Butalbital and aspirin combination (oral route)

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.

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.

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.

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).

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.

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.

• Abrocitinib
• Defibrotide
• Dichlorphenamide
• Influenza Virus Vaccine, Live
• Ketorolac
• Riociguat
• Viloxazine

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.

• Acarbose
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Acepromazine
• Acetazolamide
• Alclometasone
• Aldosterone
• Alfentanil
• Alipogene Tiparvovec
• Alprazolam
• Alteplase, Recombinant
• Amcinonide
• Amikacin
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphotericin B
• Amtolmetin Guacil
• Anagrelide
• Anileridine
• Anisindione
• Apixaban
• Aprobarbital
• Ardeparin
• Argatroban
• Aripiprazole
• Aripiprazole Lauroxil
• Asenapine
• Bacitracin
• Baclofen
• Beclomethasone
• Bemetizide
• Bemiparin
• Benazepril
• Bendroflumethiazide
• Benperidol

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.

• Ethanol
• Tobacco

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.

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

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 (mild)

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)