DIFOSFOCIN “500 MG/4 ML INJECTABLE SOLUTION”
DIFOSFOCIN “1000 MG/4 ML INJECTABLE SOLUTION”
CITICOLINE
COMPOSITION
Each 500 mg/4 ml vial contains:
Active substance: Citicoline (Cytidine diphosphate choline) 500 mg
Excipients: Water for injections, Sodium hydrate.
Each 1000 mg/4 ml vial contains:
Active substance: Citicoline (Cytidine diphosphate choline) 1000 mg
Excipients: Water for injections, Sodium hydrate.
PHARMACEUTICAL FORM AND CONTENT
500 mg/4 ml injectable solution – 5 vials of 4 ml
1000 mg/4 ml injectable solution – 3 vials of 4 ml
1000 mg/4 ml injectable solution – 5 vials of 4 ml
THERAPEUTIC CATEGORY
Psychostimulants and nootropics
MARKETING AUTHORISATION HOLDER
AESCULAPIUS FARMACEUTICI S.r.l. - Via Cefalonia, 70 - 25124 BRESCIA.
MANUFACTURER AND FINAL CONTROLLER
MITIM S.r.l. - Via Cacciamali 34-36-38 - 25125 Brescia (BS)
S.A.L.F. S.p.A. Pharmacological Laboratory - Via G. Mazzini, 9 - 24069 Cenate Sotto (BG)
THERAPEUTIC INDICATIONS
Adjunctive treatment of parkinsonian syndromes.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
PRECAUTIONS FOR USE

In cases of severe cerebral edema, it is necessary to administer concomitantly drugs that reduce intracerebral pressure, such as mannitol and corticosteroids.
In the presence of intracranial hemorrhage, high doses of the product (above 500 mg as a single dose) must not be administered, as they may increase cerebral blood flow.
In such cases, fractionated doses (100–200 mg 2–3 times daily) may be administered.
In pregnant women and in early infancy, the product should be administered only when clearly needed and under direct medical supervision.
INTERACTIONS
Exerts synergistic activity with L-Dopa (allowing reduction of its dosage) in Parkinson's disease.
The product may be used concomitantly with antihemorrhagic agents, substances that reduce intracranial pressure, and perfusion fluids.
SPECIAL WARNINGS
The product does not replace all those therapeutic measures that may be indicated in various pathological conditions, but rather complements and supports them.
In case of intravenous administration, inject very slowly.
DIFOSFOCIN does not affect the ability to drive vehicles or operate machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Up to 1000 mg daily, given as a single or divided dose by intramuscular injection, slow intravenous injection, or intravenous infusion.
In parkinsonian syndromes, the product is administered at a dose of 500–1000 mg daily by intramuscular, slow intravenous, or intravenous infusion route.
Therapeutic cycles of 3–4 weeks duration, appropriately spaced, are recommended.
UNDESIRABLE EFFECTS
Following the instructions in this leaflet reduces the risk of undesirable effects.
It is important to inform your doctor or pharmacist of any undesirable effect, even if not described in this leaflet.
EXPIRY DATE AND STORAGE
Do not use after the expiry date stated on the packaging.
No special storage precautions required.
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY:

Difosfocin