VILDAGLIPTIN KRKA

PACKAGE LEAFLET

Package leaflet: Information for the patient

Vildagliptin Krka 50 mg tablets

Generic medicine
Please read this leaflet carefully before 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 or pharmacist.
• 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 effect, including those not listed in this leaflet, talk to 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 taking 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 Vildagliptin Krka is and what it is used for

The active substance in Vildagliptin Krka, vildagliptin, belongs to a group of medicines called
"oral antidiabetics".
Vildagliptin Krka 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 Krka either alone or in combination 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, causing blood sugar levels to rise. Both of these substances are produced by the pancreas.
How Vildagliptin Krka works
Vildagliptin Krka 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, which 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 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
Consult your doctor, pharmacist, or nurse before taking Vildagliptin Krka
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 (your doctor may wish to reduce your dose of sulfonylurea while you are taking Vildagliptin Krka concomitantly to avoid low blood glucose [hypoglycaemia]).
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 pancreatic disease.

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 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 Krka.
If this occurs, you must consult your doctor immediately.

Before starting treatment with Vildagliptin Krka, 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 Krka is not recommended in children and adolescents under 18 years of age.

Other medicines and Vildagliptin Krka
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 Krka 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
some medicines acting on the nervous system.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not use Vildagliptin Krka during pregnancy. It is not known whether Vildagliptin Krka passes into breast milk. You must not use Vildagliptin Krka if you are breastfeeding or planning to breastfeed.

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

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 exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

When to take it and how much
The amount of Vildagliptin Krka that patients should take varies depending on individual circumstances. Your doctor will tell you exactly how many Vildagliptin Krka tablets you should take. The maximum daily dose is 100 mg.

The usual dose of Vildagliptin Krka is:

• 50 mg once daily in the morning if you are taking Vildagliptin Krka together 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 Krka 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 Krka

• Swallow the tablets whole with some water.

How long to take Vildagliptin Krka
Take Vildagliptin Krka every day for as long as your doctor recommends. You may need to continue this treatment for a long period of time.
Your doctor will regularly monitor your condition to ensure the treatment is working as intended.

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 treatment may be necessary. If you need to see a doctor or go to the hospital, bring the pack 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 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 a forgotten tablet.

If you stop taking Vildagliptin Krka
Do not stop taking Vildagliptin Krka unless your doctor tells you to. If you have any doubts about how long you should continue treatment with this medicine, speak to your doctor.

If you have any further questions about 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 gets them.
Some symptoms require immediate medical treatment:
You must stop taking Vildagliptin Krka 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, which may indicate a reaction called “angioedema”.
Liver disease (hepatitis) (rare): 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) (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 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 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 experienced the following side effects while taking Vildagliptin Krka 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 Krka alone:

• 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 Krka,
metformin and a sulfonylurea:

• Common: dizziness, tremor, weakness, low blood glucose levels, excessive sweating

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

• Common: headache, chills, nausea (feeling of discomfort), low blood glucose levels, heartburn
• Uncommon: diarrhoea, flatulence

During post-marketing use of this medicine, the following side effects have also been reported:

• Frequency not known (cannot be estimated from the available data): itchy skin 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 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 special temperature conditions for storage. Store in the original packaging 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Vildagliptin Krka contains
The active substance 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
glycolate starch, type A, colloidal anhydrous silica, sodium stearyl fumarate. See section 2
"Vildagliptin Krka contains sodium".
Description of the appearance of Vildagliptin Krka and contents of the pack
Round, white to almost white tablets with bevelled edges, 8 mm in diameter, thickness 3.2 – 5.0 mm.

Vildagliptin Krka is available in boxes 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
Responsible manufacturers 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 European Economic Area countries under the
following names: