MEBAAL ODS - 1500 Tablets, Orodispersible

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Mecobalamin

Available from:

Mega Lifesciences Public Company Limited, THAILAND

ATC code:

Vitamin B12 And Folic Acid

INN (International Name):

Mecobalamin

Dosage:

1500

Pharmaceutical form:

Tablets, Orodispersible

Manufactured by:

ZIM LABORATORIES LIMITED, INDIA

Product summary:

Physical description: RED COLOURED, RECTANGULAR, OPAQUE, NON-STICKY ORALLY DISINTEGRATING STRIP; Local technical representative: MEGA WECARE TANZANIA LIMITED (72635)

Authorization status:

Registered/Compliant

Authorization date:

2022-01-10

Summary of Product characteristics

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
1.1 TRADE NAME:
Mebaal ODS 1500
(MECOBALAMIN ORALLY DISINTEGRATING STRIPS 1500 mcg)
1.2 STRENGTH:1500 mcg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
Red coloured, Rectangular, Opaque, Non-sticky orally disintegrating
strips
Page 2 of 7
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mecobalamin is used in the treatment of Peripheral neuropathy &
Diabetic neuropathy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
1500 mcg once or twice daily, or as recommended by a physician.
Method of administration:For oral use. The strip should be placed on
tongue, let it
dissolve and swallow the residue.
4.3 CONTRAINDICATIONS
Hypersensitivity to mecobalamin or to any of the excipients listed.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use of Mecobalamin in deficiency states or to treat any medical
condition requires
medical supervision. A typical dose as nutritional supplements used by
pregnant woman
and nursing mothers is 12 micrograms daily. Pregnant women and nursing
mothers
should
only
use
doses
higher
than
this
if
recommended
by
their
physicians.
Administration of doses greater than 10 micrograms daily may produce a
hematological
response in those with anemia secondary to folate deficiency.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The use of Mecobalamin in deficiency states or to treat any medical
condition requires
medical supervision. A typical dose as nutritional supplements used by
pregnant woman
and nursing mothers is 12 micrograms daily. Pregnant women and nursing
mothers
should
only
use
doses
higher
than
this
if
recommended
by
their
physicians.
Administration of doses greater than 10 micrograms daily may produce a
hematological
response in those with anemia secondary to folate deficiency.
Cholestyramine: Cholestyramine may decrease the
enterohepaticreabsorption of
Mecobalamin.
Colchicine: Colchicine may cause decreased absorption of Mecobalamin.
Colestipol: Coles