Riva-Diclofenac: Uses, Side Effects and Dosage

Serious warnings and precautions box

Heart and blood vessel problems:

• RIVA-DICLOFENAC can cause heart and blood vessel problems that can lead to death, such as:

  • Myocardial infarction (heart attack);
  • Stroke (bleeding or blood clot in the brain);
  • Hypertension (high blood pressure); and
  • Congestive heart failure (heart does not pump blood as well as it should).
• The risk of having heart problems is higher if you take RIVA-DICLOFENAC for long periods of time and/or at higher doses and/or if you have heart disease when you start RIVA-DICLOFENAC. To minimize this risk, you should only take RIVA-DICLOFENAC for the fewest number of days per month, as needed.
• You and your healthcare professional should closely monitor your health for signs or symptoms of heart or blood vessel problems during your treatment with RIVA-DICLOFENAC.

Gastrointestinal problems: RIVA-DICLOFENAC can cause stomach and intestine problems like ulcers, inflammation, bleeding, holes/perforation, blockage or pain. This risk increases when RIVA-DICLOFENAC is taken with acetylsalicylic acid (ASA).

Pregnancy:

• DO NOT take RIVA-DICLOFENAC if you are pregnant and in a later stage of pregnancy (i.e., 28 weeks or later).
• If you are pregnant and in an earlier stage of pregnancy (i.e., less than 28 weeks) only take RIVA-DICLOFENAC if you are told to do so by your healthcare professional.
• Medicines like RIVA-DICLOFENAC may cause harm to you and your unborn baby. Your healthcare professional will need to closely monitor your health and that of your unborn baby (including your amniotic fluid levels) if they prescribe you RIVA-DICLOFENAC during this time.
• Tell your healthcare professional right away if you become pregnant, think you might be pregnant or are planning to get pregnant during your treatment with RIVA-DICLOFENAC.

What RIVA-DICLOFENAC is used for:

RIVA-DICLOFENAC is used in adults (18 years of age and older) for treatment of a migraine headache attack.

RIVA-DICLOFENAC should not be used to try to prevent or reduce the number of headaches you experience. RIVA-DICLOFENAC should not be used to treat pain other than that associated with migraine.

How RIVA-DICLOFENAC works:

RIVA-DICLOFENAC belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It can reduce the chemicals produced by your body which cause pain and swelling.

The ingredients in RIVA-DICLOFENAC are:

Medicinal ingredient: Diclofenac potassium

Non-medicinal ingredients: Aspartame (equivalent to 28 mg phenylalanine), Glyceryl dibehenate, Gum acacia, Maltitol, Maltodextrin, Peppermint oil, Potassium bicarbonate and Sodium saccharin.

RIVA-DICLOFENAC comes in the following dosage form:

Powder for oral solution: 50 mg of diclofenac potassium per sachet.

Do not use RIVA-DICLOFENAC if:

• you recently had, or are planning to have, heart bypass surgery.
• you have severe, uncontrolled heart failure.
• you have bleeding in the brain or other bleeding disorders.
• you are pregnant and in a later stage of pregnancy (i.e., 28 weeks or later).
• you are currently breastfeeding or planning to breastfeed.
• you are allergic to diclofenac potassium or to any of the other ingredients in RIVA-DICLOFENAC.
• you have a history of asthma, hives, growths in your nose, sinus swelling or symptoms of an allergic reaction after taking acetylsalicylic acid (ASA) or other NSAIDs.
• you have an active stomach or intestinal ulcer.
• you have an active bleeding from the stomach or gut.
• you have inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis).
• you have severe or active liver disease.
• you have severe or worsening kidney disease.
• you were told by a healthcare professional that you have high levels of potassium in your blood.
• you are under 18 years of age.

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

• are 65 years of age or older.
• have a condition that makes you physically weak.
• are currently taking any other medicines.
• have high blood pressure, high cholesterol or diabetes.
• have, or have had, heart attacks, chest pain, heart disease, stroke or heart failure.
• have poor blood flow to your extremities (like your hands and feet).
• smoke or used to smoke.
• drink a lot of alcohol.
• have a stomach infection.
• have liver or kidney problems, urinary problems, are dehydrated or on a salt-restricted diet.
• have a history of ulcer or bleeding from the stomach or gut (small or large intestine).
• have other bleeding or blood problems.
• ever had bleeding in the brain.
• have a family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list).
• have asthma or other breathing problems.
• are pregnant, think you might be pregnant or planning on becoming pregnant.
• have immune system problems.
• have porphyria (a rare genetic condition that affects the nervous system and skin).
• have a condition called phenylketonuria, as RIVA-DICLOFENAC contains aspartame (equivalent to 28 mg phenylalanine per sachet).

Other warnings you should know about:

RIVA-DICLOFENAC can cause serious side effects, including:

• Blood and bleeding problems:

  • RIVA-DICLOFENAC can cause blood problems (i.e., low levels of platelets, red or white blood cells), bleeding and prolonged bleeding.

  • Taking RIVA-DICLOFENAC with the following medicines can increase the risk of bleeding:

    • Anticoagulants (prevents blood clots), corticosteroids (anti-inflammatory), or antidepressants like selective serotonin reuptake inhibitors (SSRIs).
• Serious skin reactions: In rare cases, serious, life-threatening and fatal allergic and skin reactions have been reported with some NSAIDs, such as RIVA-DICLOFENAC. These skin problems most often happen during the first month of treatment. Stop taking RIVA-DICLOFENAC and tell your healthcare professional immediately if you notice any allergic reactions or changes in your skin during treatment.
• Sunlight sensitivity: RIVA-DICLOFENAC might cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, rash, redness, itching or discolouration, or changes to your vision such as light sensitivity. If you have a reaction from the sun, talk to your healthcare professional.

