Patient Medication Information: uses, side effects, how to take - PMS-Irbesartan-HCTZ

Serious warnings and precautions

pms-IRBESARTAN-HCTZ should not be used during pregnancy. Taking pms-IRBESARTAN-HCTZ during pregnancy can cause injury or even death to your baby. If you discover that you are pregnant while taking pms-IRBESARTAN-HCTZ, stop the medication and contact your healthcare professional as soon as possible.

What pms-IRBESARTAN-HCTZ is used for:

pms-IRBESARTAN-HCTZ is used in adults to lower high blood pressure.

How pms-IRBESARTAN-HCTZ works?

pms-IRBESARTAN-HCTZ is a combination of 2 drugs, irbesartan and hydrochlorothiazide:

Irbesartan is an angiotensin receptor blocker (ARB). It lowers blood pressure.
Hydrochlorothiazide is a diuretic or “water pill” that increases urination. This also helps to lower blood pressure.

This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking pms-IRBESARTAN-HCTZ regularly even if you feel fine.

The ingredients in pms-IRBESARTAN-HCTZ are:

Medicinal ingredient(s): Irbesartan and hydrochlorothiazide

Non-medicinal ingredients: Colloidal Silicon Dioxide, Copovidone, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate.

The coating of the tablets contains: Hypromellose, Iron Oxide Black, Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol, and Titanium Dioxide.

pms-IRBESARTAN-HCTZ comes in the following dosage form(s):

Tablets, in three strengths:

150 mg / 12.5 mg of irbesartan and hydrochlorothiazide:
300 mg / 12.5 mg of irbesartan and hydrochlorothiazide:
300 mg / 25 mg of irbesartan and hydrochlorothiazide:

Do not use pms-IRBESARTAN-HCTZ if:

you are allergic to irbesartan or hydrochlorothiazide or to any non-medicinal ingredients in the formulation.
you are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “MIDE”.
you 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 (any drug in the same class as irbesartan). Be sure to tell your healthcare professional that this has happened to you.
you have difficulty urinating or produce no urine.
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”
you are pregnant or intend to become pregnant. Taking pms-IRBESARTAN-HCTZ during pregnancy can cause injury and even death to your baby.
you are breast-feeding. pms-IRBESARTAN-HCTZ passes into breast milk.
you have one of the following rare hereditary diseases:
- Galactose intolerance,
- Lapp lactase deficiency, or
- Glucose-galactose malabsorption, because lactose is a non-medicinal ingredient in pms-IRBESARTAN-HCTZ.

pms-IRBESARTAN-HCTZ is not for use in children and adolescents (under the age of 18 years).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-IRBESARTAN-HCTZ. Talk about any health conditions or problems you may have, including if you:

have experienced an allergic reaction to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors.
are allergic to penicillin.
have narrowing of an artery or a heart valve.
have had a heart attack or stroke.
have heart failure.
have liver or kidney disease.
have diabetes. pms-IRBESARTAN-HCTZ may cause low blood sugar levels.
have gout, or lupus erythematosus.
have psoriasis or a history of psoriasis.
are on dialysis.
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 pms-IRBESARTAN-HCTZ is not recommended.
are taking an angiotensin converting enzyme (ACE) inhibitors. The combination with pms-IRBESARTAN-HCTZ is not recommended.
are taking a medicine that contains lithium. The combination with pms-IRBESARTAN-HCTZ is not recommended.
have had skin cancer or have a family history of skin cancer. have a greater chance of developing skin cancer because you have light-coloured skin, get sunburned easily, or are taking drugs to suppress your immune system.
have had breathing or lung problems (including inflammation or fluid in the lungs) in the past following the use of medication containing hydrochlorothiazide or certain diuretics (i.e., “water pills”). If you develop any severe shortness of breath or difficulty breathing after taking pms-IRBESARTAN-HCTZ, stop the medication and seek medical attention immediately.

