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DIAPREL MR 30MG TABLETS

Active substance(s): GLICLAZIDE

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Transcript
Ref: LTT0055/240214/1/F

®

Diaprel MR 30mg Tablets
(gliclazide)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* 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 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 leaflet.
Your medicine is called Diaprel MR 30mg Tablets but will be reffered to as
Diaprel throughout this leaflet.
What is in this leaflet:
1 What Diaprel is and what it is used for
2 What you need to know before you take Diaprel
3 How to take Diaprel
4 Possible side effects
5 How to store Diaprel

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). If you are in
stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor
may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide
has not yet sufficiently reduced the blood sugar, when you have not
complied with the treatment plan prescribed by your doctor or in special
stress situations. These may include thirst, frequent urination, dry mouth, dry
itchy skin, skin infections and reduced performance.

6 Contents of the pack and other information

If these symptoms occur, you must contact your doctor or pharmacist.

1

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), lowering of the haemoglobin level and breakdown of red blood
cells (haemolytic anaemia) can occur. Contact your doctor before taking this
medicinal product.

What Diaprel is and what it is used for

Diaprel is a medicine that reduces blood sugar levels (oral antidiabetic
medicine belonging to the sulphonylurea group).
Diaprel is used in a certain form of diabetes (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

What you need to know before you take Diaprel

Do not take Diaprel
* if you are allergic to gliclazide or any of the other ingredients of Diaprel
(listed in section 6), 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 keto-acidosis), a diabetic pre-coma or coma;
* if you have severe kidney or liver disease;
* if you are taking medicines to treat fungal infections (miconazole, see
Section “Taking other medicines”);
* if you are breastfeeding (see Section “Pregnancy and breastfeeding”).
Warnings and precautions
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 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 increase,
* 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 gliclazide,
* 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.

Diaprel is not recommended for use in children due to a lack of data.
Other medicines and Diaprel
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:
* 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:
* 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).
Diaprel 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 Diaprel.
Taking Diaprel with food, drink and alcohol
Diaprel can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of your
diabetes in an unpredictable manner.
Pregnancy and breastfeeding
Diaprel 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 Diaprel while you are breastfeeding.

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.

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 machines).

The following signs and symptoms may 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).

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).

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.

Ref: LTT0055/240214/1/B

®

Diaprel MR 30mg Tablets
(gliclazide)
Patient Information Leaflet (continued)
3

How to take Diaprel

Dose
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 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 recommended dose is one to four tablets (maximum 120mg) in a single
intake at breakfast time. This depends on the response to treatment.
If a combination therapy of Diaprel with metformin, an alpha glucosidase
inhibitor, a thiazlidinedione, 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.
Routes and method of administration
Oral use.
Swallow your tablets whole. Do not chew them.
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).
If you take more Diaprel 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.
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.

Digestive disorders

* Stomach pain or discomfort
* Feeling or being sick
* Indigestion
* Diarrhoea
* Constipation

These effects are reduced when Diaprel is taken with a meal as
recommended, See Section 3 “HOW TO TAKE”.
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 and side effects, talk to your doctor, pharmacist or nurse. 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 help provide more information on the safety of
this medicine.

5

How to store Diaprel

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
It should be ensured that there is always a pre-informed person that can call
a doctor in case of emergency.
If you forget to take Diaprel
It is important to take your medicine every day as regular treatment works
better.
However, if you forget to take a dose of Diaprel, 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 Diaprel
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.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines Diaprel 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 “Warnings and
precautions” in “Section 2 What you need to know before you take”.
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.
Blood disorders:
Decrease in the number of cells in the blood has been reported (e.g.
platelets, red and white blood cells).
This may cause:
* Paleness
* Prolonged bleeding
* Bruising
* Sore throat
* Fever
These symptoms usually vanish 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 medicine is stopped. Your doctor will
decide whether to stop your treatment.
Skin disorders
Skin reactions have been reported 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). The rash may
progress to widespread blistering or peeling of the skin.

Do not use Diaprel 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.
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

Contents of the pack and other infromation

What Diaprel contains
The active substance is gliclazide. One tablet contains 30 mg of gliclazide, in
a modified release formulation. The other ingredients are: colloidal
anhydrous silica, magnesium stearate, maltodextrin, hypromellose, calcium
hydrogen phosphate dihydrate.
What Diaprel looks like and contents of the pack
Diaprel tablets are white oblong tablets, engraved on both faces, ‘DIA 30’ on
one face and the Servier logo on the other. The tablets are available in
blister packs of 56 and 60 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by ANPHARM Przedsiebiorstwo
Farmaceutyczne S.A. - UI. Annopol 6B, 03-236 Warsaw, Poland, and is
procured from within the EU. Product Licence Holder: LTT Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Repackaged by Lexon (UK) Limited, Redditch, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

POM

PL 33723/0055

Revision date: 24/02/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT0055/240214/2/F

®

Diamicron 30mg MR Tablets
(gliclazide)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
beacuse it because it contains important information for you.
* 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 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 leaflet.

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.

Your medicine is called Diamicron 30mg MR Tablets but will be reffered to as
Diamicron throughout this leaflet.

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). If you are in
stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor
may temporarily switch you to insulin therapy.

What is in this leaflet
1 What Diamicron is and what it is used for
2 What you need to know before you take Diamicron
3 How to take Diamicron
4 Possible side effects
5 How to store Diamicron
6 Contents of the pack and other information

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 high blood sugar (hyperglycaemia) may occur when gliclazide
has not yet sufficiently reduced the blood sugar, when you have not
complied with the treatment plan prescribed by your doctor 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.

1

What Diamicron is and what it is used for

Diamicron is a medicine that reduces blood sugar levels (oral antidiabetic
medicine belonging to the sulphonylurea group).
Diamicron is used in a certain form of diabetes (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

What you need to know before you take Diamicron

Do not take Diamicron
* if you are allergic to gliclazide or any of the other ingredients of Diamicron
(listed in section 6), 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 keto-acidosis), a diabetic pre-coma or coma;
* if you have severe kidney or liver disease;
* if you are taking medicines to treat fungal infections (miconazole, see
Section “Taking other medicines”);
* if you are breastfeeding (see Section “Pregnancy and breastfeeding”).
Warnings and precautions
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 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 increase,
* 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 gliclazide,
* 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 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).
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.

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), lowering of the haemoglobin level and breakdown of red blood
cells (haemolytic anaemia) can occur. Contact your doctor before taking this
medicinal product.
Diamicron is not recommended for use in children due to a lack of data.
Other medicines and Diamicron
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:
* 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, 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:
* 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).
Diamicron 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 Diamicron.
Taking Diamicron with food, drink and alcohol
Diamicron can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of your
diabetes in an unpredictable manner.
Pregnancy and breastfeeding
Diamicron 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 while you are breastfeeding.
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 machines).
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).

Ref: LTT0055/240214/2/B

®

Diamicron 30mg MR Tablets
(gliclazide)
Patient Information Leaflet (continued)
3

How to take Diamicron

Dose
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 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 recommended dose is one to four tablets (maximum 120mg) in a single
intake at breakfast time. This depends on the response to treatment.
If a combination therapy of Diamicron with metformin, an alpha glucosidase
inhibitor, a thiazlidinedione, 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.
Routes and method of administration
Oral use.
Swallow your tablets whole. Do not chew them.
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).
If you take more Diamicron 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.
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.
It should be ensured that there is always a pre-informed person that can call
a doctor in case of emergency.
If you forget to take Diamicron
It is important to take your medicine every day as regular treatment works
better.
However, if you forget to take a dose of Diamicron, take the next dose at the
usual time. Do not take a double dose to make up for a forgotten dose.

