Lamzarin 30 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gliclazide

Available from:

Lexon Pharmaceuticals (Ireland) Limited

ATC code:

A10BB09

INN (International Name):

Gliclazide

Dosage:

30 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

gliclazide

Authorization status:

Marketed

Authorization date:

2019-04-05

Patient Information leaflet

PACKAGE LEAFLET
KEY PHARMACEUTICALS LTD.
LAMZARIN 30MG PROLONGED-RELEASE TABLETS
PL 34424/0037 PA23176/004/001
VERSION NO.: 08 (APRIL 2021)
Page
1
of
6
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMZARIN 30MG PROLONGED-RELEASE TABLETS
gliclazide
Your medicine is called Lamzarin 30mg 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.
WHAT LAMZARIN PROLONGED-RELEASE TABLETS ARE AND WHAT THEY ARE USED FOR
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 same group
(s

Summary of Product characteristics

Health Products Regulatory Authority
03 February 2022
CRN00CS1D
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamzarin 30 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lamzarin 30 mg Prolonged-release Tablets
Each Prolonged-release Tablet contains 30 mg gliclazide.
Excipient with known effect:
Each Prolonged-release Tablet contains 81.90 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 30 mg Prolonged-release Tablets are white biconvex capsule
shaped tablet with 'GLI 30' on one side and plain on
other side having dimensions Length 10.00 mm ± 0.15 mm, Breadth 4.50
mm ± 0.15 mm and Thickness: 3.55 mm ± 0.15 mm.
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 1 to 4 tablets per day, _i.e_. from 30 to
120 mg taken orally in a single intake at breakfast time.
It is recommended that the tablet(s) be swallowed whole.
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
treatment.
The maximum recommended daily dose is 120 mg.
_Switching from gliclazide 80 mg