VILDAGLIPTIN 50 mg/850 mg Фильм-Coated Таблетки

Содержание инструкции

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

F olio illustrativo: information for the user

Vildagliptin/Metformina cloridrato Accord 50 mg/850 mg film-coated tablets, mg/1000 mg film-coated tablets

vildagliptin/metformin hydrochloride

Read this leaflet carefully before you start to take 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 their symptoms are the same as yours, as it could 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/Metformina cloridrato Accord is and what it is used for
• 2. What you need to know before you take Vildagliptin/Metformina cloridrato Accord
• 3. How to take Vildagliptin/Metformina cloridrato Accord
• 4. Possible side effects
• 5. How to store Vildagliptin/Metformina cloridrato Accord
• 6. Contents of the pack and other information

1. What is Vildagliptin/Metformina cloridrato Accord and what it is used for

The active substances of Vildagliptin/Metformina cloridrato Accord, vildagliptin and metformina cloridrato,
belong to a group of medicines called “oral antidiabetics”.
Vildagliptin/Metformina cloridrato Accord is used to treat adult patients with type 2 diabetes.
This type of diabetes is also known as non-insulin-dependent diabetes mellitus.
Vildagliptin/Metformina cloridrato Accord 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 Vildagliptin/Metformina cloridrato Accord 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.
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 taking Vildagliptin/Metformin hydrochloride Accord

Do not take Vildagliptin/Metformin hydrochloride Accord

• 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 may be allergic to any of

these substances, talk to your doctor before taking Vildagliptin/Metformin hydrochloride Accord.

• if you suffer from diabetes that is not controlled with, for example, severe hyperglycaemia (high blood glucose levels), 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 or 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 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 special type of X-ray that involves the use of a dye injected into the body). See also the information in the “Warnings and precautions” section.
• if you have liver problems.
• if you drink alcohol in excess (either daily or occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions
Risk of lactic acidosis
Vildagliptin/Metformin hydrochloride Accord can cause an undesirable effect, very rare but very
serious, called lactic acidosis, particularly if your kidneys do not function properly. The risk of
developing lactic acidosis is greater if you have uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (for further information, see below), 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, talk to your doctor for further
instructions.

Stop taking Vildagliptin/Metformin hydrochloride Accord 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 fluids than
normal. Talk to your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking
Vildagliptin/Metformin hydrochloride Accord 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 slowed heartbeat

Lactic acidosis is a medical emergency and must be treated in hospital.
Vildagliptin/Metformin hydrochloride Accord is not a substitute for insulin. Therefore,
Vildagliptin/Metformin hydrochloride Accord should not be prescribed for the treatment of type 1
diabetes.
Talk to your doctor, pharmacist or nurse before taking Vildagliptin/Metformin hydrochloride Accord if you have or have had a disease of the pancreas.
Talk to your doctor, pharmacist or nurse before taking Vildagliptin/Metformin hydrochloride Accord if you are taking a medicine for diabetes known as a sulfonylurea. If you
take it together with Vildagliptin/Metformin hydrochloride Accord, your doctor may reduce your
dose of sulfonylurea to avoid low blood glucose levels (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.
When taking Vildagliptin/Metformin hydrochloride Accord, you are also advised to pay particular
attention to the formation of new blisters or ulcers. If this happens, you should contact your
doctor immediately.
If you are going to have major surgery, you should stop taking Vildagliptin/Metformin hydrochloride Accord during the surgery and for a certain period of time
afterwards. Your doctor will decide when you should stop and when you should resume
treatment with Vildagliptin/Metformin hydrochloride Accord.
Before starting treatment with Vildagliptin/Metformin hydrochloride Accord, a test will be performed to assess liver function, which will be repeated every three months during the first year of
treatment and subsequently periodically. This is to detect signs of increased liver enzymes as
early as possible.
During treatment with Vildagliptin/Metformin hydrochloride Accord, 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 and urine sugar levels.

Children and adolescents
In children and adolescents up to 18 years of age, the use of Vildagliptin/Metformin hydrochloride Accord is not recommended.

Other medicines and Vildagliptin/Metformin hydrochloride Accord
If you are going to have an iodine-containing contrast agent injected into your bloodstream, for
example, for an X-ray or scan, you must stop taking Vildagliptin/Metformin hydrochloride Accord before or at the time of the injection. Your doctor will decide
when you should stop and when you should resume treatment with Vildagliptin/Metformin hydrochloride Accord.
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/Metformin hydrochloride Accord. It is particularly important to mention the following:

• glucocorticoids, generally used to treat inflammation
• beta-2 agonists, generally used to treat respiratory diseases
• 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)
• some medicines that affect the thyroid
• some medicines that affect the nervous system
• some medicines used to treat angina (e.g., ranolazine)
• some medicines used to treat HIV infection (e.g., dolutegravir)
• some medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• some medicines used to treat heartburn and peptic ulcers (e.g., cimetidine)

Vildagliptin/Metformin hydrochloride Accord with alcohol
Avoid excessive alcohol consumption during treatment with Vildagliptin/Metformin hydrochloride Accord as this may increase the risk of lactic acidosis (see section “Warnings and
precautions”).

