Lonamo Duo 50 mg/850 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

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

ATC code:

A10BD07

INN (International Name):

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 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:

2022-06-16

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LONAMO DUO 50 MG/850 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, bl

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Lonamo Duo 50 mg/850 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sitagliptin hydrochloride monohydrate equivalent
to 50 mg of sitagliptin and 850 mg of
metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pink, oblong oval-shaped film-coated tablets with a scoreline on one
side and ‘SA’ on the other side.
Tablet diameter: 19.5 ± 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.
_ADULTS WITH NORMAL RENAL FUNCTION (GFR ≥ 90 ML/MIN