NTP-Risedronate: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• Treatment and prevention of osteoporosis in postmenopausal

  women.

• Treatment and prevention of osteoporosis caused by

  treatment with steroid medication such as prednisone.

• Treatment of Paget’s disease of bone.

What it does:

NTP-RISEDRONATE is a bisphosphonate drug that helps to slow bone loss. In many people, risedronate sodium helps to increase bone density. In osteoporosis, the body removes more bone than it replaces. This causes bones to get weaker and more likely to break or fracture (usually at the spine, wrist or hip). Spine fractures may result in a curved back, height loss or back pain. NTP-RISEDRONATE corrects this imbalance by decreasing the elevated rate of bone removal. NTP-RISEDRONATE can therefore help reduce the risk of spine and non-spine fractures.

Your doctor may measure the thickness (i.e., density) of your bone through a bone mineral density (BMD) test or x-ray to check your progress against further bone loss or fracture.

NTP-RISEDRONATE is not a pain reliever. Your doctor may prescribe or recommend another medicine specifically for pain relief.

When it should not be used:

• If you have low blood calcium levels (hypocalcemia),

• If you are allergic to risedronate sodium or any other

  ingredients in NTP-RISEDRONATE.

What the medicinal ingredient is:

Risedronate sodium

What the nonmedicinal ingredients are:

Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium stearyl fumarate, starch and film-coating containing the following:

5 mg: D&C yellow #10 lake, hydroxypropyl methylcellulose, iron oxide yellow, polyethylene glycol, polysorbate and titanium dioxide.

30 mg: hydroxypropyl methylcellulose, polyethylene glycol, polysorbate and titanium dioxide.

35 mg: FD&C yellow #6/sunset yellow FCF aluminium lake, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polyethylene glycol, polysorbate and titanium dioxide.

What dosage forms it comes in:

NTP-RISEDRONATE is available as tablets. Each tablet contains: risedronate sodium 5 mg (yellow), 30 mg (white) or 35 mg (orange).

WARNINGS AND PRECAUTIONS

Before you use NTP-RISEDRONATE, talk to your doctor or pharmacist if:

• You have problems or disease in your kidneys, esophagus

  (the tube connecting the mouth and stomach), stomach or intestines.

• You cannot carry out dosing instructions (see PROPER USE

  OF THIS MEDICATION).

• You are pregnant or nursing.

• You have one of the following risk factors: cancer, chemotherapy, radiotherapy of the head or neck, treatment with corticosteroids or dental problems or dental infections. If so, a dental examination and any necessary dental procedures should be considered before you start treatment with NTP-RISEDRONATE.

Calcium and vitamin D are also important for strong bones. Your doctor may ask you to take calcium and vitamin D while you are on NTP-RISEDRONATE therapy (see INTERACTIONS WITH THIS MEDICATION section).

INTERACTIONS WITH THIS MEDICATION

If taken with some other medicines, the effects of NTP-RISEDRONATE or the effects of other medicines may be changed. It is important to tell your health care providers, including doctors and dentists, about all medications you are taking, even if the medicine does not require a prescription (including vitamin and herbal supplements).

You should not take NTP-RISEDRONATE with food, as it may prevent your body from absorbing or using NTP-RISEDRONATE. You should take NTP-RISEDRONATE on an empty stomach. (See PROPER USE OF THIS MEDICATION for instruction).

Vitamins, mineral supplements, antacids and other medications may contain substances (e.g., calcium, magnesium, aluminum, and iron) which can stop your body from absorbing or using NTP-RISEDRONATE.

These medications should be taken at a different time of day than NTP-RISEDRONATE.

If you are taking this drug for Paget’s disease, talk to your doctor before taking acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs used for pain management because the risk of stomach upset may be increased.

PROPER USE OF THE MEDICATION

As with all medications, it is important to take as directed by your doctor.

