: agranulocytosis; very rarely: thrombocytopenia; leukopenia, pancytopenia. Immune system disorders Rare: hypersensitivity (including anaphylactic reactions and anaphylactic shock) Metabolic and nutritional disorders Rare: hyperlipidemia and increased lipid levels (trig liceridi, cholesterol); weight changes; not note: hyponatremia, ip omagnesiemia. Mental disorders. Uncommon: sleep disturbances; r aro: depression (and all forms of exacerbation); very rare: disorientation (and all forms of exacerbation); not a comment: hallucinations; confusion (especially in predisposed patients, since exacerbation of these events in the case of pre- existence). Pathologies of the nervous system. Uncommon: headache; dizziness; rarely: taste disturbances. Pathologies of the eye. Rarely: blurred vision/blurred vision. Gastrointestinal diseases. Uncommon: diarrhea; nausea, vomiting; bloating and bloating; constipation; dry mouth; pain and disruption in dominoes. Hepatobiliary diseases. Not often: increased levels of liver enzymes (transaminases, gamma-GT); rare: increased levels”