Remevia 50 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

A10BH01

INN (International Name):

SITAGLIPTIN 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SITAGLIPTIN 50 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:

2022-08-17

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REMEVIA 25 MG FILM-COATED TABLETS
REMEVIA 50 MG FILM-COATED TABLETS
REMEVIA 100 MG FILM-COATED TABLETS
sitagliptin
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 Remevia is and what it is used for
2.
What you need to know before you take Remevia
3.
How to take Remevia
4.
Possible side effects
5.
How to store Remevia
6.
Contents of the pack and other information
1.
WHAT REMEVIA IS AND WHAT IT IS USED FOR
Remevia contains the active substance sitagliptin which is a member of
a class of medicines called
DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood
sugar levels in adult patients
with type 2 diabetes mellitus.
This medicine helps to increase the levels of insulin produced after a
meal and decreases the amount
of sugar made by the body.
Your doctor has prescribed this medicine to help lower your blood
sugar, which is too high because
of your type 2 diabetes. This medicine can be used alone or in
combination with certain other
medicines (insulin, metformin, sulphonylureas, or glitazones) that
lower blood sugar, which you may
already be taking for your diabetes together with a food and exercise
plan.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough
insulin, and the insulin that
your body produces does not work as well as it should. Your body can
also make too much sugar.
When this happens, sugar (glucose) builds up in the blood. This can
lead to serious medical

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Remevia 25 mg film-coated tablets
Remevia 50 mg film-coated tablets
Remevia 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Remevia 25 mg film-coated tablets: Each tablet contains sitagliptin
hydrochloride, equivalent to 25
mg sitagliptin.
Remevia 50 mg film-coated tablets: Each tablet contains sitagliptin
hydrochloride, equivalent to 50
mg sitagliptin.
Remevia 100 mg film-coated tablets: Each tablet contains sitagliptin
hydrochloride, equivalent to 100
mg sitagliptin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Remevia 25 mg film-coated tablets: Pink colored, round film-coated
tablet debossed with “25” on
one side and plain on the other side, with dimension of 6.1 mm ±5%.
Remevia 50 mg film-coated tablets: Light beige colored, round,
film-coated tablets, debossed with
“50” on one side and plain on the other side, with dimension of
8.1 mm ±5%.
Remevia 100 mg film-coated tablets: Beige colored, round, film-coated
tablets, debossed with “100”
on one side and plain on the other side, with dimension of 10.1 mm
±5%.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS _ _
For adult patients with type 2 diabetes mellitus, Remevia is indicated
to improve glycaemic control:
as monotherapy:
•
in patients inadequately controlled by diet and exercise alone and for
whom metformin is
inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
•
metformin when diet and exercise plus metformin alone do not provide
adequate glycaemic
control.
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•
a sulphonylurea when diet and exercise plus maximal tolerated dose of
a sulphonylurea alone
do not provide adequate glycaemic control and when metformin is
inappropriate due to
contraindications or intolerance.
•
a peroxisome proliferator-activated receptor gamma (PPARγ) agonist
(i.e. a thiazolidinedione)
when use of a PPARγ agonist is appropriate and when diet and