CALCIBRONAT 2G CALCIUM 20 TABLETS EFFERVESCENTS

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CALCIBRONAT 2G CALCIUM 20 TABLETS EFFERVESCENTS

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CALCIBRONAT 2G CALCIUM 20 TABLETS EFFERVESCENTS

For warnings, precautions and contraindications, please consult the instructions for use.

Description CALCIBRONAT 2G CALCIUM 20 TABLETS EFFERVESCENTS

This drug is recommended in mild sleep disorders, irritability, nervousness.

Dosage  

Reserved for adults and children over 30 kg.

  • Adults: 1 to 2 effervescent tablets daily.
  • Child over 30 kg: 1 effervescent tablet daily.


Do not exceed the recommended daily dose of:

  • two effervescent tablets in adults,
  • an effervescent tablet in children over 30 kg.

In all cases, strictly adhere to the doctor's prescription.


Method and route of administration
Oral way.
Dissolve the tablet in half a glass of water.


Duration of treatment
Do not exceed 3 weeks of treatment.
In the case of readministration, observe 3 to 4 weeks between two treatments.

What to do in case of overdose
Notify a doctor urgently.

What to do in case the administration of one or more doses has been omitted
take your medicine at the usual time. Do not double the dose.

Composition  
One tablet contains 2 g calcium bromo-galactogluconate.

Excipients:   Sucrose, sodium bicarbonate, anhydrous citric acid, macrogol 4000.

List of excipients which knowledge is necessary for safe use in certain patients
Sodium, sucrose.

Conditioning :   box of   20   effervescent tablets.

This medicine MUST NOT BE USED in the following cases:

  • Juvenile acne
  • Child under 30 months
  • Elderly malnourished and / or dehydrated
  • Hypercalcemia (excessive amount of calcium in the blood)
  • Calcium lithiasis (calculation of calcium)
  • Hypercalciuria (excessive amount of calcium in the urine)
  • Calcifications (calcium deposits) in the kidneys
  • Chronic glomerular nephropathy (kidney disease)
  • Due to the presence of sucrose, this medicinal product should not be used in case of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.

This medicine should not be used unless your doctor tells you otherwise, during pregnancy and breastfeeding.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

Special warnings
If you have a neuropsychic disorder (side effects), redness or itching of the skin, stop your treatment and consult your doctor.

Precautions for use
Alcohol absorption is strongly discouraged during treatment.
In case of low salt diet, take into account the salt intake per tablet: 241 mg.
Each tablet provides about 3 g of sugar.
Take into account in the daily ration in case of low sugar diet or diabetes.
Interference is possible with the determination of chloride in the blood.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Drug Interactions and Other Interactions
In order to avoid possible interactions between several medications, you should always report any other treatment in progress to your doctor or pharmacist.

Pregnancy - Breastfeeding
the use of this drug is not recommended, unless advised by your doctor, during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor quickly: only he can adapt the treatment to your condition.
In general, during pregnancy and breastfeeding, always seek the advice of your doctor or pharmacist before using any medicine.

Drivers and users of machines
Driving or using machines is not recommended due to the risk of drowsiness associated with the use of this medication.

Summary of Product Characteristics (ANSM)

Warnings on drugs

Be careful, the drug is not a product like any other. Read the package leaflet carefully before ordering. Do not let the medicine reach children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please inform your online pharmacist of ongoing treatments to identify any incompatibilities. The order validation form contains a custom message field provided for this purpose.

Click here to find the package leaflet for this medicine on the website of the National Agency for the Safety of Medicines and Health Products.

Pharmacovigilance : Report an adverse effect (s) related to the use of a drug

VIDAL OF THE FAMILY

CALCIBRONAT

Sedative containing bromine

calcium bromogalactogluconate

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

PRESENTATIONS (summary)

CALCIBRONATE 2 g: effervescent tablet (white); box of 20.
-

CALCIBRONATE 2 g: effervescent tablet (white); box of 60.
-

Laboratory EA Pharma Laboratoires des Granions

COMPOSITION (summary)
p cp
Calcium bromo-galactogluconate 2 g
either Calcium 150.7 mg
Brome 301 mg
Sodium 241 mg
Sucrose 2.86 g

INDICATIONS (summary)
This medication is a combination of sedative substances.
It is used in adjunctive treatment for mild sleep disturbances, irritability and nervousness.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • acne ;
  • excess calcium in blood and urine, with or without lithiasis ;
  • elderly malnourished or dehydrated;
  • child under 30 months of age.
WARNING (Contents)
In the event of prolonged treatment, bromine may cause the appearance of particular buttons called bromides. Consult your doctor.
Overdose may cause behavioral disturbances, particularly in the elderly. Stop treatment immediately and tell your doctor.
This medicinal product contains sugar (sucrose) and salt ( sodium ) in significant quantities.
Avoid drinking alcohol during treatment.
This medication may induce somnolence, sometimes intense in some people. This drowsiness can be increased by taking alcohol or other sedative drugs. Driving and using hazardous machines are not recommended, especially within hours of taking the medication.
DRUG INTERACTIONS (summary)
Take at least 2 hours (or even 3 hours) between taking this medicine and cyclines , diphosphonates or iron-containing medicines.
Inform your pharmacist or doctor if you are taking a digitalis or diuretic .
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
The use of medication containing bromine in pregnant women has caused complications in the newborn . This medication is not recommended during pregnancy.

