Xywin 60 mg Prolonged-release Tablets Gliclazide

• 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 Xywin 60 mg Prolonged-release Tablets is and what it is used for
2. What you need to know before you take Xywin 60 mg Prolonged-release Tablets
3. How to take Xywin 60 mg Prolonged-release Tablets
4. Possible side effects
5. How to store Xywin 60 mg Prolonged-release Tablets
6. Contents of the pack and other information

• 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 group (sulfonylureas), or to other related medicines (hypoglycaemic sulfonamides),
• if you have insulin-dependent diabetes (type 1),
• if you have ketone bodies and sugar in your 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 Xywin”),
• if you are breast-feeding (see Section “Pregnancy and breast-feeding”).

Talk to your doctor before taking Xywin 60 mg Prolonged-release Tablets

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 and carbohydrate intake does not match this increase,
• 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 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, 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 heart beat, high blood pressure, sudden strong pain in the chest that may radiate into nearby 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.

In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, for instance 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.

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 (for instance those acting on the central nervous system and beta blockers).

If you are in stress-situations (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 Xywin 60 mg Prolonged-release Tablets"), or in special stress situations. These 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.

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

Cases of acute porphyria have been described with some other sulfonylurea drugs, in patients who have porphyria (inherited genetic disorders with accumulation in the body of porphyrins or porphyrin precursors).

Xywin 60 mg Prolonged-release Tablets 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 anti-diabetics, GLP-1 receptor inhibitors or insulin),
• antibiotics (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),
• painkiller 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 inflammation (corticosteroids),
• medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline),
• medicines 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 Xywin 60 mg Prolonged-release Tablets especially in elderly patients.

Xywin 60 mg Prolonged-release Tablets may increase the effects 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 Xywin 60mg Prolonged-release Tablets.

Xywin 60 mg Prolonged-release Tablets 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.

Xywin 60 mg Prolonged-release Tablets is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You must not take Xywin 60 mg Prolonged-release Tablets while you are breastfeeding.

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 (for instance 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).

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

• The dose is determined by the doctor, depending on your blood and possibly urine sugar levels.
• Change in external factors (weight reduction, change in life style, stress) or improvements in the blood sugar control may require changed gliclazide doses.
• The recommended daily dose is one tablet of Xywin 30 mg Prolonged-release Tablets to two tablets of Xywin 60 mg Prolonged-release Tablets (maximum 120mg) in a single intake at breakfast time. This depends on the response to treatment.

Xywin 60 mg Prolonged-release Tablets is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your tablet(s) whole and do not chew them.

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

• If a combination therapy of Xywin 60 mg Prolonged-release Tablets with metformin, an alpha glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4inhibitor, 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 this medicine as prescribed, you should contact your doctor or pharmacist.

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, for instance 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 to take your medicine every day as regular treatment works better.

However, if you forget to take a dose of Xywin 60 mg Prolonged-release Tablets, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Your doctor will decide your initial dose and monitor you more closely for a short time.

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 (hyperglycaemia) which increases the risk of developing complications of diabetes.

Decrease in the number of cells in the blood has been reported (for instance platelets, red and white blood cells)

This may cause:

• paleness,
• prolonged bleeding,
• bruising,
• sore throat
• fever

These symptoms usually vanish when the treatment is discontinued.

There have been isolated reports of abnormal liver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.

Skin reactions have been reported such as:

• rash,
• redness,
• itching,
• hives
• blisters
• angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty). Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking Xywin 60mg Prolonged-release Tablets , seek urgent advice from a doctor and tell him that you are taking this medicine.
• exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.

• Stomach pain or discomfort,
• feeling or being sick,
• indigestion,
• diarrhoea
• constipation

These effects are reduced when Xywin 60 mg Prolonged-release Tablets is taken with a meal as recommended, See Section 3 “How to take Xywin 60 mg Prolonged-release Tablets”.

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.

As for other sulfonylureas, the following adverse events have been observed:

• 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 sulfonylureas, but may lead to life threatening liver failure in isolated cases.

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is gliclazide. Each tablet contains 60 mg gliclazide in a prolonged-release formulation.

The other ingredients are: lactose monohydrate, maize starch, Hypromellose 2208, 4000 MPA.S, Hypromellose 2208,100 MPA.S, magnesium stearate.

Xywin 60 mg Prolonged-release Tablets White to off white oval shaped tablet, debossed with ‘C55’ on one side and plain on the other side.

Xywin 60 mg Prolonged-release Tablets are packaged in an aluminium/aluminium blister pack and these blisters are further packed in outer carton to give packs of 10, 14, 20, 30, 28, 50, 60, 56, 100 and 84 tablets.

Not all pack sizes may be marketed.