Patient Medication Information: uses, side effects, how to take - Ibuprofen 200 mg (Pendopharm Division of Pharmascience)
ABOUT THIS MEDICATION
What the medication is used for:
•Headaches
•Toothaches
•Menstrual pain
•Minor aches and pains associated with arthritis, muscles, joints and backache
•Reduction of fever
What it does:
Ibuprofen Caplets 200 mg contains Ibuprofen, a member of the class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen helps to relieve headaches, toothaches, menstrual pain, joint pain, and fever by reducing the production of certain substances (prostaglandins).
When it should not be used:
•If you have a history of stomach upset, peptic ulcers, heart, liver or kidney disease, or any other serious disease
•If you are sensitive (allergic) to ibuprofen, or any component of this medication (see, "What the important nonmedicinal ingredients are” section), or products containing acetylsalicylic acid (ASA), other salicylates or other anti-inflammatory drugs unless directed to do so by your doctor.
•If you are taking ASA, ASA-containing compounds, or other drugs to treat symptoms of arthritis.
If you are under 12 years of age, unless directed by a physician
What the medicinal ingredient is:
Ibuprofen
What the important nonmedicinal ingredients are: <alphabetical listing>
carnauba wax, colloidal silicon dioxide, corn starch, iron oxide, lactose, hydroxyproyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide, water.
What dosage forms it comes in:
Ibuprofen Caplet 200 mg
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
$ History of peptic ulcers, gastrointestinal bleeding or other diseases of the gastrointestinal tract
BEFORE you use Ibuprofen 200 mg talk to your doctor or pharmacist if:
•You have a history of stomach upset, peptic ulcers, heart, liver or kidney disease, or any other serious disease.
•You and your family has had asthma, nasal polyps, chronic sinusitis (nasal congestion) or chronic urticaria (hives) caused by ASA or other non-steroidal anti-inflammatory agents. •You are taking any other medication either prescription or non-prescription (see, “Interactions with this medication” section). •You have any other medical problems such as alcohol abuse, bleeding problems.
•You have blood or urine abnormalities, high blood pressure, diabetes, or are on any special diet such as low sodium or sugar. •You are pregnant or nursing a baby, unless directed by a physician.
If you are taking this medicine for a long time, your doctor should check your progress at regular visits in order to make sure that this medicine is not causing unwanted effects.
WHILE taking this medication:
•Tell any doctor, dentist, or pharmacist that you consult or see that you are taking this medication.
•Be cautious about driving or participating in activities that require alertness if you are drowsy, dizzy or light-headed after taking this medication.
•Check with you doctor if you are not getting any relief or if any problems develop.
•Report any untoward reaction to your doctor. This is very important as it will aid in the early detection and prevention of potential complications.
•Stomach problems may be more likely to occur if you drink alcoholic beverages. Therefore do not drink alcoholic beverages while taking this medication.
•Check with your physician if you vomit blood, have bloody stools, or experience any weakness.
•Some people may become more sensitive to sunlight than they are normally. Brief exposure to sunlight or sunlamps may cause sunburn, blisters on the skin, skin rash, redness, itching or discolouration or vision changes. If this happens, check with your doctor.
•Check with your doctor immediately if chills, fever, muscle aches or pains, or other flu-like symptoms occur, especially if they occur shortly before or together with a skin rash. Very rarely, these effects
may be the first sign of a serious reaction to the medication.
INTERACTIONS WITH THIS MEDICATION
IMPORTANT: PLEASE READ
Ibuprofen 200 mg
Page 35 of 36 Drugs that may interact with Ibuprofen include:
- Acetylsalicylic acid (ASA) or other NSAIDs •Acetaminophen
•Digoxin
•High blood pressure medication
•Blood thinners (i.e. warfarin)
•Oral antidiabetic agents and insulin
•Diuretics (i.e. furosemide, thiazides)
•Corticosteroids
•Methotrexate
•Lithium
PROPER USE OF THIS MEDICATION
Usual dose:
Nonprescription Use:
Adults and children over 12: Take one or two 200 mg tablets or caplets, every four hours as needed. Do not exceed six 200 mg tablets or caplets in 24 hours unless directed by a physician
Overdose:
In case of overdose, call a Poison Control Centre or a doctor at once even if there are no symptoms
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The side effects most often seen are gastrointestinal in nature, such as heartburn or indigestion, bloating, abdominal pain, loss of appetite, constipation, nausea or vomiting and diarrhea. Fluid retention, rash and headache are also commonly observed. See a doctor if the side effects do not go away.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Skin rash | T | ||
| Dizziness or change in vision | T | |||
Changes in amount or color of urine (such as dark, red or brown) | T | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Mental confusion or depression | T | |||
| Sinusitis (nasal congestion) | T | |||
| Wheezing or tightness in chest | T | |||
| Shortness of breath, troubled breathing or asthma | T | |||
Yellow discoloration of the skin or eyes, with or without fatigue | T | |||
| Any pain or difficulty in urination | T | |||
This is not a complete list of side effects. For any unexpected effects while taking <Brand Name>, contact your doctor or pharmacist.
HOW TO STORE IT
Ibuprofen should be stored in tightly closed containers under room temperature between 15 oC and 30oC.
Do not keep outdated medicine or medicine no longer needed.
Keep out of 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 at PendoPharm, Division of/de Pharmascience Inc.
1-888-550-6060
Division of/de Pharmascience Inc.
Date of preparation : February 13, 2007.