Patient Medication Information: uses, side effects, how to take - Riva-Candesartan (Laboratoire Riva, PM 00083756)
Serious Warnings and Precautions
RIVA-CANDESARTAN should not be used during pregnancy. Taking RIVA-CANDESARTAN during pregnancy can cause injury or even death to your baby. If you/your child discover that you/they are pregnant while taking RIVA-CANDESARTAN, stop the medication and contact your/their healthcare professional as soon as possible.
What is RIVA-CANDESARTAN used for?
RIVA-CANDESARTAN is used to treat:
mild to moderate high blood pressure in children (6 to 17 years of age) and adults. It may be used alone or in combination with diuretics (water pills).
- heart failure in adults. It may be used alone or with medicines called angiotensin-converting enzyme (ACE) inhibitors.
How does RIVA-CANDESARTAN work?
RIVA-CANDESARTAN is an angiotensin receptor blocker (ARB) that helps relax blood vessels. This makes it easier for your heart to pump blood around your body. You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
This medicine does not cure your/your child’s disease. It helps to control it. Therefore, it is important to continue taking RIVA-CANDESARTAN regularly even if you/your child feel fine.
What are the ingredients in RIVA-CANDESARTAN?
Medicinal ingredient: Candesartan cilexetil.
Non-medicinal ingredients: Carmellose calcium, ferric oxide red (8 mg, 16 mg & 32 mg tablets), hydroxypropyl cellulose, lactose monohydrate, magnesium aluminometasilicate type 1A, magnesium stearate, propylene glycol.
RIVA-CANDESARTAN comes in the following dosage forms:
Tablets: 4 mg, 8 mg, 16 mg and 32 mg.
Do not use RIVA-CANDESARTAN if:
- You/your child are allergic to candesartan cilexetil or to any non-medicinal ingredient in RIVA-CANDESARTAN.
- You/your child have experienced an allergic reaction (angioedema) with swelling of the hands, feet, or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing, to any ARB. Be sure to tell your healthcare professional that this has happened to you/your child.
You/your child are already taking a blood pressure-lowering medicine that contains aliskiren (such as
- Rasilez) and you/your child have diabetes or kidney disease.
- You/your child are pregnant or intend to become pregnant. Taking RIVA-CANDESARTAN during pregnancy can cause injury and even death to your baby.
- You/your child are breastfeeding. It is possible that RIVA-CANDESARTAN passes into breast milk.
- Your child is less than 1 year old
You/your child have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
because lactose is a non-medicinal ingredient in RIVA-CANDESARTAN.
To help avoid side effects and ensure proper use, talk to your/your child’s healthcare professional before you/your child take RIVA-CANDESARTAN. Talk about any health conditions or problems you/your child may have, including if you/your child:
- have experienced an allergic reaction to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors.
- have or have had heart problems such as heart attack, heart failure and narrowing of an artery or a heart valve.
- have had a stroke.
- have heart failure.
- have diabetes.
- have kidney or liver problems.
- are on dialysis.
- are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
- are taking a salt substitute that contains potassium, potassium supplements, or a potassium- sparing diuretic (a specific kind of “water pill” that makes your body keep potassium) or other drugs that may increase potassium levels such as heparin and co-trimoxazole.
- are on a low-salt diet.
- are taking an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in “-PRIL”.
- are taking an ACE inhibitor together with a medicine which belongs to the class of medicines known as mineralocorticoid receptor antagonists (for example, spironolactone, eplerenone). These medicines are for the treatment of heart failure.
Other warnings you should know about:
Use of anesthesia: If you/your child are about to have a surgery or dental procedure with anesthesia, be sure to tell your/your child’s healthcare professional that you/your child are taking RIVA-CANDESARTAN.
Driving and using machines: Before you/your child perform tasks which may require special attention, wait until you/your child know how you/they respond to RIVA-CANDESARTAN. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.
Monitoring: During your/your child’s treatment with RIVA-CANDESARTAN, your/your child’s healthcare professional may monitor:
- Your/your child’s kidney function.
- You/your child’s blood pressure.
- The amount of electrolytes in your/your child’s blood (such as potassium). Blood Tests: RIVA-CANDESARTAN can cause abnormal blood test results. Your/your child’s healthcare professional will decide when to perform blood tests and will interpret the results.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Do not use RIVA-CANDESARTAN if you/your child take:
- medicines that contain aliskiren that are used to lower blood pressure and you/your child have diabetes or kidney disease.
The following may interact with RIVA-CANDESARTAN:
- Medicines that increase the potassium in the blood, such as a salt substitute that contains potassium, potassium supplements, potassium-sparing diuretic (a specific kind of “water pill”), or other drugs that may increase potassium levels such as heparin and co-trimoxazole.
