GLICLAZIDE 80 MG TABLETS

Active substance: GLICLAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB 727-0309-APIL

Gliclazide 80 mg Tablets
Gliclazide

Read all of this leaflet carefully
before you start taking this
medicine.
• Please 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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects becomes severe, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Gliclazide 80 mg Tablets are and what they are used
for
2. Before you take Gliclazide 80 mg Tablets
3. How to take Gliclazide 80 mg Tablets
4. Possible side effects
5. How to store Gliclazide 80 mg Tablets
6. Further information
1. WHAT GLICLAZIDE 80 MG TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is Gliclazide 80 mg Tablets. The
active ingredient is gliclazide. Gliclazide is one of a group of
medicines called sulphonylureas. It works by lowering the
amount of sugar in your blood.
Gliclazide 80 mg Tablets are used to treat type II diabetes
mellitus in adults.
2. BEFORE YOU TAKE GLICLAZIDE 80 MG TABLETS
Do not take this medicine if:
• you have ever had an allergic reaction (allergic reactions
include mild symptoms such as itching and/or rash. More
severe symptoms include swelling of the face, lips, tongue
and/or throat with difficulty in swallowing or breathing) to
any of the ingredients of Gliclazide 80 mg Tablets or any
other medicines that you may have taken to treat diabetes
mellitus;
• you suffer from severe liver or kidney problems;
• you suffer from type I diabetes;
• you suffer from diabetes complications such as ketoacidosis
(excessive acid and ketones in your blood);
• you are pregnant, trying to become pregnant or
breast-feeding;
• you are under 14 years of age;
• you are suffering from severe injury, infection or
undergoing major surgery;
• you are taking miconazole (a treatment for fungal
infections)(see Taking other medicines).
Take special care with this medicine and tell you
doctor or pharmacist if:
• you have liver or kidney problems;
• you are experiencing the symptoms of low blood sugar
(such as sweating, pallor, hunger, faster heart beat and
feeling unwell).
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 if:
• you have an operation, a serious injury, fever or infection,
difficulty in eating;
• you are planning a pregnancy or become pregnant;
• you are taking any of the medicines listed in Taking
other medicines.
Tell your dentist about your treatment.
Dietary advice
This medicine may cause episodes of low blood sugar
(hypoglycaemia).
This is more likely if:
• you are on a strict diet;
• your diet is poorly balanced;

• you are taking prolonged or strenuous exercise;
• you drink alcohol;
• you are taking several medicines for high blood sugar (See
Taking other medicines).
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 heart beat, high blood
pressure, sudden strong pain in the chest that may spread 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 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 80 mg 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
Gliclazide 80 mg Tablets);
• check 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.
Taking other medicines
If you take Gliclazide 80 mg Tablets with other medications,
their actions may increase or lower your blood sugar. Tell your
doctor if you are taking any other medicines, especially the
following:
• other medicines used to treat high blood sugar (oral
antidiabetics or insulin);
• medicines for depression, e.g. monoamine oxidase
inhibitors;
• medicines for high blood pressure, e.g. captopril or
enalapril;
• medicines for heart problems such as chest pain, irregular
heart beats or heart failure, e.g. beta blockers;
• medicines for arthritis or gout, e.g. phenylbutazone;
• medicines to treat infection, e.g. antibiotics
(examples include antibiotics known as tetracyclines,
clarithromycin and the medicines called chloramphenicol
and miconazole);
• medicines known as sulfonamides, e.g. diuretics
(indapamide);
• medicines to treat blood clots, e.g. anticoagulants;
• medicines to treat stomach ulcers, e.g. cimetidine;
• medicines used to treat psychoses, e.g. chlorpromazine;
• medicines used to suppress the immune system, e.g.
corticosteroids;
• medicines used as painkillers, e.g. anti-inflammatory
agents such as ibuprofen;
• medicines containing alcohol;
• medicines to treat asthma, e.g. intravenous salbutamol or
terbutaline;
• medicines used during labour, e.g. intravenous ritodrine;
• medicines to treat breast disorders, heavy menstrual
bleeding and endometriosis, e.g. danazol.
Please tell your doctor or pharmacist if you are taking or have



recently taken any other medicines, including medicines
obtained without a prescription.
If you go to hospital tell the medical staff you are taking
Gliclazide 80 mg Tablets.
Gliclazide 80 mg Tablets can be taken with food and
non-alcoholic drinks. Drinking alcohol is not recommended as
it can alter the control of your diabetes.
Other special warnings
• You may experience low blood sugar at the beginning of
treatment while your doctor is trying to find the dose that
best suits you. Your doctor will give you further advice.
• Tell your doctor that you are taking Gliclazide 80 mg
Tablets if you are going to have an operation of any kind.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, become pregnant or if you
are breast-feeding. Gliclazide Tablets should not be used in
pregnancy or during breast-feeding.
Driving and using machines
If you experience the symptoms of low blood sugar
(hypoglycaemia), especially at the beginning of treatment, you
should not drive or operate machinery.
Important information about some of the ingredients
in Gliclazide Tablets
Tell your doctor before taking this medicine if you have been
told that you have an intolerance to some sugars. This is
because Gliclazide 80 mg Tablets contain lactose, a type of
sugar.
3. HOW TO TAKE GLICLAZIDE 80 MG TABLETS
Always take your medicine exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure. The tablet should be swallowed with water.
The usual doses of Gliclazide 80 mg Tablets are as follows:
Adults and the elderly
At first this may be 40 – 80 mg a day. Your doctor may
increase your dose if your blood sugar level does not come
down enough. The maximum daily dose is 320 mg. You should
not take more than your doctor tells you.
When the total daily dose exceeds two tablets, it should be
divided into two equal doses taken morning and evening.
The medicine should be taken immediately after food, either
with breakfast or the main meal of the day.
Children
Gliclazide 80 mg Tablets are not indicated for the treatment of
children.
If you take more tablets than you should
If you accidentally take too much of your medicine, tell your
doctor at once or contact your nearest hospital casualty
department immediately. Take your medicine with you.
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.
If you forget to take your medicine
If you forget to take a dose, just take the next dose at the usual
time. DO NOT take a double dose.
If you stop taking Gliclazide 80 mg 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.
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). Symptoms include headache, intense
hunger, feeling or being sick, lack of energy and feeling
agitated.
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
• Digestive disorders: Abdominal pain, feeling sick, nausea,
vomiting, indigestion, diarrhoea and constipation. These
effects are reduced when Gliclazide 80 mg Tablets are
taken with a meal as recommended.
• Skin disorders: Skin reactions such as rash, redness,
itching, hives and 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: Feeling tired or a 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 notice 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 with 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.
5. HOW TO STORE GLICLAZIDE 80 MG TABLETS
Do not use after the expiry date that is stated on the carton or
label.
Store the tablets in the original package. Do not store above
25ºC.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Return any unused medicine to your pharmacist.
6. FURTHER INFORMATION
What Gliclazide 80 mg Tablets contain:
Each tablet contains 80 mg of the active substance, gliclazide.
The other ingredients are lactose, silicon dioxide,
pregelatinized maize starch, talc and magnesium stearate.
What Gliclazide 80 mg Tablets look like and the
contents of the pack
Gliclazide 80 mg Tablets are white round tablets embossed
with ‘G03’ on one side. They are packed in foil blister packs
and are available in cartons of 28 and 60 tablets.
Marketing Authorisation Holder and Manufacturer:
Waymade Plc trading as Sovereign Medical, Sovereign House,
Miles Gray Road, Basildon, Essex, SS14 3FR.
This leaflet does not contain all the available information
about your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist.
The information in this leaflet applies only to Gliclazide 80 mg
Tablets.
Date of preparation of the leaflet: November 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.

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