NOVONORM 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

NovoNorm 0.5mg tablets

NovoNorm 1mg tablets

NovoNorm 2mg tablets

Repaglinide

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is NovoNorm and what is it used for
2. What you need to know before you take NovoNorm
3. How to take NovoNorm
4. Possible side effects
5. Storage of NovoNorm
6. Package contents and further information

1. What is NovoNorm and what is it used for

NovoNorm is an oral antidiabetic medicine that contains repaglinide, which helps your pancreas produce more insulin and lower your blood sugar (glucose) levels.

Type 2 diabetesis a disease in which the pancreas does not produce enough insulin to control the level of sugar in the blood, or in which the body does not respond normally to the insulin it produces.

NovoNorm is used to control type 2 diabetes in adults as a supplement to diet and exercise: treatment should be started if diet, physical exercise, and weight reduction alone have not been sufficient to control (or reduce) blood sugar levels. NovoNorm can also be taken with metformin, another diabetes medicine.

It has been shown that NovoNorm lowers blood sugar levels, which helps to prevent complications of diabetes.

2. What you need to know before you take NovoNorm

Do not take NovoNorm

• If you are allergic to repaglinide or any of the other ingredients of this medicine (listed in section 6).
• If you have type 1 diabetes.
• If your blood acid levels have increased (diabetic ketoacidosis).
• If you have severe liver disease.
• If you are taking gemfibrozil (a medicine that lowers blood fat levels).

Warnings and precautions

Talk to your doctor before starting to take NovoNorm:

Talk to your doctorif 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 old.

If you have low blood sugar (hypoglycaemia)

You may have hypoglycaemia if your blood sugar levels are too low. This can happen if:

• you take too much NovoNorm;
• you do more physical exercise than usual;
• you take other medicines or have kidney or liver problems (see other sections of section 2. What you need to know before you take NovoNorm).

Warning signs of hypoglycaemiaappear suddenly and can be: cold sweat, cool pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, weakness, and unusual nervousness or tremors, anxiety, confusion, and difficulty concentrating.

If your blood sugar levels are low or if you feel you are going to have hypoglycaemia:take glucose tablets or a sugary product or drink, and then rest.

When the symptoms of hypoglycaemia disappear or when your blood sugar levels stabilise, continue your treatment with NovoNorm.

Inform others that you are diabetic and that if you lose consciousness, due to hypoglycaemia, they should lay you on your side and seek immediate medical assistance. They should not give you anything to eat or drink, as you may choke.

• If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.
• If you have severe hypoglycaemia or repeated hypoglycaemias, tell your doctor. You may need to adjust your dose of NovoNorm, your diet, or your exercise.

If your blood sugar levels are very high

Your blood sugar levels may be very high (hyperglycaemia). This can happen:

Warning signs of high blood sugar levelsappear gradually. These include: excessive urination, thirst, dry skin, and a dry mouth feeling. Tell your doctor. You may need to adjust your dose of NovoNorm, your diet, or your exercise.

Other medicines and NovoNorm

Tell your doctoror pharmacist if you are taking, have recently taken, or might take any other medicines.

If your doctor prescribes it, you can take NovoNorm with metformin, another diabetes medicine.

If you are taking gemfibrozil (used to lower blood fat levels), you should not take NovoNorm.

Your body's response to NovoNorm may change if you take other medicines, especially:

• monoamine oxidase inhibitors (MAOIs) (for depression treatment),
• beta-blockers (for high blood pressure or heart disease treatment),
• ACE inhibitors (for heart disease treatment),
• salicylates (e.g. aspirin),
• octreotide (for cancer treatment),
• non-steroidal anti-inflammatory drugs (NSAIDs) (a type of pain reliever),
• steroids (anabolic steroids and corticosteroids, for anaemia or to treat inflammation),
• oral contraceptives (to prevent pregnancy),
• thiazides (diuretics),
• danazol (for breast cysts and endometriosis treatment),
• thyroid products (for low thyroid hormone levels treatment),
• sympathomimetics (for asthma treatment),
• clarithromycin, trimethoprim, rifampicin (antibiotics),
• itraconazole, ketoconazole (antifungals),
• gemfibrozil (to treat high blood fat levels),
• ciclosporin (to suppress the immune system),
• deferasirox (to reduce chronic iron overload),
• clopidogrel (to prevent blood clots),
• phenytoin, carbamazepine, phenobarbital (for epilepsy treatment),
• St. John's Wort (herbal medicine).

Using NovoNorm with alcohol

Alcohol may change the ability of NovoNorm to lower your blood sugar levels. Be aware of the symptoms of hypoglycaemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Do not take NovoNorm if you are pregnant or planning to become pregnant.

Do not take NovoNorm if you are breastfeeding.

Driving and using machines

Your ability to drive or use machines may be affected if your blood sugar levels are too low or too high. Be aware that you may be at risk or put others at risk. Talk to your doctor about the possibility of driving a car if:

• you have frequent hypoglycaemias;
• you have few or no symptoms of hypoglycaemia or you find it difficult to recognise them.

3. How to take NovoNorm

Take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Your doctor will calculate your dose.

• Normally, the initial dose is 0.5 mg taken immediately before each main meal. The tablets should be taken with a glass of water immediately before or within 30 minutes before each main meal.
• The dose may be adjusted by your doctor up to 4 mg, which should be taken immediately before or within 30 minutes before each main meal. The maximum recommended dose is 16 mg per day.

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 levels may become too low and cause hypoglycaemia. Please read what hypoglycaemia is and how to treat it in the section If you have low blood sugar (hypoglycaemia).

If you forget to take NovoNorm

If you forget to take a dose, take the next dose as you normally would, do not take a double dose.

If you stop taking NovoNorm

Be aware that the desired effect will not be achieved if you stop taking NovoNorm. Your diabetes may get worse. If any change in your treatment is necessary, talk to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Hypoglycaemia

The most common side effect is hypoglycaemia, which may affect up to 1 in 10 people (see If you have low blood sugar (hypoglycaemia)in section 2). Hypoglycaemic reactions are usually mild or moderate, but occasionally they can cause loss of consciousness or hypoglycaemic coma. If this happens, you need immediate medical attention.

Allergic reactions

Cases of allergic reactions are very rare (may affect up to 1 in 10,000 people). Symptoms such as swelling, difficulty breathing, palpitations, dizziness, sweating, may be signs of an anaphylactic reaction. Contact your doctor immediately.

Other side effects

Common (may affect up to 1 in 10 people)

• Stomach pain
• Diarrhoea

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

• Acute coronary syndrome (but may not be due to the medicine)

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

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

Frequency not known

• Hypersensitivity (such as rash, itching, redness, and skin swelling)
• Nausea

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of NovoNorm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

Composition of NovoNorm

• The active substance is repaglinide.
• The other ingredients are microcrystalline cellulose (E460), anhydrous calcium phosphate, maize starch, potassium polacrylate, povidone (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, yellow iron oxide (E172) only in the 1 mg tablets, and red iron oxide (E172) only in the 2 mg tablets.

Appearance of the product and package contents

NovoNorm tablets are round and convex and are engraved with the Novo Nordisk logo (Apis bull). 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. Four blister pack sizes are 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.

Date of last revision of this package leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.