Starlix

Основна информация

  • Търговско наименование:
  • Starlix
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Starlix
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Drugs used in diabetes,
  • Терапевтична област:
  • Diabetes Mellitus, Type 2
  • Терапевтични показания:
  • Nateglinide is indicated for combination therapy with metformin in type-2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
  • Каталог на резюме:
  • Revision: 13

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/000335
  • Дата Оторизация:
  • 02-04-2001
  • EMEA код:
  • EMEA/H/C/000335
  • Последна актуализация:
  • 29-03-2019

Доклад обществена оценка

European Medicines Agency

7 Westferry Circus, Canary Wharf, London E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68

E-mail: mail@emea.europa.eu http://www.emea.europa.eu

EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged

EMEA/H/C/335

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)

STARLIX

EPAR summary for the public

This document is a summary of the European Public Assessment Report (EPAR). It explains how

the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to

reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package

Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more

information on the basis of the CHMP recommendations, read the Scientific Discussion (also part

of the EPAR).

What is Starlix?

Starlix is a medicine containing the active substance nateglinide. It is available as pink, round (60 mg),

yellow, oval (120 mg) and red, oval (180 mg) tablets.

What is Starlix used for?

Starlix is used in patients who have non insulin-dependent diabetes (type 2 diabetes). Starlix is used

together with metformin (another antidiabetes medicine) to lower blood glucose (sugar) in patients

whose diabetes cannot be controlled by metformin alone.

How is Starlix used?

Starlix is given within one to 30 minutes before breakfast, lunch and dinner and the dose is adjusted to

give the best control. A doctor should regularly test the patient's blood glucose to find the lowest

effective dose. The recommended starting dose is 60 mg three times a day before meals. This dose

may need to be increased to a daily dose of 120 mg three times a day after one or two weeks. The

maximum total daily dose is 180 mg three times a day.

How does Starlix work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of

glucose in the blood. Nateglinide, the active ingredient in Starlix, stimulates the pancreas to produce

insulin more quickly. This helps to keep the blood glucose controlled after meals and is used to control

type 2 diabetes.

How has Starlix been studied?

A total of 2,122 patients received Starlix in all trials combined. The main studies compared Starlix to

placebo (a dummy treatment), or to other medicines used in type 2 diabetes (metformin, glibenclamide

or troglitazone). Other studies also looked at ‘switching’ from an antidiabetes medicine to Starlix, and

‘adding’ Starlix to other antidiabetes medicines. The studies measured the level of a substance in the

blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood

glucose is controlled. Most of the patients received treatment for up to six months: 789 received it for

at least six months, and 190 received it for a year.

EMEA 2007

What benefit has Starlix shown during the studies?

On its own, Starlix was shown to be more effective than placebo, but less effective than some

antidiabetes medicines such as metformin. In combination with metformin, which mainly affected

fasting plasma glucose (the amount of glucose in the blood when the person has not eaten anything),

the effect of Starlix on HbA1c

was better than either medicine alone.

What is the risk associated with Starlix?

Starlix may in some cases cause hypoglycaemia (low blood glucose). Other common side effects (seen

in between 1 and 10 patients in 100) are abdominal (tummy) pain, diarrhoea, dyspepsia (heartburn),

and nausea (feeling sick). For the full list of all side effects reported with Starlix, see the Package

Leaflet.

Starlix should not be used in people who may be hypersensitive (allergic) to nateglinide or any of the

other

ingredients,

have

type 1

diabetes

severe

liver

problem,

have

diabetic

ketoacidosis (a serious complication of diabetes). Its use is not recommended in pregnancy or while

breast feeding. Starlix doses might also need to be adjusted when given with some medicines used in

heart conditions, to treat pain, to treat asthma, and other conditions. The full list is available in the

Package Leaflet.

Why has Starlix been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that Starlix’s benefits are

greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients

who are not controlled despite receiving the maximum daily dose of metformin. The Committee

recommended that Starlix be given marketing authorisation.

