Donnatal Tablets

Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablets are used as adjunctive therapy in the treatment of irritable bowel syndrome (IBS) and acute enterocolitis*. Donnatal Tablets are available only by prescription. Your health care provider will determine the individual dose that is right for you depending on your needs based upon your condition, severity of symptoms, and medical history. Donnatal Tablets are prescribed for adults. The usual dosage is 1 or 2 tablets, 3 or 4 times a day. This drug has been evaluated as possibly effective for this indication.

Click here for prescribing information: Donnatal Tablets PI

How Supplied

Example of a Donnatal® Tablet (Not to scale)

Donnatal® Tablets are supplied as: White, D-shaped tablets debossed “D” on one side and “Donnatal” on the other side. Packaging:

Bottles of 100 tablets NDC 59212-425-10
Bottles of 1000 tablets NDC 59212-425-11

Each tablet contains:

Phenobarbital, USP …………………………………….16.2 mg
Hyoscyamine Sulfate, USP ……………………….0.1037 mg
Atropine Sulfate, USP ……………………………..0.0194 mg
Scopolamine Hydrobromide, USP ……………0.0065 mg

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Also available:

Donnatal® Elixir, a purple colored, graped flavored and/or green colored, mint flavored liquid, in 4 fl oz (118 mL) 10 mL, and 1 pint (473 mL) bottles.

Manufactured For:
Concordia Pharmaceuticals Inc.
St. Michael, Barbados BB11005

*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.