Teva-Alendronate: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

WHAT THE MEDICATION IS USED FOR:

TEVA-ALENDRONATE is 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 TEVA-ALENDRONATE because you have a disease known as osteoporosis. TEVA-ALENDRONATE helps to rebuild bone. This will help prevent you from developing fractures.

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

WHAT IT DOES:

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 TEVA-ALENDRONATE to treat your osteoporosis. TEVA-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, TEVA-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:

Do NOT take TEVA-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:

Each 5 mg, 10 mg or 70 mg tablet of TEVA-ALENDRONATE contains alendronate sodium monohydrate.

WHAT THE NONMEDICINAL INGREDIENTS ARE:

5 mg and 10 mg: Colloidal silicon dioxide, hydroxypropylcellulose, low-substituted hydroxypropylcellulose and sodium stearyl fumarate.

70 mg: Croscarmellose sodium, magnesium stearate and microcrystalline cellulose.

WHAT DOSAGE FORMS IT COMES IN:

TEVA-ALENDRONATE 5 mg tablet is available as a white to off-white, round flat beveled tablet, engraved with “N” on one side and “5” on the other side.

TEVA-ALENDRONATE 10 mg tablet is available as a white to off-white, oval 10 mg tablet, engraved with “N” on one side and “10” on the other side.

TEVA-ALENDRONATE once weekly is available as a white to off-white, convex oval tablet, debossed with “N” on one side and “70” on the other side.

WARNINGS AND PRECAUTIONS

BEFORE you use TEVA-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 TEVA-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 TEVA-ALENDRONATE as these could be signs of bone damage in the ear.

Use in pregnancy and breast-feeding

Do not take TEVA-ALENDRONATE if you are pregnant or breast-feeding.

Use in Children

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

Use in Elderly

TEVA-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 alendronate sodium may vary.

INTERACTIONS WITH THIS MEDICATION

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

PROPER USE OF THIS MEDICATION

USUAL DOSE:

How should I take TEVA-ALENDRONATE?

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

1. 1. For TEVA-ALENDRONATE once weekly: Choose the day of the week that best fits your schedule. Every week, take one TEVA-ALENDRONATE tablet 70 mg on your chosen day.
2. 2.

   After getting up for the day and before taking your first food, beverage, or other medication, take your TEVA-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 TEVA-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 TEVA-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 TEVA-ALENDRONATE.

1. 3. After taking your TEVA-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.
2. 4. Do NOT take TEVA-ALENDRONATE at bedtime or before getting up for the day.

The above actions will help the TEVA-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).

1. 5. After taking your TEVA-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. TEVA-ALENDRONATE is effective only if taken when your stomach is empty.
2. 6. If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking TEVA-ALENDRONATE immediately and call your doctor.
3. 7.

   Take one TEVA-ALENDRONATE tablet 5 mg or 10 mg once a day, every day.

   Take one TEVA-ALENDRONATE tablet 70 mg once a week. If you miss a dose, just take one dose of TEVA-ALENDRONATE 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.

4. 8. It is important that you continue taking TEVA-ALENDRONATE for as long as your doctor prescribes it. TEVA-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 TEVA-ALENDRONATE therapy.

It is important to take TEVA-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 TEVA-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 doses, 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 practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

MISSED DOSE:

Take TEVA-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.

TEVA-ALENDRONATE once weekly: If you miss a dose, just take one dose of TEVA-ALENDRONATE 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.

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

TEVA-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 TEVA-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 TEVA-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.

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

Reporting Side Effects

HOW TO STORE IT

Store TEVA-ALENDRONATE bottles and blister packages between 15^oC – 30^oC.

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

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

MORE INFORMATION

NOTE: This INFORMATION FOR THE CONSUMER 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 found by contacting Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

www.tevacanada.com

Last revised: July 20, 2017