GLUAMET 50 mg/1000 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. Read the leaflet carefully 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. The patient should temporarily stop taking GluaMet if they have a condition that may lead to dehydration
   5. The patient should stop taking GluaMet and immediately contact their doctor or the nearest hospital if they 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

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

• -Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 diabetes, and it can be given with other medicines for 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 disease 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 control blood sugar levels.
Vildagliptin works by stimulating the pancreas to produce insulin and reducing the production of glucagon. Metformin helps the body use insulin better.
It has been shown that the medicine lowers blood sugar levels, which can help prevent complications of diabetes.

2. Important information before taking GluaMet

When not to take GluaMet:

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• if the patient is allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to any of these ingredients, they should tell their doctor before taking GluaMet;
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), 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 a fruity odor from the mouth;
• if the patient has recently had a heart attack or if the patient has heart failure or severe circulatory problems or breathing difficulties, which may be a sign of heart failure;
• if the patient has significantly reduced kidney function;
• if the patient has a severe infection or is severely dehydrated (has lost a lot of water from the body);
• if the patient is to undergo a contrast radiological examination (a special type of examination that requires the injection of a contrast agent. For more information, see also section "Warnings and precautions");
• if the patient has liver disease;
• if the patient consumes excessive amounts of alcohol (both daily and from time to time);
• if the patient is 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 the patient has 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 part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease). If any of these situations apply to the patient, they should consult their doctor for more detailed instructions.

The patient should temporarily stop taking GluaMet if they 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. The patient should consult their doctor for more detailed instructions.

The patient should stop taking GluaMet and immediately contact their doctor or the nearest hospital if they 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 treatment in a hospital.

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GluaMet does not replace insulin. Therefore, GluaMet should not be used to treat type 1 diabetes.
Before starting GluaMet, the patient should discuss it with their doctor, pharmacist, or nurse if they have or have had pancreatic disease.
Before starting GluaMet, the patient should consult their doctor, pharmacist, or nurse if they are taking a diabetes medicine that contains sulfonylurea derivatives. The doctor may decide to reduce the dose of sulfonylurea derivatives taken with GluaMet to avoid low blood sugar (hypoglycemia).
If the patient has previously taken vildagliptin but had to stop due to liver disease, they should not take this medicine.
Diabetic skin changes are a common complication of diabetes. The patient should follow the doctor's or nurse's recommendations for skin and foot care. The patient should also pay particular attention to the occurrence of new blisters or ulcers while taking GluaMet.
If they occur, the patient should consult their doctor promptly.
If the patient is to undergo major surgery, they should not take GluaMet during the surgery and for some time after it. The doctor will decide when the patient should stop and resume GluaMet treatment.
Before starting treatment with GluaMet and at three-month intervals during the first year of treatment, and then periodically, the patient should undergo liver function tests. This will help detect elevated liver enzyme levels as soon as possible.
During treatment with GluaMet, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has worsening kidney function.
The doctor will regularly assess the patient's 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 the patient is to be injected with a contrast agent containing iodine, e.g., for an X-ray examination or computed tomography, they should stop taking GluaMet before or at the latest at the time of such injection. The doctor will decide when the patient should stop and resume GluaMet treatment.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood sugar checks and kidney function tests or dose adjustments of GluaMet by the doctor. It is especially important to inform the doctor about the use 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,
• 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).

GluaMet and alcohol

The patient 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 the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine. The doctor will discuss the possible risks and benefits of taking GluaMet during pregnancy.
• GluaMet should not be taken during pregnancy or breastfeeding (see also "When not to take GluaMet"). Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

If the patient experiences dizziness while taking GluaMet, they should not drive or operate machinery.

3. How to take GluaMet

The dose of GluaMet varies depending on the patient's condition. The doctor will determine the dose of GluaMet to be taken.
This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their 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 the patient has kidney problems, the doctor may prescribe a lower dose. If the patient is taking a diabetes medicine that contains sulfonylurea derivatives, the doctor may also prescribe a lower dose.
The doctor may prescribe this medicine 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.
• The patient should take one tablet in the morning and one in the evening with a meal or immediately after a meal. Taking the tablet immediately after a meal will help reduce the risk of stomach upset.

The patient should continue to follow their doctor's recommendations for diet. Diet is especially important when taking GluaMet if the patient is on a weight-control diet.

Taking a higher dose of GluaMet than recommended

In case of accidental ingestion of too many GluaMet tablets or if someone else has taken these tablets, the patient should immediately inform their doctor or pharmacist. The patient may need medical attention. If it is necessary to visit a doctor or hospital, the patient should take the packaging and leaflet with them.

Missing a dose of GluaMet

If the patient forgets to take a tablet, they should take it during the next meal, unless it is already time for the next tablet. The patient should not take a double dose (two tablets at once) to make up for the missed tablet.

Stopping GluaMet treatment

To maintain control of blood sugar levels, the medicine should be taken for as long as the doctor recommends. The patient should not stop taking GluaMet without their doctor's advice. If the patient has any further questions about taking GluaMet, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, GluaMet can cause side effects, although not everybody gets them.
The patient should stop taking GluaMet and immediately see their doctorif they 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 the patient, they should stop taking GluaMet and immediately contact their 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;
• uncommon (may affect up to 1 in 100 people): joint pain, fatigue, constipation, swelling of the hands, feet, or ankles (edema);
• very rare (may affect up to 1 in 10,000 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; skin redness, itching; decreased vitamin B12 levels (pallor, fatigue, psychological 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, 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, 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych,
Al. Jerozolimskie 181C
02-222 Warszawa
tel.: +48 22 49 21 301
faks: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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 (equivalent 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 (equivalent 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 Warszawa

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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