Sanofi Maalox Reflux 20mg 14 Gastro-Resistant Tablets

Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.

Warnings
MAALOX REFLUSSO can reduce the absorption of active ingredients 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) in 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. An interaction of pantoprazole with other substances metabolised via the same enzyme system cannot be excluded. However, no clinically significant interactions were observed in specific tests with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl estradi.

Although no interactions were observed during concomitant treatment with phenprocoumon or warfarin in clinical pharmacokinetic studies, some isolated cases of variation 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.

There was no evidence of interactions with concomitantly administered antacids.

COMPOSITION
Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).

Excipients
38.425 mg of Maltitol and 0.345 mg Lecithin (derived from soybean oil) (see section 4.4)

Maalox Reflux in pack of 14 tablets