Consumer Information for: MYLAN-RISEDRONATE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

MYLAN-RISEDRONATE - 35 mg

  • Treatment and prevention of osteoporosis in postmenopausal women
  • Treatment of osteoporosis in men, to improve bone mineral density

MYLAN-RISEDRONATE - 150 mg

  • Treatment of osteoporosis in postmenopausal women
What it does

MYLAN-RISEDRONATE - 35 mg

MYLAN-RISEDRONATE is a bisphosphonate drug that helps to slow bone loss. In many people, MYLAN-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. MYLAN-RISEDRONATE corrects this imbalance by decreasing the elevated rate of bone removal. MYLAN-RISEDRONATE can therefore help reduce the risk of spine and non-spine fractures.

Since it is not known how long MYLAN-RISEDRONATE should be continued for patients with osteoporosis, you should discuss the need to stay on this medication with your doctor regularly to determine if MYLAN-RISEDRONATE is still right for you.

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.

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

MYLAN-RISEDRONATE - 150 mg

MYLAN-RISEDRONATE is a bisphosphonate drug that helps to slow bone loss. In many people, MYLAN-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. MYLAN-RISEDRONATE corrects this imbalance by decreasing the elevated rate of bone removal. MYLAN-RISEDRONATE can therefore help reduce the risk of spine and non-spine fractures.

Since it is not known how long MYLAN-RISEDRONATE should be continued for patients with osteoporosis, you should discuss the need to stay on this medication with your doctor regularly to determine if MYLAN-RISEDRONATE is still right for you.

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.

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

When it should not be used

MYLAN-RISEDRONATE - 35 mg

  • If you have low blood calcium levels (hypocalcemia).
  • If you are allergic to risedronate sodium or any other ingredients in MYLAN-RISEDRONATE.

MYLAN-RISEDRONATE - 150 mg

  • If you have low blood calcium levels (hypocalcemia).
  • If you are allergic to risedronate sodium or any other ingredients in MYLAN-RISEDRONATE.
What the medicinal ingredient is

MYLAN-RISEDRONATE - 35 mg

Risedronate sodium

MYLAN-RISEDRONATE - 150 mg

Risedronate sodium

What the non-medicinal ingredients are

MYLAN-RISEDRONATE - 35 mg

35 mg
Colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, and microcrystalline cellulose.
Coating: hydroxypropylmethylcellulose, iron oxide yellow, iron oxide red, polydextrose, polyethylene glycol, titanium dioxide, and triacetin.

MYLAN-RISEDRONATE - 150 mg

150 mg
Colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, and microcrystalline cellulose.
Coating: FD&C blue #2/indigo carmine aluminum lake, FD&C yellow#6/sunset yellow FCF aluminum lake, hypromellose, polydextrose, polyethylene glycol, and titanium dioxide.

What dosage form it comes in

MYLAN-RISEDRONATE - 35 mg

MYLAN-RISEDRONATE is available as 35 mg tablets. Each 35 mg tablet contains 35 mg risedronate sodium.

MYLAN-RISEDRONATE - 150 mg

MYLAN-RISEDRONATE is available as 150 mg tablets. Each 150 mg tablet contains 150 mg risedronate sodium.

Warnings and precautions

MYLAN-RISEDRONATE - 35 mg

Before you use MYLAN-RISEDRONATE tablets, 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.
  • cannot carry out dosing instructions (see PROPER USE OF THIS MEDICATION).
  • are pregnant or nursing.
  • have one of the following risk factors: cancer, diabetes, chemotherapy, radiotherapy of the head or neck, immunosuppression, poor oral hygiene treatment with corticosteroids or angiogenesis inhibitors (drugs that slow down the growth of new blood vessels and are used mostly to treat cancer).
  • had or have pain, swelling or numbness of the jaw or loosening of a tooth or any other oral symptoms.

