Details for: APO-ALENDRONATE

Company: APOTEX INC

DIN	DIN name	Active Ingredient(s)	Strength	Dosage Form	Route of Administration
02248730	APO-ALENDRONATE	ALENDRONIC ACID (ALENDRONATE SODIUM)	70 MG	TABLET	ORAL

Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Safety Review - Bisphosphonates - Assessing the Potential Risk of Severe Bone Damage (osteonecrosis)
Summary Safety Review - Bisphosphonates - Assessing the Risk of Jaw Bone Loss (osteonecrosis of the jaw)

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

APO-ALENDRONATE - 5 or 10 mg daily dosage

APO-ALENDRONATE is the product name for the substance alendronate sodium available only on prescription from your physician. Alendronate sodium is a member of a class of non-hormonal drugs called bisphosphonates.

Your physician has prescribed APO-ALENDRONATE because you have a disease known as osteoporosis. or to prevent you from developing it. APO-ALENDRONATE prevents the loss of bone that occurs in men, postmenopausal women, and in patients receiving corticosteroid medications (for example: prednisone, methylprednisolone). APO-ALENDRONATE also helps to rebuild bone. This will help prevent you from developing fractures.

APO-ALENDRONATE - 40 mg daily dosage

APO-ALENDRONATE - 70 mg once weekly dosage

APO-ALENDRONATE is the product name for the substance alendronate sodium available only on prescription from your physician. Alendronate sodium is a member of a class of non-hormonal drugs called bisphosphonates.

Your physician has prescribed APO-ALENDRONATE because you have a disease known as osteoporosis.
APO-ALENDRONATE helps to rebuild bone. This will help prevent you from developing fractures.

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

What it does

APO-ALENDRONATE - 5 or 10 mg daily dosage

How is normal bone maintained?
Bone undergoes a normal process of rebuilding that occurs continuously throughout your skeleton. First, old bone is removed (resorbed), then new bone is laid down (formed). This balanced process of resorbing and forming bone keeps your skeleton healthy and strong.

What is osteoporosis and why should it be treated or prevented?
Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause and may also occur in men.

Osteoporosis often occurs in women several years after the menopause, which occurs when the ovaries stop producing the female hormone, estrogen, or are removed (which may occur, for example, at the time of a hysterectomy). The earlier a woman reaches the menopause, the greater the risk of osteoporosis.
Osteoporosis can also occur in men due to several causes, including aging and/or a low level of the male hormone, testosterone. In both men and women, osteoporosis may also be caused by certain medicines called corticosteroids In all instances, bone is removed faster than it is formed, so bone loss occurs and bones become weaker. Therefore, maintaining bone mass and preventing further bone loss are important to keep your skeleton healthy.

Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in fractures (broken bones). Although fractures usually cause pain, fractures of the bones of the spine may go unnoticed until they cause height loss. Fractures may occur during normal, everyday activity, such as lifting, or from minor injury that would not ordinarily fracture normal bone. Fractures usually occur at the hip, spine, or wrist and can lead not only to pain, but also to considerable deformity and disability (such as stooped posture from curvature of the spine, and loss of mobility).

How can osteoporosis be treated or prevented?
Your physician has prescribed APO-ALENDRONATE to treat your osteoporosis. or to help prevent you from developing osteoporosis.

APO-ALENDRONATE not only prevents the loss of bone but actually helps to rebuild bone you may have lost and makes bone less likely to fracture.

Thus, APO-ALENDRONATE prevents or reverses the progression of osteoporosis.

In addition, your physician may recommend one or more of the following lifestyle changes:

Stop smoking. Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of fracture.

Exercise. Like muscles, bones need exercise to stay strong and healthy. Consult your physician before you begin any exercise program.

Eat a balanced diet. Your physician can advise you whether to modify your diet or to take any dietary supplements.

APO-ALENDRONATE - 40 mg daily dosage

APO-ALENDRONATE - 70 mg once weekly dosage

How is normal bone maintained?
Bone undergoes a normal process of rebuilding that occurs continuously throughout your skeleton. First, old bone is removed (resorbed), then new bone is laid down (formed). This balanced process of resorbing and forming bone keeps your skeleton healthy and strong.

What is osteoporosis and why should it be treated or prevented?
Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause and may also occur in men.

