How does it work?

Prandin tablets contain the active ingredient repaglinide, whichis an antidiabetic medicine used to help control blood sugar levels in people with type 2 (non-insulin dependent) diabetes. Repaglinide is also available without a brand name, ie as the generic medicine.

People with diabetes have a deficiency or absence of a hormoneproduced by the pancreas called insulin. Insulin is the main hormoneresponsible for the control of sugar in the blood. In type 2 diabetes thepancreas does not produce sufficient insulin. The cells of the body arealso resistant to the low levels of insulin circulating in the blood. Insulin wouldnormally make the cells remove sugar from the blood. This means in type 2 diabetesblood sugar levels can rise too high.

Repaglinide works by acting on thecells in the pancreas that produce insulin. These cells are called beta cells.Repaglinide causes the beta cells to produce more insulin.

Repaglinide is taken before meals to enhance insulin productionduring the meal. The enhanced insulin production starts about 30 minutes aftertaking the dose of repaglinide. This results in a blood sugar lowering effectthroughout the meal, as would occur naturally in people who don't have diabetes.

What is it used for?

• Type 2 (non-insulin dependent) diabetes.

Repaglinide can be used on its own to treat people with type 2 diabetes whoseblood sugar has not been controlled sufficiently by diet, exercise and weightloss alone.

Repaglinide can also be used in combination with anotherantidiabetic medicine called metformin, for people with type 2 diabetes whoseblood sugar is not controlled using metformin alone. Since metformin mainlyhelps reduce blood sugar levels between meals (fasting blood sugar levels) andrepaglinide reduces mealtime blood sugar levels, the combination of the twoprovides an additive effect on blood sugar control.

How do I take it?

• Repaglinide tablets should usually be taken around 15 minutes before a main meal. However, if necessary, you can take your dose up to 30 minutes before the meal or just before eating.
• If you skip a meal, you should also skip your repaglinide dose for that meal. Equally, if you have an extra meal, you should add an extra repaglinide dose for that meal.

Warning!

• Your doctor may want you to check the level of sugar in your blood or urine from time to time while you are taking this medicine. Make sure you discuss how to do this and how often with your GP, pharmacist or diabetes specialist.
• Low blood sugar (hypoglycaemia) may occur as a side effect of this medicine. This is more likely to occur if you take this medicine in combination with metformin or other antidiabetic medicines. It is important that you are aware of the symptoms of hypoglycaemia (these may include cold sweats, cool pale skin, tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, excessive hunger, temporary vision changes, headache or nausea) and what to do if you experience these symptoms. Discuss this with your GP, pharmacist or diabetes specialist. You should also be aware that the risk of hypoglycaemia is increased by strenuous physical exercise and drinking alcohol.
• People who are taking antidiabetic tablets should only drink alcohol in moderation and accompanied by food. This is because alcohol can make your warning signs of low blood sugar less clear, and can cause delayed low blood sugar, even several hours after drinking.
• Your ability to concentrate or react may be reduced if you have low blood sugar, and this can cause problems driving or operating machinary. You should take precautions to avoid low blood sugar when driving - discuss this with your doctor.
• If you get an infection or fever, have an accident, or are under particular stress you should let your doctor know, because when the body is put under stress this medicine may become less effective at controlling your blood sugar. In these cases your doctor may need to temporarily replace your treatment with insulin. You should also consult your doctor about your diabetes treatment if you are due to have surgery under a general anaesthetic, or if you get pregnant. In these situations blood sugar is normally controlled with insulin.

Use with caution in

• Weak or debilitated people.
• Malnutrition.
• Decreased kidney function.

Not to be used in

• Type 1 (insulin dependent) diabetes.
• Diabetic keto-acidosis.
• Severely decreased liver function.
• Pregnancy.
• Breastfeeding.
• The manufacturer has not studied this medicine in children aged under 18 years, elderly people aged over 75 years, or people with impaired liver function. For this reason the medicine is not recommended in these groups of people.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy. If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• The safety of this medicine during pregnancy has not been established, therefore it should not be used by pregnant women. Control of diabetes in pregnancy is usually acheived using insulin, because this provides a more stable control of blood sugar. Seek medical advice from your doctor if you get pregnant while taking this medicine.
• This medicine may pass into breast milk. It should not be used by breastfeeding mothers. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Low blood sugar level (hypoglycaemia).
• Abdominal pain.
• Diarrhoea.

Very rare (affect less than 1 in 10,000 people)

• Constipation.
• Vomiting.
• Visual disturbances.
• Alteration in results of liver function tests or abnormal liver function.

Frequency not known

• Feeling sick (nausea).
• Allergic skin reactions such as rash and itch.

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer. For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

Many medicines can affect blood sugar levels. It is important totell your doctor or pharmacist what medicines you are already taking, includingthose bought without a prescription and herbal medicines, before you starttreatment with this medicine. Similarly, check with your doctor or pharmacistbefore taking any new medicines while taking this one, to ensure that thecombination is safe.

The blood sugar lowering effect of repaglinide may be enhancedor prolonged by the following medicines and these may therefore increase thechance of low blood sugar (hypoglycaemia). If you take any of these incombination with repaglinide your dose may need reducing:

• anabolic steroids, eg testosterone, nandrolone, stanozolol
• ACE inhibitors, eg captopril (these can cause unpredictable drops in blood sugar)
• azole antifungals such as itraconazole or ketoconazole
• beta-blockers, eg propranolol
• ciclosporin
• disopyramide
• gemfibrozil (gemfibrozil, used for lowering cholesterol levels, must not be taken in combination with repaglinide as this may cause severe or prolonged low blood sugar)
• macrolide antibiotics such as clarithromycin
• MAOI antidepressants, eg phenelzine
• non-steroidal anti-inflammatory drugs (NSAIDs), eg ibuprofen, diclofenac
• other antidiabetic medicines, eg metformin
• octreotide
• large doses of salicylates, eg aspirin (small pain relieving doses do not normally have this effect)
• trimethoprim or co-trimoxazole (should be avoided where possible in people taking repaglinide; blood sugar levels should be carefully monitored if trimethoprim is needed to treat an infection).

Beta-blockers, eg propranolol (including eye drops containingbeta-blockers) can mask some of the signs of low blood sugar, such as increasedheart rate and tremor. They may also prolong episodes of low blood sugar andimpair recovery back to normal glucose levels.

The following medicines may increase blood glucose levels. Ifyou start treatment with any of these your dose of repaglinide may subsequentlyneed increasing:

• asthma relievers (beta 2 agonists), eg salbutamol
• corticosteroids, eg hydrocortisone, prednisolone
• diuretics, especially thiazide diuretics, eg bendroflumethiazide
• danazol
• oestrogens and progestogens, such as those contained in oral contraceptives
• thyroid hormones, eg thyroxine.

The following medicines may affect the blood level ofrepaglinide and so could change its effect at controlling bloodsugar:

• carbamazepine
• phenobarbital
• phenytoin
• rifampicin
• the herbal remedy St John's wort (Hypericum perforatum).

If you take any of these in combination with repaglinide, yourblood sugar level should be monitored more frequently and your dose may need tobe adjusted.

Other medicines containing the same active ingredient

Repaglinide tablets are also available without a brand name, ie as the generic medicine.