Package leaflet: Information for the patient

Glypvilo, 50 mg, tablets
Vildagliptinum
Please read this leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

What Glypvilo is and what it is used for
What you need to know before taking Glypvilo
How to take Glypvilo
Possible side effects
How to store Glypvilo
Contents of the pack and other information

1. What Glypvilo is and what it is used for

The active substance in Glypvilo is vildagliptin, which belongs to a group of medicines called "oral antidiabetic drugs".
Glypvilo is a medicine used to treat adult patients with type 2 diabetes mellitus whose condition cannot be controlled by diet and exercise alone. Glypvilo helps control blood glucose levels. Your doctor may prescribe Glypvilo to be used as the only antidiabetic medicine or in combination with other antidiabetic medicines you may be taking, if they have not been sufficiently effective in controlling blood glucose levels.
Type 2 diabetes is a condition in which the body either does not produce enough insulin, or the insulin produced does not work properly. Diabetes may also develop when the body produces too much glucagon.
Insulin is a substance that helps lower blood glucose levels, especially after meals.
Glucagon is a substance that stimulates glucose production in the liver and increases blood glucose levels.
Both of these substances are produced in the pancreas.

How Glypvilo works
Glypvilo works by stimulating the pancreas to produce insulin and reducing the production of glucagon. Therefore, Glypvilo helps control blood glucose levels. It has been shown that the medicine reduces blood glucose levels, which may help prevent complications associated with diabetes. Even after starting pharmacological treatment for diabetes, it remains important for the patient to continue following an appropriate diet and (or) performing recommended physical exercise.

2. Important information before using Glypvilo

When not to use Glypvilo

if the patient is allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to vildagliptin or any of the other ingredients of Glypvilo, they should not take this medicine and should inform their doctor.

Warnings and precautions
Before starting Glypvilo, discuss this with your doctor, pharmacist, or nurse

if the patient has type 1 diabetes (i.e. the patient's body does not produce insulin) or if the patient has a condition called diabetic ketoacidosis,
if the patient is taking an antidiabetic medicine called a sulphonylurea [the doctor may wish to reduce the dose of the sulphonylurea taken together with Glypvilo to avoid low blood glucose levels (hypoglycaemia)],
if the patient has moderate or severe kidney disease (a lower dose of Glypvilo should be used),
if the patient is on dialysis,
if the patient has liver disease,
if the patient has heart failure,
if the patient has or has had pancreatic disorders.

If the patient previously took vildagliptin but had to stop due to liver disease, they should not take this medicine.
Skin complications are common in diabetes. The patient should follow the advice of their doctor or nurse regarding skin and foot care. While taking Glypvilo, the patient should pay particular attention to the development of new blisters or ulcers. If these occur, the patient should contact their doctor immediately.
Before starting treatment with Glypvilo and every three months during the first year of treatment, and periodically thereafter, liver function tests should be performed. This allows signs of increased liver enzyme activity to be detected as early as possible.

Children and adolescents
Glypvilo is not recommended for use in children and adolescents under 18 years of age.

Glypvilo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The doctor may adjust the dose of Glypvilo if the patient is taking other medicines such as:

thiazides or other diuretics (also known as water tablets),
corticosteroids (usually used to treat inflammatory conditions),
medicines used to treat thyroid disorders,
certain medicines affecting the nervous system.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Glypvilo must not be used during pregnancy. It is not known whether Glypvilo passes into human milk. Glypvilo should not be used if breastfeeding or planning to breastfeed.

Driving and operating machinery
If the patient experiences dizziness while taking Glypvilo, they should not drive or operate machinery.

Glypvilo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Glypvilo

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

What dose to take and when
The dose of Glypvilo varies depending on the patient's condition. Your doctor will determine exactly how many Glypvilo tablets you should take. The maximum daily dose is 100 mg.

The usual doses of Glypvilo are as follows:

A dose of 50 mg once daily in the morning, when Glypvilo is used in combination with a medicine called a sulfonylurea.
A dose of 100 mg daily, taken as 50 mg in the morning and 50 mg in the evening, when Glypvilo is used as monotherapy, with metformin, with a glitazone, in combination with metformin and a sulfonylurea, or with insulin.
A dose of 50 mg once daily in the morning, if the patient has moderate or severe kidney disease or is undergoing dialysis.

How to take Glypvilo
The tablets should be swallowed whole with water.

How long to take Glypvilo
Glypvilo should be taken every day for as long as your doctor has instructed. Your doctor may decide on long-term treatment.
Your doctor will regularly monitor your health to assess whether the treatment is achieving the desired effect.

Taking more Glypvilo than prescribed
If you take more Glypvilo tablets than prescribed, or if someone else takes this medicine, contact your doctor immediately. Medical attention may be required. If you need to visit a doctor's office or hospital, bring the medicine packaging with you.

If you miss a dose of Glypvilo
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. However, 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.

Stopping Glypvilo treatment
Do not stop taking Glypvilo unless instructed by your doctor. If you have any questions about how long to take this medicine, consult your doctor.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions require immediate medical attention:
If any of the following adverse reactions occur, stop taking Glypvilo immediately and consult a doctor:
Angioedema (rare: may occur in up to 1 in 1,000 patients): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives. These may indicate a reaction called "angioedema".
Liver disease (hepatitis) (frequency unknown): Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-coloured urine. These may indicate liver disease (hepatitis).
Pancreatitis (rare: may occur in up to 1 in 1,000 patients): Symptoms include severe and persistent abdominal pain (in the stomach area), which may radiate to the back, as well as nausea and vomiting.
Other adverse reactions
The following adverse reactions have been reported in some patients taking Glypvilo:
Very common (may affect more than 1 in 10 people): sore throat, cold, fever.
Common (may affect up to 1 in 10 people): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles or feet (oedema), excessive sweating, vomiting, stomach and abdominal pain (abdominal pain), diarrhoea, heartburn, nausea, blurred vision.
Uncommon (may affect up to 1 in 100 people): weight gain, chills, fatigue, sexual dysfunction, low blood glucose levels, bloating.
Rare (may affect up to 1 in 1,000 people): pancreatitis.
After this medicine was placed on the market, the following adverse reactions have also been reported:
Frequency not known (frequency cannot be estimated from available data): localised skin peeling or blistering, vasculitis, which may cause skin rash or small, flat, red, round spots under the skin surface or bruising.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Glypvilo

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 carton, marked as "EXP"/"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special temperature storage requirements for this medicine.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Glypvilo contains

The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
The other ingredients are: mannitol (E 421), hydroxypropylcellulose type EF, low-substituted hydroxypropylcellulose, microcrystalline cellulose (type 112), sodium carboxymethylstarch type A, colloidal anhydrous silica, sodium stearyl fumarate. See section 2 "Glypvilo contains sodium".

What Glypvilo looks like and contents of the pack
White to almost white, round tablets with bevelled edges, 8 mm in diameter and 3.2–5.0 mm thick.
Packaging:
OPA/Aluminium/PVC/Aluminium blisters in a cardboard box.
Pack sizes:
28, 30, 56, 60, 90, 112 or 180 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500