Caltrate D3 600MG/400UI 60 TABLETS

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3400933969554

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For warnings, the precautions and cons-indications, please see the instructions.

Description

Caltrate Vitamin D3 600 mg/440 IU is a drug indicated in adults in the following situations:

  • In the elderly, in case of deficiency of calcium and vitamin D topic
  • In combination treatment of osteoporosis when calcium intake and vitamin D is insufficient.

For adults only

Composition:

  • Calcium carbonate, vitamin D3 or Cholaciférol
  • Excipients: microcrystalline cellulose, povidone, crospovidone, sodium laurilsulfate, croscarmellose sodium, magnesium stearate, Opadry OY-S-27203, light liquid paraffin talc.

Dosage:

  • 2 tablets per day, taken with a full glass of water.

Cons-indications:

  • Allergy to vitamin D or to one of the other components of Caltrate Vitamin D3,
  • Amount of calcium in the abnormally high blood (hypercalcemia) and / or elimination of excessive calcium in the urine (hypercalciuria)
  • Kidney stones (nephrolithiasis calcium)
  • Excessive intake of vitamin D (hypervitaminosis D).

Oral

Read carefully the instructions

Packaging:   box of 60 tablets.

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

CALTRATE VITAMINE D3

Vitamin D with Calcium

calcium, vitamin D3

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

CALTRATE VITAMIN D3 600 mg / 400 IU: tablet (beige); box of 60.
Refunded at 65%. - price: 5,90 euro (s).

CALTRATE VITAMIN D3 600 mg / 400 IU: tablet (beige); box of 180.
Refunded at 65%. - price: 16,72 euro (s).

Pfizer Family Health Laboratory

COMPOSITION (summary)
p cp
Calcium 600 mg
Colecalciferol (vitamin D3) 400 IU
Soya oil +

INDICATIONS (summary)
This medicine contains calcium and vitamin D, which facilitates the absorption of calcium by the intestine and its fixation on the bones.
He is used :
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
This medicine contains vitamin D: its overdose exposes you to serious side effects. It is present in many medicines, some of which are available in self-medication: avoid associating them without medical advice.
Do not prolong the treatment beyond the prescribed time: blood tests may be necessary to check the absence of abnormal accumulation of calcium in the body.
When this medication is used to treat decalcification due to prolonged bed rest, treatment should not be started until walking resumes.
DRUG INTERACTIONS (summary)
Follow an interval of at least 2 hours between taking this drug and cyclins , thyroid hormones, biphosphonates, quinolones or iron, zinc or strontium medications.
Inform your pharmacist or doctor if you are taking digitalis or diuretics .
There are also food interactions: foods known to be rich in oxalic acid (spinach, rhubarb, sorrel, cocoa, tea) or phytic acid (chocolate, whole grains, dried vegetables) can reduce calcium absorption. It is therefore recommended to take this medicine away from meals containing these foods.
PREGNANCY AND BREAST-FEEDING (summary)
This medication may be used in pregnant or nursing women, but the dosage prescribed by the doctor should not be exceeded.
Hypercalcemia during pregnancy could be harmful to the unborn child. Be sure not to take several medications containing vitamin D during pregnancy.
DIRECTIONS FOR USE AND DOSAGE (summary)
This medication should be taken at a distance from certain foods (see Interactions).
The tablets should be swallowed with a large glass of water (200 ml). To facilitate grip and avoid a false road, especially in the elderly, the tablet can be cut in two parts before being swallowed with a large glass of water.

Usual dosage:

  • Adult and elderly: 1 tablet, 2 times a day.
  • Pregnant woman: 1 tablet per day.
TIPS (summary)
Taking this medication does not dispense with the regular consumption of dairy products, naturally rich in calcium.
POSSIBLE ADVERSE EFFECTS (summary)
Uncommon: hypercalcaemia , hypercalciuria (excess calcium in the urine may promote kidney stones).
Rarely: constipation, nausea, bloating, diarrhea, stomach pain, rash, itching.
Exceptionally: swelling of the throat, angioedema .


