Linagliptin Accord 5mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LINAGLIPTIN

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

A10BH05

INN (International Name):

LINAGLIPTIN 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LINAGLIPTIN 5 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-02-22

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
LINAGLIPTIN ACCORD 5 MG FILM-COATED TABLETS
Linagliptin
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 Accord is and what it is used for
2.
What you need to know before you take Linagliptin Accord
3.
How to take Linagliptin Accord
4.
Possible side effects
5.
How to store Linagliptin Accord
6.
Contents of the pack and other information.
1. WHAT LINAGLIPTIN ACCORD IS AND WHAT IT IS USED FOR
Linagliptin Accord contains the active substance linagliptin which
belongs to a group of medicines
called “oral anti-diabetics”. Oral anti-diabetics are used to
treat high blood sugar levels. They work by
helping the body reduce the level of sugar in your blood.
Linagliptin Accord is used for ‘type 2 diabetes’ in adults, if the
disease cannot be adequately
controlled with one oral anti-diabetic medicine (metformin or
sulphonylureas) or diet and exercise
alone. Linagliptin Accord may be used together with other
anti-diabetic medicines e.g. metformin,
sulphonylureas (e.g. glimepiride, glipizide), empagliflozin, or
insulin.
It is important to keep following the advice about diet and exercise
that you have been given by your
doctor or nurse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINAGLIPTIN ACCORD
_ _
DO NOT TAKE LINAGLIPTIN ACCORD
-
if you are allergic to linagliptin or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linagliptin Accord 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of linagliptin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
8 mm diameter round, light red, biconvex, bevel-edged film coated
tablet debossed with "L5" on one side and
plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Linagliptin Accord is indicated in adults with type 2 diabetes
mellitus as an adjunct to diet and exercise to
improve glycaemic control as:
monotherapy
•
when metformin is inappropriate due to intolerance, or contraindicated
due to renal impairment.
combination therapy
•
in combination with other medicinal products for the treatment of
diabetes, including insulin, when these do
not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1
for available data on different
combinations).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of linagliptin is 5 mg once daily. When linagliptin is added
to metformin, the dose of metformin
should be maintained, and linagliptin administered concomitantly.
When linagliptin is used in combination with a sulphonylurea or with
insulin, a lower dose of the sulphonylurea
or insulin, may be considered to reduce the risk of hypoglycaemia (see
section 4.4)
_Special populations _
_Renal impairment _
For patients with renal impairment, no dose adjustment for linagliptin
is required.
_Hepatic impairment _
Pharmacokinetic studies suggest that no dose adjustment is required
for patients with hepatic impairment but
clinical
_ _
experience in such patients is lacking.
_Elderly _
No dose adjustment is necessary based on age.
_Paediatric population _
The safety and efficacy of linagliptin in children and adolescents has
not yet been established. No data are
available.
Method of administration
The tablets can be taken with or without a meal at any time of the
day. If a dose is missed, it