NORMIX

DESCRIPTION

Normix (Rifaximin) is used to treat traveler's diarrhea caused by certain bacteria. Rifaximin is in a class of medications called antibiotics. It works by preventing the bacteria from growing inside the intestine (gut). Rifaximin will not work to treat bloody diarrhea or diarrhea with fever.

HOW TO USE THIS MEDICATION

Normix comes as a film coated tablet and granule for oral suspension to take by mouth. It is usually taken with or without food three times a day for 3 days. To help you remember to take Normix, take it around the same times every day. Follow the directions on your leaflet carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rifaximin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your symptoms should improve within 24 to 48 hours after you start taking Normix. If your symptoms do not go away or they get worse, or you develop a fever or bloody diarrhea, call your doctor.

Take Normix until you finish the prescription, even if you feel better. If you stop taking Normix too soon your infection may not be completely cured and bacteria may become resistant to antibiotics.

PRECAUTIONS I SHOULD CONSIDER DURING THERAPY

·         Inform your doctor and pharmacist if you are allergic to rifaximin, rifabutin (Mycobutin), rifampin (Rifadin, Rifamate, Rifater, Rimactane), rifapentine (Priftin), or any other medications.

·         Inform your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or have recently taken. Be sure to mention antibiotics. Your doctor may have to change the doses of your medications, monitor you carefully for side effects or treat your diarrhea differently.

·         Inform your doctor if you have or have ever had any medical condition.

·         Inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking rifaximin, call your doctor.

DIETARY INSTRUCTIONS TO FOLLOW DURING THERAPY

Unless your doctor tells you otherwise, continue your normal diet.

WHAT TO DO IF I FORGET A DOSE

Take the missed dose of Normix as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

UNDESIRABLE SIDE EFFECTS

May cause side effects. Tell your doctor if this symptom is severe or does not go away:

• vomiting

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• hives, skin rash
• itching, difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness, fever, chills, sore throat, and other signs of infection

Rifaximin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

OVER DOSAGE

No overdoses accident happened but when it happen nothing to do since it is local, gastric or intestinal lavage can be done.

STORAGE CONDITIONS

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

MANUFACTURER

Laboratory ALFA WASSERMANN – ITALY.