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GLIMEPIRIDE 3MG TABLETS

Active substance(s): GLIMEPIRIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Glimepiride 1 mg, 2 mg, 3 mg and 4 mg 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 signs of illness 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 (see section 4).

What is in this leaflet:
1. What Glimepiride is and what it is used for
2. What you need to know before you take
Glimepiride
3. How to take Glimepiride
4. Possible side effects
5. How to store Glimepiride
6. Contents of the pack and other information

1

Laboratory Tests
The level of sugar in your blood or urine should
be checked regularly. Your doctor may also take
blood tests to monitor your blood cell levels and
liver function.

What Glimepiride is and what it
is used for

Glimepiride is an orally active blood sugar
lowering drug. This drug belongs to a blood
sugar lowering group of medicines called
sulfonylureas. Glimepiride works by increasing
the amount of insulin released from your
pancreas. The insulin then lowers your blood
sugar levels.

Other medicines and Glimepiride:
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Your doctor may wish to change your dose of
glimepiride if you are taking other medicines,
which may weaken or strengthen the effect of
glimepiride on the level of sugar in your blood.

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

2

The following medicines can increase the blood
sugar lowering effect of glimepiride. This can
lead to a risk of hypoglycaemia (low blood
sugar):
• Other medicines to treat diabetes mellitus
(such as insulin or metformin)
• Medicines to treat pain and inflammation
(phenylbutazone, azopropazone,
oxyphenbutazone, aspirin-like medicines)
• Medicines to treat urinary infections (such
as some long acting sulfonamides)
• Medicines to treat bacterial and fungal
infections (tetracyclines, chloramphenicol,
fluconazole, miconazole, quinolones,
clarithromycin)
• Medicines to inhibit blood clotting (coumarin
derivatives such as warfarin)
• Medicines supporting muscle build up
(anabolics)
• Medicines used for male sex hormone
replacement therapy
• Medicines to treat depression (fluoxetine,
MAO-inhibitors)
• Medicines lowering high cholesterol level
(fibrates)
• Medicines lowering high blood pressure
(ACE inhibitors)
• Medicines called anti-arrhythmic agents used
to control abnormal heart beat
(disopyramide)
• Medicines to treat gout (allopurinol,
probenecid, sulfinpyrazone)
• Medicines to treat cancer
(cyclophosphamide, ifosfamide, trofosfamide)
• Medicines used to reduce weight
(fenfluramine)
• Medicines to increase circulation when
given in a high dose intravenous infusion
(pentoxifylline)
• Medicines to treat nasal allergies such as
hay fever (tritoqualine)
• Medicines called sympatholytics to treat
high blood pressure, heart failure, or prostate
symptoms

What you need to know before
you take Glimepiride

Do not take Glimepiride and tell your doctor if:
• you are allergic (hypersensitive) 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 (type 1) diabetes
• 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.

The following medicines may decrease the
blood sugar lowering effect of glimepiride. This
can lead to a risk of hyperglycaemia (high blood
sugar level):
• Medicines containing female sex hormones
(oestrogens, progestogens)
• Medicines supporting urine production
(thiazide diuretics)
• Medicines used to stimulate the thyroid
gland (such as levothyroxine)
• Medicines to treat allergies and
inflammation (glucocorticoids)
• Medicines to treat severe mental disorders
(chlorpromazine and other phenothiazine
derivatives)
• Medicines used to raise heart beat, to treat
asthma or nasal congestion, coughs and
colds, used to reduce weight, or used in
life-threatening emergencies (adrenaline
and sympathomimetics)
• Medicines to treat high cholesterol level
(nicotinic acid)
• Medicines to treat constipation when they
are used long term (laxatives)
• Medicines to treat seizures (phenytoin)
• Medicines to treat nervousness and sleep
problems (barbiturates)
• Medicines to treat increased pressure in
the eye (azetazolamide)
• Medicines to treat high blood pressure or
low blood sugar (diazoxide)
• Medicines to treat infections, tuberculosis
(rifampicine)
• Medicines to treat severe low blood sugar
levels (glucagon)

Lowering of the haemoglobin level and
breakdown of red blood cells (haemolytic
anemia) 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 in these patients is
not recommended.

Important information about hypoglycaemia
(low blood sugar)
When you take glimepiride, you may get
hypoglycaemia (low blood sugar). Please see
below for additional information about
hypoglycaemia, its signs and treatment.

