Riva-Telmisartan/Amlodipine: Uses, Side Effects and Dosage

What is RIVA-TELMISARTAN/AMLODIPINE used for?

• RIVA-TELMISARTAN/AMLODIPINE is used in adults to treat mild to moderate high blood pressure.

How does RIVA-TELMISARTAN/AMLODIPINE work?

RIVA-TELMISARTAN/AMLODIPINE contains 2 medicines, telmisartan and amlodipine. They work together to control your blood pressure:

• Telmisartan is an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
• Amlodipine is a calcium channel blocker.

This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking RIVA-TELMISARTAN/AMLODIPINE regularly even if you feel fine. Do not stop taking your medicine without talking to your healthcare professional.

What are the ingredients in RIVA-TELMISARTAN/AMLODIPINE?

Medicinal ingredients: Telmisartan and amlodipine (as amlodipine besylate)

Non-medicinal ingredients: Colloidal anhydrous silica, crospovidone, iron oxide red (E172) (40/5 mg and 80/5 mg), iron oxide yellow (E172) (40/10 mg and 80/10 mg), magnesium stearate, maize starch, mannitol, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide.

RIVA-TELMISARTAN/AMLODIPINE comes in the following dosage forms:

Tablets: 40 mg / 5 mg, 40 mg / 10 mg, 80 mg / 5 mg, 80 mg / 10 mg

Serious Warnings and Precautions

• RIVA-TELMISARTAN/AMLODIPINE should not be used during pregnancy. Taking RIVA-TELMISARTAN/AMLODIPINE during pregnancy can cause injury or even death to your baby.

• If you discover that you are pregnant while taking RIVA-TELMISARTAN/AMLODIPINE, stop the medication and talk to your healthcare professional as soon as possible.

Do not use RIVA-TELMISARTAN/AMLODIPINE if:

• you are allergic to:

  • telmisartan;
  • amlodipine;
  • medicines of the dihydropyridine type (a type of calcium channel blocker);
  • other ARBs;
  • any non-medicinal ingredient in RIVA-TELMISARTAN/AMLODIPINE (see What are the ingredients in RIVA-TELMISARTAN/AMLODIPINE?).
• you have had 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.
• you are pregnant or planning to become pregnant. Taking RIVA-TELMISARTAN/AMLODIPINE during pregnancy can cause injury and even death to your baby.
• you are breastfeeding. RIVA-TELMISARTAN/AMLODIPINE passes into breast milk.
• have been diagnosed with hereditary fructose intolerance, a rare genetic disorder where you cannot break down fructose. RIVA-TELMISARTAN/AMLODIPINE tablets contain similar types of sugar called mannitol and meglumine. RIVA-TELMISARTAN/AMLODIPINE tablets 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg contain 98.505 mg, 98.36 mg, 197.01 mg, 196.72 mg of a similar type of sugar called mannitol in each tablet respectively. RIVA-TELMISARTAN/AMLODIPINE tablets 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg contain 5.40 mg, 5.40 mg, 10.80 mg and 10.80 mg of a similar type of sugar called meglumine in each tablet respectively.
• you have severe liver problems or problems with drainage of the bile from the liver and gallbladder (biliary obstruction).

• you have a serious heart problem, such as:

  • cardiac shock, where your heart cannot pump enough blood to your brain and organs;
  • aortic stenosis, a narrowing of the aortic heart valve;
  • problems with the heart muscle (hypertrophic cardiomyopathy);
  • unstable heart failure after a heart attack.
• you are already taking a blood pressure-lowering medicine that contains aliskiren and you have diabetes or kidney disease.
• you have very low blood pressure (less than 90 mmHg systolic).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RIVA-TELMISARTAN/AMLODIPINE. Talk about any health conditions or problems you may have, including if you:

• are allergic to any medicine used to lower blood pressure including angiotensin converting enzyme (ACE) inhibitors.
• have a history of allergic reactions (angioedema).
• have a condition in which your body releases too much of the hormone aldosterone in your blood (primary aldosteronism).

• are taking any of the following:

  • other blood pressure lowering medicines, such as:

    • aliskiren.
    • an angiotensin-converting-enzyme inhibitor (ACEI).
    • beta blockers (i.e. acebutolol, atenolol, metoprolol, nadolol). Do NOT stop taking your beta-blocker without talking to your healthcare professional as this can cause serious side effects.

  • medicines used to treat bacterial or fungal infections, such as:

    • macrolides, e.g., clarithromycin.
    • azole antifungals, e.g., ketoconazole.
  • ritonavir, used to treat HIV infection

• have heart problems, such as:

  • chest pain (angina).
  • narrowing of an artery or heart valve.
  • heart or blood vessel disease.
  • heart failure.
  • recent heart attack.

• have kidney problems, such as:

  • a narrowing of the blood vessels to one or both kidneys (renal artery stenosis).
  • a kidney transplant.
  • you are on dialysis.
• have diabetes.
• have liver problems.
• are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• are on a low-salt diet.

• are at risk for developing high levels of potassium in your blood (hyperkalemia). This can be serious and can happen if you are taking:

  • a salt substitute that contains potassium.
  • potassium supplements.
  • a kind of “water pill” (potassium sparing) that makes your body hold on to potassium.
  • other medicines that may increase potassium in your blood, such as the blood thinner heparin.
• are 65 years of age or older. You may be more at risk of experiencing side effects.

Other warnings you should know about:

RIVA-TELMISARTAN/AMLODIPINE can cause serious side effects, including:

• Allergic reactions / Angioedema: Allergic reactions (angioedema) causing swelling of tissues under the skin, sometimes affecting the face and throat, have happened in people taking RIVA-TELMISARTAN/AMLODIPINE. These allergic reactions may happen at any time during treatment with RIVA-TELMISARTAN/AMLODIPINE and can be life threatening. Very rarely, cases have been fatal. If you experience an allergic reaction, stop taking RIVA-TELMISARTAN/AMLODIPINE and get immediate medical help.

• Hypotension (low blood pressure): You may feel dizzy or light-headed:

  • in the first few days after you start taking RIVA-TELMISARTAN/AMLODIPINE.
  • when your dose is increased.
  • when you exercise.
  • when the weather is hot.

You should lie down if this happens. If you faint, stop taking RIVA-TELMISARTAN/AMLODIPINE and talk to your healthcare professional.

• Blood disorders: RIVA-TELMISARTAN/AMLODIPINE, may cause:

  • neutropenia / agranulocytosis (decrease in white blood cells).
  • thrombocytopenia (low blood platelets).
  • anaemia (low red blood cells).

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Surgery: Before surgery or general anaesthesic (even at the dentist’s office), tell your healthcare professional that you are taking RIVA-TELMISARTAN/AMLODIPINE. You may experience a sudden fall in blood pressure when you are under general anesthesia.

Increased sensitivity of the skin to sun: Your skin may become sensitive to the sun while you are taking TYWNSTA. Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside. Talk to your healthcare professional if your skin gets itchy and red after being exposed to sunlight.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to RIVA-TELMISARTAN/AMLODIPINE. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

Blood tests: Your healthcare professional may do blood tests before you take RIVA-TELMISARTAN/AMLODIPINE and/or during treatment. These tests may check:

• the level of red and white blood cells and platelets in your body.
• that your liver or kidneys are working properly.
• the potassium levels in your blood.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with RIVA-TELMISARTAN/AMLODIPINE:

• medicines that increase the levels of potassium in your blood. These include:

  • salt substitutes that contain potassium.
  • potassium supplements.
  • potassium-sparing medicines.
  • heparin, used to thin the blood and prevent blood clots.

• medicines that lower your blood pressure. These include:

  • diuretics (“water pills”).
  • aliskiren-containing medicines.
  • angiotensin-converting-enzyme inhibitors (ACEI).
  • beta blockers.
  • diltiazem, a calcium channel blocker.
• antibiotics, medicines used to treat bacterial infections, such as clarithromycin, erythromycin, rifampicin, and rifampin.
• lithium, a medicine used to treat bipolar disease.

