Amaryl 3 mg tablet

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Glimepiride

Disponibil de la:

Sanofi-Aventis Ireland Limited T/A SANOFI

Codul ATC:

A10BB; A10BB12

INN (nume internaţional):

Glimepiride

Dozare:

3 milligram(s)

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Sulfonamides, urea derivatives; glimepiride

Statutul autorizaţiei:

Marketed

Data de autorizare:

1996-11-29

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMARYL 1MG TABLETS
AMARYL 3MG TABLETS _GLIMEPIRIDE _
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
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
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet.
IN THIS LEAFLET:
1.
What Amaryl is and what it is used for
2.
What you need to know before you take Amaryl
3.
How to take Amaryl
4.
Possible side effects
5.
How to store Amaryl
Contents of the pack and other information
1.
WHAT AMARYL IS AND WHAT IT IS USED FOR
Amaryl is an orally active blood sugar lowering medicine. This
medicine belongs to a blood sugar
lowering group of medicines called sulfonylurea. Amaryl works by
increasing the amount of insulin
released from your pancreas. The insulin then lowers your blood sugar
levels.
WHAT AMARYL IS USED FOR:
Amaryl is used to treat a certain form of diabetes (type 2 diabetes
mellitus) when diet, physical
exercise and weight reduction alone have not been able to control your
blood sugar levels
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMARYL
DO NOT TAKE AMARYL AND TELL YOUR DOCTOR IF:
.
You are allergic to: glimepiride or other sulfonylureas (medicines
used to lower your blood
sugar such as glibenclamide) or sulfonamides (medicines for bacterial
infections such as
sulfamethoxazole) or any of the other ingredients of this medicine
(listed in section 6)
.
You have insulin dependent diabetes (type 1 diabetes mellitus)
.
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

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amaryl 3 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3 mg glimepiride.
Excipients: also contains 137.0 mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
The tablets are pale yellow, oblong and scored on both sides.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amaryl
is indicated for the treatment
of type 2 diabetes mellitus,
when diet,
physical
exercise and weight
reduction
alone are not adequate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
The basis for successful treatment of diabetes is a good diet, regular
physical activity, as well as routine checks of
blood and urine. Tablets or insulin cannot compensate if the patient
does not keep to the recommended diet.
Posology
Dose is determined by the results of blood and urinary glucose
determinations.
The starting dose is 1 mg glimepiride per day. If good control is
achieved this dose should be used for maintenance
therapy.
For the different dose regimens appropriate strengths are available.
If control is unsatisfactory the dose should be increased, based on
the glycaemic control, in a stepwise manner with an
interval of about 1 to 2 weeks between each step, to 2, 3 or 4 mg
glimepiride per day.
A dose of more than 4 mg glimepiride per day gives better results only
in exceptional cases. The maximum
recommended dose is 6 mg glimepiride per day.
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