Active ingredients: Choline (Choline alfoscerate)
Delecit 600 mg oral solution
Delecit package inserts are available for packs:- Delecit 600 mg oral solution
- Delecit 1g / 4ml solution for injection
- Delecit 400 mg soft capsules
Indications Why is Delecit used? What is it for?
Delecit belongs to a group of drugs called psychostimulants as the active substance contained, choline alfoscerate, is used to stimulate brain functions in elderly patients.
Delecit is used to treat the symptoms and signs of degenerative brain diseases in the elderly, also caused by insufficient blood circulation in the brain, or to treat disorders of knowledge and disorientation that occur with:
- lack of memory
- confusion and loss of orientation
- loss of motivation and initiative
- attention reduction.
It is also indicated for treating the behavioral problems of emotional relationships in the elderly, such as:
- emotionality,
- irritability,
- indifference to the surrounding environment,
- liabilities
Contraindications When Delecit should not be used
Do not take Delecit
- if you are allergic to choline alfoscerate or any of the other ingredients of this medicine
Precautions for use What you need to know before taking Delecit
Talk to your doctor or pharmacist before taking Delecit.
Interactions Which drugs or foods can modify the effect of Delecit
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are no known interactions of the product with other drugs.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Delecit during pregnancy because this medicine is not intended to be used in this situation. However, specific studies have shown that there are no adverse toxic effects.
Driving and using machines
Delecit does not affect the ability to drive or use machines
Delecit contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate
They can cause allergic reactions (even delayed).
Dose, Method and Time of Administration How to use Delecit: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 vial to be taken twice a day.
If you think it is necessary, your doctor may increase the dose for you
Overdose What to do if you have taken too much Delecit
If you take more Delecit than you should
In case of excessive dosage, contact your doctor immediately, or go to the nearest hospital, where they will arrange for adequate treatment.
If you forget to take Delecit
Do not take a double dose to make up for a forgotten previous dose.
If you stop taking Delecit
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Delecit
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since it is naturally present in the human organism, the administration of choline alfoscerate even for long periods does not generally create tolerability problems.
During treatment with Delecit you may experience the following side effects, the frequency of which cannot be estimated, so your doctor may reduce your dose:
Effects affecting the stomach:
- nausea
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice changes in the appearance of the solution which should be clear and colorless.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Delecit contains
- The active ingredient is: Choline alfoscerate. A single-dose container of 7 ml contains 600 mg of choline alfoscerate
- The other ingredients are: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate (see section 2), sodium saccharin, orange flavor, purified water
Description of what Delecit looks like and contents of the pack
Solution for oral use
Cardboard box containing 10 single-dose 7 ml brown glass containers
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DELECIT 600 MG ORAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Oral solution
A single-dose container of 7 ml contains:
Active principle: choline alfoscerate 600 mg.
Excipients: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Oral solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Psychoorganic cerebral degenerative-involutional syndromes or secondary to cerebrovascular insufficiency, that is, primary or secondary cognitive disorders of the elderly characterized by memory deficits, confusion and disorientation, a decrease in motivation and initiative and a reduction in attention skills. of senile behavior: emotional lability, irritability, indifference to the surrounding environment.
Pseudodepression of the elderly.
04.2 Posology and method of administration
Oral solution: a single-dose container 2 times a day.
These dosages can be increased at the discretion of the treating physician.
04.3 Contraindications
Individual hypersensitivity to the product.
04.4 Special warnings and appropriate precautions for use
Keep this medicine out of the reach and sight of children.
The oral solution contains methyl p-hydroxybenzoate, propyl p-hydroxybenzoate therefore it can cause allergic reactions (even delayed).
04.5 Interactions with other medicinal products and other forms of interaction
None.
04.6 Pregnancy and lactation
The therapeutic indication of the product does not foresee its use during pregnancy. However, specific studies have highlighted the lack of embryotoxic and teratogenic effects.
04.7 Effects on ability to drive and use machines
Nobody.
04.8 Undesirable effects
As a precursor of biological constituents, even prolonged administration of choline alfoscerate generally does not pose problems of tolerability.
The possible onset of nausea (probably attributable to a secondary dopaminergic activation) could require a reduction in the dosage.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
See point 4.8.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Choline alfoscerate, as a carrier of choline and precursor of phosphatidylcholine, has the potential to carry out a preventive and corrective action on biochemical lesions, which is recognized as having particular value among the pathogenetic factors of the involutional psychoorganic syndrome, namely on the reduced cholinergic tone and on the altered phospholipid composition of neuronal membranes. The chemical structure of choline alfoscerate (containing 40.5% of choline) and the chemical-physical properties related to it, guarantee a notable supply of active and metabolically protected substance to the brain tissue. experimental preclinical pharmacology and clinical studies have validated the ability of choline alfoscerate to intervene advantageously on cognitive and memory functions, as well as on the affective and behavioral sphere compromised by the involutional brain pathology.
05.2 "Pharmacokinetic properties
The pharmacokinetic characteristics, determined by administration of the labeled compound, similar in the different animal species used (rat, dog, monkey), are the following: rapid and complete gastrointestinal absorption; rapid uptake and distribution in different tissues and organs, including the brain; renal excretion only (about 10%, in 96 hours, of the administered dose of radioactivity); higher availability in the brain than tritium-labeled choline.
05.3 Preclinical safety data
In rodents, the LD50 is greater than 1 g / kg parenterally and 10 g / kg orally. A daily oral dose of 300 mg / kg and 150 mg / kg administered for 6 months to rats and dogs, respectively, does not give rise to clinical signs of toxicity, nor to alterations in haematological, blood chemistry or urinary parameters. The drug was not mutagenic or teratogenic and did not modify the reproductive capabilities of the rat and rabbit.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Oral solution
Excipients:
methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium saccharin, orange flavor, purified water.
06.2 Incompatibility
None.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicine does not require any special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Single-dose containers 7 ml: lithographed cardboard box containing 10 single-dose containers in brown glass, type III sec. F.U. IX ed., Closed with inviolable tear-off polyethylene capsule.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
M D M S.p.A.
Viale Papiniano, 22 / B - 20123 MILAN (MI)
08.0 MARKETING AUTHORIZATION NUMBER
Oral solution: A.I.C. n. 025935040
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
5.03.1993
