Patient Medication Information: uses, side effects, how to take - Pediapharm Naproxen Suspension
Serious warnings and precautions box
Heart and blood vessel problems:
- PEDIAPHARM NAPROXEN SUSPENSION can cause heart and blood vessel problems like heart attacks, stroke, blood clots, high blood pressure and heart failure. These can lead to death.
- The risk of having heart problems is higher if you take PEDIAPHARM NAPROXEN SUSPENSION for long periods of time and/or at higher doses and/or in people who have heart disease.
- Tell your healthcare professional if you have or had heart problems, high blood pressure or diabetes.
Stomach and intestine (gastrointestinal) problems:
- PEDIAPHARM NAPROXEN SUSPENSION can cause stomach and intestine problems like ulcers, inflammation, bleeding, holes/perforation, blockage or pain.
Talk to your healthcare professional about any medical conditions you have and drugs you are taking.
Pregnancy:
- DO NOT take PEDIAPHARM NAPROXEN SUSPENSION if you are pregnant and in a later stage of pregnancy (28 weeks or later).
- If you are pregnant and in an earlier stage of pregnancy (less than 28 weeks) only take PEDIAPHARM NAPROXEN SUSPENSION if you are told to do so by your healthcare professional.
- Medicines like PEDIAPHARM NAPROXEN SUSPENSION may cause harm to you and your baby. Your healthcare professional will need to closely monitor your health and that of your baby (including your amniotic fluid levels) if they prescribe PEDIAPHARM NAPROXEN SUSPENSION during this time.
- Tell your healthcare professional right away if you become pregnant, think you may be pregnant or want to get pregnant during your treatment with PEDIAPHARM NAPROXEN SUSPENSION.
What PEDIAPHARM NAPROXEN SUSPENSION is used for:
Your healthcare professional has prescribed PEDIAPHARM NAPROXEN SUSPENSION for you for one or more of the following medical conditions:
Treat the signs and symptoms of arthritis disorders such as:
- osteoarthritis
- rheumatoid arthritis
- ankylosing spondylitis
- juvenile rheumatoid arthritis
Help relieve:
- minor aches and pains in muscles, bones and joints
- mild to moderate pain with inflammation in sprains and strains and period cramps (primary dysmenorrhea)
How PEDIAPHARM NAPROXEN SUSPENSION works:
- PEDIAPHARM NAPROXEN SUSPENSION (naproxen) belongs to a group of medicines called non-steroidal anti-inflammatory drug (NSAIDs). It can reduce the chemicals produced by your body which cause pain and swelling.
- PEDIAPHARM NAPROXEN SUSPENSION only treats the symptoms and relieves pain and inflammation as long as you take it. PEDIAPHARM NAPROXEN SUSPENSION does not cure the illness or stop it from getting worse.
The ingredients in PEDIAPHARM NAPROXEN SUSPENSION are:
Medicinal ingredient: naproxen
Non-medicinal ingredients: FD&C Yellow No. 6, fumaric acid, imitation orange flavour, imitation pineapple flavour, magnesium aluminum silicate, methylparaben, sodium chloride, sorbitol solution 70%, sucrose.
PEDIAPHARM NAPROXEN SUSPENSION comes in the following dosage form:
Suspension: 25 mg/mL
Do not use PEDIAPHARM NAPROXEN SUSPENSION if you:
- have heart bypass surgery (planning to have or recently had).
- have severe, uncontrolled heart failure.
- are bleeding in the brain or have other bleeding disorders.
- are pregnant and in a later stage of pregnancy (28 weeks or later).
- are currently breastfeeding (or planning to breastfeed).
- are allergic to naproxen or any of the other ingredients in this medicine or the container.
- 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.
- have active stomach or intestine ulcers.
- have active bleeding from the stomach or gut.
- have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis).
- have liver disease (active or severe).
- have kidney disease (severe or worsening).
- have high potassium in the blood.
Patients who took a drug in the same class as PEDIAPHARM NAPROXEN SUSPENSION after a type of heart surgery (coronary artery bypass grafting (CABG)) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lung(s), and infections or other complications than those who did NOT take that drug.
PEDIAPHARM NAPROXEN SUSPENSION should NOT be used in patients under 2 years of age since the safety and effectiveness have NOT been established.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PEDIAPHARM NAPROXEN SUSPENSION. Talk about any health conditions or problems you may have, including if you:
- have high blood pressure, high cholesterol or diabetes
- have or had heart attacks, chest pain, heart disease, stroke or heart failure
- are on a low sugar diet
- have atherosclerosis (hardening of the arteries)
- 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, urine problems or are dehydrated
- have a history of ulcer or bleeding from the stomach or gut (small or large intestine)
- have previous bleeding in the brain
- have other bleeding or blood problems
- have 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 family history of asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or hives
- are pregnant, planning on becoming or become pregnant while taking PEDIAPHARM NAPROXEN SUSPENSION
- have immune system problems
Other warnings you should know about:
Tell any doctor, dentist, pharmacist or healthcare professional that you see that you are taking this medicine. This is especially important if you are planning to have heart surgery.
