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GLIMEPIRIDE 2MG TABLETS

Active substance: GLIMEPIRIDE

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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.
The name of your medicine is Amaryl 1mg, 2mg, 3mg and
4mg tablets but it will be referred as Amaryl throughout 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 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 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 apply to you. If
you are not sure, talk to your doctor or pharmacist before
taking Amaryl.
Warnings and precautions
Talk to your doctor or pharmacist before taking your
medicine 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 Amaryl.
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 Amaryl 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 Amaryl, 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 Amaryl than needed
• Having kidneys that do not work properly
• 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 below “Other
medicines and Amaryl”)
• If you increase the amount of exercise you do and you
don't eat enough food or eat food containing less
carbohydrate than usual.
Signs of hypoglycaemia include:
• Hunger pangs, headache, nausea, vomiting,
sluggishness, sleepiness, problems sleeping,
restlessness, aggression, problems with concentration,
reduced alertness and reaction time, depression,
confusion, problems with your speech and sight, slurred
speech, shakiness, partial paralysis, dizziness,
helplessness



The following signs may also occur: sweating, clammy
skin, anxiety, fast or increased heart beat, high blood
pressure, awareness of your heart beat, sudden strong
pain in the breast that may radiate into neighbouring
areas (angina pectoris and cardiac arrhythmias).

If blood sugar levels continue to drop you may suffer from
considerable confusion (delirium), develop fits, 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.
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.
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.
Children and adolescents
Amaryl is not recommended for use in children under 18
years of age.
Other medicines and Amaryl
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 Amaryl if
you are taking other medicines, which may weaken or
strengthen the effect of Amaryl on the level of sugar in your
blood.
The following medicines can increase the blood sugar
lowering effect of Amaryl. 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
The following medicines may decrease the blood sugar
lowering effect of Amaryl. This can lead to a risk of
hyperglycaemia (high blood sugar level):
• Medicines containing female sex hormones (oestrogens,
progestogens)
• Medicines to treat high blood pressure called thiazide
diuretics (water tablets)
• 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 fits (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 lowering blood
sugar (diazoxide)
• Medicines to treat infections, tuberculosis (rifampicine)
• Medicines to treat severe low blood sugar levels
(glucagon)
The following medicines can increase or decrease the blood
sugar lowering effect of Amaryl:
• 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.
Amaryl may either increase or weaken the effects of the
following medicines:
• Medicines inhibiting blood clotting (coumarin derivatives
such as warfarin)

Amaryl with food, drink and alcohol
Alcohol intake may increase or decrease the blood sugar
lowering action of Amaryl in an unpredictable way.
Pregnancy and breast-feeding
Pregnancy
Amaryl should not be taken during pregnancy. Tell your
doctor if you are, you think you might be or are planning to
become pregnant.
Breast-feeding
Amaryl may pass into breast milk. Amaryl should not be taken
during breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Your ability to concentrate or react may be reduced 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
Amaryl contains lactose
If you have been told by your doctor that you cannot tolerate
some sugars, contact your doctor before taking this medicine.

3. How to take Amaryl
Always take this medicine exactly as your doctor has told you.
You should 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 medicine on schedule
as prescribed by your doctor. It is important not to leave
out any meal when you are on Amaryl
• Swallow the tablets with at least half glass of water. Do
not crush or chew the tablets.
How much to take
The dose of Amaryl 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 Amaryl 1mg tablet once a
day
• If necessary, your doctor may increase the dose after
each 1 - 2 weeks of treatment
• The maximum recommended dose is 6mg Amaryl per day
• A combination therapy of glimepiride plus metformin or of
glimepiride plus insulin may be started. In such a case
your doctor will determine the proper doses of glimepiride,
metformin or insulin individually for you
• Your dose of Amaryl may need to be adjusted if you
change weight, change your lifestyle, or if you are under
a lot of stress. Please speak to your doctor if any of these
situations apply to you.
• If you feel the effect of your medicine is too weak or too
strong do not change the dose yourself, but ask your
doctor.
If you take more Amaryl than you should
If you happen to have taken too much Amaryl or an
additional dose there is a danger of hypoglycaemia (signs
of hypoglycaemia see section 2) 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 coma are cases of medical emergency
requiring immediate medical treatment and admission into
hospital. It may be helpful to tell your family and friends to call
a doctor immediately if this happens to you.
If you forget to take Amaryl
If you forget to take a dose, do not take a double dose to
make up for forgotten doses.
If you stop taking Amaryl
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 get worse again. Keep taking Amaryl until
your doctor tells you to stop.
If you have any further questions on the use of this
product, ask your doctor or pharmacist

