Details for: PMS-RISEDRONATE
Company: PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02302209 | PMS-RISEDRONATE | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) | 35 MG | TABLET | ORAL |
| 02424177 | PMS-RISEDRONATE | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) | 150 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
- To treat or prevent osteoporosis in postmenopausal women.
- To increase bone density in men with osteoporosis.
What it does
In osteoporosis, the body removes more bone than it replaces. This causes bones to get weaker and
more likely to break or fracture (usually at the spine, wrist and hip). Spine fractures may result in a
curved back, height loss or back pain. pms-RISEDRONATE slows down bone loss which can help
to reduce the risk of fractures. In many people pms-RISEDRONATE helps to increase bone
density.
It is not known how long pms-RISEDRONATE should be used for treating osteoporosis. Keep
talking to your doctor about whether pms-RISEDRONATE is still right for you.
pms-RISEDRONATE is not a pain reliever.
When it should not be used
- You have low levels of calcium in your blood (hypocalcemia).
- You are allergic to risedronate sodium or any of the other ingredients in pms- RISEDRONATE.
What the medicinal ingredient is
Risedronate sodium
What the non-medicinal ingredients are
35 mg: Colloidal Silicon Dioxide, Iron Oxide Yellow, Iron Oxide Red, Maltodextrin, Mannitol,
Polyvinyl Alcohol, Polyethylene Glycol/Macrogrol, Povidone, Pregelatinized Starch, Sodium
Starch Glycolate, Sodium Stearyl Fumarate, Talc, Titanium Dioxide.
150 mg: Crospovidone, FD&C Blue #2 Indigo Carmine Aluminium Lake, Hydroxypropyl
Cellulose, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene
Glycol/Macrogol, Silica, Titanium Dioxide.
What dosage form it comes in
Tablets: 35 mg and 150 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-RISEDRONATE. Talk about any health conditions or problems you may have, including if you:
- have had problems or disease in your kidneys, esophagus (the tube connecting the mouth and the stomach),
- Have/had problems swallowing or have problems with your esophagus (the tube that connects your mouth to your stomach)
- Have/had stomach or digestive problems
- Have/had kidney problems
- Cannot stand or sit upright for at least 30 minutes (see How to take pms-RISEDRONATE)
- Are pregnant or breastfeeding
- Have one of the following risk factors: cancer, diabetes, chemotherapy, radiotherapy of the head or neck, lowered immune system (immunosuppression), poor oral hygiene, treatment with corticosteroids or cancer drugs such as angiogenesis inhibitors (drugs that slow down the growth of new blood vessels).
- Had/have pain, swelling or numbness of the jaw or loosening of a tooth or any other oral symptoms.
- Have sores in the mouth. This can lead to osteonecrosis of the jaw.
Your doctor may check you 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.
Your doctor may tell you to stop taking pms-RISEDRONATE until all sores in your mouth are
healed.
Other warnings you should know about:
Your doctor should check your mouth and may ask you to see your dentist before you start taking
pms-RISEDRONATE. Dental work should be done before you start pms-RISEDRONATE
treatment. Take good care of your teeth and gums and see the dentist for regular checkups while
taking pms-RISEDRONATE.
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 pms-RISEDRONATE.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins,
minerals, natural supplements or alternative medicines.
Interactions with this medication
Vitamins, mineral supplements and antacids may contain substances that can stop your body from
absorbing pms-RISEDRONATE. They include calcium, magnesium, aluminum and iron. Take
these medicines at a different time of day than pms-RISEDRONATE. Talk to your health care
provider about how and when to take these medications.
Taking pms-RISEDRONATE with corticosteroids or cancer drugs may increase your chance of jaw
bone problems (osteonecrosis of the jaw).
Talk to your doctor before taking pain medication like ASA or other non-steroidal antiinflammatory
drugs because they may upset your stomach on an empty stomach.
Proper use of this medication
As with all medications, it is important to take as directed by your doctor.
- Take pms-RISEDRONATE in the morning on an empty stomach, at least 30 minutes
before you eat, drink or take other medicines.
- Swallow each ACTONE tablet whole, while you are sitting or standing in an upright
position. Drink enough plain water (at least 120 mL or ½ cup) to make sure the tablet gets
to your stomach. Do not chew, cut or crush the tablets.
- Do not lie down for at least 30 minutes after taking pms-RISEDRONATE.
Usual dose
To treat osteoporosis in women after menopause:
- 35 mg per week of pms-RISEDRONATE
- 150 mg per month of pms-RISEDRONATE
To prevent osteoporosis in women after menopause:
- 35 mg per week of pms-RISEDRONATE
To increase bone density in men with osteoporosis:
- 35 mg per week of pms-RISEDRONATE
Overdose
Missed Dose
Weekly dose (35 mg tablet): If you missed your dose on your usual day, take one tablet in the
morning after you remember. You can go back to your regular schedule for the next dose. If you
have missed your dose by one week, do not take 2 tablets on the same day. Skip your missed dose
and go back to your regular schedule.
Once monthly dose (150 mg tablet): If you forget to take your monthly dose of pms-
RISEDRONATE, take it next in the morning if it is more than 7 days away. Take your next dose on
the regularly scheduled day.
If your next dose is less than 7 days away, wait until your next scheduled dose. Do not take more
than 150 mg of pms-RISEDRONATE within 7 days.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking pms-RISEDRONATE. If you
experience any side effects not listed here, contact your healthcare professional.
Drugs like pms-RISEDRONATE may cause problems in your esophagus (the tube connecting the
mouth and the stomach), stomach and intestines, including ulcers. If you have trouble or pain upon
swallowing, heartburn, chest pain and black or bloody stools, stop taking pms-RISEDRONATE and
tell your doctor right away. Remember to take pms-RISEDRONATE as directed.
The most common side effects reported with pms-RISEDRONATE were:
- Abdominal pain, heartburn, nausea
pms-RISEDRONATE may cause pain in bones, joints or muscles, rarely severe.
When you take pms-RISEDRONATE once a month, it may cause short-lasting, mild flu-like
symptoms. These symptoms usually decrease as you keep taking doses.
Patients receiving pms-RISEDRONATE or other drugs in this class have reported:
- Rarely, non-healing jaw wounds.
- Very rarely, unusual fractures in their thigh bone.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Pain in bones, joints, or muscles | ✔ | ||
| Abdominal pain | ✔ | ||
| Uncommon | |||
| Eye pain, redness or inflammation; sensitivity to light, decreased vision | ✔ | ||
| Rare | |||
| Painful tongue | ✔ | ||
| Osteonecrosis of the jaw: Jaw problems associated with numbness or feeling of heaviness in the jaw, poor healing of the gums especially after dental work, loose teeth, exposed bone in the mouth, sores, or non-healing sores in the mouth, swelling gum, infections, bad breath or pain in the mouth, teeth or jaw. | ✔ | ||
| Very rare | |||
| Allergic and skin reactions such as: hives; rash (with or without blisters); swelling of face, lips, tongue, or throat; difficult or painful swallowing; trouble breathing | ✔ | ||
| Symptoms of low blood calcium level such as numbness, tingling, muscle spasms | ✔ | ||
| New or unusual pain in hip, groin or thigh | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
- Keep pms-RISEDRONATE and all other medications out of the reach of children.
- Store between 15°C and 30°C.
- Do not keep medicine that is out of date or that you no longer need.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.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
- Talk to your healthcare professional Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.pharmascience.com, or by calling 1-888-550-6060.
This leaflet was prepared by
Pharmascience Inc.
Montréal Canada
H4P 2T4
www.pharmascience.com
Last revised: December 6, 2017