Belladonna Alkaloids/Phenobarbital, Oral

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KEY POINTS

• This medicine is a combination product taken by mouth to treat cramps or spasms in your stomach and intestines. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antispasmodic; anticholinergic

Generic and brand names: belladonna alkaloids and phenobarbital, oral; Donnatal; hyoscyamine/atropine/scopolamine/phenobarbital, oral; Donnatal Elixir; Donnatal Extentabs

What is this medicine used for?

This medicine is a combination product taken by mouth to treat cramps or spasms in your stomach and intestines due to conditions such as irritable bowel syndrome. It may also be used to treat duodenal ulcers. It may be used with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• Asthma or COPD
• Dementia
• Gastroesophageal reflux disease (GERD), hiatal hernia, or esophagitis (trouble swallowing)
• Glaucoma
• Heart problem such as heart failure, an irregular heartbeat, or a fast heartbeat
• High blood pressure
• Kidney or liver disease
• Mental health problems such as hallucinations or delusions
• Muscle diseases such as myasthenia gravis or Parkinson’s disease
• Nerve problems from diabetes, alcohol abuse, or injury
• Thyroid problems
• Trouble urinating or an enlarged prostate gland

Tell your healthcare provider if you take medicines that can irritate your esophagus such as alendronate (Fosamax) or risedronate (Actonel).

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as directed by your healthcare provider. Do not take more of it or take it longer than directed. Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually.

This medicine works best when taken 30 to 60 minutes before meals.

This medicine may come in different forms. If you have extended-release tablets, do not break, crush, or chew them. Swallow them whole. Ask your pharmacist if you have the extended-release tablets.

If you have the liquid form of this medicine, use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct.

If you are taking antacids, take them 1 hour before or 2 hours after you take this medicine.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: headache, nausea, vomiting, dry mouth, restlessness, flushing, trouble swallowing, blurred vision, large pupils, hot dry skin, dizziness, drowsiness, confusion, anxiety, seizures, irregular heartbeat.

What should I watch out for?

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

You may sweat less while you are taking this medicine. Avoid extreme heat, saunas, hot tubs, and exercising too much. You can overheat which can cause heat stroke.

This medicine may make your eyes more sensitive to light. Wear sunglasses to help protect your eyes.

This medicine may cause dry eyes and make contact lenses uncomfortable. Lubricating eyedrops may help.

This medicine may cause blurred vision, dizziness, or drowsiness. Do not drive or operate machinery unless you are fully alert and able to see clearly.

Dry mouth and constipation are common side effects of this medicine. If these become bothersome, contact your healthcare provider.

Adults over the age of 65 may be at greater risk for side effects such as nervousness or drowsiness. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); seizures.

Serious (Report these to your healthcare provider right away.): Severe vision problems or eye pain, confusion, clumsiness, slurred speech, hallucinations, muscle weakness, fast or irregular heartbeat, flushing, diarrhea, trouble urinating, high or low blood pressure.

Other: Constipation, dry mouth, decreased sweating, nausea, vomiting, change in taste, stuffy nose, restlessness, drowsiness, mild dizziness, headache, dilated pupils, blurred vision, trouble sleeping, muscle pain, change in sexual ability or desire.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Also, using these medicines together might cause harmful side effects. Talk to your healthcare provider if you are taking any of these medicines:

• Acetaminophen and medicines that contain acetaminophen
• Alzheimer’s disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• Amantadine (Symmetrel)
• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS (Take antacids at least 2 hours before or 2 hours after you take this medicine.)
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide, dronedarone (Multaq), propafenone (Rythmol), and quinidine
• Antibiotics such as chloramphenicol, doxycycline (Doryx, Monodox, Vibramycin), rifabutin (Mycobutin), and rifampin (Rifadin)
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• Antidepressants such as amitriptyline, clomipramine, desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as chlorpromazine, clozapine, fluphenazine, olanzapine (Zyprexa), prochlorperazine (Compro), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), lamotrigine (Lamictal), phenytoin (Dilantin, Phenytek), and topiramate (Qudexy, Topamax, Trokendi)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), and nebivolol (Bystolic)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Corticosteroids such as betamethasone (Celestone), cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Diarrhea medicines such as Kaopectate and Pepto-Bismol (Take them 2 hours before or 2 hours after you take this medicine)
• Digoxin (Lanoxin)
• Doxepin (Silenor)
• HIV medicines such as delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings
• Hydroxyzine (Vistaril)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as ipratropium (Atrovent) and tiotropium (Spiriva)
• Metoclopramide (Metozolv, Reglan)
• Muscle relaxants such as baclofen (Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nitrate medicines such as isosorbide (Dilatrate, Isordil, Monoket) and nitroglycerin (Minitran, Nitro-Dur, Nitrostat)
• Parkinson’s disease medicines such as amantadine (Symmetrel) and levodopa/carbidopa (Duopa, Rytary, Sinemet)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Potassium supplements or salt substitutes that contain potassium
• Pramlintide (Symlin)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sleeping pills such as flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Theophylline
• Warfarin (Coumadin)

Do not drink alcohol while taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.