Fiorinal

Fiorinal 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.

This product is available in the following dosage forms: tablets each containing Butalbital 50 mg, Aspirin 325 mg and Caffeine 40 mg.

Before using Fiorinal, you must know all about the risks and complications associated with it.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric population

• For Butalbital: Although barbiturates such as Butalbital often cause drowsiness, some children become excited after taking them.
• For Aspirin: Do not give a medicine containing aspirin to a child with fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because aspirin may cause a serious illness called Reye's syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.
• For Caffeine: There is no specific information comparing use of caffeine in children up to 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric Population

• For Butalbital: Confusion, depression, or excitement may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of Butalbital.
• For Aspirin: Elderly patients are more sensitive than younger adults to the effects of aspirin. This may increase the chance of side effects during treatment.
• For Caffeine: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of caffeine in the elderly with use in other age groups.

Pregnancy

• For Butalbital: Barbiturates such as butalbital have been shown to increase the chance of birth defects in humans. Also, one study in humans has suggested that barbiturates taken during pregnancy may increase the chance of brain tumors in the baby. Butalbital may cause breathing problems in the newborn baby if taken just before or during delivery.
• For Aspirin: Although studies in humans have not shown that aspirin causes birth defects, it has caused birth defects in animal studies. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor. Some reports have suggested that use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn baby. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. There is a chance that regular use of aspirin late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn baby. Also, use of aspirin during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn baby. In addition, too much use of aspirin during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery.
• For caffeine: Studies in humans have not shown that caffeine causes birth defects. However, use of large amounts of caffeine during pregnancy may cause problems with the heart rhythm and the growth of the fetus. Also, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to the amount in 12 to 24 cups of coffee a day).

Breastfeeding

Although this combination medicine has not been reported to cause problems, the chance always exists, especially if the medicine is taken for a long time or in large amounts.

• For butalbital: Barbiturates such as butalbital pass into the breast milk and may cause drowsiness, unusually slow heartbeat, shortness of breath, or troubled breathing in nursing babies.
• For aspirin: Aspirin passes into the breast milk. However, taking aspirin in the amounts present in these combination medicines has not been reported to cause problems in nursing babies.
• For caffeine: The caffeine in some of these combination medicines passes into the breast milk in small amounts. Taking caffeine in the amounts present in these medicines has not been reported to cause problems in nursing babies. However, studies have shown that nursing babies may appear jittery and have trouble in sleeping when their mothers drink large amounts of caffeine-containing beverages. Therefore, breast-feeding mothers who use caffeine-containing medicines should probably limit the amount of caffeine they take in from other medicines or from beverages.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Dichlorphenamide
• Influenza Virus Vaccine, Live
• Ketorolac
• Riociguat

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab Alfentanil Alipogene Tiparvovec Alprazolam Alteplase, Recombinant Amineptine Amitriptyline Amitriptylinoxide Amobarbital Amoxapine Anagrelide Anileridine Anisindione Apixaban Aprobarbital Ardeparin Argatroban
• Beta Glucan Bivalirudin Butabarbital Butalbital
• Carisoprodol Certoparin Chloral Hydrate Chlordiazepoxide Chlorzoxazone Cilostazol Citalopram Clarithromycin Clobazam Clomipramine Clonazepam Clopidogrel Clorazepate Codeine Cyclosporine
• Dabigatran Etexilate Dalteparin Danaparoid Dantrolene Darunavir Desipramine Desirudin Desvenlafaxine Diazepam Dibenzepin Dicumarol Dipyridamole Dipyrone Donepezil Dothiepin Doxepin Doxorubicin Doxorubicin Hydrochloride Liposome Droxicam Duloxetine
• Edoxaban Eliglustat Enoxaparin Eptifibatide Erlotinib Escitalopram Estazolam Ethchlorvynol
• Fentanyl Feverfew Flufenamic Acid Flunitrazepam Fluoxetine Flurazepam Fluvoxamine Fondaparinux
• Ginkgo Gossypol
• Halazepam Heparin Hydrocodone Hydromorphone
• Imipramine Ivabradine
• Ketazolam Ketoprofen
• Lepirudin Levomilnacipran Levorphanol Lofepramine Lorazepam Lormetazepam
• Medazepam Mefenamic Acid Melitracen Meperidine Mephenesin Mephobarbital Meprobamate Metaxalone Methocarbamol Methohexital Methotrexate Midazolam Milnacipran Morphine Morphine Sulfate Liposome
• Nadroparin Naloxegol Naproxen Nefazodone Nifedipine Nitrazepam Nortriptyline
• Opipramol Oxazepam Oxymorphone
• Parnaparin Paroxetine Peginterferon Alfa-2b Pemetrexed Pentobarbital Pentosan Polysulfate Sodium Pentoxifylline Phenindione Phenobarbital Phenprocoumon Piperaquine Piroxicam Pixantrone Pralatrexate Prasugrel Prazepam Primidone Propoxyphene Propyphenazone Protein C Protriptyline
• Quazepam
• Remifentanil Reteplase, Recombinant Reviparin Rivaroxaban
• Secobarbital Sertraline Sodium Oxybate Sufentanil Sulindac
• Tacrolimus Temazepam Thiopental Tianeptine Ticagrelor Ticlopidine Tinzaparin Tirofiban Treprostinil Triazolam Trimipramine
• Ulipristal
• Varicella Virus Vaccine Venlafaxine Vilazodone Vortioxetine
• Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class.

Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or Drug abuse or dependence (or history of): Dependence on butalbital may develop.
• Asthma, especially if occurring together with other allergies and nasal polyps (or history of), or Emphysema or other chronic lung disease or Hyperactivity (in children) or Kidney disease or Liver disease. The chance of serious side effects may be increased.
• Diabetes mellitus (sugar diabetes) or Mental depression or Overactive thyroid or Porphyria (or history of): Butalbital may make these conditions worse.
• Gout :Aspirin can make this condition worse and can also lessen the effects of some medicines used to treat gout.
• Heart disease (severe): The caffeine in some of these combination medicines can make some kinds of heart disease worse.
• Hemophilia or other bleeding problems or Vitamin K deficiency: Aspirin increases the chance of serious bleeding.
• Stomach ulcer, especially with a history of bleeding, or other stomach problems: Aspirin can make your condition worse.

To use Fiorinal correctly, you must follow all instructions given by your doctor.

Take this medicine with food or a full glass (8 ounces) of water to lessen stomach irritation. Do not take this medicine if it has a strong vinegar-like odor. This odor means the aspirin in it is breaking down. If you have any questions about this, check with your health care professional. Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If butalbital and aspirin combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine in some butalbital and aspirin combinations can also increase the chance of dependence. Dependence is especially likely to occur in patients who take this medicine to relieve frequent headaches. Taking too much of this combination medicine can also lead to stomach problems or to other medical problems.

This medicine will relieve a headache best if you take it as soon as the headache begins. If you get warning signs of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve headaches. People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions about taking the other medicine, even if your headaches continue to occur.

Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For Butalbital and Aspirin combination

For oral dosage form (tablets):

For tension headaches:

• Adults: One tablet every four hours as needed. You should not take more than six tablets a day.
• Children: Dose must be determined by your doctor.

For Butalbital, Aspirin, and Caffeine combination

For oral dosage forms (capsules or tablets):

For tension headaches:

• Adults: One or 2 capsules or tablets every four hours as needed. You should not take more than six capsules or tablets a day.
• Children: Dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Do not keep outdated medicine or medicine no longer needed.

In using Fiorinal, you must be careful and take some precautions as advised by your doctor.

Check with your doctor:

• If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better pain relief by increasing the dose. If you are having headaches more often than you did before you started using this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of headache medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the headache medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches. Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take.
• If any contain a barbiturate, aspirin, or other salicylates, including diflunisal, check with your health care professional. Taking them together with this medicine may cause an overdose. The butalbital in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness).
• Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, other barbiturates, medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Also, stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine. This medicine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.
• Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Serious side effects may occur if your medical doctor or dentist gives you certain other medicines without knowing that you have taken butalbital. Do not take this medicine for 5 days before any planned surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems. Before you have any medical tests, tell the person in charge that you are taking this medicine.
• Caffeine (present in some butalbital and aspirin combinations) interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of some other tests may also be affected by butalbital and aspirin combinations. If you have been taking large amounts of this medicine, or if you have been taking it regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor.

Your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects. If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once.

Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or death. Symptoms of overdose of this medicine include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe excitement, nervousness, or restlessness, severe dizziness, severe drowsiness, shortness of breath or troubled breathing, and severe weakness.

As with many medications, there are several potential side effects associated with Fiorinal.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare:

• Bluish discoloration or flushing or redness of skin (occurring together with other effects listed in this section)
• Coughing, shortness of breath, troubled breathing, tightness in chest, or wheezing difficulty in swallowing
• Dizziness or feeling faint (severe)
• Hive-like swellings (large) on eyelids, face, lips, or tongue skin rash, itching, or hives stuffy nose (occurring together with other effects listed in this section)

Rare:

• Bleeding or crusting sores on lips
• Chest pain
• Fever with or without chills
• Red, thickened, or scaly skin sores, ulcers, or white spots in mouth (painful) sore throat (unexplained)
• Tenderness, burning, or peeling of skin

Symptoms of overdose:

• Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe, especially with products containing caffeine)
• Convulsions (seizures, with products containing caffeine)
• Diarrhea (severe or continuing)
• Dizziness, lightheadedness, drowsiness, or weakness (severe)
• Frequent urination (for products containing caffeine)
• Hallucinations (seeing, hearing, or feeling things that are not there)
• Increased sensitivity to touch or pain (for products containing caffeine)
• Increased thirst muscle trembling or twitching (for products containing caffeine)
• Nausea or vomiting (severe or continuing), sometimes with blood
• Ringing or buzzing in ears (continuing) or hearing loss
• Seeing flashes of "zig-zag" lights (for products containing caffeine)
• Slow, fast, or irregular heartbeat
• Slow, fast, irregular, or troubled breathing
• Slurred speech
• Staggering
• Stomach pain (severe)
• Uncontrollable flapping movements of the hands, especially in elderly patients
• Unusual movements of the eyes
• Vision problems

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare:

• Bloody or black, tarry stools
• Bloody urine
• Confusion or mental depression
• Muscle cramps or pain
• Pinpoint red spots on skin
• Swollen or painful glands
• Unusual bleeding or bruising
• Unusual excitement

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:

• Bloated or "gassy" feeling
• Dizziness or lightheadedness (mild)
• Drowsiness (mild)
• Heartburn or indigestion
• Nausea, vomiting, or stomach pain (occurring without other symptoms of overdose)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.