PRANDIN 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Prandin 0.5 mg tablets

Prandin 1 mg tablets

Prandin 2 mg tablets

Repaglinide

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

• Keep this 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 signs of illness 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 leaflet. See section 4.

Contents of the package leaflet

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

1. What is Prandin and what is it used for

Prandin 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 blood sugar levels or in which the body does not respond normally to the insulin it produces.

Prandin 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. Prandin can also be taken with metformin, another diabetes medicine.

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

2. What you need to know before you take Prandin

Do not take Prandin

• 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 Prandin:

Talk to your doctorif any of the above applies to you. Prandin 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 Prandin;
• 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 Prandin).

Warning signs of hypoglycaemiaappear suddenly and can be: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, unusual weakness and lack of energy, 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 treatment with Prandin.

Inform others that you are diabetic and that if you lose consciousnessdue to hypoglycaemia, they should lay you on your side and seek immediate medical attention. 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, inform your doctor. You may need to adjust the dose of Prandin, 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. Inform your doctor. You may need to adjust the dose of Prandin, your diet, or your exercise.

Other medicines and Prandin

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 Prandin with metformin, another diabetes medicine.

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

Your body's response to Prandin 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 inflammation treatment),
• 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 (antifungal medicines),
• 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 (a herbal medicine).

Using Prandin with alcohol

Alcohol may change the effect of Prandin on lowering your blood sugar levels. Be aware of the symptoms of hypoglycaemia.

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.

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

Do not take Prandin if you are breast-feeding.

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 put yourself or 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 Prandin

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, ask your doctor again.

Your doctor will calculate your dose.

• Normally, the initial 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 30 minutes before each main meal.
• The 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 Prandin than your doctor has recommended.

If you take more Prandin 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 Prandin

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 Prandin

Be aware that the desired effect will not be achieved if you stop taking Prandin. 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 can affect up to 1 in 10 patients (see If you have low blood sugar (hypoglycaemia)in section 2). Hypoglycaemic reactions are usually mild or moderate but can occasionally lead to 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 patients). 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 patients)

• Stomach pain
• Diarrhoea

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

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

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 the blood

Frequency not known

• Hypersensitivity (such as rash, itching, redness, and swelling of the skin)
• 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 leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Prandin

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 on the blister after EXP. The expiry date is the last day of the month stated.

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. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Prandin

• 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 pack contents

Prandin 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 leaflet:

Other sources of information

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