Linagliptin/Metformin HCl PharOS 2.5 mg/850 mg film-coated tablets

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Malta Medicines Authority

Pieejams no:

PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece

ATĶ kods:

A10BD11

SNN (starptautisko nepatentēto nosaukumu):

LINAGLIPTIN 2.5 mg METFORMIN HYDROCHLORIDE 850 mg

Zāļu forma:

FILM-COATED TABLET

Kompozīcija:

LINAGLIPTIN 2.5 mg METFORMIN HYDROCHLORIDE 850 mg

Receptes veids:

POM

Ārstniecības joma:

DRUGS USED IN DIABETES

Autorizācija statuss:

Authorised

Autorizācija datums:

2023-07-25

Lietošanas instrukcija

Page
1
of
10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LINAGLIPTIN/METFORMIN HCL PHAROS 2.5 MG / 500 MG FILM-COATED TABLETS
LINAGLIPTIN/METFORMIN HCL PHAROS 2.5 MG / 850 MG FILM-COATED TABLETS
LINAGLIPTIN/METFORMIN HCL PHAROS 2.5 MG / 1,000 MG FILM-COATED TABLETS
linagliptin/metformin hydrochloride
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Linagliptin/Metformin HCl PharOS is and what it is used for
2.
What you need to know before you take Linagliptin/Metformin HCl PharOS
3.
How to take Linagliptin/Metformin HCl PharOS
4.
Possible side effects
5.
How to store Linagliptin/Metformin HCl PharOS
6.
Contents of the pack and other information
1.
WHAT LINAGLIPTIN/METFORMIN HCL PHAROS IS AND WHAT IT IS USED FOR
The name of your tablet is Linagliptin/Metformin HCl PharOS. It
contains two different active
substances linagliptin and metformin.
-
Linagliptin belongs to a class of medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4
inhibitors).
-
Metformin belongs to a class of medicines called biguanides.
HOW LINAGLIPTIN/METFORMIN HCL PHAROS WORKS
The two active substances work together to control blood sugar levels
in adult patients with a form of
diabetes called ‘type 2 diabetes mellitus’. Along with diet and
exercise, this medicine helps to improve
the levels and effects of insulin after a meal and lowers the amount
of sugar made by your body.
This medicine can be used alone or with certain other medicines for
diabetes like sulphonylureas or
insulin.
WHAT IS TYPE 2 DIABE

Produkta apraksts

Page
1
of
21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linagliptin/Metformin HCl PharOS 2.5 mg/500 mg film-coated tablets
Linagliptin/Metformin HCl PharOS 2.5 mg/850 mg film-coated tablets
Linagliptin/Metformin HCl PharOS 2.5 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Linagliptin/Metformin HCl PharOS 2.5 mg/500 mg film-coated tablets
Each tablet contains 2.5 mg of linagliptin and 500 mg of metformin
hydrochloride.
Linagliptin/Metformin HCl PharOS 2.5 mg/850 mg film-coated tablets
Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin
hydrochloride.
Linagliptin/Metformin HCl PharOS 2.5 mg/1,000 mg film-coated tablets
Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Linagliptin/Metformin HCl PharOS 2.5 mg/500 mg film-coated tablets
Yellow, oval shaped, biconvex film-coated tablet with break-line on
one side and debossed with
"2.5/500" on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Linagliptin/Metformin HCl PharOS 2.5 mg/850 mg film-coated tablets
Beige, oval shaped, biconvex film-coated tablet with break-line on one
side and debossed with "2.5/850"
on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses
Linagliptin/Metformin HCl PharOS 2.5 mg/1,000 mg film-coated tablets
Pink, oval shaped, biconvex film-coated tablet with break-line on one
side and debossed with "2.5/1000"
on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Linagliptin/Metformin HCl PharOS is indicated in adults with type 2
diabetes mellitus as an adjunct
to diet and exercise to improve glycaemic control:
•
in patients inadequately controlled on their maximally tolerated dose
of m