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|Donnatal Elixir

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Donnatal Elixir

Generic Name: Belladonna Alkaloids/Phenobarbital Elixir (bell-a-DON-a/fee-noe-BAR-bih-tal)
Brand Name: Donnatal

Donnatal Elixir is used for:

Treating irritable bowel syndrome and intestinal inflammation in combination with other medicines. It may also be used along with other medicines to treat intestinal ulcers. It may also be used for other conditions as determined by your doctor.

Donnatal Elixir is an anticholinergic and barbiturate combination. It works by decreasing the motion of the muscles in the stomach and intestine and providing mild sedation.

Do NOT use Donnatal Elixir if:

you are allergic to any ingredient in Donnatal Elixir
you have previously experienced restlessness or excitement after taking phenobarbital
you have glaucoma; severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia); a blockage of the stomach, bowel, or bladder; bowel motility problems; severe bowel inflammation (eg, ulcerative colitis); certain muscle problems (eg, myasthenia gravis); or heart problems with severe bleeding
you have a history of the blood disorder porphyria
you have a history of alcohol or substance abuse or dependence or may be at risk for an addiction
you are taking methoxyflurane, sodium oxybate (GHB), or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Donnatal Elixir:

Some medical conditions may interact with Donnatal Elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have nerve problems, prostate problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, diarrhea, fever, risk factors for glaucoma, kidney or liver problems, gallbladder problems, lung or breathing problems, an overactive thyroid, high blood pressure, difficulty urinating, or ulcer
if you have depression, pain, a history of suicidal thoughts or attempts, or are in shock
if you have been very ill or severely weakened
if you regularly consume alcohol

Some MEDICINES MAY INTERACT with Donnatal Elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:

Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenothiazines (eg, thioridazine), quinine, stiripentol, tricyclic antidepressants (eg, amitriptyline), valproic acid, or other anticholinergics (eg, scopolamine) because they may increase the risk of Donnatal Elixir"s side effects
Methoxyflurane orsodium oxybate (GHB) because the risk of their side effects may be increased by Donnatal Elixir
Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), clozapine, corticosteroids (eg, hydrocortisone), cyclosporine, doxorubicin, doxycycline, erlotinib, estrogens (eg, estradiol), imatinib, metronidazole, quinidine, steroidal contraceptives (eg, birth control pills), theophylline, or voriconazole because their effectiveness may be decreased by Donnatal Elixir
Halothane because Donnatal Elixir may mask the symptoms of halothane toxicity

This may not be a complete list of all interactions that may occur. Ask your health care provider if Donnatal Elixir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Donnatal Elixir:

Use Donnatal Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Donnatal Elixir by mouth with or without food.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
If you miss a dose of Donnatal Elixir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Donnatal Elixir.

Important safety information:

Donnatal Elixir may cause dizziness, drowsiness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Donnatal Elixir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Donnatal Elixir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Do not become overheated in hot weather or while you are being active; heatstroke may occur.
Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
Donnatal Elixir may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
Use Donnatal Elixir with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.
Donnatal Elixir should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
Hormonal birth control (eg, birth control pills) may not work as well while you are using Donnatal Elixir. To prevent pregnancy, use an extra form of birth control (eg, condoms).
PREGNANCY and BREAST-FEEDING: Donnatal Elixir has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Donnatal Elixir while you are pregnant. Donnatal Elixir is found in breast milk. If you are or will be breast-feeding while you use Donnatal Elixir, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Donnatal Elixir may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Donnatal Elixir stops working well. Do not take more than prescribed.

Some people who use Donnatal Elixir for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Donnatal Elixir suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, nausea, sleeplessness, body aches, seizures, and delirium.

Possible side effects of Donnatal Elixir:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; clumsiness; constipation; decreased sweating; dizziness; drowsiness; dry mouth; excessive daytime drowsiness ("hangover effect"); feeling of a whirling motion; headache; lightheadedness; nausea; nervousness; tired feeling; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; confusion; diarrhea; difficulty focusing eyes; disorientation; exaggerated feeling of well-being; excitement; fainting; fast or irregular heartbeat; hallucinations; loss of coordination; loss of taste; memory loss; muscle pain; pounding in the chest; severe or persistent trouble sleeping; trouble urinating; unusual weakness; very slow breathing; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include change in size of pupil; deep sleep; hot, dry skin; loss of consciousness; severe dry mouth; severe or persistent headache or nausea; slowed or fast breathing; trouble swallowing; vomiting.

Proper storage of Donnatal Elixir:

Store Donnatal Elixir at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Donnatal Elixir out of the reach of children and away from pets.

General information:

If you have any questions about Donnatal Elixir, please talk with your doctor, pharmacist, or other health care provider.
Donnatal Elixir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Donnatal Elixir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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