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GLIMEPIRIDE 4MG TABLETS

Active substance(s): GLIMEPIRIDE

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Patient Information Leaflet

GLIMEPIRIDE 1mg, 2mg, 3mg and 4mg TABLETS
Read all of this leaflet carefully before you
start taking this medicine.
! Keep this leaflet. You may need to read it
again.
! If you have further questions, please ask your
doctor or your pharmacist.
! This medicine has been prescribed for you
personally and you should not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
! If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Glimepiride Tablets are and what they
are used for
2. Before you take Glimepiride Tablets
3. How to take Glimepiride Tablets
4. Possible side effects
5. Storing Glimepiride Tablets
6. Further Information
1.

WHAT GLIMEPIRIDE TABLETS ARE AND
WHAT THEY ARE USED FOR

Glimepiride is one of a group of medicines called
sulphonylurea hypoglycaemics, which are used
for the treatment of diabetes by helping to control
blood sugar levels (glucose). Diabetes is a
condition where the body does not produce
enough insulin to control the level of blood
glucose.
Glimepiride Tablets are used to treat non-insulin
dependent (Type II) diabetes mellitus, in addition
to a recommended diet, regular physical exercise
and weight reduction when these have not worked
on their own.
2. BEFORE YOU TAKE GLIMEPIRIDE
Do not take Glimepiride Tablets if you:
! are allergic (hypersensitive) to glimepiride,
any of the other ingredients (listed in Section
6) or to other oral sulphonylurea anti-diabetics
or sulphonamide antibiotics
! have type I insulin-dependent diabetes
! have suffered from confusion, fainting or
coma as a result of your diabetes
! have been told by your doctor you have
'ketoacidosis' (your breath may smell of pear
drops)
! have severe kidney or liver disease, as your
diabetes will need to be treated with insulin
! are pregnant or breastfeeding.

Always contact your doctor if the any of these
symptoms occur, as they may come back,
even after you take some sugar.
Situations where you are more likely to
experience low blood sugar:
! If you do not take your medicine as prescribed
or take too much.
! If you do not eat properly or regularly, if you
skip meals, or are fasting.
! Changes in the diet.
! An imbalance between physical activity and
carbohydrate intake.
! Consumption of alcohol (especially if you also
skip meals).
! Reduced kidney function or severe liver
problems. Disorders of thyroid or adrenal
function.
! If you are taking some other medicines (see
the section “Taking other medicines”).
Laboratory investigations or tests
If you have to have blood tests or urine tests, you
must always tell the person doing the test that you
are taking Glimepiride Tablets.
Regular monitoring of the levels of glucose in your
blood and urine, haemoglobin levels, white blood
cells, and liver enzyme values are required during
treatment with Glimepiride Tablets.
Important information about some of the
ingredients of Glimepiride Tablets:
Glimepiride 2 mg Tablets contain the colourings
tartrazine (E102) and sunset yellow FCF (E110)
which may cause allergic reactions.
Do not take Glimepiride Tablets if you have a
galactose intolerance, Lapp lactase deficiency or
other problems absorbing glucose-galactose as
this product contains lactose.
Taking Glimepiride Tablets with food and drink
Glimepiride Tablets must be taken shortly before
or during a meal.
Pregnancy and Breastfeeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Do not take Glimepiride Tablets during pregnancy.
Tell your doctor if you are planning to become
pregnant.
You must not take Glimepiride Tablets if you are
breastfeeding.
Driving and using machines
You may feel sleepy or have blurred vision when
starting or changing treatment with Glimepiride
Tablets; this can also happen if you forget to take
your medicine. Do not drive or operate machinery
if affected.
You must also be aware of the symptoms of low
blood sugar before driving (see “Take special
care”)

Talk to your doctor or pharmacist before
taking the tablets if:
! you are suffering from an infection with or
without fever
! you have had a recent accident, are to have
an operation or other situation which is
stressful to the body
! you are planning to become pregnant
! you have been told by your doctor that you
have an intolerance to some sugars.
Glimepiride Tablets contain lactose.

Taking Glimepiride Tablets with other
medicines
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines including
those obtained without a prescription.
Some medicines may affect how well Glimepiride
Tablets work.

Take special care with Glimepiride Tablets
Treatment with Glimepiride Tablets may lead to
hypoglycaemia (low blood sugar) when meals are
taken irregularly or if meals are missed.
Some of the symptoms of low blood sugar:
! Headache, ravenous hunger, feeling sick,
being sick, tiredness, sleep disturbances,
restlessness, aggression, difficulty
concentrating, depression, confusion, speech
or vision disturbances, tremor, partial
paralysis, dizziness, helplessness, loss of self
control, delirium, convulsions leading to loss
of consciousness including coma, rapid or
shallow breathing and slowed heart beat.
! You may also experience sweating, clammy
skin, anxiety, faster heart beat, increased
blood pressure and other heart problems,
which if not treated can be serious.
! These symptoms usually disappear quickly
after you eat some carbohydrates (especially
sugar) but not with artificial sweeteners.

Tell your doctor if you are taking any of the
following medicines:
Medicines which may make glimepiride seem
more effective and increase the risk of low blood
sugar:
! anti-inflammatory medicines (pain killers) such
as salicylates, phenylbutazone, azapropazone
and oxyfenbutazone
! other anti-diabetic medicines (e.g. insulin,
metformin)
! P-amino salicylic acid, used to treat some
forms of tuberculosis
! male sex hormones and anabolic steroids
! medicines used to treat gout (e.g. probenecid,
sulfinpyrazone and allopurinol)
! antibacterial and antifungal agents such as
fluconazole, miconazole, chloramphenicol,
quinolones, some sulphonamides,
tetracyclines
! anti-coagulants (medicines to thin the blood or
stop blood clotting)
Continued overleaf

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medicines containing fenfluramin (diet-pills)
medicines used to treat blood pressure and
heart disease (e.g. ACE inhibitors, and high
doses of pentoxifylline)
fibrates (cholesterol lowering agents)
anti-depressants (e.g. monoamine oxidase
inhibitors, fluoxetine)
anti-cancer drugs (e.g. cyclophosphamide,
ifosfamide and trophosfamide)
tritoqualine used to treat allergies and skin
disorders.

Medicines which may weaken the effect of
glimepiride:
! the contraceptive pill, hormone replacement
therapy and other medicines containing
female hormones
! certain diuretics (water tablets)
! thyroid stimulating agents
! anti-inflammatory agents (glucocorticoids) e.g.
prednisolone
! antipsychotic drugs (e.g. chlorpromazine)
! adrenaline; some asthma medicines (e.g.
salbutamol and formeterol) decongestants
used to treat colds
! nicotinic acid at high doses
! long term use of laxatives
! medicines used to treat epilepsy (e.g.
phenytoin)
! diazoxide, used in emergency treatment of
high blood pressure or in hypoglycaemia
! glucagon, used to treat episodes of
hypoglycaemia
! sleeping pills (e.g. barbiturates)
! rifampicin, used to treat tuberculosis
! acetazolamide, used to treat glaucoma.
Others, which may increase or decrease the effect
of glimepiride:
! anti-ulcer medicines (e.g. cimetidine and
ranitidine)
! medicines used to treat high blood pressure
(e.g. beta-blockers, guanethidine, reserpine
and clonidine); these can also hide the signs
of low blood sugar so special care is needed
when taking these medicines.
! alcohol.
3. HOW TO TAKE GLIMEPIRIDE TABLETS

