GLIMEPIRIDE 2 MG TABLETS

Active substance: GLIMEPIRIDE

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PAGE 4: AFTER FOLDING REAR FACE (OUTSIDE OF REEL AFTER FOLDING AND TACKING)

of consciousness, seizures or coma.
Some patients experienced the
following side effects whilst taking
Glimepiride:
Rare side effects

5 HOW TO STORE GLIMEPIRIDE
Keep out of the reach and sight of
children. Do not store above 25°C. Do
not use Glimepiride after the expiry
date which is stated on the outer
packaging.
Medicines should not be disposed of
via waste water or household waste.

medicines no longer required. These
(hypoglycaemia) (See Section 2 - Take measures will help to protect the
special care with Glimepiride)
environment.
cells:
of bleeding or bruising)

6 FURTHER INFORMATION
What Glimepiride contains:

infections more likely)
skin pale and cause weakness or
breathlessness).
These problems generally get better
after you stop taking Glimepiride.
Very rare side effects

level in your blood (shown by blood
tests).
Other side effects include:
may occur such as itching, rash, hives
and increased sensitivity to sun.
Some mild allergic reactions may
develop into serious reactions with
swallowing or breathing problems,
swelling of your lips, throat or tongue.
Therefore in the event of one of these
side effects, tell your doctor
immediately
sulfonamides, or related drugs may
occur
when beginning treatment with
Glimepiride. This is due to changes in
blood sugar levels and should soon
improve

GLIMEPIRIDE
1, 2, 3, AND 4 mg TABLETS

Read all of this leaflet carefully before
you start taking this medicine.
read it again.
doctor or pharmacist.
you. Do not pass it on to others. It
may harm them, even if their
symptoms are the same as yours.
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

monohydrate, sodium starch
glycolate, povidone, microcrystalline
cellulose, magnesium stearate and
the following colouring agents:

green, round tablets, bisected on both
debossed with “9” on one side of the
side of the tablet is debossed with
“55” on the other
yellow to yellow, round tablets,
the tablet is debossed with “G” on
other.
light blue, round tablets, bisected on
debossed with “9” on one side of the
side of the tablet is debossed with
“56” on the other
tablets.
Not all pack sizes may be marketed.

If any of the side effects gets serious, or Marketing Authorisation Holder and
if you notice any side effects not listed manufacturer
in this leaflet, please tell your doctor or
company responsible for manufacture:
pharmacist.
This leaflet was last revised: October 2012

sugar levels determined regularly as
prescribed by your doctor.
In the first few weeks of treatment the
risk of having reduced blood sugar
levels (hypoglycaemia) may be
increased, therefore it is vital that you
are carefully monitored by your doctor.
Reduced blood sugar may occur if:
meals altogether

and your carbohydrate intake is not
increased to match this
combination with skipped meals
remedies at the same time

4 mg of glimepiride

inflammation of blood vessels, often
with skin rash) which may develop
into serious reactions with difficulty in
breathing, fall in blood pressure and
sometimes progressing to shock. If you What Glimepiride looks like and
experience any of these symptoms, tell contents of the pack:
your doctor immediately
pink, round tablets, bisected on both
yellowing of the skin and eyes
(jaundice), impairment of the bile flow debossed with “9” on one side of the
(cholestasis), inflammation of the liver
(hepatitis) or liver failure. If you
on one side of the score and “54” on
experience any of these symptoms,
the other
tell your doctor immediately
feeling full or bloated, and abdominal
pain

PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)

1. What Glimepiride is and what it is
used for
2.Before you take Glimepiride
3.How to take Glimepiride
4.Possible side effects
5.How to store Glimepiride
6.Further information

1 WHAT GLIMEPIRIDE IS AND
WHAT IT IS USED FOR

blood sugar levels (antidiabetic
medicine taken orally).

