Details for: APO-GRANISETRON
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02308894 | APO-GRANISETRON | GRANISETRON (GRANISETRON HYDROCHLORIDE) | 1 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-GRANISETRON is one of a group called antiemetics and it can only be obtained with a prescription from your doctor.
APO-GRANISETRON is intended to prevent nausea (feeling sick) and vomiting which may occur after you receive cancer chemotherapy or radiotherapy.
What it does
Cancer chemotherapies and radiation therapies are thought to cause the release of serotonin, a natural substance in the body. Serotonin can cause you to feel sick and to vomit. Granisetron, the active ingredient in APO-GRANISETRON tablets, will stop the action of serotonin and help prevent you from feeling sick and vomiting.
When it should not be used
- Do not take this medicine if you are allergic to granisetron or any of the ingredients APO-GRANISETRON contains.
- If you are taking apomorphine.
What the medicinal ingredient is
Granisetron hydrochloride
What the non-medicinal ingredients are
Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and colloidal silicon dioxide (hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol and titanium dioxide).
What dosage form it comes in
APO-GRANISETRON tablets are supplied in one strength: 1 mg tablets.
Warnings and precautions
BEFORE you use APO-GRANISETRON talk to your doctor or pharmacist if:
- you have any allergies to similar antiemetics such as dolasetron mesylate (Anzemet®) or ondansetron (Zofran®).
- you are pregnant, plan to become pregnant or are breastfeeding.
- you have liver problems
- you have a history of heart problems.
- You have galactose intolerance, lactase deficiency (lactose intolerance) or glucose-galactose absorption issues, since APO-GRANISETRON contains lactose, which is a type of sugar.
- you have been told by a doctor that you have a blockage of your gut or if you have severe constipation, pain or swelling in your stomach.
- you are taking other medications, including drugs you can buy without a prescription and herbal products.
Serotonin Syndrome is a rare but potentially life-threatening reaction that may occur if you take APO-GRANISETRON with certain other medications. It may cause serious changes in how your brain, muscles, and digestive system work. Be sure to tell your healthcare processional all the medicines you are taking.
As APO-GRANISETRON may cause drowsiness, you should avoid driving a car or operating hazardous machinery until you know it does not affect you.
Interactions with this medication
As with most medicines, interactions with other drugs are possible. To avoid potentially life-threatening reactions, tell your healthcare professional about ALL the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
Proper use of this medication
This medicine is only for you, the person for whom the prescription was written. Do not give this medication to others.
Usual adult dose
Follow your doctor’s instructions about how often you should take your medicine and how many tablets you should take. This information is also on the label of the container of your medicine and if not, of if you have any questions, you should consult your doctor or pharmacist.
Do not take more tablets or take your tablets more often than your doctor prescribes.
Overdose
In the event that you accidentally take more tablets than your doctor prescribes, immediately contact your doctor, hospital emergency department, or the nearest Poison Control Centre, even if you do not feel ill.
Missed Dose
If you forget to take a tablet at the time it should be taken, take the tablet as soon as you remember it was missed.
Side effects and what to do about them
If you experience an allergic reaction (e.g. shortness of breath, drop in blood pressure, skin lumps or hives), contact your doctor immediately. Do not take any more medicine unless instructed to do so by your doctor.
You may experience headaches, constipation, weakness, sleepiness, diarrhea or abdominal pain while taking APO-GRANISETRON. There is no need to stop the medicine but you should tell your doctor about these symptoms.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and seek immediate medical help |
|---|---|---|---|
| Rare | |||
| Allergic reaction – symptoms include swelling of the mouth, throat, difficulty in breathing, rash, hives, increased heart rate | ✔ | ||
| Disturbance in heart rhythm - dizziness, palpitations (fast, pounding or irregular heart beat), chest pain, fainting | ✔ | ||
Serotonin Syndrome - symptoms that may be observed when APO-GRANISETRON is taken with certain other medications include:
|
✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO-GRANISETRON, contact your doctor or pharmacist.
How to store
Store at room temperature 15°C - 30°C (59°F -86°F).
The expiry date of this medicine is printed on the label. Do not use the medicine after this date. Keep your medicine in a safe place out of the reach of children.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
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.
More information
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at: http://www.apotex.ca/products. This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last Prepared: June 30, 2016