- Lithium, used to treat bipolar disease.
- Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, and celecoxib, used to reduce pain and swelling.
- Blood pressure-lowering medicines, including diuretics (“water pills”) or angiotensin converting enzyme (ACE) inhibitors.
- Mineralocorticoid receptor antagonists such as spironolactone and eplerenone, and ACE inhibitors used to treat blood pressure and heart failure.
How to take RIVA-CANDESARTAN:
Take/give RIVA-CANDESARTAN exactly as your/your child’s healthcare professional has told you.
Check with your/your child’s healthcare professional if you are not sure.
It is recommended that the dose is taken at about the same time every day. Take/give RIVA-
CANDESARTAN once a day.
- If you/your child take diuretics (i.e., “water pills”), your/your child’s healthcare professional may ask you/your child to temporarily stop taking them 2 or 3 days before you/your child start your/their treatment with RIVA-CANDESARTAN. They may also reduce their dose during your/your child’s treatment. Furthermore, your/your child’s healthcare professional may also prescribe you/your child other medications depending on your/your child’s condition. Follow their instructions carefully.
Usual dose:
Adults and children (6 to 17 years of age):
Your/your child’s healthcare professional will decide on the best dose of RIVA-CANDESARTAN for you/your child and how long you/your child will take it. Your/your child’s dose will depend on:
- Other medication you/your child take
- The severity of your/your child's condition
- The health of your/your child’s kidney and liver
- How you/your child respond to treatment
Your/your child’s healthcare professional will monitor your/your child’s health throughout your/your child’s treatment and may increase or decrease your/their dose as needed.
Overdose:
If you think you, or a person you are caring for, have taken too much RIVA-CANDESARTAN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you/your child miss a dose of RIVA-CANDESARTAN and remember within 12 hours, you/your child should take your/their usual dose as soon as possible. Then go back to your/your child’s regular schedule. But if it is more than 12 hours when you/your child remember, do not take/give the missed dose. Just take/give the next dose on time. Do not take/give a double dose.
What are possible side effects from using RIVA-CANDESARTAN?
These are not all the possible side effects you/your child may have when taking RIVA-CANDESARTAN. If you/your child experience any side effects not listed here, tell your/your child’s healthcare professional.
Side effects may include:
- Dizziness, falls
- Drowsiness, difficulty falling asleep or staying asleep (insomnia)
- Rash
- Diarrhea, vomiting, nausea, constipation
- Headache
- Back or leg pain, muscle cramps
- Cough
- Sore throat
- Dry mouth
- Cold symptoms
- Infection in the lungs (pneumonia)
- Fainting spells
- Confusion
- Fatigue, lack of energy
- Pain or swelling of the hands, arms, legs or feet
Side effects in adults and children are similar, but may occur more often in children.
Serious side effects and what to do about them
Frequency/Side Effect/Symptom
Talk to your healthcare professional
Stop taking this drug and get immediate medical help
Only if severe In all cases
COMMON
Fast, slow or irregular heartbeat
| ✓ | |||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | ✓ | ||
| Increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | ✓ |
Serious side effects and what to do about them
Frequency/Side Effect/Symptom
Talk to your healthcare professional
Stop taking this drug and get immediate medical help
Only if severe In all cases
| UNCOMMON | |||
|---|---|---|---|
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✓ | ||
| Hematuria (blood in urine) | ✓ | ||
| Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue | ✓ | ||
| Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✓ | ||
| Shortness of breath, difficulty breathing (dyspnea, pulmonary edema) | ✓ | ||
| RARE | |||
| Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | ✓ | ||
| VERY RARE | |||
| Decreased Platelets: bruising, bleeding, fatigue and weakness | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, shortness of breath, weakness | ✓ | ||
| Chest Pain | ✓ | ||
| Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu-like symptoms | ✓ | ||
| Inflammation of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea and vomiting | ✓ | ||
| Stroke (cerebrovascular accident): face or arm weakness, abnormal speech and blurred vision, loss of consciousness | ✓ | ||
If you/your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your/your child’s daily activities, tell your/your child’s healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Do not transfer RIVA-CANDESARTAN to any other pill containers. Keep in the original package at room temperature (15°C to 30°C) and in a dry place. Do not keep RIVA-CANDESARTAN in the bathroom. • Do not keep or use RIVA-CANDESARTAN after the expiry date indicated on the package. Return any unused medicines, which you know you will no longer need, to your pharmacy for disposal.
Keep out of reach and sight of children.
If you want more information about RIVA-CANDESARTAN:
- Talk to your healthcare professional.
Find the full Product Monograph that is prepared for healthcare professionals and includes the
Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.labriva.com; or by calling 1-800-363-7988.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com