Skip to Content

LAAGLYDA MR 60 MG MODIFIED-RELEASE TABLETS

Active substance(s): GLICLAZIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Laaglyda® MR 60 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.
What is in this leaflet
1. What Laaglyda MR is and what it is used for
2. What you need to know before you take Laaglyda MR
3. How to take Laaglyda MR
4. Possible side effects
5. How to store Laaglyda MR
6. Contents of the pack and other inf ormation

1. What Laaglyda MR is and what it is used for


Laaglyda MR is a medicine that reduces blood sugar levels
(antidiabetic medicine taken orally, belonging to the sulphonylurea
group).
Laaglyda 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 on keeping blood sugar at the correct
level.

2. What you need to know before you take
Laaglyda MR
Do not take Laaglyda MR:
• if you are allergic to gliclazide or any of the other ingredients of
this medicine (listed in section 6), or to other medicines of the
same substance group (sulphonylureas) or to other related
medicines (hypoglycaemic sulphonamides);
• if you have insulin dependent diabetes (type I);
• if you have ketone bodies and sugar in your urine (this may mean
that you have diabetic ketoacidosis), a diabetic precoma or coma;
• if you have severe kidney or liver disease;
• if you are taking medicines to treat fungal infections (miconazole,
see section “Taking Laaglyda MR with other medicines”);
• if you are breast feeding (see section “Pregnancy and breast
feeding”).
If you think any of the above situations applies to you, tell your
doctor, nurse or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Laaglyda MR.
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).

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 too high doses of gliclazide,
• if you suffer from particular hormone induced disorders
(functional disorders of the thyroid gland, of the pituitary gland
or the adrenal cortex),
• if your renal function or liver function is severely decreased.
If you have low blood sugar you may have the following symptoms:
headache, increased hunger, nausea, vomiting, weariness, sleep
disorders, restlessness, aggressiveness, poor concentration,
reduced alertness and reaction time, depression, confusion, speech
and visual disorders, tremor, sensory disturbances, dizziness and
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
the neighbouring areas (angina pectoris).

You should observe the treatment plan prescribed by your doctor to
achieve the recommended blood sugar levels. This means regular
tablet intake in addition to a dietary regimen and physical exercise.

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, possibly resulting in coma.
The clinical picture of a severe reduced blood sugar level may
resemble that of a stroke.

In the first few weeks of treatment the risk of having reduced blood
sugar levels (hypoglycaemia) may be increased. Therefore it is vital

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.
It is possible that 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).
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. accident, surgical procedure,
fever, etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar level (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. Symptoms 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.
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 hemoglobin level
and breakdown of red blood cells (hemolytic anemia) can occur.
Contact your doctor before taking this medicinal product.
Laaglyda MR is not recommended for use in children due to lack
of data.
Children and adolescents
Laaglyda MR is not to be used for the treatment of diabetes in
children and adolescents under 18 years of age. No data are
available in these patients.

Other medicines and Laaglyda MR
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 levels (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)
• painkillers 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 inflammations (corticosteroids)
• medicines to treat asthma or used during labour (intravenous
salbutamol, ritodrine, terbutaline)
• medicines to treat breast disorders, heavy menstrual bleeding and
endometriosis (danazol).
Laaglyda MR may increase the effect 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 that you are
taking Laaglyda MR.
Laaglyda MR with food, drink and alcohol
Laaglyda 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.
Pregnancy, breast feeding and fertility
If you are pregnant or breast feeding, think you may be pregnant
or are planning to have a baby, ask your doctor so that he may
prescribe a more suitable treatment for you.
Laaglyda MR is not recommended for use during pregnancy.
You must not take Laaglyda MR while you are breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your ability to concentrate or react may be impaired if your blood
sugar level 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 levels (hypoglycaemia),
• have fewer or no warning signals of low blood sugar
(hypoglycaemia).
Laaglyda MR contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

3. How to take Laaglyda 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 is determined by your 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 blood sugar may require changed
gliclazide doses.

The recommended dose is one 30 mg modified release tablet up to
two 60 mg modified release tablets (maximum 120 mg) in a single
intake at breakfast. This depends on the response to treatment.
If a combination therapy of Laaglyda MR modified release tablet
with metformin, an alpha glucosidase inhibitor, a thiazolidinedione,
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.
Method of use
Oral use
Swallow the tablet(s) whole in one piece. Do not chew or crush.
Take your tablet(s) with a glass of water at breakfast time (and
preferably at the same time every day).
You must always eat a meal after taking your tablet(s).
If you take more Laaglyda MR than you should
If you have taken too many tablets, contact your doctor or the
nearest hospital Accident & Emergency department immediately. The
signs of an overdose and those of low blood sugar (hypoglycaemia)
are 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 or 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 Laaglyda MR
It is important that you take the medicine every day as regular
treatment works better.
However, if you forget to take a dose of Laaglyda MR take the next

dose at the usual time. Do not take a double dose to make up for
the forgotten dose.

bruising, sore throat and fever have been reported. These symptoms
usually vanish when the treatment is discontinued.

If you stop taking Laaglyda MR
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 levels (hyperglycaemia) which
increases the risk of developing complications of diabetes.

Skin diseases
Skin reactions 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) have been reported. The
rash may progress to widespread blistering or peeling of the skin.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Liver disease
Abnormal liver function tests, which can cause yellow skin and eyes.
If you get this, see your doctor immediately. Your doctor will decide
whether to stop your treatment.


What Laaglyda MR contains
• The active substance is gliclazide. Each modified release tablet
contains 60 mg gliclazide.
• The other ingredients are hypromellose, lactose monohydrate,
colloidal anhydrous silica and
magnesium stearate (see section 2).

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.

What Laaglyda MR looks like and contents of the pack
White to almost white, oval, biconvex tablets with a length 13 mm
and a thickness 3.5 mm - 4.9 mm.

Common (may affect up to 1 in 10 people):

These effects generally disappear if the medicine is stopped

The most commonly observed side effect is low blood sugar
(hypoglycaemia) (for symptoms and signs see section Warnings and
precautions).
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.

As for other sulphonylureas, the following adverse events have been
observed very rarely (may affect up to 1 in 10,000 people):
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 sulfonylurea, but
may lead to life threatening liver failure in isolated cases.

Laaglyda MR is available in boxes of 14, 15, 28, 30, 56, 60, 84,
90, 120 or 180 modified-release tablets in blisters.

Uncommon (may affect up to 1 in 100 people):

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

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.

Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhoea and
constipation. These effects are reduced when Laaglyda MR modified
release tablet is taken with meals as recommended.
Rare (may affect up to 1 in 1,000 people):
Blood disorders
Decrease in the number of cells in the blood (e.g. platelets, red and
white blood cells) which may cause paleness, prolonged bleeding,

5. How to store Laaglyda MR


Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
blister and carton after EXP. The expiry date refers to the last day of
that month.
This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Further information

Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz Lohmann Str.5,
27472 Cuxhaven, Germany
Distributed by
Consilient Health (UK) Ltd., No.1 Church Road,
Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised 07/2014
P0278

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.

Hide