Orocal Calcium 500 mg, 60 chewable tablets, is an ideal treatment for correcting calcium deficiencies associated with growth, pregnancy, or osteoporosis. Easy to take and well tolerated, it supports bone metabolism while helping to maintain good bone health.
When we talk about calcium, we immediately think of strong bones, healthy teeth, and overall balanced health. And that’s exactly where Orocal Calcium 500mg comes in—an essential source of calcium formulated to support your body during key life stages: growth, pregnancy, breastfeeding, or osteoporosis. This chewable or suckable tablet delivers 500 mg of calcium per dose, in the form of calcium carbonate, to strengthen bone mass and support physiological functions.
During growth spurts, particularly in children and adolescents, calcium needs skyrocket. Orocal then becomes a valuable ally in supporting skeletal development. It acts as a natural bone support, enabling the body to build a strong skeletal structure. In this age group, a deficiency could slow growth and lead to long-term structural weaknesses. Orocal effectively compensates for this deficiency.
In pregnant or breastfeeding women, calcium reserves are put to the test. The fetus and infant draw directly from the mother’s resources. Orocal 500 mg, thanks to its convenient chewable or suckable form, provides quick and effective supplementation without any hassle. It is a true nutritional support solution for expectant and new mothers who are concerned about maintaining their bone density.
As for older adults or those with osteoporosis, they will also benefit fully from this targeted supplementation. With age, intestinal calcium absorption decreases, while the risk of fractures increases. Orocal acts as a shield against bone demineralization, helping to reduce calcium loss and slow the progression of osteoporosis.
This product is also useful during periods of prolonged bed rest or convalescence, when immobility accelerates bone loss. By providing calcium, Orocal helps preserve bone strength, particularly in hospitalized individuals or those with limited mobility.
Finally, let’s not forget about interactions with other treatments. When taken alongside vitamin D therapy, Orocal becomes an ideal supplement, as calcium and vitamin D form an essential duo for optimal mineral absorption in the intestine. It is therefore a key complementary product in many remineralization regimens.
In summary, Orocal 500 mg stands out as a versatile, effective, and well-tolerated supplement for anyone seeking to address a calcium deficiency. It works at the core of bone health, preserves bone mineral density, and strengthens skeletal structures. For optimal support, consider combining Orocal with Caltrate 600 mg Calcium (60 tablets), a supplement with high bioavailability for enhanced prevention of osteoporosis.
Directions for Use:
Orocal 500 mg is taken orally as a chewable or dissolvable tablet. For adults, the recommended dosage is 2 to 3 tablets per day, preferably taken with meals to maximize absorption. For children, requirements vary depending on weight and height: 1 to 2 tablets per day are generally sufficient in cases of growth-related deficiency. For effective calcium intake to prevent osteoporosis, it is advisable to strictly follow medical recommendations.
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Precautions:
Calcium carbonate, xylitol, povidone, orange flavoring, magnesium stearate, sucralose, purified water, isomalt, fatty acid monoglycerides and diglycerides, ethanol
Packaging:
Orocal Calcium 500 mg is available in a box of 60 lozenges or chewable tablets, a convenient, portable format perfectly suited for long-term treatment or short-term use in cases of calcium deficiency.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: April 17, 2023
OROCAL 500 mg, lozenge/chewable tablet
Calcium
You should always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
· Keep this package insert. You may need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, tell your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. See Section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse.
Keep this medicine out of the reach of children.
What is in this package insert?
1. What is OROCAL 500 mg, a suckable/chewable tablet, and what is it used for?
2. What should you know before taking OROCAL 500 mg, a suckable/chewable tablet?
3. How should you take OROCAL 500 mg, a suckable/chewable tablet?
4. What are the possible side effects?
5. How should you store OROCAL 500 mg, a chewable or suckable tablet?
6. Package contents and other information.
1. WHAT IS OROCAL 500 mg, a chewable/suckable tablet, AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: calcium supplement - ATC code: A12AA04
This medication provides calcium.
This medication is recommended:
· for calcium deficiency during growth, pregnancy, and breastfeeding,
· as a source of calcium in cases of osteoporosis.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING OROCAL 500 mg, chewable/suckable tablet?
