Glimepiride 4mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Glimepiride

Dostupné z:

Sandoz Ltd

ATC kód:

A10BB12

INN (Medzinárodný Name):

Glimepiride

Dávkovanie:

4mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 06010201

Príbalový leták

Glimepiride is an orally active blood sugar
lowering medicine. This medicine belongs to a
blood sugar lowering group of medicines called
sulphonylureas. Glimepiride works by increasing
the amount of insulin released from your
pancreas. The insulin then lowers your blood
sugar levels.
WHAT GLIMEPIRIDE IS USED FOR
•
Glimepiride 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
DO NOT TAKE GLIMEPIRIDE AND TELL YOUR DOCTOR IF
•
you are allergic to glimepiride or other
sulphonylureas (medicines used to lower your
blood sugar such as glibenclamide) or
sulphonamides (medicines for bacterial
infections such as sulphamethoxazole) or any
of the other ingredients of this medicine
(listed in section 6),
•
you have diabetes mellitus type 1,
•
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 disease
•
you have a severe liver disease,
Do not take this medicine if any of the above
applies to you. If you are not sure, talk to your
doctor or pharmacist before taking glimepiride.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE
TAKING GLIMEPIRIDE IF
•
You are recovering from an injury, operation,
infections with fever, or from other forms of
stress, inform your doctor as temporary
change of treatment may be necessary
•
You have a severe liver or kidney disorder
If you are not sure if any of these apply to you,
talk to your doctor or pharmacist before taking
glimepiride.
Lowering of the haemoglobin level and
breakdown of red blood cells (haemolytic
anaemia) can occur in patients missing the
enzyme glucose-6-phosphate dehydrogenase.
The information available on the use of
glimepiride in people under 18 years of age is
limited. Therefore, its use

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glimepiride 4 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg of glimepiride.
Excipient with known effect
Each tablet contains 135.1 mg of lactose (as monohydrate).For the full
list of
excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Blue, slightly mottled, oblong, flat, bevelled edge tablet scored on
both sides
with the embossment ‘G4’ on one side
The tablet can be divided into equal doses. Where a lower tablet
strength is
available this should be used instead.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glimepiride 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
Posology
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.
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, 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 combinati