Briogut R SACHET

Treatment of acute infectious diarrhea of adults and children.

Prevention and treatment of antibiotic-associated colitis and diarrhea.

Addition to Vancomycin/Metronidazole: Prevention of recurrence of Clostridium difficile diseases.

Prevention of tube-feeding-associated diarrhea.

Treatment of irritable bowel syndrome.

Capsule: 1 or 2 caps, once or twice daily. The caps have to be swallowed with a mouthful of liquid.

Sachet: 1 or 2 sachets, given once or twice.

The contents of the sachet should be mixed with water or another liquid or food. It should not be poured on or mixed with very cold or very hot liquids or food, or alcoholic drinks.

Hypersensitivity to the active

Probiotics contain different types of micro-organisms such as yeast (Briogut R SACHET) and bacteria (such as lactobacillus, bifidobacterium). Micro-organisms (flora) are naturally found in the stomach/intestines/vagina. Some conditions (such as antibiotic use, travel) can change the normal balance of bacteria/yeast. Probiotics are used to improve digestion and restore normal flora.

Probiotics have been used to treat bowel problems (such as diarrhea, irritable bowel), eczema, vaginal yeast infections, lactose intolerance, and urinary tract infections.

Probiotics are available in foods (such as yogurt, milk, juices, soy beverages) and as dietary supplements (capsules, tablets, powders). Different products have different uses. Check the label for information on uses for your particular product.

Some diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details regarding the particular brand you use.

The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

How to use Briogut R SACHET

Follow all directions on the product package. Refer to the label directions for your specific product to see if the dose should be swallowed whole, chewed, sprinkled onto food or mixed with liquid. If you are uncertain about any of the information, consult your doctor or pharmacist.

Some probiotic products may contain live bacteria (such as bifidobacteria). Antibiotics may prevent these products from working well. Take any product containing live bacteria at least 2 to 3 hours before or after taking antibiotics. Follow the directions for your specific product.

If you are taking this product for diarrhea due to antibiotics, do not use it if you have a high fever or for more than 2 days, unless directed by your doctor. You may have a serious problem that requires medical treatment.

If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some medications that may interact with certain probiotics include: antibiotics, antifungals (such as clotrimazole, ketoconazole, griseofulvin, nystatin).

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

Vision may be temporarily blurred when this product is first used. Also, minor burning/stinging/irritation may temporarily occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: eye pain, change in vision, continued eye redness/irritation.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Each capsule/sachet contains lyophilized Briogut R SACHET 282.5 mg corresponding to yeast 250 mg and lactose 32.5 mg.