Icandra (previously Vildagliptin / metformin hydrochloride Novartis)

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  • Icandra (previously Vildagliptin / metformin hydrochloride Novartis)
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Staðsetning

  • Fáanlegt í:
  • Icandra (previously Vildagliptin / metformin hydrochloride Novartis)
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Drugs used in diabetes, , Combinations of oral blood glucose lowering drugs
  • Lækningarsvæði:
  • Diabetes Mellitus, Type 2
  • Ábendingar:
  • Icandra is indicated in the treatment of type-2 diabetes mellitus: Icandra is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets., Icandra is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulphonylurea., Icandra is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.,
  • Vörulýsing:
  • Revision: 18

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/001050
  • Leyfisdagur:
  • 30-11-2008
  • EMEA númer:
  • EMEA/H/C/001050
  • Síðasta uppfærsla:
  • 19-12-2018

Opinber matsskýrsla

EMA/760451/2012

EMEA/H/C/001050

EPAR summary for the public

Icandra

Vildagliptin / metformin hydrochloride

This is a summary of the European public assessment report (EPAR) for Icandra. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Icandra.

What is Icandra?

Icandra is a medicine that contains the active substances vildagliptin and metformin hydrochloride. It

is available as tablets (50 mg/850 mg and 50 mg/1,000 mg).

This medicine is the same as Eucreas, which is already authorised in the European Union (EU). The

company that makes Eucreas has agreed that its scientific data can be used for Icandra.

What is Icandra used for?

Icandra is used to treat adults with type 2 diabetes. It is used in the following ways:

in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin

taken alone;

in patients who are already taking the combination of vildagliptin and metformin as separate

tablets;

in combination with a sulphonylurea (another type of anti-diabetes medicine) together with diet

and exercise, in patients whose diabetes is not satisfactorily controlled on metformin and a

sulphonylurea.

in combination with insulin together with diet and exercise, in patients whose diabetes is

insufficiently controlled with insulin at a stable dose and metformin.

The medicine can only be obtained with a prescription.

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

How is Icandra used?

The recommended dose of Icandra is one tablet twice a day, with one tablet taken in the morning and

one in the evening. The choice of tablet strength to start with depends on the patient’s current

treatment and the expected effects of Icandra, but it is recommended to provide a dose of metformin

similar to the dose already being taken. Patients already taking vildagliptin and metformin should

switch to Icandra containing the same amounts of each active substance. Doses of vildagliptin above

100 mg are not recommended.

Taking Icandra with or just after food may reduce any stomach problems caused by metformin.

Icandra should not be used in patients who have moderate or severe problems with their kidneys or

who have problems with their liver. Elderly patients taking Icandra should have their kidney function

monitored regularly.

How does Icandra work?

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

glucose (sugar) in the blood or when the body is unable to use insulin effectively. Icandra contains two

active substances, which each have a different mode of action. Vildagliptin, which is a dipeptidyl

peptidase 4 (DPP-4) inhibitor, works by blocking the breakdown of ‘incretin’ hormones in the body.

These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing

levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin

when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low.

Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and

decreasing the levels of the hormone glucagon. Metformin works mainly by inhibiting glucose

production and reducing its absorption in the gut. As a result of the action of both substances, the

blood glucose is reduced and this helps to control type 2 diabetes.

How has Icandra been studied?

Vildagliptin on its own was approved by the EU in September 2007 under the name Galvus, and

metformin has been available in the EU since 1959. Vildagliptin can be used with metformin in type 2

diabetes patients who are not satisfactorily controlled on metformin alone. The studies with Galvus as

an add-on to metformin, metformin and a sulphonylurea, or metformin and insulin have been used to

support the use of Icandra in the same indications. The studies compared Galvus with placebo and

measured the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives

an indication of how well the blood glucose is controlled.

The applicant also presented the results of two studies showing that the active substances in the two

strengths of Icandra were absorbed in the body in the same way as when they were taken as separate

tablets.

What benefit has Icandra shown during the studies?

