Package leaflet: Information for the patient

NEOIODARSOLO

L-arginine L-2-pyrrolidone-5-carboxylate and cyanocobalamin
Please read 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, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What NEOIODARSOLO is and what it is used for

NEOIODARSOLO contains two active substances: L-arginine L-2-pyrrolidone-5-carboxylate and cyanocobalamin. L-arginine L-2-pyrrolidone-5-carboxylate is a substance useful in conditions of physical weakness and also has a beneficial effect on mental state. Cyanocobalamin is an essential vitamin involved in many metabolic processes and in the proper functioning of the nervous system.
This medicine is a tonic restorative and is indicated for use in:

conditions of physical weakness (asthenia);
convalescence, the period following surgery, illness, or trauma.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking NEOIODARSO

Do not take NEOIODARSO

if you are allergic to L-arginine L-2-pyrrolidone-5-carboxylate, cyanocobalamin, or any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding (except in cases listed under the section "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking NEOIODARSO.
Other medicines and NEOIODARSO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
No interactions between NEOIODARSO and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take NEOIODARSO if you are pregnant or breastfeeding, except in cases of absolute necessity and under direct medical supervision (See section "Do not take NEOIODARSO").
Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.
NEOIODARSO contains sucrose, sorbitol, and methyl p-hydroxybenzoate
This medicine contains sucrose and sorbitol, which are certain types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
The presence of sucrose (4 g per vial) may be harmful to teeth and should be considered in patients with diabetes mellitus or those on low-calorie diets.
NEOIODARSO contains methyl p-hydroxybenzoate which may cause allergic reactions (including delayed reactions).

3. How to take NEOIODARSOLO

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.
The recommended dose is 3 vials per day.
Do not exceed the recommended doses.
You may take the solution directly or dilute it in a small amount of water before taking.

Use in children
Children up to 6 years of age: the recommended dose is 1 vial per day.
Children over 6 years of age: the recommended dose is 2 vials per day.

If you take more NEOIODARSOLO than you should
Cases of overdose are not known.
In case of accidental ingestion or intake of an excessive dose of NEOIODARSOLO, immediately inform your doctor or go to the nearest hospital.

If you forget to take NEOIODARSOLO
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been reported with the use of this medicine.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NEOIODARSOLO

Keep this medicine out of the sight and reach of children.
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.
This medicine does not require any special storage conditions.
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 NEOIODARSOLO contains

The active substances are L-arginine L-2-pyrrolidone-5-carboxylate and cyanocobalamin. Each vial (15 ml) contains 300 mg of L-arginine L-2-pyrrolidone-5-carboxylate and 50 micrograms (mcg) of cyanocobalamin.
The other components are: 4000 mg of sucrose, 1500 mg of sorbitol, 16.5 mg of methyl p-hydroxybenzoate, 10 mg of lemon flavor, and demineralized water up to 15 ml.

Description of the appearance of NEOIODARSOLO and contents of the pack
Oral solution. Pack containing 10 vials of 15 ml each.
Marketing Authorization Holder and Manufacturer
Laboratori Baldacci S.p.A. – Via S. Michele degli Scalzi 73 – 56124 Pisa – Italy