Osteoporosis often occurs in women several years after the menopause, which occurs when the ovaries stop producing the female hormone, estrogen, or are removed (which may occur, for example, at the time of a hysterectomy). The earlier a woman reaches the menopause, the greater the risk of osteoporosis.
Osteoporosis can also occur in men due to several causes, including aging and/or a low level of the male hormone, testosterone. In all instances, bone is removed faster than it is formed, so bone loss occurs and bones become weaker. Therefore, maintaining bone mass and preventing further bone loss are important to keep your skeleton healthy. Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in fractures (broken bones). Although fractures usually cause pain, fractures of the bones of the spine may go unnoticed until they cause height loss. Fractures may occur during normal, everyday activity, such as lifting, or from minor injury that would not ordinarily fracture normal bone. Fractures usually occur at the hip, spine, or wrist and can lead not only to pain, but also to considerable deformity and disability (such as stooped posture from curvature of the spine, and loss of mobility).

How can osteoporosis be treated?
Your physician has prescribed APO-ALENDRONATE to treat your osteoporosis. APO-ALENDRONATE not only prevents the loss of bone but actually helps to rebuild bone you may have lost and makes bone less likely to fracture. Thus, APO-ALENDRONATE reverses the progression of osteoporosis.

In addition, your physician may recommend one or more of the following lifestyle changes:

Stop smoking. Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of fracture.

Exercise. Like muscles, bones need exercise to stay strong and healthy. Consult your physician before you begin any exercise program.

Eat a balanced diet. Your physician can advise you whether to modify your diet or to take any dietary supplements.

When it should not be used

APO-ALENDRONATE - 5 or 10 mg daily dosage

Do NOT take APO-ALENDRONATE if you:

Have certain disorders of the esophagus (the tube that connects your mouth with your stomach).
Are unable to stand or sit upright for at least 30 minutes.
Are allergic to any of its ingredients.
Have low blood calcium.
Have SEVERE kidney disease. If you have any doubts if this applies to you, speak to your physician.

APO-ALENDRONATE - 40 mg daily dosage

Do not take APO-ALENDRONATE if you:

Have certain disorders of the esophagus (the tube that connects your mouth with your stomach).
Are unable to stand or sit upright for at least 30 minutes.
Are allergic to any of its ingredients.
Have low blood calcium.
Have SEVERE kidney disease. If you have any doubts if this applies to you, speak to your physician.

APO-ALENDRONATE - 70 mg once weekly dosage

Do NOT take APO-ALENDRONATE if you:

Have certain disorders of the esophagus (the tube that connects your mouth with your stomach)
Are unable to stand or sit upright for at least 30 minutes.
Are allergic to any of its ingredients
Have low blood calcium.
Have SEVERE kidney disease. If you have any doubts if this applies to you, speak to your physician.

What the medicinal ingredient is

APO-ALENDRONATE - 5 or 10 mg daily dosage

Alendronate sodium

APO-ALENDRONATE - 40 mg daily dosage

Alendronate sodium

APO-ALENDRONATE - 70 mg once weekly dosage

Each 70 mg tablet of APO-ALENDRONATE contains alendronate sodium.

What the non-medicinal ingredients are

APO-ALENDRONATE - 5 or 10 mg daily dosage

Magnesium stearate, mannitol and microcrystalline cellulose.

APO-ALENDRONATE - 40 mg daily dosage

Magnesium stearate, mannitol and microcrystalline cellulose.

APO-ALENDRONATE - 70 mg once weekly dosage

Magnesium stearate, mannitol and microcrystalline cellulose.

What dosage form it comes in

APO-ALENDRONATE - 5 or 10 mg daily dosage

Tablets, 5 mg and 10 mg

APO-ALENDRONATE - 40 mg daily dosage

Tablets, 40 mg

APO-ALENDRONATE - 70 mg once weekly dosage

Tablets, 70 mg

Warnings and precautions

APO-ALENDRONATE - 5 or 10 mg daily dosage

BEFORE you use APO-ALENDRONATE talk to your doctor or pharmacist if you:

have cancer, gum disease, poor oral hygiene, or diabetes.
get chemotherapy, or radiotherapy.
take, corticosteroids, or immunosuppressive drugs.
take angiogenesis inhibitors; they are drugs that slow down the growth of new blood vessels and are used mostly to treat cancer (e.g., bevacizumab).
are or have been a smoker.
are a heavy alcohol user.

If any of the above applies to you, have a dental check-up before starting APO-ALENDRONATE.

have or have had any medical problems including known kidney disease.
have or have had any dental problems.
have any allergies.
have any swallowing or digestive problems.

Your doctor may check if you:

smoke.
have or have had teeth and/or gum disease.
have dentures that do not fit well.
have other relevant medical conditions at the same time, such as; low red blood cell count (called anemia) or if your blood cannot form clots in the normal way.

