Calcium Carbonate Oral tablet, Risedronate Sodium Oral tablet, weekly

What is this medicine?

CALCIUM CARBONATE; RISEDRONATE (KAL see um KAR bon ate; ris ED roe nate) reduces calcium loss from bones. It is used to prevent and to treat osteoporosis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• dental disease

• esophageal, stomach, or intestinal problems, like acid reflux or GERD

• hyperparathyroidism

• kidney stones or disease

• low or high blood calcium

• problems sitting or standing for 30 minutes

• trouble swallowing

• an unusual or allergic reaction to calcium, risedronate, other bisphosphonates or medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Follow the directions on the prescription label. Take risedronate on the same day of the week, every week. Take calcium on the other 6 days of the week.

On the day you take the risedronate:

You must take this medicine exactly as directly or you will lower the amount of the medicine that you absorb into your body or you may cause yourself harm. Take this medicine by mouth first thing in the morning, after you are up for the day. Do not eat or drink anything before you take this medicine. Swallow the tablet with a full glass (6 to 8 ounces) of plain water. Do not take this medicine with any other drink. Do not chew or crush the tablet. After taking this medicine, do not eat breakfast, drink, or take any other medicines or vitamins for at least 30 minutes. Stand or sit up for at least 30 minutes after you take this medicine; do not lie down. Take this medicine on the same day every week. Do not take your medicine more often than directed.

On the days you take the calcium:

Take your calcium tablet with food on the 6 days of the week that you do not take risedronate. Do not take other medicines at the same time as your calcium.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose of risedronate, take the dose on the morning after you remember. Then take your next dose on your regular scheduled day of the week. Never take 2 tablets on the same day. Do not take double or extra doses.

If you miss a dose of calcium, take it as soon as you remember with your next meal. Do not take 2 tablets with the same meal.

Do not take calcium and risedronate tablets at the same time.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• ammonium chloride

• methenamine

This medicine may also interact with the following medications:

• antacids like aluminum hydroxide or magnesium hydroxide

• antibiotics like ciprofloxacin, tetracycline and others

• aspirin

• calcium supplements

• drugs for inflammation like ibuprofen, naproxen, and others

• iron supplements

• magnesium supplements

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• steroid medicines like prednisone or cortisone

• thiazide diuretics

• thyroid hormones

• vitamins with minerals

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. It may be some time before you see the benefit from this medicine. Your doctor may order blood tests or other tests to see how you are doing.

You should make sure that you get enough calcium and vitamin D while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your health care professional.

Some people who take this medicine have severe bone, joint, and/or muscle pain. This medicine may also increase your risk for a broken thigh bone. Tell your doctor right away if you have pain in your upper leg or groin. Tell your doctor if you have any pain that does not go away or that gets worse.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• black or tarry stools

• changes in vision

• heartburn or stomach pain

• jaw pain, especially after dental work

• pain or difficulty when swallowing

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor if they continue or are bothersome):

• bone, muscle, or joint pain

• changes in taste

• diarrhea or constipation

• eye pain or itching

• headache

• nausea or vomiting

• stomach gas or fullness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.