Consumer Information for: DOM-ALENDRONATE-FC
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
Dom-ALENDRONATE/Dom-ALENDRONATE-FC is the brand name of Dominion Pharmacal 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 Dom-ALENDRONATE/Dom- ALENDRONATE-FC because you have a disease known as osteoporosis. Dom-ALENDRONATE/Dom-ALENDRONATE-FC helps to rebuild bone. This will help prevent you from developing fractures.
What it does
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 Dom-ALENDRONATE /Dom- ALENDRONATE-FC to treat your osteoporosis. Dom- ALENDRONATE/Dom-ALENDRONATE-FC 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, Dom- ALENDRONATE/Dom-ALENDRONATE-FC 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 Dom-ALENDRONATE/Dom-ALENDRONATEFC 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
Alendronate Sodium
What the non-medicinal ingredients are
Dom-ALENDRONATE : Magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, starch.
Dom-ALENDRONATE FC: hypromellose, magnesium stearate, mannitol, microcystalline cellulose, sodium starch glycolate and starch.
What dosage form it comes in
Dom-ALENDRONATE : White, non film-coated, oval tablet: 70 mg
Dom-ALENDRONATE FC: White, film-coated, oval tablet : 70 mg
Warnings and precautions
- 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 Dom-ALENDRONATE/Dom- ALENDRONATE-FC.
- 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 Dom-ALENDRONATE/Dom-ALENDRONATE-FC if you are pregnant or breast-feeding
Use in children
Dom-ALENDRONATE/Dom-ALENDRONATE-FC are not indicated for use in children under 18 years of age.
Use in elderly
Dom-ALENDRONATE/Dom-ALENDRONATE-FC 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 Dom- ALENDRONATE/Dom-ALENDRONATE-FC?
There have been side effects reported with alendronate sodium tablets that may affect your ability to drive or operate machinery. Individual responses to Dom-ALENDRONATE/Dom- ALENDRONATE-FC 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 Dom-ALENDRONATE/ Dom- ALENDRONATE-FC if they are taken at the same time. You must wait at least one-half hour after taking Dom-ALENDRONATE/ Dom-ALENDRONATE-FC before taking any other oral medication.
Proper use of this medication
Usual Dose
How should I take Dom-ALENDRONATE/Dom- ALENDRONATE-FC once weekly?
These are the important things you must do to help make sure you will benefit from Dom-ALENDRONATE/Dom- ALENDRONATE-FC:
- Choose the day of the week that best fits your schedule. Every week, take one dose of Dom-ALENDRONATE/Dom- ALENDRONATE-FC on your chosen day.
- After getting up for the day and before taking your first food, beverage, or other medication, take your Dom- ALENDRONATE/Dom-ALENDRONATE-FC tablet with a full glass (200 to 250 mL) of plain water only.
Do not take Dom-ALENDRONATE/Dom-ALENDRONATE-FC with:
- mineral water
- coffee or tea
- juice
Although it has not been tested, because of high mineral content, "hard water" may decrease absorption of Dom- ALENDRONATE/Dom-ALENDRONATE-FC. 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 Dom- ALENDRONATE/Dom-ALENDRONATE-FC.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 Dom-ALENDRONATE/Dom-ALENDRONATE-FC therapy.
Why is it important to continue to take Dom- ALENDRONATE/Dom-ALENDRONATE-FC?
It is important to take Dom-ALENDRONATE/Dom- ALENDRONATE-FC 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 Dom-ALENDRONATE/Dom-ALENDRONATE–FC 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.
Missed Dose
If you miss a dose, just take one dose of Dom-ALENDRONATE/
Dom-ALENDRONATE–FC 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
Dom-ALENDRONATE/ Dom-ALENDRONATE-FC 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 Dom-ALENDRONATE/ Dom-ALENDRONATE-FC 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 Dom-ALENDRONATE/ Dom-ALENDRONATE-FC 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 / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Allergic reactions such as: -hives -swelling of the face, lips, tongue and/or throat -difficulty in breathing or swallowing | ✔ | ||
| Bone, joint, and/or muscle pain | ✔ | ||
| New or unusual pain in the hip or thigh | ✔ | ||
| Digestive disturbances causing: -chest pain -heartburn -difficulty or pain upon swallowing -black and/or bloody stools | ✔ | ||
| Esophageal, stomach or other peptic ulcers | ✔ | ||
| Jaw problems associated with delayed healing and infection, often following tooth extraction | ✔ | ||
| Severe eye pain | ✔ | ||
| Severe skin reactions | ✔ | ||
| Symptoms of low blood calcium: -numbness or tingling around the mouth or in the hands or feet -muscle spasms in the face, hands, or feet | |||
This is not a complete list of side effects. For any unexpected effects while taking Dom-ALENDRONATE/Dom- ALENDRONATE–FC, contact your doctor or pharmacist.
How to store
Store at room temperature (15–30°C).
Do not use this medicine after the month and year written after EXP (expiry date) on the container.
Remember to keep Dom-ALENDRONATE/Dom- ALENDRONATE-FC and all medications safely away from children.
Reporting 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 three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 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 Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
How can I learn more about Dom-ALENDRONATE/Dom- ALENDRONATE-FC and osteoporosis? You may obtain further information from your physician or pharmacist, who has more detailed information about Dom- ALENDRONATE/Dom-ALENDRONATE-FC and osteoporosis.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor Dominion Pharmacal, at 1-888-550-6060.
This leaflet was prepared by
Dominion Pharmacal
Montreal Quebec
H4P 2T4
Last revised: October 30, 2012.
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