GLYPVILO 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Glypvilo, 50 mg, Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
3. What is Glypvilo and what is it used for
   1. How Glypvilo works
4. Important information before taking Glypvilo
   1. When not to take Glypvilo
   2. Warnings and precautions
   3. Before taking Glypvilo, discuss it with your doctor, pharmacist, or nurse
   4. Children and adolescents
   5. Glypvilo and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Glypvilo contains sodium
5. How to take Glypvilo
   1. What dose to take and when
   2. How to take Glypvilo
   3. How long to take Glypvilo
   4. What to do if you take more Glypvilo than you should
   5. What to do if you forget to take Glypvilo
   6. What to do if you stop taking Glypvilo
6. Possible side effects
   1. Some side effects may require immediate medical attention:
   2. Other side effects
   3. Reporting side effects
7. How to store Glypvilo
8. Contents of the pack and other information
   1. What Glypvilo contains
   2. What Glypvilo looks like and contents of the pack
   3. Marketing Authorisation Holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Glypvilo, 50 mg, Tablets

Vildagliptin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Glypvilo and what is it used for
• 2. Important information before taking Glypvilo
• 3. How to take Glypvilo
• 4. Possible side effects
• 5. How to store Glypvilo
• 6. Contents of the pack and other information

1. What is Glypvilo and what is it used for

The active substance of Glypvilo is vildagliptin, which belongs to a group of medicines called "oral antidiabetic agents".
Glypvilo is a medicine used to treat adult patients with type 2 diabetes, who cannot control their condition with diet and exercise alone. Glypvilo helps control blood sugar levels. Your doctor may prescribe Glypvilo as the only antidiabetic medicine or in combination with other antidiabetic medicines that you are already taking, if they are not sufficient to control your blood sugar levels.
Type 2 diabetes is a condition where the body does not produce enough insulin or the insulin produced by the body does not work properly. Diabetes 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 stimulates the production of sugar in the liver and increases blood sugar 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 sugar levels. It has been shown that the medicine lowers blood sugar levels, which can help prevent complications of diabetes. Despite starting pharmacological treatment for diabetes, it is essential for the patient to continue following a suitable diet and (or) performing recommended physical exercises.

2. Important information before taking Glypvilo

When not to take Glypvilo

• if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or any of the other ingredients of Glypvilo, do not take this medicine, but tell your doctor.

Warnings and precautions

Before taking Glypvilo, discuss it with your doctor, pharmacist, or nurse

• if you have type 1 diabetes (i.e., your body does not produce insulin) or if you have a condition called diabetic ketoacidosis,
• if you are taking a sulphonylurea, a type of antidiabetic medicine (your doctor may want to reduce the dose of the sulphonylurea taken with Glypvilo to avoid low blood sugar levels (hypoglycaemia)),
• if you have moderate or severe kidney disease (you will need to take a lower dose of Glypvilo),
• if you are on dialysis,
• if you have liver disease,
• if you have heart failure,
• if you have or have had pancreatitis.

If you have taken vildagliptin before but had to stop due to liver disease, you should not take this medicine.
Skin conditions are a common complication of diabetes. You should follow your doctor's or nurse's advice on skin and foot care. While taking Glypvilo, you should pay particular attention to the appearance of new blisters or ulcers. If they appear, you should contact your doctor immediately.
Before starting treatment with Glypvilo and at 3-month intervals during the first year of treatment, and periodically thereafter, you should perform liver function tests. This will help detect any signs of increased liver enzyme activity as soon as possible.

Children and adolescents

Glypvilo should not be used in children and adolescents under 18 years of age.

Glypvilo and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Your doctor may need to adjust the dose of Glypvilo if you are taking other medicines, such as:

• thiazides or other diuretics (also known as water pills),
• corticosteroids (usually used to treat inflammation),
• medicines used to treat thyroid disorders,
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Glypvilo should not be used during pregnancy. It is not known if Glypvilo passes into human breast milk. You should not take Glypvilo if you are breastfeeding or planning to breastfeed.

Driving and using machines

If you experience dizziness while taking Glypvilo, do not drive or operate machinery.

Glypvilo contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Glypvilo

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

What dose to take and when

The dose of Glypvilo is different for each patient. Your doctor will determine exactly how many Glypvilo tablets you should take. The maximum daily dose is 100 mg.
The usual dose of Glypvilo is:
50 mg once daily, taken in the morning, when Glypvilo is taken with a sulphonylurea.
100 mg once daily, taken as two doses of 50 mg in the morning and 50 mg in the evening, when Glypvilo is taken alone or with metformin or a glitazone, or in combination with metformin and a sulphonylurea or insulin.
50 mg once daily, taken in the morning, if you have moderate or severe kidney disease or if you are on dialysis.

How to take Glypvilo

Swallow the tablets whole with water.

How long to take Glypvilo

You should take Glypvilo every day, for as long as your doctor recommends. Your doctor may decide that you should take it for a long time.
Your doctor will regularly check your condition to ensure that the treatment is working.

What to do if you take more Glypvilo than you should

If you take too many Glypvilo tablets or if someone else takes your medicine, you must go to see a doctor immediately.
You may need medical attention. If you have to go to a doctor or hospital, take the medicine pack with you.

What to do if you forget to take Glypvilo

If you forget to take a dose, take it as soon as you remember. Then take the next dose at the usual time. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.

What to do if you stop taking Glypvilo

Do not stop taking Glypvilo unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Some side effects may require immediate medical attention:

If you experience any of the following side effects, stop taking Glypvilo and contact your doctor immediately:
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 rash or hives. These may be signs of angioedema.
Hepatitis (frequency not known). Symptoms include yellowing of the skin and the whites of the eyes, nausea, loss of appetite, or dark urine. These may be signs of hepatitis.
Pancreatitis (rare: may affect up to 1 in 1,000 people): Symptoms include severe and persistent stomach pain (abdominal pain) that may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients taking Glypvilo have experienced the following side effects:
Very common (may affect more than 1 in 10 people): sore throat, runny nose, 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 pain and discomfort (abdominal pain), diarrhoea, heartburn, nausea, blurred vision.
Uncommon (may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood sugar levels, bloating.
Rare (may affect up to 1 in 1,000 people): pancreatitis.
After this medicine was made available, the following side effects have also been reported:
Frequency not known (cannot be estimated from the available data): local skin peeling or blistering, vasculitis, which can cause skin rash or flat, red, round patches under the skin or bruising.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

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 which is stated on the blister and carton after "EXP" / "Expiry Date". The expiry date refers to the last day of that month.
There are no special storage precautions for this medicine.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, hypromellose, microcrystalline cellulose, sodium carboxymethylcellulose, 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, flat face, bevelled edge tablets, 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 medicine, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500

Date of last revision of the leaflet: