Ergotamine, Belladonna Alkaloids, and Phenobarbital (Systemic)

Brand Names : Bellergal-S, Bellergal, Bellergal Spacetabs

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.