Liposom

Package leaflet

LIPOSOM FORTE 28 mg/2 ml solution for injection

Hypothalamic phospholipids
COMPOSITION
Active substance: hypothalamic phospholipids 28 mg.
Excipients: mannitol, dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, esters
of p-hydroxybenzoic acid, water for injection to 2 ml.
PHARMACEUTICAL FORM
Solution for injection for i.m. or i.v. use.
5 vials of 2 ml
THERAPEUTIC PHARMACOLOGICAL CATEGORY
Other drugs of the nervous system.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Fidia Farmaceutici S.p.A. - Via Ponte della Fabbrica, 3/A - 35031 Abano Terme (PD)
THERAPEUTIC INDICATIONS
Adjuvant in the treatment of cerebral metabolic disturbances secondary to neuroendocrine disorders.
CONTRAINDICATIONS
Hypersensitivity to the components of the product and to other substances closely related from a chemical
standpoint.
PRECAUTIONS FOR USE
The drug does not require particular precautions for use.
INTERACTIONS
The product may be administered concomitantly with other drugs, in particular neuroleptics, whose hyperprolactinaemia it antagonizes, tricyclic antidepressants, whose onset of action it reduces and whose efficacy it enhances, and cardiovascular drugs.
WARNINGS
The drug may be administered during pregnancy and lactation under direct medical supervision. The drug does not interfere with the ability to drive or operate machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
1 vial daily by intramuscular or intravenous route, as prescribed by a physician.
OVERDOSE
No symptoms related to overdose have ever been reported at the recommended doses.
UNDESIRABLE EFFECTS
No adverse effects certainly related to the drug have been reported.
However, inform your physician or pharmacist about any adverse effects not described in this leaflet.
The expiry date stated on the packaging refers to the product in its original, unopened packaging, correctly stored.
Store below 25°C.
Warning: do not use the medicine after the expiry date stated on the packaging.

Fig. 1 Fig. 2
Instructions for opening:

• position the vial as shown in Figure 1;
• apply pressure with the thumb placed on the COLOURED DOT as shown in Figure 2.

Package leaflet

LIPOSOM

Hypothalamic phospholipids
COMPOSITION
Active substance: hypothalamic phospholipids 11 mg
Excipients: lidocaine hydrochloride, dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate,
parahydroxybenzoic acid esters, water for injections q.s. to 2 ml.
PHARMACEUTICAL FORM
Injectable solution for intramuscular use.
5 vials of 2 ml each
THERAPEUTIC CATEGORY
Other drugs of the nervous system.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Fidia Farmaceutici S.p.A. - Via Ponte della Fabbrica, 3/A - 35031 Abano Terme (PD)
THERAPEUTIC INDICATIONS
Adjuvant in the treatment of cerebral metabolic alterations secondary to neuroendocrine disorders.
CONTRAINDICATIONS
Hypersensitivity to the components of the product and to other substances closely related from a chemical standpoint.
PRECAUTIONS FOR USE
The drug does not require particular precautions for use.
INTERACTIONS
The product may be administered concomitantly with other drugs, in particular neuroleptics (antagonizing their hyperprolactinemia), tricyclic antidepressants (reducing their latency of action and enhancing their efficacy), and cardiovascular drugs.
WARNINGS
The drug may be administered during pregnancy and lactation under direct medical supervision. The drug does not interfere with the ability to drive or operate machinery.
DOSAGE, ADMINISTRATION ROUTE AND TIMING
1 vial daily by intramuscular injection, as prescribed by a physician.
OVERDOSE
No symptoms of overdose have ever been reported at the recommended doses.
UNDESIRABLE EFFECTS
No adverse effects certainly related to the drug have been reported.
However, any adverse effects not described in this leaflet should be reported to the attending physician or pharmacist.
The expiry date stated on the packaging refers to the product stored in its original, unopened packaging under appropriate storage conditions.
Warning: do not use the medicinal product after the expiry date stated on the packaging

Fig. 1 Fig. 2
Instructions for opening:

• position the vial as shown in figure 1;
• apply pressure with the thumb placed over the COLORED DOT as shown in figure 2.