NOTICE
ANSM - Updated on : 11/01/2024
Product name
CALCIPRAT 500 mg, sucking tablet
Sidebar
Please read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have any further questions, please ask your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- If you need more information or advice, ask your pharmacist.
- If symptoms worsen or persist, consult your doctor.
- If you notice any side effects not mentioned in this leaflet, or if you experience any of the effects mentioned as serious, please tell your doctor or pharmacist.
Leaflet summary
In this leaflet :
1. WHAT IS CALCIPRAT 500 mg, chewable tablet AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING CALCIPRAT 500 mg, Sucking Tablet?
3. HOW DO I TAKE CALCIPRAT 500 mg, Sucking Tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE CALCIPRAT 500 mg Sucking Tablets?
6. ADDITIONAL INFORMATION
1. WHAT IS CALCIPRAT 500 mg SUCKABLE TABLET AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
DRUG ACTIVE ON CALCIUM BALANCE.
(A: digestive system and metabolism)
Therapeutic indications
This medicine is indicated for calcium deficiency, particularly during growth in children, pregnancy and breast-feeding, and as adjunctive treatment for certain osteoporoses.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING CALCIPRAT 500 mg, chewable tablet?
List of information required before taking the medicine
Not applicable.
Contraindications
Never take CALCIPRAT 500 mg, sucking tablet in the following cases:
- hypersensitivity to any of the ingredients,
- abnormally high levels of calcium in the blood (hypercalcemia),
- exaggerated elimination of calcium in the urine (hypercalciuria),
- kidney stones (calcium lithiasis),
- phenylketonuria (a hereditary disease caused by an enzyme deficiency that prevents the breakdown of the amino acid phenylalanine).
In the event of prolonged immobilization accompanied by hypercalciuria and/or hypercalcemia, treatment should be discontinued. It should only be resumed when mobilization is resumed.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Use CALCIPRAT 500 mg with caution:
Warnings
This product contains terpene derivatives in the formula which, in excessive doses, may cause neurological accidents such as convulsions in infants and children.
Follow recommended dosage and duration of treatment(see Dosage).
Precautions for use
Use this product WITH CAUTION in case of:
- of prolonged treatment, it is necessary to have the quantity of calcium 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.
- associated treatment with digitalis, tetracyclines, vitamin D, sodium fluoride, biphosphonate.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
In case of old or recent epilepsy, SEEK ADVICE FROM YOUR DOCTOR.
Interactions with other drugs
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breast-feeding
Pregnancy and breast-feeding
If you are breast-feeding, do not use this product.
Sportsmen
Not applicable.
Effects on ability to drive vehicles or use machines
Not applicable.
List of excipients
List of excipients with a notorious effect:
Lactose, aspartam.
Terpene derivatives(see What are the possible side effects?).
3. HOW TO TAKE CALCIPRAT 500 mg, sucking tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Adults:
General calcium deficiency and adjunctive treatment of osteoporosis: 1 to 1.5 g daily, i.e. 2 to 3 tablets.
Children:
Calcium deficiency during growth: 500 mg to 1 g daily, i.e. 1 to 2 tablets.
Method of administration
Oral administration.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, CALCIPRAT 500 mg, sucking tablet is likely to have undesirable effects, although not everyone is subject to them.
- constipation,
- bloating,
- nausea.
TELL YOUR DOCTOR OR PHARMACIST ABOUT ANY UNWANTED OR BOTHERSOME EFFECTS NOT MENTIONED IN THIS LEAFLET.
Due to the presence of terpene derivatives and if the recommended doses are not followed:
- risk of convulsions in children and infants,
- possibility of agitation and confusion in the elderly.
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 CALCIPRAT 500 mg chewable tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use CALCIPRAT 500 mg, sucking tablet after the expiration date stated on the box or bottle.
Storage conditions
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines must not be disposed of down the drain or with household waste. Ask your pharmacist what to do with unused medicines. These measures will help protect the environment.
6. FURTHER INFORMATION
Complete list of active ingredients and excipients
What is in CALCIPRAT 500 mg, sucking tablet?
The active substance is:
Calcium carbonate ................................................................................................................ 1250.00 mg
Quantity corresponding to elemental calcium ................................................................................... 500.00 mg
For one tablet.
Other components are:
Xylitol, povidone (K 30), lactose monohydrate, aspartam, levomenthol, mint flavoring*, talc, magnesium stearate.
*Compositionof mint flavor: peppermint essential oil, gum arabic, maltodextrin, sorbitol.
Pharmaceutical form and contents
What is CALCIPRAT 500 mg chewable tablet and what does it contain?
This medicine comes in the form of a chewable tablet. Box of 60.
Name and address of marketing authorization holder and manufacturing authorization holder responsible for batch release, if different
Holder
ALFASIGMA FRANCE
Operator
ALFASIGMA FRANCE
Manufacturer
LABORATOIRES MACORS
ZI Plaines des Isles
89000 AUXERRE
Product names in member states of the European Economic Area
Not applicable.
Date of approval of the package leaflet
This leaflet was last approved on {date}.
MA under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the Afssaps (France) website.
Information reserved for healthcare professionals
Not applicable.
Other
Not applicable.