Butalbital/Acetaminophen, Oral byoo-TAL-bi-tal a-seet-a-MIN-oh-fen

What are other names for this medicine?

Type of medicine: analgesic (painkiller)

Generic and brand names: butalbital and acetaminophen; Bupap; Phrenilin; Phrenilin Forte

What is this medicine used for?

This medicine is taken by mouth to treat tension headaches. It may be used for 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 other medicine
• a blood disorder such as G6PD deficiency
• asthma, COPD, or other breathing problems
• hepatitis or other liver disease
• kidney disease
• porphyria (nerve pain or sensitivity to sunlight)
• problems with alcohol or drug abuse

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 you are receiving this medicine.

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 or for a longer period than directed by your healthcare provider. Taking too much of this medicine can be habit-forming. If you take this medicine for several weeks, do not suddenly stop taking it without first checking with your healthcare provider.

Taking too much acetaminophen can cause liver damage. You should not take more than 2800 to 4000 mg of acetaminophen per day or as instructed by your healthcare provider. If you do not know how much acetaminophen is in your medicine, ask your pharmacist. Many over the counter products for cough, colds, allergy, nasal congestion, headache, minor aches or pain, and sleep contain acetaminophen. Check the label or ask your pharmacist for the acetaminophen content to avoid taking too much acetaminophen.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

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: drowsiness, confusion, nausea, vomiting, fever, loss of appetite, unusual tiredness, sweating, seizures, coma, slurred speech, fast heartbeat, trouble walking, shallow breathing.

What should I watch out for?

If you have taken this medicine for more than 1 month, do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually.

This medicine may make you drowsy or lightheaded. Do not drive or operate machinery unless you are fully alert.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

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.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

Do not take this medicine for any other condition unless directed by your healthcare provider.

Contact your healthcare provider if your condition does not improve or if it gets worse.

If you need emergency care, surgery, lab work or dental work, tell the healthcare provider or dentist you are taking this medicine. This medicine may affect the results of certain lab tests.

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 this 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).

Serious (report these to your healthcare provider right away): Severe drowsiness, confusion, depression, or unusual nervousness; dark urine; yellow eyes or skin; trouble urinating; trouble breathing; unusual tiredness or weakness; severe stomach pain; sore throat; unexplained fever; loss of appetite; fainting; seizures; fast heartbeat; severe skin redness, peeling, or rash; unusual bleeding or bruising.

Other: Lightheadedness, dizziness, nausea, vomiting, mild stomach pain, mild drowsiness, ringing in your ears, dry mouth, constipation, headache.

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. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• acetaminophen or other medicines containing acetaminophen
• antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, diazepam (Valium), and lorazepam (Ativan)
• anticancer medicines such as dasatinib (Sprycel), imatinib (Gleevec), and sorafenib (Nexavar)
• antihistamines such as brompheniramine (Dimetane), chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• antinausea medicines such as prochlorperazine and promethazine (Phenergan)
• antipsychotic medicines such as chlorpromazine, clozapine (Clozaril), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, pimozide (Orap), thioridazine, and trifluoperazine
• antiseizure medicines such as carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital, and valproic acid (Depakene, Depakote)
• birth control pills, patches, or vaginal rings
• corticosteroids such as betamethasone (Celestone), cortisone, dexamethasone, fludrocortisone (Florinef), hydrocortisone (Cortef), methylprednisolone (Medrol), prednisolone (Orapred), prednisone, and triamcinolone (Aristospan, Kenalog)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• natural remedies such as gotu kola, kava, St. John's wort, and valerian
• isoniazid
• linezolid (Zyvox)
• MAO inhibitor antidepressants such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• muscle relaxants such as carisoprodol (Soma), cyclobenzaprine (Flexeril), and tizanidine (Zanaflex)
• narcotic painkillers such as codeine, hydrocodone (Norco, Vicodin, Lorcet), hydromorphone (Dilaudid), meperidine (Demerol), morphine, and oxycodone (Roxicodone, OxyContin)
• sleeping pills such as butabarbital (Butisol), flurazepam, pentobarbital (Nembutal), temazepam (Restoril), triazolam (Halcion), and zolpidem (Ambien)
• theophylline
• tricyclic antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline, protriptyline (Vivactil), and trimipramine (Surmontil)
• warfarin (Coumadin)

Do not drink alcohol while taking this medicine without your healthcare provider's approval.

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.

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.