Briovitase - Package Leaflet

Indications Contraindications Precautions for use Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage Other Information

Active ingredients: Magnesium (Magnesium salts)

Briovitase 450 mg + 450 mg powder for oral suspension

Why is Briovitase used? What is it for?

Briovitase is a mineral salt supplement.

Briovitase is indicated in all states of potassium and magnesium deficiency, which generally manifest themselves as a feeling of tiredness, muscle weakness and cramps. These deficiencies can be caused by excessive sweating, intense physical activity, profuse diarrhea and vomiting.

Contraindications When Briovitase should not be used

Do not take Briovitase

  • if you are allergic to magnesium aspartate tetrahydrate, potassium aspartate hemihydrate or any of the other ingredients of this medicine (listed in section 6).
  • in case of acute dehydration.
  • if you have myotonia congenita (an inherited condition which impairs muscle relaxation).
  • in high doses if you suffer from severe renal or adrenal insufficiency

Precautions for use What you need to know before taking Briovitase

Talk to your doctor or pharmacist before taking Briovitase if you have heart problems or kidney failure.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

BRIOVITASE can be used during pregnancy and breastfeeding.

Briovitase contains sucrose and phenylalanine

This medicinal product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains phenylalanine. It can be dangerous for individuals with phenylketonuria.

Dose, Method and Time of Administration How to use Briovitase: Posology

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is "

Adults: 2 sachets of powder for oral suspension per day.

Warning: do not exceed the indicated doses without medical advice.

Duration of treatment

It takes about 4 days of therapy before a subjective clinical improvement can be noticed. It is recommended to continue the administration of BRIOVITASE for at least 2 weeks.

Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.

Method of administration

Dissolve the contents of the sachet in a glass of water.

Overdose What to do if you have taken too much Briovitase

Ingestion of Briovitase, even much higher than recommended, should not induce serious disturbances.

In case of accidental ingestion / intake of an excessive dose of Briovitase, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Briovitase

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These side effects are usually transient, however if you experience any of the following symptoms you should contact your doctor or pharmacist:

  • abdominal discomfort
  • nausea
  • He retched
  • diarrhea

These symptoms can disappear by administering the product in the right dose after meals.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at "www.agenziafarmaco.gov.it/it/responsabili". By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Deadline "> Other information

What Briovitase contains

  • The active ingredients are magnesium aspartate tetrahydrate and potassium aspartate hemihydrate. One sachet of powder contains 450 mg magnesium aspartate tetrahydrate and 450 mg potassium aspartate hemihydrate.
  • The other ingredients are citric acid, pectin, orange flavor, mandarin flavor, grapefruit flavor, aspartame, sodium cyclamate, sucrose.

What Briovitase looks like and contents of the pack

Briovitase comes in the form of a powder for oral suspension.

The contents of the pack are 10, 14 or 20 single-dose sachets.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Briovitase can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

BRIOVITASE 450 MG + 450 MG POWDER FOR ORAL SUSPENSION

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

One sachet contains:

Magnesium aspartate tetrahydrate 450 mg

Potassium aspartate hemihydrate 450 mg

03.0 PHARMACEUTICAL FORM -

Powder for oral suspension.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

BRIOVITASE is indicated in all states of potassium and magnesium deficiency, which generally manifest themselves with a feeling of tiredness, muscle weakness and cramps. These deficiencies can be caused by excessive sweating, intense physical activity, profuse diarrhea and vomiting.

04.2 Posology and method of administration -

The adult dose is 2 sachets of powder for oral suspension per day. It takes about 4 days of therapy before a subjective clinical improvement can be noticed. It is recommended to continue the administration of BRIOVITASE for at least two weeks.

04.3 Contraindications -

Hypersensitivity to the active substances or to any of the excipients.

The administration of high doses of potassium aspartate and magnesium is contraindicated in the presence of severe renal or adrenal insufficiency. States of acute dehydration. Myotonia congenita.

04.4 Special warnings and appropriate precautions for use -

Caution is needed in the treatment of cardiopathic patients with renal insufficiency.

The product contains sucrose and when taken according to the recommended dosage each dose provides 3.4 g of sucrose.

It is not suitable in cases of hereditary fructose intolerance, glucose and galactose malabsorption syndrome and sucrase and isomaltase deficiency.

The product contains a source of phenylalanine.

04.5 Interactions with other medicinal products and other forms of interaction -

There are no known drug interactions following concomitant administration of other drugs.

04.6 Pregnancy and breastfeeding -

There are no particular limitations.

04.7 Effects on ability to drive and use machines -

The product does not interfere with the ability to drive or use machines.

04.8 Undesirable effects -

Abdominal discomfort, nausea, vomiting and diarrhea have been reported occasionally.

These symptoms can disappear by administering the product in the right dose after meals.

04.9 Overdose -

The ingestion of quantities of BRIOVITASE, even much higher than those recommended, should not induce serious problems; you may notice diarrhea, nausea, vomiting, sometimes gastrointestinal bleeding. In case of overdose it will still be necessary to induce vomiting, so consult a doctor to evaluate the opportunity to perform a gastric lavage.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

As deducible from its composition, BRIOVITASE exerts a clear action replenishing the organic reserves of potassium and magnesium. Aspartic acid has been shown to be one of the best "transporters" of ions such as potassium and magnesium and also seems to exert, with a mechanism similar to that of glutamic acid, an excitatory action at the level of neuromuscular junctions.

05.2 "Pharmacokinetic properties -

After oral administration of BRIOVITASE it is rapidly absorbed from the upper gastrointestinal tract. In the organism, potassium and magnesium actively participate in intra / extracellular ionic exchanges, distributing themselves mainly in the intracellular spaces. Aspartic acid participates in some metabolic cycles including that of ornithine and therefore of urea, as well as, by means of the " fumaric acid, to that of citric acid. The elimination of potassium and magnesium occurs mainly by the kidney.

05.3 Preclinical safety data -

BRIOVITASE consists of an "association of potassium and magnesium salts of aspartic acid. Both aspartic acid, a known amino acid, and potassium and magnesium are elements commonly represented in the normal diet of each individual. The natural origin of the components of BRIOVITASE explains the absence of toxic and teratogenic effects of the product.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

One sachet contains:

Citric acid; pectin; orange flavor; mandarin aroma; grapefruit flavoring; aspartame; sodium cyclamate; sucrose.

06.2 Incompatibility "-

To date, no incompatibility is known.

06.3 Period of validity "-

3 years.

The validity date refers to the intact product, correctly stored.

06.4 Special precautions for storage -

None in particular except those common to all drugs.

06.5 Nature of the immediate packaging and contents of the package -

Sachets of coupled paper / aluminum / polyethylene each containing 5 g of powder.

Packs of 10, 14 or 20 sachets.

06.6 Instructions for use and handling -

Dissolve the contents of one sachet in a glass of water.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

MONTEFARMACO OTC S.p.A. - Via IV Novembre, 92 - 20021 Bollate (MI)

08.0 MARKETING AUTHORIZATION NUMBER -

10 sachets - AIC: 034535017

14 sachets - AIC: 034535029

20 sachets - AIC: 034535031

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

July 2001 / Renewal: November 2011

10.0 DATE OF REVISION OF THE TEXT -

February 2012

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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