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DIABEZIDUM XL 30 MG PROLONGED-RELEASE TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Diabezidum XL 30 mg prolonged-release tablets
Gliclazide
Read all of this leaflet carefully before you start taking this medicine.
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 gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Diabezidum is and what it is used for
2. Before you take Diabezidum
3. How to take Diabezidum
4. Possible side effects
5. How to store Diabezidum
6. Further information

1.

WHAT DIABEZIDUM IS AND WHAT IT IS USED FOR

Diabezidum is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the
sulphonylurea group).
Diabezidum is used in type 2 diabetes mellitus in adults, when diet, exercise and weight loss

alone do not have an adequate effect on keeping blood sugar at the correct level.
2.

BEFORE YOU TAKE DIABEZIDUM

Do not take Diabezidum
- if you are allergic (hypersensitive) to gliclazide or any of the other ingredients of Diabezidum, or
to other medicines of the same group (sulphonylureas), or 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 diabetic ketoacidosis), a diabetic pre-coma or coma (unconsciousness);
- if you have severe kidney or liver disease;
- if you are taking medicines to treat fungal infections (e.g. miconazole, see section “Taking other
medicines”);
- if you are breastfeeding.
Take special care with Diabezidum
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 gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also
your glycated haemoglobin (HbA1c) is necessary.
In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may
be increased. So particularly close medical monitoring is necessary.
Low blood sugar (hypoglycaemia) may occur if you:
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- take meals irregularly or skip meals altogether,
- are fasting,
- are malnourished,
- change your diet,
- increase your physical activity and carbohydrate intake does not match this increase,
- drink alcohol, especially in combination with skipped meals,
- take other medicines or natural remedies at the same time,
- take too high doses of gliclazide,
- suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the
pituitary gland or adrenal cortex),
- your kidney function or liver function is severely decreased.
Symptoms of low blood sugar
− 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
− sweating, clammy skin
− anxiety, fast or irregular
heart beat
− high blood pressure
− sudden strong pain in the
chest (angina pectoris)

If blood sugar levels
continue to drop
− considerable
confusion (delirium)
− convulsions
− loss of self-control
− shallow breathing
− slowed-down heart
beat
− 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.
Symptoms 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 (e.g. those acting on the central nervous system and beta blockers).
Symptoms of high blood sugar (hyperglycaemia) may occur if:
- gliclazide has not yet sufficiently reduced the blood sugar,
- you have not complied with the treatment plan prescribed by your doctor,
- in special stress situations.
Symptoms of high blood sugar
− thirst,
− frequent urination,
− dry mouth,
− dry itchy skin,
− skin infections,
− reduced performance.
If these symptoms occur, you must contact your doctor or pharmacist.
If you are in stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor may
temporarily switch you to insulin therapy.

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If you suffer from the hereditary condition when the blood cells do not produce sufficient quantity of
the enzyme glucose-6-phosphate dehydrogenase, Diabezidum may cause lowering of the haemoglobin
level and breakdown of red blood cells (haemolytic anaemia), see section 4.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription, as they may interact with your Diabezidum.
The effect of the product 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 or insulin),
- antibiotics (e.g. sulphonamides),
- 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),
- painkillers or nonsteroidal antirheumatics (phenylbutazone, ibuprofen),
- medicines containing alcohol.
The blood sugar lowering effect of the product 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 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).
Diabezidum 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.
Taking Diabezidum with food and drink
Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable
manner.
Pregnancy and breastfeeding
Diabezidum is not recommended for use during pregnancy. If you are planning a pregnancy, or
become pregnant, inform your doctor so that he may prescribe a more suitable treatment for you.
You must not take Diabezidum while you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia),
or too high (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 maschines).
Please 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).
3.

HOW TO TAKE DIABEZIDUM

Always take [Gliclazide] exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Methods and routes of administration
− Do not chew the tablets, swallow them whole.
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Take your tablet(s) with a glass of water at breakfast time and preferably at the same time each
day.
You must always eat a meal after taking your tablet(s).

Dosage
The dose is determined by the doctor, depending on your blood and possibly urine sugar levels.
Change in external factors (e.g. weight reduction, change in life style, stress) or improvements in the
blood sugar control may require changed gliclazide doses.
The usual dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time.
If a combination therapy of [Gliclazide] with metformin, an alpha glucosidase inhibitor or insulin is
initiated your doctor will determine the proper dose of each medicine individually for you.
Please talk to your doctor or pharmacist if you have the impression that [Gliclazide] is too strong or
too weak.

If you take more Diabezidum than you should
If you take too many tablets, contact your doctor or the nearest hospital 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. The same should be done if somebody, e.g. a child, has taken the product
unintentionally. Unconscious patients must not be given food or drink. You should ensure that there is
always someone present who is aware of your situation and who can call a doctor in case of
emergency.

If you forget to take Diabezidum
It is important to take your medicine every day as regular treatment works better.
However, if you forget to take a dose of Diabezidum, 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 Diabezidum
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).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines Diabezidum can cause side effects, although not everybody gets them.
The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and
signs see section 2 part "Take special care with [Gliclazide]".
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.
The following side effects have been reported at the frequencies shown:
Uncommon (affecting less than 1 person in 100):
abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation

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Rare (affecting less than 1 person in 1,000):
skin rashes and itching, redness, hives, blistering
changes in your blood (such as decrease in the number of certain cells in the blood which may
cause paleness, prolonged bleeding, bruising, sore throat and fever)
changes in your liver (which can cause yellow skin and eyes). These tend to disappear when the
medicine is stopped.
your vision may be affected for a short time especially when the treatment starts. This is due to
changes in the blood sugar level.
With other medicines of the same class (sulphonylureas), cases of severe changes in the number
of blood cells and allergic inflammation of the wall of blood vessels have been described.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5.

HOW TO STORE DIABEZIDUM

Keep out of the reach and sight of children.
Do not use Diabezidum after the expiry date which is stated on the carton and the blister strip or label
on the bottle. The expiry date refers to the last day of that month.
Blisters:
Do not store above 25°C. Store in the original packaging to protect from moisture. Keep the blisters in
the outer carton.
HDPE bottle:
Do not store above 25°C. Store in the original packaging. Keep the tablet container tightly closed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.

FURTHER INFORMATION

What Diabezidum contains
The active substance is gliclazide. One tablet contains gliclazide 30.0 mg in the prolonged-release
formulation.
The other ingredients are sodium hydrogen carbonate, mannitol, calcium hydrogen phosphate
dihydrate, colloidal silicon dioxide, magnesium stearate, hypromellose K100 LV-CR.
What Diabezidum looks like and contents of the pack
Diabezidum are white, 4.5 x 10.1 mm, oval biconvex tablets with “G” on one side. The tablets are
available in blister or HDPE bottle packed in cartons of 60 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Jelfa Pharmaceutical Company SA,
21 Wincentego Pola Str., 58-500
Jelenia Góra, Poland
Manufacturer
Actavis hf
Reykjavikurvegur 78, Hafnarfjordur, Iceland

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This medicinal product is authorised in the Member States of the EEA under the following
names:
United Kingdom
Diabezidum XL 30 mg prolonged-release tablets
Czech Republic
Diabezidum 30, tablet s řízeným uvolňováním
Slovak Republic
Diabezidum XL
Hungary
Gliclazide Jelfa 30 mg módosított hatóanyagleadású tabletta
Poland
Diabezidum
Romania
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Gliclazidă Jelfa 30 mg comprimate cu eliberare prelungită
Bulgaria
Diabezidum XL 30 mg таблетки с удължено освобождаване
Latvia
Diabezidum XL 30 mg ilgstošās darbības tabletes
Lithuania
Diabezidum XL 30mg pailginto atpalaidavimo tabletės
This leaflet was last revised in

August/2011

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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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