What Actonel is used for and how to use it
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Actonel – Consumer Medicine Information

Manufacture: Actavis
Country: Canada
Condition: Osteoporosis, Paget's Disease, Prevention of Osteoporosis
Class: Bisphosphonates
Form: Tablets
Ingredients: Risedronate Sodium, Crospovidone, Ferric Oxide (5, 35 & 75 Mg), Hydroxypropyl Cellulose, Hypromellose, Indigo Carmine (150 Mg), Lactose Monohydrate (5, 30 & 35 Mg), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Silicon Dioxide And Titanium Dioxide, Edetate Disodium, Ferric Oxide Yellow, Magnesium Stearate, Methacrylic Acid Copolymer Dispersion, Polysorbate 80, Silicified Microcrystalline Cellulose, Simethicone, Sodium Starch Glycolate, Stearic Acid, Talc And Triethyl Citrate

ACTONEL

Risedronate Sodium Tablets

and

ACTONEL DR

Risedronate Sodium Delayed-Release Tablets

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
  • Treatment and prevention of osteoporosis caused by treatment with steroid medication such as prednisone
  • Treatment of Paget’s disease of bone

What it does

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

Since it is not known how long ACTONEL and ACTONEL DR should be continued for patients with osteoporosis, you should discuss the need to stay on this medication with your doctor regularly to determine if ACTONEL and ACTONEL DR are 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.

ACTONEL and ACTONEL DR are not pain relievers. 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 ACTONEL or ACTONEL DR.

What the medicinal ingredient is

Risedronate sodium

What the nonmedicinal ingredients are

ACTONEL (film-coated) tablets

Crospovidone, ferric oxide (5, 35 & 75 mg), hydroxypropyl cellulose, hypromellose, indigo carmine (150 mg), lactose monohydrate (5, 30 & 35 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide.

ACTONEL DR (delayed-release) tablets

Edetate disodium, ferric oxide yellow, magnesium stearate, methacrylic acid copolymer dispersion, polysorbate 80, silicified microcrystalline cellulose, simethicone, sodium starch glycolate, stearic acid, talc and triethyl citrate.

What dosage form it comes in

ACTONEL film-coated tablets

Each ACTONEL tablet contains risedronate sodium 5 mg (yellow), 30 mg (white), 35 mg (orange), 75 mg (pink) or 150 mg (blue).

ACTONEL DR tablets

Each yellow, enteric coated ACTONEL DR tablet contains risedronate sodium 35 mg.

The ACTONEL DR tablet has an enteric coating, which delays the release of risedronate until the small intestine.

Warnings and Precautions

Before you use ACTONEL or ACTONEL DR, 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 ACTONEL or ACTONEL DR.

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 ACTONEL or ACTONEL DR therapy (see INTERACTIONS WITH THIS MEDICATION section).

Interactions with this Medication

If taken with some other medicines, the effects of ACTONEL, ACTONEL DR 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).

ACTONEL

You should not take ACTONEL with food, as it may prevent your body from absorbing or using ACTONEL. You should take ACTONEL 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 ACTONEL. These medications should be taken at a different time of day than ACTONEL.

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

ACTONEL DR

ACTONEL DR should be taken with food. Talk to your doctor to ensure that you fully understand which dosage form you have been prescribed. Medicines which reduce stomach acid [such as Proton Pump Inhibitors (PPIs) and H2 blockers] can affect the absorption of Actonel DR. Discuss with your doctor or pharmacist how and when to take these medications.

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 ACTONEL tablet (5 mg) per day or
  • 1 ACTONEL tablet (35 mg) per week or
  • 1 ACTONEL DR tablet (35 mg) per week or
  • 1 ACTONEL tablet (75 mg) per day for two consecutive days each month, on the same two calendar days each month or
  • 1 ACTONEL tablet (150 mg) once per month, on the same calendar day each month

Prevention of postmenopausal osteoporosis

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

Treatment of osteoporosis in men, to improve bone mineral density

  • 1 ACTONEL tablet (35 mg) per week

Treatment and prevention of glucocorticoid-induced osteoporosis

  • 1 ACTONEL tablet (5 mg) per day

Paget’s disease of bone

  • 1 ACTONEL tablet (30 mg) per day

ACTONEL Dosing Instructions

(For ACTONEL DR dosing instructions see below)

  • ACTONEL 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 ACTONEL.
  • Each ACTONEL 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 ACTONEL.
  • 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.
  • ACTONEL tablets should not be chewed, cut, or crushed.

