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Laaglyda Mr 60 Mg Modified-Release Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Laaglyda® MR 60 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 Laaglyda MR is and what it is used for

2.    What you need to know before you take Laaglyda MR

3.    How to take Laaglyda MR

4.    Possible side effects

5.    How to store Laaglyda MR

6.    Contents of the pack and other inf ormation

1. What Laaglyda MR is and what it is used for

Laaglyda MR is a medicine that reduces blood sugar levels (antidiabetic medicine taken orally, belonging to the sulphonylurea group).

Laaglyda 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. What you need to know before you take Laaglyda MR

Do not take Laaglyda MR:

•    if you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), or to other medicines of the same substance group (sulphonylureas) or to other related medicines (hypoglycaemic sulphonamides);

•    if you have insulin dependent diabetes (type I);

•    if you have ketone bodies and sugar in your urine (this may mean that you have diabetic ketoacidosis), a diabetic precoma or coma;

•    if you have severe kidney or liver disease;

•    if you are taking medicines to treat fungal infections (miconazole, see section "Taking Laaglyda MR with 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Laaglyda MR.

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 (HbAlc).

You should observe the treatment plan prescribed by your doctor 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 too high doses of gliclazide,

•    if you suffer from particular hormone induced disorders (functional disorders of the thyroid gland, of the pituitary gland or the adrenal cortex),

•    if your renal function or liver function is severely decreased.

If you have low blood sugar you may have the following symptoms: headache, increased hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech and 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 and sudden strong pain in the chest that may radiate into the neighbouring 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, 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. 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.

It is possible that 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).

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. accident, surgical procedure, fever, etc.) your doctor may temporarily switch you to insulin therapy.

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

Laaglyda MR is not recommended for use in children due to lack of data.

Children and adolescents

Laaglyda MR is not to be used for the treatment of diabetes in children and adolescents under 18 years of age. No data are available in these patients.

Other medicines and Laaglyda MR

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 levels (oral antidiabetics, GLP 1 receptor agonists or insulin)

•    antibiotics (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 (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 inflammations (corticosteroids)

•    medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine, terbutaline)

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

Laaglyda 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 that you are taking Laaglyda MR.

Laaglyda MR with food, drink and alcohol

Laaglyda 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.

Pregnancy, breast feeding and fertility

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor so that he may prescribe a more suitable treatment for you.

Laaglyda MR is not recommended for use during pregnancy.

You must not take Laaglyda MR while 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 level 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 levels (hypoglycaemia),

•    have fewer or no warning signals of low blood sugar (hypoglycaemia).

Laaglyda MR contains lactose monohydrate

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

3. How to take Laaglyda MR

Dose

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 your 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 blood sugar may require changed gliclazide doses.

The recommended dose is one 30 mg modified release tablet up to two 60 mg modified release tablets (maximum 120 mg) in a single intake at breakfast. This depends on the response to treatment.

If a combination therapy of Laaglyda MR modified release tablet 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.

Method of use

Oral use

Swallow the tablet(s) whole in one piece. Do not chew or crush.

Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time every day).

You must always eat a meal after taking your tablet(s).

If you take more Laaglyda MR than you should

If you have taken too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of an overdose and those of low blood sugar (hypoglycaemia) are 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 or 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 Laaglyda MR

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

However, if you forget to take a dose of Laaglyda MR take the next

dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Laaglyda MR

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 have any further questions on the use of this medicine, 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):

The most commonly observed side effect is low blood sugar (hypoglycaemia) (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):

Digestive disorders

Abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation. These effects are reduced when Laaglyda MR modified release tablet is taken with meals as recommended.

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

Blood disorders

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 diseases

Skin reactions such as rash, redness, itching, hives, angioedema (rapid swelling of tissues 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.

Liver disease

Abnormal liver function tests, which can cause yellow skin and eyes.

If you get this, see your doctor immediately. Your doctor will decide whether to stop your treatment.

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.

These effects generally disappear if the medicine is stopped

As for other sulphonylureas, the following adverse events have been observed very rarely (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), symptoms of liver impairment (e. g. jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life threatening liver failure in isolated cases.

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

5. How to store Laaglyda 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 and carton after EXP. The expiry date refers to the last day of that month.

This medicine 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. Further information

What Laaglyda MR contains

•    The active substance is gliclazide. Each modified release tablet contains 60 mg gliclazide.

•    The other ingredients are hypromellose, lactose monohydrate, colloidal anhydrous silica and

magnesium stearate (see section 2).

What Laaglyda MR looks like and contents of the pack

White to almost white, oval, biconvex tablets with a length 13 mm and a thickness 3.5 mm - 4.9 mm.

Laaglyda MR is available in boxes of 14, 15, 28, 30, 56, 60, 84, 90, 120 or 180 modified-release tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

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

8501 Novo mesto, Slovenia

Manufacturer

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

8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz Lohmann Str.5,

27472 Cuxhaven, Germany

Distributed by

Consilient Health (UK) Ltd., No.1 Church Road,

Richmond upon Thames, Surrey. TW9 2QE.

This leaflet was last revised 07/2014

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