Leaflet: information for the user

NovoNorm 0.5mg tablets

NovoNorm 1mg tablets

NovoNorm 2mg tablets

Repaglinide

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

–If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is NovoNorm and what it is used for

2.What you need to know before starting to take NovoNorm

3.How to take NovoNorm

4.Possible side effects

5.Storage of NovoNorm

6.Contents of the pack and additional information

NovoNorm is a medicationoral antidiabetic that contains repaglinidewhich helps your pancreas to produce more insulin and lower your blood sugar (glucose).

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 complement to diet and exercise: treatment should begin if diet, physical exercise, and weight reduction alone have not been sufficient to control (or reduce) the level of sugar in the blood. NovoNorm can also be administered with metformin, another diabetes medication.

It has been shown that NovoNorm reduces blood sugar levels, which contributes to preventing diabetes complications.

Do not take NovoNorm

•If you areallergicto repaglinide or any of the other components of this medication (listed in section 6).

•If you havetype 1 diabetes.

•If your blood acid level has increased (diabetic ketoacidosis).

•If you havesevere liver disease..

•If you are takinggemfibrozil(a medication that lowers blood fat levels).

Warnings and precautions

Consult your doctor before starting to take NovoNorm:

•If you haveliver problems. NovoNorm is not recommended for patients with moderate liver disease. NovoNorm should not be taken if you have severe liver disease (seeDo not take NovoNorm);

•If you havekidney problems. NovoNorm should be taken with caution;

•If you are about to undergo amajor surgical procedureor have recently had aserious illness or infection.In these circumstances, blood sugar control may not be achieved;

•If you areunder 18orover 75years, NovoNorm is not recommended. It has not been studied in these age groups.

Consult your doctorif any of the above cases occur. NovoNorm may not be indicated for you. Your doctor will advise you.

Children and adolescents

Do not take this medication if you are under 18years.

If you have hypoglycemia (low blood sugar)

You may experience hypoglycemia if your blood sugar level is too low. This can occur if:

•You take too much NovoNorm;

•You engage in more physical exercise than usual;

•You take other medications or have kidney or liver problems (see other sections of section 2.What you need to know before starting to takeNovoNorm).

Warning signs of hypoglycemiaappear suddenly and may include: cold sweat, pale and cold skin, headache, palpitations, nausea, excessive appetite, temporary visual disturbances, fatigue, unusual weakness and tiredness, nervousness or tremor, anxiety, confusion, and difficulty concentrating.

If your blood sugar level is low or if you feel that you are about to have hypoglycemia:take glucose tablets or a sugary product or drink and then rest.

When the symptoms of hypoglycemia disappear or when blood sugar levels stabilizecontinue treatment with NovoNorm.

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

•If severe hypoglycemia is not treated, it can cause brain damage (temporary or permanent) and even death.

•If hypoglycemia causes you to lose consciousness or if you experience repeated hypoglycemia, inform your doctor. You may need to adjust the dose of NovoNorm, your diet, or exercise.

If your blood sugar level is very high

Your blood sugar level may be very high (hyperglycemia). This can occur:

•If you take too little NovoNorm;

•If you have an infection or fever;

•If you eat more than usual;

•If you engage in less physical exercise than usual.

Warning signs of high blood sugarappear gradually. These include: frequent urination, thirst, dry skin, and a sensation of dryness in the mouth. Inform your doctor. You may need to adjust the dose of NovoNorm, your diet, or exercise.

Other medications and NovoNorm

Inform your doctoror pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

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

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

•monoamine oxidase inhibitors (MAOIs) (for the treatment of depression),

•beta-blockers (for the treatment of high blood pressure or heart disease),

•ACE inhibitors (for the treatment of heart disease),

•salicylates (such as aspirin),

•octreotide (for the treatment of cancer),

•nonsteroidal anti-inflammatory drugs (NSAIDs) (a type of analgesic),

•steroids (anabolic steroids and corticosteroids, for anemia or to treat inflammation),

•oral contraceptives (to prevent pregnancy),

•thiazides (diuretics),

•danazol (for the treatment of breast cysts and endometriosis),

•thyroid products (for the treatment of low thyroid hormone levels),

•sympathomimetics (for the treatment of asthma),

•clarithromycin, trimethoprim, rifampicin (antibiotics),

•itraconazole, ketoconazole (medications for fungal infections),

•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 the treatment of epilepsy),

•St. John's Wort (herbal medicine).

Use of NovoNorm with alcohol

Alcohol can alter NovoNorm's ability to lower blood sugar levels. Be aware of the warning signs of hypoglycemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding,or think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

You should not take NovoNorm if you are pregnant or plan to become pregnant.

You should not takeNovoNormsif you are breastfeeding.

Driving and operating machines

Your ability to drive cars and operate machines may be affected if your blood sugar level is low or high. Be aware that you may put yourself or others at risk. Consult your doctor about the possibility of driving a car if:

•You have frequent hypoglycemia;

•You have few or no symptoms of hypoglycemia or find it difficult to recognize them.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Your doctor will calculate your dose.

•Normally, the initial dose is0.5 mg taken exactly before each main meal.The tablets should be taken with a glass of water just before or within 30 minutes before each main meal.

•Your dose may be adjusted by your doctor up to 4 mg, which should be taken just 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 may become too low and cause hypoglycemia. Please read what hypoglycemia is and how to treat it in the sectionif you have hypoglycemia.

If you forget to take NovoNorm

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

If you interrupt treatment with NovoNorm

Be aware that the desired effect will not be achieved if you stop taking NovoNorm. Your diabetes may worsen. If any change in your treatment is necessary, consult your doctor beforehand.

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

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

Hypoglycemia

The most common side effect is hypoglycemia, which can affect up to 1 in 10 patients (seeif you have hypoglycemiain section 2). Hypoglycemic reactions are usually mild or moderate but occasionally can lead to loss of consciousness or hypoglycemic coma. If this occurs, you need immediate medical assistance.

Allergy

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

Other side effects

Frequent (can affect up to 1 in 10 patients)

•Stomach pain

•Diarrhea

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

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

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

•Vomiting

•Constipation

•Visual disturbances

•Severe liver problems, abnormal liver function, such as elevated liver enzymes in the blood

Unknown frequency

•Hypersensitivity (such as hives, itching, redness, and swelling of the skin)

•Nausea

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of NovoNorm

–The active ingredient is repaglinide.

–The other components are microcrystalline cellulose (E460), anhydrous calcium dihydrogen phosphate, cornstarch, potassium polacrilex, povidone (polyvidone), 85% glycerol, magnesium stearate, meglumine, poloxamer, yellow iron oxide (E172) only in 1 mg tablets, and red iron oxide (E172) only in 2 mg tablets.

Appearance of the product and contents of the packaging

NovoNorm tablets are round and convex and are engraved with the Novo Nordisk logo (Apis bull). The concentrations 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-colored. There are four presentations available in blister packaging. Each package contains 30, 90, 120, or 270 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Novo Nordisk A/S,

Novo Allé, DK-2880 Bagsværd, Denmark.

Last review date of this leaflet:

Other sources of information

The detailed information aboutthis medicationis available on the European Medicines Agency website:http://www.ema.europa.eu.