You should always tell your physician about all drugs you are taking or plan to take, including those obtained without a prescription.

Talk to your doctor:

if you have ear pain and/or discharge from the ear while taking APO-ALENDRONATE as these could be signs of bone damage in the ear.

Use in pregnancy and breast-feeding
Do not take APO-ALENDRONATE if you are pregnant or breast-feeding.

Use in children
APO-ALENDRONATE is not indicated for use in children under 18 years of age.

Use in elderly
APO-ALENDRONATE works equally well in, and is equally well tolerated by, patients older and younger than 65 years of age.

Driving and using machines: There have been side effects reported with APO-ALENDRONATE that may affect your ability to drive or operate machinery. Individual responses to APO-ALENDRONATE may vary.

APO-ALENDRONATE - 40 mg daily dosage

BEFORE you use APO-ALENDRONATE talk to your doctor or pharmacist if you:

have cancer, gum disease, poor oral hygiene, or diabetes.
get chemotherapy, or radiotherapy.
take, corticosteroids, or immunosuppressive drugs.
take angiogenesis inhibitors; they are drugs that slow down the growth of new blood vessels and are used mostly to treat cancer (e.g., bevacizumab).
are or have been a smoker.
are a heavy alcohol user.

If any of the above applies to you, have a dental check-up before starting APO-ALENDRONATE.

have or have had any medical problems including known kidney disease.
have or have had any dental problems.
° have any allergies.
have any swallowing or digestive problems.

Your doctor may check if you:

smoke.
have or have had teeth and/or gum disease.
have dentures that do not fit well.
have other relevant medical conditions at the same time, such as; low red blood cell count (called anemia) or if your blood cannot form clots in the normal way.

You should always tell your physician about all drugs you are taking or plan to take, including those obtained without a prescription.

Talk to your doctor:

if you have ear pain and/or discharge from the ear while taking APO-ALENDRONATE as these could be signs of bone damage in the ear.

APO-ALENDRONATE - 70 mg once weekly dosage

BEFORE you use APO-ALENDRONATE talk to your doctor or pharmacist if you:

have cancer, gum disease, poor oral hygiene, or diabetes.
get chemotherapy, or radiotherapy.
take, corticosteroids, or immunosuppressive drugs.
take angiogenesis inhibitors; they are drugs that slow down the growth of new blood vessels and are used mostly to treat cancer (e.g., bevacizumab).
are or have been a smoker.
are a heavy alcohol user.

If you any of the above applies to you, have a dental check-up before starting APO-ALENDRONATE.

have or have had any medical problems including known kidney disease.
have or have had any dental problems.
have any allergies.
have any swallowing or digestive problems.

Your doctor may check if you:

smoke.
have or have had teeth and/or gum disease.
have dentures that do not fit well.
have other relevant medical conditions at the same time, such as; low red blood cell count (called anemia) or if your blood cannot form clots in the normal way.

You should always tell your physician about all drugs you are taking or plan to take, including those obtained without a prescription.

Talk to your doctor:

if you have ear pain and/or discharge from the ear while taking APO-ALENDRONATE as these could be signs of bone damage in the ear.

Interactions with this medication

APO-ALENDRONATE - 5 or 10 mg daily dosage

Calcium supplements, antacids, and other oral medications will interfere with the absorption of APO-ALENDRONATE if they are taken at the same time.
You must wait at least one-half hour after taking APO-ALENDRONATE before taking any other oral medication.

APO-ALENDRONATE - 40 mg daily dosage

The use of acetylsalicylic acid (ASA) with 40 mg of APO-ALENDRONATE may increase the chance of stomach upset. You should speak to your physician if you take ASA.

Calcium supplements, antacids, and other oral medications will interfere with the absorption of APO-ALENDRONATE if they are taken at the same time. You must wait at least one-half hour after taking APO-ALENDRONATE before taking any other oral medication.

APO-ALENDRONATE - 70 mg once weekly dosage

Calcium supplements, antacids, and other oral medications will interfere with the absorption of APO-ALENDRONATE if they are taken at the same time. You must wait at least one-half hour after taking APO-ALENDRONATE before taking any other oral medication.

Proper use of this medication

APO-ALENDRONATE - 5 or 10 mg daily dosage
APO-ALENDRONATE - 40 mg daily dosage
APO-ALENDRONATE - 70 mg once weekly dosage

APO-ALENDRONATE - 5 or 10 mg daily dosage

Usual Dose

How should I take APO-ALENDRONATE?

