NEUROTON

NEUROTON
500 mg/3 ml injectable solution
1000 mg/4 ml injectable solution
Citicoline

PHARMACOTHERAPEUTIC CATEGORY
Psychostimulants and nootropics

THERAPEUTIC INDICATIONS
Adjunctive treatment of parkinsonian syndromes

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.

PRECAUTIONS FOR USE
No special precautions or warnings are considered necessary beyond those generally recommended for use during pregnancy, also considering that the drug, during toxicological and pharmacological testing, has shown no influence on pregnancy or the developing fetus.

INTERACTIONS
Neuroton may be used concomitantly with antihemorrhagic agents, substances that reduce intracranial pressure, and infusion fluids.
In the treatment of Parkinson's disease, adding 500–1000 mg daily of Neuroton to the usual dose of L-Dopa allows satisfactory control of parkinsonian symptoms; in some cases, this effect may be achieved while significantly reducing the dose of L-Dopa required in combination with Neuroton.

SPECIAL WARNINGS
Neuroton does not replace other therapeutic measures that may be indicated for various pathological conditions, but rather complements and enhances them. In cases of severe cerebral edema, it is necessary to concurrently administer drugs that reduce intracranial pressure, such as mannitol and corticosteroids.
Keep the product out of reach of children.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
One vial of 500 mg once or twice daily, or one 1000 mg vial once daily, administered intramuscularly, by slow intravenous injection, or by intravenous infusion, as prescribed by a physician. In cases of delayed recovery of consciousness, continuous administration is recommended from the initial phase to promote recovery. When administered intravenously, inject very slowly.
In Parkinson's disease and parkinsonian syndromes, Neuroton is administered at a dose of 500–1000 mg/day, via intramuscular, slow intravenous, or intravenous infusion routes. Therapeutic cycles of 3–4 weeks duration, appropriately spaced, are recommended. Neuroton does not affect respiration, pulse, or arterial pressure, thus allowing prolonged and continuous treatment. In cases of intracranial hemorrhage, high doses of Neuroton (above 500 mg in a single administration) must not be given, as they may increase cerebral blood flow.

OVERDOSE
No cases of overdose have been reported.

UNDESIRABLE EFFECTS
No adverse effects have been reported or documented in the literature.
Following the instructions provided in this leaflet reduces the risk of adverse effects.
It is important to inform your doctor or pharmacist if any adverse effect occurs, even if not described in this leaflet.

EXPIRY DATE AND STORAGE
Do not use after the expiry date stated on the packaging. The expiry date refers to the product stored in its original, unopened packaging under proper storage conditions.
No special storage precautions required.

COMPOSITION
NEUROTON 500 mg/3 ml injectable solution
Each vial contains
Active substance
Citicoline (sodium salt) 524 mg, equivalent to Citicoline 500 mg.
Excipients
Water for injections q.s. to 3 ml

NEUROTON 1000 mg/4 ml injectable solution
Each vial contains
Active substance
Citicoline (sodium salt) 1048 mg, equivalent to Citicoline 1000 mg.
Excipients
Water for injections q.s. to 4 ml

PHARMACEUTICAL FORM AND CONTENT
Injectable solution for intramuscular or intravenous use
“500 mg/3 ml injectable solution” 5 vials of 3 ml
“1000 mg/4 ml injectable solution” 3 vials of 4 ml
“1000 mg/4 ml injectable solution” 5 vials of 4 ml

MARKETING AUTHORIZATION HOLDER
LANOVA FARMACEUTICI S.r.l.
Via Conca D’Oro, 212 – 00141 Rome, Italy

MANUFACTURER AND FINAL CONTROLLER:
Laboratorio Farmaceutico CT S.r.l. – Via D. Alighieri, 71 – Sanremo (Imperia), Italy

Date of renewal of marketing authorization: June 1, 2010
Revision of the summary of product characteristics by the Italian Medicines Agency (AIFA):