Amaryl M 2mg+500mg tablets film-coated

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

glimepiride, metformin (metformin hydrochloride)

متاح من:

Handok Inc.

ATC رمز:

A10AE04

INN (الاسم الدولي):

glimepiride, metformin (metformin hydrochloride)

جرعة:

2mg+500mg

الشكل الصيدلاني:

tablets film-coated

الوحدات في الحزمة:

(30/3x10/) blisters

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2016-07-25

نشرة المعلومات

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

خصائص المنتج

Summary of Product Characteristics
1.
Trade name of The Medicinal Product
Amaryl
®
M
Nonproprietary Name:
Glimepiride + Metformin
Pharmacological Group:
Oral hypoglycemic agent for combined use (biguanide+sulfonylureas).
ATC Group:
A10VD02.
2.
Quantitative and Qualitative Composition
One tablet contains:
_Active substances:_ Glimepiride micronized - 2 mg, Metformin
hydrochloride - 500 mg;
_Excipients:_ Lactose monohydrate - 50 mg, Carboxymethyl starch sodium
- 15 mg, Povidone K30
- 25 mg Microcrystalline cellulose - 50 mg, Crospovidone - 10 mg,
Magnesium stearate - 5 mg;
_Film coating:_ Hypromellose - 9.4 mg, Macrogol-6000 - 1.7 mg,
Titanium dioxide (E 171) - 1.7
mg, Carnauba wax - 0.2 mg.
Pharmaceutical form
Tablets 2 mg + 500 mg
Oval biconvex tablets, film-coated, white, with engraving - HD25 on
one side and a line on the
other side
4. Clinical Particulars
4.1 Therapeutic indications
Treatment of diabetes mellitus type 2 (in addition to diet, physical
exercise and weight loss):
-
When
glycemic
control
cannot
be
achieved
with
metformin
or
glimepiride
monotherapy;
-
In
case
of
replacement
of
combination
therapy
of
glimepiride
and
metformin
monotherapy in order to administer a combined medicine Amaril
®
M.
4.2 Posology and Method of Administration.
Typically
the
dose
of
medicine
Amaryl
®
M
should
be
determined
by
the
target
glucose
concentration in blood. It is necessary to take the lowest dose that
would be sufficient to achieve
the desired metabolic control.
During treatment with medicine Amaryl
®
M,
concentration of glucose in blood should be
regularly determined. In addition, regular control of percentage of
glycated hemoglobin is also
recommended.
Incorrect administration of the medicine, such as skipping of the next
dose, should never be
replenished by subsequent administration of higher doses.
Actions of the patient in case of mistakes while taking the medicine
(in particular in case of
skipping of the next dose of Amaryl
®
M or skipping of a meal), or in the situations where there is
no possibility to