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ZICLASEG 30MG PROLONGED-RELEASE TABLETS

Active substance(s): GLICLAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ziclaseg 30mg Prolonged Release Tablet
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 Ziclaseg Tablets are and what they are used for
2. Before you take Ziclaseg Tablets
3. How to take Ziclaseg Tablets
4. Possible side effects
5. How to store Ziclaseg Tablets
6. Further information
1. WHAT ZICLASEG TABLETS ARE AND WHAT THEY ARE
USED FOR
Ziclaseg is a medicine which reduces blood sugar levels (oral
antidiabetic medicine belonging to the sulphonylurea group).
Ziclaseg 30mg prolonged release tablets are used to keep blood
sugar at the correct level in adults with diabetes when it is not
controlled by dietary measures, physical exercise and weight
loss alone.
2. BEFORE YOU TAKE ZICLASEG TABLETS
Do not take Ziclaseg 30mg prolonged release tablets:
− if you are allergic (hypersensitive) to gliclazide or any
of the other ingredients in this medicine (see section
6,“Further Information”) or to any other medicines of the
same group (sulphonylureas or sulphonamides).
− if you have insulin-dependent (Type 1) diabetes;
− if you have ketone bodies and sugar in your urine (this
may mean you have diabetic keto-acidosis), diabetic
pre-coma or coma
− if you have severe kidney or liver disease;
− if you are taking any medicines used to treat fungal
infections (miconazole – see Section “Taking other
medicines”)
− if you are breast-feeding (see section “Pregnancy and
breastfeeding”)
Take special care with Ziclaseg 30mg prolonged release
tablets
• Take this medicine only if you have regular food intake.
Otherwise you may develop a low blood sugar (also
known as “hypoglycaemia”)

TEMPLE Packaging Pvt. Ltd. 28476001 Email:-temple@bom4.vsnl.net.in
Customer: Lupin Limited
Location: Goa
Product Code & Name: 233248 Zilclaseg 30 mg Prolonged Release Tablet (Insert-Front)
SAP Code: xxxxxxxxxxx
File No: xxxxx
Version No.: 3
Date: 08.06.2013
Open Size: 200 x 280 mm
Folding Size: 40 x 35 mm
Pharma code: 1678
Colours: (1) Black
Perforation: No
Substrate: 60 gsm Maplitho Paper
Gluing: No
Artwork Sr. No.: xxx
Artwork Status: final
Note - This approval will be considered for final printing.

Please recheck for corrections indicated earlier, in this proof also.
Prepared by :
Checked by:
Approved by:

shaji
Customer Approval


Checked by:

Packaging Dvmpt.

Production

Approved by:
Regulatory Affairs

Quality Assurance

• During Gliclazide treatment, you need regular monitoring
of your blood (and possibly urine) sugar levels and also
your glycated haemoglobin (hbA1c).
• If you have low blood sugar levels then take glucose
tablets or a sugary drink followed by biscuits, a sandwich
or your next meal (if due).
• In most cases of low blood sugar levels, symptoms will
resolve if you consume sugar in a drink or food.
• Seek medical help if taking sugar does not resolve the
symptoms.
• In severe cases, confusion and unconsciousness may
develop.
• You may not get symptoms of hypoglycaemia, especially
if you are an elderly person or suffer from a hormone
disorder, so you may not be aware that your blood sugar
is too low.
• If you are about to undergo an operation or have a
serious injury or have an infection, your doctor may
change you to insulin therapy temporarily.
• Talk to your doctor before taking Gliclazide tablets if you
know you have a family history of glucose-6-phosphate
dehydrogenase deficiency or if you know you suffer from
this condition, because lowering of the haemoglobin level
and breakdown of red blood cells (haemolytic anaemia)
can occur in patients missing the enzyme glucose-6phosphate dehydrogenase.
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 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:
• Pain killers or anti-rheumatics, such as ibuprofen or
phenylbutazone
• medicines containing alcohol
• other medicines used to treat high blood sugar (oral
anti-diabetics) or insulin
• medicines used to treat high blood pressure or heart
failure (beta blockers, ACE inhibitors such as captopril
or enalapril)
• medicines to treat fungal infections (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)
• antibacterial medicines (sulphonamides)
If you take one of the following medicines, the effect of
Gliclazide may be weakened and raised blood sugar levels
may occur:
• medicines used to treat breast disorders, heavy
menstrual bleeding and endometriosis (danzol);

• medicines to treat disorders of the central nervous
system (chlorpromazine)
• medicines inhibiting inflammation (glucocorticoids)
• medicines used to treat asthma (salbutamol, terbutaline
when given by injection)
• medicines used during labour (ritodrine given by
injection)
Gliclazide may increase the effects of medicines used to reduce
blood clotting (warfarin).
Consult your doctor before you start taking another medicine.
If you go to the hospital tell the medical staff you are taking
Ziclaseg prolonged release tablets.
Taking Ziclaseg 30mg prolonged release tablets with food
and drink:
Ziclaseg Tablets can be taken with food and drink.
It is recommended that you do not drink alcohol during
treatment with Gliclazide as it may alter the control of your
diabetes in an unpredictable manner.
Pregnancy and breast-feeding:
Pregnancy:
Ziclaseg 30mg prolonged release tablets are not recommended
for use during pregnancy. Tell your doctor if you are planning
to become pregnant or if you become pregnant, as he may
prescribe a more suitable treatment for you.
Breast-feeding:
Ziclaseg 30mg prolonged release tablets should not be taken if
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 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 (i.e.
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 ZICLASEG TABLETS
Always take Ziclaseg 30mg prolonged release tablets exactly as
your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Swallow the tablet(s) whole with a glass of water at breakfast
time (preferably the same time each day). You must always eat
a meal after taking your tablet(s).
Adults:
The usual daily dose can vary from one to four tablets per day.
• The recommended starting dose is 30mg daily.

• If necessary your doctor may increase the dose up to
60mg, 90mg or 120mg per day.
Please talk to your doctor or pharmacist if you have the
impression that the effect of this medicine is either too strong
or too weak.
Ziclaseg 30mg prolonged release tablets can be used to
replace other oral antidiabetic medicine. If a combination
therapy of Ziclaseg 30mg prolonged release tablets with other
oral antidiabetic agents or insulin is initiated, your doctor will
determine the proper dose of each medicine individually for
you.
People at risk of hypoglycaemia
You are at special risk of hypoglycaemia (low blood sugar
levels) if:
• you refuse or cannot take your tablets
• you exercise without eating an adequate amount of
carbohydrates (found in sweets, bread, pasta, potatoes
and cereals);
• you skip meals or have irregular meals;
• you are undernourished;
• you have hormone imbalance (endocrine disorders) or if
you have recently stopped steroid therapy;
• You have kidney or liver insufficiency;
• You accidentally overdose on Ziclaseg tablets (see
section – If you take more Ziclaseg Tablets than you
should);
• you take any other medicines as listed in section 4.5
Interactions.
You should take the minimum dose of Ziclaseg Tablets if any
of the above categories apply to you or if you have any other
reason to be more at risk of having low blood sugar.
To reduce the risk of hypoglycaemia it is important to take note
of any dietary advice, of taking regular exercise and of regular
monitoring of your blood glucose.
Use in children and adolescents (under 18 years of age):
You should not use Ziclaseg 30mg prolonged release tablets
for the treatment of children and adolescents.
If you take more Ziclaseg Tablets than you should:
If you have taken too many tablets than you should, contact
your doctor or the nearest hospital immediately.
The signs of overdose are those of low blood sugar
(hypoglycaemia). Symptoms of low blood sugar can be helped
by taking sugar, sugary drinks straight away, followed by a
substantial snack or meal.
Be aware that the state of hypoglycaemia may persist for
some time. Severe cases of hypoglycaemia accompanied by
altered behaviour or loss of consciousness require immediate
treatment and admission to hospital. Never put anything in
the mouth of an unconscious person, seek immediate medical
help. Ensure that you have a friend or colleague who knows
about your condition and knows when to seek medical advice.

If you forget to take Ziclaseg tablets:
If you forget to take a dose, simply take your next dose at the
regular time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Ziclaseg Tablets:
As the treatment for diabetes is usually life long, you should
discuss with your doctor before stopping your medicine.
Stopping could cause high blood sugar (hyperglycaemia).
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

5. HOW TO STORE ZICLASEG TABLETS
Keep out of the reach and sight of children.
Do not use Ziclaseg 30mg prolonged release tablets after the
expiry date, which is stated on the carton and blister. The expiry
date refers to the last day of that month.
Do not store above 25oC.
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ziclaseg Tablets can cause side-effects,
although not everybody gets them.
Hypoglycaemia is an important and common side effect
(affecting less than 1 person in 10) and will require immediate
action if you experience it (take a sugary drink or sugary
food). The symptoms include sweating, paleness, hunger,
shaking, headache, irregular or fast heart beat, blurred version,
irritability, forgetfulness and confusion.
If the hypoglycaemia is severe or prolonged even after intake of
sugar, you should stop taking Ziclaseg 30mg prolonged release
tablets and should seek immediate medical attention. If not
treated it could lead to drowsiness, loss of consciousness or
possible coma.
Other side effects have been reported at the frequencies shown
below:
Common (affecting less than 1 person in 10)
• hypoglycaemia (see above)
Uncommon (affecting less than 1 person in 100)
• abdominal pain, nausea, vomiting, indigestion, diarrhoea
and constipation
Rare (affecting less than 1 person in 1,000)
• skin rashes and itching, redness, hives, blistering;
• changes in your blood (such as decrease in the number
of certain cells in the blood which may cause paleness,
prolonged bleeding, bruising, sore throat and fever);
• changes in your liver (which can cause yellow skin and
eyes). These tend to disappear when the medicine is
stopped.
• your vision may be affected for a short time especially
when the treatment starts. This is due to changes in the
blood sugar level.
With other medicines of the same class (sulphonylureas),
cases of severe changes in the number of blood cells, allergic
inflammation of the wall of blood vessels, changes in liver
enzyme levels and even life-threatening liver failure have been
described.
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.

Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Ltd
Victoria Court
Bexton Road
Knutsford
Cheshire
UK, WA16 0PF

TEMPLE Packaging Pvt. Ltd. 28476001 Email:-temple@bom4.vsnl.net.in
Customer: Lupin Limited
Location: Goa
Product Code & Name: 233248 Zilclaseg 30 mg Prolonged Release Tablet (Insert-Back)
SAP Code: xxxxxxxxxxx
File No: xxxxx
Version No.: 3
Date: 08.06.2013
Open Size: 200 x 280 mm
Folding Size: 40 x 35 mm
Pharma code: 1678
Colours: (1) Black
Perforation: No
Substrate: 60 gsm Maplitho Paper
Gluing: No
Artwork Sr. No.: xxx
Artwork Status: final
Note - This approval will be considered for final printing.

Please recheck for corrections indicated earlier, in this proof also.
Prepared by :
Checked by:
Approved by:

shaji
Customer Approval


Checked by:

Packaging Dvmpt.

Production

Approved by:
Regulatory Affairs

Quality Assurance

6. FURTHER INFORMATION
What Ziclaseg Tablets contain:
The active substance is gliclazide.
Each prolonged release tablet contains 30mg of the active
substance gliclazide.
The other ingredients are:
calcium hydrogen phosphate dihydrate, povidone K30,
hypromellose and magnesium stearate.
What Ziclaseg Tablets look like and contents of the pack:
Ziclaseg 30mg prolonged release tablets are white to off-white
capsule shaped, biconvex tablets debossed with “30” on one
side and plain on the other side.
Ziclaseg 30mg prolonged release tablets are available in blister
packs containing 10, 20, 28, 30, 56, 60, 90 and 120 tablets*
packaged in cartons.
* Not all pack sizes may be marketed

The leaflet was last approved in June 2013
Code No. GO/DRUGS/654

ID#: 233248

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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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