Patient Medication Information: uses, side effects, how to take - Irbesartan/HCT
ABOUT THIS MEDICATION
What the medication is used for:
IRBESARTAN/HCT lowers high blood pressure.
What it does:
IRBESARTAN/HCT is a combination of 2 drugs, irbesartan and hydrochlorothiazide:
Irbesartan is an angiotensin receptor blocker (ARB). You
can recognize an ARB because its medicinal ingredient ends in “SARTAN”. It lowers blood pressure.
Hydrochlorothiazide is a diuretic or “water pill” that
increases urination. This lowers blood pressure.
This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking IRBESARTAN/HCT regularly even if you feel fine.
When it should not be used:
Do not take IRBESARTAN/HCT if you:
Are allergic to irbesartan or hydrochlorothiazide or to any
non-medicinal ingredient in the formulation.
Are allergic to any sulfonamide-derived drugs (sulfa
drugs); most of them have a medicinal ingredient that ends in “MIDE”.
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 doctor, nurse, or pharmacist that this has happened to you.
- Have difficulty urinating or produce no urine.
Are pregnant or plan to become pregnant. Taking
IRBESARTAN/HCT during pregnancy can cause injury and even death to your baby.
Are breast-feeding. IRBESARTAN/HCT passes into
breast milk.
Have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
Glucose-galactose malabsorption
- Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
Because lactose is a non-medicinal ingredient in IRBESARTAN/HCT.
What the medicinal ingredient is:
Each tablet of IRBESARTAN/HCT contains irbesartan and hydrochlorothiazide.
What the important nonmedicinal ingredients are:
IRBESARTAN/HCT 150/12.5 mg tablets contain the following nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, povidone and pregelatinized starch. In addition, the tablet film coating contains: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide red, iron oxide yellow and iron oxide black.
IRBESARTAN/HCT 300/12.5 mg tablets contain the following nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, povidone and pregelatinized starch. In addition, the tablet film coating contains: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide red, iron oxide yellow and iron oxide black.
IRBESARTAN/HCT 300/25 mg tablets contain the following nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, povidone and pregelatinized starch. In addition, the tablet film coating contains: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide red, iron oxide yellow, iron oxide black and FD&C Red #40/Allura Red AC aluminum lake.
What dosage forms it comes in:
IRBESARTAN/HCT tablets are available in three different strengths.
Tablets which contain 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide come in the form of pink, oval shaped, biconvex, coated tablet with “IH 1” on one side and “ ” logo on the other side.
The next strength contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. These come in a pink, oval shaped, biconvex, coated tablet with “IH 2” on one side and “ ” logo on the other side.
The highest strength tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide. These tablets come in the form of brown, oval shaped, biconvex, coated tablet with “IH 3” on one side and “ ” on the other side.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions - Pregnancy IRBESARTAN/HCT should not to be used during pregnancy. If you discover that you are pregnant while taking IRBESARTAN/HCT stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.
BEFORE you use IRBESARTAN/HCT tell to your doctor, nurse or pharmacist if you:
Are allergic to any drug used to lower blood pressure,
including angiotensin converting enzyme (ACE) inhibitors, or penicillin.
- Have narrowing of an artery or a heart valve.
- Have heart failure.
- Have diabetes, liver or kidney disease.
- Have gout, or lupus erythematosus.
- 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”).
Are taking a medicine that contains aliskiren, such as
Rasilez, used to lower high blood pressure. The combination with IRBESARTAN/HCT is not recommended.
Are taking an angiotensin converting enzyme (ACE)
inhibitor. You can recognize ACE inhibitors because their medicincal ingredient ends in ‘-PRIL’.
- Are on a low-salt diet.
- Are less than 18 years old.
- Have had a heart attack or stroke.
Hydrochlorothiazide in IRBESARTAN/HCT can cause Sudden Eye Disorders:
- Myopia: sudden nearsightedness or blurred vision.
- Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.
These eye disorders are related and can develop within hours to weeks of starting IRBESARTAN/HCT.
You may become sensitive to the sun while taking IRBESARTAN/HCT.
Exposure to sunlight should be minimized until you know how you respond.
Before surgery and general anesthesia (even at the dentist’s office), tell the doctor or dentist that you are taking IRBESARTAN/HCT, as there may be a sudden fall in blood pressure associated with general anesthesia.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to IRBESARTAN/HCT. Dizziness,
lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.
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 IRBESARTAN/HCT:
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.
- 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.
- 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.
PROPER USE OF THIS MEDICATION
Take IRBESARTAN/HCT every day exactly as prescribed. It is recommended to take your dose at about the same time every day.
IRBESARTAN/HCT can be taken with or without food but it should be taken the same way each day. If
IRBESARTAN/HCT causes upset stomach, take it with food or milk.
Usual Adult dose:
Patients should be individually titrated for each component separately.
Usual maintenance dose is: 1 tablet daily.
Overdose:
If you think you have taken too much IRBESARTAN/HCT, contact your doctor, nurse, pharmacist, 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:
- 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, bleeding under the skin, rash, red patches on the skin
- drowsiness, insomnia
- reduced libido
If any of these affects you severely, tell your doctor, nurse or pharmacist.
IRBESARTAN/HCT can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||
Only if severe | In all cases | |||
| Common | Low Blood Pressure: dizziness, fainting, lightheadedness May occur when you go from lying or sitting to standing up. | √ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||
| Only if severe | In all cases | |||
| Common | Edema: swelling of hands, ankles or feet | √ | ||
Tachycardia: increased heart beats | √ | |||
| Uncommon | Decreased or increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | √ | ||
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | √ | |||
Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue | √ | |||
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | √ | |||
| Increased blood sugar: frequent urination, thirst, and hunger | √ | |||
Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat | √ | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||
Only if severe | In all cases | |||
| Rare | Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | √ | ||
Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu-like symptoms | √ | |||
Decreased Platelets: bruising, bleeding, fatigue and weakness | √ | |||
| Very rare | Toxic Epidermal Necrolysis: severe skin peeling, especially in mouth and eyes | √ | ||
| Unknown | Eye disorders:
increased pressure in your eyes, eye pain | √ | ||
Anemia: fatigue, loss of energy, weakness, shortness of breath. | √ | |||
Inflammation of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting | √ | |||
This is not a complete list of side effects. For any unexpected effects while taking IRBESARTAN/HCT, contact your doctor or pharmacist.
HOW TO STORE IT
Store IRBESARTAN/HCT tablets at room temperature (15°C to 30°C). Protect from light.
Keep this medication out of the reach of children.
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 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.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Actavis Pharma Company, at: 1-866-254-6111.
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5