VILDAGLIPTIN EG

Package leaflet: Information for the patient

VILDAGLIPTIN EG 50 mg tablets

Generic 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 pass it on to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Vildagliptin EG 50 mg tablets are and what they are used for

The active substance in Vildagliptin EG 50 mg tablets, vildagliptin, belongs to a group of
medicines called "oral antidiabetics".
Vildagliptin EG 50 mg tablets are 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 EG either alone or together with other antidiabetic medicines you are
already taking, if these have not been sufficiently effective in controlling 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, leading to increased blood sugar levels. The pancreas produces
both of these substances.
How Vildagliptin EG works
Vildagliptin EG works by causing 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 is important that you continue to follow the diet and/or exercise regimen that has been
recommended to you.

2. What you need to know before taking Vildagliptin EG 50 mg tablets

Do NOT take Vildagliptin EG

• if you are allergic to vildagliptin or to any of the other ingredients of this medicine (listed in section 6).

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

• if you have type 1 diabetes (that is, 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 you are taking it together with this medicine, your doctor may wish to reduce your dose of sulfonylurea to avoid low blood sugar [hypoglycemia]);
• if you have moderate or severe kidney disease (a lower dose of Vildagliptin EG will be required);
• if you are on dialysis;
• if you have liver disease;
• if you suffer from heart failure;
• if you have or have had a disease of the pancreas.

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 recommendations for skin and foot care provided by your doctor or nurse. You should also pay particular attention to the development of blisters or ulcers while taking this medicine. If this occurs, you should consult your doctor promptly.
Before starting treatment with Vildagliptin EG, 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 EG in children and adolescents under 18 years of age is not recommended.

Other medicines and Vildagliptin EG
Tell 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 EG if you are taking other medicines such as:

• thiazides or other diuretics (also known as water tablets);
• corticosteroids (generally used to treat inflammation);
• thyroid medications;
• 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.
This medicine must not be used during pregnancy.
It is not known whether Vildagliptin EG passes into breast milk. You must not use Vildagliptin EG if you are breastfeeding or plan to breastfeed.

Driving and using machines
If you experience dizziness while taking Vildagliptin EG, do not drive or operate machinery.

Vildagliptin EG 50 mg tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Vildagliptin EG 50 mg tablets contain sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Vildagliptin EG 50 mg tablets

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

• 50 mg once daily in the morning if you are taking Vildagliptin EG 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 EG alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin (with or without metformin).
• 50 mg once daily in the morning if you have moderate or severe kidney disease or are on dialysis.

How to take Vildagliptin EG
Swallow the tablets whole with water.
How long to take Vildagliptin EG
Take Vildagliptin EG every day for as long as your doctor recommends. You may need to continue this treatment for a long time.
Your doctor will regularly check your condition to ensure the treatment is having the desired effect.
If you take more Vildagliptin EG than you should
If you take too many Vildagliptin EG tablets, or if someone else has taken your medicine, contact your doctor immediately. Medical treatment may be necessary. If you need to see a doctor or go to hospital, take the pack with you.
If you forget to take Vildagliptin EG
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 EG
Do not stop taking this medicine unless your doctor tells you to.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• 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;
• liver disease (hepatitis) (rare): symptoms include yellowing of the skin or eyes, nausea, loss of appetite or dark-coloured urine;
• inflammation of the pancreas (pancreatitis) (frequency not known): symptoms include severe and persistent pain in the abdomen (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:
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

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

Uncommon

• 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

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

Uncommon

• headache, weakness, low blood glucose levels.

Some patients experienced the following side effects while taking vildagliptin as monotherapy:
Common

• dizziness.

Uncommon

• headache, constipation, swelling of hands, ankles or feet (oedema), joint pain, low blood glucose levels.

Very rare

• sore throat, runny nose, fever.

Some patients experienced the following side effects while taking vildagliptin, metformin and a sulphonylurea:
Common

• 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

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

Uncommon

• diarrhoea, flatulence.

During the marketing of vildagliptin-only medicinal products, the following additional side effects have also been reported:
Frequency not known (frequency cannot be estimated from the available data)

• itchy skin rash, inflammation of the pancreas, localized skin peeling or blisters, muscle pain;
• liver disease (hepatitis) – usually resolves when treatment is discontinued. Symptoms include yellowing of the skin or eyes, nausea, loss of appetite or dark-coloured urine;
• abnormal liver function tests – usually reversible when treatment is stopped.

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 may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Vildagliptin EG 50 mg tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after the word “EXP.” The expiry date refers to the last day of that month.
Store the medicine in the blister to protect it from moisture.
This medicine does not require any special storage temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

Vildagliptin EG 50 mg tablets contain

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other components are lactose monohydrate, microcrystalline cellulose (E460), sodium carboxymethylstarch, and magnesium stearate (E470b).

Description of the appearance of Vildagliptin EG and package contents
Vildagliptin EG 50 mg tablets are round, flat, white to slightly yellowish in colour, with bevelled edges and a diameter of 8.0 ± 0.2 mm.
Vildagliptin EG 50 mg tablets are supplied in standard or unit-dose divisible blisters in pack sizes of 14, 28, 30, 56, 60, 90, 105, 112, and 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturer
Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel, Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
CZ Vildagliptin Stada
DE Vildagliptin AL 50 mg Tabletten
DK Vildagliptin STADA
ES Vildagliptina STADA 50 mg comprimidos EFG
FI Vildagliptin STADA 50 mg tabletit
FR Vildagliptine EG 50 mg, comprimé
GR βιλνταγλιπτίνη STADA 50 mg δισκία (Vildagliptin STADA 50 mg tablets)
IS Vildagliptin STADA 50 mg töflur
IT Vildagliptin EG
PT Vildagliptina Ciclum
SE Vildagliptin STADA 50 mg tabletter
SK Vildagliptin STADA 50mg