VITILE XL 30 MG PROLONGED-RELEASE TABLETS

Active substance: GLICLAZIDE

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Vitile XL 30mg Prolonged-release Tablets
Gliclazide

Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it again.
•  f you have any further questions, ask your doctor
I
or pharmacist.
•  his medicine has been prescribed for you. Do not
T
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
•  f any of the side effects gets serious, or if you
I
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
•  he full name of this medicine is Vitile XL 30mg
T
Prolonged-release Tablets but within the leaflet it
will be referred to as Vitile XL.

In this leaflet:
1 What Vitile XL is and what it is used for
2 Before you take
3 How to take
4 Possible side effect
5 How to store
6 Further information
1 What Vitile XL is and what it is used for
Vitile XL is a medicine that reduces blood sugar levels
(oral antidiabetic medicine belonging to the sulfonylurea
group).
Vitile XL 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 Before you take
Do not take Vitile XL
• if you are allergic (hypersensitive) to gliclazide or any of
the other ingredients of Vitile XL, or to other medicines
of the same group (sulfonylureas), or to other related
medicines (hypoglycaemic sulfonamides);
• 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”).

Take special care with Vitile XL

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.

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L19021ACT-30

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 also 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.
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.
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 haemoglobin level and
breakdown of red blood cells (haemolytic anaemia) can
occur. Contact your doctor before taking this medicinal
product.
Vitile XL is not recommended for use in children due to a
lack of data.

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, as they may
interact with your Vitile XL.
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),
• antibiotics (e.g. sulfonamides),
• 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 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).

Continued over page

Vitile XL 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 Vitile XL.

Taking Vitile XL with food and drink

Vitile XL 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.

Common: affects 1 to 10 users in 100
The most commonly observed side effect is low blood
sugar (hypoglycaemia). For symptoms and signs see
“Take special care” in “Section 2 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 temporarily controlled by eating sugar, you should seek
immediate medical attention.

Pregnancy and breast-feeding

Uncommon: affects 1 to 10 users in 1,000
Stomach pain or discomfort, nausea, vomiting,
indigestion, diarrhoea, and constipation. These effects
are reduced when Vitile XL are taken with a meal as
recommended, see section 3 “How to take”.

Pregnancy
Vitile XL is not recommended for use during pregnancy.
If you are planning a pregnancy, or become pregnant,
inform your doctor so that he may prescribe a more
suitable treatment for you.

Frequency not known:
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 and fever. These symptoms
usually resolve when the treatment is discontinued.

Ask your doctor or pharmacist for advice before taking
any medicine.

Breastfeeding
You must not take Vitile XL 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).

3 How to take
Dosage

Always take Vitile XL exactly as your doctor has told
you. You should 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 starting dose is one tablet daily
(30mg). The usual dose is one to four tablets (maximum
120mg) in a single intake at breakfast time. This depends
on the response to treatment.
Vitile XL can be used to replace other oral antidiabetics,
please consult your doctor. If a combination therapy Vitile
XL 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 Vitile XL is acting too strongly or not
strongly enough.
Methods and routes of administration
Oral use.
The tablets should be swallowed whole without chewing
or crushing.
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 Vitile XL 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 relieved 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 Vitile XL

It is important to take your medicine every day as regular
treatment works better.
However, if you forget to take a dose of Vitile XL, 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 Vitile XL

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
product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Vitile XL can cause side effects,
although not everybody gets them.
The following side effects have been reported at the
frequencies shown:
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L19021ACT-30

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 and hives. Severe reactions may
also appear.
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.
With sulfonylureas, cases of severe changes in the
number of blood cells and allergic inflammation of the
wall of blood vessels have been described. Symptoms
of liver impairment (e.g. jaundice) have been observed
which in most cases disappeared after withdrawal of the
sulfonylureas, but may lead 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
Keep out of the reach and sight of children.
Al/PVC-PVDC blister:
Do not store above 25°C.
HDPE container:
Do not store above 25°C.
Store in the original package in order to protect from
moisture.
Do not use Vitile XL after the expiry date which is stated
on the tablet container, carton and the blister strip. 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 Vitile XL contains

• The active substance is gliclazide. One tablet contains
30mg of gliclazide, in a prolonged release formulation.
• The other ingredients are: sodium hydrogen carbonate,
mannitol (E421), calcium hydrogen phosphate
dihydrate, hypromellose, silica colloidal anhydrous,
magnesium stearate.

What Vitile XL looks like and contents of the pack
Prolonged‑release tablet.
White, oval, biconvex 4.5 x 10.1 mm tablets marked “G”
on one side.
Pack sizes:
Blisters: 10, 20, 28, 30, 56, 60, 90, 98, 100, 120,
180 prolonged‑release tablets.
Tablet containers: 30, 100 and 180 prolonged‑release
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76-78
Hafnarfjordur
IS-220
Iceland

Manufacturer

Actavis hf., Reykjavikurvegi 78, P.O. Box 420,
IS-222 Hafnarfjordur, Iceland
or
Balkanpharma - Dupnitsa AD, 3 Samokovsko Str.,
Dupnitsa 2600, Bulgaria
This leaflet was last revised in – April 2010

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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