Patient Medication Information: uses, side effects, how to take - Jamp-Risedronate
What is JAMP-RISEDRONATE used for?
- To treat or prevent osteoporosis in postmenopausal women.
- To increase bone density in men with osteoporosis.
How does JAMP-RISEDRONATE work?
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. JAMP- RISEDRONATE slows down bone loss which can help to reduce the risk of fractures. In many people JAMP- RISEDRONATE helps to increase bone density
it is not known how long JAMP-RISEDRONATE should be used for treating osteoporosis. Keep talking to your doctor about whether JAMP-RISEDRONATE is still right for you.
JAMP-RISEDRONATE is not a pain reliever.
What are the ingredients in JAMP-RISEDRONATE :
Medicinal Ingredients: Risedronate sodium
Nonmedicinal ingredients:
35mg : Colloidal Silicon Dioxide, Iron Oxide Yellow, Iron Oxide Red, Maltodexterin, Mannitol, Polyvinyl Alcohol-Polyethylene Glycol/Macrogol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Sodium Stearyl Fumarate, Talc, Titanium Dioxide
JAMP-RISEDRONATE comes in the following dosage forms:
Tablets : 35 mg
Do not use JAMP-RISEDRONATE if:
- You have low levels of calcium in your blood (hypocalcemia).
- You are allergic to risedronate sodium or any of the other ingredients in JAMP- RISEDRONATE.
To help avoid side effects and ensure proper use, talk to your healthcare professional Before you use JAMP-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 for at least 30 minutes (see How to take JAMP-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 or. 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 JAMP-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 JAMP- RISEDRONATE. Dental work should be done before you start JAMP-RISEDRONATE treatment. Take good care of your teeth and gums and see the dentist for regular check-ups while taking JAMP-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 JAMP-RISEDRONATE
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with JAMP-RISEDRONATE:
Vitamins, mineral supplements, antacids may contain substances (e.g., calcium, magnesium, aluminum, and iron). Take these medicines at a different time of day than JAMP-RISEDRONATE. Talk to your health care provider about how and when to take these medications.
Taking JAMP-RISEDRONATE with corticosteroids or cancer drugs may increase your chance of bone problems (osteonecrosis of the jaw).
Talk to your doctor before taking pain medication like ASA or other non-steroidal anti- inflammatory drugs because they may upset your stomach on an empty stomach.
How to take JAMP-RISEDRONATE:
As with all medications, it is important to take as directed by your doctor.
- take JAMP-RISEDRONATE in the morning on an empty stomach at least 30 minutes before you eat, drink or take other medicines.
- Swallow each JAMP-RISEDRONATE 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 JAMP-RISEDRONATE.
Usual dose
To treat osteoporosis in women after menopause:
- 35 mg per week of JAMP-RISEDRONATE
To Prevent osteoporosis in women after menopause:
- 35 mg per week of JAMP-RISEDRONATE
To increase Bone Density in men with Osteoporosis:
- 35 mg per week of JAMP-RISEDRONATE
Overdose:
| If you think you have taken too much JAMP-RISEDRONATE drink a full glass of milk. Do not make yourself vomit. contact your doctor or a Poison Control Centre, or an emergency room of the nearest hospital immediately. |
For JAMP-RISEDRONATE overdose, Do not induce vomiting.
Missed Dose:
Weeklydose(35 mgtablet): 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.
If your next dose is less than 7 days away, wait until your next scheduled dose.
What are possible side effects from using JAMP-RISEDRONATE?
These are not all the possible side affects you may feel when taking JAMP-RISEDRONATE. If you experience any side effects not listed here, contact your healthcare professional.
Drugs like JAMP-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 JAMP-RISEDRONATE and tell your doctor right away. Remember to take JAMP-RISEDRONATE as directed
the most common side effects reported with JAMP- RISEDRONATE were:
- abdominal pain, heartburn and nausea.
JAMP-RISEDRONATE may cause pain in bones, joints or muscles, rarely severe.
Pain may start as soon as one day or up to several months after starting JAMP-RISEDRONATE.
Patients receiving JAMP-RISEDRONATE or other drugs in this class have reported:
- Rarely , non-healing jaw wounds
- Very rarely, unusual fractures in their thigh bone
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk with your healthcare professional | Stop taking drug and get immediate help | ||
| Only if severe | In all cases | |||
| 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. | √ | |||
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| 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 IT
- Keep JAMP-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.
MORE INFORMATION
If you want more information about JAMP- RISEDRONATE:
- 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-399-9091.
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Last revised: May 28, 2018
REPORTING SUSPECTED 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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report- declaration/index-eng.php) 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.