Other warnings you should know about:

Risk of skin cancer:

pms-IRBESARTAN-HCTZ contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing non-melanoma skin cancer. The risk is higher if you have been taking AVALIDE for many years (more than 3) or at a high dose.
While taking pms-IRBESARTAN-HCTZ:
- Make sure to regularly check your skin for any new lesions. Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back.
- You may become sensitive to the sun.
- Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.

Talk to your healthcare professional immediately if you become more sensitive to the sun or UV light or if you develop an unexpected skin lesion (such as a lump, bump, sore, or patch) during treatment.

Sudden eye disorders:

pms-IRBESARTAN-HCTZ contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing sudden eye problems.
Myopia: sudden nearsightedness or blurred vision.
Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.
Choroidal effusion: abnormal buildup of liquid in your eye that may result in vision changes.

If your vision changes, stop taking AVALIDE and seek immediate medical help. These eye disorders are related and can develop within hours to weeks of starting pms-IRBESARTAN-HCTZ. If you have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. Talk to your healthcare professional immediately if you develop any eye problems while taking pms-IRBESARTAN-HCTZ.

Before surgery and general anesthesia (even at the dentist’s office), tell the doctor or dentist that you are taking pms-IRBESARTAN-HCTZ, as there may be a sudden fall in blood pressure associated with general anesthesia.

Allergic reactions: Allergic reactions (swelling of areas of tissue under the skin, sometimes affecting the face and throat, hives and severe allergic reactions) have been reported. Stop taking pms-IRBESARTAN-HCTZ and get immediate medical help if you experience any symptoms of an allergic reaction.

Driving and using machines: Before you perform tasks, which may require special attention, wait until you know how you respond to pms-IRBESARTAN-HCTZ. Dizziness, lightheadedness, or fainting can occur, especially after the first dose and when the dose is increased.

Tell your healthcare professional about all the medicines you take, including any drugs vitamins, minerals, natural supplements or alternative medicines.

The following may interact with pms-IRBESARTAN-HCTZ:

Adrenocorticotropic hormone (ACTH) used to treat West Syndrome.
Alcohol, barbiturates (sleeping pills), or narcotics (strong pain medications). They may cause low blood pressure and dizziness when you go from lying or sitting to standing up.
Amphotericin B, an antifungal drug.
Anticancer drugs, including cyclophosphamide and methotrexate.
Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline.
Antidiabetic drugs, including insulin and oral medicines, such as repaglinide.
Beta-blockers (medications for heart disease).
Bile acid resins used to lower cholesterol.
Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g., RASILEZ^®*), or angiotensin converting enzyme (ACE) inhibitors.
Calcium or vitamin D supplements.
Corticosteroids used to treat joint pain and swelling and other conditions.
Digoxin, a heart medication.
Drugs that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone.
Drugs used to treat epilepsy, including carbamazepine and topiramate.
Gout medications, including allopurinol and probenecid.
Hyperglycemic agents, such as diazoxide.
Lithium used to treat bipolar disease.
Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes.
Pressor amines, such as norepinephrine.
Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
Warfarin.

How to take pms-IRBESARTAN-HCTZ:

Take pms-IRBESARTAN-HCTZ every day exactly as prescribed.
It is recommended to take your dose at about the same time every day.
pms-IRBESARTAN-HCTZ can be taken with or without food, but it should be taken the same way each day.
If pms-IRBESARTAN-HCTZ causes upset stomach, take it with food or milk.

Usual dose:

1 tablet once daily.

Overdose:

If you think you, or a person you are caring for, have taken too much pms-IRBESARTAN-HCTZ, contact a healthcare professional, hospital emergency department, regional Poison Control Centre, or Health Canada’s tollfree number, 1-844 POISON-X (1-844-764-7669), immediately, even if there are no signs or symptoms.

Missed dose:

If you have forgotten to take your dose during the day, carry on with the next dose at the usual time. Do not double the dose.

Possible side effects from using pms-IRBESARTAN-HCTZ?

