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Active substance(s): GLICLAZIDE

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Glimil 80mg Tablets
Read all of this leaet carefully before you start taking this medicine because it
contains important information for you.
• Keep this leaet. 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 signs of illness 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 leaet. See section 4.
What is in this leaet
1. What Glimil Tablets are and what they are used for
2. What you need to know before you take Glimil Tablets
3. How to take Glimil Tablets
4. Possible side effects
5. How to store Glimil Tablets
6. Contents of the pack and other information

What Glimil Tablets are and what they are used for

Glimil Tablets contain the active ingredient Gliclazide. Gliclazide belongs to a group of
medicines called 'sulphonylureas'. It is an oral hypoglycaemic medicine (blood sugar
lowering drug). Glimil Tablet is used to keep blood sugar at the correct level in adults with
non-insulin dependent diabetes when it is not controlled by diet, physical exercise and
weight loss alone.

What you need to know before you take Glimil Tablets

Do NOT take Glimil Tablets:

if you are allergic to Gliclazide or any of the other ingredients of Glimil tablets (listed
in section 6), to other medicines of the same group (sulfonylureas), to other related
medicines (hypoglycaemic sulfonamides),

if you have insulin-dependent diabetes (Type I)

if you have severe liver or kidney problems

if you are having an operation, or have a severe infection, or are suffering from
extreme stress or trauma.

if you have ketone bodies and sugar in your urine (this may mean you have ketoacidosis), a diabetic pre-coma or coma,

if you are breast-feeding (see Section 'Pregnancy and breast-feeding').

if you are taking miconazole, a medicine used to treat fungal infections (See section
'Taking other medicines')
Glimil Tablet is not recommended for use in children.
If you have been told by your doctor that you have an intolerance to some sugar (e.g.
glucose, lactose), contact your doctor before taking this medicinal product.
Warnings and precautions
Talk to your doctor before taking Glimil Tablets. You should observe the treatment plan
prescribed by your doctor to achieve proper blood sugar levels. This means, apart from
regular tablet intake, you observe the dietary regimen, have physical exercise and, where
necessary, reduce weight.
During Glimil treatment, regular monitoring of your blood (and possibly urine) sugar level
and also your glycated haemoglobin (HbA1c) is necessary.
In the rst few weeks of treatment the risk of having reduced blood sugar level
(hypoglycaemia) may be increased. So particularly close medical monitoring is
Low blood sugar (hypoglycaemia) may occur:

if you take meals irregularly or skip meals altogether, if you are fasting,

if you are malnourished,

if you change your diet,

if you increase your physical activity and carbohydrate intake does not match this

if you drink alcohol, especially in combination with skipped meals,

if you take other medicines or natural remedies at the same time,

if you take too high doses of Glimil,

if you suffer from particular hormone-induced disorders (Functional disorders of the
thyroid gland, of the pituitary gland or adrenal cortex),

if your kidney function or liver function is severely decreased.
If you have low blood sugar you may have the following symptoms: headache, intense
hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness,
poor concentration, reduced alertness and reaction time, depression, confusion, speech
or visual disorders, tremor, sensory disturbances, dizziness, and helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast
or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may
radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion
(delirium), develop convulsions, lose self-control, your breathing may be shallow and your
heart beat slowed down, you may become unconscious. In most cases the symptoms of
low blood sugar vanish very quickly when you consume some form of sugar, e.g. glucose
tablets, sugar cubes, sweet juice, sweetened tea. You should therefore always carry
some form of sugar with you (glucose tablets, sugar cubes). Remember that articial
sweeteners are not effective.
Please contact your doctor or the nearest hospital if taking sugar does not help or if the
symptoms recur.
Symptom of low blood sugar may be absent, less obvious or develop very slowly or you
are not aware in time that your blood sugar level has dropped. This may happen if you
are an elderly patient taking certain medicines (those acting on the central nervous
system and beta blockers).
If you are in stress-situations (e.g. accidents, surgical operations, fever etc.) you doctor
may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet
sufciently reduced the blood sugar, when you have not complied with the treatment plan
prescribed by your doctor, if you take St John's Wort (Hypericum perforatum)
preparations (see section "Other medicines and Gliclazide Tablets"), or in special stress
situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin
infections and reduced performance.
If these symptoms occur, you must contact your doctor or pharmacist.
While taking Glimil tablets you should:

