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EDICIL MR 30 MG MODIFIED-RELEASE TABLETS

Active substance(s): GLICLAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Edicil MR 30 mg modified-release tablets

ratiopharm

Gliclazide
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Edicil MR is and what it is used for
2. Before you take Edicil MR
3. How to take Edicil MR
4. Possible side effects
5. How to store Edicil MR
6. Further information

1. What Edicil MR is and what it is
used for
Edicil MR is a medicine to reduce blood
sugar levels (antidiabetic medicine taken
orally).
This medicine 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.

2. Before you take Edicil MR
Do not take this medicine:
• if you are allergic (hypersensitive) to
gliclazide, to other sulphonylureas, to
sulphonamides or to any of the other
ingredients of Edicil MR,
• if you have insulin-dependent (type 1)
diabetes,
• if you have ketone bodies and sugar in the
urine (this may mean you have keto-acidosis),
diabetic pre-coma or coma,
• if you have severe kidney or liver disease,
• if you are taking medicines to treat fungal
infections (miconazole)
• if you are breast feeding.
If you think any of the above situations
applies to you, tell your doctor, nurse or
pharmacist.
Take special care with this medicine
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.
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.
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.
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 consume 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 hormoneinduced disorders (functional disorders of
the thyroid gland, of the pituitary gland or
adrenal cortex),
• if your renal function or liver function is
severely decreased.
If you suffer from low blood sugar you may
have the following symptoms: headache,
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, and helplessness.
The following signs and symptoms may also
occur: sweating, clammy skin, anxiety, fast
or irregular heart beat, high blood pressure,
and sudden strong pain in the breast that
may radiate into neighbouring areas (angina
pectoris).
If your blood sugar levels continue to drop
you may suffer from considerable confusion
(delirium), develop cerebral convulsions,
lose self control, breathing may be shallow
and your heart beat slowed down, you may
fall into unconsciousness possibly resulting
in coma. The clinical picture of a severe
reduced blood sugar level may resemble
that of a stroke.

In most cases the symptoms of reduced
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 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 reduced
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 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,
acute operations, infections with fever etc.)
your doctor may temporarily switch you to
insulin therapy.
Symptoms
of
raised
blood
sugar
(hyperglycaemia) may include thirst,
frequent urination, dry mouth, dry itchy skin,
skin infections and diminished performance.
This may be due to inadequate control of
blood sugar due to poor compliance with the
treatment or stress situations such as
infections. You must contact your doctor if in
such a situation.
This medicine is not to be used for the
treatment of diabetes in children and
adolescents under 18 years of age.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
The effectiveness and safety of Edicil 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 Edicil.
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) or insulin,
• antibacterial medicines (e.g. sulphonamides),
• medicines to treat high blood pressure or
heart failure (beta blockers, ACE-inhibitors
such as captopril, or enalapril),
• medicines to treat fungal infections
(miconazole, fluconazole),
• medicines to treat indigestion and ulcers in
the stomach or duodenum (H2 receptor
antagonists such as ranitidine),
• medicines to treat depression (monoamine
oxidase inhibitors),
• 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 inhibiting inflammation
(glucocorticoids),
• medicine to treat asthma (salbutamol when
given by injection),
• medicines used during labour (ritodrine
and terbutaline given by injection),
• medicine to treat breast disorders, heavy
menstrual bleeding and endometriosis
(danazol),
Gliclazide may potentiate anticoagulation
during concurrent treatment with 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
Edicil MR.
Taking this medicine with food and drink
This medicine can be taken with food and
non-alcoholic drinks.
Avoid alcohol as it can alter the control of
your diabetes in an unpredictable manner
and can even lead to coma.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
This medicine is not recommended for use
during pregnancy. If you are planning a
pregnancy, or become pregnant, inform your
doctor.
You must not take this medicine while you
are breast-feeding.

