Fioricet

Fioricet

What is Fioricet?

Fioricet is used to treat tension headaches caused by muscle contractions.

Prolonged and repeated use of Fioricet is not recommended due to the possibility of physical dependence.

Warnings

You should not use Fioricet if you have porphyria or have recently taken alcohol, sedatives, tranquilizers or other narcotic medications.

Do not use Fioricet if you have taken an MAO inhibitor in the last 14 days. Dangerous drug interactions could occur. MAOIs include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Do not take more Fioricet than recommended.An overdose of acetaminophen can damage your liver or cause death.Call your doctor immediately if you have nausea, upper abdominal pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, paracetamol can cause a serious skin reaction.Stop taking Fioricet and call your doctor immediately if you have skin redness or a rash that spreads and causes blistering and peeling.

Before you take this medicine

Do not use Fioricet if you have taken an MAO inhibitor in the last 14 days. Dangerous drug interactions could occur. MAOIs include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use Fioricet if you are allergic to it, have porphyria, or have recently used alcohol, sedatives, tranquilizers, or other opioids.

To make sure Fioricet is safe for you, tell your doctor if you have ever had:

• Liver disease, liver cirrhosis, history of alcohol or drug addiction, or if you drink more than 3 alcoholic drinks per day;

• kidney disease;

• stomach ulcer or stomach bleeding;

• a history of rashes caused by medications; or

• a history of mental illness or suicidal thoughts.

It is not known whether Fioricet will harm an unborn baby.If you take butalbital during pregnancy, your baby could become dependent on the drug.This can lead to life-threatening withdrawal symptoms in the baby after birth. Babies born addicted to habit-forming medications may require medical treatment for several weeks. Tell your doctor if you are pregnant or planning to become pregnant.

Acetaminophen, butalbital, and caffeine can pass into breast milk and harm a breastfed baby. Tell your doctor if you are breastfeeding a baby.

Fioricet is not approved for use by people under 12 years of age.

How should I take Fioricet?

Take Fioricet exactly as directed. Follow all instructions on your prescription label. Do not take more of this medication than recommended. An overdose can damage your liver or cause death. Tell your doctor if the medicine no longer seems to be effective in relieving your pain.

Butalbital can be habit forming.Never share this medicine with another person, especially someone who has a history of drug abuse or addiction.Store the medication in a place where others cannot reach it. Selling or giving away this medicine is unlawful.

Store at room temperature, protected from moisture and heat.

Keep track of the amount of medicine used with each new bottle. Butalbital is a drug of abuse and you should be aware if someone takes your medicine improperly or without a prescription.

Dosage information

Usual Adult Dose for Headaches:

Butalbital 50 mg/Paracetamol 300 mg/Caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed, but not more than 6 capsules per day

Areas of application: To relieve the symptom complex of tension (or muscle contraction) headaches.

Usual Pediatric Dose for Headache:

12 years or older: Butalbital 50 mg/Paracetamol 300 mg/Caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed, but not more than 6 capsules per day

Comments:
-Due to high physical dependence, prolonged use of this drug is not recommended.
-The safety and effectiveness of treating multiple recurring headaches with this product are unknown.

Areas of application: To relieve the symptom complex of tension (or muscle contraction) headaches.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.An overdose of acetaminophen, butalbital and caffeine can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include upper abdominal pain, dark urine, and yellowing of your skin or the whites of your eyes.

Symptoms of overdose may also include insomnia, restlessness, tremors, diarrhea, increased shallow breathing, irregular heartbeat, seizures (convulsions), or fainting.

What should I avoid while taking Fioricet?

This medication may cause side effects that may affect your thinking or reactions. Be careful when driving or doing anything that requires you to be awake and alert.

Avoid alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist before taking other cold, allergy, pain, or sleeping medications. Acetaminophen (sometimes abbreviated APAP) is found in many combination medications.Taking certain products at the same time may cause you to receive too much acetaminophen, which could result in a fatal overdose.Check the label to see if a medicine contains acetaminophen or APAP.

While taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (e.g., ADHD medications) without your doctor's advice.

Fioricet side effects

If necessary, get emergency medical helpSigns of an allergic reaction to Fioricet:hives; difficulty breathing; Swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen can cause a serious skin reaction that can be fatal.This can happen even if you have taken acetaminophen in the past and had no reaction.Stop taking this medication and call your doctor immediately if you have skin redness or a rash that spreads and causes blistering and peeling.If you experience such a reaction, you should never take medicines that contain paracetamol again.

Stop using this medicine and call your doctor immediately if you have:

• confusion, a seizure;

• Shortness of breath;

• a light-headed feeling, as if you were going to faint; or

• Nausea, upper abdominal pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Fioricet may include:

• drowsiness, dizziness;

• dizziness;

• nausea, vomiting, stomach pain;

• drunken feeling; or

• Shortness of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Fioricet?

Taking this medicine with other medicines that make you sleepy or slow your breathing may cause dangerous or life-threatening side effects.Consult your doctor before taking Fioricet with a sleeping pill, opioid pain reliever, muscle relaxant, or anti-anxiety, depression, or seizure medication.

Other medications may interact with acetaminophen, butalbital, and caffeine, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all other medicines you are taking.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and only use Fioricet for the prescribed indication.