hormone-induced disorders
(functional disorders of the thyroid
gland, of the pituitary gland or
adrenal cortex)
decreased
given by your doctor or in this patient
package leaflet.
Please inform your doctor of such risks
so that he/she can either adjust the
dosage of Glimepiride or revise the
entire treatment plan to change it where
necessary.

of diabetes (type 2 diabetes mellitus),
when diet, exercise and weight loss
alone do not have an adequate effect. If you suffer from low blood sugar
(hypoglycaemia) you may have the
2 BEFORE YOU TAKE GLIMEPIRIDE following signs:
headache, hunger, exhaustion, nausea,
Do not take Glimepiride
vomiting, weariness, sleepiness, sleep
disorders, restlessness, aggressiveness,
glimepiride or other drugs of the
impaired concentration, reduced
same group (sulfonylureas and
alertness and reaction time, depression,
sulfonamides) or one of the other
confusion, speech and visual disorders,
ingredients of Glimepiride tablets
difficulty using or understanding
language (aphasia), shaking, slight
severely impaired
paralysis, sensory disturbances,
dizziness, and helplessness.
diabetes
The following signs may also occur:
sweating, clammy skin, anxiety,
complication of diabetes with rapid
accelerated heart beat, high blood
weight loss, nausea or vomiting)
pressure, a feeling of an abnormally
strong or irregular heartbeat
consciousness due to a strongly
(palpitations), sudden strong pain in the
increased blood sugar level (diabetic breast that may radiate into
coma).
neighbouring areas (angina pectoris),
and cardiac arrhythmias.
In cases of severe renal or hepatic
If blood sugar levels continue to drop
functional disorders, a change-over to
you may suffer from considerable
insulin is required.
confusion (delirium), develop cerebral
Take special care with Glimepiride
convulsions, lose self control, breathing
During Glimepiride treatment regular
may be shallow and your heart beat
monitoring of your blood sugar level is slowed down, you may fall into
necessary. Your doctor may also take
unconsciousness. The symptoms of a
blood tests to monitor your blood cell
severe reduced blood sugar level may
levels and liver function.
resemble that of a stroke.
You should observe the treatment plan In most cases the signs of reduced
prescribed by your doctor to achieve
blood sugar vanish very quickly when
proper blood sugar levels. This means
you consume some form of sugar, e.g.
that, apart from regular tablet intake,
grape sugar, sugar cubes, sweet juice,
you observe the dietary regimen, have sweetened tea.
physical exercise and, where necessary,
have your blood (and possibly urine)

Top of page cut-off to middle of registration mark = 44 mm

Some mild allergic reactions may
develop into serious reactions

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PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

You should therefore always take some
form of sugar with you (grape sugar,
sugar cubes). Remember that
sweeteners are not effective. Please
contact your doctor or the next hospital
if taking sugar does not help or if the
symptoms recur.
Signals of reduced blood sugar may be
absent or less pronounced or develop
very slowly. You are not aware in time
that your blood sugar level has
dropped. This may happen in elderly
patients taking certain medicinal
products (e.g. those acting on the
central nervous system and
betablockers). It may also happen when
you suffer from certain disorders of the
endocrine system (e.g. certain disorders
of thyroid function and anterior
pituitary or adreneocortical
insufficiency). Impaired liver function
may affect counter regulation.
In stress-situations (e.g. accidents,
acute operations, infections with fever,
etc.) a temporary switch to insulin may
be indicated.
Signs of raised blood sugar
(hyperglycaemia) - this may occur when
Glimepiride has not yet sufficiently
reduced the blood sugar, when you
have not complied with the treatment
plan prescribed by your doctor or in
special stress situations) may include
thirst, frequent urination, dry mouth
and dry itching skin, fungal or skin
infections and reduced performance.
In such a case, you must contact your
doctor.
If you have a deficiency in the enzyme
glucose-6-phosphate dehydrogenase,
or G6PD, glimepiride could cause a
decrease in your blood haemoglobin
levels, which might lead to low red
blood cell levels (haemolytic anaemia).
You should tell your doctor if you have
G6PD deficiency.
Children and adolescents
There is not enough information on
efficacy and safety of glimepiride in
children and adolescents. Glimepiride
tablets are not recommended in
children and adolescents.
Taking other medicines
The activity and safety of this treatment
may be affected if this medicine is taken
at the same time as certain other
medicines. Conversely, other medicines
may be affected if they are taken at the
same time as Glimepiride. Consult your
doctor before you start taking another
medicinal product.
The blood sugar lowering effect of
Glimepiride may be strengthened and
signs of low blood sugar levels may occur
when one of the following drugs is taken:
insulin
clarithromycin, quinolones,
tetracyclines, sulfonamides)
(pyrazolone-derivates, e.g.
phenylbutazone, azapropazone,
oxyfenbutazone)

