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BILXONA 60MG MODIFIED-RELEASE TABLETS

Active substance(s): GLICLAZIDE

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Package leaflet: Information for the patient

Bilxona 30mg and 60mg
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.
• I f 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.

What is in this leaflet
1 What Bilxona is and what it is used for
2 What you need to know before you take Bilxona
3 How to take Bilxona
4 Possible side effects
5 How to store Bilxona
6 Contents of the pack and other information
1 What Bilxona is and what it is used for
Bilxona is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group).
Bilxona 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 Bilxona
Do not take Bilxona:

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 heartbeat, 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.
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 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.

• 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 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 ‘Other medicines and Bilxona’)
• if you are breastfeeding (see Section ‘Pregnancy and
breastfeeding’).

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

Warnings and precautions

Other medicines and Bilxona

Talk to your doctor or pharmacist before taking Bilxona.
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. It may also be useful to monitor your own
blood sugar levels, although only following instruction from your
doctor.
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 recently stopped taking corticosteroids (medicines
that reduce inflammation) following prolonged and/or high dose
use
• if you have a severe blood circulation disorder, such as coronary
heart disease, severe carotid artery impairment or diffuse vascular
disease.
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,
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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.

Children and adolescents

Bilxona is not recommended for use in children and adolescents
due to a lack of data.
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:
•O
 ther medicines used to treat high blood sugar (oral antidiabetics or insulin)
•A
 ntibiotics (e.g. sulphonamides or clarithromycin)
•M
 edicines to treat high blood pressure or heart failure (beta
blockers, ACE-inhibitors such as captopril or enalpril)
•M
 edicines to treat fungal infections (e.g. miconazole, fluconazole
– see section ‘Do not take Bilxona’)
•M
 edicines to treat ulcers in the stomach or duodenum (H2
receptor antagonists)
•M
 edicines to treat depression (monamine oxidase inhibitors)
•P
 ainkillers or antirheumatics (phenylbutazone, ibuprofen)
•M
 edicines containing alcohol
The blood glucose lowering effect of gliclazide may be weakened
and raised blood sugar may occur when one of the following
medicines is taken:
•M
 edicines to treat disorders of the central nervous system
(chlorpromazine)
•M
 edicines reducing inflammation (corticosteroids or
tetracosactrin)
•M
 edicines to treat asthma or used during labour (intravenous
salbutamol, ritodrine and terbutaline)
•M
 edicines to treat breast disorders, heavy menstrual bleeding
and endometriosis (danazol)
Bilxona 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 to into hospital tell the medical staff you are
taking Bilxona.

Bilxona with food, drink and alcohol

Bilxona 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.
Continued over page

Pregnancy and breastfeeding

Pregnancy
Bilxona is not recommended for use during pregnancy. If you
are pregnant or breastfeeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Breastfeeding
You must not take Bilxona 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).

Bilxona contains lactose

If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.

3 How to take Bilxona
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The dose is determined by the doctor, depending on your blood
and possibly urine sugar levels.
Change in external factors (e.g. weight reduction, change in life
style, stress) or improvements in the blood sugar control may
require changed gliclazide doses.
The recommended starting dose is 30mg.
For 30mg tablets: The usual dose is one to four tablets (maximum
120mg) in a single intake at breakfast time. This depends on the
response to treatment.
For 60mg tablets: The tablet can be divided into equal doses.
The usual dose is half to two tablets (maximum 120mg) in a
single intake at breakfast time. This depends on the response to
treatment.
If a combination therapy of Bilxona with metformin, an alpha
glucosidase inhibitor or insulin is initiated your doctor will
determine the proper dose of each medicine individually for you.
Please talk to your doctor or pharmacist if you have the impression
that Bilxona is acting too strongly or not strongly enough.

Methods and routes of administration

Oral use.
For 30mg tablets: Swallow your whole tablet(s) in one piece.
For 60mg tablets: Swallow your half tablet or whole tablet(s) 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 each day).
You must always eat a meal after taking your tablet(s).

If you take more Bilxona 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 Bilxona

It is important to take your medicine every day as regular
treatment works better.
However, if you forget to take a dose of Bilxona, take the next
dose at the usual time. Do not take a double dose to make up for a
forgotten dose.

If your doctor switches you from gliclazide 80mg
tablets or from other anti-diabetics to Bilxona

Your doctor will decide your initial dose and monitor you more
closely for a short time.

If you stop taking Bilxona

As the treatment for diabetes is usually life long, you should
discuss with your doctor before stopping this medicinal product.
Stopping could cause high blood sugar (hyperglycaemia).
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine 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 ‘Warnings and
precautions’ in section 2. If left untreated these symptoms could
progress to drowsiness, loss of consciousness or possibly coma.
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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.
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 such as rash, redness, itching, hives and 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.
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,
bruising, sore throat and fever have been reported. These
symptoms usually vanish when the treatment is discontinued.
Digestive disorders
Stomach pain or discomfort, nausea, vomiting, indigestion,
diarrhoea and constipation. These effects are reduced when
Bilxona is taken with a meal as recommended, see section 3 ‘How
to take Bilxona.
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.
The following adverse events have been observed with other
sulphonylureas: Severe changes in the number of blood cells and
allergic inflammation of the wall of blood vessels; reduction in
blood sodium (hyponatraemia); and 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme
Website: 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 Bilxona
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on
the tablet carton and blister strip after ‘EXP’. The expiry date refers
to the last day of that month.
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 Contents of the pack and other information
What Bilxona contains
• The active substance is gliclazide. One tablet contains either
30mg or 60mg of gliclazide in a modified-release formulation.
• The other ingredients are: lactose monohydrate, hypromellose,
microcrystalline cellulose, colloidal, anhydrous silica, magnesium
stearate.

What Bilxona looks like and contents of the pack
Bilxona 30mg Modified-release Tablets are white, oval, biconvex
5 x 11 mm tablets marked “G” on one side.
Bilxona 60mg Modified-release Tablets are white, oval, biconvex
7 x 15 mm tablets scored on both sides, marked with “G” on one
side of the score and “60” on the other side of the score.
Blisters: 28 and 56 Modified-release Tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria
This leaflet was last revised in March 2015.

If you would like a
leaflet with larger text,
please contact
01271 385257.
Actavis, Barnstaple, EX32 8NS, UK

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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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