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GLIMEPIRIDE 2 MG TABLETS

Active substance: GLIMEPIRIDE

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231-30-88374-C LEA GLIMEPIRIDE A/S TAB TUK

Version:

2

Trackwise Parent:

22 November 2013
Child:

224822

PL Number(s),
MA Holder & Packer:
Reason for revision:

PL 00289/0943-6, Teva UK Limited Licence (Post Licence Regulatory Team).
Packed at Teva UK Limited, Eastbourne. Packing Line: B1260.
Leaflet text update. V2: Alterations in response to an RFI from the MHRA.

F. P. Code:

231-10-03141, 231-10-03171
231-10-03181, 231-10-03191
415 (10100000)
N/A
Univers.
9.7 Pt

240368

Pharma Code:
Third party code:
Fonts:
Base Font Size:

Dimensions:
L:
W:

Colours:
323 mm
160 mm

PANTONE® GREEN C

trademark of Pantone, Inc.)

BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.

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

Some patients experienced the following 25°C. Do not use Glimepiride after the
side effects whilst taking Glimepiride:
expiry date which is stated on the outer
packaging. The expiry date refers to the
Rare side effects
last day of that month.
Do not throw away any medicines via
(hypoglycaemia) (See Section 2 Warnings and precautions)
bleeding or bruising)
infections more likely)

your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

skin pale and cause weakness or
What Glimepiride 1, 2, 3 & 4 mg Tablets
breathlessness).
contain
These problems generally get better after
you stop taking Glimepiride.
4 mg of glimepiride.
Very rare side effects
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.

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

yellowing of the skin and eyes
What Glimepiride looks like and contents
(jaundice), impairment of the bile flow of the pack:
(cholestasis), inflammation of the liver
(hepatitis) or liver failure. If you
pink, round tablets, bisected on both
experience any of these symptoms, tell
your doctor immediately.
debossed with “9” on one side of the
full or bloated, and abdominal
discomfort or pain
Decrease in the amount of sodium level
in your blood (shown by blood tests).
Not known (frequency cannot be
estimated from the available data)
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.
blood platelets (thrombocytopenia)
and unusual bleeding or bruising
under the skin (thrombocytopenic
purpura).
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 via the
Yellow Card Scheme at:
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

Keep this medicine out of the sight and
reach of children. Do not store above

on one side of the score and “54” on
the other.
green, round tablets, bisected on both
debossed with “9” on one side of the
on one side of the score and “55” on
the other.
yellow to yellow, round tablets,
tablet is debossed with “G” on one
light blue, round tablets, bisected on
debossed with “9” on one side of the
on one side of the score and “56” on
the other.
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
manufacturer
company responsible for manufacture:
This leaflet was last revised:
November 2013.

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

GLIMEPIRIDE
1, 2, 3 AND 4 mg TABLETS

have your blood (and possibly urine)
sugar levels determined regularly as
prescribed by your doctor.
In the first few weeks of treatment the
risk of having reduced blood sugar levels
Read all of this leaflet carefully before
(hypoglycaemia) may be increased,
you start taking this medicine because it therefore it is vital that you are carefully
contains important information for you.
monitored by your doctor.
Reduced blood sugar may occur if:
it again.
meals altogether
doctor or pharmacist.
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
doctor, or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

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

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

WHAT GLIMEPIRIDE IS AND WHAT IT
IS USED FOR

substance glimepiride
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.

If you suffer from low blood sugar
(hypoglycaemia) you may have the
following signs:
headache, hunger, exhaustion, nausea,
vomiting, weariness, sleepiness, sleep
2 WHAT YOU NEED TO KNOW BEFORE disorders, restlessness, aggressiveness,
YOU TAKE GLIMEPIRIDE
impaired concentration, reduced
alertness and reaction time, depression,
Do not take Glimepiride
confusion, speech and visual disorders,
difficulty using or understanding
other drugs of the same group
language (aphasia), shaking, slight
(sulfonylureas and sulfonamides) or
paralysis, sensory disturbances,
any of the other ingredients of
Glimepiride Tablets (listed in section 6) dizziness, and helplessness.
The following signs may also occur:
sweating, clammy skin, anxiety,
severely impaired
accelerated heart beat, high blood
pressure, a feeling of an abnormally
diabetes
strong or irregular heartbeat
(palpitations), sudden strong pain in the
complication of diabetes with rapid
breast that may radiate into
weight loss, nausea or vomiting)
neighbouring areas (angina pectoris),
and cardiac arrhythmias.
consciousness due to a strongly
If blood sugar levels continue to drop
increased blood sugar level (diabetic
you may suffer from considerable
coma).
confusion (delirium), develop cerebral
convulsions, lose self control, breathing
In cases of severe renal or hepatic
may be shallow and your heart beat
functional disorders, a change-over to
slowed down, you may fall into
insulin is required.
unconsciousness. The symptoms of a
Warnings and precautions
severe reduced blood sugar level may
Talk to your doctor or pharmacist before resemble that of a stroke.
taking Glimepiride
In most cases the signs of reduced blood
During Glimepiride treatment regular
sugar vanish very quickly when you
monitoring of your blood sugar level is
consume some form of sugar, e.g. grape
necessary. Your doctor may also take
sugar, sugar cubes, sweet juice,
blood tests to monitor your blood cell
sweetened tea.
levels and liver function.
You should therefore always take some
You should observe the treatment plan
form of sugar with you (grape sugar,
prescribed by your doctor to achieve
sugar cubes). Remember that
proper blood sugar levels. This means
sweeteners are not effective. Please
that, apart from regular tablet intake, you contact your doctor or the next hospital if
observe the dietary regimen, have
taking sugar does not help or if the
physical exercise and, where necessary, symptoms recur.
Signals of reduced blood sugar may be
diabetes (type 2 diabetes mellitus),
when diet, exercise and weight loss
alone do not have an adequate effect.

Ref:

231-30-88374-C LEA GLIMEPIRIDE A/S TAB TUK

Version:

2

Trackwise Parent:

22 November 2013
Child:

224822

PL Number(s),
MA Holder & Packer:
Reason for revision:

PL 00289/0943-6, Teva UK Limited Licence (Post Licence Regulatory Team).
Packed at Teva UK Limited, Eastbourne. Packing Line: B1260.
Leaflet text update. V2: Alterations in response to an RFI from the MHRA.

F. P. Code:

231-10-03141, 231-10-03171
231-10-03181, 231-10-03191
415 (10100000)
N/A
Univers.
9.7 Pt

240368

Pharma Code:
Third party code:
Fonts:
Base Font Size:

Dimensions:
L:
W:

Colours:
323 mm
160 mm

PANTONE® GREEN C

trademark of Pantone, Inc.)

BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

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 beta-blockers). 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.
Other medicines and Glimepiride
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any 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. Tell your doctor
or pharmacist if you are taking, have
recently taken or might take any other
medicines, including those medicines
obtained without a prescription.

(miconazole, fluconazole)
beta-blockers, sympatholytics)
mood/antidepressants (fluoxetine,
(fenfluramine)
in the blood (fibrates)
tro- and iphosphamides)
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:
progestagens)
(saluretics, thiazide diuretics)

(pyrazolone-derivatives, e.g.
phenylbutazone, azapropazone,
oxyfenbutazone)

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 low sugar levels, (for signs
of hypoglycaemia see section 2) and
Breast-feeding
therefore you should instantly consume
Glimepiride may pass into breast milk.
enough sugar (e.g. a small bar of grape
Glimepiride should not be taken during
sugar cubes, sugar cubes, sweet juice,
breast-feeding.
sweetened tea) and inform a doctor
immediately. The same should be done if
Driving and using machines
somebody, e.g. a child, has taken the
Your ability to concentrate or react may
product unintentionally. Persons in a
be impaired if your blood sugar is
state of unconsciousness must not be
lowered (hypoglycaemia), or raised
(hyperglycaemia) or if you develop visual given food or drink.
problems as a result of such conditions. Since the state of low sugar levels may
Bear in mind that you could endanger
last for some time it is very important
yourself or others (e.g. when driving a
that the patient is carefully monitored
car or using machines). Please ask your
doctor whether you can drive a car if
into hospital may be necessary, also as a
you:
measure of precaution. Severe cases of
low blood sugar accompanied by loss of
consciousness and severe neurological
failure are cases of medical emergency
hypoglycaemia.
requiring immediate medical treatment
and admission into hospital. It should be
Glimepiride contains lactose
If you have been told by your doctor that ensured that there is always a
you have an intolerance to some sugars, pre-informed person that can call a
doctor in case of emergency.
contact your doctor before taking this
medicinal product.
If you forget to take Glimepiride
hypoglycaemia

3

HOW TO TAKE GLIMEPIRIDE

schizophrenia (phenytoin,
phenothiazine derivatives)

your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.

(diazoxide)

(acetazolamide)

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.

and sympathicomimetics)

The recommended starting dose for

in the blood (nicotinic acid derivatives)

good blood sugar control is achieved the
dosage should be used for maintenance
therapy. 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
per day.

(rifampicin)
(glucagon)

evacuation (laxatives).
Products to treat ulcers in the stomach or
duodenum (H² receptor-antagonists) or
blood pressure lowering products
(beta-blockers, clonidine and reserpine)
may either strengthen or weaken the
blood sugar lowering effect of
Glimepiride.

Glimepiride with food, drink and alcohol
ability of Glimepiride to reduce blood
sugar in an unpredictable manner.

(anabolics and male sex hormones)

Pregnancy and breast-feeding
Pregnancy
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.

(coumarin)

Glimepiride should not be taken during

(p-amino-salicylic acid)

pregnancy. If pregnancy is planned you
should discuss the treatment plan with
your doctor. If you become pregnant
during Glimepiride treatment you should
inform your doctor immediately.

(glucocorticoids)

Medicinal products with effects on the
central nervous system (beta-blockers,
The blood sugar lowering effect of
clonidine, guanethidine or reserpine)
glimepiride may be strengthened and
may mask or totally suppress the signs
signs of low blood sugar levels may
occur when one of the following drugs is of reduced blood sugar.
taken:
Glimepiride may either strengthen or
weaken the effect of products inhibiting
metformin), and insulin
blood clotting (coumarin derivatives).
clarithromycin, quinolones,
tetracyclines, sulfonamides)

FOLD
LINE. PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

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

4

POSSIBLE SIDE EFFECTS

side effects, although not everybody gets
them.
Tell your doctor immediately if you
experience any of the following
symptoms:
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

Glimepiride must be swallowed with at
yellowing of the skin and eyes
least half a glass of water. Usually the
(jaundice), problems with the bile flow
entire daily dose is taken all at once
(cholestasis), inflammation of the liver
directly before or during a substantial
(hepatitis) or liver failure
breakfast. If you do not have breakfast
you should take the product on schedule
such as itching, rash, hives and
as prescribed by your doctor. It is
increased sensitivity to sun.
important not to leave out any meal
Some mild allergic reactions may
when you are on Glimepiride.
develop into serious reactions.
Use in children
Glimepiride is not recommended for use
of consciousness, seizures or coma
in children.
blood platelets (thrombocytopenia)
Please speak with your doctor or
and unusual bleeding or bruising
pharmacist if you have the impression
under the skin (thrombocytopenic
that Glimepiride is acting too strongly or
purpura).
not strongly enough.

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.

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