Alfa Normix Tablets 200 mg

Composition:

Each film-coated tablet contains:

• Active substance: Rifaximin – 200 mg.

• Excipients: Sodium starch glycolate, glyceryl distearate, colloidal anhydrous silica, talc, microcrystalline cellulose, hypromellose, titanium dioxide (E171), sodium edetate, propylene glycol, red iron oxide (E172).

Indications for Use:

Alfa Normix is used to treat gastrointestinal infections caused by rifaximin-sensitive bacteria, including:

• Acute gastrointestinal infections

• Traveler’s diarrhea

• Small intestinal bacterial overgrowth (SIBO)

• Hepatic encephalopathy

• Symptomatic uncomplicated diverticular disease of the colon

• Chronic inflammatory bowel disease

• Prophylaxis of infectious complications in colorectal surgery

Contraindications:

• Hypersensitivity to rifaximin, other rifamycin derivatives, or any excipients in the product

• Intestinal obstruction

• Rifaximin should not be used in patients with diarrhea complicated by fever or blood in the stool.

Use During Pregnancy and Lactation:

Pregnancy:
There is limited or no data on the use of rifaximin in pregnant women. Animal studies showed transient effects on fetal ossification and skeletal variations. The clinical relevance of these findings in humans is unknown.
As a precaution, use during pregnancy is not recommended.

Lactation:
It is unknown whether rifaximin or its metabolites are excreted in human milk. A risk to breastfed infants cannot be excluded.
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from rifaximin therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility:
Animal studies do not indicate direct or indirect harmful effects on male or female fertility.

Effect on Ability to Drive and Use Machines:

In controlled clinical studies, dizziness and drowsiness have been reported.
However, rifaximin has minor influence on the ability to drive or operate machinery.

Dosage and Administration:

Adults and children over 12 years of age:

• 200 mg (1 tablet) every 8 hours or

• 400 mg (2 tablets) every 8–12 hours

• Dosage and frequency can be adjusted under medical supervision if necessary.

Duration of treatment:

Should not exceed 7 days. Repeat courses can be administered only after 20–40 days, depending on clinical evaluation.

Method of administration:

• Orally, with a glass of water

• Can be taken with or without food

Elderly patients:
No dosage adjustment required.

Hepatic impairment:
No dose adjustment is necessary.

Renal impairment:
Although dose adjustment is not required, caution is advised in patients with renal dysfunction.

Pediatric population:
Safety and efficacy have not been established in children under 12 years of age.

Storage Conditions:

• Store below 30°C.

• Keep out of reach of children.