Details for: ALENDRONATE
Company: SIVEM PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02299712 | ALENDRONATE | ALENDRONIC ACID (ALENDRONATE SODIUM) | 70 MG | TABLET | ORAL |
Summary Reports
Summary Safety Review - Bisphosphonates - Assessing the Risk of Jaw Bone Loss (osteonecrosis of the jaw)
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ALENDRONATE is the brand name 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 ALENDRONATE because you
have a disease known as osteoporosis. ALENDRONATE helps to
rebuild bone. This will help prevent you from developing
fractures.
Since it is not known how long ALENDRONATE should be
continued for osteoporosis, you should discuss the need to stay on
this medication with your doctor regularly to determine if
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 ALENDRONATE to treat your
osteoporosis. 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, 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 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 70 mg tablet of ALENDRONATE contains alendronate sodium monohydrate.
What the non-medicinal ingredients are
Croscarmellose sodium, magnesium stearate and microcrystalline cellulose.
What dosage form it comes in
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 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 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.
- 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.
Your doctor may check if you:
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 ALENDRONATE as these could be signs of bone damage in the ear.
Do not take ALENDRONATE if you are pregnant or breastfeeding.
Use in Children
ALENDRONATE is not indicated for use in children under 18 years of age.
Use in Elderly
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 ALENDRONATE if they are taken at the same time. You must wait at least one-half hour after taking ALENDRONATE before taking any other oral medication.
Proper use of this medication
Usual Dose
How should I take ALENDRONATE?
These are the important things you must do to help make sure you will benefit from ALENDRONATE:
- For ALENDRONATE once weekly: Choose the day of the week that best fits your schedule. Every week, take one ALENDRONATE tablet 70 mg on your chosen day.
- After getting up for the day and before taking your first food, beverage, or other medication, take your 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 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 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 ALENDRONATE.
- After taking your 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.
- Do NOT take ALENDRONATE at bedtime or before getting up for the day.
The above actions will help ALENDRONATE reach your stomach quickly and help reduce the potential for irritation of your esophagus (the tube that connects your mouth with your stomach).
- After taking your ALENDRONATE, wait at least 30 minutes before taking your first food, beverage, or other medication of the day, including antacids, calcium supplements and vitamins. ALENDRONATE is effective only if taken when your stomach is empty.
- If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking ALENDRONATE immediately and call your doctor.
Take one ALENDRONATE tablet 70 mg once a week. If you miss a dose, just take one dose of 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. - It is important that you continue taking ALENDRONATE for as long as your doctor prescribes it. 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 ALENDRONATE therapy.
It is important to take 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 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.
Missed Dose
ALENDRONATE once weekly: If you miss a dose, just take one dose of 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.
Side effects and what to do about them
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 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 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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
Allergic reactions such as:
|
✔ | ||
| Severe bone, joint, and/or muscle pain | ✔ | ||
| New or unusual pain in the hip or thigh | ✔ | ||
Esophageal ulcers causing:
|
✔ | ||
| Stomach or other peptic ulcers occasionally associated with black and/or bloody stools | ✔ | ||
| Jaw problems associated with delayed healing and infection, often following tooth extraction | ✔ | ||
| Eye inflammation associated with eye pain; eye redness; sensitivity to light, decreased vision | ✔ | ||
| Severe skin reactions | ✔ | ||
Symptoms of low blood calcium:
|
✔ | ||
| Rare | |||
| Persistent ear pain | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ALENDRONATE, contact your doctor or pharmacist.
How to store
Store ALENDRONATE bottles and blister packages between 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 ALENDRONATE and all medications safely away from children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- RVisiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
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 Sivem Pharmaceuticals ULC by:
Phone: 1-855-788-3153;
Or at www.sivem.ca
This leaflet was prepared by:
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec
H4R 2P7
Last revised: December 28, 2017