Digestive disorders

* Stomach pain or discomfort
* Feeling or being sick
* Indigestion
* Diarrhoea
* Constipation

These effects are reduced when Diamicron is taken with a meal as
recommended, See Section 3 “HOW TO TAKE”.
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 and side effects, talk to your doctor, pharmacist or nurse. 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 help provide more information on the safety of
this medicine.
5

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Diamicron 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.
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

If you stop taking Diamicron
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.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines Diamicron 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 “Warnings and
precautions” in “Section 2 What you need to know before you take”.
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.
Blood disorders:
Decrease in the number of cells in the blood has been reported (e.g.
platelets, red and white blood cells).
This may cause:
* Paleness
* Prolonged bleeding
* Bruising
* Sore throat
* Fever
These symptoms usually vanish 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 medicine is stopped. Your doctor will
decide whether to stop your treatment.
Skin disorders
Skin reactions have been reported 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). The rash may
progress to widespread blistering or peeling of the skin.

How to store Diamicron

Contents of the pack and other information

What Diamicron contains
The active substance is gliclazide. One tablet contains 30 mg of gliclazide, in
a modified release formulation. The other ingredients are: colloidal
anhydrous silica, magnesium stearate, maltodextrin, hypromellose, calcium
hydrogen phosphate dihydrate.
What Diamicron looks like and contents of the pack
Diamicron tablets are white oblong tablets, engraved on both faces, ‘DIA 30’
on one face and the Servier logo on the other. The tablets are available in
blister packs of 56 and 60 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by ANPHARM Przedsiebiorstwo
Farmaceutyczne S.A. - UI. Annopol 6B, 03-236 Warsaw, Poland, and is
procured from within the EU. Product Licence Holder: LTT Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Repackaged by Lexon (UK) Limited, Redditch, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

POM

PL 33723/0055

Diamicron is a registered trademark of Biofarma.
Revision date: 24/02/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT0055/240214/3/F

®

Diaprel MR 30mg Tablets
(gliclazide)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* 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 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 leaflet.
Your medicine is called Diaprel MR 30mg Tablets but will be reffered to as
Diaprel throughout this leaflet.
What is in this leaflet:
1 What Diaprel is and what it is used for
2 What you need to know before you take Diaprel
3 How to take Diaprel
4 Possible side effects
5 How to store Diaprel

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). If you are in
stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor
may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide
has not yet sufficiently reduced the blood sugar, when you have not
complied with the treatment plan prescribed by your doctor or in special
stress situations. These may include thirst, frequent urination, dry mouth, dry
itchy skin, skin infections and reduced performance.

6 Contents of the pack and other information

If these symptoms occur, you must contact your doctor or pharmacist.

1

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), lowering of the haemoglobin level and breakdown of red blood
cells (haemolytic anaemia) can occur. Contact your doctor before taking this
medicinal product.

What Diaprel is and what it is used for

Diaprel is a medicine that reduces blood sugar levels (oral antidiabetic
medicine belonging to the sulphonylurea group).
Diaprel is used in a certain form of diabetes (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

What you need to know before you take Diaprel

Do not take Diaprel
* if you are allergic to gliclazide or any of the other ingredients of Diaprel
(listed in section 6), 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 keto-acidosis), a diabetic pre-coma or coma;
* if you have severe kidney or liver disease;
* if you are taking medicines to treat fungal infections (miconazole, see
Section “Taking other medicines”);
* if you are breastfeeding (see Section “Pregnancy and breastfeeding”).
Warnings and precautions
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 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 increase,
* 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 gliclazide,
* 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.

Diaprel is not recommended for use in children due to a lack of data.
Other medicines and Diaprel
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:
* 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:
* 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).
Diaprel 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 Diaprel.
Taking Diaprel with food, drink and alcohol
Diaprel can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of your
diabetes in an unpredictable manner.
Pregnancy and breastfeeding
Diaprel 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 Diaprel while you are breastfeeding.

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.

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 machines).

The following signs and symptoms may 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).

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).

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.

Ref: LTT0055/240214/3/B

®

Diaprel MR 30mg Tablets
(gliclazide)
Patient Information Leaflet (continued)
3

How to take Diaprel

Dose
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 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 recommended dose is one to four tablets (maximum 120mg) in a single
intake at breakfast time. This depends on the response to treatment.
If a combination therapy of Diaprel with metformin, an alpha glucosidase
inhibitor, a thiazlidinedione, 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.
Routes and method of administration
Oral use.
Swallow your tablets whole. Do not chew them.
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).
If you take more Diaprel 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.
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.

