Indication and Important Safety Information
What is AEMCOLO used for?
AEMCOLO is for the treatment of adults with travelers’ diarrhea caused by certain types of bacteria called E. coli, which is not complicated by a fever or blood in the stool.
Who should NOT take AEMCOLO?
AEMCOLO is not for everyone. Do not take AEMCOLO if you have a known allergy to rifamycin or any other rifamycin antibiotics or any of the components in AEMCOLO. You should not use AEMCOLO if you have a fever and/or bloody diarrhea.
What WARNINGS and IMPORTANT INFORMATION should I know about AEMCOLO?
Stop taking AEMCOLO if diarrhea gets worse or lasts more than 48 hours and notify your healthcare provider.
With all antibiotics, there is a chance you could experience diarrhea caused by an overgrowth of bacteria (C. difficile). This can cause signs of disease ranging from mild diarrhea to life-threatening disease of the bowel.
AEMCOLO safety and how well it works in children less than 18 years old has not been studied. AEMCOLO does not treat viral infections (for example, common cold or flu).
How should I take AEMCOLO?
The recommended dose is 388 mg (2 tablets) by mouth 2 times a day (in the morning and evening) for 3 days.
- AEMCOLO tablets should be swallowed whole with a full glass of liquid (6-8 ounces).
- AEMCOLO must not be taken at the same time with alcohol.
- AEMCOLO tablets must not be chewed, crushed, or broken.
- AEMCOLO may be taken with or without food.
When taking AEMCOLO for an infection due to bacteria, it is common to feel better before the antibiotic therapy is finished. It is important to take the antibiotic exactly as directed. Do not skip doses or end before all the medication is taken. If you do, you may lower how well the drug will work and may increase the chance of the bacteria becoming resistant.
What are the most common side effects of AEMCOLO?
The most common side effects (occurrence >2%) while taking AEMCOLO are:
- Constipation (3.5%)
- Headache (3.3%)
These are not all the possible side effects of AEMCOLO. Tell your doctor if you have any side effects that bother you or do not go away. Call your doctor for medical advice about side effects.
You can report any side effects to RedHill Biopharma Inc. at 1-833-ADR-HILL
or by contacting the FDA at 1-800-FDA-1088