Repaglinide Accord 1 mg tablets

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

Do not take Repaglinide 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 Repaglinide Accord

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

Consult your doctorif any of the above applies to you, Repaglinide 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 have a hypoglycaemic episode (low blood sugar symptoms) if your blood sugar levels are too low. This can happen if:

• You take too much Repaglinide 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 takeRepaglinide Accord).

Warning symptoms of hypoglycaemiaappear suddenly and can be: cold sweat, cool pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, weakness, and unusual nervousness or tremor, anxiety, confusion, and difficulty concentrating.

If your blood sugar levels are low or if you feel that you are going to have a hypoglycaemic episode: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 Repaglinide 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 have a hypoglycaemic episodethat makes you lose consciousness or if you have repeated hypoglycaemic episodes, inform your doctor. You may need to adjust the dose or administration schedule of Repaglinide 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 Repaglinide Accord
• If you have an infection or fever
• If you eat more than usual
• If you do less exercise than usual.

Warning symptoms 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 Repaglinide Accord, your diet, or exercise.

Using Repaglinide 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 Repaglinide Accord with metformin, another medicine for diabetes.

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

Your body's response to Repaglinide 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)
• 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.

Repaglinide Accord with alcohol

Alcohol may alter the ability of Repaglinide 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 Repaglinide Accord if you are pregnant or planning to become pregnant.

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

Driving and using machines

Your ability to drive or operate machinery may be affected if your blood sugar levels are 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 hypoglycaemic episodes
• You have few or no symptoms of hypoglycaemia or find it difficult to recognise them

3. How to take Repaglinide Accord

Follow exactly the administration instructions 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 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 Repaglinide Accord than your doctor has recommended.

If you take more Repaglinide Accord than you should

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

If you forget to take Repaglinide 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 Repaglinide Accord

Be aware that the desired effect will not be achieved if you stop taking Repaglinide 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 can occasionally 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 Repaglinide Accord

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

Do not use Repaglinide 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 Repaglinide Accord

The active substance is repaglinide.

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

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

Each Repaglinide 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 Repaglinide Accord and contents of the pack

Repaglinide 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.

Repaglinide 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.

Repaglinide 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.

Repaglinide 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