Patient Medication Information: uses, side effects, how to take - PHL-Risedronate
ABOUT THIS MEDICATION
What the medication is used for:
Treatment and prevention of osteoporosis in
postmenopausal women.
Treatment of osteoporosis in men, to improve bone
mineral density.
What it does:
phl-RISEDRONATE is a non-hormonal drug (i.e., not an estrogen) that helps to slow bone loss. In many people, phl-RISEDRONATE helps to increase bone density. 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 or hip). Spine fractures may result in a curved back, height loss or back pain. phl-RISEDRONATE corrects this imbalance by decreasing the elevated rate of bone removal. phl-RISEDRONATE can therefore help reduce the risk of spine and non-spine fractures.
Your doctor may measure the thickness (i.e., density) of your bone through a bone mineral density (BMD) test or x-ray to check your progress against further bone loss or fracture.
phl-RISEDRONATE is not a pain reliever. Your doctor may prescribe or recommend another medicine specifically for pain relief.
When it should not be used:
If you have low blood calcium levels
(hypocalcemia).
If you are allergic to risedronate sodium or any
other ingredients in phl-RISEDRONATE
What the medicinal ingredient is:
Risedronate sodium
What the nonmedicinal ingredients are:
Colloidal Silicon Dioxide, Iron Oxide Yellow #10, Iron Oxide Red, Maltodexterin, Mannitol, Polyvinyl Alcohol-Polyethylene Glycol Graft Copolymer, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Sodium Stearyl Fumarate, Sucrose, Talc, Titaniun Dioxide, Triethyl Citrate.
What dosage forms it comes in:
35 mg Tablets
WARNINGS AND PRECAUTIONS
Before you use phl-RISEDRONATE, talk to your doctor or pharmacist if:
- You have had problems or disease in your kidneys, esophagus (the tube connecting the mouth and the stomach), stomach or intestines.
You cannot carry out dosing instructions (see PROPER
USE OF THIS MEDICATION).
You are pregnant or nursing.
- You have one of the following risk factors: cancer, chemotherapy, radiotherapy of the head or neck, treatment with corticosteroids, or dental problems or dental infections. If so, a dental examination and any necessary dental procedures should be considered before you start treatment with phl-RISEDRONATE.
Be sure to tell your health care providers, including doctors and dentists, about all medicines you are taking, including phl-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 phl-RISEDRONATE therapy (see INTERACTIONS WITH THIS MEDICATION section).
INTERACTIONS WITH THIS MEDICATION
Vitamin and mineral supplements, as well as antacids, may contain substances (e.g., calcium, magnesium, aluminum, and iron) which can stop your body from absorbing or using phl-RISEDRONATE. These should be taken at a different time of day.
If taken with some other medicines, the effects of phl-RISEDRONATE or the effects of other medicines may be changed. It is important to tell your doctor what other medications you are taking, even if the medicine does not require a prescription (including vitamin and herbal supplements).
Food, if taken with phl-RISEDRONATE, may prevent your body from absorbing or using phl-RISEDRONATE Take phl-RISEDRONATE on an empty stomach. See PROPER USE OF THIS MEDICATION for instructions
PROPER USE OF THIS MEDICATION
As with all medications, it is important to take as directed by your doctor.
Usual dose:
Treatment of postmenopausal osteoporosis:
- 1 tablet (35 mg) per week
Prevention of postmenopausal osteoporosis:
- 1 tablet (35 mg) per week
Treatment of Osteoporosis in Men, to Improve Bone Mineral Density:
- 1 tablet (35 mg) per week
Once weekly dosing (35 mg per week):
- Choose a day of the week to take your tablet.
On your chosen day, take one phl-RISEDRONATE tablet
first thing in the morning with plain water before you have anything to eat or drink. Aside from plain water, do not eat or drink for at least 30 minutes after taking phl-RISEDRONATE.
- Plain water is allowed at all times.
Instructions for all dosing options:
- Plain water is allowed at all times.
Take each tablet with at least ½ cup (120 mL) of
plain water. Do not take with coffee, tea, milk, or juice; they may prevent your body from absorbing phl-RISEDRONATE.
Aside from plain water, do not eat or drink for at least
30 minutes after taking phl-RISEDRONATE
Swallow whole - do not chew or wait for it to
dissolve.
Do not lie down for at least 30 minutes after taking a
dose. You may sit, stand or do normal activities like read the newspaper, take a walk, etc.
These recommendations help phl-RISEDRONATE work correctly and help you avoid possible irritation of the esophagus (the tube connecting the mouth and the stomach).
You should take phl-RISEDRONATE for as long as your doctor recommends, to continue to prevent bone loss and protect your bones from fractures.
Missed Dose:
Weekly dose (35 mg tablet): If you forget to take your dose on the regularly scheduled day, simply take 1 tablet on the day you first remember having missed your dose. Then resume your schedule by taking 1 tablet on the originally chosen day of the week. If you've missed your dose by exactly one week, do not take 2 tablets on the same day. Simply take 1 tablet as you normally would have on this day and resume your usual weekly schedule.
Overdose:
If you take too many tablets on any given day, drink a full glass of milk and contact your health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms. Do not induce vomiting.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Drugs like phl-RISEDRONATE may cause problems in your stomach and esophagus (the tube connecting the mouth and the stomach), such as trouble swallowing, heartburn, chest pain and ulcers. If you have these symptoms, stop taking phl-RISEDRONATE and tell your doctor right away. Remember to take phl-RISEDRONATE as directed.
In clinical studies of osteoporosis with risedronate sodium, the most commonly reported side effects were abdominal pain, heartburn and nausea.
phl-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 phl-RISEDRONATE.
Very rarely patients have reported non-healing jaw wounds while receiving risedronate sodium or other drugs in this class. Consult your doctor if you experience persistent pain in your mouth, teeth or jaw, or if your gums or mouth heal poorly
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||||
| HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||
| Only if severe | In all cases | ||||
| Common (more than 1 in 100) | |||||
| Pain in bones, joints, or muscles | T | ||||
| Abdominal pain | T | ||||
| Uncommon (less than 1 in 100) | |||||
| Painful and inflamed eye | T | ||||
| Rare (less than 1 in 1,000) | |||||
| Painful tongue | T | ||||
| Very rare (less than 1 in 10,000) | |||||
| Allergic reactions such as: hives; rash; swelling of face, lips, tongue, or throat; difficult or painful swallowing; trouble breathing | T | ||||
Jaw problems associated with delayed healing and infection, often following tooth extraction. | T | ||||
| Symptoms of low blood calcium level such as numbness, tingling, muscle spasms | T | ||||
This is not a complete list of side effects. For any unexpected effects while taking phl-RISEDRONATE, contact your doctor or pharmacist.
HOW TO STORE IT
- Keep phl-RISEDRONATE and all other medications out of the reach of children.
- Store at room temperature (15° - 30°C).
- Do not keep medicine that is out of data or that you no longer need.
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 3 ways: $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345 $ Complete a Canada Vigilance Reporting Form and:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Pharmel Inc. at, 1-888-550-6060.
Pharmel Inc.
Montreal Quebec
H4P 2T4