follow a regular diet: it is important to eat regular meals, including breakfast and
never to miss or delay a meal,

take your medicine regularly (see 'How to take Glimil Tablets'),

check your blood glucose regularly as recommended by your doctor.
Blood glucose disturbance (low blood sugar and high blood sugar) can occur when
gliclazide is prescribed at the same time as medicines belonging to a class of antibiotics
called uoroquinolones, especially in elderly patients. In this case, your doctor will remind
you the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6phosphate dehydrogenase (G6PD) deciency (abnormality of red blood cells), contact
your doctor before taking this medicinal product.
Other medicines and Glimil Tablets
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines. The blood sugar lowering effect of Glimil may be strengthened and signs
of low blood sugar levels may occur when one of the following medicines is taken:

other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor
inhibitors or insulin),

antibiotics (e.g. sulphonamides, clarithromycin),

medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors
such as captopril or enalapril),

medicines to treat fungal infections (miconazole, uconazole),

medicines to treat ulcers in the stomach or duodenum (cimetidine),

medicines to treat depression (monoamine oxidase inhibitors),

painkiller or antirheumatics (phenylbutazone, ibuprofen),

medicine for treating irregular heart beats (Disopyramide),

medicines containing alcohol
The blood glucose lowering effect of Glimil may be weakened and raised blood sugar
levels may occur when one of the following medicines is taken:

medicines to treat disorders of the central nervous system (chlorpromazine),

medicines reducing inammation (corticosteroids),

medicines to treat breast disorders and heavy menstrual bleeding and endometriosis

medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine
and terbutaline),

St John's Wort - Hypericum perforatum - preparations.
Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a
medicine belonging to a class of antibiotics called uoroquinolones is taken at the same
time as Gliclazide 80mg tablets, especially in elderly patients.
Glimil Tablets may increase the effects of medicines which reduce blood clotting (e.g.
Consult your doctor before you start taking another medicinal product. If you go into
hospital tell the medical staff you are taking Glimil Tablets.

21 01 16/15 02 16/12 09 17

Glimil Tablets with food, drink and alcohol
Gliclazide Tablets can be taken with food and non-alcoholic drinks. Drinking alcohol is not
recommended as it can alter the control of your diabetes.
Pregnancy and breast-feeding
Glimil Tablet is not recommended for use during pregnancy. If you are pregnant, think you
may be pregnant or are planning to have a baby, ask your doctor for advice before taking
this medicine.
You must not take Glimil tablets while you are breast-feeding.
Driving and using machines
Provided your blood glucose levels are satisfactorily controlled on Glimil tablets, your
ability to drive or use machines should not be affected. However, if your glucose levels
become too low, this could adversely affect your concentration, and therefore your ability
to perform these tasks.
Ask your doctor whether you can drive a car if you:

have frequent episodes of low blood sugar (hypoglycaemia),

have few or no warning signals of low blood sugar (hypoglycaemia).
Glimil tablets contains Lactose Lactose is a type of sugar. If you have been told by your doctor that you cannot tolerate
or digest some sugars (have an intolerance to some sugars), talk to your doctor before
taking this medicine.

How to take Glimil Tablets

Always take Glimil Tablets exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Glimil Tablets are for oral use. Take your tablets with a glass of water before a meal.
The recommended dose is as follows:
Adults and Elderly: The usual starting dose is 40 to 80mg (½ or 1 tablet) daily, adjusted
according to your response, up to a maximum of 320mg (four tablets) daily. Up to 160mg
(two tablets) can be taken at one time.
Your starting dose will be reduce if you are elderly or have liver or kidney problems.
Use in children: Glimil is not recommended for use in children.
Change in external factors (e.g. weight reduction, change in life style, stress) or
improvements in the blood sugar control may require changed Glimil doses.
You should continue to take these tablets for as long as your doctor tells you to. Do not
stop taking the tablets or alter the dosage without consulting your doctor.
If a combination therapy of Glimil Tablet with metformin, an alpha glucosidase inhibitor, a
thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin is
initiated your doctor will determine the proper dose of each medicine individually for you.
If you notice that your blood sugar levels are high although you are taking the medicine
as prescribed, you should contact your doctor or pharmacist.

