Patient Medication Information: uses, side effects, how to take - PMS-Risedronate Plus Calcium
ABOUT THIS MEDICATION
What the medication is used for:
Treatment and prevention of postmenopausal osteoporosis.
What it does:
pms-RISEDRONATE PLUS CALCIUM is a combination of pms-RISEDRONATE (risedronate sodium hemi-pentahydrate) tablets and calcium carbonate caplets.
pms-RISEDRONATE is a non-hormonal drug (i.e., not an estrogen) that builds and strengthens bones. In many people, pms-RISEDRONATE actually rebuilds some of the bone that has already been lost. 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. pms-RISEDRONATE corrects this imbalance by decreasing the elevated rate of bone removal. pms-RISEDRONATE can therefore help reduce the risk of spine and non-spine fractures.
pms-RISEDRONATE is not a pain reliever. Your doctor may prescribe or recommend another medicine specifically for pain relief.
Calcium carbonate helps to provide the calcium that your body may need to harden new bone.
Since it is not known how long pms-RISEDRONATE PLUS CALCIUM should be continued, you should discuss the need to stay on this medication with your doctor regularly to determine if pms-RISEDRONATE PLUS CALCIUM is still right for you.
When it should not be used:
- If you have low blood calcium levels (hypocalcemia).
- If you have high blood calcium levels (hypercalcemia)
- If you are allergic to pms-RISEDRONATE PLUS CALCIUM or any of its ingredients (see below).
What the medicinal ingredient is:
Risedronate sodium, Calcium (as calcium carbonate).
What the nonmedicinal ingredients are:
pms-RISEDRONATE: Colloidal Silicon Dioxide, Iron Oxide Yellow, Maltodexterin, Mannitol, Polyvinyl Alcohol- Polyethylene Glycol Graft Copolymer, Povidone, Pregelatinized Starch, Red Iron Oxide, Sodium Starch Glycolate, Sodium Stearyl Fumarate, Sucrose, Talc, Titanium Dioxide and Triethyl Citrate.
Calcium: Carnauba Wax, Crospovidone, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 5 Aluminum lake, FD&C Yellow No. 6 Aluminum Lake, Hydroxypropyl Methylcellulose,
Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polysorbate 80, Stearic Acid, Titanium Dioxide, Triethyl Citrate, Vegetable Magnesium Stearate.
What dosage form it comes in:
pms-RISEDRONATE PLUS CALCIUM is a combination pack containing:
- 4 pms-RISEDRONATE 35 mg orange tablets
- 24 calcium carbonate green film-coated caplets.
for a monthly (28 days) course of therapy.
WARNINGS AND PRECAUTIONS
Before you use pms-RISEDRONATE PLUS CALCIUM, talk to your doctor or pharmacist if:
- You have had problems or disease in your kidneys, esophagus (i.e., the tube connecting the mouth and the stomach), stomach, or intestines.
You are pregnant or nursing.
- You cannot carry out the dosing instructions (see PROPER USE OF THIS MEDICATION).
- 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 pms-RISEDRONATE.
Be sure to tell your health care providers, including doctors and dentists, about all medicines you are taking, including pms-RISEDRONATE PLUS CALCIUM.
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 the pms-RISEDRONATE in pms-RISEDRONATE PLUS CALCIUM. These should be taken at a different time of day.
If taken with some other medicines, the effects of pms-RISEDRONATE PLUS CALCIUM 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 vitamins and herbal supplements).
Calcium products may interact with medications such as digoxin, certain antibiotics, iron supplements, phenytoin, thyroid hormones, steroid medications and thiazide diuretics.
Food, if taken with pms-RISEDRONATE, may prevent your body from absorbing pms-RISEDRONATE. Take pms-RISEDRONATE on an empty stomach. (See “PROPER USE OF THIS MEDICATION” for instruction).
PROPER USE OF THIS MEDICATION
Recommended Dose:
- 1 pms-RISEDRONATE 35 mg tablet (orange) one day per week, taken orally on an empty stomach and
- 1 calcium caplet (green) daily on the other 6 days per week, taken orally with food.
pms-RISEDRONATE PLUS CALCIUM provides 500 mg of elemental calcium for 6 days per week. It is intended to increase your calcium intake towards the recommended daily intake of 1200-1500 mg in elemental calcium from diet and supplementation. The amount of calcium in this product is not enough by itself to provide you with your daily requirements.
