NATECAL CALCIUM VITAMIN D3 600MG / 400 IU orodispersible tablet

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NATECAL VITAMIN D3 600 mg / 400 IU orodispersible tablet indicated for vitamin and calcium deficiency in the elderly and Osteoporosis.

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For warnings, precautions for use and against-indications, please refer to the manual of NATECAL VITAMIN D3.

Description NATECAL VITAMIN D3 600 mg / 400 IU orodispersible tablet

NATECAL VITAMIN D3: conditions for which it may be prescribed

Vitamin D and calcium deficiency in the elderly
osteoporosis
Metabolism and nutrition therapy class

Pharmacotherapeutic group: calcium, combination with other drugs, ATC code: A12AX

Vitamin D corrects an insufficient intake of vitamin D. It increases intestinal absorption of calcium. The optimal amount of vitamin D in the elderly is 500 to 1000 IU / day.

Calcium supplementation can compensate for inadequate dietary calcium intake.

The daily dose of calcium needed in the elderly is 1500 mg / day.

Vitamin D and calcium correct secondary senile hyperparathyroidism.

Indications NATECAL VITAMIN D3

Correction of vitamin and calcium deficiencies in the elderly.

Additional calcium and VITAMIN D3 as an adjunct to specific treatment for osteoporosis in patients at high risk of combined deficiency of calcium and VITAMIN D or in whom this deficiency was diagnosed.

Directions for use and dosage of NATECAL VITAMIN D3

Adults and elderly

One tablet twice daily (eg. One tablet in the morning and one tablet in the evening). A dose reduction should be considered based on the rates in the context of monitoring of calcium, as indicated in sections Warnings and Precautions and Interactions with other drugs and other forms of interaction.

The tablets may be sucked and should not be swallowed whole.

The tablets should preferably be taken after meals.

Dosage in pregnant women

One tablet daily (see pregnancy section).

in hepatic impairment dosage

No dose adjustment is necessary.

Composition of VITAMIN D3 NATECAL

Active ingredients Calcium, Cholecalciferol
Excipients maltodextrin, aspartame (E951), hydroxypropyl cellulose (E463), Lactose, Citric acid (E330) Stearic acid (E570), DL alpha-tocopherol (E307), Soybean oil, Gelatin, Sucrose, Corn starch, Orange flavor: natural flavorings, maltodextrin, dextrin

Introducing NATECAL VITAMIN D3

Box of 60 orodispersible tablets

Warnings about medications

Attention drug NATECAL VITAMIN D3 is not a product like any other. Read the package leaflet before ordering. Do not let drugs out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Tell your pharmacist Online ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual of this drug on the website of the National Agency of Drug Safety and health products.

Pharmacovigilance : Declare one or effect (s) undesirable (s) connected (s) to the use of a drug

VIDAL OF THE FAMILY

NATECAL VITAMIN D3

Vitamin D with Calcium

calcium, vitamin D

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

PRESENTATIONS (summary)

NATECAL VITAMINE D3: orodispersible tablet (white, orange flavoring); box of 60.
Refunded at 65%. - price: 5,90 euro (s).

Laboratory Effik

COMPOSITION (summary)
p cp
Calcium carbonate 1.5 g
either Calcium 600 mg
Colecalciferol (vitamin D3) 400 IU
aspartame +
Lactose +
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.
Precautions are necessary in patients with renal insufficiency .
Do not prolong the treatment beyond the prescribed time: a blood test 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)
Due to the presence of calcium, take at least 2 hours between taking this medicine and cyclins , biphosphonates or iron-containing medicines.
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 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 preferably after meals.
Tablets should not be swallowed whole. They must be sucked.

Usual dosage:

  • Adult: 1 tablet, morning and evening. In pregnant women, the dosage is reduced to 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)
Rarely: constipation, nausea, bloating, diarrhea, stomach pain.
Allergic reaction (presence of soybean oil).
In case of prolonged treatment in high dose: hypercalcaemia , hypercalciuria (excess calcium in the urines which can promote kidney stones).


GLOSSARY (summary)


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.


orodispersible
Categorizes a tablet that breaks up in the mouth in contact with saliva. It can also be dispersed in a glass of water before ingestion.


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


phenylketonuria
An inherited disease that is characterized by the absence of an enzyme and that leads to the accumulation in the blood of a toxic product. Screening is systematic at birth. Treatment is based on a specific diet during early childhood.


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


Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


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: 22/07/2013

Name of the medicinal product

NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet

Calcium / cholecalciferol (vitamin D 3 )

framed

Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.

· Keep this leaflet, you may need to read it again

· If you have any questions, ask your doctor or pharmacist.

· Consult a physician if symptoms worsen or persist.

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

Review summary

In this notice :

1. WHAT IS NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet AND IN WHAT CASES IS IT USED?

2. BEFORE YOU TAKE NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet?

3. HOW TO TAKE NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS NATECAL VITAMIN D3, 600 mg / 400 IU, orodispersible tablet AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group

NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet contains two active ingredients, calcium carbonate and cholecalciferol (vitamin D 3 ). Calcium and vitamin D 3 are present in the diet and vitamin D is also manufactured in the skin after exposure to the sun. NATECAL VITAMIN D 3 orodispersible tablets may be prescribed by a doctor to treat and prevent vitamin-calcium deficiency.

Therapeutic indications

NATECAL VITAMINE D 3 is used:

· To treat vitamin-calcium deficiencies in the elderly,

· In combination with osteoporosis treatments when calcium and vitamin D levels are too low, or if there is a risk that they are low.

2. BEFORE YOU TAKE NATECAL VITAMIN D3, 600 mg / 400 IU, orodispersible tablet?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never take NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet in the following cases:

· If you are allergic (hypersensitive) to calcium, vitamin D 3 or any of the other ingredients of NATECAL VITAMIN D 3 (especially soybean oil);

· if you have high levels of calcium in the blood (hypercalcaemia) or in the urine (hypercalciuria);

· if you have kidney failure;

· if you have kidney stones;

· if you have high levels of vitamin D in the blood (hypervitaminosis D).

Precautions for use; special warnings

Take special care with NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet:

· if you have had kidney stones or other kidney problems (your doctor will need to closely monitor your treatment if your kidneys are not working properly to ensure that calcium does not accumulate in your blood);

· if you stay in bed for an extended period (in months) and if you have osteoporosis (fragile bones) because you can have high levels of calcium in the blood;

· if you are taking other medicines or other products containing calcium or vitamin D (your doctor or pharmacist can tell you if this is the case);

· if you suffer from sarcoidosis (your doctor will tell you if this is the case).

Interaction with other medicines

Taking or using other medicines:

Do not use this medication without first talking to your doctor or pharmacist if you are taking:

· any other medicinal product containing vitamin D;

· the following drugs for the heart: digoxin or other cardiac glycosides;

· antibiotics of the class of tetracyclines and fluoroquinolones. It is recommended to wait at least 3 hours after taking these medicines before taking NATECAL VITAMIN D 3 ;

· thiazide diuretics;

· if you are taking other medications to treat bone problems, such as biphosphonates or sodium fluoride. It is recommended to wait at least 3 hours before taking the orodispersible tablets of NATECAL VITAMIN D 3 ;

· Phenytoin (an antiepileptic) and barbiturates (drugs used for epilepsy or to help you sleep), because they can make vitamin D 3 less effective;

· Orlistat (a medication to treat obesity), cholestyramine, laxatives such as paraffin oil, because they can reduce the amount of vitamin D 3 you absorb;

· Estramustine (a drug used in chemotherapy), thyroid hormones or medicines containing iron, zinc or strontium, as the amount absorbed can be reduced. They should be taken at least two hours before or after NATECAL VITAMIN D 3 .

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.

Interactions with food and beverages

Food and drinks

This product is likely to interact with certain foods, such as those containing oxalic acid (spinach, rhubarb, sorrel, cocoa, tea, etc.), phosphates (ham, sausages, cheese spreads ...) or phytic (legumes, whole grains, chocolate ...). Therefore, it is recommended to take NATECAL VITAMIN D 3 two hours before or after meals containing these types of food.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

NATECAL VITAMIN D 3 orodispersible tablets should be used during pregnancy and lactation exclusively on the recommendation of a physician.

