Butalbital/Aspirin/Codeine/Caffeine, Oral byoo-TAL-bi-tal AS-pir-in KOH-deen kaf-EEN

What are other names for this medicine?

Type of medicine: analgesic (pain medicine)

Generic and brand names: butalbital, aspirin, and codeine w/caffeine, oral; Fiorinal with Codeine

What is this medicine used for?

This medicine contains a barbiturate, caffeine, aspirin, and codeine. This medicine is taken by mouth to relieve the pain of tension headaches.

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 brain tumor or if you have recently had a head injury
• Addison's disease
• asthma or other lung disease
• blood clotting problems or a blood disorder such as G6PD deficiency
• depression
• kidney or liver problems
• nasal polyps
• porphyria (nerve pain or sensitivity to sunlight)
• problems with alcohol or drug abuse
• stomach ulcers, ulcerative colitis, or other intestinal problems
• thyroid disease
• trouble urinating or prostate problems

To avoid taking an overdose of barbiturates, aspirin, caffeine, or codeine, tell your healthcare provider if you are taking any other medicines (including nonprescription drugs).

This medicine should not be taken by children or teenagers with symptoms of the flu or another viral infection.

This medicine may make birth control pills less effective. If you need birth control, talk to your healthcare provider about methods that are effective while you are taking this medicine.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If taken during the last months of pregnancy, it can cause a drug dependence in 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?

This medicine works best when you take it with a full glass (8Â ounces) of water. You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

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, as it may be habit-forming. Contact your health care provider if your condition does not improve in a few days or if it gets worse.

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: ringing in the ears, headache, dizziness, confusion, restless feeling, trouble sleeping, hallucinations, nausea, vomiting, fever, loss of appetite, dark urine, yellowing of the skin or eyes, sweating, severe drowsiness, slow or shallow breathing, seizures, coma, slurred speech, fast heartbeat, trouble walking, tremors.

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. It can be very dangerous to combine alcohol and other depressants with this medicine.

This medicine may make you drowsy or dizzy. 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 lessen this effect. Also, drinking alcohol may increase this effect.

This medicine may make you constipated. You may need to take a laxative or stool softener while taking this medicine. Talk with your healthcare provider or pharmacist about this.

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

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

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

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): Nausea, vomiting, stomach pain, yellow skin or eyes, unusual bleeding or bruising, black or blood stools, ringing in the ears, trouble breathing, severe confusion, trouble walking.

Other: Drowsiness, dizziness, indigestion, hangover feeling, nervousness.

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:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• acetazolamide (Diamox)
• antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Antivert, Dramamine)
• antinausea medicines such as prochlorperazine (Compro) and promethazine
• antipsychotic medicines such as chlorpromazine, clozapine (Clozaril), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, trifluoperazine, and thioridazine
• antiseizure medicines such as carbamazepine (Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), phenytoin (Dilantin), primidone (Mysoline), tiagabine (Gabitril), and topiramate (Topamax)
• aspirin and other salicylates
• barbiturates such as amobarbital (Amytal), butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• beta blockers such as acebutolol (Sectral), atenolol (Tenormin), betaxolol (Kerlone), bisoprolol (Zebeta), carteolol, metoprolol (Lopressor, nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), and timolol, Toprol XL)
• medicine that reduces the chance of blood clots forming such as clopidogrel (Plavix), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), heparin, pentoxifylline (Trental), and warfarin (Coumadin)
• birth control pills, rings, patches, and implants
• corticosteroids such as betamethasone (Celestone), cortisone, dexamethasone, fludrocortisone (Florinef), hydrocortisone (Cortef), methylprednisolone (Medrol), prednisolone (Orapred), prednisone, and triamcinolone (Aristospan, Kenalog)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• diabetes medicines such as glipizide (Glucotrol), glyburide (DiaBeta, Glynase PresTab), insulin, metformin (Glucophage), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• natural remedies such as cat's claw, dong quai, evening primrose, feverfew, garlic, ginger, ginkgo, red clover, horse chestnut, green tea, kava, St. John's wort, gotu kola, valerian, and ginseng
• 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.)
• mercaptopurine (Purinethol)
• methotrexate
• muscle relaxants such as baclofen (Lioresal), carisoprodol (Soma), cyclobenzaprine (Flexeril), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• narcotic pain medicines such as codeine, fentanyl (Duragesic, Actiq), hydrocodone/acetaminophen (Vicodin), hydromorphone (Dilaudid), meperidine (Demerol), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and oxycodone/acetaminophen (Percocet)
• nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Voltaren, Cataflam), ibuprofen (Motrin, Motrin IB, Advil), indomethacin (Indocin), ketoprofen, ketorolac (Toradol), nabumetone (Relafen), naproxen (Naprosyn, Anaprox, Aleve, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• probenecid (Benemid)
• quinidine
• sleeping pills such as chloral hydrate, zaleplon (Sonata), and zolpidem (Ambien)
• SSRI antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), theophylline (Slo-bid), and venlafaxine (Effexor)
• tranquilizers such as alprazolam (Xanax), chlordiazepoxide (Librium), diazepam (Valium), and lorazepam (Ativan)
• tricyclic antidepressants such as amitriptyline, desipramine (Norpramin), doxepin, imipramine (Tofranil), and nortriptyline (Pamelor)

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.

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.