For more information, please visit: National Institute of Diabetes and Digestive and Kidney Diseases

What is IBS?

• Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder, meaning symptoms are caused by changes in how the GI tract works. People with a functional GI disorder have frequent symptoms; however, the GI tract does not become damaged.

• IBS is a group of symptoms that occur together, not a disease.

How common is IBS? Studies estimate IBS affects 3 to 20 percent of the adult population, with most studies ranging from 10 to 15 percent (1). However, only 5 to 7 percent of the adult population has been diagnosed with the condition (2). What are the symptoms? The most common symptoms of IBS are abdominal pain or discomfort, often reported as cramping, along with changes in bowel habits. Other symptoms of IBS may include

• diarrhea
• constipation
• feeling that a bowel movement is incomplete
• passing mucus
• abdominal bloating

What causes IBS? The causes of IBS are not well understood. Researchers believe a combination of physical and mental health problems can lead to IBS.

How is IBS diagnosed? To diagnose IBS, a health care provider will conduct a physical exam and take a complete medical history. The medical history will include questions about symptoms, family history of GI disorders, recent infections, and stressful events related to the onset of symptoms.

How is IBS treated? Though IBS does not have a cure, the symptoms can be treated with a combination of:

• changes in eating, diet, and nutrition
• probiotics
• medications that may be prescribed by a physician

Is there more information regarding IBS? Explore the following sites for more information:

• International Foundation for Functional Gastrointestinal Disorders
• IBSGroup.org

⁽¹⁾Grundmann O, Yoon SL. Irritable bowel syndrome: epidemiology, diagnosis, and treatment: an update for health-care practitioners. Journal of Gastroenterology and Hepatology. 2010;25:691–699.
⁽²⁾Irritable bowel syndrome. American College of Gastroenterology website. Accessed May 27, 2014.

*This drug has been evaluated as possibly effective for this indication.  For more information, please see the Prescribing Information

INDICATIONS AND USAGE*: Based on a review of this drug by the National Academy of Sciences–National Research Council and/or other information, FDA has classified the indications as follows: “possibly” effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. Final classification of the less-than-effective indications requires further investigation. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

IMPORTANT SAFETY INFORMATION

• WHO SHOULD NOT TAKE DONNATAL?
• WHAT SHOULD I TELL MY HEALTH CARE PROVIDER BEFORE RECEIVING DONNATAL?
• WHAT ARE THE POSSIBLE SIDE EFFECTS OF DONNATAL?

WHO SHOULD NOT TAKE DONNATAL? DO NOT USE DONNATAL IF YOU HAVE:

• the eye condition called glaucoma
• blockage of the urinary tract
• blockage of the bowel
• been diagnosed with severe ulcerative colitis
• blockage of the intestines
• lack of normal tone or strength of the small bowel if you are elderly or ill
• a problem with your heart, arteries, or veins if you are bleeding
• muscle weakness and fatigue
• problems with your stomach that gives heartburn
• sensitivity or allergic reaction to DONNATAL or any of the ingredients in DONNATAL, or similar drugs (DONNATAL Elixir – mint flavor can cause allergic type reaction in people with aspirin sensitivity)
• a disorder of metabolism called acute intermittent porphyria (that shows as severe stomach pain)
• taken phenobarbital, an ingredient in DONNATAL, and experienced restlessness and/or excitement instead of feeling calm.

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING DONNATAL?: BEFORE YOU RECEIVE DONNATAL, TELL YOUR HEALTHCARE PROVIDER IF YOU:

• are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. As DONNATAL can cause harm to your baby
• are exposed to high temperatures as DONNATAL can cause overheating
• have diarrhea as it may be an early symptom of other medical problems
• have a stomach ulcer
• experience drowsiness or blurred vision
• take blood thinners
• have a nerve disorder that affects the involuntary body functions
• suffer from kidney or liver disease or liver problems
• have an overactive thyroid
• have heart disease, or have high blood pressure
• have been or are addicted to any medication or have been dependent on drugs (phenobarbital, one of the ingredients in DONNATAL, can be habit forming)
• have bile duct disease
• have an aspirin sensitivity
• have experienced a reaction to DONNATAL or any of its ingredients

WHAT ARE THE SIDE EFFECTS OF DONNATAL? WHEN USING DONNATAL YOU MAY HAVE SIDE EFFECTS.

DONNATAL may cause serious, even life threatening, allergic reactions.
Stop taking DONNATAL and call your healthcare provider right away if you have any signs of a serious allergic reaction including: swelling, particularly of the eyelids, cheeks, or lips, and skin; and inflammation of the skin with redness. Call your healthcare provider if you have any of the following side effects:

dryness of the mouth; difficulty eliminating urine; blurred vision; an increase in heart rate; feeling of heart beating quickly and strongly; widening of the pupil in the eye; difficulty focusing your eye; increased eye tension; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia (inability to fall asleep or to remain asleep); nausea; vomiting; inability in a man to have sexual intercourse; reduced breast milk production; constipation; feeling bloated; muscle and bone pain; severe allergic reaction, including anaphylaxis, and skin reactions; decreased sweating.

Rarely, phenobarbital, an ingredient in DONNATAL, can cause a flaking type of skin reaction that can cause death. This may be associated with fever, changes in behavior, and changes in liver and other internal body parts.

Phenobarbital may produce excitement. In a few cases, anemia (affecting red blood cells) has resulted from long time use of phenobarbital. Seizures and confusion can occur if DONNATAL is stopped suddenly if you are dependent on sedatives such as phenobarbital.

Elderly persons may react with feelings of excitement, agitation, drowsiness, and other ill effects.

The risk information provided here is not comprehensive. To learn more, talk about DONNATAL with your healthcare provider or pharmacist. Click here to obtain the DONNATAL full prescribing information or call Concordia Pharmaceuticals Inc. at 1-877-370-1142.

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.