How does this medication work? What will it do for me?

This medication is used to treat women with menopause symptoms and nervous tension. It is used to help manage symptoms such as hot flashes, sweating, dizzy spells, headaches, heart racing, tiredness, sleeping problems, anxiety, and nervousness associated with menopause. It is not recommended for osteoporosis or dryness of the vagina.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each speckled dark green, orange, and light lemon-yellow tablet, with an embossed "S" in a triangle on one side and a double score on the opposite side, contains ergotamine tartrate 0.6 mg, levorotatory belladonna alkaloids 0.2 mg, and phenobarbital 40 mg. Nonmedicinal ingredients: cornstarch, lactose, and tartrazine.

How should I use this medication?

The recommended adult dose of belladonna - ergotamine - phenobarbital is one tablet in the morning and one tablet in the evening. Do not take more than 16 tablets in one week.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take belladonna - ergotamine - phenobarbital if you:

  • are allergic to ergotamine, belladonna, phenobarbital, caffeine, or any ingredients of this medication
  • are pregnant or breast-feeding
  • are taking any of the following medications:
    • antifungal agents (e.g., ketoconazole, itraconazole, fluconazole)
    • certain medications for migraine headaches (e.g., ergotamine, dihydroergotamine, almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan)
    • delaviridine
    • macrolide antibiotics (e.g., erythromycin, clarithromycin)
    • protease inhibitors (e.g., ritonavir, nelfinavir, indinavir, saquinavir)
  • have a severe infection or sepsis
  • have certain types of blood circulation disorders (such as peripheral vascular disease)
  • have a history of heart attack or stroke
  • have certain types of migraine headaches (e.g., hemiplegic or basilar migraines)
  • have heart disease or cardiac arrhythmias
  • have narrow-angle glaucoma
  • have poorly controlled high blood pressure
  • have porphyria
  • have severely reduced kidney function
  • have severely reduced liver function
  • have severe breathing problems
  • suffer from malnutrition

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • chest pain or tightness (mild)
  • confusion or memory impairment
  • dizziness or lightheadedness
  • drowsiness
  • dryness of mouth, nose, throat, or skin
  • flushing
  • stomach symptoms (constipation, nausea, or diarrhea)
  • sweating
  • unusual fatigue or weakness
  • visual disturbances

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • bone pain or fractures
  • numbness or tingling in the extremities
  • signs of kidney failure (e.g., decreased urine production, swelling, fatigue, abdominal pain)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of too much medication (e.g., confusion, diarrhea, headache, muscle pain, nausea, rapid heart beat, thirst, vomiting)
  • symptoms of increased pressure in the eyes (e.g., decreased or blurred vision, eye pain, red eye, swelling of the eye)
  • weakness or pain in the arms, hands, legs or feet

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • anxiety or confusion (severe)
  • dramatic changes in body temperature (hot or cold)
  • dramatic increase or decrease in blood pressure
  • pale, bluish-coloured, or cold hands or feet (not caused by cold temperatures and occurring together with other side effects listed in this section)
  • seizures
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol and medications causing drowsiness: Alcohol and medications that cause drowsiness (e.g., tranquilizers, sedatives, anti-anxiety medications) may intensify the drowsiness caused by this medication.

Dependence: This medication may be habit-forming. If you have a history of substance abuse, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: This medication may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Heart disease: Ergotamine can cause blood vessels to narrow, which may cause chest pain or worsening angina symptoms. In severe cases, this narrowing of the blood vessels can prevent blood from reaching parts of the heart muscle, causing a heart attack. The narrowing of the blood vessels can also cause a significant increase in blood pressure. People with heart disease or high blood pressure may be more likely to experience this. If you have heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Belladonna - ergotamine - phenobarbital is broken down by the liver. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Overdose: A very dry mouth or vision changes may be a sign of overdose or sensitivity to the ingredients of this medication. Check with your doctor as a dose decrease may be necessary.

