Active ingredients: Sodium glycerophosphate, Valerian
GLYCERO-VALEROVIT syrup - coated tablets - ampoules
Why is Valerovit Glycerol used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Neurotonic and sedative drug.
THERAPEUTIC INDICATIONS
States of physical and mental fatigue. Hyperexcitability.
Contraindications When Glycerin Valerovit should not be used
Subjects with a history of hypersensitivity to one or more of the components.
States of renal failure.
Late stage atherosclerosis.
Precautions for use What you need to know before taking Valerovit Glycerol
There are no particular precautions for use.
Interactions Which drugs or foods can modify the effect of Glycerin Valerovit
None known.
Warnings It is important to know that:
Keep this medicine out of the reach and sight of children.
For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.
The coated tablets and the syrup contain sucrose: in case of ascertained intolerance to sugars, contact your doctor before taking the medicine.
The syrup contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which can cause allergic reactions (possibly delayed type).
Dose, Method and Time of Administration How to use Glycerin Valerovit: Dosage
Syrup
Boys: one to three tablespoons a day.
Adults: one to four tablespoons per day; in insomnia a spoon before bedtime.
CHILD-PROOF CLOSURE
To open: press and unscrew at the same time.
To close: screw tightly.
Vials
One to two injections per day, according to medical prescription, intramuscularly.
Coated tablets
One to two coated tablets two to three times a day.
Overdose What to do if you have taken too much Valerovit glycerol
There are no known cases of overdosing.
Side Effects What are the side effects of Glycerin Valerovit
Generally Glycerol-Valerovit is well tolerated. If unwanted effects appear after administration of the drug, they will be reported to the attending physician.
Expiry and Retention
Do not use the medicine after the expiry date indicated on the package.
Store at a temperature not exceeding 25 ° C.
Deadline "> Other information
COMPOSITION
Syrup
100 ml of syrup contain:
Active principles:
- Sodium glycerophosphate g 2,000 (equal to sodium glycerophosphate anhydrous g 1,350)
- Valerian extract g 1,000 (title 0.5% ac. Isovaleric)
Excipients
- Ammonium glycyrrhizinate, bitter flavor, methyl p-hydroxybenzoate, propyl phydroxybenzoate, citric acid, alcohol, sucrose, purified water.
Coated tablets
Each coated tablet contains:
Active principles
- Sodium glycerophosphate 40 mg (equal to anhydrous sodium glycerophosphate 26.4 g)
- Valerian extract 100 mg (title 0.5% ac. Isovaleric)
Excipients
- Pregelatinised starch, anhydrous colloidal silica, microcrystalline cellulose, talc, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol 4000, povidone, polyethylene glycol 6000, stearic acid, hydrogenated peanut oil, cetyl alcohol, titanium dioxide (E 171), sucrose.
Vials
Each 2ml vial contains:
Active principles
- Sodium glycerophosphate g 0.100 (equal to sodium glycerophosphate anhydrous g 0.066)
- Valerian extract 0.020 g (title 0.5% ac. Isovaleric)
Excipients
- Lidocaine hydrochloride, water for injections.
PHARMACEUTICAL FORMS
1 bottle of syrup of 150 ml.
50 coated tablets.
10 ampoules of 2 ml solution for injection.
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.
01.0 NAME OF THE MEDICINAL PRODUCT -
GLYCERO-VALEROVIT
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Syrup
100 ml of syrup contain:
Active principles
Sodium glycerophosphate 2,000 g
(equal to anhydrous sodium glycerophosphate g 1,350)
Valerian extract 1,000 g
(title 0.5% ac. isovaleric)
Excipients
Ammonium glycyrrhizinated 0.015 g
flavor bitter 0.500 g
methyl p-hydroxybenzoate 0.100 g
propyl p-hydroxybenzoate 0.040 g
citric acid 0.250 g
alcohol 1,250 g
sucrose 25,000 g
purified water q.s. to 100,000 ml
Coated tablets
Each tablet contains:
Active principles
Sodium glycerophosphate 40.00 mg
(equal to anhydrous sodium glycerophosphate g 26.4)
Valerian extract 100.00 mg
(title 0.5% ac. isovaleric)
Excipients
Pregelatinised starch 25.00 mg
colloidal anhydrous silica 3.23 mg
microgranular cellulose 37.16 mg
talc 21.33 mg
magnesium stearate 4.00 mg
hydroxypropylmethylcellulose 6.00 mg
polyethylene glycol 4000 2.00 mg
polyvinylpyrrolidone 1.23 mg
polyethylene glycol 6000 0.74 mg
stearic acid 0.74 mg
hydrogenated peanut oil 0.11 mg
cetyl alcohol 0.11 mg
titanium dioxide (E 171) 8.15 mg
sucrose 50.20 mg
Vials
Each 2ml vial contains:
Active principles
Sodium glycerophosphate 0.100 g
(equal to sodium glycerophosphate anhydrous 0.066 g)
Valerian extract 0.020 g
(title 0.5% ac. isovaleric)
Excipients
Lidocaine hydrochloride 0.005 g
water for injections q.s. to 2 ml
03.0 PHARMACEUTICAL FORM -
1 bottle of syrup of 150 ml.
50 coated tablets
10 ampoules of 2 ml solution for injection.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
States of physical and mental fatigue. Hyperexcitability.
04.2 Posology and method of administration -
Syrup
Boys: one to three tablespoons a day
Adults: one to four tablespoons per day; in insomnia a spoon before bedtime.
Ampoules of one to two injections per day, according to medical prescription, intramuscularly
Coated tablets one to two tablets two to three times a day.
04.3 Contraindications -
Subjects with a history of hypersensitivity to one or more of the components.
States of renal failure.
Late stage atherosclerosis.
04.4 Special warnings and appropriate precautions for use -
There are no particular precautions for use.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction -
None known.
04.6 Pregnancy and breastfeeding -
Second medical opinion.
04.7 Effects on ability to drive and use machines -
There are no known effects on the ability to drive or use machines.
04.8 Undesirable effects -
At the recommended doses, no undesirable effects are known.
04.9 Overdose -
There are no known cases of overdosing
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Glycerol-Valerovit is a specialty that associates the neurotonic activity of glycerophosphate with the sedative activity of valerian.
Current biochemical knowledge on the functions of the Central Nervous System confirms the usefulness of an exogenous supply of phosphorus through biologically usable organic combinations.
Sodium glycerophosphate, with excellent bioavailability, is the simplest compound meeting these requirements.
Valerian, the use of which is validated by decades of clinical experience, has a central sedative activity and does not cause clinically detectable intolerances even after prolonged administration.
05.2 "Pharmacokinetic properties -
Glycerophosphates are readily hydrolyzed by alkaline phosphatase and are generally well tolerated.
05.3 Preclinical safety data -
In acute and chronic toxicity studies conducted in rodents, the administration of oral doses (syrup) and parenteral doses (solution for injection) up to 70 and 180 times, respectively, the maximum active doses in humans did not cause toxic phenomena or deaths.
A similar absence of toxic signs was also found in chronic toxicity studies conducted in dogs.
In studies performed in rats and rabbits, no embryotoxic or teratogenic effects were observed.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Syrup
Excipients
Ammonium glycyrrhizinate, bitter flavor, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, citric acid, alcohol, sucrose, purified water.
Coated tablets
Excipients
Pregelatinised starch, anhydrous colloidal silica, microgranular cellulose, talc, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol 4000, polyvinylpyrrolidone, polyethylene glycol 6000, stearic acid, hydrogenated peanut oil, cetyl alcohol, titanium dioxide (E 171), sucrose
Vials
Excipients
Lidocaine hydrochloride, water for injections.
06.2 Incompatibility "-
Not known.
06.3 Period of validity "-
Syrup and coated tablets: 36 months in unopened packaging
Vials: 60 months in unopened packaging
06.4 Special precautions for storage -
None
06.5 Nature of the immediate packaging and contents of the package -
Box containing a 150 ml bottle in brown glass, hydrolytic class III according to F.U. IX Ed., Closed with a hard-to-open screw cap.
Carton containing 10 vials of 2 ml in colorless borosilicate glass.
Box containing 50 tablets coated in thermoformed blister in PVC / Al opacified with titanium dioxide.
06.6 Instructions for use and handling -
-----
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Teofarma S.r.l. - Headquarters: via F.lli Cervi, 8 - Valle Salimbene (PV)
- Building: viale Certosa 8 / A - Pavia
08.0 MARKETING AUTHORIZATION NUMBER -
Syrup A.I.C. 003803119
A.I.C. 003803095
Coated tablets A.I.C. 003803107
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
23/08/1950 - 06/2000
10.0 DATE OF REVISION OF THE TEXT -
01/06/2000
