Ibuprofen (Angita Pharma): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

Ibuprofen tablets are also an effective fever reducer and will provide relief from the aches and pain 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:

Ibuprofen -tablet starts to work fast and treat pain where it starts.

Ibuprofen is a member of a class of drugs called nonsteroidal 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:

Ibuprofen Tablets should not be used if you:

• are taking acetylsalicylic acid (ASA) or any other non-steroidal anti inflammatory medication, including any other ibuprofen product.
• 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, shock, skin reddening, rash or blisters, swelling of the face or throat or sudden collapse.
• have nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life-threatening anaphylactic reactions), urticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms.
• have been diagnosed with severe high blood pressure or have severe coronary artery disease.
• are dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake.
• 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.
• right before or after heart surgery

• are in your third trimester of pregnancy

What the medicinal ingredient is:

Ibuprofen

What the important non-medicinal ingredients are:

Ibuprofen 200 mg tablets contain following non-medicinal ingredients (alphabetical order): carnauba wax, croscarmellose sodium, hypromellose, iron oxides, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide.

IMPORTANT PLEASE READ

Ibuprofen 400 mg tablets contain following non-medicinal ingredients (alphabetical order): carnauba wax, croscarmellose sodium, hypromellose, iron oxides, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide.

What dosage forms it comes in:

Tablets: 200 mg and 400 mg

Ibuprofen 200 mg tablets are available as a brown, film-coated, biconvex round shaped tablets embossed with “IBU” and “200”; and as a brown, film-coated, biconvex capsule shaped tablets embossed with “IBU” and “200”.

Ibuprofen 400 mg tablets are available as brown, film-coated, biconvex capsule shaped tablets embossed with “IBU” and “400”.

WARNINGS AND PRECAUTIONS

Keep this medication out of the reach of children.

BEFORE you use Ibuprofen tablets talk to your doctor or pharmacist if you:

• have stomach ulcers, high blood pressure, asthma, heart failure, kidney or liver disease or thyroid disease, glaucoma,, 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 in your first or second trimester of pregnancy
• are trying to conceive

• 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)
  • 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)

Long-term continuous use may increase the risk of heart attack or stroke.

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

Drugs that may interact with 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, acetaminophen and digoxin.

Do not use this product if you are taking daily low dose ASA (81-325 mg) without talking to a doctor or pharmacist. Ibuprofen may interfere with the preventative benefits of ASA.

PROPER USE OF THIS MEDICATION

Usual dose:

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

Serious Warnings and Precautions

Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer. The chance of stomach bleeding is higher if you are: age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner or steroid drug, take with other drugs containing an NSAID like ASA, ibuprofen, naproxen, or prescription anti-inflammatory drugs, have 3 or more alcoholic drinks every day while using this product.

INTERACTIONS WITH THIS MEDICATION

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. Ibuprofen Tablets 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 or 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:

Missed 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.

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 Ibuprofen Tablets, 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 Ibuprofen contact your doctor or pharmacist.

Ibuprofen should be stored at 15 to 30^oC (59 to 86°F).

In case of overdose, even if there are no symptoms, call a health care practitioner or hospital emergency department or Poison Control Centre at once.

HOW TO STORE IT

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

MORE INFORMATION

If you want more information about 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.

html); or by calling : 1-450-449-9272.

1310 rue Nobel,

Boucherville, Québec

J4B 5H3, Canada

Date of Preparation: February 26, 2020

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/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• 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