4. Possible side effects
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

Some patients experienced the following side effects whilst
taking Amaryl:
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
Amaryl
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 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)
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 medicines may occur
• Problems with your sight may occur when beginning
treatment with Amaryl. This is due to changes in blood
sugar levels and should soon improve
• Increased liver enzymes
• Severe unusual bleeding or bruising under the skin
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

5. How to store Amaryl
Keep out of the sight and reach of children.
Do not use Amaryl after the expiry date which is stated after
‘Exp’ on the blister and carton. The expiry date refers to the
last day of that month.
Amaryl 1mg, 2mg, 3mg, and 4mg tablets: do not store above
30°C.
Store in the original package in order to protect from moisture.
Do not use Amaryl if you notice visible signs of deterioration.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Contents of the pack and other information
What Amaryl contains
• The active substance is glimepiride. Each tablet contains
1mg, 2mg, 3mg or 4mg of glimepiride depending on the
strength indicated on the blister and carton
• Each tablet also contains lactose, sodium starch glycollate,
magnesium stearate, microcrystalline cellulose and
povidone 25000.
• In addition the tablets contain the following colouring
agents:
Amaryl 1mg Tablets: red iron oxide (E172)
Amaryl 2mg Tablets: yellow iron oxide (E172), indigocarmine aluminium lake (E132)
Amaryl 3mg Tablets: yellow iron oxide (E172)
Amaryl 4mg Tablets: indigo-carmine aluminium lake
(E132)
What Amaryl looks like and contents of the pack
1mg tablets are pink, eight-shaped tablets, scored on both
sides and marked with ‘NMK’ and a logo
2mg tablets are green, eight-shaped tablets, scored on both
sides and marked with ‘NMM’ and a logo
3mg tablets are pale yellow, eight-shaped tablets, scored on
both sides and marked with ‘NMN’ and a logo
4mg tablets are pale blue, eight-shaped tablets, scored on
both sides and marked with ‘NMO’ and a logo
They are supplied in blister pack 30 tablets.
Manufactured by:
- Sanofi-Aventis Deutschland GmbH, Industriepark Hochst,
Bruningstrasse 50, D-65926 Frankfurt am Main, Germany
- Sanofi-Aventis S.p.A., Strada Stratale 17, Km 22, 67019
Scoppito (L’Aquila), Italy
- Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel,
37100 Tours, France.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU
Amaryl 1mg Tablets:
Amaryl 2mg Tablets:
Amaryl 3mg Tablets:
Amaryl 4mg Tablets:

PL No:
PL No:
PL No:
PL No:

18799/1189
18799/1190
18799/1191
18799/1192

Leaflet date: 09.08.2013
Amaryl is a registered trade mark of Sanofi Aventis

POM

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Glimepiride 1mg, 2mg, 3mg and 4mg
tablets



The following signs may also occur: sweating, clammy
skin, anxiety, fast or increased heart beat, high blood
pressure, awareness of your heart beat, sudden strong
pain in the breast that may radiate into neighbouring
areas (angina pectoris and cardiac arrhythmias).

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.
The name of your medicine is Glimepiride 1mg, 2mg, 3mg
and 4mg tablets but it will be referred as Glimepiride
throughout this leaflet.

If blood sugar levels continue to drop you may suffer from
considerable confusion (delirium), develop fits, 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.

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

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.

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.

Children and adolescents
Glimepiride is not recommended for use in children under 18
years of age.

1. What Glimepiride is and what it is used for
Glimepiride is a medicine taken by mouth to help lower blood
sugar. It belongs to a 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.
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. What you need to know before you take
Glimepiride
Do not take Glimepiride 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 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 apply 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 your
medicine 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 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 kidneys that do not work properly
• 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 below “Other
medicines and Glimepiride”)
• If you increase the amount of exercise you do and you
don't eat enough food or eat food containing less
carbohydrate than usual.
Signs of hypoglycaemia include:
• Hunger pangs, headache, nausea, vomiting,
sluggishness, sleepiness, problems sleeping,
restlessness, aggression, problems with concentration,
reduced alertness and reaction time, depression,
confusion, problems with your speech and sight, slurred
speech, shakiness, partial paralysis, dizziness,
helplessness

