Amaryl M tablets film-coated

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

glimepiride, metformin (metformin hydrochloride)

MAH:

Handok Inc.

ATC_code:

A10BD02

INN:

glimepiride, metformin (metformin hydrochloride)

dosage:

2mg+ 500mg

pharmaceutical_form:

tablets film-coated

units_in_package:

(30/3x10/) in blister

prescription_type:

Prescription

authorization_status:

Registered

authorization_date:

2020-03-04

PIL

30/05/2015 11:18 - VISTAlink folder 1271966 - Page 2/4
_GLIMEPIRIDE / METFORMIN HYDROCHLORIDE_
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 or 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 of 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 is and what it is used for
2. What you need to know before you take AMARYL M
3. How to take AMARYL M
4. Possible side effects
5. How to store AMARYL M
6. Contents of the pack and other information
1.WHAT AMARYL M IS AND WHAT IT IS USED FOR
PHARMACOTHERAPEUTIC GROUP AND THERAPEUTIC INDICATIONS
AMARYL M is a medicine taken by mouth to help lower blood sugar.
AMARYL M 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
CONTRAINDICATIONS
DO NOT TAKE AMARYL M:
- 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 (listed in section 6 under “Contents
of the pack and other
information”), to sulphonamides (medicines for bacterial infec

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amaryl
M
Nonproprietary Name: Glimepiride + Metformin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
Description
White, oval, film-coated tablets.
2.2
Composition
One tablet contains:
_Active substances:_
Glimepiride - 2 mg, Metformin hydrochloride - 500 mg;
3.
PHARMACEUTICAL FORM
Film-coated tablets 2 mg + 500 mg
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct to diet and exercise in NIDDM (type 2) patients
- In case that the monotherapy with glimepiride or metformin do not
result in adequate glycemic
control
- Replacement of combination therapy of glimepiride and metformin
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This drug should be administered once or twice per day immediately
before or with the meals.
The dosage may be individualized based on the patient’s current
treatment regimen, efficacy and
tolerability; adequate monitoring of blood glucose levels should be
performed for this. Generally,
it should be recommended to initiate the lowest effective dose and
increase the dose depending on
the patient’s current medication and blood glucose levels. The
initial daily dose of this drug in a
clinical study was glimepiride / metformin hydrochloride 2mg/500mg
which was gradually
increased up to glimepiride/ metformin hydrochloride 8mg/2000mg as per
the blood glucose
monitoring results. Although glimepiride monotherapy generally had
little additional effects when
dosed at 4mg or more a day, some patients showed improved metabolic
control when the dose was
increased up to 6mg (or 8 mg).
When switching from combination therapy, this drug should be
administered based on the dosage
and administration method of glimepiride and metformin hydrochloride
that are being currently
administered in combination.
Although the previous dose was omitted, do not overdose this drug for
the next dose.
4.3 CONTRAINDICATIONS
1) Patients with Insulin-dependent (type I) diabetes mellitus (e.g.,
diabetic patients with a history
of ketonemia), diabeti