Package leaflet: Information for the patient

Glicero-valerovit 40 mg + 100 mg film-coated tablets
Glicero-valerovit 10 mg/1 ml + 20 mg/1 ml syrup
Glicero-valerovit 20 mg + 100 mg injectable solution for intramuscular use
sodium glycerophosphate + valerian dry root extract
Please read all of this leaflet carefully before taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

What Glicero-valerovit is and what it is used for
What you need to know before taking Glicero-valerovit
How to take Glicero-valerovit
Possible side effects
How to store Glicero-valerovit
Contents of the pack and other information

1. What Glicero-valerovit is and what it is used for

Glicero-valerovit is a medicine containing the active substances sodium glycerophosphate and valerian.
Glicero-valerovit is used in conditions of physical and mental fatigue and in cases of hyperexcitability (increased reaction to physical and psychological stimuli).

2. What you need to know before taking Glicero-valerovit

Do NOT take Glicero-valerovit

if you are allergic to sodium glycerophosphate, valerian, or any of the other ingredients of this medicine (listed in section 6);
if you have kidney problems;
if you have advanced arterial wall hardening (arteriosclerosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Glicero-valerovit.
Other medicines and Glicero-valerovit
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines.
No interactions have been reported.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will prescribe Glicero-valerovit only if strictly necessary.
Driving and using machines
No effects on the ability to drive or operate machinery are known.
Glicero-valerovit coated tablets contain sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.
Glicero-valerovit coated tablets contain peanut oil
If you are allergic to peanuts or soy, do not use this medicine.
Glicero-valerovit syrup contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.
Glicero-valerovit syrup contains methylhydroxybenzoate (E218)
May cause allergic reactions (including delayed reactions).
Glicero-valerovit syrup contains propylhydroxybenzoate
May cause allergic reactions (including delayed reactions) and, exceptionally, bronchospasm.
Glicero-valerovit syrup contains 1.58 vol% ethanol (alcohol), e.g. up to 187.5 mg per tablespoon of syrup, equivalent to 4.8 ml of beer or 2 ml of wine per tablespoon of syrup.
It may be harmful for alcoholics.
This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
For those engaged in sports: the use of medicines containing ethyl alcohol may result in a positive doping test, according to alcohol concentration limits set by certain sports federations.

3. How to take Glicero-valerovit

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Syrup
Children: the recommended dose is one to three tablespoons per day.
Adults: the recommended dose is one to four tablespoons per day; in cases of insomnia, take one tablespoon before going to bed.
How to use Glicero-valerovit syrup
The bottle closure is child-resistant.

Open the bottle by pressing down and unscrewing the closure cap simultaneously.
Close the bottle by screwing the cap tightly.

Coated tablets
The recommended dose is one to two tablets two to three times a day.
Injectable solution for intramuscular use
The recommended dose is one to two vials per day.
If you take more Glicero-valerovit than you should
In case of accidental ingestion or overdose of Glicero-valerovit, contact your doctor immediately or go to the nearest hospital.
Cases of overdose are not known.
If you forget to take Glicero-valerovit
Do not take a double dose to make up for the missed dose.
If you stop using Glicero-valerovit
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicinal product may cause side effects, although not everybody gets them.
No side effects are known.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store Glicero-valerovit

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Glicero-valerovit contains
Syrup

The active substances are sodium glycerophosphate and valerian extract. 100 ml of syrup contain 2 g of sodium glycerophosphate (equivalent to 1.35 g anhydrous sodium glycerophosphate) and 1 g of extract (as dry extract) from Valeriana officinalis L. s.l., radix (valerian root) (3 - 4 : 1), extraction solvent: ethanol 60% V/V.
The other components are ammonium glycyrrhizinate, bitter flavour, methyl hydroxybenzoate, propyl parahydroxybenzoate, citric acid, alcohol, sucrose, purified water.

Coated tablets

The active substances are sodium glycerophosphate and valerian extract. Each tablet contains 40 mg of sodium glycerophosphate (equivalent to 26.4 mg anhydrous sodium glycerophosphate) and 100 mg of extract (as dry extract) from Valeriana officinalis L. s.l., radix (valerian root) (3 - 4 : 1), extraction solvent: ethanol 60% V/V.
The other components are pregelatinized 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.

Injectable solution for intramuscular use

The active substances are sodium glycerophosphate and valerian extract. Each 2 ml vial contains 100 mg of sodium glycerophosphate (equivalent to 66 mg anhydrous sodium glycerophosphate) and 20 mg of extract (as dry extract) from Valeriana officinalis L. s.l., radix (valerian root) (3 - 4 : 1), extraction solvent: ethanol 60% V/V.
The other components are lidocaine hydrochloride and water for injections.

Description of the appearance of Glicero-valerovit and contents of the package
Glicero-valerovit 40 mg + 100 mg coated tablets
50 coated tablets in PVC/AL/OPA blisters.
Glicero-valerovit 10 mg/1 ml + 20 mg/1 ml syrup
1 bottle of 150 ml.
Glicero-valerovit 20 mg + 100 mg solution for intramuscular injection
10 vials of 2 ml.
Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia