Gliptivil

Package Leaflet: Information for the User

Gliptivil, 50 mg, Tablets

Vildagliptin

Read the package leaflet carefully before taking the medicine, 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 only. 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Gliptivil and what is it used for

The active substance of Gliptivil is vildagliptin, which belongs to a group of medicines called "oral antidiabetic medicines".
Vildagliptin 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 to control blood sugar levels. Your doctor may prescribe a medicine containing vildagliptin to be taken alone or in combination with other antidiabetic medicines that you may already be taking, if they are not sufficient to control your blood sugar levels.
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 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 stimulates the production of sugar in the liver and increases blood sugar levels. Both of these substances are produced in the pancreas.

How Gliptivil works

Vildagliptin works by stimulating the pancreas to produce more insulin and reducing the production of glucagon. This helps to control blood sugar levels. It has been shown that this medicine lowers blood sugar levels, which can help to prevent complications of diabetes. Even if you are starting to take diabetes medicines for the first time, it is important to continue to follow the diet and/or exercise recommended by your doctor.

2. Important information before taking Gliptivil

When not to take Gliptivil:

• 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 Gliptivil, do not take this medicine. Tell your doctor.

Warnings and precautions

Before taking Gliptivil, talk to 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 when taking it together with vildagliptin to avoid low blood sugar levels [hypoglycaemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of vildagliptin).
• 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, do 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 Gliptivil, pay particular attention to any new blisters or ulcers. If they appear, contact your doctor immediately.
Before starting treatment with Gliptivil and at 3-month intervals during the first year of treatment, and periodically thereafter, you will need to have liver function tests. This will help to find out as soon as possible if you are at risk of liver damage.

Children and adolescents

Gliptivil is not recommended for children and adolescents under 18 years of age.

Gliptivil with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, and about any medicines you plan to take.
Your doctor may need to adjust the dose of Gliptivil 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 disease
• 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.
Do not take Gliptivil if you are pregnant. It is not known if vildagliptin passes into breast milk. Do not take Gliptivil if you are breastfeeding or plan to breastfeed.

Driving and using machines

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

Gliptivil contains lactose

Gliptivil contains lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Gliptivil contains sodium

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

3. How to take Gliptivil

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 Gliptivil depends on your condition. Your doctor will decide exactly how many tablets of Gliptivil to take. The maximum daily dose is 100 mg.
The usual dose of Gliptivil is:

• 50 mg once daily in the morning, when taken with a sulphonylurea.
• 100 mg daily, taken as 50 mg in the morning and 50 mg in the evening, when taken alone or with metformin, a thiazolidinedione, in combination with metformin and a sulphonylurea, or with insulin.
• 50 mg once daily in the morning, if you have moderate or severe kidney disease or if you are on dialysis.

How to take Gliptivil

• Swallow the tablets whole with water.

How long to take Gliptivil

• Take Gliptivil every day, for as long as your doctor recommends. You may need to 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 Gliptivil than you should

If you take too many tablets, contact your doctor immediately. You may need medical attention. If you need to go to a doctor or hospital, take the pack of Gliptivil with you.

What to do if you forget to take Gliptivil

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

What to do if you stop taking Gliptivil

Do not stop taking Gliptivil unless your doctor tells you to. If you have any questions about how long to take this medicine, ask your doctor.

4. Possible side effects

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

Some side effects may require urgent medical attention:

If you experience any of the following side effects, stop taking Gliptivil 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, which may indicate angioedema.
• Liver disease (hepatitis) (frequency not known): Symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may indicate liver disease (hepatitis).
• Pancreatitis (rare: may affect up to 1 in 1,000 people): Symptoms include severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients who took Gliptivil 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): itching, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles, or feet (oedema), excessive sweating, vomiting, stomach 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 experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system (see below). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gliptivil

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. The expiry date refers to the last day of that month.
There are no special storage requirements for this medicine.
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 Gliptivil contains

The active substance is vildagliptin.
Each tablet contains 50 mg of vildagliptin.
The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose, lactose, magnesium stearate.

What Gliptivil looks like and contents of the pack

White to light yellowish, round, flat tablets with beveled edges, with "50" engraved on one side, with a diameter of 8.1 ± 0.1 mm and a thickness of 3.2 ± 0.3 mm.
Pack sizes: 14, 28, 30, 56, and 60 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

Manufacturer:

PHARMATHEN INTERNATIONAL S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No 5
69300 Rodopi
Greece
PHARMATHEN S.A.
Dervenakion 6
15351 Pallini Attiki
Greece
Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park
Paola, PLA 3000
Malta

This medicine is authorised in the Member States of the European Economic Area under the following names:

Portugal:
Vildagliptina Generis
Poland:
Gliptivil

Date of last revision of the leaflet: 03/2023