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Bilxona 60mg Modified-Release Tablets

Informations for option: Bilxona 60mg Modified-Release Tablets, show other option

Package leaflet: Information for the patient


Bilxona 30mg and 60mg 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. See section 4.

What is in this leaflet J What Bilxona is and what it is used for

What you need to know before you take Bilxona 3j How to take Bilxona ^ Possible side effects How to store Bilxona

"6| Contents of the pack and other information

J What Bilxona is and what it is used for

Bilxona is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group).

Bilxona 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.

What you need to know before you take Bilxona Do not take Bilxona:

•    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 (sulphonylureas), or to other related medicines (hypoglycaemic sulphonamides)

•    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 Bilxona')

•    if you are breastfeeding (see Section 'Pregnancy and breastfeeding').

Warnings and precautions

Talk to your doctor or pharmacist before taking Bilxona.

You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, you 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 (HbAlc) is necessary. It may also be useful to monitor your own blood sugar levels, although only following instruction from your doctor.

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 recently stopped taking corticosteroids (medicines that reduce inflammation) following prolonged and/or high dose use

•    if you have a severe blood circulation disorder, such as coronary heart disease, severe carotid artery impairment or diffuse vascular disease.

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 heartbeat, 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, 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.

Symptoms of low blood sugar may be absent, less obvious or develop 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 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.

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.

Children and adolescents

Bilxona is not recommended for use in children and adolescents due to a lack of data.

Other medicines and Bilxona

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 or insulin)

•    Antibiotics (e.g. sulphonamides or clarithromycin)

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

•    Medicines to treat fungal infections (e.g. miconazole, fluconazole - see section 'Do not take Bilxona')

•    Medicines to treat ulcers in the stomach or duodenum (Hreceptor antagonists)

•    Medicines to treat depression (monamine oxidase inhibitors)

•    Painkillers or antirheumatics (phenylbutazone, ibuprofen)

•    Medicines containing alcohol

The blood glucose lowering effect of gliclazide may be weakened and raised blood sugar may occur when one of the following medicines is taken:

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

•    Medicines reducing inflammation (corticosteroids or tetracosactrin)

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

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

Bilxona 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 to into hospital tell the medical staff you are taking Bilxona.

Bilxona with food, drink and alcohol

Bilxona 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.

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Pregnancy and breastfeeding

Pregnancy

Bilxona is not recommended for use during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding

You must not take Bilxona 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 low blood sugar (hypoglycaemia)

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

Bilxona contains lactose

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

How to take Bilxona

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

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 30mg.

For 30mg tablets: The usual dose is one to four tablets (maximum 120mg) in a single intake at breakfast time. This depends on the response to treatment.

For 60mg tablets: The tablet can be divided into equal doses.

The usual dose is half to two tablets (maximum 120mg) in a single intake at breakfast time. This depends on the response to treatment.

If a combination therapy of Bilxona with metformin, an alpha glucosidase inhibitor 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 Bilxona is acting too strongly or not strongly enough.

Methods and routes of administration

Oral use.

For 30mg tablets: Swallow your whole tablet(s) in one piece.

For 60mg tablets: Swallow your half tablet or whole tablet(s) 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 each day).

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

If you take more Bilxona than you should

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.

If you forget to take Bilxona

It is important to take your medicine every day as regular treatment works better.

However, if you forget to take a dose of Bilxona, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If your doctor switches you from gliclazide 80mg tablets or from other anti-diabetics to Bilxona

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

If you stop taking Bilxona

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).

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

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.

Liver disorders

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 disorders

Skin reactions such as rash, redness, itching, hives and 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.

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.

Digestive disorders

Stomach pain or discomfort, nausea, vomiting, indigestion, diarrhoea and constipation. These effects are reduced when Bilxona is taken with a meal as recommended, see section 3 'How to take Bilxona.

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.

The following adverse events have been observed with other sulphonylureas: Severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels; reduction in blood sodium (hyponatraemia); and symptoms of liver impairment (e.g. jaundice), which in most cases disappeared after withdrawal of the sulphonylurea, but may lead to life threatening liver failure in isolated cases.

Reporting of side effects

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 the 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.

How to store Bilxona

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

Do not store above 25°C.

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

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 Bilxona contains

•    The active substance is gliclazide. One tablet contains either 30mg or 60mg of gliclazide in a modified-release formulation.

•    The other ingredients are: lactose monohydrate, hypromellose, microcrystalline cellulose, colloidal, anhydrous silica, magnesium stearate.

What Bilxona looks like and contents of the pack

Bilxona 30mg Modified-release Tablets are white, oval, biconvex 5 x 11 mm tablets marked "G” on one side.

Bilxona 60mg Modified-release Tablets are white, oval, biconvex 7 x 15 mm tablets scored on both sides, marked with "G” on one side of the score and "60” on the other side of the score.

Blisters: 28 and 56 Modified-release Tablets.

Marketing Authorisation Holder

Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 HafnarfjorSur Iceland

Manufacturer

Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600 Bulgaria

^ Possible side effects

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

The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs see 'Warnings and precautions' in section 2. If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma.

This leaflet was last revised in March 2015.

If you would like a leaflet with larger text, please contact 01271 385257.

^actavis


Actavis, Barnstaple, EX32 8NS, UK

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