Patient Medication Information: uses, side effects, how to take - Gen-Alendronate
ABOUT THIS MEDICATION
What the medication is used for:
GEN-ALENDRONATE is the brand name of Genpharm Inc. 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 GEN-ALENDRONATE because you have a disease known as osteoporosis or to prevent you from developing it. GEN-ALENDRONATE prevents the loss of bone that occurs in men, postmenopausal women, and in patients receiving corticosteroid medications (for example: prednisone, methylprednisone). GEN-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. 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).
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 in men and women caused by corticosteroid
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.
How can osteoporosis be treated or prevented?
Your physician has prescribed GEN-ALENDRONATE to treat your osteoporosis or to help prevent you from developing osteoporosis. GEN-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, GEN-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 GEN-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 or 10 mg tablet of GEN-ALENDRONATE contains alendronic acid as sodium alendronate.
What the important nonmedicinal ingredients are: Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone.
What dosage forms it comes in:
GEN-ALENDRONATE is available as a white, round 5 mg tablet and a white, oval 10 mg tablet.
WARNINGS AND PRECAUTIONS
Before you use GEN-ALENDRONATE talk to your doctor or pharmacist:
If you have cancer or poor oral hygiene, or are receiving
chemotherapy, head and neck radiotherapy or corticosteroids. If you have any of these conditions you should consider having a dental examination before starting GEN-ALENDRONATE.
About any medical problems you have or have had, including
known kidney disease.
- 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 these obtained without a prescription.
Use in pregnancy and breast-feeding
Do not take GEN-ALENDRONATE if you are pregnant or breast-feeding.
Use in children
GEN-ALENDRONATE is not indicated for anyone under 18 years of age and should not be given to them.
Use in elderly
GEN-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 GEN-ALENDRONATE?
GEN-ALENDRONATE should not affect your ability to drive or operate machinery.
INTERACTIONS WITH THIS MEDICATION
Calcium supplements, antacids, and other oral medications will interfere with the absorption of GEN-ALENDRONATE if they are taken at the same time. You must wait at least one half hour after taking GEN-ALENDRONATE before taking any other oral medication.
PROPER USE OF THIS MEDICATION
Usual dose:
How should I take GEN-ALENDRONATE?
These are the important things you must do to help make sure you will benefit from GEN-ALENDRONATE:
- 1.
After getting up for the day and before taking your first food, beverage, or other medication, swallow your GEN-
ALENDRONATE 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 GEN-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 GEN-ALENDRONATE.
- 2. After taking your GEN-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.
- 3.
Do not take GEN-ALENDRONATE at bedtime or before getting up for the day.
The above actions will help the GEN-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).
- 4. After swallowing your GEN-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. GEN-ALENDRONATE 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 GEN-ALENDRONATE immediately and call your doctor.
- 6. Take one GEN-ALENDRONATE tablet once a day, every day.
- 7.
It is important that you continue taking GEN-
ALENDRONATE for as long as your doctor prescribes it. GEN-ALENDRONATE can treat your osteoporosis or prevent you from developing osteoporosis only if you continue to take it.
It is important to take GEN-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 GEN-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 GEN-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 GEN-ALENDRONATE; however, as with any medicine, GEN-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 GEN-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 GEN-ALENDRONATE after developing symptoms suggesting irritation of the esophagus.
Some patients may experience bone, muscle or joint pain (rarely, with flu-like symptoms or fever) or, rarely, a rash (occasionally made worse by sunlight), itching, or eye pain. 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. 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, but it is not known whether these were caused by treatment with GEN-ALENDRONATE. 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.
Your physician or pharmacist has a more complete list. Tell your physician or pharmacist promptly about these or any other unusual symptoms.
HOW TO STORE IT
Store GEN-ALENDRONATE at 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 GEN-ALENDRONATE and all medications safely away from children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
How can I learn more about GEN-ALENDRONATE and osteoporosis?
You may obtain further information from your physician or pharmacist, who has more detailed information about GEN-ALENDRONATE and osteoporosis.
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Genpharm Inc., at: 1-800-575-1379, or at:
customerservice@genpharm.ca.
Genpharm Inc.
Etobicoke, Ontario, M8Z 2S6
Date of preparation: January 25, 2006