NOTICE
ANSM - Updated on : 12/07/2019
Product name
CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, chewable tablet
Calcium vitamin D3
Sidebar
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 of the side effects listed above, please tell 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.
What does this leaflet contain?
1. What is CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, chewable tablet and what is it used for?
2. What do I need to know before taking CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, Sucking Tablets?
3. How do I take CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, Sucking Tablets?
4. What are the possible side effects?
5. How do I keep CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, Sucking Tablets?
6. Package contents and other information.
1. WHAT IS CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, suckable tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Calcium Vitamin D Intake - ATC code: A12AX
This medicine is indicated for :
- in elderly patients with calcium and vitamin D deficiency,
- in association with osteoporosis treatments when calcium and vitamin D intake is insufficient.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, Sucking Tablet?
Do not take CALCIUM VITAMIN D3 BIOGARAN 500 mg/400 IU, sucking tablet:
- if you are allergic to calcium, vitamin D or any of the other ingredients listed in section 6,
- if you have an abnormally high level of calcium in the blood (hypercalcemia),
- if you have an exaggerated elimination of calcium in the urine (hypercalciuria),
- kidney stones (calcium lithiasis).
- in case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartam.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking CALCIUM VITAMIN D3 BIOGARAN 500 mg/400 IU.
Use with CAUTION in case of :
- of prolonged treatment, it is necessary to have the quantity of calcium in the blood and eliminated in the urine (calciuria) checked regularly. Depending on the results, your doctor may decide to reduce or discontinue your treatment,
- additional administration of high doses of calcium and vitamin D, under strict medical supervision,
- if you are taking sodium fluoride or a biphosphonate, wait two hours between taking these drugs and CALCIUM VITAMIN D3 BIOGARAN chewable tablet; if you are taking a tetracycline antibiotic, wait three hours before taking CALCIUM VITAMIN D3 BIOGARAN chewable tablet,
- in case of sarcoidosis or renal insufficiency.
Children and adolescents
Not applicable.
Other medicinal products and CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, chewable tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including digitalis, biphosphonates, sodium fluoride, thiazide diuretics, tetracyclines, vitamin D, thyroid hormones, tramadol, iron salts, strontium, zinc, antiepileptics or corticosteroids.
CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, chewable tablet with food and drink
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacistfor advicebefore taking this medicine.
In the event of pregnancy, do not exceed 1500 mg of calcium and 600 IU of CALCIUM VITAMIN D3 BIOGARAN per day, i.e. one tablet per day.
Driving and use of machinery
CALCIUM VITAMIN D3 BIOGARAN has no known or expected effect on the ability to drive and use machines.CALCIUM VITAMIN D3 BIOGARAN 500 mg/400 IU, sucking tablet contains lactose, laspartam and sorbitol .
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
This medicine is not recommended for patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Use of this drug is not recommended in patients with fructose intolerance (a rare hereditary disease).
3. HOW DO I TAKE CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, chewable 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.
Dosage
1 tablet morning and evening, i.e. 2 tablets a day.
Method of administration
Take by mouth.
Suck tablet, then take a glass of water.
Duration of treatment
In all cases, adhere strictly to your doctor's prescription.
If you have taken more CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU chewable tablet than you should have
Consult your doctor or pharmacist immediately.
When taking an excessive dose of CALCIUM VITAMIN D3 BIOGARAN, the following symptoms may occur: nausea, vomiting, intense thirst, constipation.
If you experience any of these effects, tell your doctor immediately, so he or she can take appropriate action.
In the event of prolonged overdosage, calcifications may appear in vessels or tissues.
If you forget to take CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, chewable tablet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU, sucking 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 drug may cause undesirable effects, but they do not occur systematically in everyone.
- constipation or diarrhoea,
- epigastric pain, bloating,
- nausea,
- increased calcium levels in the blood or urine in some cases.
- hypersensitivity reactions such as rapid swelling of the face, lips, tongue or throat, which can lead to breathing difficulties (angioedema or laryngeal edema),
- in patients with impaired renal function, there is a potential risk of hyperphosphatemia (increased phosphate levels in the blood), renal lithiasis (kidney stones) and nephrocalcinosis (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: www.signalement-sante.gouv.fr.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 UI, tablets to suck?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°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 BIOGARAN 500 mg / 400 IU chewable tablet contains
- The active ingredients are :
Calcium element*.................................................................................................................. 500 mg
(*as calcium carbonate)................................................................................ 1250 mg
Cholecalciferol concentrate* (vitamin D3)............................................................................ 400 IU
(*in powder form)
For one chewable tablet.
- Other ingredients include :
Xylitol, povidone K 30, aspartam, levomenthol, mint flavoring*, talc, magnesium stearate, lactose monohydrate.
*Compositionof mint flavor: peppermint essential oil, gum arabic, maltodextrin, sorbitol.
What CALCIUM VITAMIN D3 BIOGARAN 500 mg / 400 IU is and what it contains
This medicine comes in the form of chewable tablets.
Box of 60 or 180.
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
LABORATOIRES MACORS
Z.I. PLAINE DES ISLES
RUE DES CAILLOTTES
89000 AUXERRE
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 subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.