Lonamo Duo 50 mg/1000 mg film-coated tablets

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Fáanlegur frá:

Egis Pharmaceuticals PLC Kereszturi Ut 30-38 1106 Budapest, Hungary

ATC númer:

A10BD07

INN (Alþjóðlegt nafn):

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Lyfjaform:

FILM-COATED TABLET

Samsetning:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 1000 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

DRUGS USED IN DIABETES

Vörulýsing:

Licence number in the source country: NOT APPLICAPABLE

Leyfisstaða:

Authorised

Leyfisdagur:

2022-06-16

Upplýsingar fylgiseðill

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LONAMO DUO 50 MG/1000 MG FILM-COATED TABLETS
sitagliptin/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 Lonamo Duo is and what it is used for
2.
What you need to know before you take Lonamo Duo
3.
How to take Lonamo Duo
4.
Possible side effects
5.
How to store Lonamo Duo
6.
Contents of the pack and other information
1.
WHAT LONAMO DUO IS AND WHAT IT IS USED FOR
Lonamo Duo contains two different medicines called sitagliptin and
metformin.
•
sitagliptin belongs to a class of medicines called DPP-4 inhibitors
(dipeptidyl
peptidase-4 inhibitors)
•
metformin belongs to a class of medicines called biguanides.
They work together to control blood sugar levels in adult patients
with a form of diabetes called ‘type
2 diabetes mellitus’. This medicine helps to increase the levels of
insulin produced after a meal and
lowers the amount of sugar made by your body.
Along with diet and exercise, this medicine helps lower your blood
sugar. This medicine can be used
alone or with certain other medicines for diabetes (insulin,
sulphonylureas, or glitazones).
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 problems
like heart disease, kidney disease,

Vara einkenni

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1.
NAME OF THE MEDICINAL PRODUCT
Lonamo Duo 50 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of
sitagliptin and 1,000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Red to brown, oblong oval-shaped film-coated tablets with a scoreline
in between ‘S’ and ‘B’
on one side and with a scoreline on the other side.
Tablet diameter: 21.3 ± 0.5 mm.
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult patients with type 2 diabetes mellitus:
Lonamo Duo is indicated as an adjunct to diet and exercise to improve
glycaemic control in
patients inadequately controlled on their maximal tolerated dose of
metformin alone or those
already being treated with the combination of sitagliptin and
metformin.
Lonamo Duo is indicated in combination with a sulphonylurea (i.e.,
triple combination
therapy) as an adjunct to diet and exercise in patients inadequately
controlled on their maximal
tolerated dose of metformin and a sulphonylurea.
Lonamo Duo is indicated as triple combination therapy with a
peroxisome proliferator-
activated receptor gamma (PPAR

) agonist (i.e., a thiazolidinedione) as an adjunct to diet and
exercise in patients inadequately controlled on their maximal
tolerated dose of metformin and
a PPAR

agonist.
Lonamo Duo is also indicated as add-on to insulin (i.e., triple
combination therapy) as an
adjunct to diet and exercise to improve glycaemic control in patients
when stable dose of
insulin and metformin alone do not provide adequate glycaemic control.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of antihyperglycaemic therapy with Lonamo Duo should be
individualised on the
basis of the patient’s current regimen, effectiveness, and
tolerability while not exceeding the
maximum recommended daily dose of 100 mg sitagliptin.
Pa