Patient Medication Information: uses, side effects, how to take - Etidrocal (Sanis Health)
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 ETIDROCAL 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 and calcium cyclical
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:
ETIDROCAL is not suitable for everyone. Do not take ETIDROCAL if:
- You have had an allergic reaction (e.g. rash, difficulty breathing) to ETIDROCAL 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 (white tablets) contains Magnesium Stearate NF, Microcrystalline Cellulose NF, Pregelatinized Starch NF, and Starch NF (Corn).
Each calcium carbonate tablet (blue tablet) contains acacia, carnauba wax, FD&C Blue No. 2 Aluminum Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium croscarmellose, talc, and titanium dioxide.
Neither the etidronate disodium nor the calcium carbonate tablets contain lactose.
What dosage form it comes in:
The ETIDROCAL therapy is a cyclical regimen administered in 90 day cycles. It contains:
One Card- 14 white, etidronate disodium 400 mg tablets Four Cards- a total of 76 blue, calcium carbonate 1,250 mg tablets (containing 500 mg elemental calcium per tablet) Patient Information Booklet
Prescription Refill Reminder
WARNINGS AND PRECAUTIONS
BEFORE you use ETIDROCAL 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. ETIDROCAL is not intended for administration to pregnant women or during lactation
- You are allergic to ETIDROCAL 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 ETIDROCAL
Be sure to tell your health care providers, including doctors and dentists, about all medicines you are taking, including ETIDROCAL.
INTERACTIONS WITH THIS MEDICATION
If taken with some other medicines, the effects of ETIDROCAL or the effects of other medicines may be changed. Please check with your doctor or pharmacist before taking other medications with ETIDROCAL.
Drugs that may interact with ETIDROCAL 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 ETIDROCAL Package Provides 90 Days of Therapy.
- 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)
- 1) Begin in the top row on Monday. If the tablet is hard to swallow, crush or chew it.
- 2)
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.)
- 3) 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:
If you take too many tablets on any given day, contact your doctor immediately, regional poison control centre, or go to the nearest emergency department
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 and calcium cyclical therapy 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 ETIDROCAL. 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.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY OCCUR 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 | ||
| Uncommon (less than 1 in 100) | |||
| Allergic reaction such as: hives; skin rash; itching | T | ||
Eye pain, redness or inflammation; sensitivity to light, decreased vision | T | ||
| Rare (less than 1 in 1000) | |||
| Worsening of asthma | T | ||
| Blood disorders with symptoms of bleeding, bruising and increased infection | T | ||
| Skin reactions (rash, sores, blisters) involving mucous membranes | T | ||
| Pain and swelling of the tongue or esophagus (tube connecting the mouth & stomach) | T | ||
| Very Rare (less than 1 in 10,000) | |||
| Worsening of stomach and intestinal ulcers | T | ||
| New or unusual pain in hip, groin or thigh | T | ||
For any unexpected effects while taking ETIDROCAL, contact your doctor or pharmacist. This is not a complete list of side effects.
HOW TO STORE IT
The ETIDROCAL therapy should be stored at controlled room temperature (15 - 30°C) and 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:
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- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
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 0701D Ottawa, Ontario 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 found by contacting the sponsor, Sanis Health Inc., at:
Phone: 1-866-236-4076;
Fax: 905-689-1465
or quality@sanis.com
Sanis Health Inc.
Dieppe, New Brunswick
Canada, E1A 1P2