Patient Medication Information: uses, side effects, how to take - Children's Europrofen

ABOUT THIS MEDICATION

What the medication is used for:

The effective, temporarily relief of: Fever and temporary relief of minor aches and pains due to:

Sore throat
Earache
Colds
Flu
Headache
Toothache
Immunization
Body aches, sprains and strains

What it does:

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:

Children’s EUROPROFEN should not be used:

if your child is taking ibuprofen, acetylsalicylic acid (ASA) or other pain or fever medication.
if your child is allergic to any of the ingredients in the product (symptoms include facial or throat swelling, shortness of breath, low blood pressure).
if your child has peptic ulcers or gastrointestinal bleeding (bleeding in the urine or stool, or black stools).
if your child has Systemic Lupus Erythematosus.
if your child is suffering from dehydration caused by diarrhea, vomiting or lack of fluid.
right before or after heart surgery.
in adults.

What the medicinal ingredient is:

Ibuprofen

What the important nonmedicinal ingredients are:

See Inactive ingredients section of outer product carton.

What dosage forms it comes in:

Oral suspension, 100 mg/5 mL

WARNINGS AND PRECAUTIONS

BEFORE you use Children’s EUROPROFEN, talk to your doctor or pharmacist if your child:

is dehydrated (significant fluid loss) due to continued
- vomiting, diarrhea or lack of fluid intake.
- is suffering from stomach pain
- has peptic ulcers, high blood pressure, heart failure, serious kidney or liver disease, asthma, diabetes, or is under a doctor’s care for any other serious condition or are taking any other drug.
- has a history of gastrointestinal disease, blood clotting problems, or taking an anticoagulant.

Also, see your doctor if:

your child does not get any relief within 24 hours.
redness or swelling is present in the painful area.
your child’s sore throat is severe, lasts for more than 2 days or occurs with fever, headache, rash, nausea or vomiting.
your child develops any vision problems (blurred or reduced vision, colour changes occur).
any new symptoms occur.

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

INTERACTIONS WITH THIS MEDICATION

Talk to your doctor if your child is taking coumarin-type anticoagulants, diuretics (water tablets), digoxin, methotrexate, phenytoin, lithium salt, as some drug interactions could occur.

PROPER USE OF THIS MEDICATION

Usual dose:

Shake suspension well before use. Use only the enclosed dosage cup. Do not use any other dosing device. Measure dose with the dosage cup provided and ensure the complete dose is taken.

For accurate dosing, follow the instructions carefully. Find the right dose on the chart. If possible, use weight to dose, otherwise use age.

Weight		Age	Single Dose^†
(lbs)	(kg)	(years)	(mL)
Under 24	Under 11	Under 2	As directed by a doctor
24 - 35	11 - 15.9	2 - 3	5
36 - 47	16 - 21.9	4 - 5	7.5
48 - 59	22 - 26.9	6 - 8	10
60 - 71	27 - 31.9	9 - 10	12.5
72 - 95	32 - 43.9	11	15

^†Single dose may be given every 6 to 8 hours as needed but do not exceed 4 doses per day unless advised by your doctor.

Do not take for fever for more than 3 days or pain for more than 5 days unless directed by a physician. Use the lowest effective dose for the shortest duration. If the painful area is red or swollen, if condition deteriorates or new symptoms occur, consult a physician.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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:

skin rash or itching, dizziness, any change in vision, ringing or buzzing in the ears, nausea or vomiting, abdominal pain or cramps, diarrhea or constipation, heartburn, bloating, fluid retention, indigestion, headache, decreased appetite.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect	Talk with your doctor or pharmacist
Only if severe	In all cases
Common
Dizziness		✓
Uncommon
Blurred/reduced vision		✓
Vision colour changes		✓
Ringing in ears		✓
Blood in urine or stool		✓
Swelling of mouth, throat and extremities		✓
Difficulty breathing		✓
Abdominal pain	✓
Severe skin rash		✓
Weight gain/fluid retention	✓
Bruising	✓

This is not a complete list of side effects. For any unexpected effects while taking Children’s EUROPROFEN, contact your doctor or pharmacist.

HOW TO STORE IT

Store at controlled room temperature (15-30°C).

Protect from high humidity and excessive heat.

Keep out of the reach of children.

Child-resistant package.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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•Report online at www.healthcanada.gc.ca/medeffect

•Call toll-free at 1-866-234-2345

•Complete a Canada Vigilance Reporting Form and:

-Fax toll-free to 1-866-678-6789, or

-Mail to: Canada Vigilance Program

Health Canada

Postal Locator 0701D

Ottawa, Ontario

K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, PENDOPHARM, Division of Pharmascience Inc., at: 1-888-550-6060

Rx or OTC	Over-the-counter (OTC)?
DIN	02354799
Schedule(s)	NON-PRESCRIPTION DRUGS
Active ingredient(s)	Ibuprofen 100 MG
Dosage form(s)	Suspension
Route(s) of administration	Oral
Drug class (WHO ATC)	M Musculo-skeletal system drugs M01 Antiinflammatory and antirheumatic products M01A Antiinflammatory and antirheumatic products, non-steroids M01AE Propionic acid derivatives, antiinflammatory and antirheumatic products M01AE01 Ibuprofen
Company	PENDOPHARM DIVISION OF PHARMASCIENCE INC
Current status	Cancelled Post Market
Current status date	May 25, 2021

Children's Europrofen: Uses, Side Effects and Dosage