ИКАНДРА 50 mg/850 mg Film-coated tablets

Содержание инструкции

1. Icandra 50 mg/850 mg film-coated tablets, 50 mg/1000 mg film-coated tablets
   1. What is Icandra and what is it used for
   2. What you need to know before you take Icandra
   3. How to take Icandra
   4. Possible side effects
   5. How to store Icandra
   6. Package contents and other information

F ormulary: information for the user

Icandra 50 mg/850 mg film-coated tablets, 50 mg/1000 mg film-coated tablets

vildagliptin/metformin hydrochloride

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Icandra is and what it is used for
• 2. What you need to know before you take Icandra
• 3. How to take Icandra
• 4. Possible side effects
• 5. How to store Icandra
• 6. Contents of the pack and other information

1. What is Icandra and what is it 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. Icandra is used when diabetes cannot be
controlled with diet and exercise alone and/or together with other medicines used to treat
diabetes (insulin or sulfonylureas).
Type 2 diabetes develops when the body does not produce enough insulin, or if the insulin
produced by the body does not work as it should. It can also develop when the body
produces too much glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps to lower blood
sugar levels, especially after meals. Glucagon stimulates the liver to produce sugar,
causing an increase in blood sugar levels.

How Icandra works
Both active substances, vildagliptin and metformin, help to control blood
sugar levels. The substance vildagliptin works by inducing the pancreas to 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. This can help prevent
complications resulting from your diabetes.

2. What you need to know before you take Icandra

Do not take Icandra

• if you are allergic to vildagliptin, to metformin or to any of the other ingredients of this medicine (listed in section 6). If you think you might be allergic to any of these substances, ask your doctor before taking Icandra.
• if you have uncontrolled diabetes associated with, for example, severe high blood sugar (high levels of glucose in the blood), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and can lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness and breath with an unusually fruity odour.
• if you have recently had a heart attack or if you have heart failure or severe circulatory problems or difficulty breathing which could be a sign of heart problems.
• if you have severely reduced kidney function.
• if you have a severe infection or are severely dehydrated (your body has lost a lot of water).
• if you are going to have an X-ray examination with a contrast agent (a special type of X-ray that involves the use of a dye injected into the bloodstream). Also see the information in the “Warnings and precautions” section.
• if you have liver problems.
• if you drink excessive amounts of alcohol (whether you do this daily or only occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions
Risk of lactic acidosis
Icandra can cause a very rare but very serious side effect called lactic acidosis, in
particular if your kidneys do not function properly. The risk of developing lactic acidosis is higher in
people with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption,
dehydration (see below for more information), liver problems and any other
medical condition characterised by reduced oxygen supply to a part of the body (such as
in the case of severe heart disease).
If you have any of the medical conditions described above, ask your doctor for further
instructions.

Stop taking Icandra for a short period of time if you have a medical 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 usual. Ask your doctor for
further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Icandra and contact
your doctor or the nearest hospital immediately, because lactic acidosis can lead to coma.
The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of unwellness with severe tiredness
• difficulty breathing
• decreased body temperature and slower heartbeat

Lactic acidosis is a medical emergency and needs to be treated in hospital.
Icandra is not a substitute for insulin. Therefore, Icandra should not be prescribed for the treatment
of type 1 diabetes.
Ask your doctor, pharmacist or nurse before taking Icandra if you have or have had a
pancreatic disease.
Ask your doctor, pharmacist or nurse before taking Icandra if you are taking a
diabetes medicine known as a sulfonylurea. If you are taking it together with Icandra, your
doctor may decide to reduce your dose of sulfonylurea, to avoid low blood sugar (hypoglycaemia).
If you have previously taken vildagliptin but had to stop due to liver disease, you should not
take this medicine.
Skin lesions are a common complication of diabetes. You are advised to follow the
recommendations for skin and foot care provided by your doctor or nurse.
You are also advised to pay particular attention to the formation of new blisters or ulcers when
taking Icandra. If this happens, you should contact your doctor immediately.
If you are going to have major surgery, you should stop taking Icandra
during the surgery and for a certain period of time afterwards. Your doctor will decide
when you should stop and when you should restart treatment with Icandra.
Before starting treatment with Icandra, a test will be performed to assess the function of your
liver, which will be repeated every three months during the first year of treatment and subsequently
periodically. This is to detect any signs of increased liver enzymes 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 if your kidney function worsens.
Your doctor will regularly check your blood sugar and urine.

Children and adolescents
The use of Icandra is not recommended in children and adolescents under 18 years of age.

