NovoRapid 2 mg, tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

NovoNorm 0.5mg Tablets

NovoNorm 1mg Tablets

NovoNorm 2mg Tablets

Repaglinide

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What NovoNorm is and what it is used for
2. What you need to know before taking NovoNorm
3. How to take NovoNorm
4. Possible side effects
5. How to store NovoNorm
6. Contents of the pack and other information

1. What NovoNorm is and what it is used for

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

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, as an addition to diet and exercise. Treatment should be initiated when diet, physical activity, and weight reduction alone have not been sufficient to control (or lower) blood sugar levels. NovoNorm may also be given together 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 any of the other ingredients of this medicine (listed in section 6).
• If you have type 1 diabetes.
• If the level of acid in your blood has increased (diabetic ketoacidosis).
• If you have severe liver disease.
• If you are taking gemfibrozil (a medicine that lowers fat levels in the blood).

Warnings and precautions

Talk to your doctor before taking NovoNorm:

• if you have liver problems. NovoNorm is not recommended for patients with moderate liver disease. NovoNorm should 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 have recently had a serious illness or infection. In these circumstances, diabetic control may not be achieved;
• 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 situations mentioned above apply 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 experience hypoglycaemia (low blood sugar)

You may experience hypoglycaemia if your blood sugar level becomes too low. This may occur if:

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

Warning symptoms of hypoglycaemia appear suddenly and may include: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, unusual tiredness and weakness, nervousness or trembling, anxiety, confusion, and difficulty concentrating.

If your blood sugar level is low or if you feel a hypoglycaemia coming on: take glucose tablets or a sugary drink or food, and then rest.

Once the symptoms of hypoglycaemia have subsided or when blood sugar levels have stabilized, continue 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 help. Nothing should be given by mouth, as you could choke.

• If severe hypoglycaemia is not treated, it may cause brain damage (transient or permanent) and even death.
• If a hypoglycaemic episode causes you to lose consciousness or if you experience repeated hypoglycaemia, inform your doctor. Your dose of NovoNorm, diet, or exercise regimen may need to be adjusted.

If your blood sugar level is very high

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

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

Warning signs of high blood sugar develop gradually and include: frequent urination, thirst, dry skin, and dry mouth. Inform your doctor. Your dose of NovoNorm, diet, or exercise may need to be adjusted.

Other medicines and NovoNorm

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

NovoNorm may be taken together with metformin, another medicine for diabetes, if prescribed by your doctor.

You should not take NovoNorm if you are taking gemfibrozil (used to lower fat levels in the blood).

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

• monoamine oxidase inhibitors (MAOIs) (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),
• non-steroidal anti-inflammatory drugs (NSAIDs) (a type of painkiller),
• steroids (anabolic steroids and corticosteroids, used for anaemia or to treat inflammation),
• oral contraceptives (to prevent pregnancy),
• thiazides (diuretics),
• danazol (used to treat breast cysts and endometriosis),
• thyroid products (used to treat low thyroid hormone levels),
• sympathomimetics (used to treat asthma),
• clarithromycin, trimethoprim, rifampicin (antibiotic medicines),
• itraconazole, ketoconazole (medicines for fungal infections),
• gemfibrozil (used to treat high blood fat levels),
• cyclosporine (used to suppress the immune system),
• deferasirox (used to reduce chronic iron overload),
• clopidogrel (used to prevent blood clots),
• phenytoin, carbamazepine, phenobarbital (used to treat epilepsy),
• St. John's wort (herbal remedy).

Use of NovoNorm with alcohol

Alcohol may alter NovoNorm's ability to lower blood sugar. Be alert for symptoms of hypoglycaemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using 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 affected if your blood sugar level is too low or too high. Be aware that you could endanger yourself or others. Consult your doctor about whether you may drive if:

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

3. How to take NovoNorm

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Your doctor will calculate your dose.

• Normally, the starting dose is 0.5 mg taken just before each main meal. The tablets should be taken with a glass of water just before or within the 30 minutes prior to each main meal.
• Your doctor may adjust your dose up to 4 mg, which should be taken just before or within the 30 minutes prior to 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, causing hypoglycemia. Please read what hypoglycemia is and how to treat it in the section If you have hypoglycemia.

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

Please note that the desired effect will not be achieved if you stop taking NovoNorm. Your diabetes may worsen. If any change in your treatment is needed, consult your doctor first.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Hypoglycaemia

The most common adverse effect is hypoglycaemia, which may affect up to 1 in 10 patients (see If you have hypoglycaemia in section 2). Hypoglycaemic reactions are usually mild or moderate, but occasionally may lead to loss of consciousness or hypoglycaemic coma. If this occurs, immediate medical assistance is required.

Allergy

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

Other adverse effects

Frequent (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 may not be due to the medicine)

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

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

Frequency not known

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 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 it from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of NovoNorm

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

Appearance of the product and contents of the pack

NovoNorm tablets are round and biconvex, marked with the Novo Nordisk logo (the Apis bull). The available 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. Four pack sizes in blister packs are available. Each pack contains 30, 90, 120 or 270 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S,
Novo Allé, DK-2880 Bagsværd, Denmark.

Date of the most recent revision of this leaflet:

Other sources of information

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