NOTICE
ANSM - Updated on : 25/03/2025
Product name
CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, suckable or chewable tablet
Calcium/Cholecalciferol
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
Keep out of the reach of children.
What does this leaflet contain?
1. What is CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet and what is it used for?
2. What do I need to know before taking CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet?
3. How do I take CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet?
4. What are the possible side effects?
5. How do I keep CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet?
6. Package contents and other information.
1. WHAT IS CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, suckable or chewable tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: calcium in association with vitamin D and/or other substances - ATC code: A12AX.
This medicine contains two active substances, calcium and vitamin D3 (also known as cholecalciferol).
It is used :
- in people undergoing treatment for osteoporosis (a bone disease in which the bone thins and weakens), when the amount of calcium and vitamin D provided by the diet is insufficient;
- for the elderly, in case of calcium and vitamin D deficiency.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet?
Never take CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet :
- if you are allergic to calcium, vitamin D or any of the other ingredients listed in section 6;
- if you have too much calcium in your blood (hypercalcemia);
- if you have too much calcium in your urine (hypercalciuria);
- if you have been immobilized for a long time and have a high level of calcium in your urine (hypercalciuria) and/or blood (hypercalcemia);
- if you have kidney stones (calcium lithiasis) or tissue calcifications;
- if you have calcium deposits in the kidneys (nephrocalcinosis);
- if you have too much vitamin D in your body (hypervitaminosis D ;
- if you have kidney failure.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet.
Too high an intake of calcium and vitamin D may be harmful to your health.
- Calcium and alkaline intake from other sources (foods, fortified foods or other medications) should be monitored when calcium carbonate is prescribed. Milk- and alkaline-drinking syndrome may occur when high doses of calcium and alkaline substances such as bicarbonates and milk are administered concomitantly. If high doses of calcium carbonate are administered, your doctor will monitor your serum calcium levels.
- In the event of prolonged treatment, regular urine tests are necessary to monitor the amount of calcium eliminated in the urine. Depending on the results, your doctor may decide to reduce or even discontinue your treatment.
You should consult your doctor or pharmacist:
- if you suffer from kidney disease (renal insufficiency);
- if you suffer from sarcoidosis, a disease that most often manifests itself as simple fatigue, but leads to enlarged lymph nodes and inflammation of the lungs or other organs.
Children and adolescents
Not applicable.
Other medicines and CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet
You must tell your doctor or pharmacist if you are taking :
- digitalis medicines (for certain heart diseases);
- cyclin antibiotics (for infections);
- ciprofloxacin or norfloxacin (for infections)
- diuretics (for high blood pressure or swelling called edema);
- bisphosphonates (for osteoporosis);
- phenytoin (for epilepsy);
- rifampicin (for infections);
- lestramustine (to treat certain prostate cancers);
- iron salts (to treat iron deficiency or anemia);
- thyroid hormones (to treat thyroid hormone deficiency);
- strontium (to combat osteoporosis);
- zinc.
You must wait at least two hours between taking CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet and any of the following medicines:
- bisphosphonates;
- cyclin antibiotics;
- estramustine;
- thyroid hormones;
- orlistat ;
- strontium;
- zinc.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable tablet with food, drink and alcohol
If you are being treated with this medicine, you should take it away from meals, especially if you eat certain foods: spinach, rhubarb, loseille, cocoa, tea, wholegrain cereals, pulses, oilseeds, chocolate, etc.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breast-feeding, you should not take more than one tablet a day. The daily dose should not exceed 1500 mg calcium and 600 IU vitamin D3 per day.
Driving vehicles and operating machinery
CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet has no effect on your ability to drive or use machines.
CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, suckable or chewable tablet contains laspartam, sorbitol and sucrose.
This medicine contains 15 mg daspartam per tablet. Laspartam contains a source of phenylalanine. May be dangerous for people with phenylketonuria (PKU), a rare genetic disorder characterized by an accumulation of phenylalanine that cannot be eliminated properly.
This medicine contains 413.5 mg sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has informed you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder characterized by the inability to break down fructose, talk to your doctor before you (or your child) take or receive this medication.
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
3. HOW DO I TAKE CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt. Treatment should be taken away from meals (more than two hours if possible).
The recommended dose is 2 tablets a day.
Tablets may be sucked or chewed.
This medication should be taken in 1 or 2 doses per day.
If you have taken moreCALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, suckable or chewable tablet than you should have
Consult your doctor or pharmacist immediately.
Tell your doctor, pharmacist or nearest emergency department.
The following side effects may occur: nausea, vomiting, intense thirst, constipation, anorexia, abdominal pain, muscle weakness, fatigue, mental disorders, increased urine output, increased urge to urinate, bone pain, persistent headache, kidney stones, elevated blood calcium and pH, and decreased kidney function.
If you take too much CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet, over a long period of time, calcium deposits may form in blood vessels or tissues.
An extreme increase in calcium in the blood can lead to coma or death.
If you forget to takeCALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet
Do not take a double dose to make up for the one you forgot to take. Take your next dose at the usual time.
If you stop takingCALCIUM VITAMIN D3 VIATRIS 500 mg/400 UI, chewable or suckable tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
The following effects may occur:
Uncommon (occurring in at least 1/1,000 and less than 1/100 patients treated):
- an excessive increase in calcium levels in the blood or urine, in the event of prolonged treatment.
Rare (occurring in at least 1/10,000 and less than 1/1,000 patients treated):
- nausea;
- stomach pain;
- diarrhea;
- constipation;
- bloating;
- pimples all over the body, hives and itching.
Undetermined frequency:
- milk- and alkaline-drinking syndrome, usually seen only in overdose;
- allergic reactions, e.g. rapid swelling of the face and neck leading to breathing difficulties (angioedemaor laryngeal edema);
- in patients with renal insufficiency, risk of increased phosphate levels in the blood, formation of kidney stones or calcium deposits in the kidneys.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
This medicine should be stored at a temperature not exceeding 30°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet contains
- The active ingredients are :
calcium carbonate .................................................................................................. 1,248.75 mg
amount corresponding to elemental calcium ....................................................................... 500.00 mg
cholecalciferol coated at 100,000 IU/g (vitamin D3 100 CWS) ............................................... 4.00 mg
quantity corresponding to cholecalciferol ................................................................................ 400 Ul
for one chewable or suckable tablet.
- The other components are :
pregelatinized starch, sorbitol, magnesium stearate, aspartam, lemon flavor (lemon flavor composition: deterpenated lemon essential oil, ascorbic acid, citral, sucrose, maltodextrin).
What is CALCIUM VITAMIN D3 VIATRIS 500 mg/400 IU, chewable or suckable tablet and what does it contain?
This medicine takes the form of a chewable or suckable tablet. Box of 60 or 180 in tube of 20 tablets with cap and desiccant capsule (silica gel).
Not all presentations may be marketed.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
DELPHARM GAILLARD
33 RUE DE LINDUSTRIE
74240 GAILLARD
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[To be completed later by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.