Details for: APO-IBUPROFEN TAB 600MG
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00585114 | APO-IBUPROFEN TAB 600MG | IBUPROFEN | 600 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Your health care provider has prescribed APO-IBUPROFEN for you for one or more of the following medical conditions:
APO-IBUPROFEN is indicated for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
High doses (2400 mg/day) of ibuprofen may increase the risk of serious heart and blood vessel side effects. Patients with an increased risk of heart and blood vessel disease should talk to their health care
What it does
APO-IBUPROFEN is a non-steroidal antiinflammatory drug (NSAID) which can reduce the production of substances, called prostaglandins, which are involved in the development of pain and inflammation, APO-IBUPROFEN does not cure your illness or prevent it from getting worse, it can only relieve the pain and reduce swelling as long as you continue to take it.
When it should not be used
DO NOT TAKE APO-IBUPROFEN if you have any of the following medical conditions:
- Heart bypass surgery (planning to have or recently had)
- Severe, uncontrolled heart failure
- Bleeding in the brain or other bleeding disorders
- Current pregnancy (after 28 weeks of pregnancy)
- Currently breastfeeding (or planning to breastfeed)
- Allergy to ASA (Acetylsalicylic Acid) or other NSAIDs (Nonsteroidal Anti- Inflammatory Drugs)
- Ulcer (active)
- Bleeding from the stomach or gut (active)
- Inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
- Liver disease (active or severe)
- Kidney disease (severe or worsening)
- High potassium in the blood
APO-IBUPROFEN should not be used if you:
- are allergic to any ingredient in the formulation (see nonmedicinal ingredients below). Allergic reactions may appear as hives, difficulty breathing, rash, swelling of the face or throat or sudden collapse.
- have had asthma, hives or any allergic-type reactions after taking ASA or other NSAIDs (complete or partial syndrome of ASA intolerance).
- have systemic lupus erythematosus.
Patients who took a drug in the same class as APO-IBUPROFEN 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.
APO-IBUPROFEN should NOT be used in patients
under
12 years of age since the safety and effectiveness
have NOT been established.
What the medicinal ingredient is
ibuprofen
What the non-medicinal ingredients are
colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, FD&C yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.
What dosage form it comes in
Tablets: 600 mg
Warnings and precautions
If you have, or previously had, any of the following medical conditions, see your health care provider to discuss treatment options other than APO-IBUPROFEN:
- Heart Attack or Angina (chest pain)
- Stroke or Mini-stroke
- Loss of Vision
- Current Pregnancy (less than 28 weeks)
- Congestive Heart Failure
- Gastrointestinal conditions such as ulcers, stomach bleeding, blockages
- Kidney problems leading to high blood pressure
Ibuprofen, mostly at higher doses (2400 mg/day) can increase the risk of serious heart and blood vessel side effects. This risk may be higher with longer periods of use. Patients with risk factors for (high blood pressure, high cholesterol, diabetes, smokers), or who have, heart or blood vessel disease should talk to their health care provider about other treatment options.
Before taking APO-IBUPROFEN, tell your health care provider if you have any of the following:
- High blood pressure
- High cholesterol
- Diabetes mellitus or on a low sugar diet
- Atherosclerosis (hardening of the arteries)
- Poor circulation to your extremities
- Blood-clotting disorder (e.g. hemophilia, sickle cell anemia, etc.)
- Hyperkalemia (high levels of potassium in your blood)
- Kidney disease or urine problems (bladder pain, any change in the amount and colour of urine)
- Liver disease, alcoholism, systemic lupus erythematous, or any other serious disease or condition
- Previous ulcer or bleeding from the stomach or gut
- Previous bleeding in the brain
- Bleeding problems (dark urine, easy bruising, bloody or black tarry stools)
- Heart disease
- Family history of asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or hives
- 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)
- You are taking an anticoagulant (blood thinning medication), oral corticosteroid (used to treat joint pain and swelling) or any other drug
- You are taking low dose ASA
- You are dehydrated (severe fluid loss)
- You are smoker or ex-smoker
- You are over 65 years of age
- You are over 65 years of age
They may recommend an alternative analgesic such as acetaminophen.
Before taking APO-IBUPROFEN, tell your health care provider if you are planning to get pregnant.
While taking APO-IBUPROFEN:
- tell any other doctor, dentist, pharmacist or other health care professional that you see, that you are taking this medication, especially if you are planning to have heart surgery;
- do NOT drink alcoholic beverages while taking APO-IBUPROFEN because you would be more likely to develop stomach problems;
- Fertility may be decreased. The use of NovoProfen is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping APO-IBUPROFEN should be considered.
