Vildagliptin Aurobindo

Package leaflet: Information for the user

Vildagliptin Aurobindo 50 mg tablets

Equivalent medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

The active substance in Vildagliptin Aurobindo, vildagliptin, belongs to a group of medicines
called "oral antidiabetics".
Vildagliptin Aurobindo is used to treat adult patients with type 2 diabetes. It is used when diabetes
cannot be controlled by diet and exercise alone. It helps control blood sugar levels. Your doctor will
prescribe Vildagliptin Aurobindo either alone or in combination with other antidiabetic medicines you
are already taking, if these have not been sufficiently effective in controlling your diabetes.
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. Insulin is a substance that helps lower blood sugar levels, especially after meals. Glucagon
is a substance that triggers the liver to produce sugar, thereby increasing blood sugar levels. Both of
these substances are produced by the pancreas.
How Vildagliptin Aurobindo works
Vildagliptin Aurobindo works by stimulating the pancreas to produce more insulin and less glucagon.
This helps control blood sugar levels. This medicine has been shown to reduce blood sugar levels. This
may help prevent complications arising from your diabetes. Even though you are now starting to take
a medicine for diabetes, it remains important that you continue to follow the diet and/or exercise
regimen recommended to you.

2. What you need to know before taking Vildagliptin Aurobindo

Do not take Vildagliptin Aurobindo:

• if you are allergic to vildagliptin or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or to any of the excipients of Vildagliptin Aurobindo, do not take this medicine and consult your doctor.

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

• if you have type 1 diabetes (i.e. your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
• if you are taking an antidiabetic medicine known as a sulfonylurea (if taken together with Vildagliptin Aurobindo, your doctor may wish to reduce your dose of sulfonylurea to avoid low blood sugar [hypoglycaemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of Vildagliptin Aurobindo).
• if you are on dialysis
• if you have a liver disease
• if you suffer from heart failure
• if you have or have had a pancreatic disease

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. It is advisable to follow the skin and foot care recommendations provided by your doctor or nurse. You should also pay particular attention to the development of blisters or ulcers while taking Vildagliptin Aurobindo. If this occurs, you should consult your doctor promptly.
Before starting treatment with Vildagliptin 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.
Children and adolescents
The use of vildagliptin is not recommended in children and adolescents under 18 years of age.
Other medicines and Vildagliptin Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust the dose of Vildagliptin Aurobindo if you are taking other medicines such as:

• thiazides or other diuretics (also known as water tablets)
• corticosteroids (generally used to treat inflammation)
• thyroid medicines
• certain medicines acting on the nervous system.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not use Vildagliptin Aurobindo during pregnancy.
It is not known whether Vildagliptin Aurobindo passes into breast milk. You must not use Vildagliptin Aurobindo if you are breastfeeding or plan to breastfeed.
Driving and using machines
If you feel dizzy when taking Vildagliptin Aurobindo, do not drive or operate machinery.
Vildagliptin Aurobindo contains lactose
Vildagliptin Aurobindo contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Vildagliptin Aurobindo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Vildagliptin Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
How much to take and when
The amount of Vildagliptin Aurobindo you should take depends on your individual condition. Your doctor will tell you exactly how many Vildagliptin Aurobindo tablets you should take.
The maximum daily dose is 100 mg.
The usual dose of Vildagliptin Aurobindo is:

• 50 mg once daily in the morning if you are taking Vildagliptin Aurobindo with another medicine called a sulfonylurea.
• 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Vildagliptin Aurobindo alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.
• 50 mg once daily in the morning if you have moderate or severe kidney disease or are on dialysis.

How to take Vildagliptin Aurobindo

• Take the tablets with some water.

How long to take Vildagliptin Aurobindo

• Take Vildagliptin Aurobindo every day for as long as your doctor has instructed. You may need to continue this treatment for a long period of time.
• Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

If you take more Vildagliptin Aurobindo than you should
If you take too many Vildagliptin Aurobindo tablets, or if someone else has taken your medicine, contact your doctor immediately. Medical treatment may be required. If you need to see a doctor or go to hospital, take the pack with you.
If you forget to take Vildagliptin Aurobindo
If you forget to take a dose of this medicine, take it as soon as you remember. Then take your next dose at the usual time. If it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Vildagliptin Aurobindo
Do not stop taking Vildagliptin Aurobindo unless your doctor tells you to. If you have any doubts about how long you should take this medicine, speak to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some symptoms require immediate medical attention:
You must stop taking Vildagliptin Aurobindo and contact your doctor immediately if any of the following side effects occur:

Rare: may affect up to 1 in 1,000 people

• Angioedema: 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): Symptoms include yellowing of the skin or eyes, nausea, loss of appetite, or dark-coloured urine, which may indicate liver disease (hepatitis).

Not known: frequency cannot be estimated from the available data

• Inflammation of the pancreas (pancreatitis): Symptoms include severe and persistent stomach (abdominal) pain, which may spread to the back, as well as nausea and vomiting.

Other side effects
Some patients experienced the following side effects while taking vildagliptin alone:
Common: may affect up to 1 in 10 people

• Dizziness

Uncommon: may affect up to 1 in 100 people

• Headache, constipation, swelling of hands, ankles or feet (oedema), joint pain, low blood glucose levels.
  Very rare: may affect up to 1 in 10,000 people
• Sore throat, runny nose, fever.

Some patients experienced the following side effects while taking vildagliptin and
metformin:
Common: may affect up to 1 in 10 people

• Tremor, headache, dizziness, nausea, low blood glucose levels.

Uncommon: may affect up to 1 in 100 people

• Fatigue.

Some patients experienced the following side effects while taking vildagliptin and a
sulphonylurea:
Common: may affect up to 1 in 10 people

• Tremor, headache, dizziness, weakness, low blood glucose levels.

Uncommon: may affect up to 1 in 100 people

• Constipation.

Very rare: may affect up to 1 in 10,000 people

• Sore throat, runny nose.

Some patients experienced the following side effects while taking vildagliptin and a
glitazone:
Common: may affect up to 1 in 10 people

• Weight gain, swelling of hands, ankles or feet (oedema).

Uncommon: may affect up to 1 in 100 people

• Headache, weakness, low blood glucose levels.

Some patients experienced the following side effects while taking vildagliptin,
metformin and a sulphonylurea:
Common: may affect up to 1 in 10 people

• Dizziness, tremor, weakness, low blood glucose levels, excessive sweating.

Some patients experienced the following side effects while taking vildagliptin and
insulin (with or without metformin):
Common: may affect up to 1 in 10 people

• Headache, chills, nausea (feeling unwell), low blood glucose levels, stomach burning.
  Uncommon: may affect up to 1 in 100 people
• Diarrhoea, flatulence.

During the marketing of this medicine, the following side effects have also been reported:
Not known: frequency cannot be estimated from the 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 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 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 on the carton after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use a vildagliptin pack if it is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Vildagliptin Aurobindo contains

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other ingredients are lactose, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.

Description of the appearance of Vildagliptin Aurobindo and package contents
Vildagliptin Aurobindo 50 mg tablets are white to light yellow, round, flat,
with bevelled edges, marked "50" on one side, 8.1 ± 0.1 mm in diameter and 3.2 ± 0.3 mm thick.
Vildagliptin Aurobindo 50 mg tablets are packed in cardboard boxes containing
aluminum-OPA/ALU/PVC blisters with the appropriate number of tablets and a package leaflet.
Pack sizes:
Cartons containing 28 or 56 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 – Saronno (VA)
Italy

Manufacturer
Pharmathen S.A., Dervenakion 6, Pallini 15351, Attiki, Greece
Pharmathen International S.A., Industrial Park Sapes, Rodopi, Prefecture, Block No 5, Rodopi 69300,
Greece
Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola PLA3000, Malta

This medicinal product is authorized in the European Economic Area countries under the
following names:
Denmark: Vildagliptin Pharmathen
France: VILDAGLIPTINE PHARMATHEN 50 mg, comprimé
Spain: Vildagliptina Pharmathen 50mg comprimidos
Italy: Vildagliptin Aurobindo
Greece: Vildagliptin Pharmathen
Cyprus: Vildagliptin Pharmathen