Fiorinal

Aspirin may cause stomach or intestinal bleeding, which can be fatal. This can occur without warning while you are taking this medicine.

You should not use this medicine if you are allergic to aspirin, butalbital, or caffeine, or if you have:

• stomach ulcer;

• severe liver disease;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• a bleeding or blood clotting disorder (such as hemophilia); or

• asthma, or a history of severe allergic reaction (sneezing, runny or stuffy nose, wheezing, shortness of breath) after taking aspirin or another NSAID (nonsteroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Celebrex, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

To make sure aspirin, butalbital, and caffeine is safe for you, tell your doctor if you have:

• liver or kidney disease;

• asthma or another respiratory disease;

• fluid retention;

• heart disease, congestive heart failure, high blood pressure;

• a history of head injury or brain tumor;

• a stomach or intestinal disorder;

• a thyroid disorder;

• enlarged prostate or urination problems; or

• Addison's disease (an adrenal gland disorder).

It is not known whether this medicine will harm an unborn baby. If you use butalbital while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant or plan to become pregnant.

Aspirin, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Aspirin use while breast-feeding could cause bleeding in the infant. You should not breast-feed while using this medicine.

Do not give this medicine to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye's syndrome, a serious and sometimes fatal condition in children.

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you.

Ask a doctor or pharmacist before using any cough, cold, allergy, or pain medication. Aspirin and caffeine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains aspirin or caffeine.

Do not drink alcohol. Dangerous side effects, overdose, or death can occur when alcohol is combined with butalbital. Alcohol may increase your risk of stomach bleeding while you are taking aspirin.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not use aspirin, butalbital, and caffeine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• mercaptopurine;

• methotrexate;

• probenecid;

• insulin or oral diabetes medicine;

• a blood thinner--warfarin, Coumadin, Jantoven; or

• steroid medicine--prednisone, dexamethasone, and others.

This list is not complete. Other drugs may interact with aspirin, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In the U.S.

• Fiorinal
• Fortabs
• Laniroif

Available Dosage Forms:

• Tablet
• Capsule

Butalbital and aspirin combination is a pain reliever and relaxant. It is used to treat tension headaches. Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.

When you use butalbital for a long time, your body may get used to it so that larger amounts are needed to produce the same effects. This is called tolerance to the medicine. Also, butalbital may become habit-forming (causing mental or physical dependence) when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

Some of these medicines also contain caffeine. Caffeine may help to relieve headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.

Butalbital and aspirin combination is sometimes also used for other kinds of headaches or other kinds of pain, as determined by your doctor.

These medicines are available only with your doctor's prescription.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Gas.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Fiorinal is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Fiorinal in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

The most frequent adverse reactions are drowsiness and dizziness. Less frequent adverse reactions are lightheadedness and gastrointestinal disturbances including nausea, vomiting, and flatulence. A single incidence of bone marrow suppression has been reported with the use of Fiorinal. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not use Fiorinal if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• mercaptopurine;

• methotrexate;

• probenecid;

• insulin or oral diabetes medicine;

• a blood thinner - warfarin, Coumadin, Jantoven; or

• steroid medicine - prednisone, dexamethasone, and others.

This list is not complete. Other drugs may interact with aspirin, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.