December 18, 2014
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Drug Factsheets

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Rasilez

(aliskiren)

DIN (Drug Identification Number)

02302063 RASILEZ ALISKIREN 150 MG TABLET
02302071 RASILEZ ALISKIREN 300 MG TABLET

What side effects are possible with Rasilez?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • back pain
  • constipation
  • diarrhea
  • feeling tired
  • flu or cold (e.g., cough, sore throat or stuffy nose)
  • headache

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • dizziness, lightheadedness, or fainting
  • low blood pressure
  • swelling of the feet, ankles, or hands
  • symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine)
  • symptoms of too much potassium in the blood (e.g., irregular heartbeat, muscle weakness, general feeling of being unwell)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • severe diarrhea
  • symptoms of a serious allergic reaction (such as swelling of the face or throat, skin rash, hives, or difficulty breathing)
  • symptoms of a severe skin reaction (e.g., rash, redness, blistering, peeling, fever)
  • symptoms of kidney failure (such as a smaller or no amount of urine being made by the body)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Rasilez?

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.

What other drugs could interact with Rasilez?

There may be an interaction between aliskiren and any of the following:

  • ACE inhibitors (e.g. lisinopril, ramipril)
  • alfuzosin
  • alpha agonists (e.g., clonidine, methyldopa)
  • amifostine
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • ARBs (e.g., candesartan, irbesartan, losartan)
  • atorvastatin
  • barbiturates (e.g., butalbital, phenobarbital)
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • brimonidine
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carbamazepine
  • carvedilol
  • clarithromycin
  • cobicistat
  • crizotinib
  • cyclosporine
  • darunavir
  • dexamethasone
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • diazoxide
  • dipyridamole
  • doxorubicin
  • dronedarone
  • grapefruit juice
  • guanfacine
  • heparin
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • hydralazine
  • isosorbide
  • itraconazole
  • ketoconazole
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • mefloquine
  • methylphenidate
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • nefazodone
  • nilotinib
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, diclofenac, naproxen, celecoxib)
  • pentoxifylline
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • potassium-containing products
  • potassium-sparing diuretics (e.g., spironolactone, eplerenone)
  • prazosin
  • progesterone
  • quinidine
  • quinine
  • rifampin
  • rituximab
  • St. John's wort
  • sunitinib
  • tacrolimus
  • tenofovir
  • tamoxifen
  • tipranavir
  • trazodone
  • vinblastine
  • yohimbine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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