Amaryl M SR tablets prolonged-release

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

glimepiride, metformin (metformin hydrochloride)

Available from:

Handok Inc.

ATC code:

A10BD02

INN (International Name):

glimepiride, metformin (metformin hydrochloride)

Dosage:

2mg+ 500mg

Pharmaceutical form:

tablets prolonged-release

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-05-30

Patient Information leaflet

_GLIMEPIRIDE / METFORMIN HYDROCHLORIDE_
Prolonged-release film-coated tablets
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. You should 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 AMARYL M SR is and what it is used for
2. What you need to know before you take AMARYL M SR
3. How to take AMARYL M SR
4.Possible side effects
5.How to store AMARYL M SR
6. Contents of the pack and other information
1.WHAT AMARYL M SR IS AND WHAT IT IS USED FOR
PHARMACOTHERAPEUTIC GROUP AND THERAPEUTIC INDICATIONS
AMARYL M SR is a medicine taken by mouth to help lower blood sugar.
AMARYL M SR
is used, with diet and physical exercise, to treat a certain form of
diabetes (type 2
diabetes mellitus):
- in case the use of glimepiride or metformin alone does not control
your blood
glucose level,
- in place of taking the combination of glimepiride tablet with a
metformin tablet.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMARYL M SR
CONTRAINDICATIONS
DO NOT TAKE AMARYL M SR:
- if you have insulin-dependent diabetes (type 1 diabetes mellitus),
- if you have diabetic ketoacidosis (a complication of diabetes when
your acid level
is raised in your body and you may have some of the following signs:
fatigue, feeling
sick (nausea), frequent urination and muscular stiffness),
- if you are in a diabetic pre-coma,
- if you are allergic (hypersensitive) to glimepiride or metformin
hydrochloride, or any
of the other ingredients of AMARYL M SR (listed in section 6 under
“Contents of the
pack and other information”), to sulfonamides (medicines for
bacterial infection

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT Amaryl M SR 2mg/500mg prolonged-release
film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS:
Active ingredients:
Glimepiride 2mg
Metformin 500mg
Excipients: lactose monohydrate, povidone K30, hypromellose, magnesium
stearate, macrogol,
titanium dioxide, sodium laurilsulfate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
prolonged-release film-coated tablets
4.
CLINICAL PARTICULARS
4.1.THERAPEUTIC INDICATIONS
_For Glimepiride and Metformin: _As an adjunct to diet and exercise in
type 2 diabetes mellitus
patients

In case that the monotherapy with glimepiride or metformin does not
result in adequate
glycemic control

Replacement of combination therapy of glimepiride or metformin
4.2.POSOLOGY AND METHOD OF ADMINISTRATION
In principle, THE DOSAGE OF AMARYL M SR IS GOVERNED BY THE DESIRED
BLOOD GLUCOSE LEVEL. THE DOSAGE OF AMARYL M SR MUST BE THE LOWEST WHICH IS SUFFICIENT TO
ACTIVE THE DESIRED
METABOLIC CONTROL.
DURING TREATMENT WITH AMARYL M SR GLUCOSE LEVELS IN BLOOD AND URINE
MUST MEASURED
REGULARLY. Inaddition, it is recommended that regular determination of
the proportion of glycated
haemoglobin be carried out. MISTAKES, E.G. FORGETTING TO TAKE A DOSE, MUST NEVER BE CORRECTED BY
SUBSEQUENTLY TAKING A
LARGER DOSE.
Measure for dealing with such mistakes (in particular forgetting a
dose or skipping a meal) or situations
where a dose cannot be taken at the prescribed time must be discussed
and agreed between physician
and patient beforehand.
As
an
improvement
in
control
of
diabetes
is,
itself,
associated
with
higher
insulin
sensitivity,
GLIMEPIRIDE REQUIREMENTS MAY FALL AS TREATMENT PROCEEDS. TO AVOID
HIPOGLYCAEMIA TIMELY DOSE
REDUCTION OR CESSATION OF AMARYL M SR THERAPY MUST THEREFORE BE
CONSIDERED.
_If a country is registering the Immediate Release formulation: _
AMARYL M SR should be administered once or twice per day during meals.
The maximum dose of metformin per administration