Belladonna Alkaloids; Ergotamine; Phenobarbital
Belladonna Alkaloids, Ergotamine Tartrate, Phenobarbital Oral tablet
What is this medicine?
BELLADONNA ALKALOIDS; ERGOTAMINE; PHENOBARBITAL (bell a DON a; er GOT a meen; fee noe BAR bi tal) is a combination of several different drugs. It is used to help prevent headaches when it is taken on a regular basis. The medicine will not treat a headache. This drug may also be used to treat menopause symptoms.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
blood clots
chest pain
gallbladder problems
glaucoma
heart disease
high blood pressure
high cholesterol
infection
kidney disease
liver disease
myasthenia gravis
peripheral vascular disease
poor circulation
porphyria
prostate trouble
stomach problems
an unusual or allergic reaction to belladonna, ergotamine, phenobarbital, other medicines, lactose, tartrazine dye, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding
How should I use this medicine?
Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Do not crush, chew, or cut the tablets. If this medicine upsets your stomach, you may take it with food but not with grapefruit or grapefruit juice. Take your medicine at regular intervals. Do not take your medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Patients over 65 years old may have a stronger reaction and need a smaller dose.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
antibiotics like erythromycin, clarithromycin, and troleandomycin
conivaptan
delavirdine
dopamine
efavirenz
ergot alkaloids
feverfew
imatinib
isoproterenol
medicines for fungal infections like itraconazole, voriconazole, posaconazole, and ketoconazole
medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
midodrine
nefazodone
nitrates
primidone
protease inhibitors
stimulant type medicines
This medicine may also interact with the following medications:
alcohol
beta blockers
doxycycline
female hormones, like estrogens or progestins and birth control pills
griseofulvin
medicines that treat or prevent blood clots like warfarin
pain medications
phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
phenytoin
quinidine
tricyclic antidepressants
valproate
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
If you take this medicine to prevent headaches, check with your doctor if you do not get relief from this medicine.
Avoid extreme heat or cold. This medicine can stop you sweating and increase your body temperature. It can also make your body unable to stand extreme cold. Avoid hot baths and saunas. Be careful about exercising especially in hot weather. Dress warmly in cold weather and do not stay out long in the cold.
Stay out of bright light and wear sunglasses if this medicine makes your eyes more sensitive to light.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Also, immediately call your doctor if you become pregnant. You must not take this medicine if you are pregnant.
This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
changes in vision
chest pain or tightness
cold hands or feet
decrease in the amount of urine passed
irregular heartbeat
redness, blistering, peeling or loosening of the skin, including inside the mouth
tingling, pain or numbness in feet, arms, or hands
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
constipation
dizziness
drowsiness
dry mouth
flushing
nausea
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep tightly closed and protect from light and moisture. Throw away any unused medicine after the expiration date.
Belladonna Alkaloids, Ergotamine Tartrate, Phenobarbital Oral tablet, extended-release
What is this medicine?
BELLADONNA ALKALOIDS; ERGOTAMINE; PHENOBARBITAL (bell a DON a; er GOT a meen; fee noe BAR bi tal) is a combination of several different drugs. It is used to help prevent headaches when it is taken on a regular basis. The medicine will not treat a headache. This drug may also be used to treat menopause symptoms.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
blood clots
chest pain
gallbladder problems
glaucoma
heart disease
high blood pressure
high cholesterol
infection
kidney disease
liver disease
myasthenia gravis
peripheral vascular disease
poor circulation
porphyria
prostate trouble
stomach problems
an unusual or allergic reaction to belladonna, ergotamine, phenobarbital, other medicines, lactose, tartrazine dye, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding
How should I use this medicine?
Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Do not crush, chew, or cut the tablets. If this medicine upsets your stomach, you may take it with food but not with grapefruit or grapefruit juice. Take your medicine at regular intervals. Do not take your medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Patients over 65 years old may have a stronger reaction and need a smaller dose.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
antibiotics like erythromycin, clarithromycin, and troleandomycin
conivaptan
delavirdine
dopamine
efavirenz
ergot alkaloids
feverfew
imatinib
isoproterenol
medicines for fungal infections like itraconazole, voriconazole, posaconazole, and ketoconazole
medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
midodrine
nefazodone
nitrates
primidone
protease inhibitors
stimulant type medicines
This medicine may also interact with the following medications:
alcohol
beta blockers
doxycycline
female hormones, like estrogens or progestins and birth control pills
griseofulvin
medicines that treat or prevent blood clots like warfarin
pain medications
phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
phenytoin
quinidine
tricyclic antidepressants
valproate
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
If you take this medicine to prevent headaches, check with your doctor if you do not get relief from this medicine.
Avoid extreme heat or cold. This medicine can stop you sweating and increase your body temperature. It can also make your body unable to stand extreme cold. Avoid hot baths and saunas. Be careful about exercising especially in hot weather. Dress warmly in cold weather and do not stay out long in the cold.
Stay out of bright light and wear sunglasses if this medicine makes your eyes more sensitive to light.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Also, immediately call your doctor if you become pregnant. You must not take this medicine if you are pregnant.
This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
changes in vision
chest pain or tightness
cold hands or feet
decrease in the amount of urine passed
irregular heartbeat
redness, blistering, peeling or loosening of the skin, including inside the mouth
tingling, pain or numbness in feet, arms, or hands
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
constipation
dizziness
drowsiness
dry mouth
flushing
nausea
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep tightly closed and protect from light and moisture. Throw away any unused medicine after the expiration date.
Updated:  
March 21, 2017
Sources:  
U.S. FDA-approved Package Insert