AMARYL 2 MG TABLET 2.0mg Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GLIMEPIRIDE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

INN (International Name):

GLIMEPIRIDE

Dosage:

2.0mg Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
IS THIS LEAFLET HARD TO SEE OR READ?
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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
6. 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 y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amaryl 2 mg tablet.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg glimepiride.
Excipients: also contains 137.2 mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
The tablets are green, 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.
In patients not adequately controlled with the maximum daily dose of metformin, concomitant glimepiride therapy can
be initiated.
While maintaining the metformin dose, the glimepiride therapy is started with a low dose, and is then titrated up
dependin