Other medicines and Icandra
If you are going to have a contrast agent containing
iodine injected into your bloodstream, for example for a radiograph, you must stop taking Icandra before or
during the injection. Your doctor will decide when you should stop and when you should restart
treatment with Icandra.
Tell your doctor if you are taking, have recently taken or might take any other
medicines. You may need to have your blood sugar and kidney function checked more often, or your doctor may decide to adjust your dose of Icandra. It is particularly
important to mention the following:

• glucocorticoids, usually used to treat inflammation
• beta-2 agonists, usually used to treat breathing problems
• other medicines used to treat diabetes
• medicines that increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• some medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain medicines that act on the thyroid
• certain medicines that act on the nervous system
• certain medicines used to treat angina (e.g., ranolazine)
• certain medicines used to treat HIV infection (e.g., dolutegravir)
• certain medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• certain medicines used to treat heartburn and peptic ulcers (e.g., cimetidine)

Icandra with alcohol
Avoid excessive alcohol consumption while taking Icandra as this may increase the
risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

• If you are pregnant, or suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Icandra during pregnancy.
• Do not use Icandra if you are pregnant or breastfeeding (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 machines.

3. How to take Icandra

The amount of Icandra that must be taken varies depending on individual conditions. Your
doctor will tell you exactly the dose to take.
Take this medicine following exactly the instructions of your doctor. If you have doubts, consult
your doctor or pharmacist.
The recommended dose is one film-coated tablet with 50 mg/850 mg or 50 mg/1000 mg
taken twice a day.
If you have reduced kidney function, your doctor may prescribe you a lower dose. Your doctor may
prescribe you a lower dose also if you are taking an antidiabetic known as a sulfonylurea.
The doctor may prescribe you this medicine alone or with some medicines that lower the level
of sugar in the blood.

When and how to take Icandra

• Take the tablets whole with a glass of water.
• Take one tablet in the morning and the other in the evening, with food or immediately after eating. Taking the tablet immediately after eating will reduce the risk of stomach upset.

Continue to follow any dietary advice that your doctor has given you, in particular if you are following a
diet to control weight in case of diabetes, you must continue it during therapy with Icandra.

If you take more Icandra than you should
If you take too many tablets of Icandra, or if someone else takes your tablets, seek
immediate medical advice from your doctor or pharmacist. Medical treatment may be necessary. If you need

If you forget to take Icandra
If you forget to take a tablet, take it with the next meal, unless you still have to
take one. Do not take a double dose (two tablets together) to make up for the
forgotten tablet.

If you stop taking Icandra
Continue to take this medicine as long as your doctor prescribes it so that you can
continue to control your blood sugar. Do not stop treatment with Icandra unless
your doctor tells you to. If you have any doubts about how long to take this medicine, consult
your doctor.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking Icandra and contact your doctor immediatelyif you experience any of the
following side effects:

• Lactic acidosis(very rare: may affect up to 1 in 10,000 people):
• Icandra can cause a very rare but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stoptaking Icandra and seek immediate medical attention or go to the nearest hospital, because lactic acidosis can lead to coma.
• Angioedema (rare: may affect up to 1 in 1,000): symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden skin rash or hives, which may indicate a reaction called “angioedema”.
• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100): symptoms include yellowing of the skin and eyes, nausea, loss of appetite or dark urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (uncommon: may affect up to 1 in 100). Symptoms include severe and persistent abdominal pain (stomach area), which may spread to the back, as well as nausea and vomiting.

Other side effects
While taking Icandra, some patients have experienced the following side effects:

• Common (may affect up to 1 in 10 people): sore throat, runny nose, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, tremor that cannot be controlled, constipation, nausea (feeling sick), vomiting, diarrhea, flatulence, heartburn, stomach pain and around the stomach (abdominal pain).
• Uncommon (may affect up to 1 in 100): fatigue, weakness, metallic taste, low blood glucose levels, loss of appetite, swelling of hands, ankles or feet (edema), chills, inflammation of the pancreas, muscle pain.
• Very rare (may affect up to 1 in 10,000): 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 heartbeat or rapid and deep breathing; skin flushing, itching; reduced levels of vitamin B12 (paleness, fatigue, mental symptoms such as confusion or memory problems).

The following side effects have also been reported during the marketing of this medicine.

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis), which may cause skin rash or round, flat, raised, red spots under the skin surface or bruising.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through 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 the package after “EXP”/”Scad”. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.
• Store in the original package (blister) to protect the medicine from moisture.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Icandra contains

• The active ingredients are vildagliptin and metformin hydrochloride.
• Each film-coated tablet of Icandra 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 660 mg of metformin).
• Each film-coated tablet of Icandra 50 mg/1000 mg contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (equivalent 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.

Description of the appearance of Icandra and contents of the pack
The film-coated tablets of Icandra 50 mg/850 mg are yellow, oval, with “NVR” on one side and
“SEH” on the other.
The film-coated tablets of Icandra 50 mg/1000 mg are dark yellow, oval, 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 multiple packs containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Lek d.d, PE PROIZVODNJA LENDAVA
Trimlini 2D
Lendava, 9220
Slovenia
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Norimberga
Germany
Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57
1000 Ljubljana
Slovenia
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcellona
Spain
For further information on this medicine, 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 2 489 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 88 04 52 111

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
Laboratorios Gebro Pharma, S.A.
Tel: +34 93 205 86 86

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
Laboratório Normal – Produtos Farmacêuticos Lda.
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 (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu