Vildagliptin and metformin Aurobindo: detailed information

Patient Information Leaflet

Vildagliptin and Metformin Aurobindo 50 mg/850 mg film-coated tablets
Vildagliptin and Metformin Aurobindo 50 mg/1000 mg film-coated tablets
Generic medicine
Please 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

The active substances in Vildagliptin and Metformin Aurobindo, vildagliptin and metformin hydrochloride,
belong to a group of medicines called “oral antidiabetics”.
Vildagliptin and Metformin Aurobindo 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 Metformin Aurobindo is
used when diabetes cannot be controlled by diet and exercise alone and/or in combination with other
medicines used to treat diabetes (insulin or sulfonylureas).
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 Aurobindo works
Both active substances, vildagliptin and metformin hydrochloride, help control blood sugar levels. The substance vildagliptin works by stimulating 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, which may help prevent complications arising from your diabetes.

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

Do not take Vildagliptin and Metformina Aurobindo:

if you are allergic to vildagliptin, metformin hydrochloride 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 Metformina Aurobindo;
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 have recently had a heart attack or if you have heart failure or serious circulatory problems or breathing difficulties that may be signs 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 due to undergo a contrast X-ray examination (a special type of X-ray involving an injectable dye). Please refer to the information in the section “Warnings and precautions”;
if you have liver problems;
if you drink alcohol excessively (either on a daily basis or occasionally);
if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions
Risk of lactic acidosis
Vildagliptin and Metformina Aurobindo may cause a very rare but serious side effect called lactic acidosis, particularly if your kidneys are not functioning properly. The risk of developing lactic acidosis is also higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterised by reduced oxygen supply to part of the body (such as acute severe heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.
Temporarily stop taking Vildagliptin and Metformina Aurobindo if you develop a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than normal. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Vildagliptin and Metformina Aurobindo and contact your doctor or go to the nearest hospital immediately, as lactic acidosis may lead to coma.
Symptoms of lactic acidosis include:

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

Lactic acidosis is a medical emergency and must be treated in hospital.
Contact your doctor immediately for further instructions if:

you know you have a hereditary genetic disease affecting mitochondria (the components that produce energy within cells), such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes, mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD, Maternal Inherited Diabetes and Deafness);
you develop any of the following symptoms after starting metformin: seizures, decreased cognitive ability, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), headache, or deafness.

Vildagliptin and Metformina Aurobindo is not a substitute for insulin. Therefore, Vildagliptin and Metformina Aurobindo must not be prescribed for the treatment of type 1 diabetes.
Consult your doctor, pharmacist or nurse before taking Vildagliptin and Metformina Aurobindo if you have or have had a pancreatic disease.
Consult your doctor, pharmacist or nurse before taking Vildagliptin and Metformina Aurobindo if you are taking an antidiabetic medicine known as a sulfonylurea. If you take it together with Vildagliptin and Metformina Aurobindo, your doctor may decide to reduce your sulfonylurea dose to avoid low blood glucose (hypoglycaemia).
If you have previously taken vildagliptin but had to stop due to liver disease, you must not take this medicine.
Skin lesions are a common complication of diabetes. It is recommended that you follow the skin and foot care advice 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 Metformina Aurobindo. In such cases, you should contact your doctor immediately.
If you are due to undergo major surgery, you must stop taking Vildagliptin and Metformina Aurobindo during the procedure and for a certain period afterwards. Your doctor will decide when you should stop and when you should resume treatment with Vildagliptin and Metformina Aurobindo.
Before starting treatment with Vildagliptin and Metformina Aurobindo, 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 Metformina Aurobindo, your doctor will monitor 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 Metformina Aurobindo is not recommended in children and adolescents under 18 years of age.
Other medicines and Vildagliptin and Metformina Aurobindo
If you are due to receive an injection of an iodine-containing contrast medium into the bloodstream, for example for an X-ray, you must stop taking Vildagliptin and Metformina Aurobindo before or during the injection. Your doctor will decide when you should stop and when you should resume treatment with Vildagliptin and Metformina Aurobindo.
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 Metformina Aurobindo. It is particularly important to mention the following:

corticosteroids, 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 affecting the thyroid;
certain medicines affecting 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 stomach acid and peptic ulcers (e.g. cimetidine).

Vildagliptin and Metformina Aurobindo and alcohol
Avoid excessive alcohol consumption during treatment with Vildagliptin and Metformina Aurobindo, 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 of taking Vildagliptin and Metformina Aurobindo during pregnancy.

Do not take Vildagliptin and Metformina Aurobindo if you are pregnant or breastfeeding (see also “Do not take Vildagliptin and Metformina Aurobindo”).

Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you experience dizziness while taking Vildagliptin and Metformina Aurobindo, do not drive or operate tools or machinery.
Vildagliptin and Metformina Aurobindo contains maltodextrins
If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Vildagliptin and Metformin Aurobindo

The amount of Vildagliptin and Metformin Aurobindo that people need to take varies depending on individual circumstances. Your doctor will tell you exactly how much Vildagliptin and Metformin Aurobindo to take.
Always take this medicine exactly as instructed by your doctor. 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.
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

Take 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 shortly after eating may reduce the risk of stomach upset.

Continue to follow all dietary advice given by your doctor. In particular, if you are following a diet for weight control in diabetes, you must continue it during treatment 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 required. If you need to go to a doctor or to hospital, take the pack and this leaflet with you.

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 another tablet anyway. Do not take a double dose (two tablets together) to make up for a missed tablet.

If you stop taking Vildagliptin and Metformin Aurobindo
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep controlling your blood sugar levels. 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, 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 everyone gets them.
You must stop taking Vildagliptin and Metformin Aurobindo 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 Aurobindo 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 Aurobindo and seek immediate medical attention at the nearest 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) (uncommon: may occur in up to 1 in 100 people): 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) (uncommon: may occur in up to 1 in 100 people). Symptoms include severe, persistent stomach (abdominal) pain, which may extend to the back, as well as nausea and vomiting.

Other side effects
While taking vildagliptin/metformin, some patients have experienced the following side effects:

Common (may affect up to 1 in 10 people): sore throat, runny nose, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable tremor, constipation, nausea (feeling unwell), vomiting, diarrhoea, flatulence, heartburn, stomach and abdominal pain.
Uncommon (may affect up to 1 in 100 people): fatigue, weakness, metallic taste, low blood glucose levels, loss of appetite, swelling of hands, ankles or feet (oedema), chills, pancreatitis, muscle pain.
Very rare (may affect up to 1 in 10,000 people): 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, deep breathing; skin redness, itching; reduced levels of vitamin B12 (pallor, fatigue, mental symptoms such as confusion or memory disturbances).

The following side effects have also been reported during the post-marketing use of this medicine.

Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis), which may cause skin rash or round, red, flat, raised spots under the skin or bruising.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the 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 Metformin Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following “Exp”. The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging (blister) 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 in use. This will help protect the environment.

6. Package contents and other information

What Vildagliptin and Metformin Aurobindo contains

The active substances 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 components are: copovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, polydextrose, titanium dioxide (E171), talc, yellow iron oxide (E172), maltodextrins, medium-chain triglycerides.

Description of the appearance of Vildagliptin and Metformin Aurobindo and contents of the pack
The film-coated tablets of Vildagliptin and Metformin Aurobindo 50 mg/850 mg are yellow, oval-shaped,
with "50" engraved on one side and "850" on the other, 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-shaped, with "50" engraved 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 blisters made of OPA/Alu/PVC-Alu or transparent PVC/PCTFE-Alu.
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
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No.5
69300 Rodopi
Greece
This medicinal product is authorised in the European Economic Area Member States under the following
names:
Denmark VEDFA
France Vildagliptin/Metformine Arrow 50mg/1000 mg, comprimé pelliculé
Spain Vildagliptina/Metformina Aurovitas 50 mg/850 mg comprimidos recubiertos con película
EFG & Vildagliptina/Metformina Aurovitas 50 mg/1.000 mg comprimidos recubiertos con
película EFG
Italy Vildagliptin and Metformin Aurobindo
Portugal Metformina + Vildagliptina Generis
Greece VEDFA
Cyprus VEDFA