Other information about Starlix:

The European Commission granted a marketing authorisation valid throughout the European Union

for Starlix to Novartis Europharm Limited on 3 April 2001. The marketing authorisation was renewed

on 3 April 2006.

The full EPAR for Starlix is available here

This summary was last updated in 08-2007.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Starlix 60 mg film-coated tablets

Starlix 120 mg film-coated tablets

Starlix 180 mg film-coated tablets

nateglinide

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, pharmacist or nurse.

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, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet.

See section 4.

What is in this leaflet:

What Starlix is and what it is used for

What you need to know before you take Starlix

How to take Starlix

Possible side effects

How to store Starlix

Contents of the pack and other information

1.

What Starlix is and what it is used for

What Starlix is

The active substance of Starlix, nateglinide, belongs to a group of medicines called oral antidiabetics.

Starlix is used to treat adult patients with type 2 diabetes. It helps to control the level of sugar in the

blood. Your doctor will prescribe Starlix together with metformin, if inadequately controlled despite a

maximally tolerated dose of metformin.

How Starlix works

Insulin is a substance produced in the body by the pancreas. It helps to decrease blood sugar levels,

especially after meals. If you have type 2 diabetes, your body may not start producing insulin quickly

enough after meals. Starlix works by stimulating the pancreas to produce insulin more quickly, which

helps to keep blood sugar levels under control after meals.

Starlix tablets start to act within a very short time after they are swallowed and are eliminated from the

body rapidly.

2.

What you need to know before you take Starlix

Follow all instructions given to you by your doctor, pharmacist or nurse carefully, even if they are

different from what is in this leaflet.

Do not take Starlix

if you are allergic to nateglinide or any of the other ingredients of this medicine (listed in

section 6).

if you have type 1 diabetes (i.e. your body does not produce any insulin).

if you are experiencing any symptoms of severe hyperglycaemia (very high blood sugar and/or

diabetic ketoacidosis). These symptoms include excessive thirst, frequent urination, weakness,

fatigue, nausea, shortness of breath or confusion.

if you know that you have a severe liver problem.

if you are pregnant or planning to become pregnant.

if you are breast-feeding.

If any of these apply to you, do not take Starlix and talk to your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Starlix.

Diabetic patients may develop symptoms associated with low blood sugar (also called

hypoglycaemia). Oral antidiabetics, including Starlix, may also produce symptoms of hypoglycaemia.

If you have low blood sugar you may experience sweating, tremors (feeling shaky), anxiety, difficulty

concentrating, confusion, weakness or fainting or have other signs listed in section 4, “Possible side

effects”.

If this happens to you, eat or drink something containing sugar, and talk to your doctor.

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.

Watch carefully for signs of low blood sugar, especially:

if you have exercised more strenuously than usual.

if you have drunk alcohol.

Talk to your doctor before taking Starlix

if you know that you have a liver problem.

if you have a severe kidney problem.

if you have problems with drug metabolism.

if you are due to have an operation.

if you have recently suffered a fever, an accident or an infection.

Your treatment may need to be adjusted.

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.

Elderly

Starlix can be used by people over 65 years of age. Such patients should take special care to avoid low

blood sugar.

Other medicines and Starlix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

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, pharmacist or nurse if you are taking:

Non-steroidal anti-inflammatory agents (used, for example, to treat muscle and joint pain).

Salicylates such as aspirin (used as painkillers).

Monoamine oxidase inhibitors (used to treat depression).

Beta blockers or ACE inhibitors (angiotensin-converting enzyme inhibitors) (used, for example,

to treat high blood pressure and certain heart conditions).

Diuretics (used to treat 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).

Sympathomimetics (used, for example, to treat asthma).

Anabolic hormones (e.g. methandrostenolone).

St. John’s Wort, also known as Hypericum perforatum (a herbal medicine).

Somatropin (a growth hormone).

Somatostatin analogues such as lanreotide and octreotide (used to treat acromegaly).

Rifampin (used, for example, to treat tuberculosis).

Phenytoin (used, for example, to treat seizures).

Your doctor may adjust the dose of these medicines.

