ACUTIL FOSFORO - PACKAGE LEAFLET - LEAFLETS

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Acutil Fosforo - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Glutamine, Asparagine, Phosphorylserine, Vitamin B6

Oral Solution, 10 single-dose vials 10ml

Acutil Fosforo package leaflets are available for pack sizes:

Oral Solution, 10 single-dose vials 10ml
Tablets

Why is Acutil Fosforo used? What is it for?

WHAT IS IT

Acutil Fosforo belongs to the "Tonics" class, drugs useful in states of mental and / or physical fatigue.

WHY IT IS USED

Acutil Fosforo is used in states of fatigue, poor mental performance, difficulty in concentration or attention (difficulty in remembering), easy exhaustion.

Contraindications When Acutil Fosforo should not be used

WHEN IT SHOULD NOT BE USED

Hypersensitivity to components or other closely related substances from a chemical point of view.

WHEN IT CAN ONLY BE USED AFTER CONSULTING YOUR DOCTOR

Asthmatic and sensitive patients (see "It is important to know that")

Pregnancy and breastfeeding (see "What to do during pregnancy and breastfeeding")

Precautions for use What you need to know before taking Acutil Fosforo

WHAT TO DO DURING PREGNANCY AND BREASTFEEDING

In pregnant or breastfeeding women, Acutil Fosforo should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.

Consult your doctor if you suspect a pregnancy or wish to plan a maternity leave.

Interactions Which drugs or foods can modify the effect of Acutyl Phosphorus

If you are using other medicines ask your doctor or pharmacist for advice.

Warnings It is important to know that:

The product can cause mild excitability and difficulty falling asleep, so it is best to avoid administration before going to sleep.

The product, oral solution in single-dose vials, contains sodium metabisulfite; this substance can cause, in sensitive subjects and particularly in asthmatics, allergic-type reactions and severe asthmatic attacks; in this case, use the drug only after consulting your doctor.

For those who carry out sporting activities: the use of medicines containing ethyl alcohol can determine a positive anti-doping test in relation to the alcohol concentration limits indicated by some sports federations.

The assumption of the product does not alter the driving ability and the use of other machinery.

NOTES ON HEALTH EDUCATION

States of mental fatigue with difficulty concentrating and memorizing may be associated with a temporary reduction in the function of neurons, which are cells found in the brain.

The constituents of Acutyl Phosphorus (L-glutamine; L-asparagine; Phosphorylserine; and Vit. B6) contribute to the recovery of neuronal efficiency and functionality. However, after periods of intense activity, it is advisable to follow a period of rest.

Dosage and method of use How to use Acutil Fosforo: Dosage

How many

1-2 single-dose vials per day orally.

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

When and for how long

After a short period of treatment without appreciable results, consult your doctor

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

Warning: use only for short periods of treatment.

Like

To open, lift the lid upwards as illustrated and swallow the contents.

Overdose What to do if you have taken an overdose of Acutil Fosforo

In case of accidental ingestion of an excessive dose of Acutil Fosforo, notify your doctor immediately or go to the nearest hospital. Take this leaflet with you.

Side Effects What are the side effects of Acutil Fosforo

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

Side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist.

Request and fill in the undesirable effects report form available at the pharmacy (form B)

Expiry and Retention

Store at a temperature not exceeding 25 ° C

Warning: do not use the medicine after the expiry date indicated on the package.

Keep this medicine out of the reach of children

It is important to always have the information on the medicine available, so keep both the box and the package leaflet.

Composition and pharmaceutical form

COMPOSITION

Each 10 ml single-dose vial contains: Active ingredients: N-Acetyl-L-glutamine 60 mg; L-asparagine 60 mg; D, L-Phosphorylserine 60 mg; pyridoxine hydrochloride 25 mg.

Excipients: sucrose; sodium metabisulfite; methyl p-hydroxybenzoate; propyl p-hydroxybenzoate; sodium edetate; alcohol; raspberry essence; purified water.

HOW IT LOOKS

Acutil Fosforo comes in the form of single-dose vials containing an oral solution. Every

pack contains 10 single-dose vials of 10 ml.