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PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

Taking Glimepiride with food and drink
(p-amino-salicylic acid)
(anabolics and male sex hormones)
(coumarin)
(miconazol, fluconazole)
betablockers, sympatholytics)
mood/antidepressants (fluoxetine,
(fenfluramine)
in the blood (fibrates)
(cyclo- tro- and iphosphamides)
Products to treat allergies (tritoqualine)
increase blood flow (pentoxiphylline)
allopurinol, sulphinpyrazone)
irregular heart rhythm.
The blood glucose lowering effect of
Glimepiride may be weakened and raised
blood sugar levels may occur when one
of the following drugs is taken:
and progestagens)
(saluretics, thiazide diuretics)
(glucocorticoids)
schizophrenia (phenytoin,
phenothiazine derivates)
(diazoxide)
(rifampicin)
(glucagon)
(acetazolamide)
(adrenaline and sympathicomimetics)
Products lowering increased fat levels
in the blood (nicotinic acid derivatives)
evacuation (laxatives).
Products to treat ulcers in the stomach
or duodenum (H2 receptor-antagonists)
or blood pressure lowering products
(betablockers, clonidine and reserpine)
may either strengthen or weaken the
blood sugar lowering effect of
Glimepiride.
Medicinal products with effects on the
central nervous system (betablockers,
clonidine, guanethidine or reserpine)
may mask or totally suppress the signs
of reduced blood sugar.
Glimepiride may either strengthen or
weaken the effect of products inhibiting
blood clotting (coumarin derivatives).
Please tell your doctor if you are taking
or have recently taken any other
medicines, including medicines
obtained without a prescription.

doctor has told you. You should check
with your doctor or pharmacist if you
are not sure.
Please speak with your doctor or
Pregnancy
pharmacist if you have the impression
Glimepiride must not be taken during
pregnancy. If pregnancy is planned you that Glimepiride is acting too strongly
should discuss the treatment plan with or not strongly enough.
your doctor. If you become pregnant
If you take more Glimepiride than you
during Glimepiride treatment you
should
should inform your doctor immediately. If you happen to have taken too much
Glimepiride or an additional dose there
Breast-feeding
Glimepiride may pass into breast milk. is a danger of low sugar levels, (for
signs of hypoglycaemia see section 2)
Glimepiride must not be taken during
and therefore you should instantly
breast-feeding.
consume enough sugar (e.g. a small bar
Driving and using machines
of grape sugar cubes, sugar cubes,
Your ability to concentrate or react may sweet juice, sweetened tea) and inform
be impaired if your blood sugar is
a doctor immediately. The same should
lowered (hypoglycaemia), or raised
be done if somebody, e.g. a child, has
(hyperglycaemia) or if you develop
taken the product unintentionally.
visual problems as a result of such
Persons in a state of unconsciousness
conditions. Bear in mind that you could must not be given food or drink.
endanger yourself or others (e.g. when Since the state of low sugar levels may
driving a car or using machines). Please last for some time it is very important
ask your doctor whether you can drive that the patient is carefully monitored
a car if you:
until there is no more danger.
ability of Glimepiride to reduce blood
sugar in an unpredictable manner.

hypoglycaemia
hypoglycaemia.
Important information about some of
the ingredients of Glimepiride
This medicinal product contains
lactose. If you have been told by your
doctor that you have an intolerance to
some sugars, contact your doctor
before taking this medicinal product.

