VILDAGLIPTIN 50 mg Таблетка

Содержание инструкции

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

Vildagliptin Krka 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 or pharmacist.
• 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 or pharmacist (see section 4).

Contents of this leaflet

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

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

The active substance of Vildagliptin Krka, vildagliptin, belongs to the group of medicines called
"oral antidiabetics".
Vildagliptin Krka is used to treat adult patients with type 2 diabetes. It is used when the
diabetes cannot be controlled only by diet and exercise. It helps to control the level
of sugar in the blood. Your doctor will prescribe Vildagliptin Krka alone or together with other antidiabetic medicines
that you are already taking, if these have not proven sufficiently effective for
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 to 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 Krka works
Vildagliptin Krka works by inducing the pancreas to produce more insulin and less glucagon. This helps to
control the level of sugar in the blood. It has been shown that this medicine reduces blood
sugar, which 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 you take Vildagliptin Krka

Do not take Vildagliptin Krka:
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 Krka, do not take this medicine and consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Vildagliptin Krka
if you have type 1 diabetes (i.e. your body does not produce insulin) or if you suffer from a
condition called diabetic keto-acidosis.
if you are taking a medicine for diabetes known as a sulfonylurea (your doctor may
want to reduce your dose of sulfonylurea while you are taking Vildagliptin
Krka at the same time to avoid low blood sugar [hypoglycemia]).
if you have moderate or severe kidney disease (you will need to take a lower dose of
Vildagliptin Krka).
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 that are provided to you by your doctor or nurse.
It is also advisable to pay particular attention to the appearance of blisters or ulcers while you
are taking Vildagliptin Krka.
If this occurs, you should consult your doctor immediately.
Before starting treatment with Vildagliptin Krka, a test will be carried out to assess the
function of your 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 Krka is not recommended in children and adolescents under 18 years of age.

Other medicines and Vildagliptin Krka
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 Krka 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 may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You should not use Vildagliptin Krka during pregnancy. It is not known whether Vildagliptin Krka passes into
breast milk. You should not use Vildagliptin Krka if you are breastfeeding or planning to breastfeed.

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

Vildagliptin Krka 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 Krka

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

When and when not to take it
The amount of Vildagliptin Krka that patients must take varies depending on the conditions. Your
doctor will tell you exactly how many Vildagliptin Krka tablets you must take. The maximum
daily dose is 100 mg.
The usual dose of Vildagliptin Krka is:
50 mg per day taken as a single dose in the morning if you are taking Vildagliptin Krka with a
other medicine called sulfonylurea.
100 mg per day taken as 50 mg in the morning and 50 mg in the evening if you are taking Vildagliptin
Krka alone, with another medicine called metformin or a glitazone, with a combination
of metformin and a sulfonylurea, or with insulin.
50 mg per day in the morning if you have a moderate or severe degree of kidney disease or if you are on dialysis.

How to take Vildagliptin Krka

• Swallow the tablets whole with a little water.

For how long to take Vildagliptin Krka
Take Vildagliptin Krka 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.
Your doctor will regularly check your condition to verify that the treatment has
the desired effect.

If you take more Vildagliptin Krka than you should
If you take too many Vildagliptin Krka 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 the hospital, take the packaging with you.

If you forget to take Vildagliptin Krka
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 your next dose, skip the dose you have
forgotten. Do not take a double dose to make up for the missed tablet.

If you stop taking Vildagliptin Krka
Do not stop taking Vildagliptin Krka unless your doctor tells you to do so. If you have doubts about
the duration of treatment with this medicine, consult your doctor.
If you have any further questions on the use of 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 should stop taking Vildagliptin Krka 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 urticaria, which
may indicate a reaction called “angioedema”.
Liver disease (hepatitis) (rare): symptoms include yellowing of the skin and eyes, nausea, loss of
appetite or dark-colored urine, which may indicate liver disease (hepatitis).
Pancreatitis (inflammation of the pancreas) (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 Krka 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 Krka and a
sulfonylurea:

• Common: tremor, headache, 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 Krka and
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 Krka alone:

• 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 Krka,
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 Krka and
insulin (with or without metformin):

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

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

• Frequency not known (cannot be estimated from available data): itchy rash, inflammation of the pancreas, localized skin peeling or blisters, muscle pain.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vildagliptin Krka

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 packaging after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original packaging to protect the medicine from moisture.
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

What Vildagliptin Krka contains
The active ingredient is vildagliptin.
Each tablet contains 50 mg of vildagliptin.
The other ingredients (excipients) are: mannitol (E421), hydroxypropylcellulose, type EF, 300 –
600 mPas, hydroxypropylcellulose, low-substituted, microcrystalline cellulose, type 112, sodium
starch glycolate, type A, anhydrous colloidal silica, sodium stearyl fumarate. See section 2
“Vildagliptin Krka contains sodium”.

Description of the appearance of Vildagliptin Krka and contents of the pack
Round tablets, from white to almost white with bevelled edges, 8 mm in diameter, width 3.2

• 5.0 mm.

Vildagliptin Krka is available in packs containing:
14, 28, 30, 56, 60, 90, 100, 112 and 180 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturers responsible for batch release
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann- Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area under
the following denominations: