GLIPTIVIL 50 mg/1000 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Gliptivil Combo, 50 mg + 850 mg, film-coated tablets
3. Gliptivil Combo, 50 mg + 1000 mg, film-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the package leaflet
4. What is Gliptivil Combo and what is it used for
   1. How Gliptivil Combo works
5. Important information before taking Gliptivil Combo
   1. When not to take Gliptivil Combo
   2. Warnings and precautions
   3. You should temporarily stop taking Gliptivil Combo if you have a condition that may lead to dehydration
   4. In case of symptoms of lactic acidosis, you should stop taking Gliptivil Combo and immediately contact your doctor or the nearest hospital
   5. Children and adolescents
   6. Gliptivil Combo with other medicines
   7. Taking Gliptivil Combo with alcohol
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
6. How to take Gliptivil Combo
   1. When and how to take Gliptivil Combo
   2. Taking a higher dose of Gliptivil Combo than recommended
   3. Missing a dose of Gliptivil Combo
   4. Stopping treatment with Gliptivil Combo
7. Possible side effects
   1. Other side effects
   2. Reporting side effects
8. How to store Gliptivil Combo
9. Contents of the pack and other information
   1. What Gliptivil Combo contains
   2. What Gliptivil Combo looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet: 10/2024

Package Leaflet: Information for the User

Gliptivil Combo, 50 mg + 850 mg, film-coated tablets

Gliptivil Combo, 50 mg + 1000 mg, film-coated tablets

Vildagliptin and Metformin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Gliptivil Combo and what is it used for

The active substances of Gliptivil Combo are vildagliptin and metformin, which belong to the group of "oral antidiabetic medicines".
Gliptivil Combo is used to treat adults with type 2 diabetes. This type of diabetes is also called non-insulin-dependent diabetes. Gliptivil Combo is used when diabetes cannot be controlled by diet and exercise alone and/or when it is given with other medicines used to treat diabetes (insulin or sulfonylurea derivatives).
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 can also develop when the body produces too much glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps to lower blood sugar levels, especially after meals. Glucagon stimulates the liver to produce sugar, causing blood sugar levels to rise.

How Gliptivil Combo works

Both active substances, vildagliptin and metformin, help to control blood sugar levels.
Vildagliptin works by stimulating the pancreas to produce more insulin and reducing the production of glucagon. Metformin helps the body to use insulin more effectively.
It has been shown that this medicine lowers blood sugar levels, which can help to prevent complications of diabetes.

2. Important information before taking Gliptivil Combo

When not to take Gliptivil Combo

• If you are allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of these ingredients, tell your doctor before taking Gliptivil Combo.
• If you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition where substances called ketone bodies accumulate in the blood, which can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth.
• If you have recently had a heart attack or have heart failure or severe circulatory problems or breathing difficulties, which may be a sign of heart problems.
• If you have significantly reduced kidney function.
• If you have a severe infection or are severely dehydrated (lost a lot of water from your body).
• If you are scheduled to have a contrast radiology test (a special type of X-ray that requires the injection of a contrast agent). For more information, see also section "Warnings and precautions".
• If you have liver disease.
• If you drink excessive amounts of alcohol (both daily and occasionally).
• If you are breastfeeding (see also section "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Risk of lactic acidosis
Gliptivil Combo may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of developing lactic acidosis also increases in case of uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see below), liver problems, and any conditions where a part of the body has reduced oxygen supply (e.g., acute severe heart disease).
If any of these situations apply to you, you should contact your doctor for further instructions.

You should temporarily stop taking Gliptivil Combo if you have a condition that may lead to dehydration

(significant loss of water from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should contact your doctor for more detailed instructions.

In case of symptoms of lactic acidosis, you should stop taking Gliptivil Combo and immediately contact your doctor or the nearest hospital

because this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general feeling of being unwell with severe fatigue
• breathing difficulties
• lowered body temperature and slowed heart rate.

Lactic acidosis is an emergency that requires hospital treatment.
Gliptivil Combo does not replace insulin. Therefore, you should not take Gliptivil Combo to treat type 1 diabetes.
Before starting to take Gliptivil Combo, you should discuss it with your doctor, pharmacist, or nurse if you have or have had pancreatitis.
Before starting to take Gliptivil Combo, you should tell your doctor, pharmacist, or nurse if you are taking a diabetes medicine called a sulfonylurea. Your doctor may want to reduce the dose of the sulfonylurea taken with Gliptivil Combo to avoid low blood sugar levels (hypoglycemia).
If you have taken vildagliptin before but had to stop due to liver disease, you should not take this medicine.
Diabetic skin changes are a common complication of diabetes. You should follow your doctor's or nurse's advice on skin and foot care. You should also pay special attention to the occurrence of new blisters or ulcers while taking Gliptivil Combo. If they occur, you should quickly discuss them with your doctor.
In case of a planned major surgical procedure, you should stop taking Gliptivil Combo during and for some time after the procedure. Your doctor will decide when you should stop and restart treatment with Gliptivil Combo.
Before starting treatment with Gliptivil Combo and at 3-month intervals during the first year of treatment, and periodically thereafter, you should have liver function tests to detect elevated liver enzymes as soon as possible.
During treatment with Gliptivil Combo, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have worsening kidney function.
Your doctor will regularly check your blood sugar levels and urine.

