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|Belladonna Alkaloids/Ergotamine/Phenobarbital

Belladonna Alkaloids/Ergotamine/Phenobarbital

Belladonna Alkaloids/Ergotamine/Phenobarbital is used for:

Treating menopausal symptoms (eg, hot flashes, sweating, restlessness, trouble sleeping), certain heart problems (eg, fast or irregular heartbeat), certain stomach problems (eg, nervous stomach), and recurring, throbbing headaches. It may also be used for other conditions as determined by your doctor.

Belladonna Alkaloids/Ergotamine/Phenobarbital is an anticholinergic, barbiturate, and ergot combination. It works by affecting certain chemicals in the nervous system.

Do NOT use Belladonna Alkaloids/Ergotamine/Phenobarbital if:

• you are allergic to any ingredient in Belladonna Alkaloids/Ergotamine/Phenobarbital
• 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 blood vessel problems (eg, peripheral vascular disease), heart blood vessel problems, high blood pressure, liver or kidney problems, or a severe infection (eg, sepsis)
• 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 an azole antifungal (eg, voriconazole), delavirdine, efavirenz, an HIV protease inhibitor (eg, ritonavir), a ketolide antibiotic (eg, telithromycin), a macrolide antibiotic (eg, erythromycin), a selective 5-HT agonists (eg, sumatriptan), or sodium oxybate (GHB)

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

Before using Belladonna Alkaloids/Ergotamine/Phenobarbital :

Some medical conditions may interact with Belladonna Alkaloids/Ergotamine/Phenobarbital . 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 problems (eg, fast or irregular heartbeat, heart failure), hiatal hernia, diarrhea, a fever, risk factors for glaucoma, gallbladder problems, lung or breathing problems, an overactive thyroid, difficulty urinating, or an ulcer
• if you have a history of depression, anxiety, stroke, or trouble sleeping, or you have had suicidal thoughts or behaviors
• if you have been very ill or severely weakened
• if you regularly consume alcohol or you smoke

Some MEDICINES MAY INTERACT with Belladonna Alkaloids/Ergotamine/Phenobarbital . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amantadine, antihistamines (eg, diphenhydramine), beta-blockers (eg, propranolol), fluoxetine, fluvoxamine, haloperidol, monoamine oxidase (MAO) inhibitors (eg, phenelzine), nefazodone, phenothiazines (eg, thioridazine), quinine, quinolone antibiotics (eg, ciprofloxacin), saquinavir, stiripentol, sympathomimetics (eg, pseudoephedrine), tricyclic antidepressants (eg, amitriptyline), valproic acid, zileuton, or other anticholinergics (eg, scopolamine) because they may increase the risk of this medicine"s side effects
• Azole antifungals (eg, voriconazole), delavirdine, efavirenz, HIV protease inhibitors (eg, ritonavir), ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, erythromycin), or selective 5-HT agonists (eg, sumatriptan) because the risk of severe side effects, including irregular heartbeat or decreased oxygen to the extremities (eg, hands, feet), may be increased
• Sodium oxybate (GHB) because the risk of its side effects may be increased by Belladonna Alkaloids/Ergotamine/Phenobarbital
• Anticoagulants (eg, warfarin), clozapine, corticosteroids (eg, hydrocortisone), doxycycline, erlotinib, estrogens (eg, estradiol), griseofulvin, hydantoins (eg, phenytoin), imatinib, metronidazole, oral contraceptives (eg, birth control pills), quinidine, or theophylline because their effectiveness may be decreased by Belladonna Alkaloids/Ergotamine/Phenobarbital

This may not be a complete list of all interactions that may occur. Ask your health care provider if Belladonna Alkaloids/Ergotamine/Phenobarbital 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/Ergotamine/Phenobarbital :

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

• Take Belladonna Alkaloids/Ergotamine/Phenobarbital by mouth with or without food.
• Eating grapefruit or drinking grapefruit juice may affect the amount of Belladonna Alkaloids/Ergotamine/Phenobarbital in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
• If you miss a dose of Belladonna Alkaloids/Ergotamine/Phenobarbital , 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/Ergotamine/Phenobarbital .

Important safety information:

• Belladonna Alkaloids/Ergotamine/Phenobarbital may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Belladonna Alkaloids/Ergotamine/Phenobarbital 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/Ergotamine/Phenobarbital ; 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.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Use of nicotine may increase the risk of severe side effects with Belladonna Alkaloids/Ergotamine/Phenobarbital . Talk to your doctor before using Belladonna Alkaloids/Ergotamine/Phenobarbital if you smoke or use any other kind of nicotine.
• Serious and sometimes life-threatening decreases in the blood supply to the extremities (eg, hands, feet) or brain may occur if Belladonna Alkaloids/Ergotamine/Phenobarbital is taken with certain other medicines, including HIV protease inhibitors (eg, ritonavir) or macrolide antibiotics (eg, erythromycin). Do not use Belladonna Alkaloids/Ergotamine/Phenobarbital if you are also taking these other medicines. Inform your doctor of all the medicines that you are taking.
• Belladonna Alkaloids/Ergotamine/Phenobarbital may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Tell your doctor or dentist that you take Belladonna Alkaloids/Ergotamine/Phenobarbital before you receive any medical or dental care, emergency care, or surgery.
• Use Belladonna Alkaloids/Ergotamine/Phenobarbital with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.
• Belladonna Alkaloids/Ergotamine/Phenobarbital 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/Ergotamine/Phenobarbital . To prevent pregnancy, use an extra form of birth control (eg, condoms).
• PREGNANCY and BREAST-FEEDING: Do not use Belladonna Alkaloids/Ergotamine/Phenobarbital if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Belladonna Alkaloids/Ergotamine/Phenobarbital is found in breast milk. Do not breast-feed while taking Belladonna Alkaloids/Ergotamine/Phenobarbital .

When used for long periods of time or at high doses, Belladonna Alkaloids/Ergotamine/Phenobarbital 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/Ergotamine/Phenobarbital stops working well. Do not take more than prescribed. Discuss any questions or concerns with your doctor or pharmacist.

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

Possible side effects of Belladonna Alkaloids/Ergotamine/Phenobarbital :

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; 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.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; blue color of the fingers or toes; chest pain or tightness; cold or pale fingers or toes; confusion; diarrhea; difficulty focusing eyes; disorientation; exaggerated feeling of well-being; excitement; fainting; fast or irregular heartbeat; hallucinations; leg cramps or weakness; loss of coordination; loss of taste; memory loss; mental or mood changes; muscle pain; numbness or tingling of the hands, feet, or skin; pounding in the chest; ringing in the ears; seizures; severe headache; 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.

Store Belladonna Alkaloids/Ergotamine/Phenobarbital 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/Ergotamine/Phenobarbital out of the reach of children and away from pets.

General information:

• If you have any questions about Belladonna Alkaloids/Ergotamine/Phenobarbital , please talk with your doctor, pharmacist, or other health care provider.
• Belladonna Alkaloids/Ergotamine/Phenobarbital 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/Ergotamine/Phenobarbital . 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.