For doctors
What is it and how is it used?
NovoNorm is an oral antidiabetic agent containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).
Type 2 diabetes is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces (formerly known as non-insulin-dependent diabetes mellitus or maturity onset diabetes).
NovoNorm is used to control type 2 diabetes as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar. NovoNorm can also be given with metformin, another medicine for diabetes.
What do you have to consider before using it?
Do not take NovoNorm:
If any of these apply to you, tell your doctor and do not take NovoNorm.
Take special care with NovoNorm:
Talk to your doctor if any of the above applies to you. NovoNorm may not be suitable for you. Your doctor will advise you.
If you get a hypo
You may get a hypo (short for a hypoglycaemic reaction and is symptoms of low blood sugar) if your blood sugar gets too low. This may happen:
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
If your blood sugar is low or you feel a hypo coming on: eat glucose tablets or a high sugar snack or drink, then rest.
When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised continue NovoNorm treatment.
Tell people you have diabetes and that if you pass out (become unconscious) due to a hypo, they must turn you on your side and get medical help straight away. They must not give you any food or drink.It could choke you.
If your blood sugar gets too high
Your blood sugar may get too high (hyperglycaemia). This may happen:
The warning signs appear gradually. They include: increased urination; feeling thirsty; dry skin and dry mouth. Talk to your doctor. The amount of NovoNorm, food or exercise may need to be adjusted.
Using other medicines
You can take NovoNorm with metformin, another medicine for diabetes, if your doctor prescribes it. If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take NovoNorm.
Your body’s response to NovoNorm may change if you take other medicines, especially these:
Tell your doctor if you have recently taken or are planning to take any of these medicines, or any medicines obtained without a prescription.
Using NovoNorm with food and drink
Take NovoNorm before main meals. Alcohol can change the ability of NovoNorm to reduce the blood sugar. Watch for signs of a hypo.
Pregnancy and breast-feeding
You should not take NovoNorm if you are pregnant or you are planning to become pregnant. See your doctor as soon as possible if you become pregnant or are planning to become pregnant during treatment.
You should not take NovoNorm if you are breast-feeding.
Driving and using machines
Your ability to drive or operate a machine may be affected if your blood sugar is low or high. Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car if you:
How is it used?
Your doctor will work out your dose.
Do not take more NovoNorm than your doctor has recommended. Always take NovoNorm exactly as your doctor has told you. Check with your doctor if you are not sure.
If you take more NovoNorm than you should
If you take too many tablets, your blood sugar may become too low, leading to a hypo. Please see If you get a hypo on what a hypo is and how to treat it.
If you forget to take NovoNorm
If you miss a dose, take the next dose as usual - do not double the dose.
If you stop taking NovoNorm
Be aware that the desired effect is not achieved if you stop taking NovoNorm. Your diabetes may get worse. If any change of your treatment is necessary contact your doctor first.
If you have any further questions on the use of NovoNorm, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, NovoNorm can cause side effects, although not everybody gets them.
Possible side effects
Common (may affect up to 1 in 10 patients)
Rare (may affect up to 1 in 1000 patients)
Very rare (may affect up to 1 in 10,000 patients)
Frequency unknown
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How should it be stored?
Keep out of the reach and sight of children.
Store in a dry place in order to protect from moisture. Store in the original package.
Do not use after the expiry date. The expiry date refers to the last date of that month. This is stated on the outer carton and the blister foil.
Medicines should not be disposed of down the drain or in household rubbish. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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For doctors
What is it?
NovoNorm is a medicine that contains the active substance repaglinide. It is available as round tablets (white: 0.5 mg; yellow: 1 mg; peach: 2 mg).
What is it used for?
NovoNorm is used in patients who have type 2 diabetes (non-insulin-dependent diabetes). It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise. NovoNorm may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
How is it used?
NovoNorm is taken before meals, normally up to 15 minutes before each main meal. The dose is adjusted to give the best control. A doctor should regularly test the patient’s blood glucose to find the lowest effective dose. NovoNorm can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
The recommended starting dose is 0.5 mg. This dose may need to be increased after one or two weeks. If patients are transferred from another anti-diabetes medicine, the recommended starting dose is 1 mg.
NovoNorm is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
How does it work?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. NovoNorm helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
How has it been studied?
NovoNorm has been studied in 45 ‘clinical pharmacology’ studies (looking at how the medicine works in the body) and 16 clinical trials (looking at its effects in treating type 2 diabetes patients). A total of 2,156 patients received NovoNorm in all trials combined.
The main studies compared NovoNorm with other medicines used in type 2 diabetes (glibenclamide, glipizide or gliclazide). Another study looked at the effect of adding NovoNorm to metformin. The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) which gives an indication of how well the blood glucose is controlled.
What benefits has it shown during the studies?
In all studies, NovoNorm led to a decrease in the level of HbA1c, which showed that blood glucose levels had been controlled to a similar level to that seen with the comparator medicines. In the study where NovoNorm was added to metformin, the effects of the two medicines were at least additive (equivalent to the effects of the two medicines added together).
NovoNorm produced a good insulin response to a meal within 30 minutes of being dosed in type 2 diabetes patients, leading to a blood glucose-lowering effect throughout the meal. The raised insulin levels returned to normal after the meal.
What is the risk associated?
The most common side effects with NovoNorm (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels), abdominal (tummy) pain and diarrhoea. For the full list of all side effects reported with NovoNorm, see the Package Leaflet.
NovoNorm should not be used in people who may be hypersensitive (allergic) to repaglinide or any of the other ingredients. It should also not be used in patients with type 1 (insulin-dependent) diabetes who do not have any ‘C-peptide’ in their blood (a marker of type 1 diabetes). It should also not be used in patients with diabetic ketoacidosis (high levels of ketones [acids] in the blood), in patients with severe liver problems or in patients also taking gemfibrozil (a medicine used to reduce blood fat levels). NovoNorm doses may also need to be adjusted when given with some medicines used in heart conditions, and to treat pain, asthma and other conditions. The full list of these medicines is available in the Package Leaflet.
Why has it been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that NovoNorm’s benefits are greater than its risks for the treatment of type 2 diabetes. The Committee recommended that NovoNorm be given marketing authorisation.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for NovoNorm to Novo Nordisk A/S on 17 August 1998. The marketing authorisation was renewed on 17 August 2003 and on 17 August 2008.
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Name
NovoNorm 0.5 mg tablets
Composition
Each tablet contains 0.5 mg of repaglinide.
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Tablet
Repaglinide tablets are white, round and convex and engraved with Novo Nordisk logo (Apis bull).
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