Vildagliptin has been shown to be more effective than placebo (a dummy treatment) at reducing HbA1c

levels when it was added to metformin. Patients adding vildagliptin had a fall in HbA1c levels of 0.88

percentage points after 24 weeks from a starting level of 8.38%. In contrast, patients adding placebo

had smaller changes in HbA1c levels, with a rise of 0.23 percentage points from a starting level of

8.3%. In other studies, vildagliptin in combination with metformin has been shown to be more

effective than placebo when used with a sulphonylurea or insulin.

Icandra

EMA/760451/2012

Page 2/3

What is the risk associated with Icandra?

The most common side effects with Icandra (seen in more than 1 patient in 10) are nausea (feeling

sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite. For the full list of all side

effects reported with Icandra, see the package leaflet.

Icandra should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or

any of the other ingredients. It must not be used in patients who have diabetic ketoacidosis (high

levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver,

conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the

tissues such as failure of the heart or lungs or a recent heart attack. It must also not be used in

patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breast-

feeding. For the full list of restrictions, see the package leaflet.

Why has Icandra been approved?

The CHMP concluded that vildagliptin taken with metformin reduces blood glucose levels and the

combination of the two active substances in one tablet may help patients to stick to their treatment.

The CHMP also noted that the combination of vildagliptin and metformin was effective as an add-on to

a sulphonylurea or insulin. Therefore, the Committee decided that the benefits of Icandra are greater

than its risks and recommended that it be given marketing authorisation.

Other information about Icandra

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

Vildagliptin/Metformin Hydrochloride on 1 December 2008. The name of the medicine was changed to

Icandra on 6 February 2009.

The full EPAR for Icandra can be found on the Agency’s website ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. For more information about treatment with Icandra,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 11-2012.

Icandra

EMA/760451/2012

Page 3/3

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Icandra 50 mg/850 mg film-coated tablets

Icandra 50 mg/1000 mg film-coated tablets

vildagliptin/metformin hydrochloride

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 Icandra is and what it is used for

What you need to know before you take Icandra

How to take Icandra

Possible side effects

How to store Icandra

Contents of the pack and other information

1.

What Icandra is and what it is used for

The active substances of Icandra, vildagliptin and metformin, belong to a group of medicines called

“oral antidiabetics”.

Icandra is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-

insulin-dependent diabetes mellitus.

Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body

makes does not work as well as it should. It can also develop if the body produces too much glucagon.

Both insulin and glucagon are made in the pancreas. Insulin helps to lower the level of sugar in the

blood, especially after meals. Glucagon triggers the liver to make sugar, causing the blood sugar level

to rise.

How Icandra works

Both active substances, vildagliptin and metformin, help to control the level of sugar in the blood. The

substance vildagliptin works by making the pancreas produce more insulin and less glucagon. The

substance metformin works by helping the body to make better use of insulin. This medicine has been

shown to reduce blood sugar, which may help to prevent complications from your diabetes.

2.

What you need to know before you take Icandra

Do not take Icandra

if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine

(listed in section 6). If you think you may be allergic to any of these, talk to your doctor before

taking Icandra.

if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood

glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic

acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called ketone

bodies accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include

stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity

smell.

if you have recently had a heart attack or if you have heart failure or serious problems with your

blood circulation or difficulties in breathing which could be a sign of heart problems.

if you have severely reduced kidney function.

if you have a severe infection or are seriously dehydrated (have lost a lot of water from your

body).

if you are going to have a contrast x-ray (a specific type of x-ray involving an injectable dye).

Please also see information about this in section “Warnings and precautions”.

if you have liver problems.

if you drink alcohol excessively (whether every day or only from time to time).

if you are breast-feeding (see also “Pregnancy and breast-feeding”).

Warnings and precautions

Risk of lactic acidosis

Icandra may cause a very rare, but very serious side effect called lactic acidosis, particularly if your

kidneys are not working properly. The risk of developing lactic acidosis is also increased with

uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further

information below), liver problems and any medical conditions in which a part of the body has a

reduced supply of oxygen (such as acute severe heart disease).

If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Icandra for a short time if you have a condition that may be associated with

dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to

heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Icandra and contact a doctor or the nearest hospital immediately if you experience

some of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

vomiting

stomach ache (abdominal pain)

muscle cramps

a general feeling of not being well with severe tiredness

difficulty in breathing

reduced body temperature and heartbeat

Lactic acidosis is a medical emergency and must be treated in a hospital.

