Nucleo c.m.f. forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NUCLEO C.M.P. FORTE (NUCLEO C.M.P. FORTE)

Composition:

Active substances: cytidine-5'-disodium monophosphate (CMP disodium salt), uridine-5'-trisodium triphosphate (UTP trisodium salt), uridine-5'-disodium diphosphate (UDP disodium salt), uridine-5'-disodium monophosphate (UMP disodium salt);

One ampoule of lyophilisate contains:
cytidine-5'-monophosphate disodium salt (CMP disodium salt) – 10 mg,
uridine-5'-triphosphate trisodium salt (UTP trisodium salt),
uridine-5'-diphosphate disodium salt (UDP disodium salt),
uridine-5'-monophosphate disodium salt (UMP disodium salt) – total 6 mg (equivalent to 2,660 mg of pure uridine);

Excipient: mannite (E 421);

Solvent: water for injections, sodium chloride.

Pharmaceutical form. Lyophilisate for solution for injection.

Main physicochemical properties: lyophilized white powder in the form of a tablet that dissolves easily.

Pharmacotherapeutic group. Agents affecting the nervous system.

ATC code N07XX.

Pharmacological Properties

Pharmacodynamics

Nucleo C.M.F. Forte contains nucleotides in its composition: cytidine monophosphate (CMP) and uridine triphosphate (UTP), which are widely used in the treatment of central nervous system (CNS) disorders.

From a biochemical standpoint, the action of these components is as follows:

CMP participates in the synthesis of a complex of lipids forming the neuronal membrane, primarily sphingomyelin—the main component of the myelin sheath. Additionally, CMP acts as a precursor of nucleic acids (DNA and RNA), which in turn are key elements of cellular metabolism (e.g., in protein synthesis).

UTP acts as a coenzyme in the synthesis of glycolipids, neuronal structures, and the myelin sheath, complementing the action of CMP. Furthermore, UTP serves as an energy source in the process of muscle contraction.

CMP and UTP are involved in the synthesis of phospholipids and glycolipids, which primarily constitute the myelin sheath and other nerve structures. This promotes intensive metabolic activity, thereby supporting the regeneration of the myelin sheath and regulating demyelination in peripheral nerve injuries. Thus, the combined action of CMP and UTP promotes regeneration of the myelin sheath, proper conduction of nerve impulses, and restoration of muscle trophicity.

Pharmacokinetics

Nucleo C.M.F. Forte contains physiological substances naturally present in biological fluids of the body, making its study more difficult. This is the reason why, due to high radiological burden, investigations have been conducted only in experimental animals using radiolabeled compounds.

The aim of the study was to observe the absorption and pharmacokinetics of UMP, CMP, and UTP.

As a result, the same metabolic pathway was identified for UMP and UTP, showing rapid conversion via uracil into at least one additional polar radioactive fraction.

The CMP compound was rapidly converted into cytosine, uracil, and at least one other polar radioactive fraction. Subsequently, cytosine is primarily transformed into uracil. These results indicate that uracil remains metabolized in blood for the longest time in the presence of cytosine, which was initially formed following CMP administration.

Clinical characteristics.

Indications.

Treatment of osteoarticular neuropathies (sciatica, radiculitis), metabolic neuropathies (alcoholic, diabetic polyneuropathy), and infectious origin (herpes zoster).

Neuralgia of the facial nerve, trigeminal neuralgia, intercostal neuralgia, lumbago.

Contraindications.

Not established, except for known allergic reactions to individual components of the drug.

Interaction with other medicinal products and other forms of interaction.

Not established.

Special precautions for use

Nucleo CMP Forte, lyophilisate for injection solution, is intended for intramuscular administration. Prior to administration, the solvent must be transferred into the ampoule containing the lyophilized powder.

This medicinal product contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding.

Nucleo CMP Forte may be used during pregnancy or breastfeeding if, in the opinion of the physician, the expected beneficial effect for the woman outweighs the potential risk to the fetus/infant. The dosage is determined individually by the physician.

Ability to affect reaction rate when driving or operating machinery.

Nucleo CMP Forte does not affect the ability to drive or operate machinery.

Method of administration and dosage.

Nucleo C.M.F. Forte, lyophilisate for solution for injection, is intended for intramuscular administration. Before administration, the solvent must be transferred into the vial containing the lyophilized powder.

For adults, including elderly patients, the recommended dose of Nucleo C.M.F. Forte is 1 injection once daily.

Treatment should be continued using Nucleo C.M.F. Forte capsules.

Children. There is insufficient data to support the use of the drug in children.

Overdose.

Due to the low toxicity of the drug, the likelihood of poisoning is low, even in case of accidental overdose of the therapeutic dose.

Side effects.

Not described. Allergic reactions, including skin rash, itching, and skin hyperemia, are possible in individuals with hypersensitivity. If any adverse reaction related to the use of the medicinal product occurs, consult your doctor.

Shelf life. 2 years.

Storage conditions. Store in a place inaccessible to children, at a temperature not exceeding 30 °C.

Incompatibility. Not established.

Packaging. 3 ampoules with lyophilisate and 3 ampoules with 2 ml of solvent (sodium chloride, water for injections) in a blister pack within a carton box.

Prescription status. Prescription only.

Manufacturer. Ferrer Internacional, S.A.

Manufacturer's location and address of the place of business.

Legal address:

Gran Vía Carlos III, 94, 08028 Barcelona, Spain.

Place of manufacture:

c/Joan Busqueta, 1-9, 08173 Sant Cugat del Vallès (Barcelona), Spain.