Lamzarin 60 mg prolonged-release tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Gliclazide

Saadav alates:

Key Pharmaceuticals Ltd

ATC kood:

A10BB09

INN (Rahvusvaheline Nimetus):

Gliclazide

Annus:

60 milligram(s)

Ravimvorm:

Prolonged-release tablet

Terapeutiline ala:

gliclazide

Volitamisolek:

Marketed

Loa andmise kuupäev:

2019-04-05

Infovoldik

PACKAGE LEAFLET
KEY PHARMACEUTICALS LTD.
LAMZARIN 60MG PROLONGED-RELEASE TABLETS
PL 34424/0038 PA 0343/006/002
VERSION NO.: 07 (MARCH 2021)
Page
1
of
6
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMZARIN 60MG PROLONGED-RELEASE TABLETS
gliclazide
Your medicine is called Lamzarin 60mg Prolonged-release Tablets, but
it will be referred to as Lamzarin
Prolonged-release Tablets throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT LAMZARIN PROLONGED-RELEASE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMZARIN PROLONGED-RELEASE
TABLETS
3.
HOW TO TAKE LAMZARIN PROLONGED-RELEASE TABLETS
4.
POSSIBLE SIDE-EFFECTS
5.
HOW TO STORE LAMZARIN PROLONGED-RELEASE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
W
h
AT LAMZARIN PROLONGED-RELEASE TABLETS A
r
E
A
n
D
wh
AT
the
Y A
r
E
u
S
e
D
f
OR
Lamzarin Prolonged-release Tablets is a medicine that reduces blood
sugar levels (oral anti-diabetic
medicine belonging to the sulphonylurea group).
Lamzarin Prolonged-release Tablets is used in a certain form of
diabetes (type 2 diabetes mellitus) in adults,
when diet, exercise and weight loss alone do not have an adequate
effect on keeping blood sugar at the
correct level.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMZARIN PROLONGED-RELEASE
TABLETS
DO NOT TAKE LAMZARIN PROLONGED-RELEASE TABLETS IF YOU:
•
are allergic (hypersensitive) to
gliclazide
or to any of the other ingredients (see section 6 for list
of ingredients), or to other medicine of the

Toote omadused

Health Products Regulatory Authority
20 April 2020
CRN009NQY
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamzarin 60 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Prolonged-release Tablet contains 60 mg gliclazide.
Excipient with known effect:
Each Prolonged-release Tablet contains 163.8 mg lactose (as the
monohydrate) (see section 4.4)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release Tablet.
Lamzarin 60mg Prolonged-release Tablets are White biconvex oval shaped
tablet with a deep breakline on both sides and
engraved 'GLI' and '60' on either side of the breakline on both sides.
Having dimensions Length 15.00 mm ± 0.15 mm, Breadth:
7.00 mm ± 0.15 mm and Thickness: 3.65 mm ± 0.15 mm.
The 60 mg tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Non-insulin dependent diabetes (type 2) in adults when dietary
measures, physical exercise and weight loss alone are not
sufficient to control blood glucose.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The daily dose may vary from one half to two tablets per day, _i.e_.
from 30 to 120 mg taken orally in a single intake at breakfast
time.
It is recommended to swallow the dose without crushing or chewing.
If a dose is forgotten, there must be no increase in the dose taken
the next day.
As with any hypoglycaemic agent, the dose should be adjusted according
to the individual patient's metabolic response (blood
glucose, HbAlc).
_Initial dose_
The recommended starting dose is 30 mg daily.
If blood glucose is effectively controlled, this dose may be used for
maintenance treatment. If blood glucose is not adequately
controlled, the dose may be increased to 60, 90 or 120 mg daily, in
successive steps. The interval between each dose increment
should be at least 1 month except in patients whose blood glucose has
not reduced after two weeks of treatment. In such
cases, the dose may be increased at the end of the second week of
treatm