Pregnancy and breastfeeding

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

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

Driving and using machines
If you feel dizzy while taking Vildagliptin/Metformin hydrochloride Accord, do not drive or use
machines.

3. How to take Vildagliptin/Metformin hydrochloride Accord

The amount of Vildagliptin/Metformin hydrochloride Accord that you need to take 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 of 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 such 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 Vildagliptin/Metformin hydrochloride Accord

• 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, in case of diabetes,
if you are following a diet for weight control, you must continue it during therapy with
Vildagliptin/Metformin hydrochloride Accord.

If you take more Vildagliptin/Metformin hydrochloride Accord than you should
If you take too many tablets of Vildagliptin/Metformin hydrochloride Accord, or if someone else takes
your tablets, seek immediate medical advice or contact your pharmacist. Medical treatment may be needed. If you need to go to a doctor or hospital, take the package and this

If you forget to take Vildagliptin/Metformin hydrochloride Accord
If you forget to take a tablet, take it with your next meal, unless you have to
take it anyway. Do not take a double dose (two tablets together) to make up for the
forgotten tablet.

If you stop taking Vildagliptin/Metformin hydrochloride Accord
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/Metformin hydrochloride Accord unless your doctor tells you to. If you have any doubts
about how long you should take this medicine, ask your doctor.
If you have any questions about 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 everyone will experience them.
You must stop taking Vildagliptin/Metformina cloridrato Accord and contact your doctor
immediatelyif any of the following side effects occur:

• Lactic acidosis(very rare: may affect up to 1 in 10,000 people): Vildagliptin/Metformina cloridrato Accord 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/Metformina cloridrato Accord andseek 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 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) (may affect up to 1 in 100 people): symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may indicate liver disease (hepatitis).
• Pancreas inflammation (pancreatitis) (may affect up to 1 in 100 people). Symptoms include severe and persistent abdominal (stomach area) pain that may extend to the back, as well as nausea and vomiting.

Other side effects
Some patients have experienced the following side effects while taking Vildagliptin/metformina
cloridrato Accord:

• 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 unwell), vomiting, diarrhea, flatulence, heartburn, pain inside and around the stomach (abdominal pain).
• Uncommon (may affect up to 1 in 100 people): weakness, metallic taste, hypoglycemia, loss of appetite, swelling of the hands, ankles or feet (edema), chills, inflammation of the pancreas, muscle pain, fatigue.
• Very rare (may affect up to 1 in 10,000 people): 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; redness of the skin, itching; reduced levels of vitamin B12 (paleness, fatigue, mental symptoms such as confusion or memory impairment).

While taking Vildagliptin/Metformina cloridrato Accord and a sulfonylurea, some
patients have experienced the following side effects:

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

While taking Vildagliptin/Metformina cloridrato Accord and insulin, some patients have
experienced the following side effects:
The following side effects have also been reported during the post-marketing of this medicine.

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

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 Annex V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Vildagliptin/Metformina cloridrato Accord

• 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 carton after “EXP”/”Scad”.
• The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• 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/Metformin hydrochloride Accord contains

• The active ingredients are vildagliptin and metformin hydrochloride.
• Each film-coated tablet of Vildagliptin/Metformin hydrochloride Accord 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 Vildagliptin/Metformin hydrochloride Accord 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:
• Tablet core: hydroxypropylcellulose, low substituted hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate
• Film coating: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol, talc.

Description of the appearance of Vildagliptin/Metformin hydrochloride Accord and package contents
Vildagliptin/Metformin hydrochloride Accord 50 mg/850 mg film-coated tablets
Yellow, oval-shaped, biconvex, film-coated tablet, with the letters “GG2” imprinted on one side and smooth on the other. The approximate dimensions of the tablet are 20.15 x 8.00 mm.
Vildagliptin/Metformin hydrochloride Accord 50 mg/1000 mg film-coated tablets
Dark yellow, oval-shaped, biconvex, film-coated tablet, with the letters “GG3” imprinted on one side and smooth on the other. The approximate dimensions of the tablet are 21.11 x 8.38 mm.
Vildagliptin/Metformin hydrochloride Accord is available in aluminium/aluminium blister packs of 30, 60 or 180 film-coated tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Accord Healthcare S.L.U
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6 planta,
08039 Barcelona, Spain

Manufacturer
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040, Spain
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp. z o.o.
Ul. Lutomierska 50,
95-200 Pabianice, Poland
Accord Healthcare B.V.
Winthontlaan 200,Utrecht,3526 KV,
Netherlands

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