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Nazdol Mr 30 Mg Modified-Release Tablets

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Document: leaflet CONSILIENT HEALTH (UK)_PL 01656-0033 change

PACKAGE LEAFLET: INFORMATION FOR THE USER


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Nazdol MR 30 mg 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.

•    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.

What is in this leaflet:

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

1. WHAT NAzDOL MR IS AND WHAT IT IS USED FOR


Nazdol MR is a medicine to reduce blood sugar levels (antidiabetic medicine taken orally).

Nazdol MR 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 TAKENAzDOL MR


Do not take Nazdol MR

•    if you are allergic (hypersensitive) to gliclazide, to other sulphonylureas, to sulphonamides or to any of the other ingredients of this medicine (listed in section 6),

•    if you have insulin-dependent (type 1) diabetes,

•    if you have ketone bodies and sugar in the 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 medicines to treat fungal infections (miconazole, see section 'Taking other medicines'),

• if you are breast feeding (see section 'Pregnancy and breast-feeding').

If you think any of the above situations applies to you, tell your doctor, nurse or pharmacist.

Warning and precautions

This medicine should be used only if you are likely to have regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased risk of low blood sugar level (hypoglycaemia) if a meal is delayed or skipped, if an inadequate amount of food is consumed or if the food is low in carbohydrate.

During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level is necessary. Your doctor may also take blood tests to monitor your glycated haemoglobin (HbAic).

You should observe the treatment plan prescribed by your doctor in order to achieve the recommended blood sugar levels. This means regular tablet intake in addition to a dietary regimen and physical exercise.

In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. Therefore it is vital that you are carefully monitored by your doctor.

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 renal function or liver function is severely decreased.

If you suffer from low blood sugar you may have the following symptoms: headache, intense hunger, paleness, weakness, exhaustion, nausea, vomiting, weariness, sleepiness, sleep disorders, restlessness, aggressiveness, impaired 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, and sudden strong pain in the breast that may radiate into neighbouring areas (angina pectoris).

If your blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop cerebral convulsions, lose self control, breathing may be shallow and your heart beat slowed down, you may fall into unconsciousness possibly resulting in coma. The clinical picture of a severe reduced blood sugar level may resemble that of a stroke.

In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, e.g. sugar cubes, sweet juice, sweetened tea. You should therefore always take some form of sugar with you (sugar cubes). Remember that sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.

It is possible that symptoms of low blood sugar may be absent, that they develop slowly or that you do not realise 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). It may also happen when you suffer from certain disorders of the endocrine system (e.g. certain disorders of thyroid function and anterior pituitary or adrenocortical insufficiency).

If you are in stress-situations (e.g. accidents, acute operations, infections with 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. Symptoms 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.

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 hemoglobin level and breakdown of red blood cells (hemolytic anemia) can occur. Contact your doctor before taking this medicinal product.

Children and adolescents

Nazdol MR is not to be used for the treatment of diabetes in children and adolescents under 18 years of age.

Other medicines and Nazdol MR

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The effectiveness and safety of Nazdol MR may be affected if this medicine is taken at the same time as certain other medicines. Conversely, other medicines may be affected if they are taken at the same time as Nazdol MR.

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),

•    antibacterial medicines (e.g. sulphonamides, clarithromycin),

•    medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril, or enalapril),

•    medicines to treat fungal infections (miconazol, 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),

•    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:

•    medicine to treat disorders of the central nervous system (chlorpromazine),

•    medicines reducing inflammation (glucocorticoids),

•    medicine to treat asthma (salbutamol when given by injection),

•    medicines used during labour (ritodrine and terbutaline given by injection),

•    medicine to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol).

Gliclazide may potentiate anticoagulation during concurrent treatment with warfarin (a medicine that inhibits blood clotting).

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 with food and drink

Nazdol MR can be taken with food and non-alcoholic drinks.

Avoid alcohol as it can alter the control of your diabetes in an unpredictable manner and can even lead to coma. Pregnancy and breast-feeding

Nazdol MR is not recommended for use during pregnancy. 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.

You must not take Nazdol MR 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 hypoglycaemia,

•    have fewer or no warning symptoms of hypoglycaemia.

Nazdol MR contains lactose

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

3. HOW TO TAKE NAzDOL MR


Dose

Always take Nazdol MR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose of Nazdol MR 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 blood glucose is not adequately controlled, your doctor may increase it in successive steps usually not less than 1 month apart.

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.

Please talk to your doctor or pharmacist if you have the impression that Nazdol MR is acting too strongly or not strongly enough.

Routes and method of administration

Swallow your tablets whole with a glass of water whilst having your breakfast, preferably at the same time each day. Do not chew the tablets. You must always eat a meal after taking your tablet(s). It is important not to skip a meal when you are on Nazdol MR.

If you take more Nazdol MR than you should

If you happen to have taken too much gliclazide 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 Nazdol MR

If you forget to take a dose, take the next dose at the usual time.

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

If you stop taking Nazdol MR

If you interrupt or stop the treatment you should be aware that your blood sugar control will deteriorate. If any change is necessary it is absolutely important to contact your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE Side EFFECTS


Like all medicines, this medicine can cause side effects, although not everybody gets them.

The assessment of side effects is based on their frequency.

Common (may affect up to 1 in 10 people):

Hypoglycaemia (low blood sugar). For symptoms and signs see Section “Warnings and precautions” 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 it is temporarily controlled by eating sugar, you should seek immediate medical attention.

Uncommon (may affect up to 1 in 100 people):

•    Abdominal pain

•    Nausea

•    Vomiting

•    Indigestion

•    Diarrhoea

•    Constipation.

These effects are reduced when Nazdol MR is taken with a meal as recommended.

Rare (may affect up to 1 in 1,000 people):

•    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.

•    Skin reactions such as rash, redness, itching and hives, angioedema (rapid swelling of the tissue 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.

•    Abnormal liver function tests, changes in your liver (which can cause yellow skin and eyes). If you get this, see your doctor immediately.

•    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.

These effects generally disappear if the medicine is stopped.

As for other sulphonylureas, the following adverse events have been very rarely observed (may affect up to 1 in 10,000 people):

Cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), signs and symptoms of liver impairment (e.g. jaundice) which in most cases disappeared after withdrawal of the sulphonylureas, but may led to life-threatening liver failure in isolated cases.

If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE NAZDOL MR


Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister, the tablet container and the carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Nazdol MR contains

•    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.

What Nazdol MR looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

Distributed by:

Consilient Health (UK) Ltd, 500 Chiswick High Road, London, W4 5RG.

P0176


This leaflet was last revised in December 2012