Never take OROCAL 500 mg, chewable/suckable tablet:
· if you are allergic to calcium or any of the other ingredients in this medication listed in Section 6;
· if you have hypercalcemia (abnormally high levels of calcium in the blood);
· if you have hypercalciuria (excessive excretion of calcium in the urine);
· if you have calcium lithiasis (kidney stones) or tissue calcifications;
· in cases of prolonged immobility accompanied by hypercalciuria and/or hypercalcemia.
IF IN DOUBT, IT IS ESSENTIAL TO CONSULT YOUR DOCTOR OR PHARMACIST.
Warnings and Precautions
Consult your doctor or pharmacist before taking OROCAL 500 mg, a chewable/suckable tablet.
· During long-term treatment, it is necessary to have your urinary calcium levels (calciuria) checked regularly. Depending on these levels, your doctor may need to reduce or even discontinue your treatment.
· When used in combination with vitamin D, blood and urine calcium levels should be monitored regularly.
· When taking sodium fluoride, it is advisable to stagger the timing of calcium intake.
· If you are taking digitalis, calcium supplementation (especially when combined with vitamin D) requires regular monitoring: you must consult your doctor or cardiologist so they can work with you to establish a monitoring schedule.
· If you are taking oraltetracyclines(a class of antibiotics), it is recommended that you space out the intake of this medication by at least 3 hours.
TO AVOID POSSIBLE INTERACTIONS BETWEEN MULTIPLE MEDICATIONS, YOU SHOULD ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENTS YOU ARE CURRENTLY TAKING.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Children and adolescents
NEVER LEAVE WITHIN REACH OF CHILDREN.
Other Medications and OROCAL 500 mg, Suckable/Chewable Tablet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.
OROCAL 500 mg, suckable/chewable tablet with food, beverages, and alcohol.
Not applicable.
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medication.
This medication, when used as directed, is safe to use during pregnancy and while breastfeeding. In general, you should consult your doctor or pharmacist before taking any medication.
Athletes
Not applicable.
Driving and Operating Machinery
Not applicable.
OROCAL 500 mg, chewable/suckable tablet contains isomalt
Its use is not recommended in patients with fructose intolerance (a rare hereditary disorder).
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medication.
3. HOW TO TAKE OROCAL 500 mg, chewable/suckable tablet?
Oral use.
Adults: General calcium deficiency and osteoporosis: 2 to 3 chewable/suckable tablets per day.
Use in children: Calcium deficiency during growth: 1 to 2 chewable or dissolvable tablets per day, depending on weight and height.
IN ALL CASES, STRICTLY FOLLOW YOUR DOCTOR’S PRESCRIPTION.
If you have taken more OROCAL 500 mg chewable tablets than you should have
Consult your doctor or pharmacist immediately.
If you forget to take OROCAL 500 mg, chewable/suckable tablet
Do not take a double dose to make up for the dose you missed.
If you stop taking OROCAL 500 mg, chewable/suckable tablet
Not applicable.
If you have any other questions about the use of this medication, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Dry mouth when taking the medication.
Reporting Side Effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: the French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers—Website: https://signalement.social-sante.gouv.fr/.
By reporting side effects, you help provide more information on the safety of this medication.
5. HOW SHOULD OROCAL 500 mg, a suckable/chewable tablet, BE STORED?
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiration date printed on the packaging. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medication down the drain or with household trash . Ask your pharmacist how to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What OROCAL 500 mg, chewable/suckable tablet contains
· The active ingredient is:
Calcium carbonate............................................................................................... 1250.00 mg
Equivalent amount of calcium............................................................................. 500.00 mg
For one chewable/suckable tablet.
· Other ingredients are:
Xylitol, povidone, orange flavor*, magnesium stearate, sucralose, purified water.
*Composition of the orange flavoring : isomalt, orange flavoring, fatty acid monoglycerides and diglycerides, 96% ethanol.
What is OROCAL 500 mg, lozenge/chewable tablet, and contents of the outer packaging
This medication is available as a chewable/suckable tablet in either a bottle or blister packs.
