Orocal Calcium Vitamin D3 is an essential supplement in cases of bone deficiency or fragility. Its chewable format provides a daily intake of calcium and vitamin D3, ideal for supporting bone metabolism, strengthening the skeleton and accompanying osteoporosis treatments in adults and the elderly.
Are you concerned about loss of bone density or calcium and vitamin D deficiency? Orocal Calcium Vitamin D3 is a chewable tablet specifically formulated to compensate for nutritional deficiencies essential to bone strength and overall skeletal health. Thanks to its winning duo - calcium + vitamin D3 - it actively contributes to mineral balance, particularly in adults and the elderly.
This dietary supplement targets the increased need for calcium and vitamin D3, often encountered in the context of a sedentary lifestyle, ageing or osteoporosis treatment. Vitamin D3, also known as cholecalciferol, facilitates intestinal calcium absorption, while calcium carbonate directly fills the gaps in calcium intake. Together, they form an effective bulwark against the risk of demineralization.
In cases of osteoporosis, Orocal plays a supportive therapeutic role, complementing specific medical treatments. It is thus recommended when diet alone is no longer sufficient to provide the necessary intake of these two fundamental nutrients. It helps preserve bone density, reduce the risk of fractures and maintain strong bones, particularly after the menopause.
But this product goes even further. It is also very useful in cases of convalescence, immobilization or long periods of physical inactivity, all situations where calcium reserves can melt away like snow in the sun. By restoring mineral balance, it contributes to improved recovery and lasting joint comfort.
Another major advantage is its practical, chewable format, making it easy to use on a daily basis, particularly for senior citizens or patients with swallowing difficulties. The lemony taste improves compliance with treatment, while offering a pleasant sensory experience.
Finally, whether to prevent or accompany bone fragility, Orocal Calcium Vitamin D3 is an indispensable ally for your bone capital. It acts like an invisible mason, rebuilding the structure of your bones brick by brick, while restoring the vital energy of essential minerals.
For optimal bone strengthening, consider combining it with a product rich in magnesium, a complementary trace element essential to calcium metabolism.
Directions for use:
Give your opinion on the recommendations for use and dosage of Orocal Calcium Vitamin D3 with our partner Avis Vérifiés after your purchase.
Precautions for use:
Contains sugar: not recommended in cases of fructose intolerance or sucrase-isomaltase deficiency.
Ingredients:
Carbonate De Calcium, Concentrat De Cholécalciférol, Xylitol, Povidone, Stéarate De Magnésium, Sucralose, Arôme Citron Granulé, Isomalt, Arôme Citron, Mono Et Diglycérides D'acides Gras
Presentation:
Orocal Calcium Vitamin D3 is available as suckable tablets in boxes of 20 to 180 units. Its practical, on-the-go format enables flexible use, ideal for a bone supplement tailored to the daily needs of adults and the elderly.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: April 17, 2023
OROCAL VITAMIN D3 500 mg/400 IU, lozenge
Calcium/Cholecalciferol
Please read this package insert carefully before taking this medication, as it contains important information for you.
You should always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
· Keep this leaflet. 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 VITAMIN D3 500 mg/400 IU, lozenge, and what is it used for?
2. What should you know before taking OROCAL VITAMIN D3 500 mg/400 IU, lozenge?
3. How should you take OROCAL VITAMIN D3 500 mg/400 IU, lozenge?
4. What are the possible side effects?
5. How should OROCAL VITAMIN D3 500 mg/400 IU, lozenge be stored?
6. Package contents and other information.
1. WHAT IS OROCAL VITAMIN D3 500 mg/400 IU, lozenge, AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: vitamin D and calcium supplementation
(Medication affecting calcium balance. A: Digestive system and Metabolism).
This medication is indicated for adults in the following situations:
· in the elderly, in cases of calcium and vitamin D deficiency,
· in combination with osteoporosis treatments when calcium and vitamin D intake is insufficient.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING OROCAL VITAMIN D3 500 mg/400 IU, lozenge?
Never take OROCAL VITAMIN D3 500 mg/400 IU, lozenge:
· if you are allergic to calcium carbonate, cholecalciferol (vitamin D), or any of the other ingredients in this medication listed in Section 6;
· if you are immobilized for a prolonged period;
· if you have abnormally high levels of calcium in your blood (hypercalcemia);
· in cases of excessive calcium excretion in the urine (hypercalciuria);
· if you have too much vitamin D in your body (hypervitaminosis D);
· if you have kidney stones (calcium lithiasis).
IF IN DOUBT, IT IS ESSENTIAL TO CONSULT YOUR DOCTOR OR PHARMACIST.
Warnings and Precautions
Consult your doctor or pharmacist before taking OROCAL VITAMIN D3 500 mg/400 IU, lozenge:
Use this medication WITH CAUTION in the following cases:
· of long-term treatment, it is necessary to regularly monitor the amount of calcium excreted in the urine (calciuria), the amount of calcium in your blood (calcemia), and your kidney function. Depending on the results, your doctor may need to reduce or even discontinue your treatment;
· of additional high-dose calcium and vitamin D supplementation, which must be administered under strict medical supervision;
· of concomitant treatment with sodium fluoride or bisphosphonates; it is recommended to wait at least three hours between taking these medications and OROCAL VITAMIN D3;
· with concomitant treatment involving destramustine, thyroid hormones, strontium, or zinc; it is recommended to wait at least two hours between taking these medications and OROCAL VITAMIN D3;
· and in cases of treatment with a cycline-class antibiotic, it is recommended to take the antibiotic at least two hours before taking OROCAL VITAMIN D3 or 4 to 6 hours after taking OROCAL VITAMIN D3;
· of sarcoidosis or kidney failure;
· of immobility if you have osteoporosis.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Other Medications and OROCAL VITAMIN D3 500 mg/400 IU, lozenge
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications, especially digitalis, cyclines, bisphosphonates, estramustine, iron salts, thyroid hormones, strontium, zinc, thiazide diuretics, or lorlistat.
OROCAL VITAMIN D3 500 mg/400 IU, lozenge to be taken with food
The absorption of the calcium in this medication may be reduced by oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains). Do not take this medication within two hours of eating foods high in oxalic acid and phytic acid.
Pregnancy and Breastfeeding
If you are pregnant, do not exceed 1,500 mg of calcium and 600 IU of vitamin D3 per day: that is, one tablet per day.
If you are pregnant or breastfeeding, if you think you might be pregnant, or if you are planning a pregnancy, consult your doctor or pharmacist before taking this medication.
Driving and operating machinery
No specific effects.
OROCAL VITAMIN D3 500 mg/400 IU, chewable tablet contains isomalt and sucrose
This medication contains isomalt. Its use is not recommended in patients with fructose intolerance (a rare hereditary disorder).
This medication contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase/isomaltase deficiency (rare hereditary disorders).
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 VITAMIN D3 500 mg/400 IU, lozenge?
Dosage
The dosage is 2 tablets per day.
IN ALL CASES, STRICTLY FOLLOW YOUR DOCTOR’S PRESCRIPTION.
Administration
FOR ADULTS ONLY.
Oral use.
The tablets are meant to be sucked.
Dosage Frequency
IN ALL CASES, STRICTLY FOLLOW YOUR DOCTOR’S PRESCRIPTION.
Duration of treatment
IN ALL CASES, STRICTLY FOLLOW YOUR DOCTOR’S PRESCRIPTION.
If you have taken more OROCAL VITAMIN D3 500 mg/400 IU, lozenge than you should have
If you take an excessive dose of OROCAL VITAMIN D3 500 mg/400 IU, lozenge, the following symptoms may occur: loss of appetite (anorexia), nausea, vomiting, intense thirst, increased urine output, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, bone pain, kidney stones, and, in severe cases, heart rhythm disturbances. An extreme increase in blood calcium levels can lead to coma or death.
If such effects occur, notify your doctor immediately so that he or she can take the necessary measures.
In the event of prolonged overdose, the kidneys may be irreversibly damaged, and calcifications may develop in the blood vessels or tissues.
If you forget to take OROCAL VITAMIN D3 500 mg/400 IU, lozenge
Do not take a double dose to make up for the dose you missed.
If you stop taking OROCAL VITAMIN D3 500 mg/400 IU, lozenge
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.
Uncommon (occurring in at least 1 in 1,000 and fewer than 1 in 100 treated patients)
· constipation,
· diarrhea,
· abdominal pain,
· bloating,
· nausea,
· skin rash,
· itching,
· hives.
Rare (occurring in at least 1 in 10,000 and in fewer than 1 in 1,000 treated patients)
· excessive increase in calcium levels in the blood or urine, in cases of prolonged treatment.
