Active ingredients: Vitamin B1, Vitamin B6, Vitamin B12
Neurabe Rigine Capsules 100mg + 150mg + 500mcg
Why is Neuraben used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Vit. B1 in association with Vit. B6 and Vit. B12.
THERAPEUTIC INDICATIONS
Polyneuritis from Vitamin B1, B6 and B12 deficiency states.
When should it not be used?
Individual hypersensitivity already known to the components
Precautions for use What you need to know before taking Neuraben
Caution is recommended when administering to subjects undergoing levodopa treatment.
Use in pregnancy and lactation
There are no contraindications to the use of Neuraben in these conditions.
Interactions Which drugs or foods can modify the effect of Neuraben
Vit. B6 can antagonize the therapeutic effects of levodopa.
Warnings It is important to know that:
The medicine is not contraindicated for people with celiac disease.
Use of cars / driving of vehicles
No negative effects are found with the use of Neura
Dosage and method of use How to use Neuraben: Dosage
Usually 1 capsule 3 times a day.
Overdose What to do if you have taken an overdose of Neuraben
No manifestations of overdosing of the drug have been described
Side Effects What are the side effects of Neuraben
Neuraben is generally well tolerated and no toxic and accumulation effects are known.
Expiry and Retention
Be careful not to use the medicine after the expiry date indicated on the package.
SPECIAL STORAGE PRECAUTIONS
None.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains:
Active principles:
Benzoyloxymethyl-thiamine 100 mg
Pyridoxine hydrochloride 150 mg
Cyanocobalamin 500 mcg
Excipients:
Talc - magnesium stearate - polyethylene glycol 6000
The opercula contain:
Titanium dioxide (E171), Medium orange (E110), Gelatin.
PHARMACEUTICAL FORM AND PACKAGING
Each pack contains 30 hard capsules
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
NEURABEN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains:
Active principles:
Benzoyloxymethylthiamine 100 mg
Pyridoxine hydrochloride 150 mg
Cyanocobalamin 500 mcg
03.0 PHARMACEUTICAL FORM
Hard capsules for oral use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Polyneuritis from Vitamin B1, B6 and B12 deficiency states.
04.2 Posology and method of administration
Usually 1 capsule 3 times a day.
04.3 Contraindications
Individual hypersensitivity already known to the components.
04.4 Special warnings and appropriate precautions for use
Caution is recommended when administering to subjects undergoing treatment with levodopa because pyridoxine can antagonize its therapeutic effects.
Keep out of reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
Vitamin B6 can antagonize the therapeutic effects of levodopa.
04.6 Pregnancy and lactation
There are no contraindications to the use of NEURABEN in these conditions.
04.7 Effects on ability to drive and use machines
No negative effects are found with the use of Neuraben.
04.8 Undesirable effects
Neuraben is generally well tolerated and there are no known toxic and accumulation effects.
04.9 Overdose
There are no known symptoms of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
NEURABEN is a "combination of cyanocobalamin, pyridoxine hydrochloride and benzoyloxymethylthiamine, a new derivative of thiamine. Cyanocobalamin administered orally, is partly bound to intrinsic factor and through this bond is released into the circulation. Pyridoxine hydrochloride is easily absorbed by the intestine. and converted into coenzymes Benzoyloxymethyl-thiamine differs from Thiamine Hydrochloride essentially for a more rapid oral absorption, a higher blood and tissue concentration and a rapid transformation in vivo into thiamine.
Metabolism
Orally administered benzoyloxymethyl thiamine is rapidly converted into thiamine.
05.2 Pharmacokinetic properties
The absorption of Benzoyloxymethyl-thiamine was investigated after oral administration of the radioactive carbon-labeled compound. It was noted in rats that blood and tissue levels of Benzoyloxymethyl-thiamine are higher than those achieved with thiamine hydrochloride. Benzoyloxymethyl-thiamine concentrates in the nervous tissue from the 1st hour up to 24 hours after administration.
05.3 Preclinical safety data
Acute toxicity
Benzoyloxymethyl-thiamine administered orally in the rat did not show a detectable LD50. Intravenously in mice the LD50 is 100-140 mg / kg.
Chronic toxicity
Benzoyloxymethyl-thiamine in rats at a dose of 50-100-200 mg / kg, administered orally for 23 weeks, did not give rise to significant increases in mortality or changes in body weight, autopsy, urinary and humoral findings in animals. treated with respect to controls.
Fetal toxicity
Benzoyloxymethyl-thiamine administered in rats for the entire gestation period orally at a dose of 20 mg / kg per day, did not produce changes in either the number of survivors or the weight of individual animals or alterations in the morphological parameters in subjects born from mothers treated against controls.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Talc, magnesium stearate, polyethylene glycol 6000.
Each operculum contains:
Head: Titanium dioxide (E171), medium orange (E110), gelatin.
Body: Titanium dioxide (E171), medium orange (E110), gelatin.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
It is valid for 36 months when the packaging is intact.
06.4 Special precautions for storage
No special storage precautions are required.
06.5 Nature of the immediate packaging and contents of the package
Transparent PVC / Al blister.
Carton containing 30 hard capsules.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Pfizer Italia S.r.l.
Via Isonzo, 71 - 04100 Latina
08.0 MARKETING AUTHORIZATION NUMBER
AIC N ° 023585019.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
May 31, 2005.
10.0 DATE OF REVISION OF THE TEXT
March 2010
