PACKAGE LEAFLET: INFORMATION FOR THE USER

Repaglinide Eurogenus 0.5 tablets

Repaglinide Eurogenus 1 mg tablets

Repaglinide Eurogenus 2 mg tablets

Repaglinide

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.WHAT Repaglinide EurogenusIS AND WHAT IT IS USED FOR

Repaglinide Eurogenus is an oral antidiabetic agent containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).

Type 2 diabetes is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces (formerly known as non-insulin-dependent diabetes mellitus or maturity onset diabetes).

Repaglinide Eurogenus is used to control type 2 diabetes as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar. Repaglinide Eurogenus can also be given with metformin, another medicine for diabetes.

2.BEFORE YOU TAKE Repaglinide Eurogenus

Do not take Repaglinide Eurogenus

• If you are hypersensitive (allergic) to repaglinide or any of the other ingredients of the medicine. (See section 6 for list of ingredients)

• If you have type 1 diabetes (insulin-dependent diabetes).

• If the acid level in your body is raised (diabetic ketoacidosis).

• If you have a severe liver disease.

• If you take gemfibrozil (a medicine used to lower increased fat levels in the blood).

If any of these apply to you, tell your doctor and do not take Repaglinide Eurogenus.

Take special care with Repaglinide Eurogenus

• If you have liver problems. Repaglinide Eurogenus is not recommended in patients with moderate liver disease. Repaglinide Eurogenus should not be taken if you have a severe liver disease (see Do not take Repaglinide Eurogenus).

• If you have kidney problems. Repaglinide Eurogenus should be taken with caution.

• If you are about to have major surgery or you have recently suffered a severe illness or infection. At such times diabetic control may be lost.

• If you are under 18 or over 75 years of age. Repaglinide Eurogenus is not recommended. It has not been studied in these age groups.

Talk to your doctor if any of the above applies to you. Repaglinide Eurogenus may not be suitable for you. Your doctor will advise you.

If you get a hypo (hypoglycaemic reaction)

You may get a hypo (short for a hypoglycaemic reaction and symptoms of low blood sugar) if your blood sugar gets too low. This may happen:

• If you take too much Repaglinide Eurogenus.

• If you exercise more than usual.

• If you take other medicines or suffer from liver or kidney problems (see other sections of 2. Before you take Repaglinide Eurogenus).

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If your blood sugar is low or you feel a hypo coming on: take glucose tablets or eat a high sugar snack or drink, then rest.

When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilized continue Repaglinide Eurogenus treatment.

Tell people you have diabetes and that if you pass out (become unconscious) due to a hypo they must turn you on your side and get medical help straight away. They must not give you any food or drink. It could choke you.

• If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.

• If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount of Repaglinide Eurogenus, food or exercise may need to be adjusted.

If your blood sugar gets too high

Your blood sugar may get too high (hyperglycaemia). This may happen:

• If you take too little Repaglinide Eurogenus.

• If you have an infection or a fever.

• If you eat more than usual.

• If you exercise less than usual.

The warning signs appear gradually. They include: increased urination; feeling thirsty; dry skin and dry mouth. Talk to your doctor. The amount of Repaglinide Eurogenus, food or exercise may need to be adjusted.

Taking other medicines

You can take Repaglinide Eurogenus with metformin, another medicine for diabetes, if your doctor prescribes it. If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Repaglinide Eurogenus.

Your body's response to Repaglinide Eurogenus may change if you take other medicines, especially these:

• Monoamine oxidase inhibitors (MAOI) (used to treat depression).

• Beta blockers (used to treat high blood pressure or heart conditions).

• ACE-inhibitors (used to treat heart conditions).

• Salicylates (e.g. acetylsalicylic acid).

• Octreotide (used to treat cancer).

• Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkiller).

• Steroids (anabolic steroids and corticosteroids - used for anemia or to treat inflammation).

• Oral contraceptives (birth control pills).

• Thiazides (diuretics or "water pills").

• Danazol (used to treat breast cysts and endometriosis).

• Thyroid products (used to treat low levels of thyroid hormones).

• Sympathomimetics (used to treat asthma).

• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).

• Itraconazole, ketokonazole (antifungal medicines).

• Gemfibrozil (used to treat high blood fats).

• Ciclosporin (used to suppress the immune system).

• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy).

• St. John's wort (herbal medicine).

Tell your doctorif you have recently taken or are planning to take any of these medicines, or any medicines obtained without a prescription.

Taking Repaglinide Eurogenus with food and drink

Take Repaglinide Eurogenus before main meals. Alcohol can change the ability of Repaglinide Eurogenus to reduce the blood sugar. Watch for signs of a hypo.

Pregnancy and breast-feeding

You should not take Repaglinide Eurogenus if you are pregnant or you are planning to become pregnant. See your doctor as soon as possible if you become pregnant or are planning to become pregnant during treatment.

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

Driving and using machines

Your ability to drive or operate a machine may be affected if your blood sugar is low or high. Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car if you:

• have frequent hypos,

• have few or no warning signs of hypos.

3.HOW TO TAKE Repaglinide Eurogenus

Your doctor will work out your dose.

• The normal starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.

• The dose may be adjusted by your doctor by up to 4 mg to be taken immediately before or up to 30 minutes before each main meal. The maximum recommended daily dose is 16 mg.

Do not take more Repaglinide Eurogenus than your doctor has recommended. Always take Repaglinide Eurogenus exactly as your doctor has told you. Check with your doctor if you are not sure.

If you take more Repaglinide Eurogenus than you should

If you take too many tablets, your blood sugar may become too low, leading to a hypo. Please see If you get a hypo on what a hypo is and how to treat it.

If you forget to take Repaglinide Eurogenus

If you miss a dose, take the next dose as usual - do not double the dose.

If you stop taking Repaglinide Eurogenus

Be aware that the desired effect is not achieved if you stop taking Repaglinide Eurogenus. Your diabetes may get worse. If any change of your treatment is necessary contact your doctor first.

If you have any further questions on the use of Repaglinide Eurogenus, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Repaglinide Eurogenus can cause side effects, although not everybody gets them.

Possible side effects

Common: affects 1 to 10 users in 100

• Hypoglycaemia (see If you get a hypo). The risk of getting a hypo may increase if you take other medicines

• Stomach pain

• Diarrhoea.

Rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 user in 10,000

• Allergy (such as swelling, difficulty in breathing, rapid heart beat, feeling dizzy, sweating which could be signs of anaphylactic reaction). Contact a doctor immediately

• Vomiting

• Constipation

• Visual disturbances

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

Not known: frequency cannot be estimated from the available data

• Hypoglycaemic coma or unconsciousness (very severe hypoglycaemic reactions - see If you get a hypo). Contact a doctor immediately

• Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin)

• Feeling sick (nausea).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5.HOW TO STORERepaglinide Eurogenus

Keep out of the reach and sight of children.

Do not use Repaglinide Eurogenus after the expiry date which is stated on the outer carton and blister. The expiry date refers to the last day of that month.

This medicinal product 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 to protect the environment.

6. FURTHER INFORMATION

What Repaglinide Eurogenus contains

- The active substance is repaglinide.

Each Repaglinide Eurogenus 0.5 mg tablet contains 0.5 mg repaglinide.

Each Repaglinide Eurogenus 1 mg tablet contains 1 mg repaglinide.

Each Repaglinide Eurogenus 2 mg tablet contains 2 mg repaglinide.

The other ingredients are:

Microcrystalline cellulose (E460)

Calcium hydrogen phosphate, anhydrous

Maize starch

Polacrilin potassium

Povidone K-30

Glycerol 99.5%

Magnesium stearate

Poloxamer 188

Meglumine

Iron Oxide Yellow (E172) (1 mg tablet only)

Iron Oxide Red (E172) (2 mg tablet only)

What Repaglinide Eurogenus looks like and contents of the pack

Repaglinide Eurogenus 0.5 mg tablets are white, round, biconvex tablets, having a diameter of 6.0 mm approximately.

Repaglinide Eurogenus 1 mg tablets are yellow, round, biconvex tablets, having a diameter of 6.0 mm approximately and bearing a breakline on one side.

The tablets can be divided into equal halves.

Repaglinide Eurogenus 2 mg tablets are peach, round, biconvex tablets, having a diameter of 6.0 mm approximately and bearing a breakline on one side.

The tablets can be divided into equal halves.

Repaglinide Eurogenus is available in pack sizes of 30, 90, 120 and 270 tablets in blister and 90 and 270 tablets in bottle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

<To be completed nationally>

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden Repaglinide Eurogenus

Italy Repaglinide Germed

Spain Repaglinida Edigen 0,5 mg -1 mg-2 mg comprimidos

This leaflet was last approved in 2012-01-09