Skip to Content

UK Edition. Click here for US version.

GLIMEPIRIDE 3 MG TABLET

Active substance(s): GLIMEPIRIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
120 mm

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

• Keep this medicine out of the sight and
reach of children
• Do not use this medicine after the expiry
date which is stated on the label after EXP.
The expiry date refers to the last day of that
month.
• Do not store the tablets above 25º C

Some patients experienced the following side
effects whilst taking Glimepiride:

Store in the original package in order to
protect from moisture.

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)

Do not use this medicine if you notice visible
signs of deterioration.
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.

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

6. Contents of the pack and other
information
What Glimepiride tablet contains

220 mm

These problems generally get better after you
stop taking Glimepiride

The active substance is Glimepiride.
The other ingredients are lactose, sodium
starch glycolate, povidone, sodium lauryl
sulphate, magnesium stearate,
microcrystalline cellulose, red iron oxide E172
(1mg tablets), yellow iron oxide E172 (2mg
and 3mg tablets) and indigo carmine
aluminium lake E132 (2mg and 4mg tablets).

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)

What Glimepiride tablets looks like and
contents of the pack
Glimepiride 1mg tablets are Pink coloured
capsule shaped tablet with embossing “GM”
& “1” with score line on one side and score
line on the other side.
Glimepiride 2mg tablets are Pale green
coloured capsule shaped tablet with
embossing “GM” & “2” with score line on one
side and score line on the other side.
Glimepiride 3mg tablets are Pale yellow
coloured capsule shaped tablet with
embossing “GM” & “3” with score line on one
side and score line on the other side.
Glimepiride 4mg tablets are Light blue
coloured capsule shaped tablet with
embossing “GM” & “4” with score line on one
side and score line on the other side.

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

100 mm

Package leaflet: Information for the user

Glimepiride 1 mg / 2 mg /
3 mg / 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.

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:

What is in this leaflet

Talk to your doctor or pharmacist
before taking your medicine if:

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

• 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.

1. What Glimepiride is and what it
is used for
Glimepiride is one of a group of
medicines called oral
hypoglycaemics, which are used for
treatment of diabetes (a disease
where the body does not produce
enough insulin to control the level of
blood sugar). Oral hypoglycaemics
help control blood sugar level.

Lowering of the haemoglobin level
and breakdown of red blood cells
(haemolytic anemia) can occur in
patients missing the enzyme glucose6-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.

The active ingredient in your
Glimepiride tablets is Glimepiride.
What Glimepiride is used for:

Pack size: Cartons containing 30 tablets in
two blisters, each of 15 tablets.

Glimepiride is used in the treatment
of non-insulin dependent (Type II)
diabetes mellitus. You get diabetes if
your pancreas does not make
enough insulin to control the level of
glucose in your blood. Type II
diabetes can sometimes be
controlled by good diet, physical
exercise and weight reduction alone,
but where this is not possible,
Glimepiride is used in addition.

Marketing Authorisation Holder and
Manufacturer

2. What you need to know before
you take Glimepiride.

Brown & Burk UK Limited
5 Marryat Close, Hounslow West
Middlesex, TW4 5DQ
United Kingdom

Do not take Glimepiride:
• 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)

This leaflet was last updated in August
2014

• if you have insulin dependent
diabetes (Type I diabetes mellitus)
• if 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)
• if you are in a diabetic coma
• if you have severe kidney disease
• if you have a severe liver disease

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)

Reporting of side effects

4

1

100 mm

• 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.

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, MAOinhibitors)
• 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

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)

220 mm

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 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

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

2

120 mm










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
low blood sugar (diazoxide)
Medicines to treat infections, tuberculosis
(rifampicine)
Medicines to treat severe low blood sugar
levels (glucagon)

Glimepiride tablets contains
lactose
If you have been told by your doctor
that you cannot tolerate some
sugars, contact your doctor before
taking this medicinal product.
3. How to take Glimepiride
tablets.
Always take Glimepiride tablets exactly as
your doctor has told you. You should check
with your doctor 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.

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).
• Colesevelam, a medicine used to reduce
cholesterol, has an effect on the absorption
of Glimepiride. To avoid this effect, you
should be advised to take Glimepiride at
least 4 hours before colesevelam

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.

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

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.

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
feeeding.
Ask your doctor or pharmacist for advice
before taking any medicine.

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

Driving and using machines

If you stop taking Glimepiride

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.

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.
4. Possible side effects
Like all medicines, Glimepiride can cause
side effects, although not everybody gets
them.
Tell your doctor immediately if you
experience any of the following

3

Expand view ⇕

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.

Hide