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

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

Important information about some of the ingredients of NATECAL VITAMINE D 3 , 600 mg / 400 IU, orodispersible tablet:

The product contains: aspartam (E951), lactose, hydrogenated soybean oil, sucrose.

The product contains aspartame, a source of phenylalanine. Phenylalanine can be dangerous for people with phenylketonuria.

The product contains lactose and sucrose; therefore, if your doctor has told you that you are suffering from intolerance to some sugars, contact him or her before taking this medication.

The product contains soybean oil; therefore, if you are allergic to peanuts or soy beans, do not use this medicine.

3. HOW TO TAKE NATECAL VITAMIN D3, 600 mg / 400 IU, orodispersible tablet?

Instructions for proper use

Not applicable.

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

Dosage

Always follow the dosage indicated by your doctor or pharmacist. If in doubt, consult your doctor.

The usual dose for adults and the elderly is one tablet twice a day (eg one tablet in the morning and one tablet in the evening), preferably after the meal.

Administration mode

The tablets can be put in the mouth without water and must be sucked. They should not be swallowed whole.

You will feel the tablets dissolve in your mouth within minutes. This will be accompanied by a slight effervescence.

Symptoms and Instructions for Overdose

If you take more NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet than you should:

Contact your doctor. If this is not possible, go to the emergency room of the nearest hospital with the remaining tablets and packaging.

Instructions for omission of one or more doses

If you forget to take NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet:

Take it as soon as you remember. Take the next dose at the usual time. However, if the next dose is near, skip the missed dose and continue as usual. Do not take two doses at the same time.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet is likely to have side effects, although not everyone is subject to it.

The following effects are infrequent: (affecting 1 to 10 patients per 1,000):

· hypercalcemia (too much calcium in your blood) - Symptoms include nausea, vomiting, lack of appetite, constipation, stomach pain, bone pain, extreme thirst, need to urinate more often, muscle weakness, drowsiness and disorientation;

· hypercalciuria (too much calcium in your urine).

The following effects are rare: (affecting 1 to 10 patients out of 10,000):

· nausea

· stomach ache

· constipation

· diarrhea

· flatulence

· itching

· rash

· urticaria

The following effects have an unknown frequency (can not be estimated from the available data):

· Serious allergic reactions (hypersensitivity) such as swelling of the face, lips or tongue.

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

5. HOW TO STORE NATECAL VITAMIN D3, 600 mg / 400 IU, orodispersible tablet?

Keep out of the reach and sight of children.

Expiration date

Do not use NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablets after the expiry date which is stated on the box and on the pill.

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

Storage conditions

Store at a temperature not exceeding 30 ° C

Store in the original package in order to protect 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 is NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet and contents of the pack?

This medication is in the form of an orodispersible tablet.

The tablet is round with bevelled edges and is white to whitish in color.

Box of 12, 60 or 180 (3 x 60 tablets) tablets.

Not all pack sizes may be marketed.

Pharmaceutical form and content

What is NATECAL VITAMIN D 3 , 600 mg / 400 IU, orodispersible tablet and contents of the pack?

This medication is in the form of an orodispersible tablet.

The tablet is round with bevelled edges and is white to whitish in color.

Pill containing 12 or 60 tablets.

Not all pack sizes may be marketed.

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

EFFIK

9/11 RUE JEANNE BRACONNIER

BUILDING "THE NEWTON"

92366 MEUDON LA FORET CEDEX

exploiting

EFFIK

BUILDING "THE NEWTON"

9/11, RUE JEANNE BRACONNIER

92366 MEUDON LA FORET

Maker

ITALFARMACO SPA

VIALE FULVIO TESTI, 330

20126 MILAN

ITALY

Names of the medicinal product in the Member States of the European Economic Area

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

[to be completed by the holder]

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 ANSM website (France).

Information for health professionals only

The following information is intended exclusively for healthcare professionals:

Other

Not applicable.

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