AMARYL 3MG TABLETS

Active substance: GLIMEPIRIDE

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• 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.
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.
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

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.

What you need to know before you take Amaryl

• 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)

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
1

• 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, 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
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 low 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).
Colesevelam, a medicine used to reduce cholesterol, has an
effect on the absorption of Amaryl. To avoid this effect, you
should be advised to take Amaryl at least 4 hours before
colesevelam.
Amaryl with food, drink and alcohol
Alcohol intake may increase or decrease the blood sugar
lowering action of Amaryl in an unpredictable way.
2

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

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.

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 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 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.

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
3

Keep this medicine out of the sight and reach of children.
Do not use this medicine 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 1 mg, 2 mg, 3 mg, and 4 mg tablets: do not store
above 30°C.
4

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

Contents of the pack and other information
What Amaryl contains
• 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), magnesium stearate,
microcrystalline cellulose, povidone 25000.
• 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 Amaryl looks like and contents of the pack
Each tablet of Amaryl is oblong and scored on both sides.
Each tablet can be divided into equal doses.
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 14,
15 (Amaryl 1mg only), 20, 28, 30, 50, 60, 90, 112, 120,
280 and 300 tablets. Not all pack sizes and strengths may
be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Manufacturer:
Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel,
37100 Tours, France
This medicinal product is authorised in the Member States
of the EEA under the following names:
• Amaryl: Austria, Bulgaria, Cyprus, Czech Republic,
Denmark, Estonia, Finland, Germany, Iceland, Ireland,
Italy, Malta, Netherlands, Norway, Slovakia, Spain,
Sweden, United Kingdom
• Amaryl Tabletes: Latvia
• Amaryl Tabletès: Lithuania
• Amaryl Comprimate: Romania
• Amaryl Tablete: Slovenia
• Amarylle: Belgium, Luxembourg
• Amarel: France
• Solosa: Greece
This leaflet was last revised in 10/2013

526231

*526231*

• 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
Reporting of side effects
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 at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

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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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