FOSAMAX

Alendronate Sodium
Bone Metabolism Regulator

Patient Information for FOSAMAX

Osteoporosis: Please read carefully before starting Fosamax and every time your prescription is renewed.

Fosamax Tablets:

Fosamax is the brand name of Merck Frosst Canada & Co. for the substance alendronate sodium available only on prescription from your physician. Alendronate sodium is a member of a class of nonhormonal drugs called bisphosphonates. Fosamax is available as a white, round 5 mg and a white, oval 10 mg tablet. Your physician has prescribed Fosamax because you have a disease, known as osteoporosis or to prevent you from developing the disease. Fosamax prevents the loss of bone that occurs in men, postmenopausal women, and in patients receiving corticosteroid medications (for example: prednisone, methylprednisolone). Fosamax also helps to rebuild bone. This will help prevent you from developing fractures.

How should I take Fosamax?

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

1. After getting up for the day, swallow your Fosamax tablet with a full glass (200 to 250 mL ) of plain water only: not mineral water, not coffee or tea, not juice. Although it has not been tested, because of high mineral content, “hard water” may decrease absorption of Fosamax. If your normal drinking water is classified as “hard water”, you should consider taking this medication with distilled water (i.e., not mineral water).
2. After swallowing your Fosamax tablet do not lie down--stay fully upright (sitting or standing) for at least 30 minutes and until after your first food of the day. Do not chew or suck on a tablet of Fosamax.
3. Do not take Fosamax at bedtime or before getting up for the day. The above actions will help the Fosamax tablet reach your stomach quickly and help reduce the potential for irritation of your esophagus (the tube that connects your mouth with your stomach).
4. After swallowing your Fosamax tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day, including antacids, calcium supplements and vitamins. Fosamax is effective only if taken when your stomach is empty.
5. If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Fosamax immediately and call your doctor.
6. Take 1 Fosamax tablet once a day, every day.
7. It is important that you continue taking Fosamax for as long as your doctor prescribes it. Fosamax can treat your osteoporosis or help prevent you from developing osteoporosis only if you continue to take it. You should always tell your physician about all drugs you are taking or plan to take, including those obtained without a prescription.

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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.

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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. It may also be caused by certain medications called corticosteroids in both men and women. 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).

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Osteoporosis in men and in postmenopausal women:

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.

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.

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Osteoporosis in men and women caused by corticosteroids:

Corticosteroids can cause bone to be 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. It is important to take your corticosteroid medication as recommended by your physician.

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How can osteoporosis be treated or prevented?

Your physician has prescribed Fosamax to treat your osteoporosis or to help prevent you from developing osteoporosis. Fosamax 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, Fosamax 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.

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Why is it important to continue to take Fosamax?

It is important to take Fosamax 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 Fosamax 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.

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What should I know before taking Fosamax? Who should not take Fosamax?

Do not take Fosamax 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 been told by doctor that you currently have low blood calcium.

Do not take Fosamax if you have severe kidney disease. If you have any doubts if this applies to you, speak to your physician.

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What should I tell my physician or pharmacist before taking Fosamax?

Tell your physician or pharmacist about any medical problems you have or have had, including known kidney disease, and about any allergies. If you have any swallowing or digestive problems, discuss them with your physician before taking Fosamax.

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Pregnancy and Breast-feeding:

Do not take Fosamax if you are pregnant or breast-feeding.
Children: Fosamax is not indicated for anyone under 18 years of age and should not be given to them.
Elderly: Fosamax works equally well in and is equally well tolerated by patients older and younger than 65 years of age.

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Can I take Fosamax with other medicines?

See “How should I take Fosamax?”

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Can I drive or operate machinery while using Fosamax?

Fosamax should not affect your ability to drive or operate machinery.Remember to keep Fosamax and all medications safely away from children.

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What should I do in case of an 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.

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What should I do if I miss a dose?

Take Fosamax once daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule of 1 tablet once a day.

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What undesirable effects may Fosamax have?

Most patients do not have side effects from Fosamax; however, as with any medicine, Fosamax may have unintended or undesirable effects. Side effects usually have been mild. Some patients may experience digestive disturbances such as nausea, vomiting or black and/or bloody stools. Some digestive disturbances may be severe including irritation or ulceration of the esophagus (the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing. These reactions may occur especially if patients do not drink a full glass of water with Fosamax 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 Fosamax after developing symptoms suggesting irritation of the esophagus.

Some patients may experience bone, muscle or joint pain or, rarely, a rash (occasionally made worse by sunlight) or eye pain. Allergic reactions such as hives, or rarely, swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing may occur. Rarely, stomach or other peptic ulcers (some severe) have occurred, but it is not known whether these were caused by treatment with Fosamax. Mouth ulcers have occurred when the tablet was chewed or dissolved in the mouth.

Your physician or pharmacist has a more complete list. Tell your physician or pharmacist promptly about these or any other unusual symptoms.

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How can I learn more about Fosamax and osteoporosis?

You may obtain further information from your physician or pharmacist, who have more detailed information about Fosamax and osteoporosis.

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How long should I keep my medicine?

Do not use this medicine after the month and and year written after EXP on the container.

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How should I store Fosamax?

Store Fosamax at room temperature (15 to 30°C).

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How should I take Fosamax?

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

1. After getting up for the day, swallow your Fosamax tablet with a full glass (200 to 250 mL) of plain water only: not mineral water, not coffee or tea, not juice. Although it has not been tested, because of high mineral content, “hard water” may decrease absorption of Fosamax. If your normal drinking water is classified as “hard water”, you should consider taking this medication with distilled water (i.e., not mineral water).
2. After swallowing your Fosamax tablet do not lie down--stay fully upright (sitting or standing) for at least 30 minutes and until after your first food of the day. Do not chew or suck on a tablet of Fosamax.
3. Do not take Fosamax at bedtime or before getting up for the day. The above actions will help the Fosamax tablet reach your stomach quickly and help avoid irritation of your esophagus (the tube that connects your mouth with your stomach).
4. After swallowing your Fosamax tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day, including antacids, calcium supplements and vitamins. Fosamax is effective only if taken when your stomach is empty.
5. If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Fosamax immediately and call your doctor.
6. Take 1 Fosamax tablet once a day, every day.
7. It is important that you continue taking Fosamax for as long as your doctor prescribes it. You should always tell your physician about all drugs you are taking or plan to take, including those obtained without a prescription.

Fosamax Tablets: Fosamax is the brand name of Merck Frosst Canada & Co. for the substance alendronate sodium available only on prescription from your physician. Alendronate sodium is a member of a class of nonhormonal drugs called bisphosphonates. Your physician has prescribed Fosamax because you have a disease known as Paget's disease of bone.

back to the top

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.

back to the top

What is Paget's disease of bone?

In Paget's disease, bone resorption and formation are abnormally increased resulting in weakened bone. This may lead to pain, deformity, and/or fracture.

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How can Paget's disease of bone be treated?

Your physician has prescribed Fosamax to treat this disease. Fosamax slows down bone resorption, which allows
the bone-forming cells time to rebuild normal bone.

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How can I learn more about Fosamax and Paget's disease of bone?

You may obtain further information from your physician or pharmacist, who has more detailed information about Fosamax and Paget's disease of bone.

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Ingredients:

Active ingredients: Each white, triangular-shaped 40 mg tablet of Fosamax contains alendronate. Nonmedicinal ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose.

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