Pregnancy: Ergotamine can cause increased contractions of the uterus and may cause miscarriage. This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking belladonna-ergotamine-phenobarbital, it may affect your baby. Women who are breast-feeding should not take this medication.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between belladonna - ergotamine - phenobarbital and any of the following:

  • aclidinium
  • alcohol
  • aliskiren
  • alpha/beta agonists (e.g., epinephrine, norepinephrine)
  • alpha blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzepine, quetiapine, risperidone)
  • apixaban
  • aprepitant
  • aripiprazole
  • atropine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • baclofen
  • barbiturates (e.g., butalbital, phenobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • benztropine
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • bicalutamide
  • birth control pills
  • boceprevir
  • bosentan
  • bosutinib
  • brimonidine
  • bromocriptine
  • buprenorphine
  • buspirone
  • calcitriol
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carbamazepine
  • carvedilol
  • celecoxib
  • cetirizine
  • chloramphenicol
  • chloral hydrate
  • chloroquine
  • cholestyramine
  • cilostazol
  • ciprofloxacin
  • colchicines
  • conivaptan
  • cosyntropin
  • crizotinib
  • cyclobenzaprine
  • cyclosporine
  • oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • dabigatran
  • dantrolene
  • dapsone
  • dasatinib
  • deferasirox
  • desvenlafaxine
  • dexamethasone
  • dexmethylphenidate
  • dextromethorphan
  • diclofenac
  • digoxin
  • disopyramide
  • dofetilide
  • dopamine
  • doxycycline
  • dronedarone
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • erlotinib
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • ethosuximide
  • everolimus
  • felbamate
  • flavoxate
  • flutamide
  • folic acid
  • fusidic acid
  • gabapentin
  • gemfibrozil
  •  "gliptin" diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
  • grapefruit juice
  • glycopyrrolate
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • hydrochlorothiazide
  • hydrocortisone
  • imatinib
  • ipratropium
  • isoniazid
  • ivermectin
  • ketorolac
  • lacosamide
  • lamotrigine
  • lapatinib
  • leucovorin
  • levetiracetam
  • levomefolate
  • lidocaine
  • lithium
  • loperamide
  • losartan
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • magnesium sulfate
  • maraviroc
  • medications to treat cancer (e.g., carboplatin, cyclophosphamide, doxorubicin, ifosfamide, vincristine)
  • mefloquine
  • melatonin
  • meperidine
  • mestranol
  • methadone
  • methylphenidate
  • metoclopramide
  • mexiletine
  • mifepristone
  • mirtazapine
  • modafinil
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • montelukast
  • multivitamin/minerals
  • muscle relaxants (e.g., cyclobenzaprine, methocarbamol, orphenadrine)
  • nadolol
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • nateglinide
  • nefazodone
  • nilotinib
  • nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate, nitroglycerin)
  • norfloxacin
  • olopatadine
  • orlistat
  • orphenadrine
  • oxybutynin
  • oxycodone
  • perampanel
  • phenytoin
  • pimozide
  • potassium chloride
  • pramipexole
  • praziquantel
  • primaquine
  • primidone
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
  • propranolol
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • pyridoxine
  • quinidine
  • quinine
  • ranitidine
  • rasagiline
  • repaglinide
  • rifabutin
  • rifampin
  • rilpivirine
  • rivaroxaban
  • romidepsin
  • ropinirole
  • St. John's wort
  • scopolamine
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
  • sildenafil
  • simeprevir
  • sirolimus
  • sitaxentan
  • sorafenib
  • sunitinib
  • "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
  • sulfonamide antibiotics (e.g., sulfadiazine, sulfamethoxaxole, sulfisoxazole)
  • sulfonamide diabetes medications (e.g., gliclazide, glyburide, tolbutamide)
  • tacrolimus
  • tadalafil
  • tamoxifen
  • tapentadol
  • telaprevir
  • temsirolimus
  • tetracycline
  • thalidomide
  • theophylline
  • ticagrelor
  • ticlopidine
  • tiotropium
  • tolterodine
  • tolvaptan
  • topiramate
  • trabectedin
  • tramadol
  • trazodone
  • tretinoin
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • trimethoprim
  • "triptan" migraine medications (e.g., eletriptan, sumatriptan)
  • tryptophan
  • valproic acid
  • venlafaxine
  • warfarin
  • zafirlukast
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.