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|Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets

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Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets

Generic Name: Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets (bell-a-DON-a/fee-noe-BAR-bih-tal)
Brand Name: Examples include Alkabel-SR and Donnatal Extentabs

Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets 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.

Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets if:

you are allergic to any ingredient in Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets
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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets:

Some medical conditions may interact with Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets. 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets. 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets"s side effects
Methoxyflurane orsodium oxybate (GHB) because the risk of their side effects may be increased by Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets
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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets
Halothane because Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets:

Use Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets by mouth with or without food.
Swallow Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
If you miss a dose of Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets, 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets.

Important safety information:

Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets may cause dizziness, drowsiness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets; 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.
Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
Use Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.
Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets. To prevent pregnancy, use an extra form of birth control (eg, condoms).
PREGNANCY and BREAST-FEEDING: Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets while you are pregnant. Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets is found in breast milk. If you are or will be breast-feeding while you use Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, this medicine 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets stops working well. Do not take more than prescribed.

Some people who use Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, nausea, sleeplessness, body aches, seizures, and delirium.

Possible side effects of Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets:

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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets:

Store Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets 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 Belladonna Alkaloids/Phenobarbital Controlled-Release Tablets. 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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