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.
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
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 to treat high blood pressure called thiazide
diuretics (water tablets)
• 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 fits (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 lowering blood
sugar (diazoxide)
• Medicines to treat infections, tuberculosis (rifampicine)
• Medicines to treat severe low blood sugar levels
(glucagon)
The following medicines 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.
Glimepiride may either increase or weaken the effects of the
following medicines:
• Medicines inhibiting blood clotting (coumarin derivatives
such as warfarin)


Glimepiride with food, drink and alcohol
Alcohol intake may increase or decrease the blood sugar
lowering action of Glimepiride in an unpredictable way.
Pregnancy and breast-feeding
Pregnancy
Glimepiride should not be taken during pregnancy. Tell your
doctor if you are, you think you might be or are planning to
become pregnant.
Breast-feeding
Glimepiride may pass into breast milk. Glimepiride should not
be taken during breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Your ability to concentrate or react may be reduced 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
Glimepiride contains lactose
If you have been told by your doctor that you cannot tolerate
some sugars, contact your doctor before taking this medicine.

3. How to take Glimepiride
Always take this medicine exactly as your doctor has told you.
You should 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 medicine on schedule
as prescribed by your doctor. It is important not to leave
out any meal when you are on Glimepiride
• Swallow the tablets with at least half glass of water. Do
not crush or chew the tablets.
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 1mg tablet
once a day
• If necessary, your doctor may increase the dose after
each 1 - 2 weeks of treatment
• The maximum recommended dose is 6mg Glimepiride
per day
• A combination therapy of glimepiride plus metformin or of
glimepiride plus insulin may be started. In such a case
your doctor will determine the proper doses of glimepiride,
metformin or insulin individually for you
• Your dose of Glimepiride may need to be adjusted if you
change weight, change your lifestyle, or if you are under
a lot of stress. Please speak to your doctor if any of these
situations apply to you.
• If you feel the effect of your medicine is too weak or too
strong do not change the dose yourself, but ask your
doctor.
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) 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 coma are cases of medical emergency
requiring immediate medical treatment and admission into
hospital. It may be helpful to tell your family and friends to call
a doctor immediately if this happens to you.
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 get worse again. Keep taking Glimepiride until
your doctor tells you to stop.
If you have any further questions on the use of this
product, ask your doctor or pharmacist

4. Possible side effects
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
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 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)
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 medicines 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
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

5. How to store Glimepiride
Keep out of the sight and reach of children.
Do not use Glimepiride after the expiry date which is stated
after ‘Exp’ on the blister and carton. The expiry date refers to
the last day of that month.
Glimepiride 1mg, 2mg, 3mg, and 4mg tablets: do not store
above 30°C.
Store in the original package in order to protect from moisture.
Do not use Glimepiride if you notice visible signs of
deterioration.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Contents of the pack and other information
What Glimepiride contains
• The active substance is glimepiride. Each tablet contains
1mg, 2mg, 3mg or 4mg of glimepiride depending on the
strength indicated on the blister and carton
• Each tablet also contains lactose, sodium starch glycollate,
magnesium stearate, microcrystalline cellulose and
povidone 25000.
• In addition the tablets contain the following colouring
agents:
Glimepiride 1mg Tablets: red iron oxide (E172)
Glimepiride 2mg Tablets: yellow iron oxide (E172), indigocarmine aluminium lake (E132)
Glimepiride 3mg Tablets: yellow iron oxide (E172)
Glimepiride 4mg Tablets: indigo-carmine aluminium lake
(E132)
What Glimepiride looks like and contents of the pack
1mg tablets are pink, eight-shaped tablets, scored on both
sides and marked with ‘NMK’ and a logo
2mg tablets are green, eight-shaped tablets, scored on both
sides and marked with ‘NMM’ and a logo
3mg tablets are pale yellow, eight-shaped tablets, scored on
both sides and marked with ‘NMN’ and a logo
4mg tablets are pale blue, eight-shaped tablets, scored on
both sides and marked with ‘NMO’ and a logo
They are supplied in blister pack 30 tablets.
Manufactured by:
- Sanofi-Aventis Deutschland GmbH, Industriepark Hochst,
Bruningstrasse 50, D-65926 Frankfurt am Main, Germany
- Sanofi-Aventis S.p.A., Strada Stratale 17, Km 22, 67019
Scoppito (L’Aquila), Italy
- Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel,
37100 Tours, France.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU
Glimepiride 1mg Tablets:
Glimepiride 2mg Tablets:
Glimepiride 3mg Tablets:
Glimepiride 4mg Tablets:
Leaflet date: 09.08.2013

PL No:
PL No:
PL No:
PL No:

18799/1189
18799/1190
18799/1191
18799/1192

POM

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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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