NTP-Etidronate Calcium: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for

• Treatment and prevention of osteoporosis in

  postmenopausal women

• Prevention of corticosteroid induced

  osteoporosis

What it does

To understand how the NTP-ETIDRONATE CALCIUM therapy works, it is important to understand how your body lost bone mass.

Bone is living tissue that your body constantly renews. In this normal process, your body breaks down old bone tissue and replaces it with new bone. After menopause, your body goes through many changes. One change is that your body may remove more bone than it forms. The resulting bone loss can become a condition called osteoporosis, which is a bone thinning disease that causes your bones to become weak and more likely to break. As the bones weaken, people with osteoporosis can experience broken bones, pain, loss of height and humped back.

At first, osteoporosis works ‘silently’, with no symptoms you can feel. Over time, however, it produces a harmful level of bone loss - as much as 30-40% When this occurs, your bones become weak. They can break (fracture) during normal activities or from minor falls. Broken bones in the back (spinal fractures) from osteoporosis are very common. Spinal fractures often cause back pain, loss of height, and a humped back. Your body cannot restore spinal fractures to normal.

Osteoporosis can also lead to fractures of the hip or wrist. A hip fracture can cause you to be hospitalized. Later you may need help with daily activities.

Osteoporosis may also be caused by corticosteroid use. Corticosteroids are drugs that may be prescribed for a variety of conditions including asthma and rheumatoid arthritis.

Doctors tested the etidronate disodium/calcium carbonate tablets therapy in long-term studies in women with osteoporosis. The therapy successfully increased bone mass in the spine. Without therapy, women past menopause may lose bone mass every year. This loss weakens bones and makes them more likely to break.

When it should not be used

NTP-ETIDRONATE CALCIUM is not suitable for everyone. Do not take NTP-ETIDRONATE CALCIUM if:

• You have had an allergic reaction (e.g. rash, difficulty breathing) to NTP-ETIDRONATE CALCIUM and any of its ingredients (see below)
• You have unresolved osteomalacia (a softening of the bones due to lack of vitamin D)

What the medicinal ingredients are:

Etidronate Disodium

Calcium Carbonate

What the nonmedicinal ingredients are:

Each etidronate disodium tablet contains magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.

Each calcium carbonate tablet contains croscarmellose sodium, FD&C blue #2 aluminum lake, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, and vegetable magnesium stearate.

Neither the etidronate disodium nor the calcium carbonate tablets contain lactose.

What dosage forms it comes in:

The NTP-ETIDRONATE CALCIUM therapy is a cyclical regimen administered in 90 day cycles. It contains:

One Card — 14 white, etidronate disodium 400mg tablets

Four Cards — a total of 76 blue, calcium carbonate 1,250mg tablets (containing 500mg elemental calcium per tablet)

Patient Information Booklet

Prescription Refill Reminder

WARNINGS AND PRECAUTIONS

BEFORE you use NTP-ETIDRONATE CALCIUM talk to your doctor or pharmacist if:

• you have unresolved osteomalacia (a softening

  of the bones due to lack of vitamin D)

• you have a history of kidney stone formation

  or problems with your kidneys

• you are pregnant or nursing. NTP-

  ETIDRONATE CALCIUM is not intended for administration to pregnant women or during lactation.

• you are allergic to NTP-ETIDRONATE

  CALCIUM and any of its ingredients, you should not take it

• you are taking warfarin
• you are taking tetracycline

• you have a gastrointestinal disorder which

  makes you prone to diarrhea (for example, Crohn’s disease, colitis, irritable bowel syndrome, food poisoning)

• 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 NTP-ETIDRONATE CALCIUM.

Be sure to tell your health care providers, including doctors and dentists, about all medicines you are taking, including NTP-ETIDRONATE CALCIUM.

INTERACTIONS WITH THIS MEDICATION

If taken with some other medicines, the effects of NTP-ETIDRONATE CALCIUM or the effects of other medicines may be changed. Please check with your doctor or pharmacist before taking other medications with NTP-ETIDRONATE CALCIUM.

Drugs that may interact with NTP-ETIDRONATE CALCIUM include warfarin and tetracycline.

The following foods and medicines should not be taken within 2 hours of taking the white tablet (etidronate disodium): Antacids, vitamins with mineral supplements such as iron, calcium supplements, laxative containing magnesium and foods, especially food high in calcium, such as milk or milk products.

PROPER USE OF THIS MEDICATION

Usual Dose:

The NTP-ETIDRONATE CALCIUM Package Provides 90 Days of Therapy.

1. 1.

   Start the therapy with the first card (white tablets)

   • Begin in the top row on Monday. This will help you remember to take your tablet each day.
   • Take 1 tablet with plenty of water at bedtime each day for 14 days. Take at least 2 hours before or after eating.
   • Finish all white tablets before taking any blue tablets.

Do Not take the white tablet within 2 hours of taking the foods or medicines listed below. They will stop the white tablet from working properly.

• Food, especially food high in calcium, such as milk or milk products
• Antacids
• Vitamins with mineral supplements such as iron
• Calcium supplements
• Laxatives containing magnesium
• Then, start the next cards (blue tablets)
• Begin in the top row on Monday. If the tablet is hard to swallow, crush or chew it.

• Take 1 tablet with plenty of water at bedtime each day, with or without food. (A few people have low stomach acid. If you do, you should take the blue tablet with food. Ask your doctor or pharmacist for more information.)

• Finish all blue tablets on each card before going to the next card.

3 Read the refill reminder at the bottom of the box.

• Ask your doctor or pharmacist about ordering your refill.

Overdose

Missed Dose

If you miss a day (or more) of the treatment, do not take 2 tablets the same day. Take 1 tablet on the day you remember and continue with the therapy. Be sure to finish

all the tablets on the card before you begin the tablets on the next card.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

With any medication, there is some chance of side effects, The most common side effects observed with etidronate disodium/calcium carbonate tablets are nausea and diarrhea.

You may also experience headache, inflammation of the stomach, leg cramps and joint pain.

Rarely reported side effects include confusion, a burning sensation of the tongue, hair loss, and a sensation of numbness, prickling or tingling, or painful or inflamed eyes.

Very rarely patients have reported non-healing jaw wounds while receiving drugs in this class, such as NTP-ETIDRONATE CALCIUM. 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.

For any unexpected effects while taking NTP-ETIDRONATE CALCIUM, contact your doctor or pharmacist. This is not a complete list of side effects.

HOW TO STORE IT

The NTP-ETIDRONATE CALCIUM therapy should be stored between 15°C - 30°C,protected from light and moisture. Keep out of reach of children.

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:

------------------------------------------------------------

1. 1.

   Report online at

   www.healthcanada.gc.ca/medeffect

2. 2. Call toll-free at 1-866-234-2345
3. 3.

   Complete a Canada Vigilance Reporting Form and:

   • Fax toll-free to 1-866-678-6789, or

   • Mail to: Canada Vigilance Program

     Health Canada

     Postal Locator 0701E Ottawa, ON K1A 0K9

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 Teva Canada Ltd., at: 1-800-268-4127 ext.5005 (English); 1-877-777-9117 (French)

or druginfo@tevacanada.com

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: July 19, 2013