Other side effects
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea and
constipation. These effects are reduced when Glimil 80mg Tablets are taken with a meal
as recommended.
Skin disorders: Skin reactions such as rash, redness, itching and hives, angioedema
(rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may
result in breathing difculty) have been reported. The rash may progress to widespread
blistering or peeling of the skin. Exceptionally, signs of severe hypersensitivity reactions
(DRESS) have been reported: initially as u-like symptoms and a rash on the face then
an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and
white blood cells), which may cause paleness, prolonged bleeding, bruising, sore throat
and fever. These symptoms usually stop when the treatment is discontinued.
Liver disorders: There have been isolated reports of abnormal liver function which can
cause yellow skin and eyes. If you get this see your doctor immediately. The symptoms
generally disappear if the drug is stopped. Your doctor will decide whether to stop your
Eye disorders: Your vision may be affected for a short time, especially at the start of
treatment. This effect is due to changes in blood sugar levels.
As for other sulphonylureas, the following adverse events have been observed: cases of
severe changes in the number of blood cells and allergic inammation of the wall of blood
vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (e.g.
jaundice) which in most cases disappeared after withdrawal of the sulphonylurea, but
may lead to life threatening liver failure in isolated cases.
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 leaet. You can also report side effects directly via
the Yellow Card Scheme at: or search for MHRA Yellow
Card in the Google Play or Apple App Store. By reporting side effects, you can help
provide more information on the safety of this medicine.

How to store Glimil Tablets

Keep this medicine out of the sight and reach of children.
Do not use your medicine after the expiry date which is stated on the carton. The expiry
date refers to the last day of that month.
Do not store above 25°C.
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 to
protect the environment.

Contents of the pack and other information

What Glimil tablet contains
The active substance is gliclazide. Each tablet contains 80mg of gliclazide.

If you take more Glimil Tablets than you should
If you or someone else accidentally takes more Glimil Tablets than you should, seek
immediate medical help by contacting your doctor or nearest hospital casualty
department. Take the carton and any remaining tablets you have with you. The signs of
overdose are those of low blood sugar (hypoglycaemia) described in Section 2.

The other ingredients are: lactose monohydrate, silicon dioxide, pregelatinised maize
starch, talc and magnesium stearate.

The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight
away, followed by a substantial snack or meal. If the patient is unconscious, immediately
inform a doctor and call the emergency services.

The registered pack sizes are 28 and 60 tablets.

If you forget to take Glimil Tablets
It is important to take your medicine everyday as regular treatment works better. If you
have missed a dose, take it as soon as you remember unless it is nearly time for your
next dose. Do NOT take a double dose to make up for a forgotten one.
If you stop taking Glimil Tablets
As the treatment of diabetes is life long, you should discuss with your doctor before
stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia)
which increases the risk of developing complications of diabetes. If you have any further
questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Glimil Tablets can cause side effects, although not everybody gets
Low blood sugar (Hypoglycaemia)
The most commonly observed side effect is low blood sugar (hypoglycaemia). For
symptoms and signs see section Warnings and precautions.
If left untreated these symptoms could progress to drowsiness, loss of consciousness or
possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is
temporarily controlled by eating sugar, you should seek immediate medical attention.

What Glimil Tablets look like and the contents of the pack
Glimil tablets 80mg are white, round tablets scored on one side with G on the other side
Marketing Authorisation Holder:
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD
United Kingdom
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited,
HA26 Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000,
This leaet was last revised in 09/2017

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.