Gliptivil

Package leaflet: Information for the user

Gliptivil 50 mg, tablets
Vildagliptinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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:

1. What Gliptivil is and what it is used for
2. What you need to know 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 Gliptivil is and what it is used for

The active substance in Gliptivil is vildagliptin, which belongs to a group of medicines called "oral antidiabetic agents".
Vildagliptin is used in the treatment of adult patients with type 2 diabetes. It is used when diabetes cannot be controlled by diet and physical exercise alone. It helps control blood glucose levels. Your doctor may prescribe a medicine containing vildagliptin either as the only antidiabetic treatment 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 develops when the body does not produce enough insulin or when the insulin produced by the body does not work as well as it should. It 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 Gliptivil works
Vildagliptin works by stimulating the pancreas to produce insulin and by reducing glucagon production. This helps control blood glucose levels. This medicine has been shown to reduce blood glucose levels, which may help prevent complications associated with diabetes. Even if you have just started taking antidiabetic medicines, it is important to continue following the recommended diet and (or) physical exercise regimen.

2. Important information before using Gliptivil

When not to use Gliptivil:

• 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 Gliptivil, they should not take this medicine and should inform their doctor.

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

• if the patient has type 1 diabetes (i.e. their body does not produce insulin) or if they have a condition called diabetic ketoacidosis.
• if the patient is taking an antidiabetic medicine called a sulfonylurea (the doctor may wish to reduce the dose of the sulfonylurea taken together with vildagliptin to avoid low blood glucose levels [hypoglycaemia]).
• if the patient has moderate or severe kidney disease (a lower dose of vildagliptin 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 had or currently has pancreas 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 Gliptivil, 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 Gliptivil 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
Gliptivil is not recommended for use in children and adolescents under 18 years of age.
Gliptivil and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
The doctor may adjust the dose of Gliptivil 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, breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Gliptivil should not be used during pregnancy. It is not known whether vildagliptin passes into breast milk. Gliptivil should not be used during breastfeeding or if planning to breastfeed.
Driving and operating machinery
If the patient experiences dizziness while taking Gliptivil, they should not drive or operate machinery.
Gliptivil contains lactose
Gliptivil contains lactose (milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Gliptivil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Gliptivil

This medicine should always be used exactly as your doctor has instructed. If you are unsure, you should contact your doctor or pharmacist.

What dose to take and when

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

The usual dose of Gliptivil is:

• 50 mg once daily in the morning, when Gliptivil is used in combination with a medicine called a sulfonylurea.
• 100 mg daily, taken as 50 mg in the morning and 50 mg in the evening, when Gliptivil is used either alone, with metformin, with a glitazone, in combination with metformin and a sulfonylurea derivative, or with insulin.
• 50 mg once daily in the morning, if the patient has moderate or severe kidney disease or is undergoing dialysis.

How to take Gliptivil

• Tablets should be swallowed whole with water.

How long to take Gliptivil

• Gliptivil should be taken every day for as long as your doctor recommends. You may need to take it long-term.
• Your doctor will regularly monitor your health to check whether the treatment is achieving the desired effect.

Taking more Gliptivil than prescribed

If you take too many Gliptivil tablets or if someone else takes this medicine, contact your doctor immediately. Medical attention may be required. If you need to see a doctor or go to hospital, take the medicine packaging with you.

If you miss a dose of Gliptivil

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 missed dose. Do not take a double dose to make up for a missed tablet.

Stopping Gliptivil

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Some adverse reactions require immediate medical attention:
If any of the following adverse reactions occur, stop taking Gliptivil immediately
and contact your doctor:

• Angioedema (rare: may occur in no more than 1 in 1,000 people): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, breathing difficulties, sudden onset of rash or hives, which may indicate a reaction called "angioedema".
• Liver disease (hepatitis) (frequency not known): Symptoms include yellowing of the skin and eyes, nausea, loss of appetite or dark-colored urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (rare: may occur in no more than 1 in 1,000 people): Symptoms include severe and persistent abdominal pain (around 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 Gliptivil:

• 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 the medicine was placed on the market, the following adverse reactions have also been reported:

• Frequency not known (frequency cannot be estimated from available data): local skin peeling or blister formation, 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, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the 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 stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This 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 carboxymethyl starch, lactose, magnesium stearate.

What Gliptivil looks like and contents of the pack
White to slightly yellowish, round, flat tablets with bevelled edges, embossed with "50" on one side, dimensions: diameter: 8.1 ± 0.1 mm and thickness: 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 medicinal product is authorised in the European Economic Area under the following names:
Portugal: Vildagliptina Generis
Poland: Gliptivil