This medication is used to relieve symptoms related to nervousness and tension. This includes unpleasant menopausal signs (such as hot flashes or flushes, sweats, restlessness, trouble sleeping), heart/blood vessel disorders (such as fast/pounding heartbeat), stomach/intestinal disorders (such as spasms), and throbbing headaches that occur often. Ergotamine and belladonna work by blocking certain chemicals (e.g., acetylcholine) in the nervous system to help relieve these symptoms. Phenobarbital helps to calm and relax the body.
Dosage is based on your medical condition and response to therapy.
This medication should be taken only as needed. It is not meant for long-term daily use. The maximum dose is 16 tablets in any 7-day period.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, muscle twitching, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.
When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.
Inform your doctor if your condition persists or worsens.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: slow/fast/irregular heartbeat, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, difficulty urinating, signs of kidney problems (such as change in the amount of urine), mental/mood changes, tingling/pain/coldness in the fingers/toes, whitish fingers/toes/nails, loss of feeling in the fingers/toes, bluish hands/feet, muscle pain/weakness, severe stomach/abdominal pain, lower back pain, eye pain/redness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking this medication, tell your doctor or pharmacist if you are allergic to phenobarbital, ergotamine, or belladonna; or to other ergot alkaloids (e.g., dihydroergotamine); or to other barbiturates (e.g., pentobarbital); or to other belladonna alkaloids (e.g., atropine); or to primidone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation disease (e.g., peripheral vascular disease such as arteriosclerosis, thrombophlebitis, Raynaud's disease), high blood pressure, nutrient deficiency (malnutrition), heart/blood vessel disease (e.g., coronary artery disease, stroke, recent heart attack), liver disease, kidney disease, infection, severe itching, a certain eye disease (glaucoma), a certain enzyme disorder (porphyria), smoking/tobacco use, diabetes, trouble urinating, breathing problems (e.g., asthma), drug/alcohol abuse, mental/mood disorders (e.g., depression, history of suicide attempt), uncontrolled pain, myasthenia gravis, stomach/esophagus problems (e.g., ulcers, GERD), seizures, bowel disease/infection (e.g., paralytic ileus), overactive thyroid (hyperthyroidism).
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Using tobacco/nicotine products while using this medication can increase the risk of serious side effects such as heart problems (including chest pain, fast/slow/irregular heartbeat) and decreased blood flow to the brain/hands/feet. Do not use tobacco while taking this medication. If you smoke, talk to your doctor about how to stop smoking.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, unusual excitement, constipation, and urination problems. Drowsiness and confusion can increase the risk of falling.
This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, diaphragms with spermicide) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away. See also Drug Interactions section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: certain beta blockers (e.g., propranolol), cobicistat, disulfiram, dopamine, other ergot alkaloids (such as dihydroergotamine), potassium tablets/capsules, pramlintide, sodium oxybate, valproic acid, warfarin.
If you also take "triptan" migraine drugs (e.g., sumatriptan, rizatriptan), you will need to separate your "triptan" dose from your dose of this medication to reduce the risk of serious side effects. Ask your doctor how long you should wait between your doses of these drugs.
This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include certain calcium channel blockers (such as felodipine, nimodipine), certain cancer drugs (such as sunitinib), certain products used to treat chronic hepatitis C (asunaprevir, ombitasvir/paritaprevir/ritonavir), griseofulvin, theophylline, corticosteroids (such as prednisone), estrogens, doxycycline, suvorexant, voriconazole, among others.
Other medications can affect the removal of ergotamine from your body, which may affect how ergotamine works. Examples include boceprevir, mifepristone, telaprevir, St John's wort, certain antidepressants (such as nefazodone, SSRIs such as fluoxetine/paroxetine, tricyclic antidepressants such as amitriptyline), azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as erythromycin, clarithromycin), HIV protease inhibitors (such as lopinavir, ritonavir), HIV NNRTI's (such as delavirdine), rifamycins (such as rifampin, rifabutin), among others.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness or ingredients that could increase your heart rate/blood pressure. Ask your pharmacist about using those products safely.
This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe dizziness/drowsiness, loss of feeling in the fingers/toes, bluish hands/feet, slow/fast/irregular heartbeat, mental/mood changes, hot/dry skin, seizures.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised November 2016. Copyright(c) 2016 First Databank, Inc.
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