GLOSSARY (summary)


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


shortcomings
Deficit usually involving nutrients, vitamins, minerals, etc. A diversified diet is the best prevention of deficiencies.


cyclins
Family of antibiotics used especially in the treatment of acne and certain genital infections.


digitalis
Family of drugs related to digitalis, substance derived from the purple foxglove (common plant). Digitalis, used in cardiology, slow down the heart and strengthen its contractions.


diuretics
Medication allowing increased kidney water removal. Most often, this loss of water follows the loss of salts caused by the drug (salidiuretic).
Diuretics are mainly used in the treatment of high blood pressure, while their mechanism of action in this disease is poorly understood. They are also prescribed in acute or chronic heart failure, edema and other rarer ailments.
These drugs cause loss of sodium and potassium (except for some of them called "potassium-sparing"). Their prolonged administration therefore requires regular blood potassium control, to avoid heart problems that may result from hypokalemia (lack of potassium in the blood). Lack of sodium is another possible but less frequent consequence of the prolonged use of diuretics; it is also detected by a blood test.


hypercalcemia
Excess of calcium in the blood, due to illness or the use of certain drugs (excess vitamin D).


hypercalciuria
Abnormal increase in calcium in urine.


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


osteoporosis
Fragilisation of the bones, which become porous and brittle.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


angioedema
Allergy edema usually affects the face. Quincke edema results in a sometimes spectacular swelling. Eyelids are often the first to be affected. In rare cases where edema affects the throat, respiratory problems may occur and urgent treatment is required.


overdose
Excessive intake of a drug may result in an increase in the intensity of adverse effects or even in the development of specific adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.


treatment
Treatment that complements the action of a specific treatment, but generally does not achieve healing on its own.


vitamin
An essential ingredient for the growth and proper functioning of the body. Vitamin requirements are normally covered by a varied diet. In developed countries, only vitamin D deficiency, in the young child or the old man who is exposed to the sun, justifies systematic supplementation. Superior intake, especially with medicines, can lead to overdose and various disorders (mainly vitamins A and D).


way
  • Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • Set of hollow organs allowing the passage of air (airways), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 29/04/2016

Name of the medicinal product

CALTRATE VITAMIN D3 600 mg / 400 IU, film-coated tablet

Calcium and cholecalciferol

framed

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 afterwards, consult a physician.

· 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.

Review summary

In this notice :

1. WHAT IS CALTRATE VITAMIN D3 600 mg / 400 IU film-coated tablet AND WHAT IT IS USED FOR?

2. BEFORE YOU TAKE CALTRATE VITAMIN D3 600 mg / 400 IU, film-coated tablet?

3. HOW TO TAKE CALTRATE VITAMIN D3 600 mg / 400 IU film-coated tablet?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE CALTRATE VITAMIN D3 600 mg / 400 IU film-coated tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS CALTRATE VITAMIN D3 600 mg / 400 IU film-coated tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

CALCIUM IN ASSOCIATION WITH OTHER SUBSTANCES

Therapeutic indications

This medicine contains calcium and vitamin D3, which facilitates the absorption of calcium by the intestine and its fixation on the bones.

He is used:

· in the treatment of calcium deficiencies and vitamin D in the elderly,

· in combination with the treatment of osteoporosis when the intake of calcium and vitamin D is insufficient.

2. BEFORE YOU TAKE CALTRATE VITAMIN D3 600 mg / 400 IU, film-coated tablet?

List of information needed before taking the medication

Not applicable.

Cons-indications

Do not take CALTRATE VITAMINE D3 600 mg / 400 IU film-coated tablets in the following cases:

· If you are allergic to vitamin D or any of the other ingredients of Caltrate Vitamin D3.

· if you have an abnormally high amount of calcium in the blood (hypercalcaemia) and / or an exaggerated elimination of calcium in the urine (hypercalciuria)

· if you have kidney stones (calcium lithiasis)

· if you have an excessive intake of vitamin D (hypervitaminosis D)

Precautions for use; special warnings

Take special care with CALTRATE VITAMINE D3 600 mg / 400 IU film-coated tablet:

· In case of prolonged treatment with Caltrate Vitamin D3, it is necessary to have regularly check the amount of calcium present in the blood (calcemia). This control is particularly important in the elderly and during associated treatment based on cardiotonic glycosides or diuretics.
Depending on the outcome, your doctor may have to reduce or even interrupt your treatment.

· If you frequently have kidney stones.

· If your doctor has informed you that you are suffering from kidney failure.

· If your doctor has informed you that you have a sarcoidosis

· If you are immobilized and have a decrease in bone mass (osteoporosis)

· If you are taking other medicines containing vitamin D3 or calcium

Interaction with other medicines

Taking 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.

In particular, you should tell your doctor if you are taking or have recently taken any of the following medicines:

· thiazide diuretics,

· corticosteroids by the general route,

· a treatment based on ion exchange resins such as cholestyramine or laxatives such as paraffin oil,

· an antibiotic treatment of the tetracycline family in case of simultaneous administration. It is recommended to shift the intake of tetracyclines at least 2 hours before or 4 to 6 hours after oral calcium intake,

· a treatment based on digitalis in case of simultaneous administration. You will then need to be monitored regularly (ECG and calcemia control),

· a treatment based on biphosphonate or sodium fluoride. It is recommended to shift Caltrate Vitamin D3 by at least 3 hours, as their digestive absorption can be reduced.

Interactions with food and beverages

Food and drinks

Within two hours of taking Caltrate Vitamin D3, you should avoid ingesting foods containing oxalic acid (present in spinach and rhubarb) or phytic acid (found in whole grains) that can inhibit the absorption of calcium.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy - Breastfeeding

In pregnancy, the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D, one tablet per day.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines:

The effect of Caltrate Vitamin D3 on the ability to drive or use machines has not been studied. However, no effect is known or expected.

List of excipients with known effect

Not applicable.

3. HOW TO TAKE CALTRATE VITAMIN D3 600 mg / 400 IU film-coated tablet?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Always take the dose recommended by your doctor. In case of uncertainty consult your doctor or pharmacist.

Caltrate Vitamin D3 comes in the form of film-coated tablets to be taken orally.

The usual dose is 2 tablets per day, to be swallowed with a large glass of water.

Symptoms and Instructions for Overdose

If you take more CALTRATE VITAMIN D3 600 mg / 400 IU, film-coated tablet than you should:

When taking an overdose of Caltrate Vitamin D3, the following symptoms may occur: anorexia, excessive thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, tiredness, mental disorders, increased urine volume, bone pain , kidney stones.

In case of prolonged overdose, calcifications may occur in vessels or tissues.

In cases of significant overdose cardiac arrest may occur.

If any of these effects occur, stop taking Caltrate Vitamin D3 and immediately notify your doctor who will take the necessary action.

Instructions for omission of one or more doses

If you forget to take CALTRATE VITAMIN D3 600 mg / 400 IU, film-coated tablet:

Do not take a double dose to make up for a missed dose.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, CALTRATE VITAMIN D3 600 mg / 400 IU, film-coated tablets may have side effects, although not everyone is exposed to them.

Uncommon side effects (affects 1 to 10 users in 1000): Excessive calcium in blood or urine.

Rare side effects (affects 1 to 10 users in 10,000): constipation, bloating, nausea, abdominal pain, diarrhea, itching, rash and urticaria.

Other side effects (unknown): kidney stones.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CALTRATE VITAMIN D3 600 mg / 400 IU film-coated tablet?

Keep out of the reach and sight of children.

Expiration date

Do not use Caltrate Vitamin D3 after the expiry date which is stated on the carton and vial.

The expiry date refers to the last day of the month.

Storage conditions

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

Keep the bottle tightly closed, away from moisture.

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.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does CALTRATE VITAMIN D3 600 mg / 400 IU contain, film-coated tablets?

The active substance is:

Calcium carbonate ............................................... .................................................. 1498.50 mg

Quantity corresponding to calcium element ............................................. ........................................ 600.00 mg

Cholecalciferol or Vitamin D3 .............................................. .................................................. ........ 400.00 IU

For a scored film-coated tablet.

The other components are:

Microcrystalline cellulose, povidone, crospovidone, sodium laurilsulfate, croscarmellose sodium, magnesium stearate, OPADRY OY-S-27203, light liquid paraffin, talc.

Pharmaceutical form and content

What is CALTRATE VITAMINE D3 600 mg / 400 IU film-coated tablet and contents of the pack?

This medication is in the form of a scored film-coated tablet.

Bottle of 30, 60, 90 and 180.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

PFIZER FAMILY HEALTH

23-25, avenue du Docteur Lannelongue

75014 PARIS

exploiting

PFIZER FAMILY HEALTH

23-25 ​​rue du Docteur Lannelongue

75014 PARIS

Maker

WYETH MEDICA IRELAND

NEWBRIDGE

CO. KILDANE

IRELAND

or

PFIZER CONSUMER MANUFACTURING ITALY SRL

VIA NETTUNENSE 90

04011 APRILIA (LT)

ITALY

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.

Internet Information

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

Information for health professionals only

Not applicable.

Other

Not applicable.

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