Consumer Information for: MYLAN-ALENDRONATE
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-ALENDRONATE - 10 mg
MYLAN-ALENDRONATE is the brand name of Mylan Pharmaceuticals ULC 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 MYLAN-ALENDRONATE because you have a disease known as osteoporosis. MYLAN-ALENDRONATE helps to rebuild bone. This will help prevent you from MYLAN-ALENDRONATEing fractures.
MYLAN-ALENDRONATE also prevents the loss of bone that occurs in postmenopausal women not taking estrogen and receiving corticosteroid medications (for example: prednisone, methylprednisolone).
Since it is not known how long alendronate sodium should be continued for osteoporosis, you should discuss the need to stay on this medication with your doctor regularly to determine if MYLAN-ALENDRONATE is still right for you.
MYLAN-ALENDRONATE - 70 mg
MYLAN-ALENDRONATE is the brand name of Mylan Pharmaceuticals ULC 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 MYLAN-ALENDRONATE because you have a disease known as osteoporosis. MYLAN-ALENDRONATE helps to rebuild bone. This will help prevent you from developing fractures.
Since it is not known how long alendronate sodium should be continued for osteoporosis, you should discuss the need to stay on this medication with your doctor regularly to determine if
MYLAN-ALENDRONATE is still right for you.
What it does
MYLAN-ALENDRONATE - 10 mg
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?
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 prescribed MYLAN-ALENDRONATE to
treat your osteoporosis. MYLAN-ALENDRONATE actually
helps to rebuild bone you may have lost and makes bone less
likely to fracture. Thus, MYLAN-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.
MYLAN-ALENDRONATE - 70 mg
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 MYLAN-ALENDRONATE to treat your osteoporosis. MYLAN-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, MYLAN-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
MYLAN-ALENDRONATE - 10 mg
Do not take MYLAN-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.
MYLAN-ALENDRONATE - 70 mg
Do NOT take MYLAN-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
MYLAN-ALENDRONATE - 10 mg
Each 10 mg tablet of MYLAN-ALENDRONATE contains alendronic acid as alendronate sodium trihydrate.
MYLAN-ALENDRONATE - 70 mg
Each 70 mg tablet of MYLAN-ALENDRONATE contains alendronate sodium trihydrate.
What the non-medicinal ingredients are
MYLAN-ALENDRONATE - 10 mg
Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone.
MYLAN-ALENDRONATE - 70 mg
Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone.
What dosage form it comes in
MYLAN-ALENDRONATE - 10 mg
MYLAN-ALENDRONATE is available as a white, capsuleshaped 10 mg tablet.
MYLAN-ALENDRONATE - 70 mg
MYLAN-ALENDRONATE once weekly is available as a white, oval 70 mg tablet. Packaged in blister packages of 4 tablets.
Warnings and precautions
MYLAN-ALENDRONATE - 10 mg
BEFORE you use MYLAN-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 apply to you, have a dental check-up before starting MYLAN-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 MYLAN-ALENDRONATE as these could be signs of bone damage in the ear.
Use in pregnancy and breast-feeding
Do not take MYLAN-ALENDRONATE if you are pregnant or breast-feeding.
Use in children
MYLAN-ALENDRONATE is not indicated for use in children under 18 years of age.
Use in elderly
MYLAN-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 alendronate sodium that may affect your ability to drive or operate machinery. Individual responses to MYLAN-ALENDRONATE may vary.
MYLAN-ALENDRONATE - 70 mg
BEFORE you use MYLAN-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 apply to you, have a dental check-up before starting MYLAN-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 MYLAN-ALENDRONATE as these could be signs of bone damage in the ear.
Use in pregnancy and breast-feeding
Do not take MYLAN-ALENDRONATE if you are pregnant or breast-feeding.
Use in children
MYLAN-ALENDRONATE is not indicated for use in children under 18 years of age.
Use in elderly
MYLAN-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 alendronate sodium that may affect your ability to drive or operate machinery. Individual responses to MYLAN-ALENDRONATE may vary.
Interactions with this medication
MYLAN-ALENDRONATE - 10 mg
Calcium supplements, antacids, and other oral medications will interfere with the absorption of MYLAN-ALENDRONATE if they are taken at the same time. You must wait at least one-half hour after taking MYLAN-ALENDRONATE before taking any other oral medication.
MYLAN-ALENDRONATE - 70 mg
Calcium supplements, antacids, and other oral medications will interfere with the absorption of MYLAN-ALENDRONATE if they are taken at the same time. You must wait at least one-half hour after taking MYLAN-ALENDRONATE before taking any other oral medication.
