Starlix tablets contain the active substance nateglinide. Starlix tablets also contain the following nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, iron oxide (red or yellow), lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide.

Starlix is a medicine to lower blood sugar (glucose), which is taken by mouth (such medicines are known as oral antidiabetics).

It is used in patients with type 2 diabetes whose condition cannot be controlled by diet and exercise alone. This kind of diabetes is also called non-insulin-dependent diabetes mellitus.

Insulin (produced by an organ called the pancreas) is a substance that helps to decrease blood sugar levels, especially after meals. In patients with type 2 diabetes, the body does not respond well to insulin and may not start to make it quickly enough after meals. Starlix works by stimulating the pancreas to produce insulin more quickly and this helps to keep the blood sugar controlled after meals.

Your doctor will prescribe Starlix either by itself or together with metformin if one medicine alone is not sufficient to control your blood sugar levels. Even though you are now starting a medicine for your diabetes, it is important that you continue to follow the diet and/or exercise advised for you.

Starlix tablets start to act within a very short time after intake and are eliminated from the body rapidly.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you take Starlix, follow all instructions given to you by your doctor or pharmacist carefully, and read the following information before you take Starlix.

Do Not Take Starlix:

• If you are allergic (hypersensitive) to nateglinide or any of the other ingredients of Starlix.
  
• If you have type 1 diabetes (i.e., your body does not produce any insulin)
  
• If you have diabetic ketoacidosis
  
• If you are pregnant or planning to become pregnant
  
• If you are breast-feeding
  

Talk to your doctor if you have any further questions or you think that any of these may apply to you.

Take Special Care with Starlix:

Diabetic patients may develop symptoms associated with low blood sugar (also known as hypoglycemia). These symptoms include sweating, dizziness, shaking, weakness, hunger, palpitations (perceivable and fast heart beat), tiredness and nausea.

Oral antidiabetic drugs, including Starlix, may also produce symptoms of hypoglycemia. Certain patients are more sensitive to this effect of antidiabetic treatment than others. These include patients who have exercised more strenuously than usual or drunk alcohol, who are elderly or undernourished, who are taking other oral antidiabetics, or who have another medical condition that may cause low blood sugar (e.g., an underactive pituitary or adrenal gland). Such patients should monitor their blood sugar levels more carefully and talk to their doctor about this.

If you know that you have a severe liver problem, talk to your doctor.

Taking Starlix with Food and Drink: Take Starlix before meals (see under section “When to take Starlix”); its effect may be delayed if it is taken during or after meals.

Since alcohol may disturb the control of your blood sugar, you are advised to talk to your doctor about this.

Use in the Elderly: Starlix can be used by elderly patients.

Use in Children: The use of Starlix in children has not been studied and therefore it is not recommended.

Pregnancy: Consult your doctor as soon as possible if you become pregnant during treatment.

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.

Breast-feeding: Do not breast-feed during treatment with Starlix.

Ask your doctor or pharmacist for advice before taking any medicine while you are breast-feeding.

Driving and Using Machines: All diabetic patients who drive need to be particularly careful to avoid low blood sugar. If you experience symptoms of low blood sugar you should not drive or use machines.

Taking Other Medicines: Tell your doctor or pharmacist about any other medicines you are taking or have recently taken, including any you have bought without a prescription.

Other medicines may affect the actions of Starlix and, conversely, Starlix may affect the actions of other medicines. This may result in an increase or a decrease in your blood sugar levels.

It is particularly important that you tell your doctor or pharmacist if you are taking any of the following:

• Nonsteroidal anti-inflammatory agents (used, for example, to treat muscle and joint pain).
  
• Salicylates such as aspirin (used as pain-killers).
  
• Monoamine oxidase inhibitors (used to treat depression).
  
• Beta-blockers (used, for example, to treat high blood pressure and certain heart conditions).
  
• Thiazides (used in the treatment of high blood pressure).
  
• Corticosteroids such as prednisone and cortisone (used to treat inflammatory disorders).
  
• Thyroid products (used to treat patients with low production of thyroid hormones).
  
• Sympathomimetics (used, for example, to treat asthma).
  

Your doctor may adjust the dose of these medicines.

How to Use Starlix:

Follow all instructions given to you by your doctor and pharmacist carefully. Do not take more Starlix than your doctor has prescribed.

The usual dose of Starlix is 120 mg before main meals (usually breakfast, lunch and dinner). The maximum recommended dose is 180 mg before main meals. Your doctor may need to adjust the dosage to your particular needs.

He/she will prescribe Starlix either by itself or together with metformin if one medicine alone is not sufficient to control your blood sugar levels.

If You Take More Starlix Than You Should

Seek medical advice if you have accidentally taken too many tablets. If you experience symptoms of low blood sugar--e.g. you feel dizzy, light-headed, hungry, nervous and shaky, drowsy, confused, and/or sweaty--you should eat or drink something containing sugar.

Call for urgent medical assistance--or make sure that someone else does this for you--if you feel as if you are about to suffer a severe hypoglycemic episode (loss of consciousness, seizure).

If You Forget to Take Starlix

If you forget to take a tablet simply skip that dose and take the next one before your next meal.

Do not take a double dose of Starlix to make up for the one that you missed.

Possible Side Effects

Like all medicines, Starlix can have side effects. The side effects caused by Starlix are usually mild to moderate.

The most common side effects are symptoms of low blood sugar (hypoglycemia) which are usually mild. These symptoms include sweating, dizziness, shaking, weakness, hunger, palpitations (perceivable and fast heart beat), tiredness and nausea. It can also be caused by lack of food or too high a dose of any antidiabetic medicine you are taking. If you experience symptoms of low blood sugar, you should eat or drink something containing sugar.

Rare cases of mild abnormalities in liver function tests and allergic (hypersensitivity) reactions such as rash and itching were reported.

Inform your doctor or pharmacist if you notice any other side effects not mentioned in this leaflet.

Storing Starlix

• Keep Starlix out of the reach of children.
  
• Store in the original package.
  
• Store Starlix between 15 and 30°C.
  
• Do not use Starlix after the expiry date shown on the pack.
  
• Do not use any Starlix pack that is damaged or shows signs of tampering.