VIDAGLIPTIN 50 mg/850 mg Film-Coated Tablets

Зміст інструкції

1. What is Vildagliptin and Metformina Aurobindo and what is it used for
2. What you need to know before taking Vildagliptin and Metformin Aurobindo
3. How to take Vildagliptin and Metformin Aurobindo
4. Possible side effects
5. How to store Vildagliptin and Metformina Aurobindo
6. Package Contents and Other Information

Vildagliptin and Metformin Aurobindo 50 mg/850 mg film-coated tablets Vildagliptin and
Metformin Aurobindo 50 mg/1000 mg film-coated tablets
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 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 Vildagliptin and Metformin Aurobindo is and what it is used for
• 2. What you need to know before you take Vildagliptin and Metformin Aurobindo
• 3. How to take Vildagliptin and Metformin Aurobindo
• 4. Possible side effects
• 5. How to store Vildagliptin and Metformin Aurobindo
• 6. Contents of the pack and other information

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

The active substances of Vildagliptin and Metformina Aurobindo, vildagliptin and metformin hydrochloride ,
belong to a group of medicines called “oral antidiabetics”.
Vildagliptin and Metformina Aurobindo 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 Aurobindo works
Both active substances, vildagliptin and metformin hydrochloride, 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, which can
help to prevent complications resulting from its diabetes.

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

Do not take Vildagliptin and Metformin Aurobindo:

• if you are allergic to vildagliptin, to metformin 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 Metformin Aurobindo;
• if you have uncontrolled diabetes associated 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 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 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 contrast agent (a special type of X-ray that involves the use of a dye injected into the body). See information in the “Warnings and precautions” section;
• if you have liver problems;
• if you drink excessive amounts of alcohol (whether daily or occasionally);
• if you are breastfeeding (see also “Pregnancy and breastfeeding” below).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Vildagliptin and Metformin Aurobindo.

Risk of lactic acidosis
Vildagliptin and Metformin Aurobindo can cause a very rare but very serious side effect called lactic acidosis, particularly if your kidneys do not function properly. The risk of developing lactic acidosis is also higher if you have 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 acute severe heart disease).
If you have any of the medical conditions described above, talk to your doctor for further instructions.

Stop taking Vildagliptin and Metformin Aurobindo 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 usual. Talk to your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Vildagliptin and Metformin Aurobindo 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.
Vildagliptin and Metformin Aurobindo is not a substitute for insulin. Therefore, Vildagliptin and Metformin Aurobindo should not be prescribed to you for the treatment of type 1 diabetes.
Talk to your doctor, pharmacist or nurse before taking Vildagliptin and Metformin Aurobindo if you have or have had a disease of the pancreas.
Talk to your doctor, pharmacist or nurse before taking Vildagliptin and Metformin Aurobindo if you are taking a medicine for diabetes known as a sulfonylurea. If you take it together with Vildagliptin and Metformin Aurobindo, your doctor may want to reduce your dose of sulfonylurea, to avoid low blood glucose (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 that are provided by your doctor or nurse.
You are also advised to pay particular attention to the formation of new blisters or ulcers while taking Vildagliptin and Metformin Aurobindo. In this case, you should contact your doctor immediately.
If you are going to have major surgery, you should stop taking Vildagliptin and Metformin Aurobindo 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 Vildagliptin and Metformin Aurobindo.
Before starting treatment with Vildagliptin and Metformin Aurobindo, a test will be carried out to assess liver function, which will be repeated at intervals of 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 and Metformin Aurobindo, 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 Aurobindo is not recommended in children and adolescents under 18 years of age.

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

• glucocorticoids, generally used to treat inflammation;
• beta-2 agonists, generally used to treat breathing 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 blockers);
• certain medicines that affect the thyroid;
• certain medicines that affect the nervous system.

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

Pregnancy and breastfeeding
If you are pregnant, 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 risk of taking Vildagliptin and Metformin Aurobindo during pregnancy. Vildagliptin and Metformin Aurobindo should not be taken during pregnancy.
Do not take Vildagliptin and Metformin Aurobindo if you are breastfeeding (see also “Do not take Vildagliptin and Metformin Aurobindo”).
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
If you experience dizziness while taking Vildagliptin and Metformin Aurobindo, do not drive or use tools or machines.