Starlix with food, drink and alcohol

Take Starlix before meals (see section 3, “How to take Starlix”); its effect may be delayed if it is taken

during or after meals.

Alcohol may disturb the control of your blood sugar so you are advised to talk to your doctor about

drinking alcohol while taking Starlix.

Pregnancy, breast-feeding and fertility

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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor, pharmacist or nurse for advice before taking this medicine.

Driving and using machines

Your ability to concentrate or react may be reduced if you have low blood sugar (hypoglycaemia).

Bear this in mind if you drive a car or operate machines as you might put yourself or others at risk.

You should ask for doctor advice on driving if you have frequent episodes of hypoglycaemia or if you

are not aware of the first signs of hypoglycaemia.

Starlix contains lactose

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 medicine.

3.

How to take Starlix

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your

doctor, pharmacist or nurse if you are not sure.

The recommended starting dose of Starlix is 60 mg three times daily, taken before each of the three

main meals.

Your doctor may check the amount of Starlix that you are taking on a regular basis and

may adjust the dose according to your needs. The maximum recommended dose is 180 mg three times

daily, taken before each of the three main meals.

Take Starlix before meals. Its effect may be delayed if it is taken during or after meals.

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.

Swallow the tablets whole with a glass of water.

Even though you are taking medicines for your diabetes, it is important to keep following the diet

and/or exercise programme your doctor has recommended for you.

If you take more Starlix than you should

If you have accidentally taken too many tablets, or if someone else takes your tablets, talk to a doctor

or pharmacist immediately. Medical attention may be necessary. If you experience symptoms of low

blood sugar (listed 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 have to go to a doctor or hospital, take the pack and this leaflet with 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 to make up for a forgotten dose.

If you stop taking Starlix

Continue to take this medicine as long as your doctor prescribes it so that it can continue to control

your blood sugar. Do not stop taking Starlix unless your doctor tells you to.

If you have any further questions on the use of this medicine, talk to your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects caused by Starlix are usually mild to moderate.

Common (may affect up to 1 in 10 people):

These 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)

These symptoms 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.

Other side effects may include:

Common (may affect up to 1 in 10 people): abdominal pain, indigestion, diarrhoea, nausea

Uncommon (may affect up to 1 in 100 people): vomiting

Rare (may affect up to 1 in 1,000 people): mild abnormalities in liver function tests, allergic

(hypersensitivity) reactions such as rash and itching

Very rare (may affect up to 1 in 10,000 people): skin rash with blisters affecting the lips, eyes

and/or mouth, sometimes with headache, fever and/or diarrhoea

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 national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store Starlix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date

refers to the last day of that month.

Store in the original package.

Do not store above 30°C.

Do not use any Starlix pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Starlix contains

The active substance is nateglinide. Each tablet contains 60, 120 or 180 mg 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

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farma S.p.A.

Via Provinciale Schito, 131

I-80058 Torre Annunziata - Napoli

Italy

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Lietuva

SIA „Novartis Baltics“ Lietuvos filialas

Tel: +370 5 269 16 50

България

Novartis Bulgaria EOOD

Тел.: +359 2 976 98 28

Luxembourg/Luxemburg

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Magyarország

Novartis Hungária Kft.

Tel.: +36 1 457 65 00

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2122 2872

Deutschland

Novartis Pharma GmbH

Tel: +49 911 273 0

Nederland

Novartis Pharma B.V.

Tel: +31 26 37 82 111

Eesti

SIA Novartis Baltics Eesti filiaal

Tel: +372 66 30 810

Norge

Novartis Norge AS

Tlf: +47 23 05 20 00

Ελλάδα

Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12

Österreich

Novartis Pharma GmbH

Tel: +43 1 86 6570

España

Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888

France

Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600

Hrvatska

Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220

România

Novartis Pharma Services Romania SRL

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 50

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

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

Κύπρος

Novartis Pharma Services Inc.

Τηλ: +357 22 690 690

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

Latvija

SIA “Novartis Baltics”

Tel: +371 67 887 070

United Kingdom

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

http://www.ema.europa.eu