VILDAGLIPTIN 50 mg/850 mg Фильм-Coated Таблетки

Содержание инструкции

1. Vildagliptin and metformina Krka 50 mg/850 mg film-coated tablets, mg/1000 mg film-coated tablets
   1. What Vildagliptin and metformina Krka is and what it is used for
   2. What you need to know before taking Vildagliptin and metformina Krka
   3. How to take Vildagliptin and metformina Krka
   4. Possible side effects
   5. How to store Vildagliptin and metformina Krka
   6. Package Contents and Other Information

Vildagliptin and metformina Krka 50 mg/850 mg film-coated tablets, mg/1000 mg film-coated tablets

vildagliptin/metformina hydrochloride
Generic medicine

Read this leaflet carefully before you start 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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet

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

1. What Vildagliptin and metformina Krka is and what it is used for

The active substances of Vildagliptin and metformina Krka, vildagliptin and metformina, belong to a
group of medicines called “oral antidiabetics”.
Vildagliptin and metformina Krka is used to treat adult patients with type 2 diabetes. This type of
diabetes is also known as non-insulin-dependent diabetes mellitus. Vildagliptin and metformina
Krka is used when diabetes cannot be controlled with diet and exercise alone and/or
together with other medicines used to treat diabetes (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 Vildagliptin and metformina Krka works
Both active substances, vildagliptin and metformina, help to control blood
sugar levels. The substance vildagliptin works by inducing the pancreas to produce more insulin and less glucagon.
The substance metformina works by helping the body to make better use of insulin. It has been
shown that this medicine reduces blood sugar. This can help to prevent
complications resulting from its diabetes.

2. What you need to know before taking Vildagliptin and metformina Krka

Do not take Vildagliptin and metformina Krka

• if you are allergic to vildagliptin or to metformina hydrochloride or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of these substances, ask your doctor before taking Vildagliptin and metformina Krka.
• if you have uncontrolled diabetes associated with, for example, severe hyperglycemia (high blood glucose levels), nausea, vomiting, diarrhea, 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 precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness and breath with an unusually fruity odor.
• if you have recently had a heart attack or if you have heart failure or severe circulatory problems or difficulty breathing which may 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 particular type of X-ray that involves the use of a dye injected into the bloodstream). See also the information in the “Warnings and precautions” section.
• if you have liver problems.
• if you drink alcohol in excess (whether daily or occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

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

Stop taking Vildagliptin and metformina Krka 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, diarrhea, fever, exposure to heat or if you drink less fluids than usual.
Ask your doctor for further instructions.

Stop taking Vildagliptin and metformina Krka and immediately contact your doctor or
the nearest hospitalif you experience any of the symptoms of lactic acidosis,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.
Vildagliptin and metformina Krka is not a substitute for insulin. Therefore, Vildagliptin and metformina Krka
should not be prescribed for the treatment of type 1 diabetes.
Ask your doctor, pharmacist or nurse before taking Vildagliptin and metformina Krka if
you have or have had a disease of the pancreas.
Ask your doctor, pharmacist or nurse before taking Vildagliptin and metformina Krka if
you are taking a medicine for diabetes known as a sulfonylurea. If you take it together with
Vildagliptin and metformina Krka, your doctor may want to reduce your dose of sulfonylurea, to avoid
low blood glucose (hypoglycemia).
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 Vildagliptin and metformina Krka. If this happens, you should contact your doctor immediately.
If you are going to have major surgery, you should stop taking
Vildagliptin and metformina Krka during the surgery and for a certain period of time afterwards. Your doctor will decide when you should stop and when to resume treatment with
Vildagliptin and metformina Krka.
Before starting treatment with Vildagliptin and metformina Krka, 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
then periodically. This is to detect any signs of increased liver enzymes as early as possible.
During treatment with Vildagliptin and metformina Krka, your doctor will check the function of
your kidneys 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 and urine sugar levels.

Children and adolescents
The use of Vildagliptin and metformina Krka is not recommended in children and adolescents up to 18
years of age.

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

• glucocorticoids, generally used to treat inflammation
• beta-2 agonists, generally 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 for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain medicines that affect the thyroid
• certain medicines that affect 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).

Vildagliptin and metformina Krka with alcohol
Avoid excessive alcohol consumption during treatment with Vildagliptin and metformina Krka as
this may increase the risk of lactic acidosis (see “Warnings and precautions”).

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Vildagliptin and metformina Krka during pregnancy.
• Do not use Vildagliptin and metformina Krka if you are pregnant or breastfeeding (see also “Do not take Vildagliptin and metformina Krka”).

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

Driving and using machines
If you feel dizzy while taking Vildagliptin and metformina Krka, do not drive or use tools or
machinery.

Vildagliptin and metformina Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Vildagliptin and metformina Krka

The amount of Vildagliptin and metformina Krka that must be taken varies depending on individual conditions.
Your doctor will tell you exactly the dose of Vildagliptin and metformina Krka to take.
Take this medicine following always exactly the instructions of the doctor or the pharmacist. If you have
doubts consult your doctor or the 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
blood sugar.

When and how to take Vildagliptin and metformina Krka

• Swallow 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 Vildagliptin and
metformina Krka.

If you take more Vildagliptin and metformina Krka than you should
If you take too many tablets of Vildagliptin and metformina Krka, or if someone else takes your
tablets, seek immediate medical advice or contact your pharmacist. Medical care may be necessary. If you need to go to a doctor or to the hospital, bring with you the package and this

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

If you stop taking Vildagliptin and metformina Krka
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 Vildagliptin and
metformina Krka unless your doctor tells you to. If you have any doubts about how long to take
this medicine, ask your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking Vildagliptin and metformina Krka and immediately contact your
doctorif you experience the following side effects:

• Lactic acidosis(very rare: may affect up to 1 in 10,000 people): Vildagliptin and metformina Krka can cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Vildagliptin and metformina Krka and immediately contact yourdoctor or the nearest hospital, because lactic acidosis can lead to coma.
• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden appearance of skin rashes or hives, which may indicate a reaction called “angioedema”.
• Liver disease (hepatitis) (rare): 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) (frequency not known): symptoms include severe and persistent pain in the abdomen (stomach area), which may spread to the back, as well as nausea and vomiting.

Other side effects
Some patients have experienced the following side effects while taking Vildagliptin and metformina
Krka:

• Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhea, stomach pain or discomfort (abdominal pain), loss of appetite.
• Common (may affect up to 1 in 10 people): dizziness, headache, tremor that cannot be controlled, metallic taste, low blood glucose levels.
• Uncommon (may affect up to 1 in 100 people): joint pain, fatigue, constipation, swelling of hands, ankles or feet (edema).
• 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 heartbeat or rapid and deep
breathing; skin flushing, itchy skin; reduced levels of vitamin B12
(paleness, fatigue, mental symptoms such as confusion or memory problems).
While taking Vildagliptin and metformina Krka and a sulfonylurea, some patients have
experienced the following side effects:

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

While taking Vildagliptin and metformina Krka and other medicines for the treatment of
diabetes some patients have shown the following side effects:

• Common: headache, chills, nausea (feeling unwell), low blood glucose levels, heartburn.
• Uncommon: diarrhea, flatulence. The following side effects have also been reported during the post-marketing of this medicine:
• Frequency not known (cannot be estimated from the available data): itchy rash, inflammation of the pancreas, localized skin peeling or blisters, muscle pain.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system reported at the
address https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Vildagliptin and metformina Krka

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 and blister 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 packaging 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 Vildagliptin and metformina Krka contains

• The active ingredients are vildagliptin and metformina hydrochloride. Vildagliptin and metformina Krka 50 mg/850 mg film-coated tablets: Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformina hydrochloride. Vildagliptin and metformina Krka 50 mg/1000 mg film-coated tablets: Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformina hydrochloride.
• The other ingredients (excipients) are hydroxypropylcellulose (E463), mannitol (E421), sodium stearyl fumarate (E470a) and magnesium stearate (E470b) in the tablet core and hypromellose (E464), titanium dioxide (E171), talc (E553b), propylene glycol (E1520) and yellow iron oxide (E172) in the tablet coating. See section 2 “Vildagliptin and metformina Krka contains sodium”.

Description of the appearance of Vildagliptin and metformina Krka and package contents
Vildagliptin and metformina Krka 50 mg/850 mg: brownish-yellow, oval, film-coated tablets,
biconvex, marked with V1 on one side of the tablet. Tablet dimensions: approximately 20 x
11 mm.
Vildagliptin and metformina Krka 50 mg/1000 mg: brownish-yellow, oval, film-coated tablets,
biconvex, marked with V2 on one side of the tablet. Tablet dimensions: approximately 21 x
11 mm.
Vildagliptin and metformina Krka is available in packs containing 10, 30, 60, 120 and 180 film-coated
tablets and in multiple packs containing 120 (2 x 60) and 180 (3 x 60) film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann - Straβe 5, 27472 Cuxhaven, Germany

Local Representative for Italy
KRKA Farmaceutici Milano S.r.l. - Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following names: