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”)

•    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-6-phosphate 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.

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.

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 25^oC.

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 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

Marketing Authorisation Holder and Manufacturer

Lupin (Europe) Ltd Victoria Court Bexton Road Knutsford Cheshire UK, WA16 0PF

The leaflet was last approved in June 2013

Code No. GO/DRUGS/654

ID#: 233248

Packaging Dvmpt. Production    Regulatory Affairs    Quality Assurance