Following factors could increase the risk of
you getting hypoglycaemia:
• Undernourishment, irregular meal time,
missed or delayed meal or period of fasting
• Changes to your diet
• Taking more glimepiride than needed
• Having decreased kidney function
• Having severe liver disease
• If you suffer from particular hormone-induced
disorders (disorders of the thyroid glands, of
the pituitary gland or adrenal cortex)
• Drinking alcohol (especially when you skip a
meal)
• Taking certain other medicines (See Taking
other medicines below)
• If you increase your body exercise and you
do not eat enough or eat food containing less
carbohydrate than normal

The following medicinal products can increase
or decrease the blood sugar lowering effect of
glimepiride:
• Medicines to treat stomach ulcers (called H2
antagonists)
• Medicines to treat high blood pressure or
heart failure such as beta-blockers,
clonidine, guanethidine and reserpine.
These can also hide the signs of
hypoglycaemia, so special care is needed
when taking these medicines

Signs of hypoglycaemia include:
• Hunger pangs, headache, nausea, vomiting,
sluggishness, sleepiness, disordered sleep,
restlessness, aggression, impaired
concentration, reduced alertness and reaction
time, depression, confusion, speech and
visual disorders, slurred speech, shakiness,
partial paralysis, sensory disturbances,
dizziness, helplessness
• The following signs may also occur:
sweating, clammy skin, anxiety, accelerated
heart beat, high blood pressure, palpitations,
sudden strong pain in the breast that may
radiate into neighbouring areas (angina
pectoris and cardiac arrhythmias).

Glimepiride may either increase or weaken the
effects of the following medicines:
• Medicines inhibiting blood clotting (coumarin
derivatives such as warfarin)
Glimepiride with food and drink:
Alcohol intake may increase or decrease the
blood sugar lowering action of glimepiride in an
unpredictable way.

If blood sugar levels continue to drop you
may suffer from considerable confusion
(delirium), develop convulsions, lose self
control, breathing may be shallow and your
heart beat slowed down, you may fall into
unconsciousness. The clinical picture of a
severe reduced blood sugar level may
resemble that of a stroke.

Pregnancy and breast-feeding:
Glimepiride should not be taken during
pregnancy.

Treating hypoglycaemia:
In most cases the signs of reduced blood sugar
vanish very quickly when you consume some
form of sugar, e.g. sugar cubes, sweet juice,
sweetened tea.
You should therefore always take some form of
sugar with you (e.g. sugar cubes).
Remember that artificial sweeteners are not
effective. Please contact your doctor or go to
the hospital if taking sugar does not help or if
the symptoms recur.

Breast feeding
Glimepiride may pass into breast milk.
Glimepiride should not be taken during breast
feeding.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Continued on the next page >>

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Driving and using machines:
Your ability to concentrate or react may be
impaired if your blood sugar is lowered
(hypoglycaemia), or raised (hyperglycaemia) or
if you develop visual problems as a result of
such conditions. Bear in mind that you could
endanger yourself or others (e.g. when driving a
car or using machines). Please ask your doctor
whether you can drive a car if you:
• have frequent episodes of hypoglycaemia,
• have fewer or no warning signals of
hypoglycaemia

difficulty in breathing, fall in blood pressure
and sometimes progressing to shock. If you
experience any of these symptoms, tell your
doctor immediately
• Abnormal liver function including yellowing of
the skin and eyes (jaundice), impairment of
the bile flow (cholestasis), inflammation of the
liver (hepatitis) or liver failure. If you
experience any of these symptoms, tell your
doctor immediately
• Feeling or being sick, diarrhoea, feeling full or
bloated, and abdominal pain
• Decrease in the amount of sodium level in
your blood (shown by blood tests)

Glimepiride contains lactose.
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicine.

3

Other side effects include:
• Allergy (hypersensitivity) of the skin 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
• Allergic reactions with sulfonylureas,
sulfonamides, or related drugs may occur
• Problems with your sight may occur when
beginning treatment with glimepiride. This is
due to changes in blood sugar levels and
should soon improve.
• Increased liver enzymes
• Severe unusual bleeding or bruising under
the skin

How to take Glimepiride

Always take glimepiride exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.

Taking this medicine
• Take this medicine by mouth, just before or
with the first main meal of the day (usually
breakfast). If you do not have breakfast you
should take the product on schedule as
prescribed by your doctor. It is important not
to leave out any meal when you are on
glimepiride
• Swallow the tablets whole with at least half
glass of water. Do not crush or chew the
tablets

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet You can also
report side effects directly via Yellow Card
Scheme: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

How much to take
The dose of glimepiride depends on your needs,
condition and results of blood and urine sugar
tests and is determined by your doctor. Do not
take more tablets than your doctor has
prescribed.
• The usual starting dose is one glimepiride
1 mg tablet once a day
• If necessary, your doctor may increase the
dose after each 1 - 2 weeks of treatment
• The maximum recommended dose is 6 mg
per day
• A combination therapy of glimepiride plus
metformin or of glimepiride plus insulin may
be initiated. In such a case your doctor will
determine the proper doses of glimepiride,
metformin or insulin individually for you
• If your weight changes or if you change your
lifestyle, or you are in a stress situation this
may require changed glimepiride doses,
therefore inform your doctor
• If you feel the effect of your medicine is too
weak or too strong do not change the dose
yourself, but ask your doctor

5

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date
which is stated on the carton after EXP. The
expiry date refers to the last day of that
month.
• Do not store above 25°C.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.