Your doctor should inspect your mouth and may ask that you have a dental examination prior to treatment with MYLAN-RISEDRONATE. Dental work should be done before you receive treatment with MYLAN-RISEDRONATE, and dental procedures should be avoided during treatment. It is important that you practice good dental hygiene, routine dental care and have regular dental check-ups while being treated with MYLAN-RISEDRONATE. Immediately report any oral symptoms such as loosening of a tooth, pain, swelling, or non-healing sores or discharge (pus or oozing) during your treatment with MYLAN-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 MYLAN-RISEDRONATE therapy (see INTERACTIONS WITH THIS MEDICATION section).

MYLAN-RISEDRONATE - 150 mg

Before you use MYLAN-RISEDRONATE tablets, 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.
  • cannot carry out dosing instructions (see PROPER USE OF THIS MEDICATION).
  • are pregnant or nursing.
  • have one of the following risk factors: cancer, diabetes, chemotherapy, radiotherapy of the head or neck, immunosuppression, poor oral hygiene treatment with corticosteroids or angiogenesis inhibitors (drugs that slow down the growth of new blood vessels and are used mostly to treat cancer).
  • had or have pain, swelling or numbness of the jaw or loosening of a tooth or any other oral symptoms.

Your doctor should inspect your mouth and may ask that you have a dental examination prior to treatment with MYLAN-RISEDRONATE. Dental work should be done before you receive treatment with MYLAN-RISEDRONATE, and dental procedures should be avoided during treatment. It is important that you practice good dental hygiene, routine dental care and have regular dental check-ups while being treated with MYLAN-RISEDRONATE. Immediately report any oral symptoms such as loosening of a tooth, pain, swelling, or non-healing sores or discharge (pus or oozing) during your treatment with MYLAN-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 MYLAN-RISEDRONATE therapy (see INTERACTIONS WITH THIS MEDICATION section).

Interactions with this medication

MYLAN-RISEDRONATE - 35 mg

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

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 MYLAN-RISEDRONATE. These medications should be taken at a different time of day than MYLAN-RISEDRONATE. Talk to your health care provider about how and when to take these medications.

Taking MYLAN-RISEDRONATE with corticosteroids or angiogenesis inhibitors may increase your chance of osteonecrosis of the jaw.

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

MYLAN-RISEDRONATE - 150 mg

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

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 MYLAN-RISEDRONATE. These medications should be taken at a different time of day than MYLAN-RISEDRONATE. Talk to your health care provider about how and when to take these medications.

Taking MYLAN-RISEDRONATE with corticosteroids or angiogenesis inhibitors may increase your chance of osteonecrosis of the jaw.

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

Proper use of this medication

MYLAN-RISEDRONATE - 35 mg

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

MYLAN-RISEDRONATE INSTRUCTIONS

  • MYLAN-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 MYLAN-RISEDRONATE.
  • Each MYLAN-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 MYLAN-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.
  • MYLAN-RISEDRONATE tablets should not be chewed, cut, or crushed.

These recommendations help MYLAN-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 MYLAN-RISEDRONATE tablet first thing in the morning with plain water before you have anything to eat or drink.

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

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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

MYLAN-RISEDRONATE - 150 mg

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

Usual Dose

Treatment of postmenopausal osteoporosis:

  • 1 tablet (150 mg) once per month on the same calendar day each month

MYLAN-RISEDRONATE INSTRUCTIONS

  • MYLAN-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 MYLAN-RISEDRONATE.
  • Each MYLAN-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 MYLAN-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.
  • MYLAN-RISEDRONATE tablets should not be chewed, cut, or crushed.

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

Once monthly dosing (150 mg total dose):

  • Choose a day of the month that you will remember and that best fits your schedule to take your MYLAN-RISEDRONATE dose (1 tablet of 150 mg) once per month.
  • On your chosen day each month, take 1 MYLAN-RISEDRONATE 150 mg tablet first thing in the morning with plain water before you have anything to eat or drink.

Missed Dose

Once monthly dose (150 mg tablet): If you miss the 150 mg dose of MYLAN-RISEDRONATE (1 tablet of 150 mg) in the morning, do not take it later in the day. If the next month’s scheduled dose is more than 7 days away, take the missed tablet on the morning after the day it is remembered. You should then return to your usual schedule of MYLAN-RISEDRONATE 150 mg.

