Patient Medication Information: uses, side effects, how to take - Lupin-Rifaximin
What is LUPIN-RIFAXIMIN used for?
LUPIN-RIFAXIMIN is an antibiotic that acts on the bacteria in the gut.
LUPIN-RIFAXIMIN is used to treat irritable bowel syndrome with diarrhea (IBS-D) in adults.
LUPIN-RIFAXIMIN is used to help prevent recurring episodes of a condition called hepatic encephalopathy (HE) in adults. LUPIN-RIFAXIMIN may be used with lactulose. Your healthcare professional will decide if you should take LUPIN-RIFAXIMIN with lactulose.
Antibacterial drugs like LUPIN-RIFAXIMIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, LUPIN-RIFAXIMIN should be taken exactly as directed. Misuse or overuse of LUPIN-RIFAXIMIN could lead to the growth of bacteria that will not be killed by LUPIN-RIFAXIMIN (resistance). This means that LUPIN-RIFAXIMIN may not work for you in the future. Do not share your medicine.
How does LUPIN-RIFAXIMIN work?
Hepatic Encephalopathy
The bacteria in the gut release toxins into the blood. LUPIN-RIFAXIMIN is thought to work by reducing the production of those toxins.
Irritable Bowel Syndrome with Diarrhea
LUPIN-RIFAXIMIN is thought to work by reducing the amount of bacteria and bacterial products in the gut. This can help with the most common symptoms of IBS-D. These symptoms include bloating, abdominal pain and diarrhea.
What are the ingredients in LUPIN-RIFAXIMIN?
Medicinal ingredients: Rifaximin
Non-medicinal ingredients: colloidal silicon dioxide, glyceryl distearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, red iron oxide, gluten-free sodium starch glycolate, talc, and titanium dioxide.
LUPIN-RIFAXIMIN comes in the following dosage forms:
Tablets: 550 mg
Do not use LUPIN-RIFAXIMIN if:
- If you are allergic to the active substance rifaximin, rifamycin antibacterial agents, or any of the other ingredients of LUPIN-RIFAXIMIN (see What the nonmedicinal ingredients are).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LUPIN-RIFAXIMIN. Talk about any health conditions or problems you may have, including if you:
- have severe liver problems including cirrhosis.
- have any allergies to this drug or its ingredients.
are pregnant or think you may be pregnant. Ask your healthcare professional or pharmacist for advice before taking this medicine. Your healthcare professional can discuss with you the risks and benefits involved.
- are breastfeeding. Ask your healthcare professional or pharmacist for advice before taking this medicine. It is not known whether LUPIN-RIFAXIMIN passes into breast milk.
- Have an intestinal blockage
LUPIN-RIFAXIMIN should not be used in children or adolescents less than 18 years of age.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with LUPIN-RIFAXIMIN:
- Cyclosporine - a drug used to treat organ rejection after a transplant
- Warfarin – a drug used to treat and prevent blood clots.
- Oral Contraceptives – a drug used for pregnancy prevention.
How to take LUPIN-RIFAXIMIN:
LUPIN-RIFAXIMIN can be taken with or without food.
- LUPIN-RIFAXIMIN tablets should be swallowed whole with plenty of water. Do not crush tablets.
- Although you may feel better early in treatment, LUPIN-RIFAXIMIN should be used exactly as directed.
- Do not misuse or overuse LUPIN-RIFAXIMIN.
- Do not share your medicine.
Usual dose:
Hepatic Encephalopathy
The recommended dosage is one tablet twice daily.
Irritable Bowel Syndrome with Diarrhea
The recommended dosage is one tablet three times a day for 14 days. If your symptoms come back, your doctor may consider retreatment when needed.
Overdose:
If you think you, or a person you are caring for, have taken too much LUPIN-RIFAXIMIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
- If you forget to take a dose, it should be taken as soon as possible. However, if it is almost time for the next dose, no additional dose should be taken and the regular dosing schedule should be resume.
- If you are taking LUPIN-RIFAXIMIN for Hepatic Encephalopathy:
What are possible side effects from using LUPIN-RIFAXIMIN?
These are not all the possible side effects you may have when taking LUPIN-RIFAXIMIN. If you experience any side effects not listed here, tell your healthcare professional.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effects reported with LUPIN-RIFAXIMIN are:
- Diarrhea
- Nausea
- Vomiting
- Abdominal pain or bloating
- Muscle spasms
- Dizziness or unsteadiness
- Headache
- Itchiness
- Rash
- Fever
- Shortness of breath
- Joint pain
- Swelling in the legs
LUPIN-RIFAXIMIN may cause a reddish discoloration of the urine, tears and sweat.
LUPIN-RIFAXIMIN can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
| Clostridium difficile colitis (gut inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | √ | ||
| UNKNOWN | |||
| Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | √ | ||
Severe skin reactions in patients with cirrhosis (Stevens-Johnson syndrome and toxic epidermal necrolysis) life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Keep out of reach and sight of children.
- Store LUPIN-RIFAXIMIN at room temperature (15°C to 30°C).
- Keep container tightly closed.
- Keep away from heat and direct light.
If you want more information about LUPIN-RIFAXIMIN:
- Talk to your healthcare professional
Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website
www.lupinpharma.ca, or by calling 1 844-587-4623.
Lupin Pharma Canada Limited Montreal, QC, J4K 5G4