Do NOT drink alcoholic beverages while taking PEDIAPHARM NAPROXEN SUSPENSION as you will be more likely to develop stomach problems.
Serious Side Effects: PEDIAPHARM NAPROXEN SUSPENSION can cause serious side effects, including:
Blood and Bleeding Problems:
- PEDIAPHARM NAPROXEN SUSPENSION can cause blood problems, bleeding problems and prolonged bleeding.
Taking PEDIAPHARM NAPROXEN SUSPENSION with the following drugs can increase the risk of bleeding:
- Anticoagulants (prevent blood clots), corticosteroids (anti-inflammatory) or antidepressants like selective serotonin reuptake inhibitors (SSRIs).
Serious Skin Reactions:
- In rare cases, serious or life-threatening allergic skin reactions have been reported with the use of PEDIAPHARM NAPROXEN SUSPENSION and other NSAIDs. These skin problems most often happen during the first month of treatment. Tell your healthcare professional immediately if you develop chills, fever, muscle aches or pains, or other flu-like symptoms, especially if they occur with a skin rash. These symptoms may be the first signs of a serious allergic reaction to this medication.
- PEDIAPHARM NAPROXEN SUSPENSION might cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have a reaction from the sun, talk to your healthcare professional.
Check-ups and Testing: You will have regular visits with your healthcare professional during treatment with PEDIAPHARM NAPROXEN SUSPENSION to monitor your health. They will:
- Check your blood pressure.
- Check your eyes. PEDIAPHARM NAPROXEN SUSPENSION can cause blurred or reduced vision.
- Do blood and urine tests to check your liver, kidney and blood health.
Driving and Using Machines: PEDIAPHARM NAPROXEN SUSPENSION 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 or light-headed after taking PEDIAPHARM NAPROXEN SUSPENSION, do NOT drive or operate machinery.
Fertility in Women: PEDIAPHARM NAPROXEN SUSPENSION 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 PEDIAPHARM NAPROXEN SUSPENSION. Talk to your healthcare professional if you have questions about this.
Adults (65 years or older): Side effects like gastrointestinal problems may happen more often. Your healthcare professional might have you start with a lower dose of PEDIAPHARM NAPROXEN SUSPENSION. 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 PEDIAPHARM NAPROXEN SUSPENSION:
- Acetylsalicylic Acid (ASA) or other NSAIDs, used to treat pain, fever and inflammation, like celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen
- Antacids, used to treat symptoms of excess stomach acid
- Medicines used to treat depression (antidepressants) like citalopram, fluoxetine, paroxetine, sertraline, and lithium
Medicines used to treat high blood pressure like:
- ACE (angiotensin converting enzyme) inhibitors (e.g. enalapril, ramipril, lisinopril, perindopril, propranolol)
- ARBs (angiotensin II receptor blockers) (e.g. candesartan, irbesartan, losartan, valsartan)
- Medicines used as blood thinners or to prevent blood clots, like warfarin, ASA, clopidogrel
- Medicines used to lower extra fluid levels (diuretics), like furosemide, hydrochlorothiazide
- Medicines used to lower the risk of organ rejection, like tacrolimus and cyclosporin
- Medicines used to treat diabetes, like sulphonylurea or other oral hypoglycemics
- Medicines used to treat bacteria infections (antibiotics) like quinolone or sulphonamide
- Corticosteroids (including glucocorticoids such as prednisone) used as an anti-inflammatory
- Cholestyramine, used to lower cholesterol levels
- Digoxin, used to treat heart disorders
- Hydantoin, used to treat seizures
- Medicines used to treat different cancers, like methotrexate and pemetrexed
- Oral birth control, used to prevent pregnancy
- Probenecid, used to prevent gout
- Alcohol
Your healthcare professional may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you are taking PEDIAPHARM NAPROXEN SUSPENSION. Take only the amount of ASA prescribed by your healthcare professional. You are more likely to upset or damage your stomach if you take both PEDIAPHARM NAPROXEN SUSPENSION and ASA than if you took PEDIAPHARM NAPROXEN SUSPENSION alone.
How to take PEDIAPHARM NAPROXEN SUSPENSION:
- PEDIAPHARM NAPROXEN SUSPENSION is intended for use in patients older than 2 years of age for the shortest possible duration. Do NOT use in patients under 2 years of age since safety and effectiveness have NOT been established.
- Take PEDIAPHARM NAPROXEN SUSPENSION only as directed by your healthcare professional. 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. If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much PEDIAPHARM NAPROXEN SUSPENSION may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.
- If you will be using PEDIAPHARM NAPROXEN SUSPENSION for more than 7 days, see your healthcare professional regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects.
- 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.
Usual dose:
18 years or older:
| Indication | Starting Dose | Dose Frequency | |||||
|---|---|---|---|---|---|---|---|
| Indication | Starting Dose | Dose Frequency | |||||
| Osteoarthritis/ Rheumatoid Arthritis/ Ankylosing Spondylitis | 10 mL | Twice a day | |||||
| Pain relief for minor aches and pains in muscles, bones and joints/Relief of pain and inflammation in sprains and strains | 15 mL | Twice a day | |||||
| OR | |||||||
| 10 mL | Three times a day | ||||||
| Painful menstruation | First dose only: 20 mL Following dose(s): 10 mL | Once Every 6-8 hours, as needed | |||||
| OR | |||||||
| 20 mL | Twice a day | ||||||
| Do not increase the starting dose unless directed by your healthcare professional. | |||||||
Juvenile Rheumatoid Arthritis (2-16 years):
The recommended total daily dose in children aged 2 and up is approximately 5 mg/kg, every 12 hours. See the following dosing guide:
| Child’s weight | Dose (25 mg per mL) | Dose Frequency | ||
|---|---|---|---|---|
| 13 kg (29 lbs.) | 2.6 mL | Twice a day (12 hours apart) | ||
| 15 kg (33 lbs.) | 3 mL | |||
| 20 kg (44 lbs.) | 4 mL | |||
| 25 kg (55 lbs.) | 5 mL | |||
| 30 kg (66 lbs.) | 6 mL | |||
| 40 kg (88 lbs.) | 8 mL | |||
| 50 kg (110 lbs.) | 10 mL | |||
Overdose:
If you think you, or a person you are caring for, have taken too much PEDIAPHARM NAPROXEN SUSPENSION, 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 miss a dose of PEDIAPHARM NAPROXEN SUSPENSION take it as soon as possible. Take your next dose at the usual time.
- If it is close to the time of your next dose, skip the missed dose. Take your next dose at the usual time.
- Do not take two doses at the same time to make up for a forgotten dose.
Possible side effects from using PEDIAPHARM NAPROXEN SUSPENSION:
These are not all the possible side effects you may have when taking PEDIAPHARM NAPROXEN SUSPENSION. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- nausea, vomiting, diarrhea, constipation, stomach upset/abdominal pain, heartburn, indigestion, feeling gassy
- headache, dizziness, light-headedness
- feeling of burning/prickliness/numbing
- confusion, hard to concentrate or think, short-term memory loss, nervousness
- bruises
- skin rash
- taste disorder, thirst, dry mouth
- muscle pain
- mouth sores
- hair loss
- increased sweating
- problems with your period (women)
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 | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Common | |||
| Gastrointestinal (GI) problems (bleeding, blockage, holes, ulcers or inflammation in your GI tract): blood in vomit, black tarry stool or bloody stool, dizziness, stomach pain, bloating, loss of appetite, weight loss, nausea, vomiting, constipation or diarrhea, chills or fever | ✓ | ||
| Hypertension (high blood pressure): fatigue, dizziness or fainting, chest pain | ✓ | ||
| Uncommon | |||
| Allergic reaction: difficulty swallowing or breathing, feeling sick to your stomach and throwing up, skin rash, hives, itching, swelling of the face, lips, tongue or throat | ✓ | ||
| Aseptic meningitis (inflammation of the protective lining of the brain that is not caused by infection): headaches, stiff neck, nausea, vomiting, fever or clouding of consciousness | ✓ | ||
| Blood problems (low white and/or red blood cell or platelet count): feeling tired or weak, pale skin, bruising or bleeding for longer than usual if you hurt yourself, fever, chills | ✓ | ||
| Congestive heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue, weakness, swelling of the ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise | ✓ | ||
| Cystitis (bladder infection): increased need to urinate, pain in the pelvis or lower back, frequent urination during the night, cloudy urine that may contain blood, burning or pain urinating | ✓ | ||
| Depression (sad mood that will not go away): difficulty sleeping or sleeping too much, changes in appetite or weight, reduced sex drive and thoughts of death or suicide | ✓ | ||
| Kidney disorder/problems (including kidney failure): nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, mental status changes (drowsiness, confusion, coma) | ✓ | ||
| Liver problems (including hepatitis, liver failure, cholestasis): yellowing of your skin or eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness | ✓ | ||
| Lung problems, asthma: increased shortness of breath, wheezing, difficulty breathing, cough or chest tightness, irregular heartbeat | ✓ | ||
| Myocardial infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat | ✓ | ||
| Stroke (bleeding or blood clot in the brain): sudden numbness, weakness or tingling of the face, arm, or leg, particularly on one side of the body, sudden headache, blurry vision, difficulty swallowing or speaking, lethargy, dizziness, fainting, vomiting, trouble understanding, trouble with walking and loss of balance | ✓ | ||
| Tinnitus (hearing problems): includes ringing, buzzing, clicking or hissing in ears, loss of hearing | ✓ | ||
| Vertigo (a sense of severe spinning dizziness, light-headedness) | ✓ | ||
| Rare | |||
| Serious skin reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, swelling of face and/or legs, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine, hives, red or dry itchy skin, purple or red spots on skin | ✓ | ||
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 not exceeding 25°C. Protect from light. Store upright.
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 PEDIAPHARM NAPROXEN SUSPENSION:
- 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 http://www.medexus.com; or by calling
1-877-633-3987.
Date of Authorization: 2025-10-27