If the next month’s scheduled dose is 1 to 7 days away, you should wait until next month’s scheduled dose and then resume taking MYLAN-RISEDRONATE 150 mg as originally scheduled. Do not take more than 150 mg of MYLAN-RISEDRONATE within 7 days.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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

Side effects and what to do about them

MYLAN-RISEDRONATE - 35 mg

Drugs like MYLAN-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 MYLAN-RISEDRONATE and tell your doctor right away. Remember to take MYLAN-RISEDRONATE as directed.

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

MYLAN-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 MYLAN-RISEDRONATE.

MYLAN-RISEDRONATE at monthly doses may cause short-lasting, mild flu-like symptoms. These symptoms usually decrease after subsequent doses.

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.

Serious side effects, how often they happen and what to do about them
Symptom / Effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention
Common (more than 1 in 100)
Pain in bones, joints, or muscles ✔    
Abdominal pain ✔    
Uncommon (less than 1 in 100)
Eye pain, redness or inflammation; sensitivity to light, decreased vision     ✔
Rare (less than 1 in 1,000)
Painful tongue   ✔  
Osteonecrosis of the jaw: Jaw problems associated with numbness or feeling of heaviness in the jaw, poor healing of the gums especially after dental work, loose teeth, exposed bone in the mouth, sores or nonhealing sores in the mouth, discharge, dry mouth, swelling gum, infections, bad breath or pain in the mouth, teeth or jaw.   ✔  
Very rare (less than 1 in 10,000)
Allergic and skin reactions such as : hives; rash (with or without blisters); swelling of face, lips, tongue, or throat; difficult or painful swallowing; trouble breathing     ✔
Symptoms of low blood calcium level such as numbness, tingling, muscle spasms   ✔  
New or unusual pain in hip, groin or thigh   ✔  

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

MYLAN-RISEDRONATE - 150 mg

Drugs like MYLAN-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 MYLAN-RISEDRONATE and tell your doctor right away. Remember to take MYLAN-RISEDRONATE as directed.

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

MYLAN-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 MYLAN-RISEDRONATE.

MYLAN-RISEDRONATE at monthly doses may cause short-lasting, mild flu-like symptoms. These symptoms usually decrease after subsequent doses.

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.

Serious side effects, how often they happen and what to do about them
Symptom / Effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention
Common (more than 1 in 100)
Pain in bones, joints, or muscles ✔    
Abdominal pain ✔    
Uncommon (less than 1 in 100)
Eye pain, redness or inflammation; sensitivity to light, decreased vision     ✔
Rare (less than 1 in 1,000)
Painful tongue   ✔  
Osteonecrosis of the jaw: Jaw problems associated with numbness or feeling of heaviness in the jaw, poor healing of the gums especially after dental work, loose teeth, exposed bone in the mouth, sores or nonhealing sores in the mouth, discharge, dry mouth, swelling gum, infections, bad breath or pain in the mouth, teeth or jaw.   ✔  
Very rare (less than 1 in 10,000)
Allergic and skin reactions such as : hives; rash (with or without blisters); swelling of face, lips, tongue, or throat; difficult or painful swallowing; trouble breathing     ✔
Symptoms of low blood calcium level such as numbness, tingling, muscle spasms   ✔  
New or unusual pain in hip, groin or thigh   ✔  

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

MYLAN-RISEDRONATE - 35 mg

  • Keep MYLAN-RISEDRONATE and all other medications out of the reach of children.
  • Keep the tablets in their original package. Store in tightly closed containers between 15°C and 30°C.
  • Do not keep medicine that is out of date or that you no longer need.

MYLAN-RISEDRONATE - 150 mg

  • Keep MYLAN-RISEDRONATE and all other medications out of the reach of children.
  • Keep the tablets in their original package. Store in tightly closed containers between 15°C and 30°C.
  • Do not keep medicine that is out of date or that you no longer need.
Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
                    Health Canada, Postal Locator
                    0701E
                    Ottawa, ON
                    K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

This leaflet was prepared by Mylan Pharmaceuticals ULC Etobicoke, Ontario M8Z 2S6

Revised on: July 14, 2016

Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca

Date modified: