• 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. See section 4.

1. What Nazdol MR is and what it is used for
2. What you need to know before you take Nazdol MR
3. How to take Nazdol MR
4. Possible side effects
5. How to store Nazdol MR
6. Contents of the pack and other information

• if you are allergic to gliclazide or to any of the other ingredients of this medicine (listed in section 6) or to other medicines of the same group (sulfonylureas) or other related medicines (hypoglycaemic sulfonamides),
• if you have insulin-dependent diabetes(type 1),
• if you have ketone bodies and sugar in the 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 Nazdol MR”),
• if you are breast feeding (see section ‘Pregnancy and breast-feeding’).

Talk to your doctor or pharmacist before taking Nazdol MR.

You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake to 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 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 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 low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleepiness, 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 heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).

If your blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop cerebral 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 take 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, if you take St John’s Wort (Hypericum perforatum) preparations (see section “Other medicines and Nazdol MR”) or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and diminished performance.

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

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when gliclazide is prescribed at the same time than medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you the importance of monitoring your blood glucose.

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 (hemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.

Nazdol MR is not recommended for use in children 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:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• antibiotics (e.g. sulfonamides, 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 (ibuprofen, phenylbutazone),
• 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),
• medicine to treat asthma,
• or used during labour (intravenous salbutamol, ritodrine and terbutaline),
• medicine to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol),
• St John’s Wort -Hypericum perforatum- preparations.

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time than Nazdol MR, especially in elderly patients.

Nazdol 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 you are taking Nazdol MR.

Nazdol 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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby while taking this medicine, inform your doctor so that he may prescribe a more suitable treatment for you.

Nazdol MR is not recommended for use during pregnancy.

You must not take Nazdol MR while you are breast-feeding.

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 symptoms of hypoglycaemia.

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

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 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 once daily.

The usual dose can vary from one to a maximum of four tablets in a single intake at breakfast. This depends on the response to treatment.

If a combination therapy of Nazdol MR 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.

Oral use

Swallow your tablets whole. Do not chew them.

Take your tablets with a glass of water at breakfast, preferably at the same time each day. You must always eat a meal after taking your tablet(s).

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.

It is important that you take the medicine every day as regular treatment works better.

However, if you forget to take a dose of Nazdol MR, take the next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

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.

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 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.

• The active substance is gliclazide. Each modified-release tablet contains 30 mg gliclazide.
• The other ingredients are lactose monohydrate, hypromellose, calcium carbonate, colloidal anhydrous silica, magnesium stearate (see section 2).

The modified-release tablets are white, oval, biconvex tablets.

Nazdol MR is available in blisters in boxes of 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 120 or 180 tablets and in tablet containers of 90, 120 or 180 tablets.

Not all pack sizes may be marketed.