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AMARYL 3MG TABLETS

Active substance(s): GLIMEPIRIDE / GLIMEPIRIDE / GLIMEPIRIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Amaryl 1mg, 2mg, 3mg and 4mg 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 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.
2.
3.
4.
5.
6.

What Amaryl is and what it is used for
What you need to know before you take Amaryl
How to take Amaryl
Possible side effects
How to store Amaryl
Contents of the pack and other information

1.

What Amaryl is and what it is used for

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.
2.

What you need to know before you take Amaryl

Do not take Amaryl and tell your doctor if:
• You are allergic to: glimepiride or other sulfonylureas (medicines used to lower your blood
sugar such as glibenclamide) or sulphonamides (medicines for bacterial infections such as
sulfamethoxazole) or any of the other ingredients of this medicine (listed in section 6)
• You have Diabetes mellitus type I



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.
Warnings and precautions

Talk to your doctor or pharmacist before taking your medicine if:
• You are recovering from any 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 anaemia) 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



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 procedure 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 sulphonamides)
• 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 (anabolilcs)
• Medicines used for male sex hormone replacement therapy
• Medicines to treat depression (fluoxetine, MAO-inhibitors)
• 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, ifosamide, trofosfamide)
• Medicines used to reduce weight (fenfluramine)





Medicines to increase circulation when given in a high dose intravenous infusion
(pentoxifylline)
Medicines used 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 high the sigs 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 lower action of Amaryl in an
unpredictable way.
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 feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
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.
3.

How to take Amaryl

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 a glass of water. Do not crush or chew the tablets
• Each tablet can be divided into equal doses
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 1mg tablet once a day
• If necessary, your doctor may increase the dose after each 1-2 weeks of treatment
• The maximum recommended dose is 6mg 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 addition 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 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

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.
• 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
• Weight gain
• Hair loss
• Changes in your sense of taste
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
development 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)

Not known, frequency cannot be estimated from the available data:
• 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, sulphonamides, 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/yellow card.
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Amaryl

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 1mg, 2mg, 3mg and 4mg tablets: do not store above 30°C.
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.

6.

Contents of the pack and other information

What Amaryl contains
• The active substance is glimepiride. Each tablet contains 1mg, 2mg, 3mg or 4mg 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:
• 1mg tablets contain red iron oxide (E172)
• 2mg tablets contain yellow iron oxide (E172) and indigo-carmine aluminium lake (E132)
• 3mg tablets contain yellow iron oxide (E172)
• 4mg 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:
• 1mg tablets are pink
• 2mg tablets are green
• 3mg tablets are pale yellow
• 4mg 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:
All presentations:
Sanofi S.p.A., Strada Statale 17, Km 22, 67019 Scoppito (L’Aquila), Italy
Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel, 37100 Tours, France
For 2mg and 3mg:
UAB “Oriola Vilnius”, Laisvės pr. 75, LT-06144 Vilnius, Lithuania
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, Italy, Netherlands, Norway, Romania, Slovakia, Spain, Sweden, United Kingdom
• Amaryl Tabletes: Latvia
• Amaryl Tabletés: Lithuania
• Amaryl Tablete: Slovenia
• Amarylle: Belgium, Luxembourg
• Amarel: France
• Solosa: Greece
This leaflet was last revised in 03/2017.

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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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