Symptoms of overdosing are: Feeling sick, being
sick and abdominal pain. The hypoglycaemia is in
general accompanied by neurological symptoms
such as agitation, tremor, vision disturbances,coordination problems, sleepiness, coma, and
convulsions.Symptoms may occur up to 24hrs
after ingestion of Glimepiride Tablets. In general
hospitalisation is therefore recommended.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Glimepiride Tablets can cause
side effects in some people.
Stop taking the tablets and tell your doctor
immediately or go to the nearest hospital
casualty department if you notice any of the
following side effects:
! An allergic reaction which may cause skin
rash. This may very rarely develop into a
severe reaction with swelling of the face, lips
or tongue, difficulty swallowing or breathing,
low blood pressure and shock.
Contact your doctor if you experience any of
the following rare or very rare effects:
! Low blood sugar (hypoglycaemia), for
symptoms see section 2 “Take special care”.
! Changes in the blood, which may cause
anaemia, tiredness, unusual bruising, nose
bleeds or more frequent infections.
! Liver problems, which may cause yellowing of
the skin and whites of eyes.
Other side effects
Uncommon side effects (reported in less than
1 in 100 people):
! Temporary visual disturbances.
Rare side effects (reported in less than 1 in
1000 people):
! Increased liver enzymes.
Very rare side effects (reported in less than 1
in 10,000 people):
! Allergic inflammation of vessels, cross allergy
with antibiotics (sulphonamides).
! Nausea, vomiting, diarrhoea, bloating,
stomach pain.
! Increased skin sensitivity to sunlight.

The basis for successful treatment of diabetes is a
healthy diet, regular physical activity, as well as
routine checks of blood and urine. It is important
to continue with the recommended diet as well as
taking Glimepiride Tablets.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Your doctor will decide the right dose for you
depending on your condition. Follow your doctor's
instructions carefully. Check the pharmacy label
and ask your doctor or pharmacist if you're not
sure.

Keep out of the reach and sight of children
Do not store Glimepiride Tablets above 30oC.
Store in the original packaging.
Do not use after the expiry date stated on the
carton. Unused tablets should be taken back to
the pharmacist for safe disposal.

Adults including the elderly:
! Take the tablets shortly before or during a
substantial breakfast or first main meal.
! Swallow the tablets whole with some liquid.
! The usual starting dose is 1mg glimepiride per
day.
! If control is not achieved your doctor may
increase your dose by 1mg every 1 to 2
weeks to 2mg, 3mg or 4mg per day.
! The recommended maximum dose is 6mg
glimepiride per day.
If you are already taking other oral diabetic agents
(such as metformin) or insulin, and your condition
is not stable, your doctor may also give you
glimepiride tablets, starting at a low dose of 1mg
per day and increasing the dose every 1-2 weeks
until the required control is achieved.
Your doctor will monitor you carefully when adding
other medicines or when changing to or from
another anti-diabetic medicine.
Children: Glimepiride Tablets are not
recommended in children.
If you forget to take a tablet:
Take another as soon as you remember or wait
until the next dose is due then continue as before.
Do not take a double dose to make up for a
missed dose.
If you take more Glimepiride Tablets than you
should:
Contact your doctor immediately or go to your
nearest Accident and Emergency department.
Take this leaflet, the container and any remaining
tablets with you, so that the medical staff know
exactly what you have taken.

5. STORING GLIMEPIRIDE TABLETS

6. FURTHER INFORMATION
What is in this medicine:
Each tablet contains 1mg, 2mg, 3mg or 4mg of
the active ingredient glimepiride.
The other ingredients are lactose monohydrate,
sodium starch glycolate (type A), magnesium
stearate, microcrystalline cellulose, povidone and
the following colourings:
Glimepiride 1 mg Tablets: Red iron oxide (E172)
Glimepiride 2 mg Tablets: Yellow iron oxide
(E172), Sunset yellow FCF (E110), tartrazine
(E102), brilliant blue FCF (E133)
Glimepiride 3 mg Tablets: Yellow iron oxide (E172)
Glimepiride 4 mg Tablets: Indigo Carmine (E132)
What this medicine looks like and contents of
the pack:
Glimepiride Tablets are flat, oblong tablets with
bevelled edges, with a score on one side and
marked with “G” on the other side. The 1mg
tablets are pink, the 2mg tablets are green, the
3mg tablets are yellow and the 4mg tablets are
blue.
They are supplied in blister packs of 30 tablets.
Marketing Authorisation Holder:
Strandhaven Limited (T/A Somex Pharma), High
Road, Seven Kings, llford, Essex, IG3 8BS, UK.
Manufacturer:
Strandhaven Limited (T/A Somex Pharma), High
Road, Seven Kings, llford, Essex, IG3 8RA, UK.
Leaflet last approved: February 2009

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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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