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

ACTONEL is not the same as ACTONEL DR. Clinical benefits may be compromised by failure to take ACTONEL on an empty stomach. Only ACTONEL DR can be taken with food. Talk to your health professional to ensure that you are clear on the dosage form you have been prescribed.

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

  • Take 1 ACTONEL tablet first thing in the morning with plain water before you have anything to eat or drink.

Once weekly dosing (35 mg per week – see below for ACTONEL DR dosing instructions)

  • 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.

Monthly duet dosing (75 mg on two consecutive days per month)

  • Choose 2 days in a row each month that you will remember and that best fits your schedule to take your ACTONEL doses.
  • Take 1 ACTONEL tablet first thing in the morning with plain water before you have anything to eat or drink on your first chosen day.
  • Take the second ACTONEL tablet in the morning of the following day with plain water before you have anything to eat or drink.
  • ACTONEL should be taken on the same two consecutive calendar days each month.

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 ACTONEL dose (1 tablet of 150 mg) once per month.
  • On your chosen day each month, take 1 ACTONEL 150 mg tablet first thing in the morning with plain water before you have anything to eat or drink.

ACTONEL DR Dosing Instructions

  • ACTONEL DR should be taken in the morning with breakfast (including high fat foods, coffee, tea, milk, orange juice, etc.). Do not take ACTONEL DR before breakfast or on an empty stomach. This may cause upper abdominal pain.
  • Each ACTONEL DR 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.
  • 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.
  • ACTONEL DR tablets should not be chewed, cut, or crushed. Care should be taken not to break the outer coating which is designed to remain intact until the tablet reaches the small intestine where the tablet coating dissolves and releases the active ingredient.

These recommendations help ACTONEL DR work correctly and help you avoid possible irritation of the esophagus (i.e., the tube connecting the mouth and the stomach).

ACTONEL DR Once weekly dosing (35 mg per week):

  • Choose a day of the week to take your tablet.
  • On your chosen day, take 1 ACTONEL DR tablet in the morning with plain water.

Missed Dose

Daily dose (ACTONEL 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 ACTONEL tablet or 35 mg ACTONEL DR 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.

Monthly duet dose (ACTONEL 75 mg tablet):

If you miss one or both tablets of your dose of ACTONEL 75 mg in the morning, do not take it later in the day. If the next month’s scheduled doses are more than 7 days away do the following:

  • If both tablets were missed, take the first ACTONEL 75 mg tablet on the morning after the day it is remembered and the second tablet on the next consecutive morning.
  • If only one tablet is missed, take the missed tablet on the morning after the day it is remembered.

You should then continue your usual schedule of ACTONEL 75 mg on two consecutive days each month. Do not take more than two 75 mg tablets within 7 days.

If the next month's scheduled doses are 1 to 7 days away, you should wait until next month’s scheduled doses and then resume taking ACTONEL 75 mg on two consecutive days each month as originally scheduled.

Once monthly dose (ACTONEL 150 mg tablet):

If you miss the 150 mg dose of ACTONEL (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 ACTONEL 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 ACTONEL 150 mg as originally scheduled. Do not take more than 150 mg of ACTONEL within 7 days.

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 ACTONEL overdose, drink a full glass of milk. Do not induce vomiting.

Side Effects and what to do about them

Drugs like ACTONEL and ACTONEL DR 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 ACTONEL or ACTONEL DR and tell your doctor right away. Remember to take ACTONEL or ACTONEL DR as directed.

ACTONEL side effects

In clinical studies of osteoporosis with ACTONEL, 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.

ACTONEL 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 ACTONEL.

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

Rarely patients have reported non-healing jaw wounds while receiving ACTONEL 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.

ACTONEL DR side effects

Other side effects of ACTONEL DR include.

Most common side effects:

  • Abdominal pain, heartburn, nausea

Other common side effects:

  • Pain in bones, joints, or muscles, rarely severe. The pain may start as soon as one day or up to several months after starting ACTONEL DR.
  • Diarrhea, constipation, inflammation of the pharynx and/or nose, upper respiratory tract infection.

Rare Side Effects:

  • Non-healing jaw. Talk to your doctor if you experience persistent pain in your mouth, teeth or jaw, or if your gums or mouth heal poorly.

Very Rare Side Effects:

  • Unusual fractures in the thigh bone. Talk to your doctor if you experience new or unusual pain in your hip, groin or thigh.
Important Side Effects, how often they Happen and what to do about them
Symptom / EffectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor or
pharmacist
Only if
severe
In all
cases
Common (more than 1 in 100)
Pain in bones, joints, or musclesX
Abdominal painX
Uncommon (less than 1 in 100)
Eye pain, redness or inflammation; sensitivity to light, decreased visionX
Rare (less than 1 in 1,000)
Painful tongueX
Jaw problems associated with delayed healing and infection, often following tooth extraction.X
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 breathingX
Symptoms of low blood calcium level such as numbness, tingling, muscle spasmsX
New or unusual pain in hip, groin or thighX

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

How to Store it

  • Keep ACTONEL or ACTONEL DR and all other medications out of the reach of children.
  • Keep the tablets in their original package and store at controlled room temperature (20°-25°C) .
  • 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:

  • 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, Ontario 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

For more information, please visit http://www.actonel.ca.


This document plus the full product monograph, prepared for health professionals is available by contacting Warner Chilcott Canada Co. at: 1-855-892-8766.

ACTONEL DR

Risedronate Sodium Delayed-Release Tablets

About this Medication

What the medication is used for

  • Treatment of osteoporosis in postmenopausal women

What it does

ACTONEL DR is a bisphosphonate drug that helps to slow bone loss. In many people, ACTONEL DR 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. ACTONEL DR corrects this imbalance by decreasing the elevated rate of bone removal. ACTONEL DR 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.

ACTONEL DR is not a pain reliever. Your doctor may prescribe or recommend another medicine specifically for pain relief.

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

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 ACTONEL DR.

What the medicinal ingredient is

Risedronate sodium

What the nonmedicinal ingredients are

Edetate disodium, ferric oxide yellow, magnesium stearate, methacrylic acid copolymer dispersion, polysorbate 80, silicified microcrystalline cellulose, simethicone, sodium starch glycolate, stearic acid, talc and triethyl citrate.

What dosage form it comes in

Each yellow, enteric coated ACTONEL DR tablet contains risedronate sodium 35 mg.

The ACTONEL DR tablet has an enteric coating, which delays the release of risedronate until the small intestine.

Warnings and Precautions

Before you use ACTONEL DR, 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 ACTONEL DR.

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 ACTONEL DR therapy (see INTERACTIONS WITH THIS MEDICATION section).

Interactions with this Medication

If taken with some other medicines, the effects of ACTONEL DR 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).

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 ACTONEL DR. These medications should be taken at a different time of day than ACTONEL DR. Medicines which reduce stomach acid [such as Proton Pump Inhibitors (PPIs) and H2 blockers] can affect the absorption of Actonel DR. Discuss with your doctor or pharmacist how and when to take these medications.

Proper Use of this Medication

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

Usual Dose

  • 1 ACTONEL DR tablet (35 mg) per week
  • Choose a day of the week to take your tablet.
  • On your chosen day, take 1 ACTONEL DR tablet in the morning with plain water.

Instructions for Use

  • ACTONEL DR should be taken in the morning with breakfast (including high fat foods, coffee, tea, milk, orange juice, etc.). Do not take ACTONEL DR before breakfast or on an empty stomach. This may cause upper abdominal pain.
  • Each ACTONEL DR tablet should be swallowed whole while in an upright position and with sufficient plain water (≥ 120 mL or ½ cup) to facilitate delivery to the stomach.
  • 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.
  • ACTONEL DR tablets should not be chewed, cut, or crushed. Care should be taken not to break the outer coating which is designed to remain intact until the tablet reaches the small intestine where the tablet coating dissolves and releases the active ingredient.

These recommendations help ACTONEL DR work correctly and help you avoid possible irritation of the esophagus (i.e., the tube connecting the mouth and the stomach).

Missed Dose

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.

Side Effects and what to do about them

Drugs like ACTONEL DR 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 ACTONEL DR and tell your doctor right away. Other side effects of ACTONEL DR include.

Most common side effects:

  • Abdominal pain, heartburn, nausea

Other common side effects:

  • Pain in bones, joints, or muscles, rarely severe. The pain may start as soon as one day or up to several months after starting ACTONEL DR.
  • Diarrhea, constipation, inflammation of the pharynx and/or nose, upper respiratory tract infection.

Rare Side Effects:

  • Non-healing jaw. Talk to your doctor if you experience persistent pain in your mouth, teeth or jaw, or if your gums or mouth heal poorly.

