Each capsule contains Nifuroxazide - 200 mg.
Excipients/Inactive Ingredients: (Diluent) Lactose Hydrate - 80 mg, (Diluent) Microcrystalline Cellulose - 30 mg. (Lubricant) Magnesium Stearate - 6 mg.
Hard Gelatin capsule ingredients: Gelatin - 76.0163 mg, Titanium Dioxide (CI Number 77891) - 0.9240 mg, Quinoline Yellow WS (CI Number 47005) - 0.0449 mg, Sunset Yellow FCF (CI Number 15985) - 0.0148 mg.
Ingredients of the Ink: Shellac* Glaze ~45% (20% Esterified); In Ethanol* (*USP/NF, PhEur, JP); Isopropyl alcohol (USP, PhEur, JP); Iron oxide Black JPE; N-butyl alcohol NF; Propylene glycol (USP, FCC, PhEur, JP, JSFA); Ammonium hydroxide 28% (NF, PhEur, FCC).
Pharmacotherapeutic group: Other intestinal anti-infectives. ATC Code: A07AX03.
Treatment of acute diarrhea presumed to be bacterial origin in the absence of suspected invasive phenomena (impaired general condition, fever, sign of toxicity or infection).
The level of rehydration by means of an oral or IV rehydration solution must be adapted according to the severity of diarrhea, and patient's age/characteristics (concomitant diseases).
Oral: Adults and young persons over 15 years of age: 1 capsule 4 times daily at 4 hours intervals or as directed by a doctor.
Duration of treatment: limited to 7 days. Or directed by a doctor.
Patients with hypersensitivity to Nitrofuran derivatives or to any of the ingredients of Rapiz Capsule. Please consult to the doctor before use.
If diarrhea persists after 2 days of Rapiz Capsule administration, the treatment method may need to be re-evaluated and rehydration using an oral or IV rehydration solution should be envisaged.
In the event of an infectious diarrhea with clinical symptoms suggesting an invasive phenomenon, antibacterial agents with good systemic distribution are recommended to be used.
Due to the presence of lactose, Rapiz Capsule must not be used in the event of lactose intolerance.
If a rehydration solution does not need to be prescribed, it is still essential to emphasize the need to rehydrate by providing a plentiful supply of drinks, sweetened or unsweetened, in order to compensate for the fluid loss due to diarrhea (the average daily amount of water is 2L).
Maintain feeding throughout the duration of diarrhea; excluding certain types of food, especially raw vegetables, fruit, green vegetables, spicy foods, together with iced drinks or foods; giving preference to grilled meats and rice.
Animal studies have not demonstrated any teratogenic effects. In the absence of teratogenic effects in animals, no teratogenic effects are expected in humans. To date, substances causing malformations in humans have been shown to be teratogenic in animals during studies conducted properly in 2 species. In a clinical context, there are no sufficient relevant data yet in order to evaluate the possible teratogenic or fetotoxic effect of Nifuroxazide when administered during pregnancy. Consequently, as precautionary measure, use of Rapiz Capsule should preferably be avoided during pregnancy. Breastfeeding is possible in the event of brief treatment with Rapiz Capsule.
Possibility of allergic reactions eg, skin rash, urticaria, Quincke's edema or anaphylactic shock.
A07AX03 - nifuroxazide ; Belongs to the class of other intestinal antiinfectives.