Very rare (occurring in fewer than 1 in 10,000 treated patients)
· allergic reactions, such as rapid swelling of the face and neck that may cause breathing difficulties (angioedema or laryngeal edema).
In patients with renal insufficiency, there is a risk of increased phosphate levels in the blood, the formation of kidney stones, or calcium deposits in the kidneys.
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 package insert. 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 VITAMIN D3 500 mg/400 IU, lozenge, BE STORED?
Keep this medication out of the sight and reach of children.
This medicine should be stored at a temperature not exceeding 25°C.
Keep the bottle tightly closed.
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 VITAMIN D3 500 mg/400 IU, lozenge contains
· The active ingredients are:
Calcium carbonate......................................................................................................... 1250 mg
Amount corresponding to elemental calcium ............................................................................ 500 mg
Cholecalciferol concentrate* ................................................................................................. 4 mg
Amount corresponding to VitaminD3................................................................................... 400 IU
For one chewable tablet.
*Composition of the cholecalciferol concentrate: cholecalciferol, DL-α-tocopherol, sucrose, modified food-grade starch, medium-chain triglycerides, sodium ascorbate, silicon dioxide.
· Other ingredients are: xylitol, povidone, magnesium stearate, sucralose, granulated lemon flavoring (isomalt (E 953), lemon flavoring, mono- and diglycerides of fatty acids).
What is OROCAL VITAMIN D3 500 mg/400 IU, lozenge, and outer packaging contents
This medication comes in the form of a lozenge. Box of 20, 30, 50, 60, 90, 100, 120, or 180.
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 calcium and vitamin D, which helps the intestines absorb calcium and facilitates its incorporation into the bones.
The prices listed do not include the pharmacist’s “dispensing fee.”
| per tablet | per tablet | per tablet | |
| Calcium | 500 mg | 500 mg | 500 mg |
| Cholecalciferol (vitamin D3) | 200 IU | 400 IU | 1,000 IU |
| Isomalt | + | + | + |
| Sucrose | + | + | + |
This medication contains vitamin D: an overdose can lead to serious side effects. Vitamin D is present in many medications, some of which are available over the counter: avoid combining them without medical advice.
Precautions are necessary in cases of sarcoidosis or renal insufficiency.
Do not continue treatment beyond the prescribed duration: a blood test may be necessary to ensure there is no abnormal accumulation of calcium in the body.
When this medication is used to treat decalcification caused by prolonged bed rest, treatment should not be started until the patient has resumed walking.
Due to the presence of calcium, allow at least a 2-hour interval between taking this medication and taking cyclines, bisphosphonates, thyroid hormones, or medications containing ciprofloxacin, norfloxacin, sodium fluoride, iron, zinc, strontium, or estramustine.
Also, inform your pharmacist or doctor if you are taking a digitalis, a diuretic, or orlistat.
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) may reduce calcium absorption. It is therefore recommended to take this medication away from meals containing these foods.
This medication can be used by pregnant or breastfeeding women, but the dosage prescribed by the doctor must not be exceeded.
Hypercalcemia during pregnancy could be harmful to the unborn child. Be sure not to take multiple medications containing vitamin D during pregnancy.
This medication should be taken away from certain foods (see Interactions).
The 500 mg/200 IU and 500 mg/1000 IU tablets can be chewed or sucked.
The 500 mg/400 IU tablets are meant to be sucked.
Taking this medication does not replace the need for regular consumption of dairy products, which are naturally rich in calcium.
Uncommon: hypercalcemia, hypercalciuria (excess calcium in the urine, which may contribute to kidney stones).
Rare: constipation, nausea, bloating, diarrhea, stomach pain, skin rash, itching, hives.
Frequency unknown: angioedema.
Accumulation of air or gas in the intestine.
See the article: Bloating, Flatulence, and Aerophagia
A concretion (stone) that forms in the excretory ducts of certain organs: urinary, biliary, or salivary tracts.
Synonym: lithiasis.
A deficiency usually involving nutrients, vitamins, minerals, etc. A varied diet is the best way to prevent deficiencies.
A slowing of intestinal transit resulting in less frequent bowel movements.
See the article: Constipation in Adults or Constipation in Infants and Children
A class of antibiotics used primarily to treat acne and certain genital infections.
The strict medical definition of diarrhea is “excessively frequent and voluminous bowel movements.” In common parlance, however, diarrhea is equated with frequent, loose stools. Normally, stools are soft and paste-like, but the passage of loose or barely formed stools—without pain or any specific associated symptoms—is not considered pathological. Diarrhea is diagnosed when liquid bowel movements occur repeatedly throughout the day, and the urge to defecate is urgent or painful.
Many medications can speed up intestinal transit and make stools more liquid, without this side effect being a cause for serious concern.
Antibiotics can alter the gut flora, which is essential for digestion, and cause diarrhea that is more or less bothersome but benign. The effect appears immediately or after a few days of treatment. A severe and rare form of diarrhea, pseudomembranous colitis, can occur after antibiotic treatment; this condition is characterized by the passage of mucus and pseudomembranes (resembling shreds of skin) accompanied by abdominal pain; constipation may replace the initial diarrhea. Pseudomembranous colitis can occur several days after stopping antibiotic treatment and requires urgent medical attention.
See the article: Diarrhea and Gastroenteritis in Adults or Diarrhea and Gastroenteritis in Children
A class of drugs related to digitalin, a substance derived from purple foxglove (a common plant). Digitalis preparations, used in cardiology, slow the heart rate and strengthen heart contractions.
A medication that increases the excretion of water by the kidneys. Most often, this loss of water follows the loss of salts caused by the medication (salidiuretic).
Diuretics are primarily used to treat high blood pressure, although their mechanism of action in this condition is not well understood. They are also prescribed for acute or chronic heart failure, edema, and other rarer conditions.
These medications cause a loss of sodium and potassium (except for certain types known as “potassium-sparing” diuretics). Long-term use therefore requires regular monitoring of blood potassium levels to prevent cardiac complications that could result from hypokalemia (low potassium levels in the blood). Low sodium levels are another possible—though rarer at standard dosages—consequence of long-term diuretic use; this can also be detected through a blood test.
The appearance of pimples or patches on the skin. These lesions may be caused by a food or a medication and may indicate an allergy or a toxic reaction. Many viruses can also cause rashes: those associated with rubella, roseola, and measles are the best known.
The frequency of an adverse reaction is described in official documents as follows:
The current trend in official documents is to report all bothersome symptoms observed—even exceptionally—in people who have used the drug. Some of these symptoms are actually attributable to the drug, while others may occur during treatment purely by coincidence, even though the drug is likely not responsible.
For the sake of completeness, we have chosen to list all the symptoms enumerated in official documents, although we are aware of the risk of causing unnecessary concern. Providing accurate information to the public remains our top priority, however. Please be aware that these symptoms are not necessarily caused by the medication.
A family of hormones that accelerate metabolism, secreted by the thyroid gland. They can be measured in the blood and are called T3 and T4.
Excess calcium in the blood, resulting from a medical condition 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.
Weakening of the bones, which become porous and brittle.
See the article: Osteoporosis.
An allergic reaction that typically affects the face. Quincke’s edema causes swelling that can sometimes be dramatic. The eyelids are often the first to be affected. In rare cases where the edema affects the throat, breathing difficulties may occur, and urgent treatment is necessary.
Sucrose is the substance that makes up table sugar and industrial sugar found in cookies, cakes, candies, and sugary drinks (a 1.5-liter bottle of soda contains the equivalent of thirty sugar cubes). Some people are intolerant to fructose, which is produced during the digestion of sucrose, and consequently suffer from bloating and diarrhea. Some medications contain sucrose as an excipient (a component with no therapeutic activity).
See the article: Are All Carbohydrates the Same?
A disease of unknown cause that primarily affects young adults and most often manifests as simple fatigue.
It causes enlarged lymph nodes and inflammation of the lungs or other organs.
A mineral that can form salts, particularly with chlorine (sodium chloride, or table salt).
Abbreviation for International Unit. A standardized unit of measurement that indicates the activity of a substance.
A rash of hives on the skin, most often caused by an allergic reaction. The hives resemble stings from stinging nettles and range in color from pale pink to red. Hives can appear or disappear within a few minutes and cause intense itching; it can be localized or spread across the entire skin surface. When hives occur daily and no cause can be identified, the condition is referred to as chronic spontaneous urticaria.
A substance essential for the growth and proper functioning of the body. Vitamin requirements are normally met through a varied diet. In developed countries, only vitamin D deficiency—in young children or the elderly who have little exposure to sunlight—warrants systematic supplementation. An intake exceeding the body’s needs—particularly through medications—can lead to an overdose and various health problems (primarily vitamins A and D).
See the article: Vitamins.
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