Vivazide (gliclazide)

How does it work?

Vivazide tablets contain the active ingredient gliclazide, which is a type of medicine called a sulphonylurea. (NB. Gliclazide is also available without a brand name, ie as the generic medicine.) Gliclazide is used to help control blood sugar levels in people with type 2 diabetes.

People with type 2 diabetes (non-insulin dependent diabetes) have a deficiency of a hormone called insulin. Insulin is produced by the pancreas and is the main hormone responsible for controlling sugar levels in the blood. It normally makes the cells of the body remove excess sugar from the blood. In type 2 diabetes insulin is produced inefficiently in response to surges of blood sugar, such as following a meal. The cells of the body also become resistant to the action of insulin that is produced, which means that blood sugar levels can become too high.

Gliclazide works mainly by stimulating the cells in the pancreas that produce insulin. These cells are called beta cells. Gliclazide causes the beta cells to produce more insulin. This helps to decrease the amount of sugar in the blood of people with type 2 diabetes.

Gliclazide improves insulin production immediately after eating. This is called early or first phase insulin secretion. The enhanced insulin production results in a blood sugar lowering effect in response to meals or glucose, as occurs naturally in people without diabetes.

Gliclazide is used when dietary measures, weight loss and physical exercise are not enough to control blood sugar levels in people with type 2 diabetes.

Gliclazide also has effects in the blood vessels. It has been shown to prevent blood cells called platelets from clumping together in the blood. It also increases the breakdown of blood clots that form within the blood vessels. This may help prevent the long-term complications of diabetes, which may be partly due to changes in the blood vessels caused by these mechanisms.

What is it used for?

Type 2 (non-insulin dependent) diabetes, when diet, exercise and weight loss have failed to fully control blood sugar.

Warning!

Your doctor may want you to check your blood sugar level from time to time while you are taking this medicine. Make sure you discuss how to do this and how often with your GP, pharmacist or diabetes specialist.

On rare occasions, low blood sugar can occur as a side effect of this medicine. This is more likely to happen if you suddenly do more exercise than normal, have your meals at irregular times, eat less than usual, or miss meals altogether. For this reason, it is important that you follow any dietary or exercise advice given to you by your doctor. You should also make sure you are aware of the symptoms of hypoglycaemia (these may include cold sweats, cool pale skin, tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, excessive hunger, temporary vision changes, headache or nausea) and what to do if you experience these symptoms. Discuss this with your GP, pharmacist or diabetes specialist.

People who are taking antidiabetic tablets should only drink alcohol in moderation and accompanied by food. This is because alcohol can make your warning signs of low blood sugar less clear, and can cause delayed low blood sugar, even several hours after drinking.

If you get an infection or illness, or have an accident while taking this medicine you should let your doctor know, because when the body is put under stress this medicine may become less effective at controlling your blood sugar. In these cases your doctor may need to temporarily replace your treatment with insulin. You should also consult your doctor about your diabetes treatment if you are due to have surgery under a general anaesthetic, or if you get pregnant. In these situations blood sugar is normally controlled by insulin.

This type of medicine can cause liver problems on rare occasions. For this reason, you should let your doctor know if you develop any of the following symptoms while taking this medicine, as they may indicate a problem with your liver: unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, darkened urine or yellowing of the skin or whites of the eyes (jaundice).

Use with caution in

Elderly people

Decreased kidney function

Decreased liver function

Underactive thyroid gland

Insufficient production of hormones by the pituitary gland (pituitary insufficiency)

Insufficient production of natural steroid hormones by the adrenal glands (adrenal insufficiency)

Malnutrition

Severe vascular disease, eg severe coronary heart disease.

Not to be used in

Children under 12 years of age

Allergy to medicines from the sulphonamide group, eg the antibiotic sulfamethoxazole

Allergy to other sulphonylureas, eg glibenclamide, tolbutamide

Type 1 (insulin dependent) diabetes

Diabetic ketoacidosis

Coma due to ketoacidosis in severe and inadequately treated diabetes (diabetic coma or pre-coma)

Severely decreased kidney function

Severely decreased liver function

Hereditary blood disorders called porphyrias

Pregnancy

Breastfeeding.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used during pregnancy. Diabetes is usually controlled using insulin during pregnancy, because this provides a more stable control of blood sugar. If you get pregnant while taking this medicine, or are planning a pregnancy, you should seek medical advice from your doctor.

It is not known if this medicine passes into breast milk. It should not be used by breastfeeding women, because it could potentially cause low blood sugar in a nursing infant. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Disturbances of the gut such as diarrhoea, constipation, indigestion, nausea, vomiting or abdominal pain

Temporary visual disturbances at start of treatment

Low blood glucose level (hypoglycaemia)

Skin reactions such as rash and itch

Disturbances in the normal levels of blood cells in the blood

Yellowing of the skin and eyes (jaundice)

Disturbance in liver function

Inflammation of the liver (hepatitis)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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