Vildagliptin and Metformin Aurobindo contains maltodextrin
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Vildagliptin and Metformin Aurobindo

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your
doctor or pharmacist.
The amount of Vildagliptin and Metformin Aurobindo that people need to take varies depending on
individual conditions. Your doctor will tell you exactly the dose of Vildagliptin and Metformin Aurobindo to
take.
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
also prescribe you a lower dose if you are taking an antidiabetic medicine known as a sulfonylurea.
Your doctor may prescribe this medicine alone or together with other medicines that lower
blood sugar levels.

When and how to take Vildagliptin and Metformin Aurobindo

• Vildagliptin and Metformin Aurobindo is for oral use.
• 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 provided by your doctor. In particular, if you are following a diet to control your weight in case of diabetes, you should continue it during therapy with Vildagliptin and Metformin Aurobindo.

If you take more Vildagliptin and Metformin Aurobindo than you should
If you take too many tablets of Vildagliptin and Metformin Aurobindo, or if someone else takes your
tablets, seek immediate medical advice from your doctor or pharmacist. Medical assistance may be
needed. If you need to go to a doctor or hospital, take the package with you and

If you forget to take Vildagliptin and Metformin Aurobindo
If you forget to take a tablet, take it with your next meal, unless you are due to
take it anyway. Do not take a double dose to make up for a missed
tablet.

If you stop taking Vildagliptin and Metformin Aurobindo
Continue to take this medicine as long as your doctor prescribes it so that you can
continue to control your blood sugar level. Do not stop treatment with
Vildagliptin and Metformin Aurobindo 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 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 everybody gets them.
You must stop taking Vildagliptin and Metformin Aurobindo 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 and Metformin Aurobindo can cause a very rare but very serious side effect called lactic acidosis (see also section 2, “Warnings and precautions”). If this happens, you must stop taking Vildagliptin and Metformin Aurobindo 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 skin rash or hives.
• Liver disease (hepatitis) (rare): symptoms include yellowing of the skin and eyes, nausea, loss of appetite or dark urine.
• Inflammation of the pancreas (pancreatitis) (frequency not known: cannot be estimated from available data). Symptoms include severe and persistent abdominal pain (stomach area), which 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/metformin hydrochloride tablets:

• Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhoea, stomach pain (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 (oedema).
• Very rare: 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 B (paleness, fatigue, mental symptoms such as confusion or memory problems).

While taking vildagliptin/metformin hydrochloride tablets 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 tablets and insulin,
some patients have had the following side effects:

• Common: headache, chills, nausea (feeling sick), low blood glucose levels, heartburn.
• Uncommon: diarrhoea, flatulence.

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

• Frequency not known: itchy rash, inflammation of the pancreas, localised skin peeling or blisters, muscle pain.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Aurobindo

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 packaging after “Scad”.
The expiry date refers to the last day of the 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 waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Package Contents and Other Information

What Vildagliptin and Metformin Aurobindo contains

• The active ingredients are vildagliptin and metformin hydrochloride.
• Each film-coated tablet of Vildagliptin and Metformin Aurobindo 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 Aurobindo 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: copovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, polydextrose, titanium dioxide (E171), talc, yellow iron oxide (E172), maltodextrin, medium chain triglycerides.

Description of the appearance of Vildagliptin and Metformin Aurobindo and package contents
The film-coated tablets of Vildagliptin and Metformin Aurobindo 50 mg/850 mg are yellow,
oval, with “50” imprinted on one side and “850” on the other side, with the following dimensions: length 21.6
± 0.2 mm, width 8.6 ± 0.2 mm and thickness 7.4 ± 0.4 mm.
The film-coated tablets of Vildagliptin and Metformin Aurobindo 50 mg/1000 mg are dark yellow,
oval, with “50” imprinted on one side and “1000” on the other, with the following dimensions: length

• 22.0 ± 0.2 mm, width 9.0± 0.2 mm and thickness 8.1 ± 0.4 mm. Vildagliptin and Metformin Aurobindo is packaged in a cardboard box containing the appropriate number of OPA/Alu/PVC-Alu or PVC/PE/PCTFE-Alu transparent blisters.

Vildagliptin and Metformin Aurobindo is available in packs containing 60 film-coated tablets
.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102

• 21047 – Saronno (VA) Italy Manufacturer

Pharmathen S.A.
6, Dervenakion Str
15351 Pallini Attiki
Greece
or
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No.5
69300 Rodopi
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Denmark VEDFA
France VEDFA 50mg/850mg and 50mg/1000mg film-coated tablets
Spain VEDFA 50 mg/850 mg and 50 mg/1.000 mg film-coated tablets EFG
Italy Vildagliptin e Metformina Aurobindo
Portugal VEDFA
Greece VEDFA
Cyprus VEDFA