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GLICLAZIDE 80 MG TABLETS

Active substance(s): GLICLAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GLICLAZIDE 80mg
TABLETS
Gliclazide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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Keep this leaflet. You may need to read it again.

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If you have any further questions, ask your doctor or pharmacist.

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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.

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If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet:
1. What Gliclazide Tablets are and what they are used for
2. What you need to know before you take Gliclazide Tablets
3. How to take Gliclazide Tablets

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).

6. Contents of the pack and other information

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.

1. What Gliclazide Tablets are and what they are
used for

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.

4. Possible side effects
5. How to store Gliclazide Tablets

The full name of your medicine is Gliclazide 80mg Tablets but
within the leaflet it will be referred to as Gliclazide Tablets. It
contains the active substance gliclazide, one of a group of
medicines called sulphonylureas. It is an oral hypoglycaemic
medicine (blood sugar lowering drug).
Gliclazide Tablets 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.

You should therefore always carry some form of sugar with you
(glucose tablets, sugar cubes). Remember that artificial
sweeteners are not effective.
Please contact your doctor or the nearest hospital if taking sugar
does not help or if the symptoms recur.
While taking Gliclazide Tablets you should:
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2. What you need to know before you take
Gliclazide Tablets
Do not take Gliclazide Tablets
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if you are allergic to gliclazide or any of the other ingredients
of this medicine (listed in section 6), to other medicines of the
same group (sulphonylureas), to other related medicines
(hypoglycaemic sulphonamides);
if you have insulin-dependent diabetes (type 1);
if you have ketone bodies and sugar in your urine (this may
mean you have keto-acidosis), a diabetic pre-coma and coma;
if you have severe kidney or liver disease;
if you are taking miconazole (a treatment for fungal infections)
(see Other medicines and Gliclazide Tablets);
if you are breastfeeding (see Pregnancy and breastfeeding).

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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.
Other medicines and Gliclazide Tablets
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:
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Gliclazide Tablets are not recommended for use in children.
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Warnings and precautions

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Follow your doctor's advice about diet and treatment. This is to
reduce the chances of very low blood sugar (hypoglycaemia).

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Make sure your doctor knows
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if you have an operation, a serious injury, fever or infection,
difficulty in eating,
if you plan a pregnancy or become pregnant,
if you are taking any of the medicines listed in Other
medicines and Gliclazide Tablets.

Tell your dentist about your treatment.
Dietary advice

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This is more likely if:

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you are on a strict diet,
your diet is poorly balanced,
you are taking prolonged or strenuous exercise,
you drink alcohol,
if you are taking several medicines for high blood sugar (See
Other medicines and Gliclazide Tablets).

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.

other medicines used to treat high blood sugar (oral
antidiabetics, GLP-1 receptor agonists 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, fluconazole),
medicines to treat ulcers in the stomach or duodenum (H2
receptor antagonists),
medicines to treat depression (monoamine oxidase inhibitors),
painkiller or antirheumatics (phenylbutazone, ibuprofen),
medicines containing alcohol.

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:

This medicine may cause episodes of low blood sugar
(hypoglycaemia).
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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 Gliclazide
Tablets);
check your blood glucose regularly as recommended by your
doctor.

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medicines to treat disorders of the central nervous system
(chlorpromazine),
medicines reducing inflammation (corticosteroids),
medicines to treat asthma or used during labour (intravenous
salbutamol, ritodrine and terbutaline),
medicines to treat breast disorders, heavy menstrual bleeding
and endometriosis (danazol).

Gliclazide Tablets may increase the effects of medicines which
reduce blood clotting (e.g. warfarin).
Consult your doctor before you start taking another medicinal
product. If you go into hospital tell the medical staff you are taking
Gliclazide Tablets.
Gliclazide 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
Gliclazide Tablets are 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, ask your doctor for
advice before taking this medicine. He may prescribe a more
suitable treatment for you.

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.
Other side effects
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You must not take Gliclazide Tablets while you are breast-feeding.
Driving and using machines
Provided your blood glucose levels are satisfactorily controlled on
Gliclazide Tablets, 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.

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Ask your doctor whether you can drive a car if you:
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have frequent episodes of low blood sugar (hypoglycaemia),
have few or no warning signals of low blood sugar
(hypoglycaemia).

Gliclazide Tablets contain lactose

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If you have been told by your doctor that you have an intolerance
to some sugars (e.g. glucose, lactose, galactose), contact your
doctor before taking this medicinal product.
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3. How to take Gliclazide Tablets
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 Gliclazide Tablets 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.

Digestive disorders: Abdominal pain, nausea, vomiting,
indigestion, diarrhoea and constipation. These effects are
reduced when Gliclazide Tablets are 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.
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 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.

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.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.

Routes and method of administration
Oral use.

5. How to store Gliclazide Tablets

Swallow your tablets whole. DO NOT chew them.

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.

Take your tablet(s) with a glass of water before a meal.
The tablet can be divided into equal doses.
If you take more Gliclazide Tablets 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.
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If the patient is unconscious, IMMEDIATELY inform a doctor and
call the emergency services.

Do not use this medicine after the expiry date which is stated on
the carton and the blister pack after EXP. The expiry date refers to
the last day of that month.
This medicinal product does not require any special storage
conditions. Store in the original package.
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 Gliclazide Tablets contain
The active substance is gliclazide. Each tablet contains 80mg
of gliclazide.
The other ingredients are: lactose monohydrate, maize starch,
povidone, silica colloidal anhydrous, magnesium stearate.

If you forget to take Gliclazide Tablets

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It is important to take your medicine every day as regular
treatment works better.

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However, if you forget to take a dose of Gliclazide Tablets, take
the next dose at the usual time. DO NOT take a double dose to
make up for a forgotten dose.

What Gliclazide Tablets look like and contents of the pack

If you stop taking Gliclazide Tablets
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.

Gliclazide 80mg are white, round (» 7.5mm diameter), flat faced
beveled edge tablets with break line on one side and plain on
other side.
Gliclazide Tablets are available in PVC/PVDC-Aluminium blister
packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Crescent Pharma Limited,

4. Possible side effects

Polhampton Lane, Overton,

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

Units 3 & 4, Quidhampton Business Units,
Hants RG25 3ED
United Kingdom
This leaflet was last revised in 02/2016.

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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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