Interactions with this medication
Talk to your health care provider and pharmacist if you are taking any other medication (prescription or non-prescription) such as any of the following (NOT a complete list):
- Acetylsalicylic Acid (ASA) or other NSAIDs
- e.g. ASA, celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen
- Antacids
- Antidepressants
- Selective Serotonin Reuptake Inhibitors(SSRIs)
- e.g. citalopram, fluoxetine, paroxetine, sertraline
- Selective Serotonin Reuptake Inhibitors(SSRIs)
- Blood pressure medications
- ACE (angiotensin converting enzyme) inhibitors
- e.g. enalapril, lisinopril, perindopril, ramipril
- ARBs (angiotensin II receptor blockers)
- e.g. candesartan, irbesartan, losartan, valsartan
- ACE (angiotensin converting enzyme) inhibitors
- Blood thinners
- e.g. warfarin, ASA, clopidogrel
- Corticosteroids (including glucocorticoids)
- e.g. prednisone
- Cyclosporin
- Digoxin
- Diuretics
- e.g. furosemide, hydrochlorothiazide
- Lithium
- Methotrexate
- Oral contraceptives
- Oral hypoglycemics (diabetes medications)
- Tacrolimus
- Phenytoin
Your health care provider 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 APO-IBUPROFEN. Take only the amount of ASA prescribed by your health care provider. You are more likely to upset or damage your stomach if you take both APO-IBUPROFEN and ASA than if you took APO-IBUPROFEN alone.
Proper use of this medication
Usual Adult Dose
- Starting Dose: 600 mg twice daily
- Maintenance Dosage: 600 to 1200 mg daily (1 to 2 tablets daily)
- Maximum Dosage: 1800 mg daily
Take APO-IBUPROFEN only as directed by your health care provider. 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 health care provider recommended. You should take the lowest dose of APO-IBUPROFEN for the shortest time period. Taking too much APO-IBUPROFEN 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 APO-IBUPROFEN for more than 7 days, see your health care provider 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.
APO-IBUPROFEN is NOT recommended for use in patients under 12 years of age since safety and effectiveness have NOT been established.
APO-IBUPROFEN must be taken with food.
Overdose
Missed Dose
If you miss a dose, just resume your usual schedule the following day. Do not take an extra dose.
Side effects and what to do about them
APO-IBUPROFEN may cause some side effects, especially when used for a long time or in large doses. When these side effects occur, you may require medical attention. Report all symptoms or side effects to your health care provider.
APO-IBUPROFEN may cause you to become drowsy or tired. Be careful about driving or participating in activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking Novo- Profen, do NOT drive or operate machinery.
Check with your health care provider IMMEDIATELY if you develop chills, fever, muscle aches or pains, or other flu-like symptoms, especially if they occur before or together with a skin rash. These symptoms may be the first signs of a SERIOUS ALLERGIC REACTION to this medication.
Side effects may include
- Rash, itching
- Trouble sleeping (insomnia)
- Nausea, vomiting, stomach pain and/ or cramps, heartburn, diarrhea, indigestion, constipation, bloating, gas
| Symptom / effect | Talk with your healthcare provider or pharmacist Only if severe | Talk with your healthcare provider or pharmacist In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Bloody or black tarry stools | ✔ | ||
| Allergic reactions with symptoms such as shortness of breath, wheezing, any trouble breathing, chest tightness, skin rash, hives, swelling or itching | ✔ | ||
| Blurred vision, or any vision problems | ✔ | ||
| Bleeding problems with symptoms such as any change in the amount or colour of urine (red or brown) | ✔ | ||
| Any pain or difficulty experienced while urinating | ✔ | ||
| Swelling of the feet, lower legs; weight gain | ✔ | ||
| Liver problems with symptoms such as yellow of the skin or eyes, persistent indigestion, vomiting, stomach pain, nausea | ✔ | ||
| Generally feeling unwell, fatigue, loss of appetite | ✔ | ||
| Headaches, stiff neck | ✔ | ||
| Mental confusion, depression | ✔ | ||
| Dizziness, lightheadedness | ✔ | ||
| Hearing problems | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking APO-IBUPROFEN, contact your physician or pharmacist.
How to store
Store at room temperature (15°C to 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.
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/healthcanada/services/drugs-healthproducts/medeffect-canada/adverse-reactionreporting.html)
- 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.
More information
If you want more information about APO-IBUPROFEN:
- 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 http://www.apotex.ca/products, or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Last revised: December 8, 2017