NovoNorm® is an oral antidiabetic medicine 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.
NovoNorm® is used to control type 2 diabetes in adults 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 or thiazolidinediones, other medicines for diabetes.
NovoNorm® has been shown to lower the blood sugar, which helps to prevent complications from your diabetes.

Do not take NovoNorm®:
• If you are allergic to repaglinide or any of the other ingredients in this medicine
• If you have type 1 diabetes
• If the acid level in your blood 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).

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.

Children and adolescents
Do not take this medicine if you are under 18 years of age.
If you get a hypo (low blood sugar) You may get a hypo (short for hypoglycaemia) 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 kidney or liver problems (see
other sections of 2. What you need to know 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 sugary 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 of too high blood
sugar 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.

Other medicines and NovoNorm®
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
You can take NovoNorm® with metformin or thiazolidinediones, other medicines 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 anaemia 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, ketoconazole (antifungal medicines)
• Gemfibrozil (used to treat high blood fats)
• Ciclosporin (used to suppress the immune system)
• Deferasirox (used to reduce chronic iron overload)
• Clopidogrel (prevents blood clots)

• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John’s wort (herbal medicine).
NovoNorm® with alcohol
Alcohol can change the ability of NovoNorm® to reduce the blood sugar.
Watch for signs of a hypo.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this medicine.
You should not take NovoNorm® if you are pregnant or are planning to become
pregnant. You should not take NovoNorm® if you are breast-feeding.
Driving and using machines
Your ability to drive or use 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

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

Like all medicines, NovoNorm® can cause side effects, although not everybody gets
them.

Hypoglycaemia
The most frequent side effect is hypoglycaemia which may affect up to 1 in 10 patients (see If you get a hypo).
Hypoglycaemic reactions are generally mild/moderate but may occasionally develop into hypoglycaemic unconsciousness or coma. If this happens, medical assistance is needed immediately.

Allergy
Allergy is very rare (may affect up to 1 in 10,000 patients). Symptoms such as
swelling, difficulty in breathing, rapid heartbeat, feeling dizzy and sweating could be signs of anaphylactic reaction.
Contact a doctor immediately.

Other side effects
Common (may affect up to 1 in 10 patients)
• Stomach pain
• Diarrhoea.
Rare (may affect up to 1 in 1,000 patients)
• Acute coronary syndrome (but it may not be due to the medicine).
Very rare (may affect up to 1 in 10,000 patients)
• Vomiting
• Constipation
• Visual disturbances

• Severe liver problems, abnormal liver function such as increased liver enzymes in your blood.

Frequency not known
• Hypersensitivity (such as rash, itchy skin, redening of the skin, swelling of the skin)
• Feeling sick (nausea).
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Keep NovoNorm® out of the sight and
reach of children.
Do not use after the expiry date which is stated on the carton and the blister foil after ‘Expiry’. The expiry date refers to the
last date of that month.
Store in the original package below 30°C to protect from moisture
Do not throw away medicines down the drain or in household rubbish. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the environment.