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Active substance: GLICLAZIDE

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Package Leaflet: Information for the user


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
•  eep this leaflet. You may need to read it again.
• f you have any further questions, ask your doctor or pharmacist.
•  his 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.
• f 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
Diamicron 80 mg Tablets will be referred as to Diamicron 80 mg

2. What you need to know before you take Diamicron 80 mg
Do not take Diamicron 80 mg
• f you are allergic to gliclazide or any of the other ingredients
of Diamicron 80 mg (listed in section 6), to other medicines of
the same group (sulphonylureas), to other related medicines
(hypoglycaemic sulphonamides);
• f you have insulin-dependent diabetes (type 1);
• f you have ketone bodies and sugar in your urine (this may mean
you have keto-acidosis), a diabetic pre-coma and coma;
• f you have severe kidney or liver disease;
• f you are taking miconazole (a treatment for fungal infections)
(see Taking other medicines);
• f you are breastfeeding (see Pregnancy and breastfeeding).

1. What Diamicron 80 mg is and what it is used for
2. What you need to know before you take Diamicron 80 mg
3. How to take Diamicron 80 mg
4. Possible side effects
5. How to store Diamicron 80 mg
6. Contents of the pack and other information
1. What Diamicron 80 mg is and what it is used for
Diamicron 80 mg contains the active substance gliclazide, one of a
group of medicines called sulphonylureas. It is an oral hypoglycaemic
medicine (blood sugar lowering drug).
Diamicron 80 mg 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.

Diamicron 80 mg is not recommended for use in children.
If you have been told by your doctor that you have an intolerance to
some sugars (eg glucose, lactose, galactose), contact your doctor
before taking this medicinal product.

Warnings and precautions
Follow your doctor’s advice about diet and treatment. This is to
reduce the chances of very low blood sugar (hypoglycaemia).
Make sure your doctor knows
• f you have an operation, a serious injury, fever or infection, difficulty
in eating,
• f you plan a pregnancy or become pregnant,
• f you are taking any of the medicines listed in Taking other
Tell your dentist about your treatment.

Please contact your doctor or the nearest hospital if taking sugar
does not help or if the symptoms recur.
While taking Diamicron 80 mg you should:
• ollow a regular diet: it is important to eat regular meals, including
breakfast and never to miss or delay a meal;
• ake your medicine regularly (see How to take Diamicron 80 mg);
•  heck your blood glucose regularly as recommended by your doctor.
If you have a family history of or know you have the hereditary condition
glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of
red blood cells), contact your doctor before taking this medicinal product.

Dietary advice
This medicine may cause episodes of low blood sugar (hypoglycaemia).
This is more likely if:
•  ou are on a strict diet,
•  our diet is poorly balanced,
•  ou are taking prolonged or strenuous exercise,
•  ou drink alcohol,
• f you are taking several medicines for high blood sugar (See
Taking other medicines).

Other medicines and Diamicron 80 mg
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened
and signs of low blood sugar levels may occur when one of the
following medicines is taken:
•  ther medicines used to treat high blood sugar (oral antidiabetics,
GLP-1 receptor inhibitors or insulin),
•  ntibiotics (e.g. sulphonamides, clarithromycin),
•  edicines to treat high blood pressure or heart failure (beta
blockers, ACE-inhibitors such as captopril or enalapril),
•  edicines to treat fungal infections (miconazole, fluconazole),
•  edicines to treat ulcers in the stomach or duodenum (H2 receptor
•  edicines to treat depression (monoamine oxidase inhibitors),
•  ainkiller or antirheumatics (phenylbutazone, ibuprofen),
•  edicines containing alcohol.

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
The following signs and symptoms may also occur: sweating,
clammy skin, anxiety, fast or irregular heart beat, high blood
pressure, sudden strong pain in the chest that may radiate into
nearby areas (angina pectoris).

