Linagliptin/Metformin Sandoz 2.5 mg/850 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC code:

A10BD11

INN (International Name):

LINAGLIPTIN 2.5 mg METFORMIN HYDROCHLORIDE 850 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LINAGLIPTIN 2.5 mg METFORMIN HYDROCHLORIDE 850 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Authorization status:

Authorised

Authorization date:

2023-08-11

Patient Information leaflet

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
LINAGLIPTIN/METFORMIN SANDOZ 2.5 MG/500 MG FILM-COATED TABLETS
LINAGLIPTIN/METFORMIN SANDOZ 2.5 MG/850 MG FILM-COATED TABLETS
LINAGLIPTIN/METFORMIN SANDOZ 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 Sandoz is and what it is used for
2.
What you need to know before you take Linagliptin/Metformin Sandoz
3.
How to take Linagliptin/Metformin Sandoz
4.
Possible side effects
5.
How to store Linagliptin/Metformin Sandoz
6.
Contents of the pack and other information
1.
WHAT LINAGLIPTIN/METFORMIN SANDOZ IS AND WHAT IT IS USED FOR
The name of your tablet is Linagliptin/Metformin Sandoz. 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 SANDOZ 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, empagliflozin, or insulin.
WHAT IS TYPE 2 DIABETES?
Type 2 di

Summary of Product characteristics

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SUMMARY OF PRODUCT
CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linagliptin/Metformin Sandoz 2.5 mg/500 mg film-coated tablets
Linagliptin/Metformin Sandoz 2.5 mg/850 mg film-coated tablets
Linagliptin/Metformin Sandoz 2.5 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Linagliptin/Metformin Sandoz 2.5 mg/500 mg film-coated tablets
Each tablet contains 2.5 mg of linagliptin and 500 mg of metformin
hydrochloride.
Linagliptin/Metformin Sandoz 2.5 mg/850 mg film-coated tablets
Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin
hydrochloride.
Linagliptin/Metformin Sandoz 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 Sandoz 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 Sandoz 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 Sandoz 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 Sandoz is indicated in adults with type 2
diabetes mellitus as
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an adjunct to diet and exercise to improve glycaemic control:
•
in patients inadequately controlled on their maximally tolerated dose
of metformin
alone,
•
in comb