Icandra is not a substitute for insulin. Therefore, you should not receive Icandra for the treatment of

type 1 diabetes.

Talk to your doctor, pharmacist or nurse before taking Icandra if you have or have had a disease of the

pancreas.

Talk to your doctor, pharmacist or nurse before taking Icandra if you are taking an anti-diabetic

medicine known as a sulphonylurea. Your doctor may want to reduce your dose of the sulphonylurea

when you take it together with Icandra in order to avoid low blood glucose (hypoglycaemia).

If you have previously taken vildagliptin but had to stop taking it because of liver disease, you should

not take this medicine.

Diabetic skin lesions are a common complication of diabetes. You are advised to follow the

recommendations for skin and foot care that you are given by your doctor or nurse. You are also

advised to pay particular attention to new onset of blisters or ulcers while taking Icandra. Should these

occur, you should promptly consult your doctor.

If you need to have major surgery you must stop taking Icandra during and for some time after the

procedure. Your doctor will decide when you must stop and when to restart your treatment with

Icandra.

A test to determine your liver function will be performed before the start of Icandra treatment, at

three-month intervals for the first year and periodically thereafter. This is so that signs of increased

liver enzymes can be detected as early as possible.

During treatment with Icandra, your doctor will check your kidney function at least once a year or

more frequently if you are elderly and/or have worsening renal function.

Your doctor will test your blood and urine for sugar regularly.

Children and adolescents

The use of Icandra in children and adolescents up to 18 years of age is not recommended.

Other medicines and Icandra

If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for

example in the context of an X-ray or scan, you must stop taking Eucreas before or at the time of the

injection. Your doctor will decide when you must stop and when to restart your treatment with

Eucreas.

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

need more frequent blood glucose and kidney function tests or your doctor may need to adjust the

dosage of Icandra. It is especially important to mention the following:

glucocorticoids generally used to treat inflammation

beta-2 agonists generally used to treat respiratory disorders

other medicines used to treat diabetes

medicines which increase urine production (diuretics)

medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as

ibuprofen and celecoxib)

certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II

receptor antagonists)

certain medicines affecting the thyroid, or

certain medicines affecting the nervous system.

Icandra with alcohol

Avoid excessive alcohol intake while taking Icandra since this may increase the risk of lactic acidosis

(please see section “Warnings and precautions”).

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor

for advice before taking this medicine. Your doctor will discuss with you the potential risk of

taking Icandra during pregnancy.

Do not use Icandra if you are pregnant or breast-feeding (see also “Do not take Icandra”).

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

Driving and using machines

If you feel dizzy while taking Icandra, do not drive or use any tools or machines.

3.

How to take Icandra

The amount of Icandra that people have to take varies depending on their condition. Your doctor will

tell you exactly the dose of Icandra to take.

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

if you are not sure.

The recommended dose is one film-coated tablet of either 50 mg/850 mg or 50 mg/1000 mg taken

twice a day.

If you have reduced kidney function, your doctor may prescribe a lower dose. Also if you are taking

an anti-diabetic medicine known as a sulphonylurea your doctor may prescribe a lower dose.

Your doctor may prescribe this medicine alone or with certain other medicines that lower the level of

sugar in your blood.

When and how to take Icandra

Swallow the tablets whole with a glass of water,

Take one tablet in the morning and the other in the evening with or just after food. Taking the

tablet just after food will lower the risk of an upset stomach.

Continue to follow any advice about diet that your doctor has given you. In particular, if you are

following a diabetic weight control diet, continue with this while you are taking Icandra.

If you take more Icandra than you should

If you take too many Icandra tablets, or if someone else takes your tablets, talk to a doctor or

pharmacist immediately. Medical attention may be necessary. If you have to go to a doctor or

hospital, take the pack and this leaflet with you.

If you forget to take Icandra

If you forget to take a tablet, take it with your next meal unless you are due to take one then anyway.

Do not take a double dose (two tablets at once) to make up for a forgotten tablet.

If you stop taking Icandra

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 Icandra unless your doctor tells you to. If you have any questions

about how long to take this medicine, talk to your doctor.

