Repaglinide Accord 0.5 mg tablets

Introduction

Package Leaflet: Information for the User

Repaglinida Accord 0.5 mg tablets EFG

Repaglinida Accord 1 mg tablets EFG

Repaglinida Accord 2 mg tablets EFG

Repaglinida

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 get 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 pack:

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

1. What is Repaglinida Accord and what is it used for

Repaglinida Accord is an oral anti-diabetic 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 your pancreas does not produce enough insulin to control your blood sugar levels or in which your body does not respond normally to the insulin it produces.

Repaglinida Accord 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 lower) your blood sugar levels. Repaglinida Accord can also be given with metformin, another medicine for diabetes.

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

2. What you need to know before you take Repaglinida Accord

Do not take Repaglinida Accord

• If you are hypersensitive (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 used to lower blood fat levels).

Warnings and precautions

Consult your doctor before taking Repaglinida Accord

• If you have liver problems. Repaglinida Accord is not recommended for patients with moderate liver disease. Repaglinida Accord should not be taken if you have severe liver disease (see Do not take Repaglinida Accord).
• If you have kidney problems. Repaglinida Accord should be taken with caution.
• If you are going to have a major surgical operationor have recently suffered a serious illness or infection. In these circumstances, you may not achieve diabetic control.
• If you are under 18or over 75 years, Repaglinida Accord is not recommended. It has not been studied in these age groups.

Consult your doctorif any of the above applies to you, Repaglinida Accord 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 hypoglycaemia (low blood sugar)

You may experience hypoglycaemia (a symptom of low blood sugar) if your blood sugar levels are too low. This can happen if:

• You take too much Repaglinida Accord
• 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 takeRepaglinida Accord).

Warning signs of hypoglycaemiaappear suddenly and can be: cold sweat, cool 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 a hypoglycaemic attack: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 Repaglinida Accord.

Inform others that you are diabeticand 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 hypoglycaemiais not treated, it can cause brain damage (temporary or permanent) and even death.
• If you experience hypoglycaemiathat makes you lose consciousness or if you suffer from repeated hypoglycaemic attacks, inform your doctor. You may need to adjust the dose or administration schedule of Repaglinida Accord, your diet, or exercise.

If your blood sugar levels are too high

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

• If you take too little Repaglinida Accord
• If you have an infection or fever
• If you eat more than usual
• If you do less exercise than usual.

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

Using Repaglinida Accord with other medicines

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

If your doctor prescribes it, you can take Repaglinida Accord with metformin, another medicine for diabetes.

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

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

• Monoamine oxidase inhibitors (MAOIs) (for the treatment of depression)
• Beta-blockers (for the treatment of high blood pressure or heart disease)
• Angiotensin-converting enzyme (ACE) inhibitors (for the treatment of heart disease)
• Salicylates (e.g. aspirin)
• Octreotide (for the treatment of cancer).
• 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 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 (antibiotic medicines)
• Itraconazole, ketoconazole (medicine 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 (to treat epilepsy)
• St John's Wort (a herbal medicinal plant)

Inform your doctor if you are using or have recently used other medicines, even those obtained without a prescription.

Repaglinida Accord with alcohol

Alcohol may alter the ability of Repaglinida Accord to lower 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.

You should not take Repaglinida Accord if you are pregnant or planning to become pregnant.

You should not take Repaglinida Accord if you are breast-feeding.

Driving and using machines

Your ability to drive or operate 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.

Consult your doctor about the possibility of driving a car, if:

• You have frequent hypoglycaemic attacks
• You have few or no symptoms of hypoglycaemia or find it difficult to recognise them

3. How to take Repaglinida Accord

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

Your doctor will calculate your dose.

• Normally, the initial doseis 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 Repaglinida Accord than your doctor has recommended.

If you take more Repaglinida Accord than you should

If you take too many tablets, your blood sugar levels may become too low and you may experience hypoglycaemia. Please read what hypoglycaemia is and how to treat it in the section If you have hypoglycaemia.

If you forget to take Repaglinida Accord

If you forget to take a dose, take the next dose as you normally would, never take a double dose.

If you stop taking Repaglinida Accord

Be aware that the desired effect will not be achieved if you stop taking Repaglinida Accord. Your diabetes may worsen. If any change in your treatment is necessary, consult 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 hypoglycaemiain section 2). Hypoglycaemic reactions are normally 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, symptoms of dizziness, and 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.

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.
• Severe liver problems, abnormal liver function, and increased liver enzymes in the blood.

Frequency not known

• Hypersensitivity (such as rash, itching, skin redness, and 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 leaflet. You can also report side effects directly via 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. Storage of Repaglinida Accord

Keep this medicine out of the sight and reach of children

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

This medicine does not require any special storage conditions.

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 other information

Composition of Repaglinida Accord

The active substance is repaglinide.

Each Repaglinida Accord 0.5 mg tablet contains 0.5 mg of repaglinide.

Each Repaglinida Accord 1 mg tablet contains 1 mg of repaglinide.

Each Repaglinida Accord 2 mg tablet contains 2 mg of repaglinide.

The other ingredients are: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate, maize starch, meglumine, poloxamer 188, povidone, glycerol, magnesium stearate, yellow iron oxide (E172) (only in the 1 mg tablets) and red iron oxide (E172) (only in the 2 mg tablets).

Appearance of Repaglinida Accord and contents of the pack

The Repaglinida Accord 0.5 mg tablets are white to almost white, round, biconvex, with bevelled edges, with the inscription “R” on one side and smooth on the other.

The Repaglinida Accord 1 mg tablets are light yellow to yellow, round, biconvex, with bevelled edges, with the inscription “R” on one side and smooth on the other, may have a speckled appearance.

The Repaglinida Accord 2 mg tablets are peach, round, biconvex, with bevelled edges, with the inscription “R” on one side and smooth on the other, may have a speckled appearance.

Repaglinida Accord is available in the following pack sizes:

30, 90, 120, 180 or 270 tablets in blisters.

100 tablets in an HDPE bottle.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Date of last 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