Vildagliptin and metformin Teva: detailed information

PACKAGE LEAFLET

Package leaflet: information for the user

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

vildagliptin/metformin hydrochloride
Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Vildagliptin and Metformin Teva is and what it is used for
What you need to know before taking Vildagliptin and Metformin Teva
How to take Vildagliptin and Metformin Teva
Possible side effects
How to store Vildagliptin and Metformin Teva
Contents of the pack and other information

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

The active substances in Vildagliptin and Metformin Teva, vildagliptin and metformin, belong to a
group of medicines called "oral antidiabetics".
Vildagliptin and Metformin 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 when the insulin
produced by the body does not work properly. It may also develop when the body produces too
much glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps lower blood sugar levels,
especially after meals. Glucagon stimulates the liver to produce sugar, causing an increase in blood
sugar levels.
How Vildagliptin and Metformin Teva works
Both active ingredients, vildagliptin and metformin, help control blood sugar levels. The substance vildagliptin works by prompting the pancreas to produce more insulin and less
glucagon. The substance metformin works by helping the body make better use of insulin. This medicine has been shown to reduce blood sugar levels. This may help prevent complications arising from your 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, 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 substances, consult your doctor before taking Vildagliptin and Metformin Teva;
if you have uncontrolled diabetes associated, for example, with 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 may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, and breath with an unusual fruity odour;
if you recently had a heart attack or have heart failure or severe circulatory problems or breathing difficulties that may be signs of heart problems;
if you have severely reduced kidney function;
if you have a serious infection or are severely dehydrated (your body has lost a lot of water);
if you are due to undergo an X-ray examination with a contrast agent (a special type of X-ray involving injection of a dye). See also the information in the section “Warnings and precautions”;
if you have liver problems;
if you drink alcohol excessively (either daily or occasionally);
if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions
Risk of lactic acidosis
Vildagliptin and Metformin Teva may cause a very rare but very serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, serious infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, and any other medical condition characterised by reduced oxygen supply to part of the body (such as severe heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.
Temporarily stop taking Vildagliptin and Metformin Teva 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 are drinking 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 consult your doctor or go to the nearest hospital immediately, because lactic acidosis may lead to coma.
Symptoms of lactic acidosis include:

vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of malaise associated with severe fatigue
difficulty breathing
reduced body temperature and slower heart rate.

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 must 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 disease of the pancreas.
Consult your doctor, pharmacist, or nurse before taking Vildagliptin and Metformin Teva if you are taking an antidiabetic medicine known as a sulphonylurea. If you take it together with Vildagliptin and Metformin Teva, your doctor may decide to reduce your dose of sulphonylurea to avoid low blood glucose levels (hypoglycaemia).
If you previously took vildagliptin but had to stop due to liver disease, you must not take this medicine.
Skin lesions are a common complication of diabetes. You are advised to follow the skin and foot care recommendations provided by your doctor or nurse.
You are also advised to pay particular attention to the development of new blisters or ulcers while taking Vildagliptin and Metformin Teva. If this occurs, you should consult your doctor immediately.
If you are undergoing major surgery, you must stop taking Vildagliptin and Metformin Teva during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart 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 periodically thereafter. This is to detect as early as possible any signs of increased liver enzymes.
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 kidney function worsens.
Your doctor will regularly monitor your blood and urine sugar levels.
Children and adolescents
The use of Vildagliptin and Metformin Teva is not recommended in children and adolescents under 18 years of age.
Other medicines and Vildagliptin and Metformin Teva
If you are due to receive an injection of an iodine-containing contrast agent into the bloodstream, for example for an X-ray, CT scan, or magnetic resonance imaging (MRI), you must stop taking Vildagliptin and Metformin Teva before or during the injection. Your doctor will decide when to stop and when to restart treatment with Vildagliptin and Metformin Teva.
Inform your doctor if you are taking, have recently taken, or might take any other medicine. You may need to have more frequent blood glucose and kidney function tests, or your doctor may decide to adjust the dose of Vildagliptin and Metformin Teva. It is particularly 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 that increase urine production (diuretics)
medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
certain medicines used to treat 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 section “Warnings and precautions”).
Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. Your doctor will discuss with you the potential risks 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”). Consult your doctor or pharmacist before taking any medicine.