Very Rare Side Effects:

  • Unusual fractures in the thigh bone. Talk to your doctor if you experience new or unusual pain in your hip, groin or thigh.
Important Side Effects, how often they Happen and what to do about them
Symptom / EffectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor or
pharmacist
Only if
severe
In all
cases
Common (more than 1 in 100)
Pain in bones, joints, or musclesX
Abdominal painX
Uncommon (less than 1 in 100)
Eye pain, redness or inflammation; sensitivity to light, decreased visionX
Rare (less than 1 in 1,000)
Painful tongueX
Jaw problems associated with delayed healing and infection, often following tooth extraction.X
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 breathingX
Symptoms of low blood calcium level such as numbness, tingling, muscle spasmsX
New or unusual pain in hip, groin or thighX

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

How to Store it

  • Keep ACTONEL DR and all other medications out of the reach of children.
  • Keep the tablets in their original package and store at controlled room temperature (20°-25°C).
  • 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:

  • 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, Ontario 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

For more information, please visit http://www.actonel.ca.


This document plus the full product monograph, prepared for health professionals is available by contacting Warner Chilcott Canada Co. at: 1-855-892-8766.

ACTONEL 75 mg

Risedronate Sodium

About this Medication

What the medication is used for

Treatment of osteoporosis in postmenopausal women.

What it does

ACTONEL is a bisphosphonate drug that helps to slow bone loss. In many people, ACTONEL 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. ACTONEL corrects this imbalance by decreasing the elevated rate of bone removal. ACTONEL 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.

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

Since it is not known how long ACTONEL should be continued for treating and preventing osteoporosis, you should discuss the need to stay on this medication with your doctor regularly to determine if ACTONEL is still right for you.

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 ACTONEL.

What the medicinal ingredient is

Risedronate sodium

What the nonmedicinal ingredients are

Crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide.

What dosage form it comes in

Each ACTONEL 75 mg pink tablet contains risedronate sodium 75 mg.

Warnings and Precautions

Before you use ACTONEL, 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 ACTONEL.

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 ACTONEL therapy. (see INTERACTIONS WITH THIS MEDICATION section).

Interactions with this Medication

If taken with some other medicines, the effects of ACTONEL or the effects of other medicines may be changed. It is important to tell your health care providorse, 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 ACTONEL with food, as it may prevent your body from absorbing or using ACTONEL. You should take ACTONEL on an empty stomach. (See PROPER USE OF THIS MEDICATION for instruction).

Vitamin and mineral supplements, as well as antacids, may contain substances (e.g., calcium, magnesium, aluminum, and iron) which can stop your body from absorbing or using ACTONEL. These should be taken at a different time of day.

Proper Use of this Medication

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

Usual Dose

Treatment of postmenopausal osteoporosis

Monthly Duet Dose

  • ACTONEL 75 mg is a “monthly duet” given as 1 tablet per day for two consecutive days each month, on the same two calendar days each month.
  • Choose 2 days in a row each month that you will remember and that best fit your schedule to take your ACTONEL 75 mg doses.
  • Take the first ACTONEL 75 mg tablet of the monthly duet first thing in the morning with plain water before you have anything to eat or drink on your first chosen day.
  • Take the second ACTONEL 75 mg tablet of the monthly duet in the morning of the following day with plain water before you have anything to eat or drink.
  • ACTONEL 75 mg should be taken on the same two consecutive calendar days each month.

Dosing Instructions

  • ACTONEL 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 ACTONEL.
  • Each ACTONEL 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.
  • 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.
  • ACTONEL tablets should not be chewed, cut, or crushed.

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

Missed Dose

Monthly duet

If you miss one or both tablets of your dose of ACTONEL 75 mg in the morning, do not take it later in the day. If the next month’s scheduled doses are more than 7 days away do the following:

  • If both tablets were missed, take the first ACTONEL 75 mg tablet on the morning after the day it is remembered and the second tablet on the next consecutive morning.
  • If only one tablet is missed, take the missed tablet on the morning after the day it is remembered.

You should then continue your usual schedule of ACTONEL 75 mg on two consecutive days each month. Do not take more than two 75 mg tablets within 7 days.

If the next month's scheduled doses are 1 to 7 days away, you should wait until next month’s scheduled doses and then resume taking ACTONEL 75 mg on two consecutive days each month as originally scheduled.

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. Drink a full glass of milk. Do not induce vomiting.

Side Effects and what to do about them

Drugs like ACTONEL 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 ACTONEL and tell your doctor right away. Remember to take ACTONEL as directed.

In clinical studies of osteoporosis with ACTONEL, 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.

ACTONEL 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 ACTONEL.

