NovoNorm

Chemical Name: REPAGLINIDE

General Information

This medicine contains the active ingredient repaglinide, which is a type of medicine used to treat type 2 diabetes.

People with diabetes have either a deficiency or an absence of a hormone manufactured by the pancreas, called insulin. Insulin is the main hormone responsible for the control of sugar in the blood. It causes cells in the liver, muscle and fat tissue to increase their uptake of glucose from the bloodstream. It also decreases the production of glucose by the liver, and has various other effects that lower the amount of glucose in the blood.

People with type 2 or non-insulin dependent diabetes (NIDDM) have a deficiency of insulin. In addition, the cells in the body are resistant to the action of insulin. Both these problems mean that blood sugar levels can become too high.

Repaglinide is an antidiabetic medicine that is used to help lower blood sugar in people with type 2 diabetes. It works by acting on the cells in the pancreas that produce insulin. These cells are called beta cells. Repaglinide causes the beta cells to produce more insulin.

Repaglinide is taken before meals so that insulin production is enhanced during the meal. The enhanced insulin production starts about 30 minutes after taking the dose of repaglinide, and the result is a blood sugar lowering effect throughout the meal, as occurs naturally in non-diabetic people.

Repaglinide is used in people whose type 2 diabetes has not been controlled by diet, exercise and weight reduction alone. It is also used in combination with metformin in people with type 2 diabetes whose blood sugar is not controlled using metformin alone. Since metformin mainly helps reduce blood sugar levels between meals (fasting blood sugar levels), and repaglinide reduces mealtime blood sugar levels, the combination of the two provides an additive effect on blood sugar control.

Warning!

Blood sugar levels should be checked regularly when taking this medicine.

Taking this medicine in combination with metformin is more likely to cause low blood sugar levels (hypoglycaemia) than metformin alone. It is important that you take precautions to avoid hypoglycaemia when driving or operating machinary. You should also be aware that the risk of hypoglycaemia is increased by strenuous physical exercise and drinking alcohol.

If you experience stress such as trauma, surgery, infection or fever while stabilised on an oral antidiabetic medicine, your blood sugar control may be reduced or lost. In these cases your doctor may temporarily replace your treatment with insulin.

Your ability to concentrate or react may be reduced if you have low blood sugar, and this can cause problems driving or operating machinary. You should take precautions to avoid low blood sugar when driving - discuss this with your doctor.

This medicine has not been studied in children aged under 18 years, elderly people aged over 75 years, or people with impaired liver function, and for this reason the medicine is not recommended in these groups of people.

Use with caution in

• Decreased kidney function
• Malnutrition
• Weak or debilitated people

Not to be used in

• Breastfeeding
• Children under 12 years of age
• Diabetic keto-acidosis
• Pregnancy
• Severely decreased liver function
• Type 1 (insulin dependent) diabetes

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

The safety of this medicine during pregnancy has not been established therefore it should not be used by pregnant women. Control of diabetes in pregnancy is usually acheived using insulin because it provides a more stable control of blood sugar. Please consult with your doctor.

This medicine may pass into breast milk. It should not be used by breastfeeding mothers. Seek medical advice from your doctor.

Side effects

• Abdominal pain
• Constipation
• Diarrhoea
• Visual disturbances
• Low blood glucose level (hypoglycaemia)
• Alteration in results of liver function tests
• Nausea and vomiting
• Skin reactions such as rash and itch

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

Interaction with other drugs

The blood sugar lowering effect of repaglinide may be enhanced or prolonged by the following:

• other antidiabetic medicines, eg metformin
• gemfibrozil (gemfibrozil, used for lowering cholesterol levels, must not be taken in combination with repaglinide as this may cause severe or prolonged low blood sugar)
• octreotide
• disopyramide
• anabolic steroids, eg testosterone, nandrolone, stanozolol
• beta-blockers, eg propranolol
• ACE inhibitors, eg captopril (these can cause unpredictable drops in blood sugar)
• MAOI antidepressants, eg phenelzine
• non-steroidal anti-inflammatory drugs (NSAIDs), eg ibuprofen
• large doses of salicylates, eg aspirin (small pain relieving doses do not normally have this effect)
• clarithromycin
• itraconazole
• ketoconazole
• alcohol.

Beta-blockers, eg propranolol (including eye drops containing beta-blockers) can mask some of the signs of low blood sugar, such as increased heart rate and tremor. They may also prolong episodes of low blood sugar and impair recovery back to normal glucose levels.

The following medicines may increase blood glucose levels and may therefore decrease the effect of repaglinide:

• corticosteroids, eg hydrocortisone, prednisolone
• diuretics, especially thiazide diuretics, eg bendrofluazide
• danazol
• oestrogens and progesterones, such as those contained in oral contraceptives
• thyroid hormones, eg thyroxine
• asthma relievers, eg salbutamol.

Simvastatin may increase the blood level of repaglinide.

Rifampicin may decrease the blood level of repaglinide.