Ozinc DT Tablet, Dispersible 20

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Zinc Sulfate Monohydrate

Available from:

IPCA Laboratories Limited, INDIA

ATC code:

Other mineral supplements

INN (International Name):

Zinc Sulfate Monohydrate

Dosage:

20

Pharmaceutical form:

Tablet, Dispersible

Manufactured by:

IPCA LABORATORIES LIMITED , INDIA

Product summary:

Physical description: White to off white, round, flat faced bevel edge, uncoated dispersible tablets with break line on one side and debossed with ‘C 70’ on other side; Local technical representative: Phillips Distributors Limited (9823)

Authorization status:

Registered/Compliant

Authorization date:

2021-11-26

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ozin
c-DT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
uncoated
dispersible
tablet
contains: Zinc sulfate monohydrate
USP
(54.9
mg)
equivalent
to
elemental zinc…….20 mg
Excipient with known effect:
Each
uncoated
dispersible
tablet
contains
46.43
mg
of
Aspartame.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to off white, round, flat faced bevel edge, uncoated dispersible
tablets with
break line on one side and debossed with ‘C 70’ on other side. The
tablet can be
divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ozinc-DT is indicated for the treatment of acute and persistent
diarrhoea in infants
and children up to 5 years of age.
_This product is intended for use in children. Nonetheless, safety
information is _
_provided with respect to adult health issues such as liver disease,
pregnancy _
_and lactation, to allow full access to all relevant information._
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_For _
_acute _
_and _
_persistent _
_diarrhoea_
For children less than 6 months of age: ½ tablet once daily for 10-14
days.
For children 6 months of age to 5 years of age: 1 tablet once daily
for 10-14
days.
The tablet (or half tablet) should be dispersed completely in 1
teaspoon (5 ml) of
clean water or breast milk and the entire amount administered orally
to the infant or
child.
It is recommended that doses be administered between meals and a
repeat dose be
given if vomiting occurs within 30 minutes.
For missed doses, the missing dose can be taken as soon as possible,
unless
there is less than 6 hours until the next dose.
4.3
CONTRAINDICATIONS
The product is contraindicated in case of hypersensitivity to the
active substance or
any of the excipients listed in section 6.1. as well as in Copper
deficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE Accumulation of zinc may occur in cases of renal failure.
Drugs which may inhibit zinc absorption, such as penicillamine, sodium
va