Linagliptin Clonmel 5 mg film-coated tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Linagliptin

Prieinama:

Clonmel Healthcare Ltd

ATC kodas:

A10BH05

INN (Tarptautinis Pavadinimas):

Linagliptin

Dozė:

5 milligram(s)

Vaisto forma:

Film-coated tablet

Gydymo sritis:

linagliptin

Autorizacija statusas:

Not marketed

Leidimo data:

2021-06-04

Pakuotės lapelis

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINAGLIPTIN CLONMEL 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 Clonmel is and what it is used for
2. What you need to know before you take Linagliptin Clonmel
3. How to take Linagliptin Clonmel
4. Possible side effects
5. How to store Linagliptin Clonmel
6. Contents of the pack and other information.
1. WHAT LINAGLIPTIN CLONMEL IS AND WHAT IT IS USED FOR
Linagliptin Clonmel 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 Clonmel 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
Clonmel
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 CLONMEL
DO NOT TAKE LINAGLIPTIN CLONMEL

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 befor

Prekės savybės

Health Products Regulatory Authority
09 June 2021
CRN009L8Z
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linagliptin Clonmel 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).
Greyish red, round, biconvex film-coated tablet (with dimensions of 8
mm x 5 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Linagliptin Clonmel 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