Orocal D3 500 mg 400 IU lozenge Calcium and vitamin D deficiency - Adults

Orocal vitamin D3 500 mg / 400 IU is a medicine reserved for adults and particularly in the elderly, in the event of calcium deficiency and vitamin D and as an accompaniment to treatments for osteoporosis when calcium intake and vitamin D is insufficient. Orocal Vitamin D3 500 mg / 400 IU contains 1,250 mg of calcium carbonate, or 500 mg of elemental calcium, 4 mg of cholecalciferol concentrate*, or 400 IU of vitamin D3, for one lozenge.< a i=7> *Composition of cholecalciferol concentrate: cholecalciferol, DL-alpha-tocopherol, sucrose, modified food starch, medium chain triglycerides, sodium ascorbate, silicone dioxide. The other ingredients are: xylitol, povidone, magnesium stearate, sucralose, granulated lemon flavor (isomalt (E953), lemon flavor, mono and diglycerides of fatty acids).

Dosage of Orocal Vitamin D3 500 mg / 400 IU

This medication is reserved for adults for a dosage of 2 lozenges per day. 

Please read the following full disclosure before buying or using this product.

NOTICE

ANSM - Updated on: 04/17/2023

Medication Name

OROCAL VITAMIN D3 500 mg/400 IU, chewable tablet

Calcium/Cholecalciferol

Boxed Warning

Please read this leaflet carefully before taking this medication as it contains important information for you.

You must always take this medication strictly following the information provided in this leaflet or 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, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should consult your doctor if you do not feel any improvement or if you feel worse.

Do not leave this medication within reach of children.

What is in this leaflet?

1. What is OROCAL VITAMIN D3 500 mg/400 IU, chewable tablet and what is it used for?

2. What you need to know before taking OROCAL VITAMIN D3 500 mg/400 IU, chewable tablet?

3. How to take OROCAL VITAMIN D3 500 mg/400 IU, chewable tablet?

4. What are the possible side effects?

5. How to store OROCAL VITAMIN D3 500 mg/400 IU, chewable tablet?

6. Contents of the pack and other information.

7. WHAT IS OROCAL VITAMIN D3 500 mg/400 IU, CHEWABLE TABLET AND WHAT IS IT USED FOR?

Pharmacotherapeutic class - ATC code: Vitamin D and calcium supplement

(Medication active on the calcium balance. A: Digestive system and metabolism).

This medication is indicated in adults in the following situations:

· in the elderly, in case of calcium and vitamin D deficiency,

· in association with osteoporosis treatments when calcium and vitamin D intake is insufficient.

2. WHAT YOU NEED TO KNOW BEFORE TAKING OROCAL VITAMIN D3 500 mg/400 IU, CHEWABLE TABLET?

Never take OROCAL VITAMIN D3 500 mg/400 IU, chewable tablet:

· if you are allergic to calcium carbonate or cholecalciferol (vitamin D) or any of the other ingredients in this medication, listed in section 6;

· in case of prolonged immobilization;

· if you have abnormally high levels of calcium in your blood (hypercalcemia);

· in case of excessive elimination of calcium in the urine (hypercalciuria);

· if you have too much vitamin D in your body (hypervitaminosis D);

· if you suffer from kidney stones (calcium lithiasis).

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

Warnings and Precautions

Talk to your doctor or pharmacist before taking OROCAL VITAMIN D3 500 mg/400 IU, chewable tablet:

Use this medication WITH CAUTION in case of:

· prolonged treatment, it is necessary to regularly check the amount of calcium eliminated in the urine (calciuria), the amount of calcium in your blood (calcemia), and your kidney function. Depending on the result, your doctor may need to reduce or even stop your treatment;

· additional administration of calcium and vitamin D at high doses must be done under strict medical supervision;

· associated treatment with sodium fluoride, bisphosphonates, it is advised to wait at least three hours between taking these medications and OROCAL VITAMIN D3;

· associated treatment with estramustine, thyroid hormones, strontium, zinc, it is advised to wait at least two hours between taking these medications and OROCAL VITAMIN D3;

· and in case of treatment with a tetracycline antibiotic, it is advised to take the antibiotic at least two hours before taking OROCAL VITAMIN D3 or 4 to 6 hours after taking OROCAL VITAMIN D3;

· sarcoidosis or renal insufficiency;

· immobilization if you suffer from osteoporosis.

IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

Other medicines and OROCAL VITAMIN D3 500 mg/400 IU, chewable tablet

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially digitalis, tetracyclines, bisphosphonates, estramustine, iron salts, thyroid hormones, strontium, zinc, thiazide diuretics, orlistat.

OROCAL VITAMIN D3 500 mg/400 IU,

Other Medications and OROCAL VITAMIN D3 500 mg/400 IU, Chewable Tablet

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, especially digitalis, cyclines, bisphosphonates, estramustine, iron salts, thyroid hormones, strontium, zinc, thiazide diuretics, or orlistat.

