BEFORE
USING
READ CAREFULLY ALL THE INFORMATION CONTAINED IN THE EXPLANATORY
LEAFLET
This
is a SELF-TREATMENT medicinal product, which can be used in case
of mild and transitory ailments easy to be identified and solved
with no need for medical help.
Though purchasable without prescription, it is to be correctly used
in order to ensure efficacy and reduce undesirable effects. For
better information and advice, consult the pharmacist.
If the problem should persist after a short period of treatment,
advise with your physician. |
ACUTIL
FOSFORO
Oral Solution
COMPOSITION
Each 10-ml monodose bottle contains:
Active substances: N-Acetyl-L-glutamine mg 60; L-asparagine mg
60; D,L-Phosphorylserine mg 60; pyridoxine hydrochloride mg 25.
Excipients: saccharose; sodium metabisulfite; methyl p-hydroxybenzoate;
propyl p-hydroxybenzoate; sodium edetate; alcohol; raspberry essence;
purified water.
PHARMACEUTICAL FORM
Acutil
Fosforo is marketed in the form of monodose bottles containing an oral
solution. Each package contains 10 monodose bottles of 10 ml.
WHAT
IT IS
Acutil Fosforo belongs to the group of “Tonics”, helpful medications
for states of mental and/or physical tiredness.
MARKETING
AUTHORIZATION HOLDER
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A., viale
Amelia 70, 00181 Rome
MANUFACTURER/S
AND FINAL INSPECTOR/S
Manufacturer
BIOLOGICI ITALIA LABORATOIRES S.r.l.
Novate Milanese (MI)
Final Inspector
I.S.F. S.p.A.
Via Tiburtina Km 10,400 - ROME
Manufacturer and final inspector
A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22 -60131 Ancona -
I.S.F. S.p.A.
Via Tiburtina Km 10,400 - ROMA
WHAT
IT IS USED FOR
Acutil Fosforo is used for states of tiredness, low mental performance,
concentration or attention disorders (difficulty in recalling), quickness
to exhaustion.
WHEN
IT SHOULD NOT BE USED
Hypersensitivity
to any of the constituents or other strictly related chemical substances.
WHEN
IT SHOULD ONLY BE USED ON MEDICAL ADVICE
Asthmatic
and susceptible patients (see “It is important to know that”)
Pregnancy and lactation (see “How to behave in pregnancy and
lactation”)
HOW
TO BEHAVE IN PREGNANCY AND LACTATION
IIn pregnant or breast-feeding women, Acutil Fosforo should only be used
after consulting the doctor and assessing with him the individual risk/benefit
ratio.
Consult the physician if you suspect or wish to plan a pregnancy.
MEDICINAL
PRODUCTS OR FOOD ABLE TO ALTER THE MEDICATION EFFECT
If
you are using other medications, ask your physician or pharmacist for
advice.
IT
IS IMPORTANT FOR YOU TO KNOW THAT
The medication is not
contraindicated in subjects with celiac disease
The product may cause mild excitability and difficulty in falling asleep,
and therefore it is not advisable to take it before going to sleep.
The product, oral solution monodose bottles, contains sodium metabisulfite;
in susceptible, and particularly in asthmatic subjects, this substance
may cause allergic reactions and serious asthma attacks; in those cases,
consult the doctor before using the medicinal product.
To the attention of sportsmen: use of medications containing ethyl alcohol
may cause positive results in anti-doping tests, with respect to the alcoholemic
concentration limits indicated by some sports federations.
Use of the product does not affect the ability to drive and use machines.
NOTES
OF HEALTH EDUCATION
States
of mental tiredness with difficulty in concentrating and memorizing may
be related to a transitorily reduced function of neurons, which are cells
found in the brain.
Acutil Fosforo constituents (L-glutamine; L-asparagine; Phosphorylserine;
and Vit. B6) help recovering the neuronal efficiency and function.
However, a period of rest is advisable after periods of intensive activity.
HOW
TO USE THIS MEDICINAL PRODUCT
How
much
1 or 2 monodose bottles daily, oral.
Caution: do not exceed the doses recommended without advising with the
doctor.
When
and how long
In case of not significant results after a short period of treatment,
advise with your physician
Consult the doctor if the problem occurs repeatedly or you recently noticed
changes in its characteristics.
Warning: use for short periods of treatment only.
Which way
Open lifting the cap upwards as shown in the figure, and swallow the contents.
WHAT
TO DO IN CASE OF OVERDOSING
If you have accidentally swallowed an excess dose of Acutil Fosforo, inform
the doctor immediately or refer to the closest hospital. Take this explanatory
leaflet with you.
UNDESIRABLE
EFFECTS
Observance of directions contained in the explanatory leaflet reduces
the risk of undesired effects.
The undesired effects are usually transitory. However, if they occur,
it is advisable to consult the physician or the pharmacist.
Ask for and fill in the side effects form available at the pharmacy (B
form).
EXPIRY
AND STORAGE
Keep
at temperature not exceeding 25°C
Warning: do not use the medication after the expiry date reported on the
package.
Keep the medication out of the reach of children.
It is important that the drug-related information be available all the
time, thus keep both box and explanatory leaflet.
EXPLANATORY
LEAFLET REVISED BY THE DRUG ITALIAN AGENCY: March 10,
2006
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