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DACADIS MR 30 MG MODIFIED-RELEASE TABLETS

Active substance(s): GLICLAZIDE

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PACKAGE LEAFLET

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Package leaflet: Information for the patient
DACADIS® MR 30 mg MODIFIED-RELEASE TABLETS
gliclazide
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. See section 4.
In this leaflet:
1.
What Dacadis MR is and what it is used for
2.
What you need to know before you take Dacadis MR
3.
How to take Dacadis MR
4.
Possible side effects
5.
How to store Dacadis MR
6.
Contents of the pack and other information
1.

What Dacadis MR is and what it is used for

Dacadis MR is a medicine to reduce blood sugar levels (oral antidiabetic medicine belonging
to the sulphonylurea group of medicines).
Dacadis MR 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.
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What you need to know before you take Dacadis MR

Do not take Dacadis MR
if you are allergic to gliclazide or to any of the other ingredients of this medicine (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 (type 1) diabetes,
if you have ketone bodies and sugar in the urine (this may mean you have diabetic ketoacidosis), 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 ‘Other
medicines and Dacadis MR’),
if you are breast feeding.
If you think any of the above situations applies to you, tell your doctor or pharmacist.
Warnings and precautions
This medicine should be used only if you are likely to have regular food intake (including
breakfast). It is important to have a regular carbohydrate intake due to the increased risk of
low blood sugar level (hypoglycaemia) if a meal is delayed or skipped, if an inadequate
amount of food is consumed or if the food is low in carbohydrate.
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During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level
is necessary. Your doctor may also take blood tests to monitor your glycated haemoglobin
(HbA1c).
You should observe the treatment plan prescribed by your doctor in order to achieve the
recommended blood sugar levels. This means regular tablet intake in addition to a dietary
regimen and physical exercise and, where necessary, reduced weight.
In the first few weeks of treatment the risk of having reduced blood sugar levels
(hypoglycaemia) may be increased. Therefore it is vital that you are carefully monitored by
your doctor.
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 without an appropriate increase in carbohydrate
intake,
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 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 suffer from low blood sugar you may have the following symptoms: headache, intense
hunger, paleness, weakness, exhaustion, nausea, vomiting, weariness, sleepiness, sleep
disorders, restlessness, aggressiveness, impaired concentration, reduced alertness and reaction
time, depression, confusion, speech or visual disorders, tremor, sensory disturbances,
dizziness, helplessness. The following signs and symptoms may also occur: sweating, clammy
skin, anxiety, fast or irregular heartbeat, high blood pressure, and sudden strong pain in the
chest that may radiate into nearby areas (angina pectoris).
If your blood sugar levels continue to drop you may suffer from considerable confusion
(delirium), develop convulsions, lose self-control, breathing may be shallow and your heart
beat slowed down, you may fall into unconsciousness possibly resulting in coma.
In most cases the symptoms of low blood sugar vanish very quickly when you consume some
form of sugar, e.g. sugar cubes, sweet juice, sweetened tea. You should therefore always take
some form of sugar with you (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.
It is possible that symptoms of low blood sugar may be absent, that they develop slowly or
that you do not realise 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). It may also happen when you suffer from
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certain disorders of the endocrine system (e.g. certain disorders of thyroid function and
anterior pituitary or adrenocortical insufficiency).
If you are in stress-situations (e.g. accidents, surgical operations, infections with 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 taken the medicine in the way your
doctor has told you or in special stress situations. Signs of high blood sugar may include
thirst, frequent urination, dry mouth, dry itchy skin, skin infections and diminished
performance. Contact your doctor or pharmacist if you experience any of these.
If you have a family history of or know that you have the hereditary condition glucose-6phosphate 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.
Children and adolescents
Dacadis MR is not to be used for the treatment of diabetes in children and adolescents under
18 years of age.
Other medicines and Dacadis MR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.
The effectiveness and safety of Dacadis MR may be affected if this medicine is taken at the
same time as certain other medicines. Conversely, other medicines may be affected if they are
taken at the same time as Dacadis MR.
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),
antibacterial medicines (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 indigestion and ulcers in the stomach or duodenum (H2 receptor
antagonists such as ranitidine),
medicines to treat depression (monoamine oxidase inhibitors such as selegiline,
phenelzine),
painkillers or antirheumatics (ibuprofen, phenylbutazone),
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:
medicine to treat disorders of the central nervous system (chlorpromazine),
medicines reducing inflammation (glucocorticoids such as hydrocortisone,
prednisolone),
medicine to treat asthma (salbutamol when given by injection),
medicines used during labour (ritodrine and terbutaline given by injection),
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medicine to treat breast disorders, heavy menstrual bleeding and endometriosis
(danazol),

Gliclazide may increase the effect of warfarin (a medicine that inhibits blood clotting).
Consult your doctor before you start taking another medicinal product. If you go into hospital
tell the medical staff you are taking Dacadis MR.
Dacadis MR with food, drink and alcohol
Dacadis MR 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 and can even lead to coma.
Pregnancy and breast-feeding
Dacadis MR is not recommended for use during pregnancy.
You must not take Dacadis MR while you are breastfeeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor may
prescribe a more suitable treatment for you.
Driving and using machines
Dacadis MR has not known influence on the ability to drive and use machines. However, 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. This can occur more often at the beginning of treatment with Dacadis MR.
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 hypoglycaemia,
have fewer or no warning symptoms of hypoglycaemia.
Dacadis MR contains lactose.
If you have been told by your doctor that you have intolerance to some sugars, contact your
doctor before taking this medicinal product.
3.

