VILDAGLIPTIN 50 mg/850 mg Film-Coated Tablets

Содержание инструкции

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

Vildagliptin and Metformin Teva 50 mg/850 mg film-coated tablets, mg/1000 mg film-coated tablets

vildagliptin/metformin 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, 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, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Vildagliptin and Metformina Teva and what it is used for

The active substances of Vildagliptin and Metformina Teva, vildagliptin and metformin, belong to a
group of medicines called “oral antidiabetics”.
Vildagliptin and Metformina Teva 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 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 Teva 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. It is
proven that this medicine reduces blood sugar. This can help prevent
complications resulting from its diabetes.

2. What you need to know before taking Vildagliptin and Metformin Teva

Do not take Vildagliptin and Metformin Teva

• 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, ask your doctor before taking Vildagliptin and Metformin Teva;
• 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 special 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 you do it daily or only occasionally);
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions
Risk of lactic acidosis
Vildagliptin and Metformin Teva 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 a 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, consult your doctor for further
instructions.

Stop taking Vildagliptin and Metformin Teva 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
normal. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Vildagliptin and
Metformin Teva and immediately contact your doctor or the nearest hospital, 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 associated with severe fatigue
• difficulty breathing
• decreased body temperature and slower heartbeat.

Lactic acidosis is a medical emergency and must be treated in hospital.
Vildagliptin and Metformin Teva is not a substitute for insulin. Therefore, Vildagliptin and Metformin
Teva should not be prescribed for the treatment of type 1 diabetes.
Consult your doctor, pharmacist or nurse before taking Vildagliptin and Metformin Teva
if you have or have had a pancreatic disease.
Consult your doctor, pharmacist or nurse before taking Vildagliptin and Metformin Teva
if you are taking a medicine for diabetes known as a sulfonylurea. If you take it together
with Vildagliptin and Metformin Teva, your doctor may decide to reduce your dose of
sulfonylurea to avoid low blood glucose levels (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 be particularly careful about the formation of new blisters or ulcers
when taking Vildagliptin and Metformin Teva. If this happens, you should contact your doctor immediately.
If you are going to have major surgery, you should stop taking
Vildagliptin and Metformin Teva during the surgery and for a certain period of time afterwards. The doctor will decide when you should stop and when you should resume treatment with
Vildagliptin and Metformin Teva.
Before starting treatment with Vildagliptin and Metformin Teva, a test will be performed
to assess liver function, which will be repeated every three months during the first year of
treatment and then periodically. This is to detect signs of increased
liver enzymes as early as possible.
During treatment with Vildagliptin and Metformin Teva, 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
The use of Vildagliptin and Metformin Teva is not recommended in children and adolescents up to
18 years of age.

Other medicines and Vildagliptin and Metformin Teva
If you are going to have an iodine-containing contrast agent injected into your bloodstream, for
example for a radiograph, CT scan or MRI, you must stop taking Vildagliptin and Metformin Teva before or during the injection. The doctor will decide
when you should stop and when you should resume treatment with Vildagliptin and Metformin
Teva.
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 Metformin
Teva. It is particularly important to mention the following:

• glucocorticoids, usually used to treat inflammation
• beta-2-agonists, usually used to treat respiratory disorders
• 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, or
• certain medicines that affect the nervous system.

Vildagliptin and Metformin Teva with alcohol
Avoid excessive alcohol consumption during treatment with Vildagliptin and Metformin Teva 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 for advice before taking this medicine. Your doctor will discuss with you the potential risk associated with taking Vildagliptin and Metformin Teva during pregnancy.
• Do not use Vildagliptin and Metformin Teva if you are pregnant or breastfeeding (see also “Do not take Vildagliptin and Metformin Teva”). Ask your doctor or pharmacist for advice before taking any medicine.

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

3. How to take Vildagliptin and Metformin Teva

The amount of Vildagliptin and Metformin Teva that you need to take varies depending on your
individual conditions. Your doctor will tell you exactly the dose of Vildagliptin and Metformin Teva to
take.
Take this medicine following your doctor’s instructions exactly. If you have any doubts, ask 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 medicine known as a sulfonylurea.
The doctor may prescribe this medicine to you alone or with some medicines that lower the level
of sugar in the blood.