Usual Dose:

Treatment of postmenopausal osteoporosis:

• 1 tablet (5 mg) per day or
• 1 tablet (35 mg) per week

Prevention of postmenopausal osteoporosis:

• 1 tablet (5 mg) per day or
• 1 tablet (35 mg) per week

Treatment and prevention of glucocorticoid-induced osteoporosis:

• 1 tablet (5 mg) per day

Paget’s disease of the bone:

• 1 tablet (30 mg) per day

DOSING INSTRUCTIONS

• NTP-RISEDRONATE should be taken in the morning on

  an empty stomach at least 30 minutes before consuming the first food, drink (other than plain water) and/or any other medication of the day. Food, medication or drink other than plain water can interfere with the absorption of NTP-RISEDRONATE.

• Each NTP-RISEDRONATE tablet should be swallowed

  whole while you are in an upright position and with sufficient plain water (≥ 120 mL or ½ cup) to facilitate delivery to the stomach.

• Aside from plain water, do not eat or drink for at

  least 30 minutes after taking NTP-RISEDRONATE.

• You should not lie down for at least 30 minutes

  after taking the medication. You may sit, stand or do normal activities like read the newspaper, take a walk, etc.

• NTP-RISEDRONATE tablets should not be chewed, cut, or

  crushed.

These recommendations help NTP-RISEDRONATE work correctly and help you avoid possible irritation of the esophagus (the tube connecting the mouth and the stomach).

Once daily dosing (5 mg or 30 mg per day):

• Take 1 NTP-RISEDRONATE tablet first thing in the morning with plain water before you have

anything to eat or drink.

Once weekly dosing (35 mg per week):

• Choose a day of the week to take your tablet.

• On your chosen day, take 1 ACTONEL tablet

  first thing in the morning with plain water before you have anything to eat or drink.

You should take NTP-RISEDRONATE for as long as your doctor recommends, to continue to prevent bone loss and protect your bones from fractures.

Missed Dose:

Daily dose (5 mg or 30 mg tablet): If you forget to take your dose, do not double your next dose (i.e., do not take 2 tablets on the same day). Simply take 1 tablet at your next scheduled time.

Weekly dose (35 mg tablet): If you forget to take your dose on the regularly scheduled day, simply take 1 tablet on the day you first remember having missed your dose. Then resume your schedule by taking 1 tablet on the originally chosen day of the week. If you’ve missed your dose by exactly one week, do not take 2 tablets on the same day. Simply take 1 tablet as you normally would have on this day and resume your usual weekly schedule.

Overdose:

For NTP-RISEDRONATE overdose, drink a full glass of milk. Do not induce vomiting.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Drugs like NTP-RISEDRONATE may cause problems in your esophagus (the tube that connects the mouth and the stomach), stomach and intestines, including ulcers. If you have trouble or pain upon swallowing, heartburn, chest pain and black or bloody stools stop taking NTP-RISEDRONATE and tell your doctor right away. Remember to take NTP-RISEDRONATE as directed.

In clinical studies of osteoporosis with risedronate sodium, the most commonly reported side effects were abdominal pain, heartburn and nausea. In studies of Paget’s disease, diarrhea and headache were also commonly reported.

NTP-RISEDRONATE may cause pain in bones, joints or muscles, rarely severe. Pain may start as soon as one day or up to several months after starting NTP-RISEDRONATE.

Very rarely patients have reported non-healing jaw wounds while receiving risedronate sodium or other drugs in this class. Consult your doctor if you experience persistent pain in your mouth, teeth or jaw, or if your gums or mouth heal poorly.

Very rarely patients have reported unusual fractures in their thigh bone while receiving drugs in this class. Consult your doctor if you experience new or unusual pain in your hip, groin, or thigh.

If you take too many tablets on any given day, contact your doctor, or a Poison Control Centre, or an

emergency room of the nearest hospital immediately. IMPORTANT SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

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

HOW TO STORE IT

• Keep NTP-RISEDRONATE and all other medications out of

  the reach of children.

• Keep the tablets in their original package and store at

  controlled room temperature (15°C - 30°C). Protect from light.

• Do not keep medicine that is out of date or that you no longer

  need.

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 Teva Canada Limited at:

1-800-268-4127 ext. 5005 (English);

1-877-777-9117 (French)

or druginfo@tevacanada.com

NT Pharma Canada Ltd. 5691 Main Street Stouffville, ON L4A 1H5

Canada

Last revised: July 26, 2012