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

4.

Possible side effects

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

You should stop taking Icandra and see your doctor immediately if you experience the following

side effects:

Lactic acidosis (very rare: may affect up to 1 user in 10,000):

Icandra may cause a very rare, but very serious side effect called lactic acidosis (see section

“Warnings and precautions”). If this happens you must stop taking Icandra and contact a

doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swollen face, tongue

or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives, which may

indicate a reaction called “angioedema”.

Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite

or dark-coloured urine, which may indicate liver disease (hepatitis).

Inflammation of the pancreas (pancreatitis) (frequency not known): Symptoms include severe

and persistent pain in the abdomen (stomach area), which might reach through to your back as

well as nausea and vomiting.

Other side effects

Some patients have experienced the following side effects while taking Icandra:

Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhoea, pain in and

around the stomach (abdominal pain), loss of appetite.

Common (may affect up to 1 in 10 people): dizziness, headache, trembling that cannot be

controlled, metallic taste, low blood glucose.

Uncommon (may affect up to 1 in 100 people): joint pain, tiredness, constipation, swollen

hands, ankle or feet (oedema).

Very rare (may affect up to 1 in 10,000 people): sore throat, runny nose, fever; signs of a high

level of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness,

severe nausea or vomiting, abdominal pain, irregular heart beat or deep, rapid breathing;

redness of the skin, itching; decreased vitamin B12 levels (paleness, tiredness, mental

symptoms such as confusion or memory disturbances).

Some patients have experienced the following side effects while taking Icandra and a sulphonylurea:

Common: dizziness, tremor, weakness, low blood glucose, excessive sweating.

Some patients have had the following side effects while taking Icandra and insulin:

Common: headache, chills, nausea (feeling sick),

low blood glucose, heartburn.

Uncommon: diarrhoea, flatulence.

Since this product has been marketed, the following side effects have also been reported:

Frequency not known (cannot be estimated from the available data): itchy rash, inflammation of

the pancreas, localised peeling of skin or blisters, muscle pain.

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 Icandra

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 blister and carton after

“EXP”. The expiry date refers to the last day of that month.

Do not store above 30

Store in the original package (blister) in order to protect from moisture.

6.

Contents of the pack and other information

What Icandra contains

The active substances are vildagliptin and metformin hydrochloride.

Each Icandra 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg

metformin hydrochloride (corresponding to 660 mg of metformin).

Each Icandra 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg

metformin hydrochloride (corresponding to 780 mg of metformin).

The other ingredients are: Hydroxypropylcellulose, magnesium stearate, hypromellose, titanium

dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 and talc.

What Icandra looks like and contents of the pack

Icandra 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and

“SEH” on the other.

Icandra 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and

“FLO” on the other.

Icandra is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-

packs containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets. Not all pack sizes and

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 Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

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

Authorisation Holder:

Lietuva

Novartis Pharma Services Inc.

Tel: +370 5 269 16 50

Luxembourg/Luxemburg

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Magyarország

Novartis Hungária Kft. Pharma

Tel.: +36 1 457 65 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2122 2872

Nederland

Novartis Pharma B.V.

Tel: +31 26 37 82 111

Norge

Novartis Norge AS

Tlf: +47 23 05 20 00

Österreich

Novartis Pharma GmbH

Tel: +43 1 86 6570

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888

Portugal

Merck, S.A.

Tel. +351 21 3613 500

România

Novartis Pharma Services Romania SRL

Tel: +40 21 31299 01

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 50

Slovenská republika

Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439

België/Belgique/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

България

Novartis Pharma Services Inc.

Тел.: +359 2 489 98 28

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Deutschland

UCB Innere Medizin GmbH

& Co. KG

Tel: +49 2173 48 4949

Eesti

Novartis Pharma Services

Inc. Tel: +372 66 30 810

Ελλάδα

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

Τηλ: +30 210 281 17 12

España

Mylan Pharmaceuticals, S.L.

Tel: +34 93 378 64 00

France

Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00

Hrvatska

Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220

Ireland

Novartis Ireland Limited Tel:

+353 1 260 12 55

Ísland

Vistor hf.

Sími: +354 535 7000

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

Novartis Pharma Services Inc.

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