Caltrate 600 mg is a drug indicated in case of calcium deficiency following an increase in needs (growth, pregnancy, breastfeeding), but also in adjunctive treatment of bone decalcifications in the elderly, or following menopause, corticosteroid therapy prolonged immobilization after resumption of mobility.
For warnings, precautions for use and contraindications, please consult the instructions for use.
Caltrate 600 mg is a drug indicated in case of calcium deficiency following an increase in needs (growth, pregnancy, lactation), but also as an adjunct treatment of bone decalcifications in the elderly, or following menopause, corticosteroid therapy , prolonged immobilization after resumption of mobility. Reserved for adults and children over 6 years old.
What is calcium used for ?
Calcium is an essential mineral for the body. No question of ignoring it when you know that it is used to:
Dosage :
Contraindications :
Precaution for use : Read the instructions carefully
Box of 60 film-coated tablets to swallow.
What causes calcium deficiency ?
Care should be taken to consume calcium regularly. A calcium deficiency can lead to:
Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 08/02/2016
CALTRATE 600 mg film-coated tablet
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
In this notice :
1. WHAT CALTRATE 600 mg, film-coated tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE CALTRATE 600 mg film-coated tablet?
3. HOW TO TAKE CALTRATE 600 mg film-coated tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CALTRATE 600 mg film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT CALTRATE 600 mg, film-coated tablet AND WHAT IT IS USED FOR?
MINERAL SUPPLEMENTS.
This medicine contains calcium.
It is recommended:
· in case of calcium deficiency following an increase in needs (growth, pregnancy, breastfeeding).
· in supportive treatment of bone decalcifications in the elderly, or after menopause, corticosteroids, prolonged immobilization after resumption of mobility.
2. BEFORE YOU TAKE CALTRATE 600 mg film-coated tablet?
List of information needed before taking the medication
Not applicable.
Do not take CALTRATE 600 mg film-coated tablets in the following cases :
· Hyper-sensitivity to one of the compounds,
· abnormally high blood calcium (hypercalcemia),
· excessive elimination of calcium by urine (hypercalciuria),
· kidney stones (calcium lithiasis), calcium deposits in the tissues,
· prolonged immobilisation accompanied by hypercalcaemia and / or hypercalciuria: calcium should be administered only at the resumption of mobility.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with CALTRATE 600 mg film-coated tablet:
Special warnings
Excessive calcium intake can be dangerous. DO NOT USE THIS MEDICINE WITHOUT MEDICAL ADVICE.
Precautions for use
Use this medicine with caution in case of prolonged treatment or renal insufficiency: it is necessary to have the calcium level in the urine and in the blood.
This medicinal product is likely to interact with certain foods rich in oxalic acid (spinach, rhubarb, sorrel, cocoa, tea, etc.) and phytic acid (wholegrain cereals, pulses, oilseeds, chocolate ...). is recommended to take it away from meals containing this type of food.
It is advisable to wait at least two hours between taking bisphosphonate, cyclin or estramustine and taking CALTRATE 600 mg film-coated tablets.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, YOU MUST SIGNAL SYSTEMATICALLY ANY OTHER PROCESSING IN PROGRESS TO YOUR DOCTOR OR TO YOUR PHARMACIST in particular digitalics, cyclins, bisphosphonates, estramustine, iron salts and diuretics thiazides.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
In case of deficiency, your doctor may prescribe this medication during pregnancy or lactation.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE CALTRATE 600 mg film-coated tablet?
Not applicable.
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.
In adults :
· Calcium deficiencies in general and adjunctive treatment of osteoporosis (maintenance treatment): 2 to 3 tablets per day.
In children over 6 years :
Calcium deficiencies in growth period according to age: 1 to 2 tablets per day.
Method and route of administration
Oral use.
The tablets should be swallowed with a large glass of water.
Frequency of Administration
IN ALL CASES, CONFORM TO STRICTLY THE MEDICAL PRESCRIPTION.
Duration of treatment
IN ALL CASES, CONFORM TO STRICTLY THE MEDICAL PRESCRIPTION.
Symptoms and Instructions for Overdose
If you take more CALTRATE 600 mg film-coated tablets than you should, the following symptoms may appear:
· nausea, vomiting, intense thirst, constipation.
If any of these effects occur, tell your doctor immediately and take the necessary measures.
In case of prolonged overdose, calcifications may occur in vessels or tissues
Instructions for omission of one or more doses
Do not take a double dose to make up for the single dose that you have forgotten to take.
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Digestive disorders such as constipation, flatulence, nausea.
· In case of prolonged treatment at high doses: risk of alteration of the calcium level in blood or urine,
· rash, urticaria and itching.
Declaration of 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 adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE CALTRATE 600 mg film-coated tablet?
Keep out of the reach and sight of children.
Do not use CALTRATE 600 mg film-coated tablets after the expiry date which is stated on the carton.
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
Full list of active substances and excipients
What CALTRATE 600 mg contains, film-coated tablet
The active substance is:
Calcium carbonate ............................................... .................................................. .............. 1498.500 mg
Quantity corresponding to Calcium element ............................................. ....................................... 600.00 mg
For a film-coated tablet.
Other components are: microcrystalline cellulose, croscarmellose, magnesium stearate, crospovidone, povidone, sodium lauryl sulfate, hypromellose, titanium dioxide, light liquid paraffin, talc.
Pharmaceutical form and content
What is CALTRATE 600 mg film-coated tablets and contents of the pack?
This medication is in the form of film-coated tablets. Box of 30, 60, 90.
PFIZER FAMILY HEALTH
23-25, avenue du Docteur Lannelongue
75014 PARIS
PFIZER FAMILY HEALTH
23-25 rue du Docteur Lannelongue
75014 PARIS
WYETH LEDERLE SPA
VIA NETTUNENSE 90
04011 APRILIA (LT)
ITALY
or
WYETH MEDICA IRELAND
NEWBRIDGE
CO. KILDARE
IRELAND
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Not applicable.
Mineral element: calcium
calcium
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
CALTRATE 600 mg: scored tablet (white); box of 60.
Refunded at 65%. - price: 5,90 euro (s).
Pfizer Family Health Laboratory
| p cp | |
| Calcium carbonate | 1.498 g |
| either Calcium | 600 mg |
Usual dosage:
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