Ratio-Risedronate: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• Treatment and prevention of osteoporosis in

  postmenopausal women

• Treatment of osteoporosis in men, to improve bone mineral

  density

What it does:

ratio-RISEDRONATE is a bisphonate drug that helps to slow

bone loss. In many people, ratio-RISEDRONATE 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. ratio-RISEDRONATE corrects this imbalance by

decreasing the elevated rate of bone removal. ratio-

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.

ratio-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 ratio-RISEDRONATE.

What the medicinal ingredient is:

Risedronate sodium as risedronate sodium hemi-pentahydrate

What the nonmedicinal ingredients are:

Microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, lactose monohydrate, hydroxypropyl methylcellulose, FD&C yellow, iron oxide yellow, polyethylene glycol, titanium dioxide.

What dosage form it comes in:

ratio-RISEDRONATE is available as tablets, containing risedronate sodium 35 mg (orange).

WARNINGS AND PRECAUTIONS

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

• You have had problems or disease in your kidneys, esophagus (the tube connecting the mouth and the 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 ratio-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 ratio-RISEDRONATE therapy (see

INTERACTIONS WITH THIS MEDICATION section).

INTERACTIONS WITH THIS MEDICATION

If taken with some other medicines, the effects of ratio-RISEDRONATE or the effects of the 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 ratio-RISEDRONATE with food, as it may prevent your body from absorbing or using ratio-RISEDRONATE. You should take ratio-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 ratio-RISEDRONATE.

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

PROPER USE OF THIS MEDICATION

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

Usual Dose:

Treatment of postmenopausal osteoporosis:

• 1 tablet (35 mg) per week

Prevention of postmenopausal osteoporosis:

• 1 tablet (35 mg) per week

Treatment of Osteoporosis in Men, to Improve Bone Mineral Density:

• 1 tablet (35 mg) per week

DOSING INSTRUCTIONS

• ratio-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 ratio-RISEDRONATE.

• Each ratio-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 ratio-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.

• ratio-RISEDRONATE tablets should not be chewed, cut,

  or crushed.

These recommendations help ratio-RISEDRONATE work

correctly and help you avoid possible irritation of the esophagus

(the tube connecting the mouth and the stomach).

Once weekly dosing (35 mg per week):

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

• On your chosen day, take 1 ratio-RISEDRONATE tablet

  first thing in the morning with plain water before you have

  anything to eat or drink.

You should take ratio-RISEDRONATE for as long as your

doctor recommends, to continue to prevent bone loss and

protect your bones from fractures.

Missed Dose:

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:

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.

For ratio-RISEDRONATE overdose, drink a full glass of milk.

Do not induce vomiting.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Drugs like ratio-RISEDRONATE may cause problems in your esophagus (the tube connecting 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 ratio-RISEDRONATE and tell your doctor right away. Remember to take ratio-RISEDRONATE as directed.

In clinical studies of osteoporosis with risedronate, the most commonly reported side effects were abdominal pain, heartburn and nausea.

ratio-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 ratio-RISEDRONATE.

Very rarely patients have reported non-healing jaw wounds while receiving ratio-RISEDRONATE 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.

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

HOW TO STORE IT

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™ 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 ratiopharm at: 1-800-268-4127 ext. 5005 (English);

1-877-777-9117 (French)

or druginfo@tevacanada.com ratiopharm inc.

17800 Rue Lapointe

Mirabel, Quebec

Canada J7J 1P3

Last revised: May 31, 2012