Breastfeeding:
This medication passes into breast milk: it is not recommended during breast-feeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
Effervescent tablets should be dissolved in half a glass of water.
Do not prolong or increase the dose without your doctor or pharmacist.

Usual dosage:

  • Adult: 1 or 2 tablets per day.
  • Children over 30 kg: 1 tablet per day.
TIPS (summary)
Bromine remains present several days in the body after stopping the drug. Also, to avoid any risk of accumulation:
  • the duration of the treatment must in no case exceed 3 weeks;
  • a minimum delay of 3 to 4 weeks is required between 2 treatments with this medication.
Medicines are not the only response to stress: a better hygiene of life, a moderate consumption of excitants (coffee, tea, alcoholic beverages ...) also make it possible to fight against the excess of nervousness and its manifestations ( palpitations , sleeping troubles).
This medication should be stored away from moisture.
POSSIBLE ADVERSE EFFECTS (summary)
Loss of appetite, constipation.
Rarely: rashes especially in case of prolonged treatment, psychic disorders especially in case of overdose (see CAUTION).


GLOSSARY (summary)


acne
Skin disorders associated with sebum retention forming comedones (blackheads and microcysts). These are the site of a proliferation of bacteria and turn into pustules.


alcohol
General name designating a family of substances that have the property of being able to be mixed with water and fatty substances. The most common alcohol is ethyl alcohol (ethanol), but there are many other alcohols: methanol, butanol, etc. The degree of alcoholic solution corresponds to the volume of pure alcohol present in 100 ml of solution, knowing that 1 glass of wine or 1/2 of beer (25 cl) contains about 8 g of alcohol.
When alcohol is used as an antiseptic, an unpleasant odor denaturant is often added to prevent drinking. Contrary to a widespread belief, alcohol at 70o (or even at 60o) is a better antiseptic than alcohol at 90o.


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


undernourished
Deficiency of nutrients due to insufficient food intake.


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.


diuretic
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.


Rashes
Appearance of pimples or plaques on the skin. These lesions can be due to a food, a drug, and translate an allergy or a toxic effect. Many viruses can also cause pimple eruptions: rubella, roseola and measles are the most common.


gallstone
Concretion (stone) that forms in the excretory pathways of certain organs: urinary, biliary, salivary.
Synonym: calculation.


new born
Child less than one month old.


palpitations
Abnormal perception of irregular heartbeat.


sedative
  • Quiets, calms down.
  • Medication belonging to different families: anxiolytics, hypnotics, analgesics, cough suppressants, antiepileptics, neuroleptics, etc. but also antidepressants, antihistamines H1, antihypertensives. A sedative can be responsible for drowsiness and increase the effects of alcohol.


salt
Chemical substance of which the best known is sodium chloride, or table salt. The diet salt does not contain sodium; this is generally replaced by potassium.


sodium
An inorganic substance which can form salts, especially with chlorine (sodium chloride, or table salt).


sugar
General term for various substances of which the most widely used is sucrose. Other sugars can be contained in drugs: glucose, fructose, lactose, etc. Glucose is the sugar used by the body; it is the only one to circulate in considerable quantity in the blood.
Sweeteners (false sugar) are allowed in diabetics or people on a diet, and are very low in calories.


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.

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: 17/08/2012

Name of the medicinal product

CALCIBRONATE 2 g, effervescent tablet

Calcium bromo-galactogluconate

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, 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.

Review summary

In this notice :

1. WHAT IS CALCIBRONATE 2 g, effervescent tablet AND WHAT IT IS USED FOR?

2. BEFORE YOU TAKE CALCIBRONATE 2 g, effervescent tablet?

3. HOW TO TAKE CALCIBRONATE 2 g, effervescent tablet?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE CALCIBRONATE 2 g, effervescent tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS CALCIBRONATE 2 g, effervescent tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

HYPNOTIC AND SEDATIVE

(N: Central Nervous System)

Therapeutic indications

This drug is recommended in mild sleep disturbances, irritability, nervousness.

