Patient Medication Information: uses, side effects, how to take - Granisetron Hydrochloride Injection (Sandoz Canada)
ABOUT THIS MEDICATION
What the medication is used for:
Granisetron Hydrochloride Injection is one of a group called antiemetics and it can only be obtained with a prescription from your doctor.
Granisetron Hydrochloride Injection is intended to prevent nausea (feeling sick) and vomiting which may occur after you receive cancer chemotherapy.
What it does:
Cancer chemotherapies 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 Granisetron Hydrochloride Injection, 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 Granisetron Hydrochloride Injection contains.
- If you are taking apomorphine.
What the medicinal ingredient is:
Granisetron hydrochloride
What the nonmedicinal ingredients are:
Citric acid (monohydrate) 0.2%, methylparaben 0.12% and propylparaben 0.015% (as preservatives), sodium chloride 0.9%, hydrochloric acid and/or sodium hydroxide to adjust pH and water for injection.
What dosage forms it comes in:
Granisetron Hydrochloride Injection is supplied in 1 mL amber multidose vials, boxes of 10 and in 4 mL amber multidose vials, boxes of 1.
WARNINGS AND PRECAUTIONS
BEFORE you use Granisetron Hydrochloride Injection talk to your doctor or pharmacist if:
- you have any allergies to similar antiemetics such as dolasetron mesylate or ondansetron
you are pregnant, plan to become pregnant or are breastfeeding
- you have liver problems
- you have a history of heart problems
- 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 Granisetron Hydrochloride Injection with certain other medications. It may cause serious changes in how your brain, muscles, and digestive system work. Be sure to tell your healthcare professional all the medicines you are taking.
As Granisetron Hydrochloride Injection 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:
Granisetron Hydrochloride Injection will be given to you by hospital staff before and/or after your therapy.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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 Granisetron Hydrochloride Injection. You may also experience pain, anemia or fever while on Granisetron Hydrochloride Injection. There is no need to stop the medicine but you should tell your doctor about these symptoms.
| 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 and seek immediate medical help | ||
| Only if severe | In all cases | |||
| 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 granisetron hydrochloride is taken with certain other medications include: •Fever, sweating, shivering, diarrhea, nausea, vomiting •Muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination •Fast heartbeat, changes in blood pressure •Confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma | ✓ | |||
This is not a complete list of side effects. For any unexpected effects while taking Granisetron Hydrochloride Injection, contact your doctor or pharmacist.
HOW TO STORE IT
Granisetron Hydrochloride Injection should be stored between 15 and 30°C. Discard 28 days after initial use.
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 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:
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. |
Online at MedEffect;
By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:MORE INFORMATION
This document, plus the full Product Monograph prepared for health professionals, can be obtained by contacting the sponsor, Sandoz Canada Inc., at:
1-800-361-3062
Or by written request at:
145, Jules-Léger
Boucherville, (QC), Canada
J4B 7K8
Patient leaflet also available at www.sandoz.ca