Talk to your doctor about whether you are getting enough calcium from your diet and supplements.
Other medications which may also contain calcium (e.g., multivitamins, antacids) should be taken at separate times of the day with food. All medications containing calcium should be taken at a different time of the day than your pms-RISEDRONATE tablet.
pms-RISEDRONATE PLUS CALCIUM does not contain vitamin D . Talk to your doctor or pharmacist about taking a vitamin D supplement.
pms-RISEDRONATE tablets (orange)
Choose a day of the week to take the orange pms-RISEDRONATE tablet. On your chosen day take one pms-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 pms-RISEDRONATE. Plain water is allowed at all times.
Instructions for all dosing options
- Take 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 pms-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.
Calcium caplets (green)
Take 1 green caplet on each of the other 6 days per week that you don’t take the orange pms-RISEDRONATE tablets. Calcium caplets should be taken with food.
These recommendations help pms-RISEDRONATE PLUS CALCIUM work correctly and help you avoid possible irritation of the esophagus (i.e., the tube connecting the mouth and the stomach).
Missed Dose:
pms-RISEDRONATE tablet (orange): 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. Do not take a calcium caplet on that day. Then resume your schedule by taking 1 tablet on the originally chosen day of the 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 weekly schedule.
Calcium caplets (green): If you forget to take your dose, simply continue to take 1 caplet on the next day. Do not double your next dose (i.e., do not take more than 1 caplet on the same day). If the day that you remember is your regularly scheduled pms-RISEDRONATE day, do not take the missed calcium caplet.
Discard any unused calcium caplets at the end of week.
Overdose:
| If you took too many orange pms-RISEDRONATE tablets, drink a full glass of milk and contact your doctor or Poison Control Centre immediately. Do not induce vomiting. If you took a large number of green calcium caplets, discontinue use and seek medical attention. |
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Drugs like pms-RISEDRONATE may cause problems in your stomach and 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 PLUS CALCIUM as directed.
In clinical studies of osteoporosis with pms-RISEDRONATE, the most commonly reported side effects were abdominal pain, heartburn and nausea.
pms-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 pms-RISEDRONATE.
Calcium carbonate may cause constipation, flatulence, nausea, abdominal pain and bloating.
Very rarely patients have reported non-healing jaw wounds while receiving risedronate 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.
Very rarely patients have reported unusual fractures in their thigh bone while receiving drugs in this class. Consult your doctor if you experience new or unusual pain in your hip, groin, or thigh.
| IMPORTANT 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 | ✓ | ||||||
| Abdominal pain | ✓ | ||||||
| Uncommon (less than 1 in 100) | |||||||
| Eye pain, redness or inflammation; sensitivity to light, decreased vision | ✓ | ||||||
| Rare (less than 1 in 1,000) | |||||||
| Painful tongue | ✓ | ||||||
| Very rare (less than 1 in 10,000) | |||||||
| Allergic reactions such as: hives; rash (with or without blisters); swelling of face, lips, tongue, or throat; difficult or painful swallowing; trouble breathing | ✓ | ||||||
| Jaw problems associated with delayed healing and infection, often following tooth extraction | ✓ | ||||||
| New or unusual pain in hip, groin or thigh | ✓ | ||||||
| Symptoms of low blood calcium level such as numbness, tingling, muscle spasms | ✓ | ||||||
This is not a complete list of side effects. For any unexpected effects while taking pms-RISEDRONATE PLUS CALCIUM, contact your doctor or pharmacist.
HOW TO STORE IT
- Keep pms-RISEDRONATE PLUS CALCIUM and all other medications out of the reach of children.
- Keep the tablets & caplets in their original package and store at controlled room temperature (15°C – 30°C).
- Do not keep medicine that is out of date or that you no longer need.
REPORTING SUSPECTED 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:
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, Pharmascience Inc. at, 1-888-550-6060.
Pharmascience Inc.
Montreal Quebec
H4P 2T4
www.pharmascience.com