NTP-Irbesartan/HCTZ: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NTP-IRBESARTAN/HCTZ is used to treat hypertension (high blood pressure).

What it does:

The irbesartan ingredient of NTP-

IRBESARTAN/HCTZ lowers blood pressure by specifically blocking a naturally occurring substance called angiotensin II, which normally narrows your blood vessels. The irbesartan ingredient of NTP-IRBESARTAN/HCTZ allows the blood vessels to relax. The hydrochlorothiazide ingredient of NTP-IRBESARTAN/HCTZ works by making your kidneys pass more water and salt. Together irbesartan and hydrochlorothiazide lower high blood pressure. 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 NTP-IRBESARTAN/HCTZ.

If your blood pressure remains too high after an adequate trial period, your doctor may decide to increase the dose of either irbesartan or hydrochlorothiazide.

When it should not be used:

Do not take NTP-IRBESARTAN/HCTZ:

• If you are allergic to any of its ingredients or to

  sulfonamide. (See What the nonmedicinal ingredients are)

• If you have difficulty in producing urine.

  • If you are not sure whether you should start taking NTP-IRBESARTAN/HCTZ, contact your doctor or your pharmacist.

  • Pregnancy and Breast-feeding: It is not recommended that you use NTP-

    IRBESARTAN/HCTZ while you are pregnant or breast-feeding. If you are pregnant or planning to become pregnant while taking NTP-IRBESARTAN/HCTZ, talk to your doctor as soon as possible.

Children: NTP-IRBESARTAN/HCTZ should not be given to children.

What the medicinal ingredient is:

Each tablet of NTP-IRBESARTAN/HCTZ contains irbesartan and hydrochlorothiazide.

What the nonmedicinal ingredients are: NTP-IRBESARTAN/HCTZ tablets contain the following nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, pregelatinized starch.

150/12.5 mg and 300/12.5 mg tablets also contain as film coating: hypromellose, iron oxide black, iron oxide red, iron oxide yellow, macrogol and titanium dioxide.

300/25 mg tablets also contain as film coating: FD&C Blue # 2, hypromellose, iron oxide black, iron oxide red, macrogol and titanium dioxide.

What dosage forms it comes in:

NTP-IRBESARTAN/HCTZ 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 light pink to pink, film coated, capsule shaped tablet. One side of the tablet debossed with the number "93". The other side of the tablet debossed with the number "7238".

The next strength contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. These come in a similar form and colour, light pink to pink, film coated, capsule shaped tablet. One side of the tablet debossed with the number "93". The other side of the tablet debossed with the number "7239".

The highest strength tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide. These tablets come in the form of pink to dark pink, film coated, capsule shaped tablet. One side of the tablet debossed with the number "93". The other side of the tablet debossed with the number "7469".

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions NTP-IRBESARTAN/HCTZ should not to be used during pregnancy. If you discover that you are pregnant while taking NTP-

IRBESARTAN/HCTZ stop the medication and please contact your physician.

BEFORE you use NTP-IRBESARTAN/HCTZ talk to your doctor or pharmacist about any medical problems you have or have had, and about any allergies. Tell your doctor if you have recently suffered from excess vomiting or diarrhea.

• It is particularly important to tell your doctor if you have liver or kidney disease, gout, diabetes, lupus erythematosus, or if you are being treated with other diuretics (water pills). In these cases, your doctor may need to adjust the dose of your medications. -Before surgery and general anesthesia (even at the dentist’s office), tell the doctor or dentist that you are taking NTP-IRBESARTAN/HCTZ, as there may be a sudden fall in blood pressure associated with general anesthesia.
• You are pregnant, breast-feeding or thinking of becoming pregnant?

Taking NTP-IRBESARTAN/HCTZ during pregnancy can cause injury and even death to your baby. This medication should not be used during pregnancy. If you are planning to become pregnant while taking NTP-IRBESARTAN/HCTZ, contact immediately your

doctor.

It is possible that NTP-IRBESARTAN/HCTZ passes into breast milk. You should discuss with your doctor about taking NTP-IRBESARTAN/HCTZ while breast-feeding.

Wait until you know how you respond to your medication before performing tasks that require special attention (for example, driving an automobile or operating dangerous machinery).

INTERACTIONS WITH THIS MEDICATION

You should have informed your doctor of any medicines you are taking. These include medicines obtained without prescription.

The diuretic agent, hydrochlorothiazide, contained in NTP-IRBESARTAN/HCTZ may interact with other medicines.

Preparations containing lithium should not be taken with NTP-IRBESARTAN/HCTZ without close supervision by your doctor. Special precautionary measures (e.g., blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium sparing medicines, other diuretics (water pills), warfarin, digoxin, antidiabetic drugs, alcohol, barbiturates, narcotics, pressor amines, skeletal muscle relaxants, cholestyramine and colestipol resins.

If calcium or a calcium sparing drug (e.g., vitamin D therapy) is prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly.

It is important for your doctor to know if you are taking other medicines to reduce your blood pressure, or if you are taking steroids, or anti-inflammatory medicines used in arthritis.

PROPER USE OF THIS MEDICATION

Usual dose:

Take NTP-IRBESARTAN/HCTZ every day exactly as your doctor has instructed.

It is important to continue taking NTP-

IRBESARTAN/HCTZ for as long as your doctor prescribes it in order to maintain control of your blood pressure.

NTP-IRBESARTAN/HCTZ may be taken with or without food, however it should be taken consistently with respect to food intake.

Overdose:

For management of a suspected drug overdose, or in case of an actual overdose, contact your Regional Poison Centre or your doctor immediately, so that medical attention may be given promptly.

Missed Dose:

Try to take NTP-IRBESARTAN/HCTZ 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 NTP-IRBESARTAN/HCTZ, may cause side effects. In most patients,

irbesartan/hydrochlorothiazide is well tolerated. Side effects may include:

• Headache
• Dizziness
• Fatigue
• Muscle pain

Side effects such as myalgia (muscle pain), myasthenia (muscle weakness), myositis (muscle inflammation) and rhabdomyolysis (a muscle-wasting disease), in rare cases leading to kidney failure, have been reported with the use of angiotensin II receptor blockers, the class of drugs to which a component of NTP-IRBESARTAN/HCTZ belongs. You should contact your physician promptly if you experience muscle pain that you cannot explain, muscle tenderness or weakness, generalised weakness, or when you notice dark/brown urine. Your physician or pharmacist has a more complete list. Tell your physician or pharmacist promptly about these or any other unusual symptoms.

This is not a complete list of side effects. If you have any unexpected effects while taking NTP-IRBESARTAN/HCTZ, contact your doctor or pharmacist.

HOW TO STORE IT

Store NTP-IRBESARTAN/HCTZ tablets at room temperature (15 to 30ºC).

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:

---------------------------------------------------------------- $ 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 0701C 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 Teva Canada Ltd.

at: 1-800-268-4127 ext. 5005 (English) or 1-877-777-9117 (French)

or druginfo@TevaCanada.com

Teva Canada Ltd.

30 Novopharm Court

Toronto, Ontario

Canada, M1B2K9

Last revised: September 4, 2013