3 HOW TO TAKE GLIMEPIRIDE
Dosage
The dose is fixed by the doctor,
depending on your blood and urine
sugar levels.
Change in external factors (e.g. weight
reduction, change in life style, stress) or
improvements in the disease may
require changed Glimepiride doses.

necessary, also as a measure of
precaution. Severe cases of low blood
sugar accompanied by loss of
consciousness and severe neurological
failure are cases of medical emergency
requiring immediate medical treatment
and admission into hospital. It should
be ensured that there is always a
pre-informed person that can call a
doctor in case of emergency.
If you forget to take Glimepiride
If you forget to take a dose, do not take
the missed dose, just take the next dose
on time. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Glimepiride
If you interrupt or stop the treatment
you should be aware that the desired
blood sugar lowering effect is not
achieved or that the disease will
deteriorate again. If any change is
necessary it is absolutely important for
you to contact your doctor first.

of Glimepiride per day. If good blood
sugar control is achieved the dosage
should be used for maintenance therapy.
4 POSSIBLE SIDE EFFECTS
Doses of more than 4 mg of Glimepiride
per day give better results only in
exceptional cases. The maximum
recommended dose is 6 mg Glimepiride cause side effects, although not
everybody gets them.
per day.
Tell your doctor immediately if you
plus metformin, or of Glimepiride plus experience any of the following
insulin may be initiated. In such a case symptoms:
your doctor will determine the proper
inflammation of blood vessels, often
doses of Glimepiride, metformin or
with skin rash) which may develop
insulin individually for you.
into serious reactions with difficulty in
Glimepiride must be swallowed with at
breathing, fall in blood pressure and
least half a glass of water. Usually the
sometimes progressing to shock
entire daily dose is taken all at once
directly before or during a substantial
yellowing of the skin and eyes
breakfast. If you do not have breakfast
(jaundice), problems with the bile
you should take the product on
flow (cholestasis), inflammation of the
schedule as prescribed by your doctor.
liver (hepatitis) or liver failure
It is important not to leave out any meal
when you are on Glimepiride.
such as itching, rash, hives and
increased sensitivity to sun.

GLIMEPIRIDE 1, 2, 3 AND 4 mg TABLETS

Glimepiride UK
280x160 mm Side B

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this
medicine.

IN THIS LEAFLET:
1. What Glimepiride is and what it is used for
2. Before you take Glimepiride
3. How to take Glimepiride
4. Possible side effects
5. How to store Glimepiride
6. Further information

1

WHAT GLIMEPIRIDE IS AND WHAT IT IS USED FOR

2

BEFORE YOU TAKE GLIMEPIRIDE

Taking other medicines

Do not take Glimepiride

Take special care with Glimepiride

886
low blood sugar (hypoglycaemia)

Taking Glimepiride with food and drink

886

Children and adolescents

Pregnancy

Glimepiride UK
280x160 mm Side B

Rare side effects
Breast-feeding

Driving and using machines

Very rare side effects

tell your doctor immediately

Important information about some of the ingredients of
Glimepiride
lactose

tell your doctor
immediately

3

HOW TO TAKE GLIMEPIRIDE

Dosage

886

Other side effects include:

tell your doctor immediately

5

HOW TO STORE GLIMEPIRIDE

Keep out of the reach and sight of children.

886
If you take more Glimepiride than you should

6

FURTHER INFORMATION

What Glimepiride contains:

What Glimepiride looks like and contents of the pack:

If you forget to take Glimepiride

If you stop taking Glimepiride

4

POSSIBLE SIDE EFFECTS

Tell your doctor immediately if you experience any of the
following symptoms:
Marketing Authorisation Holder and manufacturer

This leaflet was last revised: October 2012

322K005331112

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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