Boxes of 20, 30, 50, 60, 90, 100, 120, or 180 chewable/suckable tablets.
Not all strengths may be available.
Marketing Authorization Holder
26 AVENUE TONY GARNIER
69007 LYON
Marketing Authorization Holder
26 Avenue Tony Garnier
69007 LYON
ASKER CONTRACT MANUFACTURING AS
DRAMMENSVEIEN 852
1383 ASKER
NORWAY
OR
Tjoapack Netherlands B.V.
Nieuwe Donk 9
4879 AC Etten-Leur
Netherlands
Drug names in the member states of the European Economic Area
Not applicable.
The date this package insert was last revised is
[to be completed later by the marketing authorization holder]
Detailed information about this medication is available on the ANSM (France) website.
This medication contains a high amount of calcium, the main component of bone.
It is used in cases of increased calcium requirements (growth periods, pregnancy, breastfeeding) or bone demineralization (postmenopausal osteoporosis, long-term cortisone treatment).
The prices listed do not include the pharmacist’s “dispensing fee.”
| per tablet | |
| Calcium carbonate | 1.25 g |
| equivalent to Calcium | 500 mg |
| Aspartame | + |
Excessive calcium intake can be dangerous, particularly in cases of kidney failure. Do not use this medication without medical advice.
When this medication is used to treat bone demineralization caused by prolonged immobilization, it should only be taken once the patient has resumed walking.
Calcium is sometimes combined with vitamin D, which promotes its absorption; blood tests may be ordered to ensure there is no abnormal accumulation of calcium in the body.
Allow at least a 2-hour interval between taking this medication and taking cyclines, bisphosphonates, thyroid hormones, or medications containing iron, zinc, or strontium.
Also, inform your pharmacist or doctor if you are taking a medication containing digoxin or a diuretic (such as hydrochlorothiazide).
There are also food interactions: foods known to be high in oxalic acid (spinach, rhubarb, sorrel, cocoa, tea) or phytic acid (chocolate, whole grains, legumes) can reduce calcium absorption. It is therefore recommended to take this medication away from meals containing these foods.
The total daily intake of calcium from medication during pregnancy or breastfeeding should not exceed 1,500 mg.
The tablets should be sucked.
Taking this medication does not replace the need for regular consumption of dairy products, which are naturally rich in calcium.
Dry mouth.
In cases of prolonged treatment at high doses: hypercalcemia, hypercalciuria (excess calcium in the urine, which may contribute to kidney stones).
A concretion (stone) that forms in the excretory ducts of certain organs: urinary, biliary, or salivary tracts.
Synonym: lithiasis.
A hormone secreted by the adrenal glands. It helps regulate the body’s sugars, fats, and proteins, as well as the body’s response to stress. Its powerful anti-inflammatory properties are used in medical treatment. Natural cortisone is called cortisol (which can be measured through blood tests). Hydrocortisone is the medicinal form most similar to natural cortisone; it is primarily used in replacement therapy for conditions caused by a cortisone deficiency. Other, more potent chemical derivatives are used when an anti-inflammatory effect is desired: prednisone, prednisolone, betamethasone, dexamethasone, etc.
Excess calcium in the blood, resulting from a disease or the use of certain medications (excess vitamin D).
An abnormal increase in calcium levels in the urine.
The kidneys’ inability to eliminate waste products or medications. Advanced kidney failure does not necessarily result in a decrease in urine output. Only a blood test and measurement of creatinine levels can detect this condition.
A concretion (stone) that forms in the excretory tracts of certain organs: urinary, biliary, or salivary tracts.
Synonym: calculus.
The gradual cessation of menstrual cycles, which occurs in women around the age of 50. Menopause is caused by a sharp decrease in hormone secretion by the ovaries. It can also result from surgical removal of the ovaries or from medication.
See the article: Menopause
A condition in which bones become weak, porous, and brittle.
See the article: Osteoporosis.
An inherited disorder characterized by the absence of an enzyme, leading to the accumulation of a toxic substance in the blood. Screening for this condition is routine at birth. Treatment involves a specific diet during early childhood.
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