Patient Medication Information: uses, side effects, how to take - Q-Irbesartan
ABOUT THIS MEDICATION
What the medication is used for:
- Q-IRBESARTAN lowers high blood pressure
If you have high blood pressure, type 2 diabetes
and kidney disease, Q-IRBESARTAN may help to protect kidney function.
What it does:
Q-IRBESARTAN is an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
This medicine does not cure your disease, it helps to control it. Therefore, it is important to continue taking Q-IRBESARTAN regularly even if you feel fine.
When it should not be used:
Do not take Q-IRBESARTAN if you:
Are allergic to irbesartan or to any non-medicinal
ingredient in the formulation.
Have experienced an allergic reaction
(angioedema) with swelling of the hands, feet or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing, to any ARB.. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
Have diabetes or kidney disease and are already
taking:
- a blood pressure-lowering medicine that contains aliskiren (such as Rasilez)
- an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.
Are pregnant or intend to become pregnant.
taking Q-IRBESARTAN during pregnancy can cause injury and even death to your baby.
Are breastfeeding. It is possible that Q-
IRBESARTAN passes into breast milk.
Have one of the following rare hereditary diseases:
o Galactose intolerance
o Lapp lactase deficiency
o Glucose-galactose malabsorption
Because lactose is a non-medicinal ingredient in Q-IRBESARTAN.
Q-IRBESARTAN is not recommended for use in children and adolescents (under the age of 18 years).
What the medicinal ingredient is:
Irbesartan.
What the nonmedicinal ingredients are:
Colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, hydroxypropyl methylcellulose, polyethylene glycol, polysorbate, and titanium dioxide.
What dosage forms it comes in:
Q-IRBESARTAN (irbesartan) 75 mg tablets are white, oblong, biconvex film-coated tablets, engraved “IS 75” on one side and "M" on the other side.
Q-IRBESARTAN (irbesartan) 150 mg tablets are white, oblong, biconvex film-coated tablets, engraved “IS 150” on one side and "M" on the other side.
Q-IRBESARTAN (irbesartan) 300 mg tablets are white, oblong, biconvex film-coated tablets, engraved “IS 300” on one side and "M" on the other side.
Q-IRBESARTAN 75, 150 and 300 mg tablets are available in bottles of 90 tablets.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions - Pregnancy Q-IRBESARTAN should not be used during pregnancy. If you discover that you are pregnant while taking Q-IRBESARTAN, stop the medication and contact your physician as soon as possible.
BEFORE you use Q-IRBESARTAN talk to your doctor, nurse or pharmacist if you:
Have experienced an allergic reaction to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE)
inhibitors.
- Have narrowing of an artery or a heart valve.
- Have had a heart attack or stroke.
- Have heart failure.
- Are on dialysis.
| IMPORTANT: PLEASE READ |
Are dehydrated or suffer from excessive
vomiting, diarrhea, or sweating.
Are taking a -salt substitute that contains
potassium, potassium supplements or a potassium-sparing diuretic (a specific kind of “water pill” that makes your body keep potassium).
- Are on a low-salt diet.
Are taking a medicine that contains aliskiren,
such as Rasilez, used to lower high blood pressure. The combination with Q-IRBESARTAN is not recommended.
Are taking an angiotensin converting enzyme
(ACE) inhibitor. The combination with Q-IRBESARTAN is not recommended.
- Are less than 18 years old.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to Q-IRBESARTAN. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.
Please remember:
If you are to undergo any surgery or receive
anaesthetics, you should make sure your doctor knows that you are taking Q-IRBESARTAN.
INTERACTIONS WITH THIS MEDICATION
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with Q-IRBESARTAN:
- Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”).
- Lithium used to treat bipolar disease.
- Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
Blood pressure-lowering drugs, including
diuretics (“water pills”), aliskiren-containing products (e.g. RASILEZ ), or angiotensin converting enzyme (ACE) inhibitors.
Certain medications tend to increase your blood
pressure, for example, preparations for appetite control, asthma, colds, coughs, hay fever and sinus problems.
PROPER USE OF THIS MEDICATION
Take Q-IRBESARTAN as prescribed. It is recommended to take your dose at about the same time every day.
Do not stop taking your medication without having first informed your doctor.
Usual Adult dose:
High Blood Pressure (hypertension) including in patients with Type 2 Diabetes Mellitus:
Recommended Initial Dose: 150 mg once a day.
Your doctor can increase the dosage to 300 mg once daily when required.
Q-IRBESARTAN may be taken with or without food.
Remember that your doctor has prescribed this medicine only for you. Never give it to anyone else.
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. |
Missed Dose:
If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- dizziness
- drowsiness, insomnia, being tired
- rash
- diarrhea, vomiting
- headache
- back or leg pain, muscle cramps
- lightheadedness
If any of these affects you severely, tell your doctor, nurse or pharmacist.
Q-IRBESARTAN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| IMPORTANT: PLEASE READ |
| 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 seek immediate emergency medical attention | ||||
Only if severe | In all cases | |||||
| Common | Increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | ✓ | ||||
| Uncommon | Low blood pressure: Dizziness/ Fainting/ Light- headedness | ✓ | ||||
Jaundice (Liver disorder): yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✓ | |||||
Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue | ✓ | |||||
| Rare | Rhabdomyolysi s: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | ✓ | ||||
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or | ✓ | |||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
Symptom / effect breathing | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||||
Only if severe | In all cases | |||||
| Very Rare | Decreased Platelets: bruising, bleeding, fatigue and weakness | ✓ | ||||
This is not a complete list of side effects. If you have any unexpected effects while taking Q-IRBESARTAN, contact your doctor or pharmacist.
HOW TO STORE IT
Q-IRBESARTAN should be stored between 15°C and 30°C.
Keep this medication out of the reach and sight of children.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting
Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
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.
| IMPORTANT: PLEASE READ |
MORE INFORMATION
This document can be found at:
www.qdpharmaceuticals.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, QD Pharmaceuticals ULC at: 1-800-661-3429.
Revised on: June 3, 2015