Ran-Alendronate: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

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 monopause, 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 RAN-Alendronate to treat your osteoporosis or to help prevent you from developing osteoporosis. RAN-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, RAN-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.

When it should not be used:

Do not take RAN-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 RAN-Alendronate 5 mg or 10 mg tablet contains alendronate sodium.

What the nonmedicinal ingredients are:

anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.

What dosage forms it comes in:

RAN-Alendronate 5 mg , a white to off white , round, flat faced beveled edged, uncoated tablet with inscription ‘5’ on one side and plain on the other side and

RAN-Alendronate 10 mg, a white to off-white, oval biconvex uncoated tablet with inscription ‘10’ on one side

and plain on the other side. Available in blister packages of 28 tablets.

WARNINGS AND PRECAUTIONS

Before you use RAN-Alendronate talk to your doctor or pharmacist:

• If you have cancer, gum disease, poor oral hygiene, or diabetes. If you are receiving chemotherapy, radiotherapy, corticosteroids, or immunosuppressive drugs. If you are or have been a smoker, or are a heavy alcohol user. If you have any of these conditions you should consider having a dental examination before starting RAN-Alendronate.
• About any medical problems you have or have had, including known kidney disease.
• About any dental problems you have or have had.
• About any allergies.
• If you have any swallowing or digestive problems.

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

Use in pregnancy and breast-feeding

Do not take RAN-Alendronate if you are pregnant or breast-feeding.

Use in children

RAN-Alendronate is not indicated for use in children under 18 years of age.

Use in elderly

RAN-Alendronate works equally well in, and is equally well tolerated by, patients older and younger than 65 years of age.

Can I drive or operate machinery while using RAN-Alendronate?

There have been side effects reported with alendronate sodium that may affect your ability to drive or operate machinery. Individual responses to RAN-Alendronate may vary (See SIDE EFFECTS AND WHAT TO DO ABOUT THEM).

INTERACTIONS WITH THIS MEDICATION

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

PROPER USE OF THIS MEDICATION

Usual dose:

How should I take RAN-Alendronate?

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

1. 1.

   After getting up for the day and before taking your

   first food, beverage, or other medication, swallow your RAN-Alendronate 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 RAN-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 RAN-Alendronate.

1. 2. After swallowing your RAN-Alendronate 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. 3. Do not take RAN-Alendronate at bedtime or before getting up for the day.

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

1. 4. After swallowing your RAN-Alendronate, wait at least 30 minutes before taking your first food, beverage, or other medication of the day, including antacids, calcium supplements and vitamins. RAN-Alendronate is effective only if taken when your stomach is empty.
2. 5. If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking RAN-Alendronate immediately and call your doctor.
3. 6. Take one RAN-Alendronate once a day, every day.
4. 7. It is important that you continue taking RAN-Alendronate for as long as your doctor prescribes it. RAN-Alendronate can treat your osteoporosis or help prevent you from developing 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 RAN-Alendronate therapy.

Why is it important to continue to take RAN-Alendronate? It is important to take RAN-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 RAN-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 overdosage, contact a health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.

Missed dose:

Take RAN-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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Most patients do not have side effects from RAN-Alendronate; however, as with any medicine, RAN-Alendronate 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 RAN-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 RAN-Alendronate after developing symptoms suggesting irritation of the esophagus.

Some patients may experience bone, muscle and/or joint pain which is rarely severe. Patients who develop severe bone, joint, and/or muscle pain should contact their physician. Most patients experienced relief after stopping the drug. Rarely, patients may also experience joint swelling or swelling in their hands or legs. Transient flu-like symptoms (rarely with fever), typically at the start of treatment, have occurred. In rare cases, patients taking RAN-Alendronate may get itching or eye pain, or a rash that may be made worse by sunlight. Hair loss has been reported. Rarely, severe skin reactions may occur. 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. Patients may experience dizziness, vertigo (spinning sensation) or a changed sense of taste. Rarely, symptoms of low blood calcium may occur (for example, numbness or tingling around the mouth or in the hands or feet; muscle spasms in the face, hands, or feet). Rarely, stomach or other peptic ulcers (some severe) have occurred. Mouth ulcers have occurred when the tablet was chewed or dissolved in the mouth.

Rarely, patients have had jaw problems associated with delayed healing and infection, often following tooth extraction.

Rarely, patients have experienced fracture in a specific part of the thigh bone. If you develop new or unusual pain in the hip or thigh, contact your doctor.

Anytime you have a medical problem you think may be from taking RAN-Alendronate, even if it is not listed above, talk to your doctor.

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

HOW TO STORE IT

Store RAN-Alendronate at 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 RAN-Alendronate and all medications safely away from children.

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 telephone: 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 Locater 0701E Ottawa ON 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 the side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

How can I learn more about RAN-Alendronate and osteoporosis?

You may obtain further information from your physician or pharmacist, who has more detailed information about RAN-Alendronate and osteoporosis.

This document, plus the full Product Monograph prepared for health professionals, can be obtained by contacting the sponsor, Ranbaxy Pharmaceuticals Canada Inc., at: 1-866-840-1340

Last revised: May 8, 2012