GLUAMET 50 mg/850 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. GluaMet, 50 mg + 850 mg, film-coated tablets
3. GluaMet, 50 mg + 1000 mg, film-coated tablets
   1. You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is GluaMet and what is it used for
   1. How GluaMet works
5. Important information before taking GluaMet
   1. When not to take GluaMet:
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. You should temporarily stop taking GluaMet if you have a condition that may lead to dehydration
   5. You should stop taking GluaMet and immediately contact your doctor or the nearest hospital if you experience any symptoms of lactic acidosis
   6. Children and adolescents
   7. GluaMet and other medicines
   8. GluaMet and alcohol
   9. Pregnancy and breastfeeding
   10. Driving and using machines
6. How to take GluaMet
   1. When and how to take GluaMet
   2. Taking a higher dose of GluaMet than recommended
   3. Missing a dose of GluaMet
   4. Stopping GluaMet treatment
7. Possible side effects
   1. Other side effects
   2. Reporting side effects
8. How to store GluaMet
9. Contents of the packaging and other information
   1. What GluaMet contains
   2. What GluaMet looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: April 2022

Leaflet accompanying the packaging: information for the user

GluaMet, 50 mg + 850 mg, film-coated tablets

GluaMet, 50 mg + 1000 mg, film-coated tablets

Vildagliptin + Metformin hydrochloride

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• -You should keep this leaflet, so you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you by a doctor and should not be given to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is GluaMet and what is it used for

The active substances of GluaMet are vildagliptin and metformin, which belong to a group of medicines called oral antidiabetic medicines. GluaMet is used when diet and exercise alone are not enough to control blood sugar levels and when it is taken with other medicines used to treat diabetes (insulin or sulfonylurea derivatives).
GluaMet is used to treat adult patients with type 2 diabetes. This type of diabetes is also called non-insulin-dependent diabetes.
Type 2 diabetes is a condition in which the body does not produce enough insulin or the insulin produced by the body does not work properly. Type 2 diabetes 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 is a substance that stimulates the production of sugar in the liver and increases blood sugar levels.

How GluaMet works

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

2. Important information before taking GluaMet

When not to take GluaMet:

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• 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, you should tell your doctor before taking GluaMet;
• if you have uncontrolled diabetes, such as 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 in which substances called ketone bodies accumulate in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth;
• if you have recently had a heart attack or if you have heart failure or severe circulatory disorders or breathing difficulties, which may be a sign of heart failure;
• if you have significantly reduced kidney function;
• if you have a severe infection or are severely dehydrated (have lost a lot of water from your body);
• if you are to undergo a radiological examination with a contrast agent (a special type of examination that requires the injection of a contrast agent. For more information, see also section "Warnings and precautions");
• if you have liver disease;
• if you consume excessive amounts of alcohol (both daily and from time to time);
• if you are breastfeeding (see also section "Pregnancy and breastfeeding").

Warnings and precautions

Risk of lactic acidosis

GluaMet may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver disease, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease). If any of these situations apply to you, you should consult your doctor for more detailed instructions.

You should temporarily stop taking GluaMet 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 taking less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking GluaMet and immediately contact your doctor or the nearest hospital if you experience any symptoms of lactic acidosis

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,
• decreased body temperature and slowed heart rate. Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.

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GluaMet does not replace insulin. Therefore, you should not take GluaMet to treat type 1 diabetes.
Before starting GluaMet, you should discuss it with your doctor, pharmacist, or nurse if you have or have had pancreatic disease.
Before starting GluaMet, you should consult your doctor, pharmacist, or nurse if you are taking a diabetes medicine that contains a sulfonylurea derivative. Your doctor may decide to reduce the dose of the sulfonylurea derivative taken with GluaMet to avoid low blood sugar levels (hypoglycemia).
If you have previously taken vildagliptin but had to stop taking it due to liver disease, you should not take this medicine.
Diabetic skin changes are a common complication of diabetes. You should follow the recommendations of your doctor or nurse regarding skin and foot care. You should also pay particular attention to the occurrence of new blisters or ulcers while taking GluaMet.
If they occur, you should consult your doctor promptly.
If you are to undergo major surgery, you should not take GluaMet during the surgery and for some time after it. Your doctor will decide when you should stop and resume GluaMet treatment.
Before starting treatment with GluaMet and at 3-month intervals during the first year of treatment, and then periodically, you should have liver function tests. This will help to detect any signs of increased liver enzyme activity as soon as possible.
During treatment with GluaMet, 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 assess your blood and urine sugar levels.

Children and adolescents

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

GluaMet and other medicines

If you are to be injected with a contrast agent containing iodine, e.g., for an X-ray examination or computed tomography, you should stop taking GluaMet before or at the latest at the time of such injection. Your doctor will decide when you should stop and resume GluaMet treatment.
You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood sugar checks or kidney function tests, or your doctor may need to adjust your GluaMet dose. It is especially important to inform your doctor if you are taking any of the following medicines:

• corticosteroids, usually used to treat inflammatory conditions,
• beta-2-adrenergic receptor agonists, usually used to treat respiratory disorders,
• other diabetes medicines,
• diuretics,
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as 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).

GluaMet and alcohol

You should avoid consuming excessive amounts of alcohol while taking GluaMet, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to have a baby, you should consult your doctor before taking this medicine. Your doctor will discuss with you the possible risks of taking GluaMet during pregnancy.
• You should not take GluaMet during pregnancy or breastfeeding (see also "When not to take GluaMet"). Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

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

3. How to take GluaMet

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

When and how to take GluaMet

• Tablets should be swallowed whole with a glass of water.
• You should take one tablet in the morning and one tablet in the evening with a meal or immediately after a meal. Taking the tablet immediately after a meal will help to reduce the risk of stomach upset.

You should continue to follow your doctor's recommendations regarding diet. Following a diet while taking GluaMet is especially important if you are following a weight-control diet.

Taking a higher dose of GluaMet than recommended

If you accidentally take too many GluaMet tablets or if someone else takes them, you should immediately inform your doctor or pharmacist. You may need medical attention. If you need to see a doctor or go to the hospital, you should take the packaging and leaflet with you.

Missing a dose of GluaMet

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

Stopping GluaMet treatment

To maintain control of your blood sugar levels, you should take the medicine for as long as your doctor recommends. You should not stop taking GluaMet without your doctor's advice. If you have any questions about how long to take GluaMet, 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, GluaMet can cause side effects, although not everybody gets them.
You should stop taking GluaMet and immediately see your doctorif you experience any of the following side effects:

• lactic acidosis(very rare: may affect up to 1 in 10,000 people): GluaMet may very rarely cause a very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens to you, you should stop taking GluaMet 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, breathing difficulties, sudden appearance of rash or hives. These may indicate a condition called "angioedema";
• liver disease (hepatitis) (rare): symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark urine. These may indicate liver disease (hepatitis);
• pancreatitis (frequency not known: cannot be estimated from the available data): 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

During treatment with vildagliptin and metformin hydrochloride, some patients have experienced the following side effects:

• very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhea, stomach pain or abdominal pain, loss of appetite;
• common (may affect up to 1 in 10 people): dizziness, headache, uncontrolled shaking, metallic taste in the mouth, low blood sugar levels;
• uncommon (may affect up to 1 in 100 people): joint pain, fatigue, constipation, swelling of the hands, feet, or ankles (edema);
• rare (may affect up to 1 in 1,000 people): sore throat, runny nose, fever; 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; decreased vitamin B12 levels (pallor, fatigue, mental symptoms such as confusion or memory disorders).

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In some patients taking vildagliptin and metformin hydrochloride and sulfonylurea derivatives, the following side effects have occurred:

• common: dizziness, shaking, weakness, low blood sugar levels, excessive sweating.

In some patients taking vildagliptin and metformin hydrochloride and insulin, the following side effects have occurred:

• common: headache, chills, nausea (nausea), low blood sugar levels, heartburn;
• uncommon: diarrhea, bloating.

After the medicine was placed on the market, the following side effects have also been reported:

• frequency not known (frequency cannot be estimated from the available data): itchy rash, pancreatitis, localized skin peeling or blistering, muscle pain.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
Side effects can also be reported 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 GluaMet

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after "EXP"/"Expiry date (EXP)". The expiry date refers to the last day of the month.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What GluaMet contains

• The active substances of GluaMet are vildagliptin and metformin hydrochloride.
• Each GluaMet 50 mg + 850 mg film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (which corresponds to 660 mg of metformin).

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• Each GluaMet 50 mg + 1000 mg 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: microcrystalline cellulose, copovidone K25, crospovidone (type B), hydroxypropylcellulose, magnesium stearate, hypromellose (type 2910), titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 8000 (E 1521), and talc (E 553b).

What GluaMet looks like and contents of the pack

GluaMet 50 mg + 850 mg are yellow, oval, film-coated tablets with beveled edges and a smooth surface on both sides, approximately 20.7 x 8.8 mm in size.
GluaMet 50 mg + 1000 mg are dark yellow, oval, film-coated tablets with beveled edges and a smooth surface on both sides, approximately 21.3 x 10.1 mm in size.
GluaMet is available in packs containing 10, 30, 56, 60, 120, 180, or 360 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sp. z o.o.
Al. Jerozolimskie 142B
02-305 Warsaw

Manufacturer/Importer

Pharmacare Premium Ltd
HHF003 Hal Far Industrial Estate
Birzebbugia, BBG3000
Malta
Bluepharma Industria Farmaceutica, S.A.
Sao Martinho do Bispo
3045-016 Coimbra
Portugal

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

GluaMet: Denmark, Malta, Poland, Portugal, Romania, Hungary

Date of last revision of the leaflet: April 2022

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