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.

What is in this leaflet:

1 What Repaglinide tablets are and what they are used for
2 What you need to know before you take
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other information

Do not take Repaglinide tablets:

• if you are allergic to repaglinide or any of the other ingredients in this medicine (listed in section 6).
• if you have type 1 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).

Warning and precautions

Talk to your doctor before taking Repaglinide:

• if you have liver problems. Repaglinide is not recommended in patients with moderate liver disease. Repaglinide should not be taken if you have a severe liver disease (see Do not take Repaglinide tablets).
• if you have kidney problems. Repaglinide 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 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 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 get a hypo (low blood sugar)

You may get a hypo (short for hypoglycaemia) if your blood sugar gets too low. This may happen:

• if you take too much Repaglinide.
• if you exercise more than usual.
• if you take other medicines or suffer from liver or kidney problems (see other sections of 2. What you need to know before you take).

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: eat glucose tablets or a high sugar snack or drink, then rest.

When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised continue Repaglinide 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, 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
• if you have an infection or a fever
• if you eat more than usual
• if you exercise less than usual.

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

Other medicines and Repaglinide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You can take Repaglinide 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.

Your body’s response to Repaglinide 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. aspirin)
• Octreotide (used to treat cancer)
• Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkiller)
• Steroids (anabolic steroids and corticosteroids – used for anaemia 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, ketoconazole (antifungal medicines)
• Gemfibrozil (used to treat high blood fats)
• Ciclosporin (used to suppress the immune system)
• Deferasirox (used to reduce chronic iron overload)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John’s wort (herbal medicine)
• Clopidogrel (prevents blood clots)

Repaglinide with alcohol

Alcohol can change the ability of Repaglinide to reduce the blood sugar. Watch for signs of a hypo.

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 if you are pregnant or you are planning to become pregnant.

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

Driving and using machines

Your ability to drive or use 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.

If you take more Repaglinide 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

If you miss a dose, take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Repaglinide

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

Reporting of side effects

If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

What Repaglinide tablets contain

• The active substance is repaglinide. One tablet contains 0.5mg, 1mg or 2mg repaglinide.
• The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous, poloxamer, povidone, glycerol 85%, meglumine, polacrilin potassium, maize starch, magnesium stearate. Repaglinide tablets 1mg contains iron oxide yellow (E172). Repaglinide tablets 2mg contains iron oxide red (E172)

What Repaglinide tablets looks like and contents of the pack

Repaglinide tablets 0.5mg tablets are white, round, biconvex and engraved with RE on one side.

Repaglinide tablets 1mg tablets are mottled yellow, round, biconvex and engraved with RE1 on one side.

Repaglinide tablets 2mg tablets are mottled pink, round, biconvex and engraved with RE2 on one side.

Blisters (Aluminium/Aluminium).

Pack sizes: 30, 60, 90, 100,120 and 180 tablets

Plastic (polyethylene) container with desiccant canister (filled with silica gel).

Pack sizes: 100 tablets

Not all pack sizes may be marketed.

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