Patient Medication Information: uses, side effects, how to take - Bustab
ABOUT THIS MEDICATION
What the medication is used for:
BUSTAB is used for the temporary relief of excessive anxiety (worry).
What it does:
Buspirone affects behaviours which depend on a chemical messenger in the brain called dopamine.
When it should not be used:
Do not take BUSTAB if you have experimented unusual or allergic reactions to buspirone hydrochloride or any other ingredients in this medication (see what the important non medicinal ingredients are).
Do not take Bustab if you have serious liver or renal problem.
What the medicinal ingredient is:
Buspirone hydrochloride, USP
What the important nonmedicinal ingredients are: BUSTAB tablets contain: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
What dosage forms it comes in:
Tablet 5 mg and 10 mg
WARNINGS AND PRECAUTIONS
Taking Buspirone and Monoamine Oxidase Inhibitor (IMAO) antidepressants may cause high blood pressure. Therefore, you should avoid taking IMAO antidepressants while taking this medication (see interaction with this medication).
Movement disorders, trembling in hands, arms, legs, jaw, and face: rigidity may be noticed while taking Bustab. Talk to your doctor if you experience any of the effects while taking this medication.
WARNINGS AND PRECAUTIONS CONTINUED
Buspirone may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. 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.
BEFORE you take BUSTAB talk to your doctor or pharmacist if you have any of the following conditions:
- Allergies: Tell you doctor if you have ever had any unusual or allergic reaction to buspirone. Inform your doctor if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy: Buspirone has not been studied in pregnant women. Therefore, if you are pregnant or plan to become pregnant inform your physician of your condition before taking the drug.
- Breast-feeding: It is not known if buspirone passes into the breast milk of humans.
- Children: Studies with buspirone have been done only in adult patients.
- Older adults: Buspirone has been studied in this age group and has not been shown to cause different side effects or problems in older people than it does in younger adults. • Tell your doctor all the medication you are taking (see interaction with this medication).
Other medical problems: the presence of other medical problems may affect the use of buspirone. Make sure you tell your doctor if you have any other medical problem, especially:
- kidney disease, or
- liver disease (the effects of buspirone may be increased, which may increase the chance of side effects).
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with BUSTAB include:
- Cimetidine
- Diazepam
Nefazodone, Erythromycin, Itraconazole, Diltiazem,
Verapamil, Rifampicin
- Haloperidol
Monoamine Oxidase Inhibitors (see Warnings and
Precautions)
- Ketoconazole or Ritonavir, Dexamethasone or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine). • Phenytoin, Propranolol and Warfarin
- Trazodone
Other interactions that may occur with BUSTAB include: food, grapefruit juice and alcohol. Avoid consuming alcohol and large amount of grapefruit juice.
Bustab when taken with alcohol or medicines that slow down the nervous system, such as antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquillizers, or sleeping medicine; prescription pain medicine or narcotics, barbiturates/medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics, the chance of drowsiness may increase. Therefore, you should avoid taking this medication with alcohol or other CNS depressants.
PROPER USE OF THIS MEDICATION
Take BUSTAB 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. To do so may increase the chances of unwanted effects.
After you start taking BUSTAB, 1 or 2 weeks may pass before you feel the full effects of this medicine.
Usual dose:
Your doctor will decide the dose and duration of treatment. Do not change your dose unless directed by your doctor.
Adults: to start, 5 milligrams two or three times a day. Your doctor may adjust your dose depending on your needs, tolerance and condition to be treated.
Overdose:
If you or someone else may have taken an overdose of buspirone, get emergency help immediately. Some symptoms of an overdose are dizziness or drowsiness; stomach upset, including nausea or vomiting.
Missed Dose:
If you are taking BUSTAB regularly and you miss a dose, 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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Along with its needed effects, a medicine may cause some unwanted effects. Although, not all of these side effects may occur, if they do occur they may need medical attention.
Some commonly experienced 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. However, check with your doctor these side effects continue or are bothersome.
The most common adverse reactions are: dizziness, drowsiness, headache and nausea.
Some less common adverse reactions are: blurred vision, decreased concentration, dryness of mouth, cramps or stiffness, muscle pain, nightmares, ringing in ears, spasms, stomach upset, trouble sleeping, unusual tiredness or weakness and vivid dreams.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if Severe | In all cases | |||
| Rare |
depression
pounding heart beat
weakness
| T T T T T T T | ||
This is not a complete list of side effects. For any unexpected effects while taking BUSTAB, contact your doctor or pharmacist.
HOW TO STORE IT
Storage of BUSTAB for proper storage of the tablets:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Do not keep outdated medicine or medicine no longer needed.
Be sure that any discarded medicine is out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Valeant Canada Limited, at: 1-514-744-6792.
Valeant Canada Limited
4787 Levy St.
Montréal, Québec, H4R 2P9
Canada