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Alfa Wassermann S.P.A - Italy

NIFEDICOR RETARD
NORMIX
VESSEL DUE F Capsules
VESSEL DUE F Inj.

Forms and presentation
Normix Tablets: Coated tablets. Box of 12.
Normix Suspension: Granules for oral suspension: Bottle of 60 ml.

Composition
Normix Tablets: Each coated tablet contains: Rifaximine: 200 mg. Excipients: glycolate sodium starch, palmito stearic ester of glycerol, silica precipitate, talc microgranular cellulose, hydroxypropylmethylcellulose, titanium dioxide E171, disodium edetate, propylene glycol, red iron oxide E172.
Normix Suspension: Each ml of thereconstituted suspension contain: Rifaximine: 20 mg. Excipients: microgranular cellulose, sodium salt carboxymethylcellulose, pectin, kaolin, sodium saccharin, sodium benzoate, saccharose, black cherry flavouring.

Indications
Acute and chronic intestinal infections sustained by Gram+ and Gram- bacteria; diarrhoeic syndrome.
Diarrhoea caused by an altered equilibrium of the intestinal microbial flora (summer diarrhoea, traveller’s diarrhoea, enterocholitis).
Pre- and post-operative prophylaxis of infective complications in surgery of the gastroenteric region.
Coadjuvant in the treatment of hyperammonemia.

Contraindications
Cases of hypersensitivity to rifamycins. Cases of intestinal obstruction, even partial, or severe ulcerous lesions of the intestine.

Precautions
During prolonged treatment at high doses, or when there are lesions of the intestinal mucosa, only a small part of the product may be absorbed (< 1 %) determining a reddish-pink colour in the urine when eliminated; this exclusively depends on the active ingredient which, like most antibiotics of the same group (rifamycins), is reddish-orange in colour.
In case of pregnancy and during early childhood, the product should be administered only when strictly necessary, and under direct physician’s surveillance. Should microorganisms which are not sensitive to the antibiotic develop, treatment must be interrupted and suitable therapy carried out.

Drug interactions
The product does not cause problems of pharmacological interactions at the systemic level.

Side effects
In some cases nausea has been observed, occuring in association with the first administrations of the drug, and rapidly regressed without having to suspend treatment. During prolonged treatments at high doses, urticaria-type skin reactions may occasionally occur.

Dosage and administration
Doses may be modified in quantity and frequency, depending on the physician’s advice.
Unless otherwise prescribed, treatment should not exceed 7 days.
Anti-diarrhoeic treatment:Recommended dose:
Adults and children over 12 years: 1 tablet every 6 hrs.
Children from 6-12 years: ½-1 tablet every 6 hrs.
Children from 2-6 years: 1, 5 ml dose of oral suspension (equal to 100 mg) every 6 hrs.
Pre and post-operative treatment: Recommended dose:
Adults and children over 12 years: 2 tablets every 12 hrs.
Children from 6-12 years: 1-2 tablets every 12 hrs.
Children from 2-6 years: 1-2, 5 ml doses (equal to 100-200 mg) every 12 hrs.
Coadjuvant treatment of hyperammonemia: Recommended dose:
Adults and children over 12 years: 2 tablets every 8 hrs.
Children from 6-12 years: 1-1½ tablets every 8 hrs.
Children from 2-6 years: 1-2, 5 ml doses (equal to 100-200 mg) every 8 hrs.

Origin: Italy
Laboratories: Alfa Wassermann
Distributor: Droguerie Phenicia
Number & Year of Registration 
Tablets: 405939/2000
Suspension: 405931/2000