6

If you take more Glimepiride than you
should:
If you happen to have taken too much
glimepiride or an additional dose there is a
danger of hypoglycaemia (signs of
hypoglycaemia see Section 2 - Take special
care) and therefore you should instantly
consume enough sugar (e.g. a small bar of
sugar cubes, sweet juice, sweetened tea) and
inform a doctor immediately. When treating
hypoglycaemia due to accidental intake in
children, the quantity of sugar given must be
carefully controlled to avoid the possibility of
producing dangerous hyperglycaemia.
Persons in a state of unconsciousness must not
be given food or drink.
Since the state of hypoglycaemia may last for
some time it is very important that the patient is
carefully monitored until there is no more
danger. Admission into hospital may be
necessary, also as a measure of precaution.
Show the doctor the package or remaining
tablets, so the doctor knows what has been
taken.
Severe cases of hypoglycaemia 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.

Contents of the pack and other
information

What Glimepiride contains
The active substance is glimepiride. One tablet
contains 1 mg, 2 mg, 3 mg or 4 mg glimepiride.
The other ingredients are:
• 1 mg tablet: Lactose monohydrate, sodium
starch glycollate (type A), povidone K30, iron
oxide red (E172), microcrystalline cellulose,
magnesium stearate.
• 2 mg tablet: Lactose monohydrate, sodium
starch glycollate (type A), povidone K30, iron
oxide yellow (E172), indigo carmine (E132),
microcrystalline cellulose, magnesium
stearate.
• 3 mg tablet: Lactose monohydrate, sodium
starch glycollate (type A), povidone K30, iron
oxide yellow (E172), microcrystalline
cellulose, magnesium stearate
• 4 mg tablet: Lactose monohydrate, sodium
starch glycollate (type A), povidone K30,
indigo carmine (E132), microcrystalline
cellulose, magnesium stearate

What Glimepiride looks like and contents of
the pack
• 1 mg tablet: Pink, slightly mottled, oblong, flat,
bevelled edge tablet scored on both sides
with the embossment ‘G1’ on one side
• 2 mg tablet: Green, slightly mottled, oblong,
flat, bevelled edge tablet scored on both sides
with the embossment ‘G2’ on one side
• 3 mg tablet: Light yellow, slightly mottled,
oblong, flat, bevelled edge tablet scored on
both sides with the embossment ‘G3’ on one
side
• 4 mg tablet: Blue, slightly mottled, oblong,
flat, bevelled edge tablet scored on both sides
with the embossment ‘G4’ on one side

If you forget to take Glimepiride:
If you forget to take a dose, do not take a
double dose to make up for forgotten doses.

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. Keep taking glimepiride until
your doctor tells you to stop.

Transparent PVC/PE/PVDC//Aluminium blister:
7, 14, 15, 28, 30, 56, 60, 90, 98, 100, 120, 180,
200 and 100x1 tablets.
White PP-tablet container with LDPE or
MDPE-lid: 100 and 250 tablets.

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4

How to store Glimepiride

Not all pack sizes may be marketed.

Possible side effects

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately if you
experience any of the following symptoms:
• Allergic reactions (including 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
• Abnormal liver function including yellowing of
the skin and eyes (jaundice), problems with
the bile flow (cholestasis), inflammation of the
liver (hepatitis) or liver failure
• Allergy (hypersensitivity) of the skin such as
itching, rash, hives and increased sensitivity
to sun. Some mild allergic reactions may
develop into serious reactions
• Severe hypoglycaemia including loss of
consciousness, seizures or coma

Manufacturer:
Lek Pharmaceuticals d.d., Verovśkova 57,
1526 Ljubljana, Slovenia or
Sandoz GmbH, Biochemiestrasse 10,
6250 Kundl, Austria or

LEK S.A., Ul. Podlipie 16, 95-010 Stryków,
Poland or
LEK S.A., Ul. Domaniewska 50 C,
02-672 Warsaw, Poland.

This leaflet was last revised in 03/2016

Some patients experienced the following side
effects whilst taking glimepiride:

Rare side effects (may affect up to 1 in 1,000
people)
• Lower blood sugar than normal
(hypoglycaemia) (See Section 2)
• Decrease in the number of blood cells:
- Blood platelets (which increases risk of
bleeding or bruising)
- White blood cells (which makes infections
more likely)
- Red blood cells (which can make the skin
pale and cause weakness or
breathlessness)
These problems generally get better after
you stop taking glimepiride.
Very rare side effects (may affect up to 1 in
10,000 people)
• Allergic reactions (including inflammation of
blood vessels, often with skin rash) which
may develop into serious reactions with

SZ00000LT000

Artwork Proof Box
Ref: P001: Noti fication article 61 (3) to align the PIL to the SmPC.
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Date prepared:
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Colours:
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Dimensions: 145 x 560 mm

Font size:
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Fonts:
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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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