2. BEFORE YOU TAKE CALCIBRONATE 2 g, effervescent tablet?

List of information needed before taking the medication

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

Cons-indications

Never take CALCIBRONAT 2 g, effervescent tablet in the following cases:

· Juvenile acne.

· Child under 30 months.

· Elderly undernutrition and / or dehydrated.

· Hypercalcemia, (excessive amount of calcium in the blood).

· Lithium calcium (calculation of calcium).

· Hypercalciuria (excessive amount of calcium in the urine).

· Calcifications (deposits of calcium) in the kidneys.

· Chronic glomerular nephropathy (kidney disease).

· Due to the presence of sucrose, this drug should not be used in patients with fructose intolerance, glucose-malabsorption and gaschrose or sucrase-isomaltase deficiency syndrome.

This medicine should not be used during pregnancy unless your doctor tells you otherwise.

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 CALCIBRONAT 2 g, effervescent tablet:

Special warnings

If you have neuropsychic disorders ( see What are the possible side effects? ), Redness or itching of the skin, stop treatment and see your doctor.

This medicine contains sucrose. Its use is not recommended in patients with intolerance to sucrose (rare hereditary disease).

Precautions for use

· Absorption of alcohol is strongly discouraged during treatment.

· This medicine contains sodium. This medicine contains 241 mg sodium per effervescent tablet. To be taken into account in patients controlling their sodium dietary intake.

· This medicine contains 2.86 g of sucrose per effervescent tablet to be taken into account in the daily diet in the case of a low-sugar diet or diabetes.

· Interference is possible with the determination of chlorides in the blood.

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

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 beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

The use of this medication is not recommended unless your doctor tells you otherwise during pregnancy.

If you discover that you are pregnant during treatment, consult your doctor promptly: he alone will be able to adapt the treatment to your condition.

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

Driving or using machines is not recommended because of the risk of drowsiness associated with the use of this medication.

List of excipients with known effect

List of excipients with a known effect: sodium, sucrose.

3. HOW TO TAKE CALCIBRONATE 2 g, effervescent tablet?

Instructions for proper use

Not applicable.

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

Dosage

Reserved for adults and children over 30 kg.

Adult: 1 to 2 effervescent tablets per day.

Child over 30 kg: 1 effervescent tablet per day.

Do not exceed the daily dose of:

· two effervescent tablets in adults,

· an effervescent tablet in children over 30 kg.

IN ALL CASES, COMPLY STRICTLY TO THE PRESCRIPTION OF THE PHYSICIAN.

Administration mode

Oral use.

Dissolve the tablet in half a glass of water.

Duration of the treatment

Do not exceed 3 weeks of treatment.

Symptoms and Instructions for Overdose

If you take more CALCIBRONAT 2 g, effervescent tablet than you should:

Notify an emergency doctor.

Instructions for omission of one or more doses

If you forget to take CALCIBRONAT 2 g, effervescent tablet:

Take your medicine at the usual time. Do not double the dose.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, CALCIBRONAT 2 g, effervescent tablet is likely to have undesirable effects, although not everyone is subject to it:

· Diurnal somnolence, irritability, disorientation, confusion, hallucinations; these effects are observed in particular in the elderly and at high dosages.

· Loss of appetite, constipation.

· Very rarely: skin involvement (redness, itching),

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 CALCIBRONATE 2 g, effervescent tablet?

Keep out of the reach and sight of children.

Expiration date

Do not use CALCIBRONAT 2 g effervescent tablet after the expiry date which is stated on the carton.

Storage conditions

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.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does CALCIBRONAT 2 g contain, effervescent tablet?

The active substance is:

Calcium bromo-galactogluconate (1) .......................................... .................................................. ... 2,000 g

For an effervescent tablet.

(1) Corresponding to bromine at 301 mg or 3.77 mmol and calcium at 150.7 mg or 3.77 mmol.

The other components are:

Sucrose, sodium bicarbonate, anhydrous citric acid, polyethylene glycol 4000.

Pharmaceutical form and content

What is CALCIBRONAT 2 g, effervescent tablet and contents of the pack?

This medication is in the form of an effervescent tablet. Box of 20 or 60.

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

SPC

2720, CHEMIN DE SAINT BERNARD

06220 VALLAURIS

LA FRANCE

exploiting

LABORATORY OF GRANIONS

THE MERCATOR

7, RUE DE L'INDUSTRIE

98000 MONACO

Maker

FAMAR France

1, avenue du Champ de Mars

45072 ORLEANS

LA FRANCE

or

LABORATORY OF GRANIONS

The Mercator

7, rue de l'Industrie

98000 MONACO

or

FAMAR ORLEANS

5, avenue de Concyr

45071 ORLEANS CEDEX 2

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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