These are the important things you must do to help make sure you will benefit from APO-ALENDRONATE:

After getting up for the day and before taking your first food, beverage, or other medication, swallow your APO-ALENDRONATE tablet with a full glass (200 to 250 mL) of plain water only.

Do NOT take APO-ALENDRONATE with:
- mineral water
- coffee or tea
- juice
Although it has not been tested, because of high mineral content, “hard water” may decrease absorption of APO-ALENDRONATE. If your normal drinking water is classified as “hard water”, you should consider taking this medication with distilled water (i.e., not mineral water).

After taking your APO-ALENDRONATE tablet do not lie down – stay fully upright (sitting, standing or walking) for at least 30 minutes and do not lie down until after your first food of the day.

Do not take APO-ALENDRONATE at bedtime or before getting up for the day.

The above actions will help the APO-ALENDRONATE tablet reach your stomach quickly and help reduce the potential for irritation of your esophagus (the tube that connects your mouth with your stomach).

After taking your APO-ALENDRONATE tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day, including antacids, calcium supplements and vitamins. APO-ALENDRONATE is effective only if taken when your stomach is empty.

If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking APO-ALENDRONATE immediately and call your doctor.

Take one APO-ALENDRONATE tablet once a day, every day.

It is important that you continue taking APO-ALENDRONATE for as long as your doctor prescribes it. APO-ALENDRONATE can treat your osteoporosis only if you continue to take it.

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 APO-ALENDRONATE therapy.

Why is it important to continue to take APO-ALENDRONATE?
It is important to take APO-ALENDRONATE over the long-term to continue to prevent loss of bone and to help rebuild bone you may have lost. It is, therefore, important to follow your physician’s instructions for taking APO-ALENDRONATE without skipping doses or varying from your prescribed treatment schedule. It is also important to continue to follow your physician’s advice on lifestyle changes.

Overdose

If you take too many tablets, drink a full glass of milk and contact your physician immediately. Do not induce vomiting. Do not lie down.

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

Missed Dose

Take APO-ALENDRONATE once daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule of one tablet once a day.

APO-ALENDRONATE - 40 mg daily dosage

Usual Dose

How should I take APO-ALENDRONATE?
These are the important things you must do to help make sure you will benefit from APO-ALENDRONATE:

After getting up for the day and before taking your first food, beverage, or other medication, swallow your APO-ALENDRONATE tablet with a full glass (200 to 250 mL) of plain water only.

Do NOT take APO-ALENDRONATE with:
- mineral water
- coffee or tea
- juice
Although it has not been tested, because of high mineral content, “hard water” may decrease absorption of APO-ALENDRONATE. If your normal drinking water is classified as “hard water”, you should consider taking this medication with distilled water (i.e., not mineral water).

Do not chew or suck on a tablet of APO-ALENDRONATE.

After taking your APO-ALENDRONATE tablet do not lie down – stay fully upright (sitting, standing or walking) for at least 30 minutes and do not lie down until after your first food of the day.

Do not take APO-ALENDRONATE at bedtime or before getting up for the day.

The above actions will help the APO-ALENDRONATE tablet reach your stomach quickly and help reduce the potential for irritation of your esophagus (the tube that connects your mouth with your stomach).

After taking your APO-ALENDRONATE tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day, including antacids, calcium supplements and vitamins. APO-ALENDRONATE is effective only if taken when your stomach is empty.

If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking APO-ALENDRONATE immediately and call your doctor.

Take one APO-ALENDRONATE tablet once a day, every day.

It is important that you continue taking APO-ALENDRONATE for as long as your doctor prescribes it.

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 APO-ALENDRONATE therapy.

Overdosage

If you take too many tablets, drink a full glass of milk and contact your physician immediately. Do not induce vomiting. Do not lie down.

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

Missed Dose

Take APO-ALENDRONATE once daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule of one tablet once a day.

APO-ALENDRONATE - 70 mg once weekly dosage

Usual Dose

Your doctor has prescribed APO-ALENDRONATE tablets once weekly.

These are the important things you must do to help make sure you will benefit from APO-ALENDRONATE.

Choose the day of the week that best fits your schedule. Every week, take one APO-ALENDRONATE tablet on your chosen day.

After getting up for the day and before taking your first food, beverage, or other medication, take your APO-ALENDRONATE with plain water only as follows:

Swallow one tablet with a full glass (200 to 250 mL) of plain water.

