Patient Medication Information: uses, side effects, how to take - Teva-Risedronate/Calcium
What TEVA-RISEDRONATE/CALCIUM is used for:
- To treat or to prevent osteoporosis in postmenopausal women.
How does TEVA-RISEDRONATE/CALCIUM work?
TEVA-RISEDRONATE/CALCIUM is a combination of TEVA-RISEDRONATE (risedronate sodium monohydrate) tablets and calcium carbonate tablets.
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. TEVA-RISEDRONATE slows down bone loss which can help to reduce the risk of fractures. In many people, TEVA-RISEDRONATE helps to increase bone density.
TEVA-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.
It is not known how long TEVA-RISEDRONATE/CALCIUM should be used for treating osteoporosis. Keep talking to your doctor about whether TEVA-RISEDRONATE/CALCIUM is still right for you.
What are the ingredients in TEVA-RISEDRONATE/CALCIUM?
Medicinal ingredients:
Risedronate sodium, calcium (as calcium carbonate)
Nonmedicinal ingredients:
TEVA-RISEDRONATE: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium stearyl fumarate, starch and film-coating containing: FD&C yellow #6/sunset yellow FCF, aluminium lake, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polyethylene glycol, polysorbate and titanium dioxide.
Calcium: microcrystalline cellulose, croscarmellose sodium, vegetable stearic acid, vegetable magnesium stearate, silicon dioxide, titanium dioxide, polyethylene glycol, FD&C Blue #2, sorbitol, talc, polyvinyl alcohol.
TEVA-RISEDRONATE/CALCIUM comes in the following dosage forms:
TEVA-RISEDRONATE/CALCIUM is a combination pack containing TEVA-RISEDRONATE tablets and calcium carbonate tablets. It is supplied as a monthly (28 days) course of therapy.
Each carton contains 4 strips of calcium 500 mg tablets (4 x 6) and 1 strip of TEVA-RISEDRONATE 35 mg tablets (1 x 4) blister packaged.
Do not use TEVA-RISEDRONATE/CALCIUM if:
- If you have low blood calcium levels (hypocalcemia).
- If you have high blood calcium levels (hypercalcemia)
- If you are allergic to TEVA-RISEDRONATE/CALCIUM or any of its ingredients (see below).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-RISEDRONATE/CALCIUM. Talk about any health conditions or problems you may have, including if you:
- 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 TEVA-RISEDRONATE/CALCIUM)
You 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 if you:
- Smoke
- Have or have had tooth 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 TEVA-RISEDRONATE/CALCIUM 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 TEVA-RISEDRONATE. Dental work should be done before you start TEVA-RISEDRONATE treatment Take good care of your teeth and gums and see the dentist for regular checkups while taking TEVA-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 TEVA-RISEDRONATE/CALCIUM:
Vitamins, mineral supplements and antacids may contain substances that can stop your body from absorbing the TEVA-RISEDRONATE in TEVA-RISEDRONATE/CALCIUM. They contain calcium, magnesium, aluminium and iron. Take these medicines at a different time of day than TEVA-RISEDRONATE/CALCIUM. Talk to your healthcare provider about how and when to take these medicines.
Taking TEVA-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 anti-inflammatory drugs because they may upset your stomach.
Calcium products may interact with medications such as digoxin, certain antibiotics, iron supplements, phenytoin, thyroid hormones, steroid medications and thiazide diuretics.
Usual Dose:
1 TEVA-RISEDRONATE 35 mg tablet (orange) one day per week, taken orally on an empty stomach and
- 1 calcium tablet (blue) daily on the other 6 days per week, taken orally with food.
TEVA-RISEDRONATE/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 TEVA-RISEDRONATE tablet.
TEVA-RISEDRONATE/CALCIUM does not contain vitamin D. Talk to your doctor or pharmacist about taking a vitamin D supplement.
How to take TEVA-RISEDRONATE/CALCIUM:
TEVA-RISEDRONATE tablets (orange)
Choose a day of the week to take the orange TEVA-RISEDRONATE tablet. On your chosen day take one TEVA-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 TEVA-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 TEVA-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 tablets (blue)
- Take 1 blue tablet on each of the other 6 days per week that you don’t take the orange TEVA-RISEDRONATE tablets. Calcium tablets should be taken with food.
These recommendations help TEVA-RISEDRONATE/ CALCIUM work correctly and help you avoid possible irritation of the esophagus (i.e., the tube connecting the mouth and the stomach).
Overdose:
If you think you have taken too many orange TEVA-RISEDRONATE tablets, drink a full glass of milk. Do not make yourself vomit. Contact your healthcare professional, hospital emergency room or regional Poison Control Centre immediately, even if there are no symptoms. If you took a large number of blue calcium tablets, discontinue use and seek medical attention. |
Missed Dose:
TEVA-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 tablet 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 tablets (blue): If you forget to take your dose, simply continue to take 1 tablet on the next day. Do not double your next dose (i.e., do not take more than 1 tablet on the same day). If the day that you remember is your regularly scheduled TEVA-RISEDRONATE day, do not take the missed calcium tablet.
Discard any unused calcium tablets at the end of week.
What are possible side effects from using TEVA-RISEDRONATE/ CALCIUM?
These are not all the possible side effects you may feel when taking TEVA-RISEDRONATE/ CALCIUM. If you experience any side effects not listed here, contact your healthcare professional.
Drugs like TEVA-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 TEVA-RISEDRONATE and tell your doctor right away. Remember to take TEVA-RISEDRONATE/ CALCIUM as directed.
The most common side effects reported with TEVA-RISEDRONATE are abdominal pain, heartburn and nausea.
TEVA-RISEDRONATE may cause pain in bones, joints or muscles, rarely severe.
Calcium carbonate may cause constipation, flatulence, nausea, abdominal pain and bloating.
Patients receiving TEVA-RISEDRONATE or other drugs in this class have reported:
- Rarely, non-healing jaw wounds
- Very rarely, unusual fractures in their thigh bone. Consult your doctor in you experience new or unusual pain in your hip, groin, or thigh.
- 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 And What To Do About Them
| Symptom / Effect | Talk with your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Common | |||
| Pain in bones, joints, or muscles | √ | ||
| Abdominal pain | √ | ||
| Uncommon | |||
Eye pain, redness or swelling; sensitivity to light, decreased vision | √ | ||
| Rare | |||
| Painful tongue | √ | ||
Jaw bone problems (osteonecrosis). Numbness or a feeling of heaviness in the jaw; poor healing of gums; loose teeth; exposed bone in the mouth; sores in the mouth; discharge; dry mouth; swelling gums; infections; bad breath; pain in the mouth, teeth or jaw. | √ | ||
| Very rare | |||
| Allergic and skin reactions such as hives; rash (with or without blisters); swelling of the face, lips, tongue, or throat; difficult or painful swallowing; trouble breathing | √ | ||
| New or unusual pain in hip, groin or thigh | √ | ||
| Symptoms of low levels of calcium in the blood such as numbness, tingling or muscle spasms | √ | ||
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.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
Storage:
- Keep TEVA-RISEDRONATE/CALCIUM and all other medications out of the reach and sight of children.
- Keep the tablets in their original package and store at room temperature between 15ºC and 30ºC. Protect from light. Do not keep medicine that is out of date or that you no longer need.
If you want more information about TEVA-RISEDRONATE/ CALCIUM:
- 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://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.
Prepared on: March 29, 2018