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

3. How to take Vildagliptin and Metformin Teva

The amount of Vildagliptin and Metformin Teva you should take varies depending on your individual condition. Your doctor will tell you exactly what dose of Vildagliptin and Metformin Teva to take.
Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 50 mg/850 mg or one 50 mg/1000 mg film-coated tablet taken twice daily.
If you have reduced kidney function, your doctor may prescribe a lower dose. Your doctor may also prescribe a lower dose if you are taking an antidiabetic medicine known as a sulfonamide derivative (sulfonylurea).
Your doctor may prescribe this medicine alone or in combination with certain other medicines that lower blood sugar levels.

When and how to take Vildagliptin and Metformin Teva

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

The break line on the tablet is only intended to facilitate splitting the tablet if you have difficulty swallowing it whole.
Continue to follow all dietary advice given to you by your doctor. In particular, if you are following a diet for weight control in 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, contact your doctor or pharmacist immediately. Medical treatment may be necessary. If you need to see a doctor or go to hospital, bring the pack and this leaflet with you.

If you forget to take Vildagliptin and Metformin Teva
If you forget to take a tablet, take it with your next meal, unless it is already time for your next scheduled dose. Do not take a double dose (two tablets together) to make up for a forgotten tablet.

If you stop taking Vildagliptin and Metformin Teva
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep your blood sugar under control. 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, consult your doctor.

If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
You must stop taking Vildagliptin and Metformin Teva and contact your doctor immediately if you experience any of the following side effects:

Lactic acidosis (very rare: may affect up to 1 in 10,000 people): Vildagliptin and Metformin Teva may cause a very rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Vildagliptin and Metformin Teva and seek immediate medical attention at the nearest doctor or hospital, as 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 or eyes, nausea, loss of appetite, or dark-coloured urine, which may indicate liver disease (hepatitis).
Inflammation of the pancreas (pancreatitis) (frequency not known: frequency cannot be estimated based on available data): symptoms include severe and persistent abdominal pain (in the stomach area), which may extend to the back, as well as nausea and vomiting.

Other side effects
Some patients experienced the following side effects while taking Vildagliptin and Metformin Teva:

Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhoea, stomach or abdominal pain, loss of appetite.
Common (may affect up to 1 in 10 people): dizziness, headache, uncontrollable tremor, 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 (oedema).
Very rare (may affect up to 1 in 10,000 people): sore throat, runny nose, fever; signs of high levels 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 redness, itching; reduced vitamin B12 levels (pallor, fatigue, mental symptoms such as confusion or memory disturbances).

During treatment with vildagliptin/metformin hydrochloride and a sulfonylurea, some patients experienced the following side effects:

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

During treatment with vildagliptin/metformin hydrochloride and insulin, some patients experienced the following side effects:

Common: headache, chills, nausea (feeling of discomfort), low blood glucose levels, heartburn.

Uncommon: diarrhoea, flatulence.

During the marketing of this medicine, the following side effects have also been reported:

Frequency not known: (cannot be estimated from available data): itchy rash, inflammation of the pancreas, localized skin peeling or blisters, muscle pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the carton and blister pack after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original packaging to protect the medicine from moisture. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

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

The active substances 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 components are: Tablet core: hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate. 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 packaging
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, with a score line on one side and engraved with "A 850" on the other.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet 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, with a score line on one side and engraved with "A 051" on the other.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet 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
The 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 - The Netherlands
Teva Operations Poland Sp. z.o.o, ul.
Mogilska 80, 31-546 Krakow - Poland
Teva Pharma B.V.
Swensweg 5, 2031GA Haarlem - The Netherlands
TEVA UK Ltd.
Brampton Road, Hampden Park Eastbourne, East Sussex BN22 9AG - United Kingdom