How to take Dacadis MR

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 of Dacadis MR is determined by the doctor, depending on your blood and possibly
urine sugar levels. Changes 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 starting dose is one tablet (30 mg) once daily. The usual dose can vary
from one to a maximum of four tablets (30 to 120 mg) taken at the same time, with breakfast.
This depends on the response to treatment.
If blood glucose is not adequately controlled, your doctor may increase your dose in
successive steps usually not less than 1 month apart.
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If a combination therapy of Dacadis MR with metformin, an alpha glucosidase inhibitor, a
thiazolidinedione, a 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 still high or have become too low although you
are taking the medicine as instructed, contact your doctor or pharmacist.
Route and method of administration
Oral use.
Swallow your tablets whole with a glass of water while having your breakfast, preferably at
the same time each day. You must always eat a meal after or while taking your tablets. It is
also important not to skip a meal when you are on Dacadis MR.
Do not crush or chew your tablets. If you do, there is a danger you could overdose because the
medicine will be absorbed into your body too quickly.
Use in children and adolescents
Dacadis MR is not recommended for use in children and adolescents as there is no data
available.
If you take more Dacadis MR 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 Dacadis MR
If you forget to take a dose take the next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Dacadis MR If you interrupt or stop the treatment you should be aware
that your blood sugar control will deteriorate. Stopping could lead to high blood sugar
(hyperglycaemia), which increases the risk of developing complications of diabetes. If any
change is necessary it is important to contact your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following side effects, which can
be serious:
Rare (may affect up to 1 in 1,000 people):
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Decrease in the number of red or white blood cells, or platelets in the blood, which may
cause tiredness, shortness of breath or pale skin, fever, severe chills, sore throat or mouth
ulcers (reduced white blood cells), bleeding or bruising more easily than usual or nose
bleeds.
Inflammation of the liver (hepatitis) which may cause nausea, vomiting, loss of appetite,
feeling generally unwell, fever, itching, yellowing of the skin or whites of the eyes
(jaundice), light coloured bowel motions, dark coloured urine
Severe skin reactions including red skin, blistering of the lips, eyes or mouth, peeling of
the skin, fever.
Angioedema, which causes rapid swelling of the eyelids, face, lips, mouth, tongue or
throat and may result in difficulty breathing.

Not known (frequency cannot be estimated from the available data):
 Signs of a serious allergic reaction, which may include an itchy skin rash, difficulty
breathing, wheezing
Your medicine will need to be stopped. Your doctor will tell you how to do this.
Other side effects
Common (may affect up to 1 in 10 people):
 Hypoglycaemia (low blood sugar). For symptoms and signs see section 2,
‘Warnings and precautions’. If left untreated these symptoms could progress to
drowsiness, loss of consciousness and 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.
Uncommon (may affect up to 1 in 100 people):
 Abdominal pain
 Nausea
 Vomiting
 Indigestion
 Diarrhoea
 Constipation.
These effects are reduced when Dacadis MR is taken with a meal as recommended.
Rare (may affect up to 1 in 1,000 people):
 Decrease in the number of cells in the blood(e.g. platelets and red blood cells), which may
cause paleness, prolonged bleeding, bruising, tiredness, headaches, shortness of breath or
dizziness. These symptoms usually vanish when the treatment is stopped.
 Skin reactions such as rash, redness, itching and hives.
 Abnormal liver function tests.
 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.
These generally disappear if the medicine is stopped.
Not known (frequency cannot be estimated from the available data):
 Allergic inflammation of the walls of blood vessels

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Low sodium levels in the blood, which may cause confusion, tiredness, loss of
appetite, restlessness or irritability, muscle weakness, cramps or uncontrollable
movement.

Reporting of side effects
If you get any 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 can help provide more information on the safety of this
medicine.
5.

How to store Dacadis MR

Keep this medicine out of the sight and reach of children.
Expiry date
Do not use this medicine after the expiry date which is stated on the blister, the tablet
container and the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to thrown away medicines you no longer use. These measures will help protect the
environment.
6.

Contents of the pack and other information

What Dacadis MR contains
The active substance is gliclazide. Each modified-release tablet contains 30 mg
gliclazide.
The other ingredients are lactose monohydrate (see section 2, “Dacadis MR contains
lactose”), hypromellose, calcium carbonate, colloidal anhydrous silica, magnesium
stearate.
What Dacadis MR looks like and contents of the pack
The modified-release tablets are white, oval, biconvex tablets.
Dacadis MR is available in blisters in boxes of 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 120 or
180 tablets and in tablet containers of 90, 120 or 180 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturer
Krka, d.d., Novo Mesto, Smarješka Cesta 6, 8501 Slovenia
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary
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This leaflet was last revised in
December 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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