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Fiorinal with Codeine III

Generic Name: aspirin/butalbital/caffeine/codeine (AS-pir-in/bue-TAL-bi-tal/KAF-een/KOE-deen)
Brand Name: Examples include Ascomp-Codeine and Fiorinal with Codeine

Some children have had serious and sometimes fatal breathing problems when using Fiorinal with Codeine III after surgery to remove tonsils or adenoids. Fiorinal with Codeine III should not be used in children to treat pain after surgery to remove tonsils or adenoids. Talk with your doctor for more information.

Fiorinal with Codeine III is used for:

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

Fiorinal with Codeine III is a salicylate, barbiturate, caffeine, and narcotic combination. How these medicines work is not completely understood. Aspirin reduces pain and inflammation. Caffeine may work by constricting blood vessels that may cause headaches. Butalbital has a depressant effect that reduces anxiety and causes relaxation. Codeine works in the central nervous system to decrease pain.

Do NOT use Fiorinal with Codeine III if:

  • you are allergic to nonsteroidal anti-inflammatory drugs (NSAIDs), any ingredient in Fiorinal with Codeine III, or any other codeine- or morphine-related medicine (eg, oxycodone).
  • you have von Willebrand disease, the blood disease porphyria, severe stomach or intestinal problems (eg, peptic ulcer, pseudomembranous colitis), blood clotting problems (eg, hemophilia), severe bleeding, severe liver damage, or severe low levels of vitamin K
  • you are taking sodium oxybate (GHB)
  • you are a child or teenager that has the flu, chickenpox, or joint problems
  • the patient is a child being treated for pain after surgery to remove tonsils or adenoids

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

Before using Fiorinal with Codeine III:

Some medical conditions may interact with Fiorinal with Codeine III. 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 asthma, stomach or intestinal problems (eg, inflammatory bowel disease), liver problems, the flu, nasal polyps, kidney problems, lung or respiratory tract disease, an enlarged prostate, severe heart disease, difficulty urinating, chickenpox, underactive thyroid, or vitamin K deficiency
  • if you are in very poor health or have a history of stroke, anxiety, substance abuse or dependence, depression, or suicidal thoughts or behaviors
  • if you have had head trauma, growths in the brain, or stomach or intestinal surgery

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

  • Anticoagulants (eg warfarin), celecoxib, clopidogrel, heparin, or NSAIDs (eg, ibuprofen) because the risk of serious side effects, such as stomach ulcers and bleeding, may be increased
  • Benzodiazepines (eg, chlordiazepoxide), cimetidine, HIV protease inhibitors (eg, ritonavir), 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 Fiorinal with Codeine III's side effects
  • Naltrexone because it may decrease Fiorinal with Codeine III's effectiveness
  • Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinides (eg, repaglinide), methotrexate, quinolone antibiotics (eg, ciprofloxacin), or valproic acid because the risk of their side effects may be increased by Fiorinal with Codeine III
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril), antipsychotics (eg, clozapine), beta-blockers (eg, atenolol), corticosteroids (eg, prednisone), doxycycline, estrogens (eg, estradiol), metronidazole, oral contraceptives (eg, norethindrone/ethinyl estradiol), probenecid, quinidine, sulfinpyrazone, theophylline, or tricyclic antidepressants (eg, amitriptyline) because their effectiveness may be decreased by Fiorinal with Codeine III

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fiorinal with Codeine III 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 Fiorinal with Codeine III:

Use Fiorinal with Codeine III as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Fiorinal with Codeine III by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
  • If you miss a dose of Fiorinal with Codeine III and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fiorinal with Codeine III.

Important safety information:

  • Fiorinal with Codeine III may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fiorinal with Codeine III 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 Fiorinal with Codeine III; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Serious stomach ulcers or bleeding can occur with the use of Fiorinal with Codeine III. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Fiorinal with Codeine III with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
  • Tell your doctor or dentist that you take Fiorinal with Codeine III before you receive any medical or dental care, emergency care, or surgery.
  • Fiorinal with Codeine III has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Taking more than the recommended dose or taking Fiorinal with Codeine III for longer than prescribed may be habit-forming.
  • Aspirin has been linked to a serious illness called Reye syndrome. Do not give Fiorinal with Codeine III to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Fiorinal with Codeine III. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Use Fiorinal with Codeine III with caution in the ELDERLY; they may be more sensitive to its effects.
  • Fiorinal with Codeine III should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Fiorinal with Codeine III while you are pregnant. Fiorinal with Codeine III is not recommended during the last 6 months (second and third trimesters) of pregnancy because it may cause harm to the fetus. Fiorinal with Codeine III is found in breast milk. If you are or will be breast-feeding while you use Fiorinal with Codeine III, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Fiorinal with Codeine III 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 Fiorinal with Codeine III stops working well. Do not take more than prescribed.

Some people who use Fiorinal with Codeine III 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 suddenly stop taking Fiorinal with Codeine III, you may experience WITHDRAWAL symptoms, including anxiety, dizziness, hallucinations, lightheadedness, muscle twitching, nausea, seizures, sleeplessness, trembling hands and fingers, vomiting, or weakness.

Possible side effects of Fiorinal with Codeine III:

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; gas; indigestion; lightheadedness; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; severe drowsiness; shallow breathing; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; constriction of the pupils; fast or irregular heartbeat; loss of consciousness; nausea; ringing in the ears; sleeplessness; slow or shallow breathing; stomach pain; tremor; unusual drowsiness or dizziness; vomiting.

Proper storage of Fiorinal with Codeine III:

Store Fiorinal with Codeine III at room temperature, below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fiorinal with Codeine III out of the reach of children and away from pets.

General information:

  • If you have any questions about Fiorinal with Codeine III, please talk with your doctor, pharmacist, or other health care provider.
  • Fiorinal with Codeine III 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Fiorinal with Codeine III or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Fiorinal with Codeine III. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Fiorinal with Codeine III. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Fiorinal with Codeine III.

Issue Date: June 3, 2015