Children and adolescents

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

Gliptivil Combo with other medicines

If you are going to have a contrast agent injected into your bloodstream, for example, for an X-ray or CT scan, you should stop taking Gliptivil Combo before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Gliptivil Combo.
You should tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. It may be necessary to perform more frequent blood sugar tests or kidney function tests or adjust the dose of Gliptivil Combo by your doctor. It is especially important to inform about the following medicines:

• corticosteroids commonly used to treat inflammatory conditions
• beta-2-adrenergic receptor agonists used to treat respiratory diseases
• other diabetes medicines
• diuretics (medicines that increase urine production)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)

ibuprofen and celecoxib

• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain medicines that affect the thyroid gland
• certain medicines that affect the nervous system
• certain medicines used to treat angina (e.g., ranolazine)
• certain medicines used to treat HIV infection (e.g., dolutegravir)
• certain medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• certain medicines used to treat heartburn and stomach ulcers (e.g., cimetidine).

Taking Gliptivil Combo with alcohol

You should avoid excessive alcohol consumption while taking Gliptivil Combo, as it may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

• If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Gliptivil Combo during pregnancy.
• You should not take Gliptivil Combo if you are pregnant or breastfeeding (see also "When not to take Gliptivil Combo").

Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

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

3. How to take Gliptivil Combo

The dose of Gliptivil Combo that you should take varies depending on your condition. Your doctor will determine the exact dose of Gliptivil Combo that you should take.
This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg film-coated tablet twice a day.
If you have kidney problems, your doctor may prescribe a lower dose. If you are taking a diabetes medicine called a sulfonylurea, your doctor may also prescribe a lower dose.
Your doctor may prescribe this medicine alone (as monotherapy) or with certain other medicines that lower blood sugar levels.

When and how to take Gliptivil Combo

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one in the evening with a meal or shortly after a meal. Taking the tablet shortly after a meal will help reduce the risk of stomach upset.

You should continue to follow your doctor's advice on diet. In particular, if you are following a diabetic diet to control your weight, you should continue it while taking Gliptivil Combo.

Taking a higher dose of Gliptivil Combo than recommended

If you accidentally take too many Gliptivil Combo tablets or take them by someone else, you should immediately inform your doctor or pharmacist. Medical attention may be necessary. If you need to go to a doctor or hospital, take the medicine pack and this leaflet with you.

Missing a dose of Gliptivil Combo

If you forget to take a tablet, you should take it at the next meal, unless it is time for your next dose.
You should not take a double dose (two tablets at the same time) to make up for a missed tablet.

Stopping treatment with Gliptivil Combo

You should continue to take this medicine for as long as your doctor tells you to, in order to keep your blood sugar levels under control. You should not stop taking Gliptivil Combo unless your doctor tells you to. If you have any questions about how long to take Gliptivil Combo, you should ask your doctor.
If you have any further questions about taking this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Gliptivil Combo and immediately contact your doctorif you experience any of the following side effects:

• Lactic acidosis (very rare: may affect up to 1 in 10,000 people): Gliptivil Combo may cause a very rare but very serious side effect called lactic acidosis (see section "Warnings and precautions"). In this case, you should stop taking Gliptivil Combo and immediately contact your doctor or the nearest hospital, as lactic acidosis can lead to coma.
• 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 rash or hives, which may indicate a reaction called "angioedema".
• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people): Symptoms include yellowing of the skin and the whites of the eyes, nausea, loss of appetite, or dark urine, which may indicate liver disease (hepatitis).
• Pancreatitis (uncommon: may affect up to 1 in 100 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 side effects

Some patients taking Gliptivil Combo have experienced the following side effects:

• Common (may affect up to 1 in 10 people): sore throat, runny nose, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrolled shaking, constipation, nausea, vomiting, diarrhea, bloating, heartburn, stomach pain, and abdominal pain.
• Uncommon (may affect up to 1 in 100 people): fatigue, weakness, metallic taste in the mouth, low blood sugar levels, loss of appetite, swelling of hands, feet, or ankles (edema), chills, pancreatitis, muscle pain.

Very rare (may affect up to 1 in 10,000 people): symptoms of high lactic acid levels in the blood (called lactic acidosis), such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat, or deep and rapid breathing; redness of the skin, itching; reduced levels of vitamin B12 (pallor, fatigue, psychological symptoms, such as confusion or memory problems).

After this medicine was made available, the following side effects have also been reported:

• Frequency not known (frequency cannot be estimated from available data): local skin peeling or blistering, vasculitis, which can cause skin rash or purpura, or flat, red, round patches under the skin or bruises.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Monitoring, 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gliptivil Combo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after: EXP. The expiry date refers to the last day of the month.
Do not store above 30°C.
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. This will help protect the environment.

6. Contents of the pack and other information

What Gliptivil Combo contains

The active substances are vildagliptin and metformin hydrochloride.
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (which corresponds to 660 mg of metformin).
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (which corresponds to 780 mg of metformin).
The other ingredients are: copovidone (K-28), colloidal anhydrous silica, magnesium stearate, hypromellose 2910 (E 464), polydextrose (E 1200), titanium dioxide (E 171), talc (E 553b), yellow iron oxide (E 172), maltodextrin, and medium-chain triglycerides.

What Gliptivil Combo looks like and contents of the pack

Film-coated tablet.
Gliptivil Combo, 50 mg + 850 mg, film-coated tablets are yellow, oval, with beveled edges, with the number "50" embossed on one side and "850" on the other.
Gliptivil Combo, 50 mg + 1000 mg, film-coated tablets are yellow, oval, with beveled edges, with the number "50" embossed on one side and "1000" on the other side.
Gliptivil Combo, film-coated tablets are packaged in blisters.
Pack sizes: 10, 30, 60, 90, 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
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

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

Poland:
Gliptivil Combo
Portugal:
Metformina + Vildagliptina Generis Phar

Date of last revision of the leaflet: 10/2024