Belladonna Alkaloids; Ergotamine; Phenobarbital tablets

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.

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.

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

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

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.

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.

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

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.