Do NOT take APO-ALENDRONATE tablet with:
- mineral water
- coffee or tea
- juice
Although it has not been tested, because of high mineral content, “hard water” may decrease absorption of APO-ALENDRONATE. If your normal drinking water is classified as “hard water”, you should consider taking this medication with distilled water (i.e., not mineral water).

Do NOT chew or suck on a tablet of APO-ALENDRONATE.

After taking your APO-ALENDRONATE tablet do not lie down – stay fully upright (sitting, standing or walking) for at least 30 minutes and do not lie down until after your first food of the day.

Do not take APO-ALENDRONATE at bedtime or before getting up for the day.

The above actions will help APO-ALENDRONATE tablet reach your stomach quickly and help reduce the potential for irritation of your esophagus (the tube that connects your mouth with your stomach).

After taking APO-ALENDRONATE tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day, including antacids, calcium supplements and vitamins. APO-ALENDRONATE is effective only if taken when your stomach is empty.

If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking APO-ALENDRONATE immediately and call your doctor.

It is important that you continue taking APO-ALENDRONATE for as long as your doctor prescribes it. APO-ALENDRONATE can treat your osteoporosis only if you continue to take it.

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 APO-ALENDRONATE therapy.

It is important to take APO-ALENDRONATE over the long-term to continue to help rebuild bone you may have lost. It is, therefore, important to follow your physician’s instructions for taking APO-ALENDRONATE without skipping doses or varying from your prescribed treatment schedule. It is also important to continue to follow your physician’s advice on lifestyle changes.

Overdose

If you take too many tablets, drink a full glass of milk and contact your physician immediately. Do not induce vomiting. Do not lie down.

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

Missed Dose

If you miss a dose, just take one dose of APO-ALENDRONATE tablet on the morning after you remember. Do NOT take two doses on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.

Side effects and what to do about them

APO-ALENDRONATE - 5 or 10 mg daily dosage

APO-ALENDRONATE may have unintended or undesirable effects:

digestive problems such as nausea, vomiting, diarrhea or constipation.

disorders of your esophagus (the tube that connects your mouth with your stomach) including irritation which can cause chest pain, heartburn or difficulty or pain upon swallowing. These reactions may occur especially if patients do not drink the recommended amount of water with APO-ALENDRONATE and/or if they lie down in less than 30 minutes or before their first food of the day. Esophageal reactions may worsen if patients continue to take APO-ALENDRONATE after developing symptoms suggesting irritation of the esophagus.

bone, muscle and/or joint pain.

joint swelling or swelling in their hands or legs.

transient flu-like symptoms (rarely with fever).

rash that may be made worse by sunlight, hair loss.

dizziness, veritgo (spinning sensation) or a changed sense of taste.

symptoms of low blood calcium (for example, numbness or tingling around the mouth or in the hands or feet; muscle spasms in the face, hands, or feet).

mouth ulcers have occurred when the tablet was chewed or dissolved in the mouth.

If any of these affects you severely, tell your doctor or pharmacist.

Serious side effects, how often they happen and what to do about them
Symptom / effect	Talk with your doctor or pharmacist In all cases	Stop taking drug and call your doctor or pharmacist
Uncommon
Allergic reactions such as: hives swelling of the face, lips, tongue and/or throat difficulty in breathing or swallowing		✔
Severe bone, joint, and/or muscle pain	✔
New or unusual pain in the hip or thigh	✔
Esophageal ulcers causing: chest pain heartburn difficulty or pain upon swallowing		✔
Stomach or other peptic ulcers occasionally associated with black and/or bloody stools		✔
Jaw problems associated with delayed healing and infection, often following tooth extraction		✔
Eye inflammation associated with eye pain; eye redness; sensitivity to light, decreased vision.		✔
Severe skin reactions		✔
Symptoms of low blood calcium: numbness or tingling around the mouth or in the hands or feet muscle spasms in the face, hands, or feet		✔
Rare
Persistent ear pain	✔

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

APO-ALENDRONATE - 40 mg daily dosage

APO-ALENDRONATE may have unintended or undesirable effects.

digestive problems such as nausea, vomiting, diarrhea or constipation.

disorders of your esophagus (the tube that connects your mouth with your stomach) including irritation which can cause chest pain, heartburn or difficulty or pain upon swallowing. These reactions may occur especially if patients do not drink the recommended amount of water with APO-ALENDRONATE and/or if they lie down in less than 30 minutes or before their first food of the day. Esophageal reactions may worsen if patients continue to take APO-ALENDRONATE after developing symptoms suggesting irritation of the esophagus.

bone, muscle and/or joint pain.

joint swelling or swelling in their hands or legs.

transient flu-like symptoms (rarely with fever).

rash that may be made worse by sunlight, hair loss.

dizziness, veritgo (spinning sensation) or a changed sense of taste.

symptoms of low blood calcium (for example, numbness or tingling around the mouth or in the hands or feet; muscle spasms in the face, hands, or feet).

mouth ulcers have occurred when the tablet was chewed or dissolved in the mouth.