• nonsteroidal anti-inflammatory drugs (NSAIDs), medicines used to reduce pain and swelling, such as acetylsalicylic acid, ibuprofen, naproxen, and celecoxib

  Serious Drug Interactions

Do not take RIVA-TELMISARTAN/AMLODIPINE with other blood pressure lowering drugs, including diuretics (“water pills”), aliskiren-containing products, or angiotensin-converting-enzyme inhibitors (ACEI) if you have diabetes (type 1 or type 2) or serious kidney problems. When taken together with RIVA-TELMISARTAN/AMLODIPINE, they may cause very low blood pressure.

• vasodilators (including nitrates), medicines used to treat chest pain, such as nitroglycerin.
• corticosteroids, medicines used to treat inflammation, taken by mouth or injection.
• digoxin, a medicine used to treat heart problems.
• warfarin, a medicine used to thin the blood to prevent blood clots.
• medicines used to treat epilepsy, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin and primidone.
• medicines used to treat HIV/AIDS, such as ritonavir.
• medicines used to treat fungal infections, such as ketoconazole, itraconazole.
• medicines used to lower cholesterol, such as atorvastatin and simvastatin.
• sildenafil, a medicine used to treat erectile dysfunction.
• St. John’s Wort, an herbal medicine used to treat depression.
• mTOR inhibitors, medicines used to prevent organ rejection, such as sirolimus, temsirolimus, and everolimus.
• medicines that suppress the immune system, such as cyclosporine and tacrolimus.
• dantrolene, a medicine used to treat muscle spasms and back pain.
• antidepressants, medicines used to treat depression, such as imipramine.
• barbiturates, medicines used to help you sleep.
• narcotics, medicines used to relieve pain.
• alcohol.
• quinidine, flecainide, and propafenone, medicines used to treat heart rhythm problems.
• terfenadine, a medicine used to treat allergies.
• benzodiazepines, medicines used to help you sleep or that help reduce anxiety.
• theophylline, a medicine used to treat breathing problems.
• grapefruit. Do not eat grapefruit or drink grapefruit juice while on RIVA-TELMISARTAN/AMLODIPINE.

How to take RIVA-TELMISARTAN/AMLODIPINE:

• Take RIVA-TELMISARTAN/AMLODIPINE:

  • exactly as prescribed
  • at about the same time everyday, preferably in the morning
  • swallowed whole, with water

  • with or without food, but it should be taken the same way each day

• Remove your RIVA-TELMISARTAN/AMLODIPINE tablet from the blister just before you take it.

Usual dose:

Your healthcare professional will decide the best dose for you based on your needs.

Overdose:

If you think you, or a person you are caring for, have taken too much RIVA-TELMISARTAN/AMLODIPINE, 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 have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.

What are possible side effects from using RIVA-TELMISARTAN/AMLODIPINE?

These are not all the possible side effects you may have when taking RIVA-TELMISARTAN/AMLODIPINE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• dizziness, vertigo (feeling of spinning)
• drowsiness, insomnia, fatigue
• urge to urinate during the night
• rash, itching, skin discolouration, photosensitivity reaction
• increased sweating
• hair loss
• diarrhea, vomiting, constipation, nausea, upset stomach, abdominal pain, flatulence, change in bowel habits
• taste abnormalities
• swelling of the gums
• dry mouth
• headache, migraine
• anxiety, mood changes
• ringing in the ears
• back or leg pain, muscle cramps, spasms or stiffness, joint pain or swelling
• vision changes (double vision, blurred vision, etc.)
• upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), flu-like symptoms, cough, sneezing, runny nose, shortness of breath
• enlargement of breasts in men
• changes in weight (increased or decreased)
• tingling or numbness of hands and feet

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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.

Storage:

Store at 15°C to 30°C. Store in the original package in order to protect from moisture and light.

Do not use RIVA-TELMISARTAN/AMLODIPINE after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Keep out of reach and sight of children.

If you want more information about RIVA-TELMISARTAN/AMLODIPINE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada 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 the manufacturer, Laboratoire RIVA Inc., at: 1-800-363-7988.

660 Boul. Industriel

Blainville, Quebec

J7C 3V4

www.labriva.com

The information in this leaflet is current up to the time of the last revision date shown below, but more current information may be available from the manufacturer.

Last Revised: JUL 31, 2025