NovoNorm 2 mg tablets

 

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 you are hypersensitive (allergic) to repaglinide or any of the other components of the medicine
  • If you have type 1 diabetes ( insulin-dependent diabetes)
  • If the acid level in your body is raised (diabetic ketoacidosis)
  • If you have a severe liver disease
  • If you take gemfibrozil (a medicine used to lower increased fat levels in the blood).

If any of these apply to you, tell your doctor and do not take NovoNorm.

Take special care with NovoNorm:

  • If you have liver problems. NovoNorm is not recommended in patients with moderate liver disease. NovoNorm should not be taken if you have a severe liver disease (see Do not take NovoNorm).
  • If you have kidney problems. NovoNorm should be taken with caution.
  • If you are about to have major surgery or you have recently suffered a severe illness or infection. At such times diabetic control may be lost.
  • If you are under 18 or over 75 years of age. NovoNorm is not recommended. It has not been studied in these age groups.

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:

  • If you take too much NovoNorm
  • If you exercise more than usual
  • If you take other medicines or suffer from liver or kidney problems (see other sections of 2. Before you take NovoNorm).

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 severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.
  • If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount of NovoNorm, food or exercise may need to be adjusted.

If your blood sugar gets too high

Your blood sugar may get too high (hyperglycaemia). This may happen:

  • If you take too little NovoNorm
  • If you have an infection or a fever
  • If you eat more than usual
  • If you exercise less than usual.

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:

  • Monoamine oxidase inhibitors (MAOI) (used to treat depression)
  • Beta blockers (used to treat high blood pressure or heart conditions)
  • ACE-inhibitors (used to treat heart conditions)
  • Salicylates (e.g. aspirin)
  • Octreotide (used to treat cancer)
  • Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkillers)
  • Steroids (anabolic steroids and corticosteroids – used for anemia or to treat inflammation)
  • Oral contraceptives (birth control pills)
  • Thiazides (diuretics or “water pills”)
  • Danazol (used to treat breast cysts and endometriosis)
  • Thyroid products (used to treat low levels of thyroid hormones)
  • Sympathomimetics (used to treat asthma)
  • Clarithromycin, trimethoprim, rifampicin (antibiotic medicines)
  • Itraconazole, ketokonazole (antifungal medicines)
  • Gemfibrozil (used to treat high blood fats)
  • Ciclosporin (used to suppress the immune system)
  • Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
  • St. John’s wort (herbal medicine).

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:

  • Have frequent hypos
  • Have few or no warning signs of hypos.

How is it used?

Your doctor will work out your dose.

  • The normal starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
  • The dose may be adjusted by your doctor by up to 4 mg to be taken immediately before or up to 30 minutes before each main meal. The maximum recommended daily dose is 16 mg.

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)

  • Hypoglycaemia (see If you get a hypo). The risk of getting a hypo may increase if you take other medicines
  • Stomach pain
  • Diarrhoea.

Rare (may affect up to 1 in 1000 patients)

  • Acute coronary syndrome (but it may not be due to the drug).

Very rare (may affect up to 1 in 10,000 patients)

  • Allergy (such as swelling, difficulty in breathing, rapid heart beat, feeling dizzy, sweating which could be signs of anaphylactic reaction). Contact a doctor immediately
  • Vomiting
  • Constipation
  • Visual disturbances
  • Severe liver problems, abnormal liver function, increased liver enzymes in your blood.

Frequency unknown

  • Hypoglycaemic coma or unconsciousness (very severe hypoglycaemic reactions – see If you get a hypo). Contact a doctor immediately
  • Hypersensitivity (such as rash, itchy skin, redening of the skin, swelling of the skin)
  • Feeling sick (nausea).

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.

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.