Serious side effects, how often they happen and what to do about them
Symptom / effect	Talk with your doctor or pharmacist In all cases	Stop taking drug and call your doctor or pharmacist
Uncommon
Allergic reactions such as: - hives swelling of the face, lips, tongue and/or throat difficulty in breathing or swallowing		✔
Severe bone, joint, and/or muscle pain	✔
New or unusual pain in the hip or thigh	✔
Esophageal ulcers causing: chest pain heartburn difficulty or pain upon swallowing		✔
Stomach or other peptic ulcers occasionally associated with black and/or bloody stools		✔
Jaw problems associated with delayed healing and infection, often following tooth extraction		✔
Eye inflammation associated with eye pain; eye redness; sensitivity to light, decreased vision.		✔
Severe skin reactions		✔
Symptoms of low blood calcium: numbness or tingling around the mouth or in the hands or feet muscle spasms in the face, hands, or feet		✔
Rare
Persistent ear pain	✔

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

APO-ALENDRONATE - 70 mg once weekly dosage

APO-ALENDRONATE may have unintended or undesirable effects.

digestive problems such as nausea, vomiting, diarrhea or constipation.

disorders of your esophagus (the tube that connects your mouth with your stomach) including irritation which can cause chest pain, heartburn or difficulty or pain upon swallowing. These reactions may occur especially if patients do not drink the recommended amount of water with APO-ALENDRONATE and/or if they lie down in less than 30 minutes or before their first food of the day. Esophageal reactions may worsen if patients continue to take APO-ALENDRONATE after developing symptoms suggesting irritation of the esophagus.

bone, muscle and/or joint pain.

joint swelling or swelling in their hands or legs.

transient flu-like symptoms (rarely with fever).

rash that may be made worse by sunlight, hair loss.

dizziness, veritgo (spinning sensation) or a changed sense of taste.

symptoms of low blood calcium (for example, numbness or tingling around the mouth or in the hands or feet; muscle spasms in the face, hands, or feet).

mouth ulcers have occurred when the tablet was chewed or dissolved in the mouth.

If any of these affects you severely, tell your doctor or pharmacist.

Serious side effects, how often they happen and what to do about them
Symptom / effect	Talk with your doctor or pharmacist In all cases	Stop taking drug and call your doctor or pharmacist
Uncommon
Allergic reactions such as: hives swelling of the face, lips, tongue and/or throat difficulty in breathing or swallowing	✔
Severe bone, joint, and/or muscle pain	✔
New or unusual pain in the hip or thigh	✔
Esophageal ulcers causing: chest pain heartburn difficulty or pain upon swallowing		✔
Stomach or other peptic ulcers occasionally associated with black and/or bloody stools		✔
Jaw problems associated with delayed healing and infection, often following tooth extraction		✔
Eye inflammation associated with eye pain; eye redness; sensitivity to light, decreased vision.		✔
Severe skin reactions		✔
Symptoms of low blood calcium: numbness or tingling around the mouth or in the hands or feet muscle spasms in the face, hands, or feet		✔
Rare
Persistent ear pain	✔

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

How to store

APO-ALENDRONATE - 5 or 10 mg daily dosage

Store APO-ALENDRONATE at room temperature 15°C to 30°C.

Do not use this medicine after the month and year written after EXP (expiry date) on the container.

Remember to keep APO-ALENDRONATE and all medications safely away from children.

APO-ALENDRONATE - 40 mg daily dosage

APO-ALENDRONATE - 70 mg once weekly dosage

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 (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html)
By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax 1-866-678-6789 (toll free), or
- Mail to: Canada Vigilance Program
  Health Canada
  Postal Locator 1908C
  Ottawa, Ontario
  KIA OK9

Postage paid labels and the Consumer Side Effect Reporting Form is available at MedEffectTM (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html)

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

NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service, at 1-800-667-4708. This leaflet can also be found at http://www.apotex.ca/products.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Date of Revision: November 15, 2017

Date modified:: 2016-04-13