When and how to take Vildagliptin and Metformin Teva

• 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.

The score line on the tablet is only to help you break it if you have
difficulty swallowing it whole.
Continue to follow all the dietary advice that your doctor has given you. In particular, if you are following a
diet to control your weight in case of diabetes, you must continue to follow it during treatment with
Vildagliptin and Metformin Teva.

If you take more Vildagliptin and Metformin Teva than you should
If you take too many tablets of Vildagliptin and Metformin Teva, or if someone else takes your
tablets, seek immediate medical advice from your doctor or 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 and Metformin Teva
If you forget to take a tablet, take it with your next meal, unless you are due to
take one anyway. Do not take a double dose (two tablets together) to make up for the
missed tablet.

If you stop taking Vildagliptin and Metformin Teva
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
Metformin Teva 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 questions about using 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 and Metformina Teva and immediately contact your
doctorif any of the following side effects occur:

• Lactic acidosis(very rare: may affect up to 1 in 10,000 people): Vildagliptin and Metformina Teva 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 Teva and immediately seek
  medical attention or go to the nearest hospital, because lactic acidosis can lead to coma.
• Angioedema (rare: may affect up to 1 in 1000 people): symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset 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: cannot be estimated based on available data): Symptoms include severe and persistent abdominal pain (stomach area) 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 and
Metformina Teva:

• 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 high lactic acid levels 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 redness, itching; reduced levels of vitamin B12 (pallor, fatigue, mental symptoms such as confusion or memory problems).

While taking vildagliptin/metformin hydrochloride and a sulfonylurea, some patients have
experienced the following side effects:

• Common: dizziness, tremor, weakness, low blood glucose levels, excessive sweating. While taking vildagliptin/metformin hydrochloride and insulin, some patients have experienced 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 based on 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, pharmacist or nurse. You can also report side effects directly
through the national reporting system available at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting
side effects you can help provide more information on the safety of this
medicine.

5. How to store Vildagliptin and Metformin Teva

• 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 package and blister after “Exp”. The expiry date refers to the last day of that month.
• Do not store at a temperature above 25°C.
• Store in the original package 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.

6Contents of the pack and other information
What Vildagliptin and Metformin Teva contains

• The active ingredients are vildagliptin and metformin hydrochloride.
• Each film-coated tablet of Vildagliptin and Metformin Teva 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 and Metformin Teva 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, microcrystalline cellulose, magnesium stearate. Film coating:-hypromellose 2910, 6 cps, titanium dioxide (E171), copovidone, polydextrose, macrogol 3350, yellow iron oxide (E172), medium chain triglycerides.

Description of the appearance of Vildagliptin and Metformin Teva and contents of the pack
The film-coated tablets of Vildagliptin and Metformin Teva 50 mg/850 mg are oval and
biconvex, yellow in colour, 8.5 x 21 mm in size, with a score line on one side and imprinted with “A
850” on the other.
The score line on the tablet is to aid in breaking the tablet to facilitate swallowing and not to divide it into equal doses.
The film-coated tablets of Vildagliptin and Metformin Teva 50 mg/1000 mg are oval and
biconvex, dark yellow in colour, 9.2 x 23 mm in size, with a score line on one side and imprinted
“A 051” on the other.
The score line on the tablet is to aid in breaking the tablet to facilitate swallowing and not to divide it into equal doses.
Vildagliptin and Metformin Teva is available in blisters containing 10, 60, 100 and 180 film-coated
tablets and in unit-dose divisible blisters containing 30 x 1 and 60 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA B.V.
Swensweg 5,
2031 GA Haarlem
Netherlands

Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000 - Malta
Merckle GmbH
Ludwig-Merckle-Strasse 3, 89143 Blaubeuren - Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, 10000 Zagreb - Croatia
Teva Nederland B.V.
Swensweg 5, 2031GA Haarlem - Netherlands
Teva Operations Poland Sp. z.o.o, ul.
Mogilska 80, 31-546 Krakow - Poland
Teva Pharma B.V.
Swensweg 5, 2031GA Haarlem - Netherlands
TEVA UK Ltd.
Brampton Road, Hampden Park Eastbourne, East Sussex BN22 9AG - United Kingdom