Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
May 15, 2014
Health Canada has issued new restrictions concerning the use of Kytril (granisetron). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Drowsiness/reduced alertness: There have been occasional reports of drowsiness by people who have taken granisetron. Avoid operating motor vehicles or doing other potentially hazardous activities until you determine the how this medication effects you.
Heart rhythm: Granisetron, like other medications in the same family, can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Serotonin Syndrome: Severe reactions are possible when granisetron is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression.
If you are taking antidepressants, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms of a reaction, such as muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation, get immediate medical attention. Coma and death are possible.
Pregnancy: The safety of granisetron for use by pregnant women has not been established. This medication is not recommended for use during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if granisetron passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of granisetron have not been established for children or adolescents under 18 years of age. Its use by this age group is not recommended.