Digestive disorders

* Stomach pain or discomfort
* Feeling or being sick
* Indigestion
* Diarrhoea
* Constipation

These effects are reduced when Diaprel is taken with a meal as
recommended, See Section 3 “HOW TO TAKE”.
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 of pharmacist; this includes any
possible side effects not listed in this leaflet.
Reporting of side effects
If you get and side effects, talk to your doctor, pharmacist or nurse. 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 help provide more information on the safety of
this medicine.

5

How to store Diaprel

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
It should be ensured that there is always a pre-informed person that can call
a doctor in case of emergency.
If you forget to take Diaprel
It is important to take your medicine every day as regular treatment works
better.
However, if you forget to take a dose of Diaprel, 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 Diaprel
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.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines Diaprel 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 “Warnings and
precautions” in “Section 2 What you need to know before you take”.
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.
Blood disorders:
Decrease in the number of cells in the blood has been reported (e.g.
platelets, red and white blood cells).
This may cause:
* Paleness
* Prolonged bleeding
* Bruising
* Sore throat
* Fever
These symptoms usually vanish 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 medicine is stopped. Your doctor will
decide whether to stop your treatment.
Skin disorders
Skin reactions have been reported 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). The rash may
progress to widespread blistering or peeling of the skin.

Do not use Diaprel 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.
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

Contents of the pack and other infromation

What Diaprel contains
The active substance is gliclazide. One tablet contains 30 mg of gliclazide, in
a modified release formulation. The other ingredients are: colloidal
anhydrous silica, magnesium stearate, maltodextrin, hypromellose, calcium
hydrogen phosphate dihydrate.
What Diaprel looks like and contents of the pack
Diaprel tablets are white oblong tablets, engraved on both faces, ‘DIA 30’ on
one face and the Servier logo on the other. The tablets are available in
blister packs of 56 and 60 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Les Laboratoires Servier Industrie, 905
route de Saran, 45520 Gidy, France, and is procured from within the EU.
Product Licence Holder: LTT Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK)
Limited, Redditch, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

POM

PL 33723/0055

Revision date: 24/02/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT0055/240214/4/F

®

Diamicron 30mg MR Tablets
(gliclazide)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
beacuse it because it contains important information for you.
* 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 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 leaflet.

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.

Your medicine is called Diamicron 30mg MR Tablets but will be reffered to as
Diamicron throughout this leaflet.

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). If you are in
stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor
may temporarily switch you to insulin therapy.

What is in this leaflet
1 What Diamicron is and what it is used for
2 What you need to know before you take Diamicron
3 How to take Diamicron
4 Possible side effects
5 How to store Diamicron
6 Contents of the pack and other information

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 high blood sugar (hyperglycaemia) may occur when gliclazide
has not yet sufficiently reduced the blood sugar, when you have not
complied with the treatment plan prescribed by your doctor 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.

1

What Diamicron is and what it is used for

Diamicron is a medicine that reduces blood sugar levels (oral antidiabetic
medicine belonging to the sulphonylurea group).
Diamicron is used in a certain form of diabetes (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

What you need to know before you take Diamicron

Do not take Diamicron
* if you are allergic to gliclazide or any of the other ingredients of Diamicron
(listed in section 6), 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 keto-acidosis), a diabetic pre-coma or coma;
* if you have severe kidney or liver disease;
* if you are taking medicines to treat fungal infections (miconazole, see
Section “Taking other medicines”);
* if you are breastfeeding (see Section “Pregnancy and breastfeeding”).
Warnings and precautions
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 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 increase,
* 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 gliclazide,
* 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 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).
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.

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), lowering of the haemoglobin level and breakdown of red blood
cells (haemolytic anaemia) can occur. Contact your doctor before taking this
medicinal product.
Diamicron is not recommended for use in children due to a lack of data.
Other medicines and Diamicron
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:
* 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, 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:
* 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).
Diamicron 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 Diamicron.
Taking Diamicron with food, drink and alcohol
Diamicron can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of your
diabetes in an unpredictable manner.
Pregnancy and breastfeeding
Diamicron 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 while you are breastfeeding.
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 machines).
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).

