Amaryl 1mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Glimepiride

Verfügbar ab:

Zentiva Pharma UK Ltd

ATC-Code:

A10BB12

INN (Internationale Bezeichnung):

Glimepiride

Dosierung:

1mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 06010201; GTIN: 5013841201760

Gebrauchsinformation

PACKAGE LEAFLET:
INFORMATION FOR THE USER
AMARYL 1MG, 2MG, 3MG AND 4MG TABLETS
glimepiride
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.
WHAT IS 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 a medicine taken by mouth to help lower blood sugar. It
belongs to a group of
medicines called sulfonylureas.
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 sulphonamides (medicines for bacterial
infections such as
sulfamethoxazole) or any of the other ingredients of this medicine
(listed in section 6)
•
You have Diabetes mellitus type I
•
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)
•
You are in a diabetic coma
•
You have severe kidney

Fachinformation

AMARYL 1MG TABLETS
Summary of Product Characteristics Updated 06-Nov-2013 | Zentiva
1. Name of the medicinal product
Amaryl 1 mg, tablet
2. Qualitative and quantitative composition
[Each tablet contains 1 mg glimepiride.]
Excipients: also contains 69.0 mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
The tablets are pink, 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 depending on the desired level of metabolic control up to
the maximum daily dose. The
combination therapy should be initiated under close medical
supervision.
In patients not adequately controlled with the maxim