STARLIX 120 mg film-coated tablets

Starlix is a medicine to lower blood sugar (glucose), which is taken by mouth (these medicines are also known as oral anti-diabetics).

It is used by people with type 2 diabetes. (This kind of diabetes is also called non-insulin-dependent diabetes mellitus.)

Insulin is a substance produced by a body organ called the pancreas. It helps to decrease blood sugar levels, especially after meals. In patients with type 2 diabetes, the body may not start producing insulin quickly enough after meals. Starlix works by stimulating the pancreas to produce insulin more quickly. This helps to keep the blood sugar controlled after meals.

Your doctor will prescribe Starlix together with another oral anti-diabetic containing metformin.

Starlix tablets start to act quickly after you take them and are eliminated from the body rapidly.

Follow all instructions given to you by your doctor and pharmacist carefully, even if they are different from what is in this leaflet.

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 know that you have a severe liver problem.
• 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

People with diabetes sometimes get symptoms of low blood sugar (also called hypoglycaemia). Medicines, including Starlix, may also produce symptoms of low blood sugar.

If you get any of these symptoms ? feeling dizzy, light-headed, hungry, shaky or any of the other signs in section 4, ?Possible side effects? ? eat or drink something containing sugar.

Some people are more likely to get symptoms of low blood sugar than others. Take care

• if you are over 65 years of age.
• if you are undernourished.
• if you have another medical condition that may cause low blood sugar (e.g. an under-active pituitary or adrenal gland).

If any of these apply to you, monitor your blood sugar levels more carefully.

Talk to your doctor

• if you know that you have a liver problem.
• if you have a severe kidney problem.
• if you have problems of drug metabolism.
• if you are due to have an operation.
• if you have suffered a fever, an accident or an infection. Your treatment may need to be adjusted.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The amount of Starlix that you need may change if you take other medicines as these may cause your blood sugar levels to go up or down.

It is especially important that you tell your doctor or pharmacist if you are taking:

• Beta blockers or angiotensin-converting enzyme inhibitors (used, for example, to treat high blood pressure and certain heart conditions).
• Diuretics (used in the treatment of high blood pressure).
• Corticosteroids such as prednisone and cortisone (used to treat inflammatory disorders).
• Inhibitors of drug metabolism such as fluconazole (used to treat fungal infection), gemfibrozil (used to treat dyslipidaemia) or sulfinpyrazone (used to treat chronic gout). Your doctor may adjust the dose of these medicines.

Food, drink and exercise

Take Starlix before meals (see section 3, ?How to take Starlix?). Its effect may be delayed if it is taken during or after meals.

Even though you are taking medicines for your diabetes, it is important to keep following the diet and/or exercise your doctor has recommended for you.

Watch carefully for signs of low blood sugar, especially

• if you have exercised more strenuously than usual.
• if you have drunk alcohol.

Alcohol may upset the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking Starlix. If you do get symptoms of low blood sugar, eat or drink something containing sugar and talk to your doctor.

Starlix and older people

Starlix can be used by people over 65 years of age. Take special care to avoid low blood sugar.

Starlix and children and adolescents

Starlix is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied.

Pregnancy and breast-feeding

Do not take Starlix if you are pregnant or planning to become pregnant. See your doctor as soon as possible if you become pregnant during treatment.

Do not breast-feed during treatment with Starlix.

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

Driving and using machines

You are advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important if you have reduced or absent awareness of the warning signs of hypoglycaemia or if you have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

Important information about some of the ingredients of Starlix

Starlix tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take Starlix exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

When to take Starlix

Take Starlix before the three main meals, usually:

• 1 dose before breakfast
• 1 dose before lunch
• 1 dose before dinner

It is best to take it right before a main meal but you can take it up to 30 minutes before.

Do not take it if you are not going to eat a main meal.If you miss a meal, skip that dose of Starlix and wait until your next meal.

How much to take

Take Starlix as your doctor told you to. Your doctor will determine the dosage you require.

The usual dose of Starlix to start with is 60 mg before the three main meals. In some cases your doctor may prescribe higher doses. The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals.

Swallow the tablets whole with a glass of water before the meal.

How long to take Starlix

Take Starlix daily until your doctor tells you to stop.

If you take more Starlix than you should

If you have accidentally taken too many tablets, talk to a doctor straight away. If you experience symptoms of low blood sugar ? if you feel dizzy, light-headed, hungry, shaky, or any of the other signs in section 4, ?Possible side effects? ? eat or drink something containing sugar.

If you feel as if you are about to have a severe hypoglycaemic attack (which may lead to loss of consciousness or seizure), call for urgent medical help ? or make sure that someone else does this for you.

If you forget to take Starlix

If you forget to take a tablet simply 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.

Like all medicines, Starlix can cause side effects, although not everybody gets them. The side effects caused by Starlix are usually mild to moderate.

The most common side effects are symptoms of low blood sugar (hypoglycaemia), which are usually mild. These include

• sweating,
• dizziness,
• shaking,
• weakness,
• hunger,
• feeling your heart beating fast,
• tiredness,
• feeling sick (nausea).

They can also be caused by lack of food or too high a dose of any anti-diabetic medicine you are taking. If you do get symptoms of low blood sugar, eat or drink something containing sugar.

Abdominal pain, indigestion, diarrhoea, nausea and vomiting have been reported.

Rare effects are mild abnormalities in liver function tests and allergic (hypersensitivity) reactions such as rash and itching.

A very rare effect is skin rash with blisters affecting the lips, eyes, mouth, sometimes with headache, fever and/or diarrhoea.

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.

Keep out of the reach and sight of children.
Store in the original package.
Do not use Starlix after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not use any Starlix pack that is damaged or shows signs of tampering.
Do not store above 30°C.
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.

What Starlix contains

• The active substance is nateglinide.
• The other ingredients are lactose monohydrate; cellulose, microcrystalline; povidone; croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous.
• The tablet coating contains hypromellose; titanium dioxide (E171); talc; macrogol and red (60 and 180 mg tablets) or yellow (120 mg tablets) iron oxide (E172).

What Starlix looks like and contents of the pack
Starlix 60 mg film-coated tablets are pink, round tablets with ?STARLIX? marked on one side and ?60? on the other.

Starlix 120 mg film-coated tablets are yellow, ovaloid tablets with ?STARLIX? marked on one side and ?120? on the other.

Starlix 180 mg film-coated tablets are red, ovaloid tablets with ?STARLIX? marked on one side and ?180? on the other.

Each blister pack contains 12, 24, 30, 60, 84, 120 or 360 tablets. Not all pack sizes or tablet strengths may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Farma S.p.A.
Via Provinciale Schito, 131
I-80058 Torre Annunziata - Napoli
Italy

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH TélTel 49 911 273 0

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 60 62 400 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Jaba Recordati, S.A. Tel 351 21 432 95 00

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 77

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 9 61 33 22 11

357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 7 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in