GLIPTIVIL 50 mg/850 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 all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
4. What Gliptivil Combo is and what it is used for
   1. How Gliptivil Combo works
5. What you need to know before you take Gliptivil Combo
   1. Do not take Gliptivil Combo
   2. Warnings and precautions
   3. You must temporarily stop taking Gliptivil Combo if you have a condition that may lead to dehydration
   4. If you experience any symptoms of lactic acidosis, you must stop taking Gliptivil Combo and contact your doctor or the nearest hospital immediately
   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. If you take more Gliptivil Combo than you should
   3. If you forget to take Gliptivil Combo
   4. If you stop taking Gliptivil Combo
7. Possible side effects
   1. Other side effects
   2. Reporting of 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:
   7. Poland:
   8. Portugal:
   9. 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 all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness 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 pack and other information

• 1. What Gliptivil Combo is and what it is used for
• 2. What you need to know before you take 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 Gliptivil Combo is and what it is used for

The active substances of Gliptivil Combo are vildagliptin and metformin, which belong to a group of medicines called "oral antidiabetics".
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 other antidiabetic medicines are being taken.

How Gliptivil Combo works

Both active substances, vildagliptin and metformin, help to control blood sugar levels.
Vildagliptin works by increasing the amount of insulin produced by the pancreas and decreasing the amount of glucose released by the liver. Metformin helps the body to use insulin more effectively.

2. What you need to know before you take Gliptivil Combo

Do not 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, talk to your doctor before taking Gliptivil Combo.
• If you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or diabetic ketoacidosis. Diabetic ketoacidosis is a condition where substances called ketone bodies build up in the blood, which can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a 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 going to have a contrast agent injected into your bloodstream for a radiological examination (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 regularly 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 if you have uncontrolled diabetes, severe infections, prolonged fasting, or excessive alcohol consumption, dehydration (see below), liver problems, or any conditions where part of the body has reduced oxygen supply (e.g., severe heart disease).
If any of these situations apply to you, you should talk to your doctor for further instructions.

You must 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 talk to your doctor for more detailed instructions.

If you experience any symptoms of lactic acidosis, you must stop taking Gliptivil Combo and contact your doctor or the nearest hospital immediately

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

• vomiting
• abdominal pain
• muscle cramps
• general feeling of being unwell with severe tiredness
• breathing difficulties
• low body temperature and slow 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 taking Gliptivil Combo, you should discuss this with your doctor, pharmacist, or nurse if you have or have had pancreatitis.
Before taking Gliptivil Combo, you should talk to your doctor, pharmacist, or nurse if you are taking a sulfonylurea, a type of antidiabetic medicine.
Your doctor may want to reduce the dose of sulfonylurea taken with Gliptivil Combo to avoid low blood sugar (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 particular attention to the occurrence of new blisters or ulcers while taking Gliptivil Combo. If they occur, you should talk to your doctor promptly.
If you need to undergo a major surgical operation, you should stop taking Gliptivil Combo during and for some time after the operation. Your doctor will decide when you should stop and restart treatment with Gliptivil Combo.
Before and during 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 early 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 and urine levels.

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 that contains iodine, for example, for an X-ray examination or computed tomography, 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 have more frequent blood sugar and kidney function tests or to adjust the dose of Gliptivil Combo by your doctor. In particular, you should inform your doctor about the following medicines:

• corticosteroids used to treat inflammatory conditions
• beta-2-adrenergic receptor agonists used to treat respiratory diseases
• other antidiabetic 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 carcinoma) (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 this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist 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 "Do not 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 take will depend on your condition. Your doctor will determine the exact dose of Gliptivil Combo that you should take.
You should always take this medicine 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 sulfonylurea, a type of antidiabetic medicine, your doctor may also prescribe a lower dose.
Your doctor may prescribe this medicine alone (monotherapy) or with 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 food or shortly after food. Taking the tablet shortly after food 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.

If you take more Gliptivil Combo than you should

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

If you forget to take Gliptivil Combo

If you forget to take a tablet, you should take it at the next mealtime, 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 forgotten tablet.

If you stop taking Gliptivil Combo

You should continue to take this medicine for as long as your doctor recommends 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 talk to 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 contact your doctor immediatelyif 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 contact your doctor or the nearest hospital immediately, 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, breathing difficulties, sudden appearance of rash or hives, which may indicate a condition 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 (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): tiredness, weakness, metallic taste in the mouth, low blood sugar, loss of appetite, swelling of the 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 (lactic acidosis), such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat or deep and rapid breathing; skin redness, itching; decreased vitamin B12 levels (pallor, tiredness, psychological symptoms, such as confusion or memory problems).

After this medicine has been marketed, the following side effects have also been reported:

• Frequency not known (frequency cannot be estimated from the available data): localized skin peeling or blistering, vasculitis, which can cause skin rash or purpura.

Reporting of 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 Department of Drug Monitoring, 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
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 which is stated on the blister or carton after EXP. The expiry date refers to the last day of that 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. These measures 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 "50" engraved on one side and "850" on the other.
Gliptivil Combo, 50 mg + 1000 mg, film-coated tablets are yellow, oval, with beveled edges, with "50" engraved on one side and "1000" on the other side.
Gliptivil Combo is 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