Driving and using machines
Your ability to concentrate or react may be
impaired if your blood sugar is too low
(hypoglycaemia), or too high (hyperglycaemia)
or if you develop visual problems as a result
of such conditions. Bear in mind that you
could endanger yourself or others (e.g. when
driving a car or using maschines). Please ask
your doctor whether you can drive a car if
you:
• have frequent episodes of hypoglycaemia,
• have fewer or no warning symptoms of
hypoglycaemia.
Important information about some of the
ingredients of this medicine
This medicine 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 Edicil MR
Always take this medicine exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.
The dose of this medicine 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 starting dose is one
tablet once daily. The usual dose can vary
from one to a maximum of four tablets once
daily. This depends on the response to
treatment.
If blood glucose is not adequately controlled,
your doctor may increase it in successive
steps usually not less than 1 month apart.
Edicil MR modified-release tablets can be
used to replace other oral antidiabetic
medicine, exactly like your doctor has told
you. If a combination therapy of Edicil MR
with metformin, an alpha glucosidase
inhibitor or insulin is initiated your doctor
will determine the proper dose of each
medicine individually for you.
Please speak with your doctor or pharmacist
if you have the impression that this medicine
is acting too strongly or not strongly
enough.
Swallow your tablets whole with a glass of
water whilst having your breakfast,
preferably at the same time each day. It is
important not to skip a mealwhen you are on
this medicine.
If you take more Edicil MR than you should
If you happen to have taken too much
gliclazide or an additional dose there is a
danger of low blood sugar levels, (signs of
hypoglycaemia see section 2) and therefore
you should instantly consume enough sugar
(e.g. a small bar of grape cubes, sugar cubes,
sweet juice, sweetened tea) and inform a
doctor immediately. The same should be
done if somebody, e.g. a child, has taken the
product unintentionally. Persons in a state of
unconsciousness must not be given food or
drink.
Since the state of hypoglycaemia may last
for some time it is very important that the
patient is carefully monitored until there is
no more danger. Admission into hospital
may be necessary, also as a measure of
precaution. Severe cases of hypoglycaemia
accompanied by loss of consciousness and
severe neurological failure are cases of
medical emergency requiring immediate
medical treatment and admission into a
hospital. 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 Edicil MR
If you forget your tablet(s) on one day,
continue taking your tablet(s) as usual on the
following day. You must not increase the
next dose you take.
Do not take a double dose to make up for a
forgotten tablet.
If you stop taking Edicil MR
If you interrupt or stop the treatment you
should be aware that your blood sugar
control will deteriorate. If any change is
necessary it is absolutely 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.
The assessment of side effects is based on
their frequency.
Common (occur in less than 1 in 10 but more
than 1 in 100 patients treated):
• Hypoglycaemia (low blood sugar). The
symptoms include sweating, pallor, hunger,
irregular or fast heart beat and loss of
consciousness and other (see point 2 Before
you take Edicil MR). The symptoms can be
helped by taking glucose or sugary drinks,
followed by a substantial snack or meal. If
the patient does not respond to the sugar
or is not alert call nearest emergency
department immediately. Never put anything
into the mouth of an unconscious person!

Uncommon (occur in less than 1 in 100 but
more than 1 in 1000 patients treated):
• Abdominal pain
• Nausea
• Vomiting
• Indigestion
• Diarrhoea
• Constipation.
These effects are reduced when Edicil MR is
taken with a meal as recommended.
Rare (occur in less than 1 in 1,000 but more
than 1 in 10,000 patients treated):
• Decrease in the number of cells in the
blood including (anaemia).
• Changes in blood values (which may cause
paleness, prolonged bleeding, bruising,
sore throat and fever) normally vanish
when the treatment is discontinued.
• Skin reactions such as redness, itching and
hives (rash). Severe skin reactions may
also appear.
• Abnormal liver function tests, changes in
your liver (which can cause yellow skin and
eyes).
• 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.
Severe changes in the number of blood cells
and allergic inflammation of the wall of
blood vessels have been described very
rarely for other sulphonylureas. With other
sulphonylureas signs and symptoms of liver
impairment (e.g. jaundice) have been
observed rarely which in most cases
disappeared after withdrawal of the
sulphonylureas, but may led to life-threatening
liver failure in isolated cases.
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. How to store Edicil MR
Keep out of the reach and sight of children.
This medicinal product does not require any
special storage conditions.
Expiry date
Do not use Edicil MR 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.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further information
What Edicil MR contains
• The active substance is gliclazide. Each
modified-release tablet contains 30 mg
gliclazide.
• The other ingredients are lactose
monohydrate, hypromellose, calcium
carbonate, colloidal anhydrous silica,
magnesium stearate.
What Edicil MR looks like and contents of the
pack
The modified-release tablets are white, oval,
biconvex tablets.
Edicil 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
or180 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ratiopharm GmbH, Graf-Arco-Str.3, 89079
Ulm, Germany.
Manufacturer
Krka, d.d., Novo mesto, Slovenia.
This medicinal product is authorised in the
Member States of the EEA under the
following names:
Germany:
Gliclazid-ratiopharm
30 mg retardtabletten
United Kingdom: EDICIL MR 30 mg
modified release tablets
France:
Gliclazide ratiopharm
30 mg comprimé à
libération modifiée
Denmark:
Gliclazid ratiopharm
30 mg tabletter med
modificeret udløsning
Portugal:
Gliclazida ratiopharm
30 mg ccomprimidos
delibertaçãoprolongada
Belgium:
Gliclazide-ratiopharm
30 mg tabletten met
gereguleerde afgifte
Czech Republic:
Gliclazid-ratiopharm
retard 30 mg
Slovak Republic: Gliclazid-ratiopharm
retard 30 mg
Hungary:
Gliclazid-ratiopharm
30 mg retard tabletta
Austria:
Gliclazid-ratiopharm
retard 30 mg tabletten
This leaflet was last approved in December
2007.

ratiopharm

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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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