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

Overuse of RIVA-DICLOFENAC: As with other migraine treatments, repeated use of RIVA-DICLOFENAC can cause daily headaches or make your migraine headaches worse. Ask your healthcare professional if you think this is the case for you. You may need to stop using RIVA-DICLOFENAC to correct the problem.

Check-ups and testing: You will have regular visits with your healthcare professional during treatment with RIVA-DICLOFENAC. They will:

• Check your blood pressure.
• Check your eyes. RIVA-DICLOFENAC can cause blurred or reduced vision.
• Do blood and urine tests to check your liver, kidney and blood health.

Surgery: Tell any doctor, dentist, pharmacist or healthcare professional that you see, that you are taking this medicine. This is especially important if you will be having heart surgery.

Driving and using machinery: RIVA-DICLOFENAC may cause eye or nervous system problems. This includes tiredness, trouble sleeping, blurred vision, spinning or dizziness (vertigo), hearing problems or depression. Be careful about driving or doing activities that require you to be alert. If you become drowsy, dizzy, light-headed or have blurred vision after taking RIVA-DICLOFENAC, do NOT drive or operate machinery.

Fertility in women: RIVA-DICLOFENAC may affect your fertility. This means that it may be difficult for you to have a child. If you have trouble having a child, you might need to stop taking RIVA-DICLOFENAC. Talk to your healthcare professional if you have any questions about this.

Adults (65 years of age or older): Side effects like gastrointestinal problems may happen more often. Your healthcare professional might have you start with a lower dose of RIVA-DICLOFENAC. They will monitor your health during and after treatment.

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-DICLOFENAC:

• other medicines containing diclofenac. Do NOT take these medicines when you take RIVA-DICLOFENAC.
• acetylsalicylic acid (ASA) or other NSAIDs, used to treat pain, fever and inflammation, like celecoxib, ibuprofen, naproxen, indomethacin, ketorolac, meloxicam.
• medicines known as “strong CYP2C9 inhibitors” like sulfinpyrazone, voriconazole.
• medicines used as blood thinners or to prevent blood clots like warfarin, ASA, clopidogrel.
• medicines used to treat high blood pressure like enalapril, ramipril, candesartan, irbesartan, propranolol, lisinopril, metoprolol, losartan, valsartan, perindopril.
• medicines used to lower the risk of organ rejection like tacrolimus and cyclosporine.
• medicines used to treat depression like citalopram, fluoxetine, paroxetine, sertraline.
• medicines used to move extra fluid and salt out of your body (also known as diuretics).
• corticosteroids (including glucocorticoids such as prednisone), used to treat inflammation and overactive immune system responses.
• certain antibiotics, used to treat bacterial infection, like ciprofloxacin, levofloxacin and moxifloxacin.
• oral hypoglycemics, used to treat diabetes.
• lithium, used to treat manic episodes in bipolar disorder.
• methotrexate, used to treat inflammation caused by arthritis.
• phenytoin, used to treat seizures.
• probenecid, used to treat gout.
• acetaminophen, used to treat fever and pain. Do NOT take this medicine when you take RIVA-DICLOFENAC.
• digoxin, used to treat heart disorders.
• alcohol.

How to take RIVA-DICLOFENAC:

• Take RIVA-DICLOFENAC exactly as your healthcare professional has told you.
• Do NOT take more of it, do NOT take it more often and do NOT take it for a longer period of time than your healthcare professional recommended.
• Take RIVA-DICLOFENAC for the fewest number of days per month. This is to avoid potential side effects that may affect your heart, blood vessels, stomach or intestines. Your risk of experiencing these side effects may increase if you are elderly, have other diseases or take other medications.
• This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.

Directions for use:

• Open individual dose sachet only when ready to use.
• Empty the contents of one individual dose sachet into 30 to 60 mL (1 to 2 ounces) of water.
• Do not use liquids other than water.
• Mix to ensure that the powder is completely dissolved.
• Drink the water-powder mixture immediately after mixing.

• Taking RIVA-DICLOFENAC with a meal may delay pain relief. However, food may reduce possible stomach and intestinal side effects.

Usual dose:

Adult dosage: One sachet at any time during a migraine attack.

Overdose:

If you think you, or a person you are caring for, have taken too much RIVA-DICLOFENAC, 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.

Possible side effects from using RIVA-DICLOFENAC:

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

Side effects with RIVA-DICLOFENAC may include:

• Abdominal pain, nausea, vomiting, constipation, indigestion, heartburn, belching, feeling gassy or bloated
• Skin sensitivity to light, bruising, itchy skin, purple discoloured spots on the skin, hives, skin rash, redness of the skin
• Headache
• Migraine
• Difficulty sleeping
• “Pins and needles” sensation on the skin
• Feeling restless, irritable, nervous or agitated
• Muscle pain
• Hair loss
• Excessive sweating
• Lack of energy or feeling weak

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 (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:

• Store at room temperature 15 – 30°C.
• Do NOT keep outdated medicine or medicine no longer needed. Any outdated or unused medicine should be returned to your pharmacist.
• Keep out of reach and sight of children.

If you want more information about RIVA-DICLOFENAC:

• 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

Date of Authorization: 2026-04-28