Regular Ibuprofen: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Since everyone’s pain is different, there are 24 levels of pain relief to suit your needs. So you can choose your relief, Ibuprofen products are available in two strengths; REGULAR IBUPROFEN 200 mg) and EXTRA STRENGTH IBUPROFEN (400 mg).

REGULAR IBUPROFEN and EXTRA STRENGTH IBUPROFEN products provide fast and effective relief of PAIN from:

• headache, including mild to moderate migraine and

  tension headache

• menstrual cramps
• toothache (dental pain), including dental extraction
• inflammation from arthritis, muscle strain, and sprains

• muscles, bones and joints, including back pain, bursitis

  and tendonitis pain

REGULAR IBUPROFEN and EXTRA STRENGTH IBUPROFEN are alson effective fever reducers and will provide relief from the aches and fever due to the common cold and flu.

Clinical studies show long lasting relief for up to 8 hours for fever and up to 6 hours for pain.

What it does:

REGULAR IBUPROFEN and EXTRA STRENTH IBUPROFEN (ibuprofen) starts to work fast and treats pain where it starts.

Ibuprofen is a member of a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).

NSAIDs work within the body by blocking the production of substances, called prostaglandins, which are involved in the development of pain and inflammation.

When it should not be used:

REGULAR IBUPROFEN and EXTRA STRENGTH IBUPROFEN should not be used if you:

• are allergic or have had a reaction to ibuprofen, acetylsalicylic acid (ASA), other non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates, or to any ingredient in the formulation (see non-medicinal ingredients below). Allergic reactions may appear as hives, difficulty breathing, rash, swelling of the face or throat or sudden collapse.
• have complete or partial syndrome of ASA intolerance.

• have active or recurrent stomach ulcer, gastrointestinal

  (GI) bleeding, or active inflammatory bowel disease (e.g. Crohn’s, colitis)

• have liver or kidney disease.
• have systemic lupus erythematosus.

• are pregnant, unless advised otherwise by a doctor.

What the medicinal ingredient is:

Ibuprofen

What the nonmedicinal ingredients are:

REGULAR IBUPROFEN (ibuprofen) 200 mg caplets contain ibuprofen 200 mg and the following non-medicinal ingredients in alphabetic order: carnauba wax, colloidal silicon dioxide, D&C yellow # 10 aluminum lake, FD&C yellow # 6 aluminum lake, hydroxypropyl methyl cellulose, magnesium staerate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.

EXTRA STRENGTH IBUPROFEN (ibuprofen) 400 mg tablets contain ibuprofen 400 mg and the following non-medicinal ingredients in alphabetic order: carnauba wax, colloidal silicon dioxide, FD&C yellow # 6 aluminum lake, hydroxypropyl methyl cellulose, magnesium staerate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.

What dosage forms it comes in:

Tablets: 200mg, , and 400mg

Caplets: 200 mg

WARNINGS AND PRECAUTIONS

• Patients with heart disease and high blood pressure should not take this drug unless directed by a physician
• Caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention.
• Caution in patients prone to gastrointestinal tract irritation, particularly those with a history of peptic ulcer, diverticulosis or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis and Crohn’s disease.
• The elderly and patients with impaired renal function, heart failure, liver dysfunction, and those taking diuretics are at increased risk of renal toxicity.
• If persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria and cystitis occur, the drug should be stopped immediately.
• Ibuprofen use during nursing should be avoided Keep this medication out of the reach of children.

BEFORE you use REGULAR IBUPROFEN and EXTRA STRENGTH IBUPROFEN talk to your doctor or pharmacist if you:

• have stomach ulcers, high blood pressure, asthma, heart

  failure, kidney or liver disease, diabetes, alcoholism, a history of stomach bleeding, systemic lupus erythematosus, or any other serious disease or condition.

• are taking an anticoagulant (blood thinning

  medication),oral corticosteroid or any other drug.

• are nursing an infant.
• are over 65 years of age.
• are taking low-dose ASA.

• suffer from asthma or have nasal polyps (a swelling inside

  the nose)

• are dehydrated (severe fluid loss)

• have a blood-clotting disorder (e.g. hemophilia, sickle cell

  anemia, etc.)

• have a heart disease

• have any unusual urinary symptoms (e.g. bladder

  problems)

• are on a special diet (e.g. low-sodium)

• suffer from hyperkalemia (high levels of potassium in your

  blood)

They may recommend an alternative analgesic such as acetaminophen.

INTERACTIONS WITH THIS MEDICATION

Always tell any doctor, dentist, or pharmacist you consult that you are taking this medicine.

Drugs that may interact with REGULAR IBUPROFEN and EXTRA STRENGTH IBUPROFEN include: acetylsalicylic acid (ASA) or other NSAIDs, blood thinning medications (anticoagulants), blood pressure medication (anti-hypertensives), diuretics (water pills), oral steroids (glucocorticoids), lithium, , diabetes medications (hypoglycemics), methotrexate, phenytoin.

PROPER USE OF THIS MEDICATION

Usual dose:

For accurate dosing of each product strength, refer to the dosage table and follow the instructions carefully.

The single oral dose may be taken every 4-6 hours as needed. Do not take more than the maximum daily dose (1200 mg in 24 hours) unless advised by a doctor. Take with food or milk if mild stomach upset occurs with use. REGULAR IBUPROFEN and EXTRA STRENGTH IBUPROFEN should not be taken for pain for more than 5 consecutive days or for fever for more than 3 days without first talking to your doctor or dentist.

Do not take this product while taking ASA, other ibuprofen containing products or any other pain or fever medicine.

For effective use of this medicine, unless recommended by your doctor or dentist, DO NOT take:

• more than the recommended number of tablets, caplets or gelcaps in each single dose
• a dose more often than every 4-6 hours
• this product longer than the recommended period of time
• more than the smallest dose that will relieve your symptoms

Overdose:

In case of accidental overdose, even if there are no symptoms, call a doctor or Poison Control Centre at once.

Missed Dose:

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip the missed dose. Do not take two doses at the same time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately: nausea, vomiting, abdominal pain or diarrhea; heartburn, bloating or constipation; fluid retention; skin rash or itching; dizziness; any change in vision; ringing or buzzing in the ears, vomiting any blood or have tarry stools, jaundice (yellowing of the eyes or skin due to liver problems).

If you experience dizziness, blurred vision, or hearing problems while taking REGULAR IBUPROFEN and

EXTRA STRENGTH IBUPROFEN, please use caution when carrying out activities requiring alertness.

Ibuprofen may cause a severe allergic reaction that could include wheezing, facial swelling, hives, shortness of breath, shock or a fast, irregular heartbeat. Any of these reactions could be serious. Stop using the product and get emergency medical help immediately.

This is not a complete list of side effects. For any unexpected effects while taking REGULAR IBUPROFEN and EXTRA STRENGTH IBUPROFEN, contact your doctor or pharmacist.

HOW TO STORE IT

Store between 15°C and 30°C. Unit dose strips should be stored between 15°C and 25 °C and protected from high humidity.

Keep Out of the Reach of Children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345

toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited

at: 1-800-268-4127 ext. 1255005 (English Canada) or druginfo@tevacanada.com

or 1-877-777-9117 (French Canada)

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: January 27, 2014