Repaglinide Accord 2 mg tablets

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 that lowers 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 from 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 low blood sugar (hypoglycaemia)

You may experience hypoglycaemia (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 include: cold sweat, cool pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, unusual weakness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.

If your blood sugar levels are low or if you feel that 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 assistance. 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 have 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 become 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 dry mouth feeling. 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 depression treatment)
• Beta-blockers (for high blood pressure or heart disease treatment)
• Angiotensin-converting enzyme (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 (antibiotic medicines)
• Itraconazole, ketoconazole (medicines 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 formation)
• Phenytoin, carbamazepine, phenobarbital (for epilepsy treatment)
• St John's Wort (a herbal medicinal plant)

Inform your doctor if you are using or have recently used other medicines, including 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 warning signs 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 Repaglinida Accord if you are pregnant or planning to become pregnant.

Do 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 administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor again.

Your doctor will calculate your dose.

• Normally, the initial doseis 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 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 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 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 low blood sugar (hypoglycaemia)in section 2). Hypoglycaemic reactions are normally mild or moderate, but occasionally they can lead to loss of consciousness or hypoglycaemic coma. If this happens, you need immediate medical assistance.

Allergic reactions

Cases of allergy are very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, palpitations, dizziness symptoms, 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. This 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 1 mg tablets) and red iron oxide (E172) (only in 2 mg tablets).

Appearance of Repaglinida Accord and contents of the pack

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.

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.

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