PULSATYL SDK Tablet, Film-coated 50
Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Summary of Product characteristics
(SPC)
22-03-2023
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Active ingredient:
Metoprolol
Available from:
ILKO ILAC SAN VE TIC. A.S., TURKEY
ATC code:
Selective calcium channel blockers with mainly vas
INN (International Name):
Metoprolol
Dosage:
50
Pharmaceutical form:
Tablet, Film-coated
Manufactured by:
ilko ilac San. ve Tic. A.S, TURKEY
Product summary:
Physical description: Homogeneous, white coloured, round, biconvex scored on one side film coated tablets; Local technical representative: GENERICS & SPECIALITIES LIMITED (9801)
Authorization status:
Registered/Compliant
Authorization date:
2021-08-20
Summary of Product characteristics
Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR PULSATYL SDK (METOPROLOL SUCCINATE 47.5
MG EQUIVALENT TO METOPROLOL TARTRATE 50 MG) CONTROLLED RELEASE FILM
COATED TABLETS
VERSION NUMBER 1
3
RD
JANUARY, 2023
TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA
ROAD, P. O. BOX
1253, DODOMA – TANZANIA, TELEPHONE: +255 (26) 2961989/2061990/+255
(22)
2450512/2450751/2452108, EMAIL: INFO@TMDA.OG.TZ, Website:
WWW.TMDA.GO.TZ
Toll free: 0800110084
Effective date: 03/10/2022
1
1.
INTRODUCTION
PULSATYL
SDK
is
a
generic
medicine
of
Lopressor.
PULSATYL
SDK
is
an
antihypertensive
medicine belonging to
C07AB02-
Beta-receptor blocker, selective
group. Metoprolol is a beta-1 selective beta blocker. It has a
relatively greater blocking
effect on beta receptors (i.e. those mediating adrenergic stimulation
of heart rate and
contractility and release of the fatty acids from fat stores) than on
beta receptors which
are chiefly involved in broncho and vasodilation. Metoprolol only
exhibits insignificant
membrane stabilising effect and has no agonist effect. Metoprolol
reduces or blocks the
stimulating effect of catecholamines (particularly released in case of
physical or mental
stress) on the heart. Metoprolol reduces tachycardia, decreases the
cardiac output and
the
contractility,
and
lowers
the
blood
pressure.
If
required,
metoprolol
may
be
administered
concomitantly
with
a
beta-2
agonist
to
patients
with
symptoms
of
obstructive pulmonary disease. PULSATYL SDK is approved in Tanzania
for use in
adults and elderly.
1.1
PRODUCT DETAILS
Registration number
TAN 21 HM 0325
Brand name
PULSATYL SDK
Generic name, strength and
form
Metoprolol succinate
ATC classification
C07AB02- Beta-receptor blocker, selective
Distribution category
POM
Country of origin
Turkey
Associated product
State any other product of formulation, strength or
site that is linked or associated with the product if
applicable
Marketi
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