NTP-Telmisartan HCTZ: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NTP-TELMISARTAN HCTZ is prescribed to treat patients with high blood pressure where treatment with just one drug was not effective. The two drugs contained in this combination tablet treat high blood pressure in different ways, so it is expected that this combination may be more effective than either drug taken alone. In addition, it may be more convenient for you to take just one tablet than two tablets every day.

What it does:

NTP-TELMISARTAN HCTZ contains a combination of two drugs. The drug telmisartan, acts to inhibit the naturally occurring substances in your body that induce constriction of blood vessels, which plays a part in development of high blood pressure. The drug hydrochlorothiazide, acts by a different mechanism, that being to induce diuresis or urination which leads to decreased amount of body water which is beneficial in patients with high blood pressure.

When it should not be used:

• NTP-TELMISARTAN HCTZ should not be used in patients

  who are hypersensitive to any component of this product (see the section “What the nonmedicinal ingredients are”).

• Patients who are in their second/third trimester of pregnancy should not take NTP-TELMISARTAN HCTZ.

• Patients who are breastfeeding should not take NTP-

  TELMISARTAN HCTZ.

• Patients who are fructose intolerant and lactose intolerant.

• Due to the hydrochlorothiazide component, NTP-

  TELMISARTAN HCTZ should not be used in patients with an absent production of urine or hypersensitivity to other sulfonamide-related drugs.

What the medicinal ingredients are:

Telmisartan (as Telmisartan Sodium) and hydrochlorothiazide

What the important nonmedicinal ingredients are: hydroxy propyl cellulose, hydroxyl propyl methyl cellulose, lactose monohydrate, meglumine, mannitol, magnesium stearate, purified water, red iron oxide (for 80/12.5 mg only), sodium

hydroxide, sorbitol, talc and yellow iron oxide (for 80/25 mg only).

If you are on a special diet or if you are allergic to anything, ask your doctor or pharmacist whether any of these ingredients may cause a problem for you.

What dosage forms it comes in:

NTP-TELMISARTAN HCTZ 80 /12.5 mg and 80/25 mg tablets.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

NTP-TELMISARTAN HCTZ should not be used during pregnancy. If you discover that you are pregnant while taking NTP-TELMISARTAN HCTZ, stop the medication and please contact your physician.

Before you use NTP-TELMISARTAN HCTZ, you should tell your doctor the following:

• If you have any allergies to this drug or to any ingredient in the formulation or component of the container.
• If you have a history of allergy or bronchial asthma.
• If you have narrowing of a heart valve.
• If you recently suffered from excess sweating, diarrhea or vomiting.
• If you have any other health problems, including liver or kidney disease, gout, diabetes, lupus erythematosus, or if you are being treated with other diuretics (known as water pills).
• If you are taking any other medication, including both prescription and over-the -counter (non-prescription).
• Before surgery and general anesthesia, (even at the dentist's office), tell the doctor or dentist that you are taking NTP-TELMISARTAN HCTZ as there may be a sudden fall in blood pressure associated with general anesthesia.
• If you have hereditary fructose intolerance.

• Lactose is a non-medicinal ingredient in NTP-TELMISARTAN HCTZ. Do not take NTP-TELMISARTAN HCTZ if a doctor has told you that you have one of the following rare hereditary disease:

  • Galactose intolerance
  • Lapp lactase deficiency
  • glucose-galactose malabsorption

Please remember:

• Dizziness or drowsiness may occasionally occur when taking any medicine to lower blood pressure. 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 your medicine.

• If you have any other questions about NTP-TELMISARTAN HCTZ, contact your doctor or pharmacist.

Effects on Pregnancy and Breastfeeding:

• Taking NTP-TELMISARTAN HCTZ during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you are planning to become pregnant while taking NTP-TELMISARTAN HCTZ, contact immediately your doctor. It is possible that NTP-TELMISARTAN HCTZ passes into breast milk. NTP-TELMISARTAN HCTZ should not be used in patients who are breastfeeding.

NTP-TELMISARTAN HCTZ has been prescribed to treat your condition. Do not give it to other people. INTERACTIONS WITH THIS MEDICATION

INTERACTIONS WITH THIS MEDICATION

Foods - Use potassium-containing salt substitutes only after consulting with your doctor.

As with most medicines, interaction with other drugs is possible. Therefore, do not take any other medication without your doctor’s or pharmacist’s advice.

Drugs that may interact with NTP-TELMISARTAN HCTZ include:

Drugs that may interact with telmisartan:

Diuretics (also known as water pills); Agents Increasing Serum Potassium; Digoxin; Lithium salts; Warfarin; Ramipril and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as acetylsalicylic acid (ASA).

Drugs that may interact with hydrochlorothiazide: Alcohol, Barbiturates and Narcotics; Anti-Diabetic Drugs (oral agents and insulin); Cholestyramine and Colestipol Resins (cholesterol lowering drugs); Corticosteroids, ACTH; Lithium Salts; Non-Steroidal Anti-Inflammatory Drugs (NSAIDs including acetylsalicylic acid (ASA) and COX-2 Inhibitors); Pressor Amines (e.g. norepinephrine); Skeletal Muscle Relaxants, Nondepolarizing (e.g. tubocurarine); Other Antihypertensive Drugs.

PROPER USE OF THIS MEDICATION

Usual dose:

Take NTP-TELMISARTAN HCTZ exactly as instructed by your doctor. The usual dosing schedule is one tablet daily, taken at the same time each day, preferably in the morning.

NTP-TELMISARTAN HCTZ may be taken with or without food, but it should be taken the same way each day.

Overdose:

For management of a suspected drug overdose contact your regional Poison Control Centre.

If you experience dizziness and/or fainting, racing heart rate, or have taken too many pills, contact your doctor immediately or go to the nearest emergency room so that medical attention may be given promptly.

Missed Dose:

If you have missed a dose, do not take a double dose. Just carry on with the next dose at the usual time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like any drug product, NTP-TELMISARTAN HCTZ may cause some undesirable effects along with good effects. Tell your doctor or pharmacist promptly about these or any other unusual symptoms.

If you develop an allergic reaction involving swelling of the face, lips and/or tongue, stop taking NTP-TELMISARTAN HCTZ and contact your doctor immediately.

Side effects such as muscle pain, muscle weakness, muscle inflammation and 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-TELMISARTAN 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.

The following side effects for telmisartan are very common (frequency > 1/10) or common (frequency > 1/100, < 1/10): chest pain, influenza-like symptoms, symptoms of infection (e.g. urinary tract infection including cystitis, insomnia, abdominal pain, diarrhoea, dyspepsia, arthralgia, muscle spasms (cramps in legs) or pain in extremity (leg pain), myalgia, back pain, anxiety, depression, upper respiratory tract infections, dyspnea, eczema and rash.

This is not a complete list of side effects. For any unexpected effects while taking NTP-TELMISARTAN HCTZ contact your doctor or pharmacist.

HOW TO STORE IT

Store NTP-TELMISARTAN HCTZ at room temperature (15-30°C) in the package provided by your doctor or pharmacist and protect from excessive moisture. Do not remove tablets from blisters until immediately prior to administration.

Store NTP-TELMISARTAN HCTZ out of the reach of children and pets.

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 the 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:

at: 1-800-268-4127 ext. 5005

or druginfo@tevacanada.com

Teva Canada Ltd.

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: September 23, 2013