Proper use of this medication
MYLAN-ALENDRONATE - 70 mg
MYLAN-ALENDRONATE - 10 mg
Usual dose
How should I take MYLAN-ALENDRONATE?
These are the important things you must do to help make sure
you will benefit from MYLAN-ALENDRONATE:
- After getting up for the day and before taking your first food, beverage, or other medication, take your MYLAN-ALENDRONATE tablet with plain water only as follows:
- Swallow one tablet with a full glass (200 to 250 mL) of plain water.
Do NOT take MYLAN-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 MYLAN-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 MYLAN-ALENDRONATE.
The above actions will help the MYLAN-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).
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-LENDRONATE therapy.
It is important to take MYLAN-ALENDRONATE over the long-term to help rebuild bone you may have lost. It is, therefore, important to follow your physician’s instructions for taking MYLAN-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.
Missed Dose
Take MYLAN-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.
MYLAN-ALENDRONATE - 70 mg
Usual dose
Your doctor has prescribed MYLAN-ALENDRONATE once weekly as tablets.
These are the important things you must do to help make sure you will benefit from MYLAN-ALENDRONATE:
- Choose the day of the week that best fits your schedule. Every week, take one MYLAN-ALENDRONATE tablet on your chosen day.
- After getting up for the day and before taking your first food, beverage, or other medication, take your MYLAN-ALENDRONATE tablet with plain water only as follows:
- Avalez un comprimé avec un grand verre (200 à 250 mL) d’eau ordinaire.
Do NOT take MYLAN-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 MYLAN-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 MYLAN-ALENDRONATE.
The above actions will help the MYLAN-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).
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-ALENDRONATE therapy.
It is important to take MYLAN-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 MYLAN-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.
Missed Dose
If you miss a dose, just take one MYLAN-ALENDRONATE tablet on the morning after you remember. Do NOT take two doses on the same day. Return to taking one dose once a week, as originally scheduled on your chosen day.
Side effects and what to do about them
MYLAN-ALENDRONATE - 10 mg
MYLAN-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 MYLAN-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 MYLAN-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, vertigo (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.
| Symptom/effects | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
Allergic
reactions such
as:
|
✔ | ||
| Severe bone, joint, and/or muscle pain | ✔ | ||
| New or unusual pain in the hip or thigh | ✔ | ||
Esophageal ulcers causing:
|
✔ | ||
| 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:
|
✔ | ||
| Rare | |||
| Persistent ear pain | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking MYLAN-ALENDRONATE, contact your doctor or pharmacist.
MYLAN-ALENDRONATE - 70 mg
MYLAN-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 MYLAN-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 MYLAN-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, vertigo (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.
| Symptom/effects | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
Allergic
reactions such
as:
|
✔ | ||
| Severe bone, joint, and/or muscle pain | ✔ | ||
| New or unusual pain in the hip or thigh | ✔ | ||
Esophageal ulcers causing:
|
✔ | ||
| 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:
|
✔ | ||
| Rare | |||
| Persistent ear pain | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking MYLAN-ALENDRONATE, contact your doctor or pharmacist.
How to store
MYLAN-ALENDRONATE - 10 mg
Store MYLAN-ALENDRONATE at controlled room temperature (15ºC – 30ºC).
Do not use this medicine after the month and year written after EXP (expiry date) on the container.
Remember to keep MYLAN-ALENDRONATE and all medications safely away from children.
Keep out of reach and sight of children.
MYLAN-ALENDRONATE - 70 mg
Store MYLAN-ALENDRONATE at controlled room temperature (15°C - 30°C).
Do not use this medicine after the month and year written after EXP (expiry date) on the container.
Remember to keep MYLAN-ALENDRONATE and all medications safely away from children.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
MYLAN-ALENDRONATE - 10 mg
If you want more information about MYLAN-ALENDRONATE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website; or by calling 1-844-596-9526
- This document can be found at: www.mylan.ca.
This leaflet was prepared by Mylan Pharmaceuticals ULC,
Etobicoke, Ontario M8Z 2S6
Revised on: June 27, 2017
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-844-596-9526
www.mylan.ca
MYLAN-ALENDRONATE - 70 mg
If you want more information about MYLAN-ALENDRONATE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website; or by calling 1-844-596-9526
- This document can be found at: www.mylan.ca.
This leaflet was prepared by Mylan Pharmaceuticals ULC,
Etobicoke, Ontario M8Z 2S6
Revised on: September 7, 2017
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-844-596-9526
www.mylan.ca
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