Patient Medication Information: uses, side effects, how to take - Apo-Butalbital-Acetylsalicylic Acid-Caffeine
ABOUT THIS MEDICATION
What the medication is used for:
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE is used for the relief of tension-type headaches.
What it does:
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE consists of acetylsalicylic acid (ASA), caffeine and butalbital. ASA reduces pain, fever and inflammation. Caffeine is a mild stimulant which may enhance pain-relieving effects. Butalbital is a sedative that causes relaxation. This combination is used to relieve tension-type headaches.
When it should not be used:
You should NOT take APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE if you:
- have a history of allergic reactions to ASA, caffeine, butalbital or any other components of the APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE capsules (see “What the nonmedicinal ingredients are”)
have a condition that predisposes to bleeding such as hemophilia, hyproprothrombinemia, von Willebrand’s disease, thrombocytopenia, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage
- have nasal polyps, allergic reaction or bronchospastic reactivity to ASA or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- have stomach ulcers or other serious stomach or bowel sores
- have a disease called porphyria
have a history of drug abuse or drug overdose due to alcohol, sleeping pills, drugs to treat pain or any other prescription or illegal drugs
- are pregnant and in a later stage of pregnancy (28 weeks or later), in labour or breast-feeding.
What the medicinal ingredients are:
ASA (acetylsalicylic acid), caffeine and butalbital.
What the nonmedicinal ingredients are:
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE capsules contain the following non-medicinal ingredients: cornstarch, microcrystalline cellulose, stearic acid and talc.
What dosage forms it comes in:
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE capsules contain 330 mg ASA, 40 mg caffeine, 50 mg butalbital.
WARNINGS AND PRECAUTIONS
Keep APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE out of the reach of children. You should not give APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE to anyone as inappropriate use may have severe medical consequences.
BEFORE you use APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE talk to your doctor or pharmacist if you:
- are allergic to ASA as it can cause anaphylactic shock and other severe allergic reactions
- have nasal polyps or asthma
- have a history of stomach ulcers, sores in your stomach or bowel or any other serious stomach problems
- have a history of bleeding
- will be having surgery
- have severe liver or kidney disease
- have a blood clotting disorder or are taking blood thinners
- have recently suffered a head injury or elevated
- have problems with your thyroid gland
- have narrowing of the urethra caused by injury or disease
- have Addison’s disease
- have an enlarged prostate gland
- have softening or weakening of bones or osteoporosis
- have any allergies to any medicines, food, dyes or preservatives
- have the flu or chickenpox
- are pregnant, planning on becoming or become pregnant while taking APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE
- are in labour or breastfeeding.
Serious Skin Reactions: In rare cases, serious or life-threatening skin reactions listed below have been reported with some NSAIDs, such as APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE.
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Stevens-Johnson syndrome (SJS),
- toxic epidermal necrolysis (TEN),
- exfoliative dermatitis and
- erythema multiforme
You may be at a greater risk of experiencing a serious skin reaction usually during the first month of treatment. See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE is a controlled medication. Butalbital is habit-forming (tolerance, mental and physical dependence) and potentially abusable. Some patients, particularly those who have abused drugs in the past, may have a higher risk of abusing or developing an addiction while taking a barbiturate-containing product such as APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE. Physical dependence may lead to withdrawal side effects when you stop taking this medicine. Continuous daily use of APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE should be avoided as medication overuse (rebound) headaches may result in addition to the tolerance and dependence risks. Patients should take APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
While there are important differences between physical dependence and addiction, each is a reason for close medical supervision and honest discussions with your doctor. If you have questions or concerns about abuse, addiction or physical dependence, please tell your doctor.
ASA may increase the risk of Reye's syndrome, a rare but often fatal condition. Caution should be used in administering ASA-containing medications to young adults who have fever, flu or chicken pox. APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE should not be administered to children.
Before you have any medical tests done, tell the person in charge that you are taking APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE. ASA may interfere with the results of certain tests done in blood and urine.
Driving and operating machinery
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE may impair the mental and/or physical abilities required for performance of potentially hazardous task such as driving a car or operating machinery. If you experience drowsiness or dizziness, such tasks should be avoided. Avoid alcohol as it can increase drowsiness and dizziness.
Pregnancy, labour and breastfeeding
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE is not recommended during pregnancy because it may cause withdrawal symptoms in the newborn baby. Taking APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE close to delivery may make delivery longer or lead to bleeding in the mother or in the newborn baby.
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE passes into breast milk and may harm a nursing infant.
DO NOT take APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE if you are pregnant and in a later stage of pregnancy (28 weeks or later).
If you are pregnant and in an earlier stage of pregnancy (less than 28 weeks) only take APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE if you are told to do so by your doctor. Medicines like APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE may cause harm to you and your baby. Your doctor will need to closely monitor your health and that of your baby (including your amniotic fluid levels) if they prescribe APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE during this time.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist if you are taking or have recently taken any other prescription or over-the-counter medicines, vitamins or natural health products during your treatment with APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE.
Check with your doctor or pharmacist before taking any other medication with APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE.
Tell your doctor if you are taking any of the following medications:
- alcohol and other CNS depressants (such as sleeping pills, muscle relaxants, pain killers, allergy medication (antihistamines), drugs used to treat anxiety, panic attacks and seizures)
- monoamine oxidase (MAO) inhibitors e.g., phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
- corticosteroids
- oral drugs to treat diabetes and/or insulin
- blood thinners such as warfarin
- drugs used to suppress the immune system such as 6-mercaptopurine and methotrexate
- NSAIDs (non-steroidal anti-inflammatory drugs) to treat pain such as ibuprofen and naproxen
- tranquilizers such as chlordiazepoxide
- drugs used to treat gout such as probenecid and sulfinpyrazone
- birth control pills.
PROPER USE OF THIS MEDICATION
Take APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE exactly as directed by your doctor.
Usual dose:
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE comes as a capsule to take by mouth.
Adults: Take 2 capsules at once, followed if necessary, by 1 capsule every 3 to 4 hours. Do not take more than 6 capsules daily or as prescribed.
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you forget to take a dose of APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE, do not worry. Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for the missed one.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE may cause unwanted reactions called side effects. Not all of these side effects may occur. Check with your doctor if the unwanted effects do not go away during treatment or become bothersome.
The following side effects may occur during treatment:
- drowsiness, lightheadedness and/or dizziness
- constipation
- skin rash
- small pupils
- nausea, vomiting indigestion and/or gas
- increased risk of infection
- fast or irregular heart beat
- irritability
- tremor
- lack of coordination
- difficulty thinking
- poor memory and judgement
- decreased attention
- mood swings
- exaggeration of personality traits.
If any of these side effects affects you severely, tell your doctor.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all case s | |||
| Rare | Serious Skin Reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, swelling of face and/or legs, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine | √ | ||
| Uncom mon | Reye's syndrome: rash on the palms of hands and feet, severe vomiting, high fever, weakness, confusions, headache, fast breathing leading to unresponsivenes s and death | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||||
|---|---|---|---|---|---|---|---|
| Only if severe | In all case s | ||||||
| Allergic reactions: itching, rash, hives, difficulty breathing or swallowing not present before using this medicine | √ | ||||||
| Unkno wn | Serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson syndrome erythema multiforme and exfoliative dermatitis: fever, itching, skin sores | √ | |||||
| Anemia: fatigue, breathing difficulties, irregular heart beat or pale skin | √ | ||||||
| Stomach ulcer: heartburn, long lasting stomach pain, loss of appetite and weight loss | √ | ||||||
| Prolonged bleeding time | √ | ||||||
| Hepatitis: loss of appetite, dark urine, yellowing of eyes and skin | √ | ||||||
| Blood in the stool | √ | ||||||
This is not a complete list of side effects. For any unexpected effects while taking APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE, contact your doctor or pharmacist.
HOW TO STORE IT
- store your APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE capsules at room temperature (between 15-30°C)
- keep out of reach and sight of children
- discard any expired medicine or medicine no longer needed.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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MORE INFORMATION
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.