These are not all the possible side effects you may feel when taking pms-IRBESARTAN-HCTZ. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

back or leg pain, muscle cramps, spasms and pain, weakness, restlessness;
dizziness, pins and needles in your fingers, headache and fatigue;
constipation, diarrhea, nausea, vomiting, decreased appetite, upset stomach, enlargement of the glands in your mouth;
abdominal pain;
rash, red patches on the skin;
drowsiness;
insomnia;
reduced libido;
lightheadedness;
ringing in the ears.

pms-IRBESARTAN-HCTZ can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them

Frequency/Side Effect/Symptom	Talk to your healthcare professional	Stop taking this drug and get immediate medical help
Frequency/Side Effect/Symptom	Talk to your healthcare professional	Stop taking this drug and get immediate medical help
Frequency/Side Effect/Symptom	Talk to your healthcare professional	Stop taking this drug and get immediate medical help
Only if severe	In all cases
Only if severe	In all cases
Only if severe	In all cases
Common
Decreased or increased levels of potassium in the blood: irregular heartbeats, muscle weakness, generally feeling unwell		✓
Edema: unusual swelling of arms, hands, legs, ankles, feet, face, or air passages		✓
Hypotension (low blood pressure): dizziness, fainting, light-headedness. May occur when you go from lying or sitting to standing up.	✓
Increased levels of creatine phosphokinase: blood tests may show raised levels of an enzyme that measures breakdown of muscle (creatine phosphokinase)			✓
Non-melanoma skin cancer: lump or discoloured patch on the skin that stays after a few weeks and slowly changes. Cancerous lumps are red/pink and firm and sometimes turn into ulcers. Cancerous patches are usually flat and scaly.		✓
Tachycardia: (abnormally fast heartbeat)		✓
Uncommon
Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing			✓
Kidney problems: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue		✓
Liver problems: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite		✓
High blood sugar: frequent urination, thirst, and hunger	✓
Rare
Decreased platelets: bruising, bleeding, fatigue, weakness, small purple or red dots under the skin		✓
Gastrointestinal: Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhea		✓
Decreased white blood cells: infections, fatigue, fever, aches, pains, and flu-like symptoms		✓
Rhabdomyolysis (breakdown of damaged muscle): muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine		✓
Very Rare
Acute respiratory distress (inflammation of lung tissue or excess fluid in the lungs): severe shortness of breath or difficulty breathing, fever, weakness, and confusion.			✓
Serious skin reactions (Steven-Johnson Syndrome, and Toxic Epidermal Necrolysis): any combination of itchy skin rash, redness, blistering and peeling of the skin and/or of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or joint pain, yellowing of the skin or eyes, dark urine			✓
Unknown
Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, weakness, shortness of breath.		✓
Eye disorders: Myopia (near sightedness): blurred vision, difficulty focusing on objects far away, need to squint, headache caused by eyestrain, eye fatigue			✓
Glaucoma (increased pressure in your eyes): eye and head pain, swelling or redness in or around the eye, changes in vision, hazy or blurred vision, sudden sight loss Choroidal effusion (fluid buildup in the eye): blind spots, eye pain, redness of the eye, blurred vision, sensitivity to light
Inflammation of the pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting		✓
Low blood pressure: sweating, weakness, hunger, dizziness, trembling, headache			✓
Skin problems: psoriasis, increased skin sensitivity to sunlight		✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store between 15°C and 30°C.

Keep out of reach and sight of children.

If you want more information about pms-IRBESARTAN-HCTZ:

Talk to your healthcare professional.
Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (www.pharmascience.com), or by calling 1-888-550-6060.

Date of Authorization: 2026-02-19

*RASILEZ^®is a trademark of Novartis AG, Switzerland and not a trademark of PMS. Novartis is not affiliated with and does not endorse PMS or its products.

PMS-Irbesartan-HCTZ: Uses, Side Effects and Dosage