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 Acutil Fosforo is available 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 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 Incompatibilities 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 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER CIO 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

ACUTYL PHOSPHORUS

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active principles:

L-asparagine 25.00 mg

L-glutamine 25.00 mg

D, L-phosphorylserine 25.00 mg

pyridoxine hydrochloride 10.00 mg

Excipients

corn starch 107.00 mg

lactose 50.00 mg

gelatin 6.00 mg

magnesium stearate 2.00 mg

Average weight per tablet 250.00 mg

Each 10 ml single-dose vial contains:

Active principles:

N-acetyl-L-glutamine 60.00 mg

L-asparagine 60.00 mg

D, L-phosphorylserine 60.00 mg

pyridoxine hydrochloride 25.00 mg

Excipients

sucrose 3.50 g

sodium metabisulfite 10.00 mg

methyl p-hydroxybenzoate 8.00 mg

propyl p-hydroxybenzoate 1.60 mg

sodium edetate 1.50 mg

alcohol 0.0481 ml

raspberry essence 0.0019 ml

purified water q.s. to. 10.00 ml

100 ml of syrup contain:

Active principles:

N-acetyl-L-glutamine 300.00 mg

L-asparagine 300.00 mg

D, L-phosphorylserine 300.00 mg

pyridoxine hydrochloride 125.00 mg

Excipients

sucrose 50.00 g

methyl p-hydroxybenzoate 100.00 mg

propyl p-hydroxybenzoate 20.00 mg

sodium edetate 15.00 mg

alcohol 0.481 ml

raspberry essence 0.019 ml

purified water q.s. to 100.00 ml

03.0 PHARMACEUTICAL FORM

Tablets

Oral solution

Syrup

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

States of fatigue, easy exhaustion and poor mental performance.

Difficulty concentrating or paying attention.

04.2 Posology and method of administration

Tablets: 2-6 tablets per day

Single-dose vials: 1-2 vials per day.

Syrup: 1 tablespoon of syrup 2-4 times a day.

Do not exceed the recommended dose.

04.3 Contraindications

Individual ascertained hypersensitivity to the product.

04.4 Special warnings and appropriate precautions for use

No special precautions are required for use.

Warnings:

The product can cause slight excitability and insomnia, therefore it is not recommended to administer it in the evening. Single-dose vials of oral solution contain sodium metabisulfite; this substance can cause allergic reactions and severe asthmatic attacks in sensitive subjects and particularly in asthmatics.

After a short period of treatment without appreciable results, consult your doctor

Keep out of reach of children.

04.5 Interactions with other medicinal products and other forms of interaction

There are no known adverse interactions of any kind.

04.6 Pregnancy and lactation

In pregnant women, the product should be administered in case of need.

04.7 Effects on ability to drive and use machines

The specialty does not modify the ability to drive in any way and does not produce any undesirable effects on the use of machines.

04.8 Undesirable effects

There are no known undesirable effects due to the use of the product.

04.9 Overdose

There are no known symptoms to refer to overdose of the drug.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

L "Acutil Fosforo is a specialty whose active ingredients are l-glutamine, l-asparagine, d, l-phosphorylserine and pyridoxine hydrochloride, a substance physiologically present in the nervous system and recognized as fundamental in the metabolism of the nerve cell.

Their function is confirmed by recent research in the biochemical, pharmacological and clinical fields.

L-glutamine and l-asparagine are the direct precursors, capable of overcoming the blood-brain barrier, of neurotransmitters such as glutamic acid, aspartic acid and gamma-aminobutyric acid which are difficult to pass from the blood to the brain tissue.

The presence of phosphorylserine allows, through its inhibiting action on phospholipases, a preservation of the phospholipid structures of the nervous tissue.

GAD, glutamate-decarboxylase is an enzyme containing pyridoxal-phosphate and therefore pyridoxine, another active ingredient of the specialty, is an indispensable element in the structure of the glutamate-decarboxylase coenzyme. Pyridoxal-phosphate is also involved in numerous reactions of the metabolism of amino acids and phospholipids.

The association of phosphorylserine with the other components of Acutil Fosforo (glutamine, aspargina, pyridoxine) responds to the metabolic needs of the brain tissue. The contribution of the two starches, made consistent by the relative ease with which they cross the blood-brain barrier, promotes an immediate equilibrium with the relative glutamic and aspartic amino acids and between the amino acids themselves.

The pharmacological enhancement of the action of the single components of the association, as shown by recent researches, is fully compatible with the related biochemical mechanisms and with their demonstrated metabolic integration.

In the syrup preparations and monodose vials of Acutil Fosforo, l-glutamine is present as an acetyl derivative, which is stable in aqueous solution at neutral pH and which is transformed in the body into glutamine substantially by an acylase.

After repeated treatments with labeled acetyl-glutamine it is possible to find labeled glutamine in the brain.

Acutyl phosphorus is very well tolerated. Acute toxicity (expressed as lethal dose 50) after oral administration in mice and rats was greater than 5000 mg / kg and after intraperitoneal administration was greater than 1500 mg / kg in mice, rats and guinea pigs.

Chronic oral administration in dogs (100 mg / kg) and rats (300 mg / kg) did not show any signs of toxicity.

The product was also found to be devoid of genotoxic and teratogenic potential.