Patient Medication Information: uses, side effects, how to take - Bio-Irbesartan
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed irbesartan tablets because you have a condition known as hypertension or high blood pressure. Your doctor may have also prescribed irbesartan tablets if you have high blood pressure and type 2 diabetes mellitus to protect your kidney function.
What it does:
Irbesartan belongs to a class of drugs known as angiotensin II AT1 receptor blockers (ARB) which have been proven to be effective in lowering blood pressure.
Irbesartan lowers blood pressure by specifically blocking a natural substance called angiotensin II, which normally narrows your blood vessels. Treatment with irbesartan tablets allows the blood vessels to relax. Although your doctor will be able to tell you that the medicine is working by measuring your blood pressure, you will probably feel no different while you are taking irbesartan tablets.
In addition to controlling and lowering your blood pressure, recent studies have shown that irbesartan tablets protects your kidneys by reducing protein in the urine. This in turn slows the progression of your kidney disease.
This medicine does not cure high blood pressure, but does help control it. Therefore, it is important to continue taking irbesartan tablets regularly to keep your blood pressure down even if you feel fine.
When it should not be used:
Do not take irbesartan tablets if you:
- Are allergic to irbesartan or to any non-medicinal ingredient in the formulation.
- Ever have experienced an allergic reaction and in particular with swelling of the face, lips, tongue, throat, or sudden difficulty breathing or swallowing, to any drug in the same class as irbesartan (ARB) Be sure to tell your doctor that this has happened to you.
- Are pregnant or thinking of becoming pregnant.
- Are breastfeeding, you should discuss with your physician about taking irbesartan.
- Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
If any of the above apply to you, inform your doctor or pharmacist first and ask for their advice.
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:
Lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, croscarmellose sodium, hypromellose, starch pregelatinised, magnesium stearate, titanium dioxide and macrogol.
What dosage forms it comes in:
Oval tablets (white to off white); 75 mg, 150 mg, and 300 mg.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Irbesartan should not be used during pregnancy. If you
discover that you are pregnant while taking irbesartan, stop the medication and contact your physician as soon as possible.
BEFORE you use irbesartan tablets talk to your doctor or pharmacist if you:
- Have any of these health problems: liver disease, kidney disease or heart disease.
- Have narrowing of a heart valve.
- Have recently suffered from severe diarrhea or excessive vomiting.
Are on a low-salt diet or use salt substitutes that contain potassium, potassium supplements, potassium-sparing diuretics
(a specific kind of “water pills”), or any medicine that may increase your potassium level.
- Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with irbesartan is not recommended.
- Are taking an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘PRIL’.
- Are on dialysis.
- Have ever experienced an allergic reaction to any drug to lower blood pressure. Be sure to tell your doctor that this has happened to you. The doctor will decide if irbesartan tablets are right for you.
Please remember:
- To tell any other doctor, dentist or pharmacist with whom you consult that you are using irbesartan tablets
Dizziness or drowsiness may occasionally occur when taking irbesartan tablets. Therefore, before you perform tasks which may require special attention (driving a car or operating dangerous machinery), wait until you know how you respond to irbesartan tablets.
- If you are to undergo any surgery or receive anaesthetics, you should make sure your doctor knows that you are taking irbesartan.
Effects on Pregnancy and Breastfeeding:
Taking irbesartan tablets during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you become pregnant or are planning to become pregnant while taking irbesartan tablets, contact your doctor immediately. It is possible that irbesartan passes into breast milk. Therefore, you should discuss with your doctor about taking irbesartan tablets while breast-feeding.
INTERACTIONS WITH THIS MEDICATION
Before taking irbesartan tablets, tell your doctor or pharmacist about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Drugs that may interact with irbesartan include:
- Any substance that may increase your potassium level, including salt substitutes that contain potassium, potassium supplements, potassium-sparing diuretics (a specific kind of “water pills”).
- Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin converting enzyme (ACE) inhibitors.
- Lithium-containing medicines to treat some types of depression.
- Nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin and ibuprofen. NSAIDs are used to reduce pain, fever, and swelling.
- 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 irbesartan tablets exactly as prescribed by your doctor. It may be easier to take your dose if you do it at the same time every day.
Do not stop taking your medication without having first informed your doctor.
Usual dose:
High Blood Pressure (hypertension) including in patients with Type 2 Diabetes Mellitus: 150 mg once daily. Your doctor can increase the dosage to 300 mg once daily when required.
Irbesartan tablets 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:
Try to take irbesartan tablets daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your normal schedule.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Along with its intended action, any medication, including irbesartan, may cause side effects. Most patients do not have side effects from taking irbesartan tablets, but if you notice any of the following or any other unusual symptoms tell your pharmacist or your doctor right away:
- Dizziness
- Lightheadedness
- Rash
- Being tired
- Diarrhea
| 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 immedia te medical help | ||
Only if severe | In all cases | |||
| Uncommon | Hypotension: Dizziness/Fainting/ Light-headedness | ✔ | ||
Jaundice: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | |||
| Rare | Rhabdomylosis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | ✔ | ||
Allergy Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty in swallowing or breathing | ✔ | |||
| Unknown | Hyperkalemia: increased levels of potassium in the blood, heart skips a beat, muscle weakness and generally feeling unwell | ✔ | ||
This is not a complete list of side effects. If you have any unexpected effects while taking Bio-IRBESARTAN tablets, contact your doctor or pharmacist.
Bio-IRBESARTAN Page 25 of 25 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:
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 0701E
Ottawa, ON 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.
HOW TO STORE IT
Store irbesartan tablets at room temperature (15°C to 30°C).
Keep this medication out of the reach and sight of children.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting Biomed Pharma.
Biomed Pharma
100-5950, Ch. de la Côte de Liesse
Mont-Royal, QC, H4T 1E2
Phone# (514) 731-2003; Fax: (514) 731-2004
Date of Preparation: September 21, 2015