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Active substance(s): GLIMEPIRIDE

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Glimiperide 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 any further questions, ask your doctor or pharmacist
This medicine has been prescribed for you. Do 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:
What Glimepiride tablets are and what they are used for
Before you take
How to take
Possible side effects
How to store
Further information



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



Do not take Glimepiride tablets and tell your doctor if:
You are allergic (hypersensitive) to: glimepiride or other sulphonylureas (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 Glimepiride tablets (listed in Section 6: What
Glimepiride tablets contain)
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 tablets.
Take special care with Glimepiride tablets
Check with 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 tablets.
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 tablets 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 tablets 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
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)
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.
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Your doctor may wish to change your dose of Glimepiride tablets 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 tablets. This can lead to
a risk of hypoglycaemia (low blood sugar):
Other medicinal products to treat diabetes mellitus (such as insulin or metformin)
Medicinal products to treat pain and inflammation (phenylbutazone, azopropazone,

oxyphenbutazone, aspirin-like medicines)
Medicinal products to treat urinary infections (such as some long acting sulfonamides)
Medicinal products to treat bacterial and fungal infections (tetracyclines, chloramphenicol,
fluconazole, miconazole, quinolones, clarithromycin)
Medicinal products to inhibit blood clotting (coumarin derivatives such as warfarin)
Medicinal products supporting muscle build up (anabolics)
Medicinal products used for male sex hormone replacement therapy
Medicinal products to treat depression (fluoxetine, MAO-inhibitors)
Medicinal products lowering high cholesterol level (fibrates)
Medicinal products lowering high blood pressure (ACE inhibitors)
Medicinal products called anti-arrhythmic agents used to control abnormal heart beat
Medicinal products to treat gout (allopurinol, probenecid, sulfinpyrazone)
Medicinal products to treat cancer (cyclophosphamide, ifosfamide, trofosfamide)
Medicinal products used to reduce weight (fenfluramine)
Medicinal product to increase circulation when given in a high dose intravenous infusion
Medicinal products to treat nasal allergies such as hay fever (tritoqualine)
Medicinal products called sympatholytics to treat high blood pressure, heart failure, or prostate
The following medicines may decrease the blood sugar lowering effect of Glimepiride tablets. This can lead
to a risk of hyperglycaemia (high blood sugar level):
Medicinal products containing female sex hormones (oestrogens, progestogens)
Medicinal products supporting urine production (thiazide diuretics)
Medicinal products used to stimulate the thyroid gland (such as levothyroxine)
Medicinal products to treat allergies and inflammation (glucocorticoids)
Medicinal products to treat severe mental disorders (chlorpromazine and other phenothiazine
Medicinal products 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
Medicinal products to treat high cholesterol level (nicotinic acid)
Medicinal products to treat constipation when they are used long term (laxatives)
Medicinal products to treat seizures (phenytoin)
Medicinal products to treat nervousness and sleep problems (barbiturates)
Medicinal products to treat increased pressure in the eye (azetazolamide)
Medicinal products to treat high blood pressure or lowering blood sugar (diazoxide)
Medicinal products to treat infections, tuberculosis (rifampicine)
Medicinal products to treat severe low blood sugar levels (glucagon)
The following medicinal products can increase or decrease the blood sugar lowering effect of Glimepiride
Medicinal products to treat stomach ulcers (called H2 antagonists)
Medicinal products 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 tablets may either increase or weaken the effects of the following medicines:
Medicinal products inhibiting blood clotting (coumarin derivatives such as warfarin)
Taking Glimepiride tablets with food and drink
Alcohol intake may increase or decrease the blood sugar lowering action of Glimepiride tablets
in an unpredictable way.

Pregnancy and breast-feeding
Glimepiride tablets 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 tablets 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 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
Important information about some of the ingredients of Glimepiride tablets
Glimepiride tablets contain lactose. If you have been told by your doctor that you cannot tolerate some
sugars, contact your doctor before taking this medicinal product.



Always take Glimepiride tablets 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 product on schedule as prescribed by your doctor.
It is important not to leave out any meal when you are on Glimepiride tablets.
Swallow the tablets whole with at least half glass of water. Do not crush or chew the tablets
How much to take
The dose of Glimepiride tablets 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 glimepiride 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
If you take more Glimepiride tablets 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 with Glimepiride tablets) 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.
If you forget to take Glimepiride tablets
If you forget to take a dose, do not take a double dose to make up for forgotten doses.
If you stop taking Glimepiride tablets
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 tablets until your doctor tells you
to stop.
If you have any further questions on the use of this product, ask your doctor or pharmacist.



Like all medicines, Glimepiride tablets 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 tablets:
Rare side effects (affects 1 to 10 patients in 10,000)
Lower blood sugar than normal (hypoglycaemia) (See Section 2 - Take special care with
Glimepiride tablets)
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 tablets.
Very rare side effects (affects less than 1 patient in 10,000)
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 sulphonylureas, sulfonamides, or related drugs may occur
Problems with your sight may occur when beginning treatment with Glimepiride tablets. This is due
to changes in blood sugar levels and should soon improve
Increased liver enzymes
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.



Keep out of the reach and sight of children.
Do not use Glimepiride tablets 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.
This medicinal product does not require any special storage conditions.
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.



What Glimepiride tablets contain
The active substance is glimepiride.
Each tablet contains 1 mg, 2 mg, 3 mg or 4 mg of glimepiride depending on the strength indicated on
the blister and carton
The other ingredients are: lactose monohydrate, sodium starch glycollate (type A),
microcrystalline cellulose, povidone K30, magnesium stearate
In addition the tablets contain colouring agents:
1 mg tablets contain red iron oxide (E172)
2 mg tablets contain yellow iron oxide (E172) and indigo-carmine aluminium lake (E132)
3 mg tablets contain yellow iron oxide (E172)
4 mg tablets contain indigo-carmine aluminium lake (E132)
What Glimepiride tablets look like and contents of the pack
Each strength of Glimepiride tablets is oblong and scored on both sides. They are different in colour:
1 mg tablets are pink
2 mg tablets are green
3 mg tablets are pale yellow
4 mg tablets are light blue
They are supplied in blister packs of 10, 20, 30, 50, 60, 90, and 120 tablets. Not all pack sizes and strengths
may be marketed.
Marketing Authorisation Holder and Manufacturer

Actavis UK Limited, Whiddon Valley, Barnstaple, EX32 8NS, UK

This leaflet was last revised in March 2012

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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.