INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KELTICAN (KELTICAN)

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 capsule contains:
cytidine-5’-disodium monophosphate 5.0 mg;
uridine-5’-trisodium triphosphate, uridine-5’-disodium diphosphate, uridine-5’-disodium monophosphate – total 3.0 mg (equivalent to 1.330 mg of uridine);

Excipients:
citric acid monohydrate; sodium citrate; magnesium stearate; colloidal anhydrous silicon dioxide; mannitol (E 421);

Capsule shell:
Capsule body:
iron oxide black (E 172); titanium dioxide (E 171); gelatin;
Capsule cap:
indigocarmine; titanium dioxide (E 171); gelatin.

Pharmaceutical form.
Hard capsules.

Main physicochemical properties:
capsules (size № 2) with a blue cap and a grey body, containing a white hygroscopic powder.

Pharmacotherapeutic group.
Agents used in nervous system disorders. ATC code N07XX.

Pharmacological properties.

The activity of the drug Keltykan is provided by phosphate groups, which are necessary for the combination of monosaccharides with ceramides to form cerebrosides, and for phosphatidic acids, which are the basis of sphingomyelin and glycerophospholipids. Sphingomyelin and glycerophospholipids are the main components of the myelin sheath. Thus, administration of Keltykan enhances trophic properties promoting maturation and regeneration of nerve tissue axons.

Clinical characteristics.

Indications.

Treatment of osteoarticular neuropathies (sciatica, radiculitis), metabolic neuropathies (alcoholic, diabetic polyneuropathy), and infectious origin (herpes zoster). Neuralgia of the facial and trigeminal nerves, intercostal neuralgia, lumbago.

Contraindications.

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other types of interactions. Not established.

Special precautions.

The administration of Keltikan is not related to food intake. Therefore, the drug can be taken before, during, or after meals.

Keltikan contains mannitol, which may exert a mild laxative effect. In case of gastrointestinal disturbances, it is recommended to take Keltikan during meals.

Use during pregnancy or breastfeeding.

The safety of Keltikan during pregnancy and breastfeeding has not been established. Keltikan should be used in pregnant women or women who may become pregnant, as well as during breastfeeding, only if the expected therapeutic benefit outweighs any possible risk to the fetus/child.

Ability to affect reaction speed when driving or operating machinery.

Keltikan does not affect the ability to drive or operate vehicles and other complex machinery.

Dosage and Administration.

Take orally, independent of food intake.

Adults: The recommended dose is 1 capsule three times daily.

The duration of treatment is determined individually by a physician.

Children.
Do not use in children.

Overdose.

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

In case of overdose, symptomatic treatment is required.

Side effects.

Not described. However, hypersensitivity reactions may occur.

Shelf life. 2 years.

Storage conditions. Store at a temperature not exceeding 30 °C. Keep out of reach of children!

Packaging. 15 capsules per blister; 2 blisters per cardboard box.

Prescription status. Prescription only.

Manufacturer. Ferrer Internacional, S.A., Spain.

Manufacturer's address and place of business.

Joan Buscalla, 1-9, Sant Cugat del Valls, 08173 Barcelona, Spain / Joan Buscalla, 1-9, Sant Cugat del Valles, 08173 Barcelona, Spain.