Package leaflet: Information for the user

NovoNorm 0.5 mg tablets, 1 mg tablets, 2 mg tablets

Repaglinide
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What NovoNorm is and what it is used for
What you need to know before taking NovoNorm
How to take NovoNorm
Possible side effects
How to store NovoNorm
Contents of the pack and other information

1. What NovoNorm is and what it is used for

NovoNorm is an oral antidiabetic agent containing repaglinide that helps the pancreas produce
a greater amount of insulin, thereby reducing the level of sugar (glucose) in the blood.
Type 2 diabetes is a condition in which the pancreas does not produce enough insulin to control
blood sugar levels, or in which the body does not respond normally to the insulin it produces.
NovoNorm is used to control type 2 diabetes in adults, in addition to diet and exercise; treatment is
usually started when diet, physical activity, and weight reduction alone are not sufficient to control
(or reduce) blood sugar levels. NovoNorm may also be given in combination with metformin, another
diabetes medicine.
NovoNorm has been shown to reduce blood sugar levels, thereby helping to prevent diabetes-related complications.

2. What you need to know before taking NovoNorm

Do not take NovoNorm

if you are allergic to repaglinide or to any of the other ingredients in this medicine (listed in section 6).
if you have type 1 diabetes.
if the level of acid in your body is high ( diabetic ketoacidosis ).
if you have severe liver disease.
if you are taking gemfibrozil (a medicine used to lower fat levels in the blood).

Warnings and precautions
Talk to your doctor before taking NovoNorm:

If you have liver problems. NovoNorm is not recommended in patients with moderate liver disease. NovoNorm must not be taken if you have severe liver disease (see Do not take NovoNorm).
If you have kidney problems. NovoNorm should be taken with caution.
If you are about to undergo major surgery or if you have recently had a serious illness or infection. In these cases, your diabetes may no longer be under control.
NovoNorm is not recommended if you are under 18 years of age or over 75 years of age. NovoNorm has not been studied in these age groups.

Talk to your doctor if any of the above conditions apply to you, as 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 have hypoglycaemia (low blood sugar)
If your blood sugar level drops too low, you may experience hypoglycaemia (shortened to "hypo"). This may happen:

If you have taken too much NovoNorm
If you do more physical activity than usual
If you take other medicines or have liver or kidney disorders (see other sections of paragraph 2. What you need to know before taking NovoNorm).

Early signs of hypoglycaemia may occur suddenly and may include: cold sweat; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
If your blood sugar is low or if you feel a hypoglycaemic episode coming on: eat glucose tablets or a snack or drink a sugary beverage, then rest.
Once the symptoms of hypoglycaemia have subsided or your blood sugar has stabilized, continue your treatment with NovoNorm.
Inform those around you that you are diabetic and that, if you faint (lose consciousness) due to a hypo, they must turn you onto your side and seek immediate medical help. They must not give you food or drink. These could cause you to choke.
If severe hypoglycaemia is not treated, it may lead to brain damage (temporary or permanent) and even death.
If you experience hypoglycaemia that causes you to lose consciousness, or if you have repeated episodes of hypoglycaemia, consult your doctor. It may be necessary to adjust your dose of NovoNorm, your diet, or your physical activity.
If your blood sugar becomes too high
The level of sugar in your blood may become too high (hyperglycaemia). This may happen:

If you have not taken enough NovoNorm
If you have an infection or fever
If you have eaten more than usual
If you have done less physical activity than usual

Signs of high blood sugar levels develop gradually. They include: increased urination; thirst; dryness of the skin and mouth. Consult your doctor. It may be necessary to adjust the dose of NovoNorm, your diet, or your physical activity.
Other medicines and NovoNorm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You may take NovoNorm in combination with metformin, another diabetes medicine, if prescribed by your doctor.
If you are taking gemfibrozil (used to lower fat levels in the blood), you must not take NovoNorm.
Your body's response to NovoNorm may be altered if you take other medicines, particularly:

Monoamine oxidase inhibitors (MAOIs, used to treat depression)
Beta-blockers (used to treat high blood pressure and heart conditions)
ACE inhibitors (used to treat heart conditions)
Salicylates (e.g. aspirin)
Octreotide (used to treat tumours)
Non-steroidal anti-inflammatory drugs (NSAIDs, a type of painkiller)
Steroids (anabolic steroids and corticosteroids – used for anaemia or to treat inflammation)
Oral contraceptives (used for birth control)
Thiazides (diuretics or 'water pills')
Danazol (used to treat breast cysts and endometriosis)
Thyroid hormones (used in case of low thyroid hormone levels)
Sympathomimetics (used to treat asthma)
Clarithromycin, trimethoprim, rifampicin (antibiotics)
Itraconazole, ketoconazole (medicines for fungal infections)
Gemfibrozil (used to lower fat levels in the blood)
Cyclosporine (used to suppress the immune system)
Deferasirox (used to reduce chronically high iron levels)
Clopidogrel (prevents blood clots)
Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
St. John's Wort (herbal medicine).

NovoNorm and alcohol
The ability of NovoNorm to lower blood glucose may be altered if you drink alcohol. Be alert for signs of hypoglycaemia.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, inform your doctor before taking this medicine.
You must not take NovoNorm if you are pregnant or planning to become pregnant.
You must not take NovoNorm if you are breastfeeding.
Driving and using machines
Your ability to drive or operate machinery may be impaired by low or high blood sugar levels. Be aware that you could be putting yourself and others at risk. Ask your doctor whether you may drive if:

you experience frequent hypoglycaemic episodes
you have few or no warning signs of hypoglycaemia.

3. How to take NovoNorm

Use this medicine exactly as your doctor has told you. If you have any doubts,
consult your doctor.
Your doctor will determine the dose for you.

The usual starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before each main meal or within the 30 minutes preceding the meal.
Your doctor may adjust the dose up to a maximum of 4 mg taken immediately before each main meal or within the 30 minutes preceding the meal. The maximum recommended daily dose is 16 mg.

Do not take more NovoNorm than prescribed by your doctor.
If you take more NovoNorm than you should
If you take too many tablets, your blood sugar may become too low, leading to hypoglycaemia. See If you have a hypo for information 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, but do not double the dose.
If you stop taking NovoNorm
Please note that if you stop treatment with NovoNorm, the desired effect will not be achieved. Your diabetes may worsen. Contact your doctor before changing your treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

Hypoglycaemia
The most common side effect is hypoglycaemia, which may affect up to 1 in 10 patients (see If you have a hypo in section 2). Hypoglycaemic reactions are generally mild/moderate, but may occasionally progress to unconsciousness or hypoglycaemic coma. In such cases, immediate medical assistance must be sought.

Allergy
Allergic reactions are very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty in breathing, rapid heartbeat, dizziness and sweating may be signs of an anaphylactic reaction. Contact a doctor immediately.

Other side effects

Common (may affect up to 1 in 10 patients)

Stomach ache
Diarrhoea

Rare (may affect up to 1 in 1,000 patients)

Acute coronary syndrome (however, this effect may not be related to the medicine)

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

Vomiting
Constipation
Visual disturbances
Severe liver problems, abnormal liver function, increased liver enzymes in the blood

Frequency not known

Hypersensitivity (such as skin rash, itching, skin redness, skin swelling)
Malaise (nausea)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NovoNorm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What NovoNorm contains
The active substance is repaglinide.
The excipients are microcrystalline cellulose (E460), anhydrous monohydrogen calcium phosphate,
corn starch, polacrilin potassium, povidone (polyvidone), 85% glycerol, magnesium stearate,
meglumine and poloxamer, yellow iron oxide (E172) only in the 1 mg tablets and red iron oxide (E172) only in the 2 mg tablets.
Description of the appearance of NovoNorm and contents of the pack
NovoNorm tablets are round, convex, and imprinted with the Novo Nordisk logo (the bull Api).
The strengths are 0.5 mg, 1 mg and 2 mg. The 0.5 mg tablets are white, the 1 mg tablets are yellow and the 2 mg tablets are peach-coloured. There are four types of blister packs available.
Each pack contains 30, 90, 120 or 270 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé, DK-2880 Bagsværd, Denmark
Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/ .