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|Acetaminophen/Butalbital

Acetaminophen/Butalbital

Acetaminophen/Butalbital is used for:

Relieving tension headaches. It may also be used for other conditions as determined by your doctor.

How these medicines work is not completely understood. Acetaminophen works in the brain to relieve pain. Butalbital has a depressant effect that reduces anxiety and causes relaxation.

Do NOT use Acetaminophen/Butalbital if:

• you are allergic to any ingredient in Acetaminophen/Butalbital
• you have the blood disease porphyria
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen/Butalbital :

Some medical conditions may interact with Acetaminophen/Butalbital . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver problems, severe kidney problems, severe heart disease, a lung or respiratory tract disease, or difficulty sleeping
• if you have a history of substance abuse or dependence, anxiety, depression, or suicidal thoughts or behaviors

Some MEDICINES MAY INTERACT with Acetaminophen/Butalbital . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Benzodiazepines (eg, chlordiazepoxide), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic analgesics (eg, morphine), sleeping medicines (eg, temazepam), or sodium oxybate (GHB) because they may increase the risk of Acetaminophen/Butalbital "s side effects
• Anticoagulants (eg, warfarin) or isoniazid because the risk of side effects, including bleeding and liver problems, may be increased
• Beta-blockers (eg, atenolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogens (eg, estradiol, oral contraceptives), metronidazole, quinidine, quinolone antibiotics (eg, ciprofloxacin), or theophylline because their effectiveness may be decreased by Acetaminophen/Butalbital

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Butalbital may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen/Butalbital :

Use Acetaminophen/Butalbital as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Acetaminophen/Butalbital by mouth with or without food.
• If you miss a dose of Acetaminophen/Butalbital and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is almost time for your next dose, do not double the dose to catch up, unless advised to do so by your doctor. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Butalbital .

Important safety information:

• Acetaminophen/Butalbital may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Butalbital with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Acetaminophen/Butalbital ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Pain medications work best if they are used as the first signs of pain (or migraine) occur. If you wait until the pain has significantly worsened, the pain medicine may not work as well.
• Acetaminophen/Butalbital has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Acetaminophen/Butalbital may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Butalbital . Talk to your doctor before you take Acetaminophen/Butalbital or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day.
• Tell your doctor or dentist that you take Acetaminophen/Butalbital before you receive any medical or dental care, emergency care, or surgery.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Acetaminophen/Butalbital . To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Lab tests, including liver and kidney function, may be performed while you use Acetaminophen/Butalbital . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Acetaminophen/Butalbital with caution in the ELDERLY; they may be more sensitive to its effects.
• Acetaminophen/Butalbital should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen/Butalbital while you are pregnant. Acetaminophen/Butalbital is found in breast milk. Do not breast-feed while taking Acetaminophen/Butalbital .

When used for long periods of time or at high doses, Acetaminophen/Butalbital may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Acetaminophen/Butalbital stops working well. Do not take more than prescribed.

Some people who use Acetaminophen/Butalbital for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Acetaminophen/Butalbital suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, muscle twitching, trembling hands and fingers, weakness, dizziness, hallucinations, nausea, vomiting, sleeplessness, lightheadedness, or seizures.

Possible side effects of Acetaminophen/Butalbital :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; intoxicated feeling; lightheadedness; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; seizures; severe drowsiness; shortness of breath; slurred speech; stomach pain; weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include cold or clammy skin; confusion; dark urine; excessive sweating; extremely fast heartbeat; fatigue; lack of alertness; lightheadedness; loss of consciousness; nausea; sleeplessness; slow or shallow breathing; stomach pain; tremor; unusual drowsiness or dizziness; vomiting.

Store Acetaminophen/Butalbital at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Butalbital out of the reach of children and away from pets.

General information:

• If you have any questions about Acetaminophen/Butalbital , please talk with your doctor, pharmacist, or other health care provider.
• Acetaminophen/Butalbital is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Acetaminophen/Butalbital . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.