Repaglinide Accord

Patient Information Leaflet: Information for the User

Repaglinide Accord 0.5 mg tablets, 1 mg tablets, 2 mg tablets

Repaglinide
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Repaglinide Accord is an oral antidiabetic medicinal product containing repaglinide that helps the pancreas produce a greater amount of insulin, thereby reducing the level of sugar (glucose) in the blood.
Type 2 diabetes is a condition 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.
Repaglinide Accord is used to control type 2 diabetes in adults, in addition to diet and physical exercise. Treatment is usually started when diet, physical activity, and weight reduction alone are not sufficient to control (or reduce) blood glucose levels.
Repaglinide Accord may also be administered in combination with metformin, another antidiabetic medicine.
Repaglinide Accord has been shown to reduce blood sugar levels, thereby helping to prevent the complications of diabetes.

2. What you need to know before taking Repaglinide Accord

Do not take Repaglinide Accord:

• If you are allergic to repaglinide or to any of the other ingredients of this medicine (listed in section 6).
• If you have type 1 diabetes.
• If your blood acid level is high ( diabetic ketoacidosis ).
• If you have severe liver disease.
• If you are taking gemfibrozil (a medicine used to lower fat levels in the blood).

Warnings and precautions
Talk to your doctor before taking Repaglinide Accord:

• If you have liver problems. Repaglinide Accord is not recommended for patients with moderate liver disease. Repaglinide Accord must 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 about to undergo major surgery or if you have recently had a serious illness or infection. In these cases, your diabetes may become difficult to control.
• Repaglinide Accord is not recommended if you are under 18 years of age or over 75 years of age. Repaglinide Accord has not been studied in these age groups.

Talk to your doctor if any of the conditions listed above apply to you, as 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 of age.
If you have hypoglycaemia (low blood sugar)
If the sugar level in your blood becomes too low, you may experience hypoglycaemia (short for hypoglycaemic episode). This can happen:

• If you take too much Repaglinide Accord
• If you do more physical activity than usual
• If you take other medicines or have liver or kidney disorders (see other sections of paragraph 2. What you need to know before taking Repaglinide Accord).

Warning signs of a hypoglycaemic episode may occur suddenly and can include: cold sweat; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
If your blood sugar is low or if you feel a hypoglycaemic episode coming on: eat sugar lumps or have a snack or a sugary drink, then rest.
Once symptoms of hypoglycaemia have subsided or your blood sugar has stabilized, continue your treatment with Repaglinide Accord.
Explain to people around you that you are diabetic and that, if you faint (lose consciousness) due to hypoglycaemia, they should turn you onto your side and seek immediate medical help. Do not give you food or drink. These could cause you to choke.

• If severe hypoglycaemia is not treated, it may lead to brain damage (temporary or permanent) and even death.
• If you experience hypoglycaemia that causes you to lose consciousness, or if you have repeated episodes of hypoglycaemia, consult your doctor. Your dose of Repaglinide Accord, your diet, or your physical activity may need to be adjusted.

If your blood sugar becomes too high
The sugar level in your blood may become too high (hyperglycaemia). This may happen:

• If you do not take enough Repaglinide Accord
• If you have an infection or fever
• If you eat more than usual
• If you do less physical activity than usual.

Signs of high blood sugar develop gradually. They include: increased urination; thirst; dryness of the skin and mouth. Consult your doctor.
Your dose of Repaglinide Accord, your diet, or your physical activity may need to be adjusted.
Other medicines and Repaglinide Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You may take Repaglinide Accord in combination with metformin, another diabetes medicine, if prescribed by your doctor.
Do not take Repaglinide Accord if you are taking gemfibrozil (used to lower fat levels in the blood).
Your body's response to Repaglinide Accord may change if you take other medicines, especially:

• Monoamine oxidase inhibitors (MAOIs, used to treat depression)
• Beta-blockers (used to treat high blood pressure and heart conditions)
• ACE inhibitors (used to treat heart conditions)
• Salicylates (e.g. aspirin)
• Octreotide (used to treat tumours)
• Non-steroidal anti-inflammatory drugs (NSAIDs, a type of painkiller)
• Steroids (anabolic steroids and corticosteroids – used for anaemia or to treat inflammation)
• Oral contraceptives (used for birth control)
• Thiazides (diuretics or “water pills”)
• Danazol (used to treat breast cysts and endometriosis)
• Thyroid hormones (used when thyroid hormone levels are low)
• Sympathomimetics (used to treat asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotics)
• Itraconazole, ketoconazole (medicines for fungal infections)
• Gemfibrozil (used to lower fat levels in the blood)
• Cyclosporine (used to suppress the immune system)
• Deferasirox (used to reduce chronically high iron levels)
• Clopidogrel (prevents blood clots)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St John’s wort (herbal medicine).

Repaglinide Accord and alcohol
The ability of Repaglinide Accord to lower blood sugar may be altered if you drink alcohol. Be alert for signs of hypoglycaemia.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
You must not take Repaglinide Accord if you are pregnant or planning to become pregnant.
You must not take Repaglinide Accord if you are breastfeeding.
Driving and using machines
Your ability to drive or operate machinery may be impaired by low or high blood sugar levels. Be aware that you could be putting yourself and others at risk. Ask your doctor whether you can drive if:

• You frequently experience hypoglycaemic episodes
• You do not notice the warning signs of hypoglycaemia or notice only a few.

3. How to take Repaglinide Accord

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
Your doctor will determine the dose for you.

• The usual starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before each main meal or within the 30 minutes preceding the meal.
• Your doctor may adjust the dose up to a maximum of 4 mg to be taken immediately before each main meal or within the 30 minutes preceding the meal. The maximum recommended daily dose is 16 mg.

Do not take higher doses of Repaglinide Accord than those prescribed by your doctor.
If you take more Repaglinide Accord than you should
If you take too many tablets, your blood sugar may become too low, leading to hypoglycaemia. See If you have a hypo for information on what a hypo is and how to treat it.
If you forget to take Repaglinide Accord
If you miss a dose, take the next dose as usual. Do not take a double dose to make up for the missed dose.
If you stop taking Repaglinide Accord
Please note that if you stop treatment with Repaglinide Accord, the desired effect will not be achieved and your diabetes may worsen. Contact your doctor before stopping or changing your treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Hypoglycaemia
The most common side effect is hypoglycaemia, which may affect up to 1 in 10 people (see If you have a hypo in section 2). Hypoglycaemic reactions are usually mild to moderate, but may occasionally progress to hypoglycaemic unconsciousness or coma. In such cases, immediate medical assistance must be sought.

Allergic reaction
Allergy is very rare (may affect up to 1 in 10,000 people). Symptoms such as swelling, difficulty breathing, rapid heartbeat, dizziness, and sweating may be signs of an anaphylactic reaction. Contact a doctor immediately.

Other side effects

Common (may affect up to 1 in 10 people)

• Stomach ache
• Diarrhoea

Rare (may affect up to 1 in 1,000 people)

• Acute coronary syndrome (however, this effect may not be related to the medicine)

Very rare (may affect up to 1 in 10,000 people)

• Vomiting
• Constipation
• Vision disorders
• Severe liver problems, abnormal liver function, increased liver enzymes in the blood

Frequency not known

• Hypersensitivity (for example, skin rash, itching, redness of the skin, skin swelling)
• Malaise (nausea)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through 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. How to store 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, bottle,
label and blister after Exp./. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Repaglinide Accord contains
The active substance is repaglinide.
Repaglinide Accord 0.5 mg: each tablet contains 0.5 mg of repaglinide.
Repaglinide Accord 1 mg: each tablet contains 1 mg of repaglinide.
Repaglinide Accord 2 mg: each tablet contains 2 mg of repaglinide.
The other components are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch,
meglumine, poloxamer 188, povidone, glycerin, magnesium stearate, yellow iron oxide (E172) only in the 1 mg tablets, and red iron oxide (E172) only in the 2 mg tablets.

Description of the appearance of Repaglinide Accord and contents of the pack
The Repaglinide Accord 0.5 mg tablet is round, biconvex, with a bevelled edge, white to off-white in colour, with the imprint 'R' on one side and smooth on the other side.
The Repaglinide Accord 1 mg tablet is round, biconvex, with a bevelled edge, pale yellow to yellow in colour, with the imprint 'R' on one side and smooth on the other side; it may have a non-uniform colour.
The Repaglinide Accord 2 mg tablet is round, biconvex, with a bevelled edge, peach-coloured, with the imprint 'R' on one side and smooth on the other side; it may have a non-uniform colour.
Repaglinide Accord is available in the following pack sizes:
30, 90, 120, 180 and 270 tablets in blisters.
100 tablets in an HDPE (high-density polyethylene) bottle.
Not all pack sizes may be marketed.

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,
The Netherlands

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu