Jamp-Irbesartan and Hydrochlorothiazide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Jamp-Irbesartan and hydrochlorothiazide lowers high blood pressure.

What it does:

Jamp-Irbesartan and hydrochlorothiazide tablet 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 Jamp-Irbesartan and

hydrochlorothiazide tablets regularly even if you feel fine.

When it should not be used:

Do not take Jamp-Irbesartan and

hydrochlorothiazide if you:

• Are allergic to irbesartan or

  hydrochlorothiazide or to any non-medicinal ingredients 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 Jamp-Irbesartan and

    hydrochlorothiazide during pregnancy can cause injury and even death to your baby.

  • Are breast-feeding. Jamp-Irbesartan and hydrochlorothiazide 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 Jamp-Irbesartan and hydrochlorothiazide tablets.

What the medicinal ingredients are: Irbesartan and hydrochlorothiazide.

What the nonmedicinal ingredients are: Jamp-Irbesartan and hydrochlorothiazide 150/12.5 mg and 300/12.5 mg tablets contain: lactose monohydrate, microcrystalline cellulose, starch pregelantinized, croscarmellose sodium, povidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and iron oxide yellow.

Jamp-Irbesartan and hydrochlorothiazide 300/25 mg tablet contains: lactose monohydrate, microcrystalline cellulose, starch pregelantinized, croscarmellose sodium, povidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and iron oxide black.

What dosage forms it comes in:

Tablets in three strengths:

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

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions - Pregnancy

Jamp-Irbesartan and hydrochlorothiazide should not to be used during pregnancy. If you discover

Jamp-Irbesartan and Hydrochlorothiazide Page 37 of 40

that you are pregnant while taking Jamp-Irbesartan and hydrochlorothiazide stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use Jamp-Irbesartan and hydrochlorothiazide tablets tell 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 Jamp-Irbesartan and hydrochlorothiazide is not recommended.

• Are taking an angiotensin converting

  enzyme (ACE) inhibitor. You can recognize ACE inhibitor because their medicinal ingredients ends in ‘’-PRIL’’.

• Are on a low-salt diet.
• Are less than 18 years old.
• Have had a heart attack or stroke.

Hydrochlorothiazide in Jamp-Irbesartan and hydrochlorothiazide tablets 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 Jamp-Irbesartan and hydrochlorothiazide.

You may become sensitive to the sun while taking Jamp-Irbesartan and hydrochlorothiazide. 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 Jamp-Irbesartan and

hydrochlorothiazide, 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 Jamp-Irbesartan and hydrochlorothiazide. 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 Jamp-Irbesartan and hydrochlorothiazide:

• 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.

Jamp-Irbesartan and Hydrochlorothiazide Page 38 of 40

• 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 Jamp-Irbesartan and hydrochlorothiazide tablets every day exactly as prescribed. It is recommended to take your dose at about the same time every day.

Jamp-Irbesartan and hydrochlorothiazide can be taken with or without food but it should be taken the same way each day. If Jamp-Irbesartan and hydrochlorothiazide 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 Jamp-Irbesartan and hydrochlorothiazide, 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.

Jamp-Irbesartan and hydrochlorothiazide can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Jamp-Irbesartan and Hydrochlorothiazide Page 39 of 40

This is not a complete list of side effects. For any unexpected effects while taking Jamp-Irbesartan and hydrochlorothiazide, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store at room temperature (15°C to 30°C).

Keep out of the reach and sight of children.

Jamp-Irbesartan and Hydrochlorothiazide Page 40 of 40

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^TM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effect, 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 professional can be obtained by contacting Jamp Pharma Corporation, at 1-866-399-9091.

JAMP PHARMA CORPORATION 1380-203 Newton

Boucherville, Québec

J4B 5H2

Date of Preparation: December 11, 2013