The blood glucose lowering effect of gliclazide may be weakened
and raised blood sugar levels may occur when one of the following
medicines is taken:
•  edicines to treat disorders of the central nervous system
•  edicines reducing inflammation (corticosteroids),
•  edicines to treat asthma or used during labour (intravenous
salbutamol, ritodrine and terbutaline),
•  edicines to treat breast disorders, heavy menstrual bleeding
and endometriosis (danazol).
Diamicron 80mg may increase the effects of medicines which
reduce blood clotting (e.g. warfarin).

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 artificial sweeteners
are not effective.

Consult your doctor before you start taking another medicinal
product. If you go into hospital tell the medical staff you are taking
Diamicron 80mg.

taking the medicine as prescribed, you should contact your doctor
or pharmacist.
Routes and method of administration
Oral use.
Swallow your tablets whole. Do not chew them.
Take your tablet(s) with a glass of water before a meal.

Taking Diamicron 80 mg with food, drink and alcohol
Diamicron 80 mg can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of
your diabetes.

If you take more Diamicron 80 mg than you should
If you take too many tablets, contact your doctor or the nearest
hospital Accident & Emergency department immediately.
The signs of overdose are those of low blood sugar (hypoglycaemia)
described in Section 2.
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.

Pregnancy and breastfeeding
Diamicron 80 mg is not recommended for use during pregnancy. If
you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby while taking this medicine, inform your
doctor so that he may prescribe a more suitable treatment for you.
You must not take Diamicron 80 mg while you are breastfeeding.
Driving and using machines
Provided your blood glucose levels are satisfactorily controlled on
Diamicron 80 mg, your ability to drive or use machines should not
be affected.
However, if your blood 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:
•  ave frequent episodes of low blood sugar (hypoglycaemia),
•  ave few or no warning signals of low blood sugar (hypoglycaemia).

If you forget to take Diamicron 80 mg
It is important to take your medicine every day as regular treatment
works better.
However, if you forget to take a dose of Diamicron 80 mg, take the
next dose at the usual time. Do not take a double dose to make up
for a forgotten dose.
If you stop taking Diamicron 80 mg
As the treatment for diabetes is usually 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.

3. How to take Diamicron 80 mg
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is from one half to four tablets. This depends
on the response to treatment. When the total daily dose exceeds
two tablets, it should be divided into two equal doses taken morning
and evening.
If a combination therapy of Diamicron 80 mg 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

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.
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.

Do not use this medicine after the expiry date which is stated on
the carton and the blister strip. The expiry date refers to the last
day of that month.
Store in the original package.
This medicinal product does not require any special storage

Other side effects
• Digestive disorders: Abdominal pain, nausea, vomiting, indigestion,

diarrhoea and constipation. These effects are reduced when
Diamicron 80 mg is taken with a meal as recommended.
• Skin disorders: Skin reactions such as rash, redness, itching, hives

angioedema (rapid swelling of tissues such as eyelids, face, lips,
mouth, tongue or throat that may result in breathing difficulty) have
been reported. The rash may progress to widespread blistering
or peeling of the skin.
•  lood 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.
•  iver 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 treatment.
• 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.

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 Diamicron 80 mg contains
The active substance is gliclazide. Each tablet contains 80 mg of
The other ingredients are: lactose monohydrate, maize starch,
pregelatinised maize starch, talc, magnesium stearate.
What Diamicron 80 mg looks like and contents of the pack
Diamicron 80 mg is a white, circular tablet with flat bevelled edges
and cross scoring on one face and come in cartons of 28, 56, 60
and 112 tablets.
Not all pack sizes may be marketed.

As for other sulphonylureas, the following adverse events have been
observed: cases of severe changes in the number of blood cells
and allergic inflammation 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.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Servier Laboratories Ltd
Rowley, Wexham Springs,
Slough SL3 6PJ, England
United Kingdom

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
5. How to store Diamicron 80 mg

Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France

Keep this medicine out of the sight and reach of children.

This leaflet was last revised in 02/2012.

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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.