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|Bellergal Spacetabs

ERGOTAMINE, BELLADONNA ALKALOIDS, AND PHENOBARBITAL (Systemic)

Some commonly used brand names are:

In the U.S.—

• Bellergal-S

In Canada—

• Bellergal
• Bellergal Spacetabs

Category

• Menopausal symptoms suppressant
• Vascular headache prophylactic

Description

Ergotamine, belladonna alkaloids , and phenobarbital (er-GOT-a-meen, bell-a-DON-a AL-ka-loids , and feen-oh-BAR-bi-tal) combination is used to treat some symptoms of menopause (such as hot flashes, sweating, restlessness, and trouble in sleeping). However, it is not effective against other problems that may occur after menopause, such as osteoporosis. This medicine is also used to prevent migraine or cluster headaches in people who get these headaches often. It is not used to treat a headache that has already started. This combination medicine may also be used for other problems as determined by your doctor.

The phenobarbital in this combination medicine belongs to the group of medicines known as barbiturates.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Tablets (Canada)
• Extended-release tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ergotamine, belladonna alkaloids, and phenobarbital combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ergotamine or other ergot medicines, atropine, belladonna, or barbiturates. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—

• For ergotamine —Ergotamine is not recommended for use during pregnancy since it has been shown to increase the chance of early labor, which could result in a miscarriage.
• For belladonna alkaloids —Belladonna alkaloids have not been shown to cause problems in humans.
• For phenobarbital —Barbiturates such as phenobarbital have been shown to increase the chance of birth defects. Also, when taken during pregnancy, barbiturates may cause bleeding problems in the newborn baby. Be sure that you have discussed these problems with your doctor before taking this medicine.

Breast-feeding—

• For ergotamine —Ergotamine passes into the breast milk and may cause unwanted effects, such as vomiting, diarrhea, weak pulse, unstable blood pressure, or convulsions (seizures), in nursing babies whose mothers take large amounts of the medicine. Large amounts of ergotamine may also decrease the flow of breast milk.
• For belladonna alkaloids —Although belladonna alkaloids pass into the breast milk, the amount of belladonna alkaloids in this combination medicine has not been shown to cause problems in nursing babies. However, because the belladonna alkaloids tend to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some patients.
• For phenobarbital —Phenobarbital passes into the breast milk. Taking this combination medicine two or three times a day is not likely to cause problems in nursing babies. However, larger amounts of the medicine may cause drowsiness, unusually slow heartbeat, shortness of breath, or troubled breathing in nursing babies.

Children—Children may be especially sensitive to the effects of the belladonna alkaloids and the phenobarbital in this combination medicine. This may increase the chance of side effects during treatment. Although there is no specific information about the use of ergotamine in children, it is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Elderly people are especially sensitive to the effects of ergotamine, belladonna alkaloids, and barbiturates such as phenobarbital. This may increase the chance of side effects during treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this combination medicine, it is especially important that your health care professional know if you are taking any of the following:

• Antacids or
• Diarrhea medicine containing kaolin or attapulgite—These medicines may decrease the effects of the belladonna alkaloids and the phenobarbital in this combination medicine; to prevent this, take the 2 medicines at least 1 hour apart

• Anticoagulants (blood thinners)—The phenobarbital in this combination medicine may decrease the effects of anticoagulants; a change in the dose of anticoagulant may be needed

• Anticholinergics (medicine for abdominal or stomach spasms or cramps) or
• Carbamazepine (e.g., Tegretol) or
• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Cocaine or
• Contraceptives, oral, (birth control pills) containing estrogens or progestins or
• Digitalis glycosides (heart medicine) or
• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate] (taken currently or within the past 2 weeks) or
• Other ergot medicines (dihydroergotamine [e.g., D.H.E. 45], ergoloid mesylates [e.g., Hydergine], ergonovine [e.g., Ergotrate], methylergonovine [e.g., Methergine], methysergide [e.g., Sansert]) or
• Other medicines for migraine that contain ergotamine in combination with other ingredients, such as ergotamine and caffeine (e.g., Cafergot), or
• Potassium chloride (e.g., Kay Ciel) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—The chance of serious side effects may be increased

