Pendo-Ibuprofen: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Since everyone’s pain is different, PENDO-IBUPROFEN/ PENDO-IBUPROFEN ES offers 2 levels of pain relief to suit your needs. So you can choose your relief, PENDO-IBUPROFEN/ PENDO-IBUPROFEN ES products are available in two strengths, including PENDO-IBUPROFEN (200 mg) and PENDO-IBUPROFEN ES (400 mg).

PENDO-IBUPROFEN/ PENDO-IBUPROFEN ES 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

PENDO-IBUPROFEN/ PENDO-IBUPROFEN ES are also an effective fever reducer 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:

PENDO-IBUPROFEN/ PENDO-IBUPROFEN ES 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:

PENDO-IBUPROFEN/ PENDO-IBUPROFEN ES 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 nonmedicinal 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:

PENDO-IBUPROFEN 200 mg tablets are available as red - brown, round , biconvex, coated tablets debossed with “ 200" and “ IBU” on one side and nothing on the other side.

PENDO-IBUPROFEN 200 mg caplets are available as are available as red - brown, round, biconvex, coated caplets debossed with “ 200" and “ IBU” on one side and nothing on the other side .

PENDO-IBUPROFEN 200 mg tablets and caplets contain ibuprofen 200 mg

PENDO-IBUPROFEN ES 400 mg tablets are available as red- brown, capsule- shaped, coated tablet, debossed with “ IBU 400" on one side and nothing on the other side .

PENDO-IBUPROFEN ES 400 mg contains ibuprofen 400 mg

What the important nonmedicinal ingredients are:

PENDO-IBUPROFEN 200 mg tablets and caplets contain the following non-medicinal ingredients in alphabetical order: Colloidal silicon dioxide, Hypromellose, Iron Oxide Red, Lactose, Povidone, Pregelatinised Starch, Sodium Starch Glycolate, Starch, Stearic Acid; Titanium Dioxide and Triacetin.

PENDO-IBUPROFEN ES 400 mg contains the following non-medicinal ingredients in alphabetical order: Colloidal Silicon dioxide, Hypromellose, Iron Oxide Red, Lactose, Povidone, Pregelatinised Starch, Sodium Starch Glycolate, Starch, Stearic Acid, Titanium Dioxide and Triacetin.

What dosage forms it comes in:

Tablets: 200 mg, 400mg

Caplets: 200 mg

WARNINGS AND PRECAUTIONS

BEFORE you use PENDO-IBUPROFEN/ PENDO-IBUPROFEN ES 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 PENDO-IBUPROFEN/ PENDO-IBUPROFEN ES 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 Adult Dose:

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

Children’s ibuprofen formulations are available to treat children under 12 year of age.

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. PENDO-IBUPROFEN/ PENDO-IBUPROFEN ES 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.

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

• more than recommended number of tablets, caplets 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 Center at once.

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 PENDO-IBUPROFEN/ PENDO-IBUPROFEN ES, 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.

HOW TO STORE IT

Tablets and caplets: Store away from heat and direct light at controlled room temperature (15°C - 30°C).

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safely, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

By toll- free telephone: 866-234-2345 By toll-free fax: 866-678-6789 Online: www.healthcanada.gc.ca/medeffect By email: Canada Vigilance@ hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office

Marketed Health Products Safety Evaluation and Effectiveness Information Bureau

Marketed Health Products Directorate

Health Products and Food Branch

Health Canada

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

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

Note: Should you require information related to the management of side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Pendopharm, division of Pharmascience Inc., at:

1-888-550-6060

Last revised: October 23, 2008.