VILDAGLIPTIN 50 mg Film-Coated Tablets

Зміст інструкції

1. VILDAGLIPTIN EG 50 mg tablets
   1. What Vildagliptin EG 50 mg tablets are and what they are used for
   2. What you need to know before taking Vildagliptin EG 50 mg tablets
   3. How to take Vildagliptin EG 50 mg tablets
   4. Possible side effects
   5. How to store Vildagliptin EG 50 mg tablets
   6. Contents of the pack and other information

VILDAGLIPTIN EG 50 mg 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 their symptoms are the same as yours, as it could 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 EG is and what it is used for
• 2. What you need to know before you take 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 of Vildagliptin EG 50 mg tablets, vildagliptin, belongs to a group of
medicines called “oral antidiabetics”.
Vildagliptin EG 50 mg tablets is used to treat adult patients with type 2 diabetes. It is
used when diabetes cannot be controlled only by diet and exercise. It helps to
control blood sugar levels. Your doctor will prescribe Vildagliptin EG alone or together
with other antidiabetic medicines that you are already taking, if these have not proven
sufficiently effective in controlling diabetes.
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.
Insulin is a substance that helps lower blood sugar levels, especially after
meals. Glucagon is a substance that triggers the production of sugar by the liver,
causing an increase in blood sugar levels. The pancreas produces both of these
substances.

How Vildagliptin EG works
Vildagliptin EG works by inducing the pancreas to produce more insulin and less glucagon. This helps to
control blood sugar levels. This medicine has been shown to reduce blood
sugar. This can help prevent complications resulting from your diabetes. Even if you now
start taking a medicine for diabetes, it is important that you continue to follow the diet and/or
exercise 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 (i.e. your body does not produce insulin) or if you suffer from a condition called diabetic ketoacidosis;
• if you are taking a medicine for diabetes known as a sulfonylurea (if you take it together with this medicine, your doctor may want to reduce your dose of sulfonylurea, to avoid low blood glucose [hypoglycemia]);
• if you have moderate or severe kidney disease (you will need to take a lower dose of Vildagliptin EG);
• 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 have previously taken vildagliptin but had to stop it due to liver disease, you should 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 to you by your doctor or
nurse. It is also advisable to pay particular attention to the appearance of blisters or
ulcers while taking this medicine. If this occurs, you should quickly consult your
doctor.
Before starting treatment with Vildagliptin EG, a test will be performed to assess the
functioning of the liver, which will be repeated every three months during the first year of treatment and
then periodically. This is to detect as early as possible signs of increased liver enzymes.

Children and adolescents
The use of Vildagliptin EG in children and adolescents up to 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 want to adjust the dose of Vildagliptin EG if you are taking other medicines such as
for example:

• thiazides or other diuretics (also called water tablets);
• corticosteroids (generally used for the treatment of inflammation);
• medicines for the thyroid;
• certain medicines that act on the nervous system.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be used during pregnancy.
It is not known whether Vildagliptin EG passes into breast milk. You should not use Vildagliptin EG if you
are breastfeeding or planning to breastfeed.

Driving and using machines
If you feel dizzy when taking Vildagliptin EG, do not drive or use machines.

Vildagliptin EG 50 mg tablets contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact him/her before taking
this medicine.

Vildagliptin EG 50 mg tablets contains 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

Dose
The amount of Vildagliptin EG that you need to take varies depending on individual conditions. Your
doctor will tell you exactly how many Vildagliptin EG tablets you need to take. The maximum
daily dose is 100 mg.
The usual dose of Vildagliptin EG is:

• 50 mg per day taken as a single dose in the morning if you take Vildagliptin EG with another medicine called a sulfonylurea.
• 100 mg per day taken as 50 mg in the morning and 50 mg in the evening if you take 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 per day in the morning if you have a moderate or severe kidney disease or if you are on dialysis.

How to take Vildagliptin EG
Swallow the tablets whole with water.

For how long to take Vildagliptin EG
Take Vildagliptin EG every day until your doctor advises you to do so. It is possible that you may
need to continue this treatment for a long period of time.
The doctor will regularly check your condition to verify that 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 care may be necessary. If you need to see a
doctor or go to hospital, take the packaging 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
the next dose at the usual time. If it is almost time for the next dose, skip the dose you have
forgotten. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Vildagliptin EG
Do not stop taking the medicine unless your doctor has decided to do so.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some symptoms require immediate medical attention:
You must stop taking Vildagliptin EG and contact your doctor immediately if you experience any
of the following side effects:

• 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 onset of skin rashes 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): 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 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 have experienced the following side effects while taking vildagliptin and a
sulfonylurea:

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 have experienced the following side effects while taking vildagliptin and a
glitazone:

Common

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

Uncommon

• headache, weakness, low blood glucose levels.

Some patients have experienced the following side effects while taking vildagliptin in
monotherapy:

Common

• dizziness.

Uncommon

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

Very rare

• sore throat, runny nose, fever.

Some patients have experienced the following side effects while taking vildagliptin, metformin
and a sulfonylurea:

Common

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

Some patients have experienced the following side effects while taking vildagliptin and insulin
(with or without metformin):

Common

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

Uncommon

• diarrhoea, flatulence.

During the post-marketing of medicines containing only vildagliptin, the following effects have also been reported:

Frequency not known (frequency cannot be estimated from available data)

• itchy skin rash, inflammation of the pancreas, localised skin scaling or blisters, muscle pain;
• liver disease (hepatitis) - usually disappears when treatment is stopped. Symptoms include yellowing of the skin and eyes, nausea, loss of appetite or dark urine;
• abnormal liver function tests - usually reversible when treatment is stopped.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. 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 EG 50 mg tablets

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 or the packaging after the
words “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 particular storage temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

Vildagliptin EG 50 mg tablets contains

• The active ingredient is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), sodium carboxymethyl starch and magnesium stearate (E470b).

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

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

Manufacturer
Stada Arzneimittel AG
Stadastrase 2-18
Bad Vilbel 61118 Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
CZ Vildagliptin Stada
DE Vildagliptin AL 50 mg Tablets
DK Vildagliptin STADA
ES Vildagliptina STADA 50 mg tablets EFG
FI Vildagliptin STADA 50 mg tablets
FR Vildagliptine EG 50 mg, tablet
GR βιλνταγλιπτίνη STADA 50 mg δισκία (Vildagliptin STADA 50 mg tablets)
IS Vildagliptin STADA 50 mg tablets
IT Vildagliptin EG
PT Vildagliptina Ciclum
SE Vildagliptin STADA 50 mg tablets
SK Vildagliptin STADA 50mg