• Ketoconazole (e.g., Nizoral)—The belladonna alkaloids in this combination medicine may reduce the effects of ketoconazole; to prevent this, take the ergotamine, belladonna alkaloids, and phenobarbital combination at least 2 hours after taking ketoconazole

Other medical problems—The presence of other medical problems may affect the use of this combination medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma (or history of), emphysema, or other chronic lung disease or
• Brain damage (in children) or
• Difficult urination or
• Down"s syndrome (mongolism) or
• Dry mouth (severe and continuing) or
• Enlarged prostate or
• Heart or blood vessel disease or
• High blood pressure (severe) or
• Hyperactivity (in children) or
• Infection or
• Intestinal blockage or other intestinal problems or
• Itching (severe) or
• Kidney disease or
• Liver disease or
• Overactive thyroid or
• Porphyria or
• Spastic paralysis (in children) or
• Urinary tract blockage—The chance of side effects may be increased

• Glaucoma—The belladonna alkaloids in this combination medicine may make your condition worse

• Also tell your doctor if you have recently had an angioplasty (a procedure done to improve the flow of blood in a blocked blood vessel) or surgery on a blood vessel, because the chance of side effects caused by the ergotamine in this combination medicine may be increased.

Proper Use of This Medicine

Take this medicine only as directed by your doctor . If the amount you are to take does not seem to work, do not take more than your doctor ordered. Instead, check with your doctor. Taking too much of this medicine or taking it too often may cause serious effects such as nausea and vomiting; cold, painful hands or feet; or even gangrene. Also, if too much is used, it may become habit-forming.

To take the extended-release tablet form of this medicine:

• Swallow the tablet whole.
• Do not crush, break, or chew the tablet before swallowing it.

Dosing—The dose of this combination medicine will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral tablet dosage form:
  • For relieving symptoms of menopause and for preventing headaches:
    • Adults—One tablet in the morning, one tablet at noon, and two tablets at bedtime.
    • Children—Use and dose must be determined by your doctor.
• For oral extended-release tablet dosage form:
  • For relieving symptoms of menopause and for preventing headaches:
    • Adults—One tablet in the morning and one tablet in the evening.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children since overdose is especially dangerous in children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat and moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If you have been taking this medicine regularly, do not stop taking it without first checking with your doctor . Your doctor may want you to reduce gradually the amount you are using before stopping completely.

Do not take antacids or medicine for diarrhea within 1 hour of taking this medicine. Taking them too close together will make the belladonna alkaloids less effective.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine . Also, alcohol may make headaches worse, so it is best to avoid alcoholic beverages if you are taking this medicine to prevent headaches.

This medicine may cause some people to have blurred vision or to become drowsy, dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and able to see well .

Since smoking may increase some of the harmful effects of this medicine, it is best to avoid smoking while you are using it. If you have any questions about this, check with your doctor.

This medicine may make you more sensitive to cold temperatures, especially if you have blood circulation problems. It tends to decrease blood circulation in the skin, fingers, and toes. Dress warmly during cold weather and be careful during prolonged exposure to cold, such as in winter sports. This is especially important for elderly people, who are more likely than younger adults to already have problems with their circulation.

Belladonna alkaloids (contained in this combination medicine) will often make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine , as overheating may result in a heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine. This is especially important in children taking this medicine.

This medicine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses may help lessen the discomfort from bright light.

If you have a serious infection or illness of any kind, check with your doctor before taking this medicine, since you may be more sensitive to its effects.

This medicine may cause dryness of the mouth, nose and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

After you stop taking this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were taking and how long you took it. During this time check with your doctor if your headaches or other symptoms begin again or worsen.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 08/30/1994

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