Ref: LTT0055/240214/4/B

®

Diamicron 30mg MR Tablets
(gliclazide)
Patient Information Leaflet (continued)
3

How to take Diamicron

Dose
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 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 recommended dose is one to four tablets (maximum 120mg) in a single
intake at breakfast time. This depends on the response to treatment.
If a combination therapy of Diamicron with metformin, an alpha glucosidase
inhibitor, a thiazlidinedione, 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.
Routes and method of administration
Oral use.
Swallow your tablets whole. Do not chew them.
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).
If you take more Diamicron 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.
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.
It should be ensured that there is always a pre-informed person that can call
a doctor in case of emergency.
If you forget to take Diamicron
It is important to take your medicine every day as regular treatment works
better.
However, if you forget to take a dose of Diamicron, take the next dose at the
usual time. Do not take a double dose to make up for a forgotten dose.

Digestive disorders

* Stomach pain or discomfort
* Feeling or being sick
* Indigestion
* Diarrhoea
* Constipation

These effects are reduced when Diamicron is taken with a meal as
recommended, See Section 3 “HOW TO TAKE”.
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 and side effects, talk to your doctor, pharmacist or nurse. 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 help provide more information on the safety of
this medicine.
5

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Diamicron 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.
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

If you stop taking Diamicron
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.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines Diamicron 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 “Warnings and
precautions” in “Section 2 What you need to know before you take”.
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.
Blood disorders:
Decrease in the number of cells in the blood has been reported (e.g.
platelets, red and white blood cells).
This may cause:
* Paleness
* Prolonged bleeding
* Bruising
* Sore throat
* Fever
These symptoms usually vanish 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 medicine is stopped. Your doctor will
decide whether to stop your treatment.
Skin disorders
Skin reactions have been reported 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). The rash may
progress to widespread blistering or peeling of the skin.

How to store Diamicron

Contents of the pack and other information

What Diamicron contains
The active substance is gliclazide. One tablet contains 30 mg of gliclazide, in
a modified release formulation. The other ingredients are: colloidal
anhydrous silica, magnesium stearate, maltodextrin, hypromellose, calcium
hydrogen phosphate dihydrate.
What Diamicron looks like and contents of the pack
Diamicron tablets are white oblong tablets, engraved on both faces, ‘DIA 30’
on one face and the Servier logo on the other. The tablets are available in
blister packs of 56 and 60 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Les Laboratoires Servier Industrie, 905
route de Saran, 45520 Gidy, France, and is procured from within the EU.
Product Licence Holder: LTT Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK)
Limited, Redditch, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

POM PL 33723/0055
Diamicron is a registered trademark of Biofarma.
Revision date: 24/02/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT0055/240214/5/F

®

Diaprel MR 30mg Tablets
(gliclazide)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* 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 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 leaflet.
Your medicine is called Diaprel MR 30mg Tablets but will be reffered to as
Diaprel throughout this leaflet.
What is in this leaflet:
1 What Diaprel is and what it is used for
2 What you need to know before you take Diaprel
3 How to take Diaprel
4 Possible side effects
5 How to store Diaprel

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). If you are in
stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor
may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide
has not yet sufficiently reduced the blood sugar, when you have not
complied with the treatment plan prescribed by your doctor or in special
stress situations. These may include thirst, frequent urination, dry mouth, dry
itchy skin, skin infections and reduced performance.

6 Contents of the pack and other information

If these symptoms occur, you must contact your doctor or pharmacist.

1

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), lowering of the haemoglobin level and breakdown of red blood
cells (haemolytic anaemia) can occur. Contact your doctor before taking this
medicinal product.

What Diaprel is and what it is used for

Diaprel is a medicine that reduces blood sugar levels (oral antidiabetic
medicine belonging to the sulphonylurea group).
Diaprel is used in a certain form of diabetes (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

What you need to know before you take Diaprel

Do not take Diaprel
* if you are allergic to gliclazide or any of the other ingredients of Diaprel
(listed in section 6), 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 keto-acidosis), a diabetic pre-coma or coma;
* if you have severe kidney or liver disease;
* if you are taking medicines to treat fungal infections (miconazole, see
Section “Taking other medicines”);
* if you are breastfeeding (see Section “Pregnancy and breastfeeding”).
Warnings and precautions
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 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 increase,
* 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 gliclazide,
* 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.

Diaprel is not recommended for use in children due to a lack of data.
Other medicines and Diaprel
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:
* 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:
* 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).
Diaprel 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 Diaprel.
Taking Diaprel with food, drink and alcohol
Diaprel can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of your
diabetes in an unpredictable manner.
Pregnancy and breastfeeding
Diaprel 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 Diaprel while you are breastfeeding.

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.

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 machines).

The following signs and symptoms may 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).

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).

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.

Ref: LTT0055/240214/5/B

®

Diaprel MR 30mg Tablets
(gliclazide)
Patient Information Leaflet (continued)
3

How to take Diaprel

Dose
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 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 recommended dose is one to four tablets (maximum 120mg) in a single
intake at breakfast time. This depends on the response to treatment.
If a combination therapy of Diaprel with metformin, an alpha glucosidase
inhibitor, a thiazlidinedione, 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.
Routes and method of administration
Oral use.
Swallow your tablets whole. Do not chew them.
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).
If you take more Diaprel 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.
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.

Digestive disorders

* Stomach pain or discomfort
* Feeling or being sick
* Indigestion
* Diarrhoea
* Constipation

These effects are reduced when Diaprel is taken with a meal as
recommended, See Section 3 “HOW TO TAKE”.
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 and side effects, talk to your doctor, pharmacist or nurse. 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 help provide more information on the safety of
this medicine.

5

How to store Diaprel

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
It should be ensured that there is always a pre-informed person that can call
a doctor in case of emergency.
If you forget to take Diaprel
It is important to take your medicine every day as regular treatment works
better.
However, if you forget to take a dose of Diaprel, 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 Diaprel
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.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines Diaprel 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 “Warnings and
precautions” in “Section 2 What you need to know before you take”.
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.
Blood disorders:
Decrease in the number of cells in the blood has been reported (e.g.
platelets, red and white blood cells).
This may cause:
* Paleness
* Prolonged bleeding
* Bruising
* Sore throat
* Fever
These symptoms usually vanish 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 medicine is stopped. Your doctor will
decide whether to stop your treatment.
Skin disorders
Skin reactions have been reported 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). The rash may
progress to widespread blistering or peeling of the skin.

Do not use Diaprel 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.
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

Contents of the pack and other infromation

What Diaprel contains
The active substance is gliclazide. One tablet contains 30 mg of gliclazide, in
a modified release formulation. The other ingredients are: colloidal
anhydrous silica, magnesium stearate, maltodextrin, hypromellose, calcium
hydrogen phosphate dihydrate.
What Diaprel looks like and contents of the pack
Diaprel tablets are white oblong tablets, engraved on both faces, ‘DIA 30’ on
one face and the Servier logo on the other. The tablets are available in
blister packs of 56 and 60 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Servier (Ireland) Industries Ltd, Gorey
Road, Arklow - Co. Wicklow, Ireland, and is procured from within the EU.
Product Licence Holder: LTT Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK)
Limited, Redditch, B98 0RE
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

POM

PL 33723/0055

Revision date: 24/02/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT0055/240214/6/F

®

Diamicron 30mg MR Tablets
(gliclazide)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
beacuse it because it contains important information for you.
* 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 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 leaflet.

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.

Your medicine is called Diamicron 30mg MR Tablets but will be reffered to as
Diamicron throughout this leaflet.

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). If you are in
stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor
may temporarily switch you to insulin therapy.

What is in this leaflet
1 What Diamicron is and what it is used for
2 What you need to know before you take Diamicron
3 How to take Diamicron
4 Possible side effects
5 How to store Diamicron
6 Contents of the pack and other information

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 high blood sugar (hyperglycaemia) may occur when gliclazide
has not yet sufficiently reduced the blood sugar, when you have not
complied with the treatment plan prescribed by your doctor 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.

1

What Diamicron is and what it is used for

Diamicron is a medicine that reduces blood sugar levels (oral antidiabetic
medicine belonging to the sulphonylurea group).
Diamicron is used in a certain form of diabetes (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

What you need to know before you take Diamicron

Do not take Diamicron
* if you are allergic to gliclazide or any of the other ingredients of Diamicron
(listed in section 6), 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 keto-acidosis), a diabetic pre-coma or coma;
* if you have severe kidney or liver disease;
* if you are taking medicines to treat fungal infections (miconazole, see
Section “Taking other medicines”);
* if you are breastfeeding (see Section “Pregnancy and breastfeeding”).
Warnings and precautions
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 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 increase,
* 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 gliclazide,
* 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 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).
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.

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), lowering of the haemoglobin level and breakdown of red blood
cells (haemolytic anaemia) can occur. Contact your doctor before taking this
medicinal product.
Diamicron is not recommended for use in children due to a lack of data.
Other medicines and Diamicron
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:
* 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, 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:
* 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).
Diamicron 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 Diamicron.
Taking Diamicron with food, drink and alcohol
Diamicron can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of your
diabetes in an unpredictable manner.
Pregnancy and breastfeeding
Diamicron 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 while you are breastfeeding.
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 machines).
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).

Ref: LTT0055/240214/6/B

®

Diamicron 30mg MR Tablets
(gliclazide)
Patient Information Leaflet (continued)
3

How to take Diamicron

Dose
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 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 recommended dose is one to four tablets (maximum 120mg) in a single
intake at breakfast time. This depends on the response to treatment.
If a combination therapy of Diamicron with metformin, an alpha glucosidase
inhibitor, a thiazlidinedione, 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.
Routes and method of administration
Oral use.
Swallow your tablets whole. Do not chew them.
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).
If you take more Diamicron 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.
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.
It should be ensured that there is always a pre-informed person that can call
a doctor in case of emergency.
If you forget to take Diamicron
It is important to take your medicine every day as regular treatment works
better.
However, if you forget to take a dose of Diamicron, take the next dose at the
usual time. Do not take a double dose to make up for a forgotten dose.

Digestive disorders

* Stomach pain or discomfort
* Feeling or being sick
* Indigestion
* Diarrhoea
* Constipation

These effects are reduced when Diamicron is taken with a meal as
recommended, See Section 3 “HOW TO TAKE”.
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 and side effects, talk to your doctor, pharmacist or nurse. 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 help provide more information on the safety of
this medicine.
5

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Diamicron 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.
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

If you stop taking Diamicron
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.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines Diamicron 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 “Warnings and
precautions” in “Section 2 What you need to know before you take”.
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.
Blood disorders:
Decrease in the number of cells in the blood has been reported (e.g.
platelets, red and white blood cells).
This may cause:
* Paleness
* Prolonged bleeding
* Bruising
* Sore throat
* Fever
These symptoms usually vanish 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 medicine is stopped. Your doctor will
decide whether to stop your treatment.
Skin disorders
Skin reactions have been reported 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). The rash may
progress to widespread blistering or peeling of the skin.

How to store Diamicron

Contents of the pack and other information

What Diamicron contains
The active substance is gliclazide. One tablet contains 30 mg of gliclazide, in
a modified release formulation. The other ingredients are: colloidal
anhydrous silica, magnesium stearate, maltodextrin, hypromellose, calcium
hydrogen phosphate dihydrate.
What Diamicron looks like and contents of the pack
Diamicron tablets are white oblong tablets, engraved on both faces, ‘DIA 30’
on one face and the Servier logo on the other. The tablets are available in
blister packs of 56 and 60 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Servier (Ireland) Industries Ltd, Gorey
Road, Arklow - Co. Wicklow, Ireland, and is procured from within the EU.
Product Licence Holder: LTT Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK)
Limited, Redditch, B98 0RE
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

POM

PL 33723/0055

Diamicron is a registered trademark of Biofarma.
Revision date: 24/02/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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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