METHYCOBAL Tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Methycobal 500μg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 500μg of mecobalamin.
3. Pharmaceutical form
Methycobal Tablets is available as a white, round, biconvex, sugar-coated tablet marked with E322 on one side. Clinical Particulars Methycobal Tablets is a mecobalamin preparation developed by Eisai Co., ...
4.1. Therapeutic indications
Peripheral neuropathies.
4.2. Posology and method of administration
The usual daily dose for adults is 3 tablets, equivalent to a total of 1500 μg of mecobalamin, administered orally in 3 divided doses. The dose should be adjusted according to the age of patient and severity ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Methycobal Tablets should not be aimlessly used for more than one month unless it is effective. Prolonged use of larger doses of Methycobal Tablets is not recommended for patients whose occupation requires ...
4.5. Interaction with other medicinal products and other forms of interaction
No notable interaction has been reported.
4.6. Pregnancy and lactation
Pregnancy Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy. Clinical studies have been done on pregnant women and no harmful effects have been reported. Brest-feeding ...
4.7. Effects on ability to drive and use machines
Based on the pharmacodynamic properties and adverse events profile, it is unlikely that Methycobal would cause an impairment of driving performance or compromise the ability to use machinery.
4.8. Undesirable effects
Adverse reactions were reported in 146 of 15,180 patients (0.96%). (At the end of the investigation for incidence of adverse reactions). 5% > ≥0.1% <0.1% Gastrointestinal Anorexia, nausea/vomiting ...
4.9. Overdose
Experience to date with deliberate or accidental overdose is limited. No specific antidote is known. As in any case of overdose, treatment should be symptomatic and general supportive measures should be ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> other antipsychotics <b>ATC code:</b> B03BA05 The active ingredient of Methycobal Tablets is mecobalamin (INN, JAN), that is an analogue of vitamin Β<sub>12</sub> developed ...
5.2. Pharmacokinetic properties
Single-dose administration When Methycobal Tablets was administered orally to healthy adult male volunteers at single doses of 120 μg and 1,500 µg<sup>note)*</sup> during fasting, the peak serum total ...
5.3. Preclinical safety data
Animal studies Distribution In rat given a 25 μg oral dose of 57Co-labeled mecobalamin, radioactivity was found to be higher in the kidneys, adrenal glands, pancreas, liver, and stomach (listed in order ...
6.1. List of excipients
Carnauba wax Microcrystalline cellulose Titanium oxide Stearic acid Calcium stearate Sucrose Talc Precipitated calcium carbonate Corn starch Lactose hydrate White shellac Hydroxypropylcellulose Pullulan ...
6.2. Incompatibilities
There is not incompatibility reported.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Methycobal Tablets should be stored below 25°C. Methycobal Tablets should be protected from light and moisture after opening the pillow. (Light decreases the content and tablets may turn reddish with exposure ...
6.5. Nature and contents of container
PTP (Press-Through-Package) blister pack in Aluminium pillow. Boxes of 30 and 100 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
Medilink Pharmaceuticals Ltd., 30 Armenias, 2003 Strovolos, Nicosia, Cyprus
8. Marketing authorization number(s)
20202
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 19 November 1998
10. Date of revision of the text
05/02/2018
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