OROCAL VITAMIN D3 500 mg/400 IU, Chewable Tablet with Food

The absorption of calcium in this medicine can 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 consuming foods high in oxalic and phytic acids.

Pregnancy and Breastfeeding

During pregnancy, do not exceed 1500 mg of calcium and 600 IU per day of vitamin D3: equivalent to one tablet per day.

If you are pregnant or breastfeeding, think you might be pregnant, or are planning a pregnancy, seek advice from your doctor or pharmacist before taking this medication.

Driving and Using Machines

No particular effect.

OROCAL VITAMIN D3 500 mg/400 IU, Chewable Tablet Contains Isomalt and Sucrose

This medication contains isomalt. Its use is not recommended for patients with fructose intolerance (a rare hereditary disease).

This medication contains sucrose. Its use is not recommended for patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency (rare hereditary diseases).

If your doctor has informed you of an intolerance to certain sugars, contact them before taking this medication.

3. HOW TO TAKE OROCAL VITAMIN D3 500 mg/400 IU, Chewable Tablet?

Always take this medication exactly as directed in this leaflet or as instructed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Dosage

The dosage is 2 tablets per day.

IN ALL CASES, STRICTLY FOLLOW YOUR DOCTOR'S PRESCRIPTION.

Method of Administration

FOR ADULT USE ONLY.

Oral route.

The tablets are to be chewed.

Frequency of Administration

IN ALL CASES, STRICTLY FOLLOW YOUR DOCTOR'S PRESCRIPTION.

Duration of Treatment

IN ALL CASES, STRICTLY FOLLOW YOUR DOCTOR'S PRESCRIPTION.

If you take more OROCAL VITAMIN D3 500 mg/400 IU, Chewable Tablet than you should

Symptoms of an overdose of OROCAL VITAMIN D3 500 mg/400 IU, Chewable Tablet may include: loss of appetite (anorexia), nausea, vomiting, intense thirst, increased urine output, constipation, abdominal pain, muscle weakness, fatigue, mental disorders, bone pain, kidney stones, and in severe cases, cardiac rhythm disturbances. An extreme increase in blood calcium can lead to coma or death.

If such effects occur, immediately notify your doctor who will take the necessary measures.

In case of prolonged overdose, the kidneys may suffer irreversible damage, and calcifications may appear in the vessels or tissues.

If you forget to take OROCAL VITAMIN D3 500 mg/400 IU, Chewable Tablet

Do not take a double dose to make up for the forgotten dose.

If you stop taking OROCAL VITAMIN D3 500 mg/400 IU, Chewable Tablet

Not applicable.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medication can cause side effects, although not everybody gets them.

Uncommon (occurring in at least 1/1,000 and less than 1/100 patients treated)

• constipation,
• diarrhea,
• abdominal pain,
• bloated stomach,
• nausea,
• skin rash,
• itching,
• hives.

Rare (occurring in at least 1/10,000 and less than 1/1,000 patients treated)

• excessive increase in calcium levels in the blood or urine, in case of prolonged treatment.

Very rare (occurring in less than 1/10,000 patients treated)

• allergic reactions, such as rapid swelling of the face and neck that can cause breathing difficulties (angioedema or laryngeal edema).

In patients with renal insufficiency, there is a risk of increased blood phosphate levels, kidney stone formation, 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 mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (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 the medicine.

5. HOW TO STORE OROCAL VITAMIN D3 500 mg/400 IU, Chewable Tablet?

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of that month.

This medicine should be stored at a temperature not exceeding 25°C.

Keep the bottle tightly closed.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What OROCAL VITAMIN D3 500 mg/400 IU, Chewable Tablet contains

• The active substances are:

Calcium carbonate ....................................................................................................... 1250 mg Amount corresponding to elemental calcium ................................................................... 500 mg Cholecalciferol concentrate* .......................................................................................... 4 mg Amount corresponding to Vitamin D3 ........................................................................... 400 IU For one chewable tablet.

*Composition of cholecalciferol concentrate: cholecalciferol, DL-α-tocopherol, sucrose, modified food starch, medium-chain triglycerides, sodium ascorbate, silicon dioxide.

• The other components are: xylitol, povidone, magnesium stearate, sucralose, granulated lemon flavor (isomalt (E 953), lemon flavor, mono and diglycerides of fatty acids).

What is OROCAL VITAMIN D3 500 mg/400 IU, Chewable Tablet and contents of the outer packaging

This medicine is in the form of a chewable tablet. Box of 20, 30, 50, 60, 90, 100, 120, or 180.

Marketing Authorization Holder

ARROW GENERIQUES 26 AVENUE TONY GARNIER 69007 LYON

Marketing Authorization Operator

ARROW GENERIQUES 26 AVENUE TONY GARNIER 69007 LYON

Manufacturer

ASKER CONTRACT MANUFACTURING AS DRAMMENSVEIEN 852 1383 ASKER NORWAY

OR

TJOAPACK NETHERLANDS B.V. Nieuwe Donk 9 4879 AC ETTEN-LEUR NETHERLANDS

Medicine names in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the website of the ANSM (France).