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
February 4, 2014
Health Canada has issued new restrictions concerning the use of aliskiren. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Diabetes: People with type 2 diabetes may be at higher risk of side effects such as kidney problems, stroke, high potassium levels in the blood, and blood pressure that's too low. If you have type 2 diabetes, discuss with your doctor how this medication may affect your medical condition and whether any special monitoring is needed. If you have type 2 diabetes and are also taking certain high blood pressure-lowering medications, you should not take aliskiren (see the "Who should not take this medication?" section). Talk to your doctor for more information.
Diarrhea: Stop taking this medication and contact your doctor if you experience severe and persistent diarrhea.
Kidney problems: This medication may cause reduced kidney function. If you have reduced kidney function or kidney disease, 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. Aliskiren is not recommended for people with severely reduced kidney function.
Liver Problems: Aliskiren may caused reduced liver function. 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.
Low blood pressure: This medication can cause low blood pressure, especially for people who are taking other diuretics (water pills), are receiving dialysis, or have lost fluid from diarrhea and vomiting. If you feel dizzy and lightheaded while taking this medication, lie down until these symptoms go away and contact your doctor.
Other blood pressure medications: When combined with blood pressure medications in the angiotensin converting enzyme inhibitor (ACEI) family or the angiotensin receptor blocker (ARB) family, aliskiren has been linked to stroke, severely low blood pressure and decreased kidney function. If you are taking a medication in either of these families, avoid taking aliskiren until you speak with your doctor or pharmacist.
Pregnancy: Aliskiren may cause harm to the developing baby if this medication is taken by the mother while pregnant. It should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if aliskiren 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 or taking this medication.
Children: The safety and effectiveness of using this medication are unknown for children under the age of 18.