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

Rarely patients have reported non-healing jaw wounds while receiving ACTONEL 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.

Important Side Effects, how often they Happen and what to do about them
Symptom / EffectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor or
pharmacist
Only if
severe
In all
cases
Common (more than 1 in 100)
Pain in bones, joints, or musclesX
Abdominal painX
Uncommon (less than 1 in 100)
Eye pain, redness or inflammation; sensitivity to light, decreased visionX
Rare (less than 1 in 1,000)
Painful tongueX
Jaw problems associated with delayed healing and infection, often following tooth extraction.X
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 breathingX
Symptoms of low blood calcium level such as numbness, tingling, muscle spasmsX
New or unusual pain in hip, groin or thighX

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

How to Store it

  • Keep ACTONEL DR and all other medications out of the reach of children.
  • Keep the tablets in their original package and store at controlled room temperature (20°-25°C).
  • 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:

  • 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, Ontario 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

For more information, please visit http://www.actonel.ca.


This document plus the full product monograph, prepared for health professionals is available by contacting Warner Chilcott Canada Co. at: 1-855-892-8766.

ACTONEL 150 mg

Risedronate Sodium

About this Medication

What the medication is used for

Treatment of osteoporosis in postmenopausal women.

What it does

ACTONEL is a bisphosphonate drug that helps to slow bone loss. In many people, ACTONEL 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. ACTONEL corrects this imbalance by decreasing the elevated rate of bone removal. ACTONEL 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.

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

Since it is not known how long ACTONEL should be continued for treating and preventing osteoporosis, you should discuss the need to stay on this medication with your doctor regularly to determine if ACTONEL is still right for you.

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 ACTONEL.

What the medicinal ingredient is

Risedronate sodium

What the nonmedicinal ingredients are

Crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide.

What dosage form it comes in

Each ACTONEL 150 mg pink tablet contains risedronate sodium 150 mg.

Warnings and Precautions

Before you use ACTONEL, 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 ACTONEL.

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 ACTONEL therapy. (see INTERACTIONS WITH THIS MEDICATION section).

Interactions with this Medication

If taken with some other medicines, the effects of ACTONEL or the effects of other medicines may be changed. It is important to tell your health care providorse, 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 ACTONEL with food, as it may prevent your body from absorbing or using ACTONEL. You should take ACTONEL on an empty stomach. (See PROPER USE OF THIS MEDICATION for instruction).

Vitamin and mineral supplements, as well as antacids, may contain substances (e.g., calcium, magnesium, aluminum, and iron) which can stop your body from absorbing or using ACTONEL. These should be taken at a different time of day.

Proper Use of this Medication

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

Usual Dose

Treatment of postmenopausal osteoporosis

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

Dosing Instructions

  • ACTONEL 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 ACTONEL.
  • Each ACTONEL 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.
  • 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.
  • ACTONEL tablets should not be chewed, cut, or crushed.

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

Missed Dose

If you miss a dose of ACTONEL 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 ACTONEL 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 ACTONEL 150 mg as originally scheduled. Do not take more than 150 mg of ACTONEL within 7 days.

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. Drink a full glass of milk. Do not induce vomiting.

Side Effects and what to do about them

Drugs like ACTONEL 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 ACTONEL and tell your doctor right away. Remember to take ACTONEL as directed.

In clinical studies of osteoporosis with ACTONEL, 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.

ACTONEL 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 ACTONEL.

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

Rarely patients have reported non-healing jaw wounds while receiving ACTONEL 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.

Important Side Effects, how often they Happen and what to do about them
Symptom / EffectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor or
pharmacist
Only if
severe
In all
cases
Common (more than 1 in 100)
Pain in bones, joints, or musclesX
Abdominal painX
Uncommon (less than 1 in 100)
Eye pain, redness or inflammation; sensitivity to light, decreased visionX
Rare (less than 1 in 1,000)
Painful tongueX
Jaw problems associated with delayed healing and infection, often following tooth extraction.X
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 breathingX
Symptoms of low blood calcium level such as numbness, tingling, muscle spasmsX
New or unusual pain in hip, groin or thighX

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

How to Store it

  • Keep ACTONEL DR and all other medications out of the reach of children.
  • Keep the tablets in their original package and store at controlled room temperature (20°-25°C).
  • 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:

  • 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, Ontario 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

For more information, please visit http://www.actonel.ca.


This document plus the full product monograph, prepared for health professionals is available by contacting Warner Chilcott Canada Co. at: 1-855-892-8766.