XUVELEX 1000 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Xuvelex XR, 500 mg, prolonged-release tablets
3. Xuvelex XR, 750 mg, prolonged-release tablets
4. Xuvelex XR, 1000 mg, prolonged-release tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What Xuvelex XR is and what it is used for
6. Important information before taking Xuvelex XR
   1. When not to take Xuvelex XR:
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. You should stop taking Xuvelex XR for a short time in case of a condition that may be associated with dehydration
   5. You should stop taking Xuvelex XR and immediately contact your doctor or the nearest hospital if you experience any symptoms of lactic acidosis
   6. Children and adolescents
   7. Xuvelex XR and other medicines
   8. Taking Xuvelex XR with alcohol
   9. Pregnancy and breastfeeding
   10. Driving and using machines
   11. Xuvelex XR contains sodium
7. How to take Xuvelex XR
   1. Taking a higher dose of Xuvelex XR than recommended
   2. Missing a dose of Xuvelex XR
8. Possible side effects
   1. Reporting side effects
9. How to store Xuvelex XR
10. Contents of the packaging and other information
    1. What Xuvelex XR contains
    2. What Xuvelex XR looks like and contents of the pack
    3. Pack contents
    4. Marketing authorization holder
    5. Importer
    6. This medicine is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the leaflet:

Leaflet accompanying the packaging: information for the user

Xuvelex XR, 500 mg, prolonged-release tablets

Xuvelex XR, 750 mg, prolonged-release tablets

Xuvelex XR, 1000 mg, prolonged-release tablets

Metformin hydrochloride

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on 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 or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Xuvelex XR is and what it is used for

Xuvelex XR contains the active substance metformin hydrochloride and belongs to a group of medicines called biguanides, used to treat patients with type 2 diabetes (also called non-insulin-dependent diabetes).
Xuvelex XR is used to treat type 2 diabetes when diet and exercise alone have not been able to control blood sugar levels. It is particularly used in patients who are overweight. Insulin is a hormone that allows the body to take up glucose from the blood and use it for energy or store it for future use.
In type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin produced. This leads to high blood sugar levels, which can cause a number of serious, long-term problems, so it is important to continue taking the medicine, even if you do not have any obvious symptoms.
Xuvelex XR increases the body's sensitivity to insulin and helps restore normal glucose use.
If you are overweight, taking Xuvelex XR for a long time also reduces the risk of complications associated with diabetes. Taking Xuvelex XR is associated with either weight loss or no change in body weight.
Xuvelex XR is a prolonged-release tablet that is specially designed to release the medicine slowly in the body and therefore differs from many other types of metformin tablets.

2. Important information before taking Xuvelex XR

When not to take Xuvelex XR:

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a rash, itching, or difficulty breathing.
• if you have liver problems.
• if you have severely reduced kidney function.
• if you have uncontrolled diabetes, for example, 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 pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a unusual fruity odor from the mouth.
• in case of excessive water loss from the body (dehydration). Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below).
• in case of severe infection, such as pneumonia, bronchitis, or pyelonephritis. Severe infections can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below).
• in case of treatment for acute heart failure or recent myocardial infarction, severe circulatory problems, or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below).
• if you drink a lot of alcohol.

If any of the above situations apply to you, you should consult your doctor before taking this medicine.
You must consult your doctor if:

• a radiological examination or an examination requiring the injection of a contrast agent containing iodine into the bloodstream is necessary,
• a major surgical procedure is necessary. You should stop taking Xuvelex XR for a certain period before the examination or surgical procedure and after the examination or surgical procedure. Your doctor will decide whether you need other treatment during this time. It is essential to follow your doctor's instructions.

Warnings and precautions

You should talk to your doctor before taking Xuvelex XR.

Risk of lactic acidosis

Xuvelex XR 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 infection, prolonged fasting, or excessive alcohol consumption, dehydration (see more information below), liver problems, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., acute severe heart disease).
If any of the above conditions apply to you, you should consult your doctor for more detailed instructions.

You should stop taking Xuvelex XR for a short time in case of a condition that may be associated with dehydration

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

You should stop taking Xuvelex XR 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 (stomach 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.
If you are going to have a major surgical procedure, you should stop taking Xuvelex XR during the procedure and for a certain period after it. Your doctor will decide when you should stop and restart Xuvelex XR treatment.
Xuvelex XR does not cause hypoglycemia (low blood sugar).
However, if Xuvelex XR is taken with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking something containing sugar usually helps.
During treatment with Xuvelex XR, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function.
Tablet residues may be visible in the stool. You should not be concerned, as this is normal when taking this type of tablet.
You should follow all dietary recommendations given by your doctor and ensure that you consume the recommended amount of carbohydrates evenly distributed throughout the day.
You should not stop taking this medicine without consulting your doctor.

Children and adolescents

Due to the lack of data, Xuvelex XR should not be used in children and adolescents.

Xuvelex XR and other medicines

If you are going to have a contrast agent containing iodine injected into your bloodstream, for example, for an X-ray examination or computed tomography, you should stop taking Xuvelex XR before or at the latest at the time of injection. Your doctor will decide when you should stop and restart Xuvelex XR treatment.
You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood glucose monitoring and kidney function tests or dose adjustments of Xuvelex XR by your doctor. It is particularly important to inform your doctor about the following medicines:

• diuretics (e.g., furosemide).
• 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).
• beta-2 adrenergic receptor agonists, such as salbutamol or terbutaline (used to treat asthma).
• corticosteroids (used to treat various diseases, such as severe skin inflammation, allergic reactions, or asthma) such as prednisolone, mometasone, beclomethasone,
• other medicines used to treat diabetes.
• sympathomimetic medicines, including epinephrine and dopamine used to treat heart attacks and low blood pressure. Epinephrine is also part of some dental anesthetics.
• medicines that may change metformin levels in the blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Taking Xuvelex XR with alcohol

You should avoid excessive alcohol consumption while taking Xuvelex XR, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor for advice before taking this medicine.
If you are pregnant or think you may be pregnant, or are planning to have a baby, you should ask your doctor for advice in case any changes are needed in your treatment or blood sugar control.
This medicine is not recommended if you are breastfeeding or planning to breastfeed.

Driving and using machines

Xuvelex XR taken alone does not cause hypoglycemia (symptoms of low blood sugar or hypoglycemia, such as fainting, confusion, and increased sweating), and therefore should not affect your ability to drive or use machines.
However, you should be aware that Xuvelex XR taken with other anti-diabetic medicines (such as sulfonylurea derivatives, insulin, meglitinides) may cause hypoglycemia, so you should be careful while driving or using machines.

Xuvelex XR contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, which means that it is essentially "sodium-free".

3. How to take Xuvelex XR

Your doctor may prescribe Xuvelex XR to be taken alone or in combination with other oral anti-diabetic medicines or insulin.
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.
Xuvelex XR does not replace the benefits of a healthy lifestyle. You should continue to follow all dietary recommendations given by your doctor and regularly exercise.
Recommended dose for adults
Treatment usually starts with 500 mg of Xuvelex XR taken once a day. After about 2 weeks of taking Xuvelex XR, your doctor may adjust the dose based on blood glucose measurements. The maximum daily dose of Xuvelex XR is 2000 mg.
If you have reduced kidney function, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will tell you how to start taking Xuvelex XR.
Treatment monitoring

• Your doctor will prescribe regular blood glucose tests and adjust the dose of Xuvelex XR based on blood glucose levels. You should make sure you have regular contact with your doctor. This is especially important if you are elderly.
• Your doctor will also check your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function.

How to take Xuvelex XR
Usually, the tablets are taken once a day with the evening meal. This will help avoid gastrointestinal side effects.
In some cases, your doctor may recommend taking the tablets twice a day. The tablets should always be taken with food.
The tablets should be swallowed whole with a glass of water; do not crush or chew them.

Taking a higher dose of Xuvelex XR than recommended

If you take a higher dose of Xuvelex XR than recommended, you may experience lactic acidosis. Symptoms of lactic acidosis are non-specific, such as vomiting, abdominal pain (stomach pain) with muscle cramps, general feeling of being unwell with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If you experience any of these symptoms, you should immediately seek medical attention, as lactic acidosis can lead to coma. You should stop taking Xuvelex XR and immediately contact your doctor or the nearest hospital.

Missing a dose of Xuvelex XR

If you miss a tablet, you should take it as soon as you remember or take the next dose at the usual time with food. Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xuvelex XR can cause side effects, although not everybody gets them.
The following side effects may occur:

Xuvelex XRmay very rarely (may affect up to 1 in 10,000 people) cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should stop taking Xuvelex XR and immediately contact your doctor or the nearest hospital, as lactic acidosis can lead to coma.
Xuvelex XR may cause changes in liver function test results and liver inflammation, which can cause jaundice (may affect up to 1 in 10,000 people). If you experience yellowing of the eyes and/or skin you should stop taking Xuvelex XR and immediately contact your doctor.
Other possible side effects are listed below by frequency of occurrence:

Very common (may affect more than 1 in 10 people):

• Diarrhea, nausea, vomiting, abdominal pain, loss of appetite. If you experience these symptoms, you should not stop taking the tablets, as they usually disappear after about 2 weeks. Taking the tablets with food or immediately after food may help.

Common (may affect up to 1 in 10 people):

• Taste disturbances.
• Decreased or low vitamin B12 levels in the blood (symptoms may include: extreme fatigue, pain, and redness of the tongue, numbness or tingling, or pale or yellowish skin). Your doctor may prescribe some tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

Very rare (may affect up to 1 in 10,000 people):

• Skin rash, including redness, itching, and hives.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects 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
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 Xuvelex XR

The medicine should be stored 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 month stated.
Store in a temperature below 25°C.
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 Xuvelex XR contains

The active substance of Xuvelex XR is metformin hydrochloride.
Xuvelex XR, 500 mg prolonged-release tablets:
each prolonged-release tablet contains 500 mg of metformin hydrochloride, which corresponds to 389.938 mg of metformin.
Xuvelex XR, 750 mg prolonged-release tablets:
each prolonged-release tablet contains 750 mg of metformin hydrochloride, which corresponds to 584.907 mg of metformin.
Xuvelex XR, 1000 mg prolonged-release tablets:
each prolonged-release tablet contains 1000 mg of metformin hydrochloride, which corresponds to 779.876 mg of metformin.
The other ingredients are: povidone K-90F, colloidal anhydrous silica, sodium carmellose 2500-3500 mPa·s, hypromellose 10,000 cps, microcrystalline cellulose, magnesium stearate.

What Xuvelex XR looks like and contents of the pack

Description
Xuvelex XR, 500 mg prolonged-release tablets: white or almost white, round, biconvex tablets with "500" embossed on one side and smooth on the other side.
The tablets have a diameter of about 12.15 mm.
Xuvelex XR, 750 mg prolonged-release tablets: white or almost white, biconvex tablets in the shape of a capsule with "750" embossed on one side and smooth on the other side. The tablets have a length of about 20.0 mm and a width of about 9.6 mm.
Xuvelex XR, 1000 mg prolonged-release tablets: white or almost white, biconvex tablets in the shape of a capsule with "1000" embossed on one side and smooth on the other side. The tablets have a length of about 22.6 mm and a width of about 10.6 mm.

Pack contents

Xuvelex XR, 500 mg prolonged-release tablets: the tablets are available in PVC/PVDC/Aluminum blisters of 20, 30, 60, and 90 tablets.
Xuvelex XR, 750 mg prolonged-release tablets: the tablets are available in PVC/PVDC/Aluminum blisters of 20, 30, 60, and 90 tablets.
Xuvelex XR, 1000 mg prolonged-release tablets: the tablets are available in PVC/PVDC/Aluminum blisters of 10, 30, 60, and 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Importer

PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbugia, BBG3000, Malta

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

Hungary
Xuvelex XR 500mg, 750mg & 1000mg, Retard tabletta
Czech Republic
Xuvelex
Poland
Xuvelex XR
Romania
Xuvelex XR 500mg, 750mg & 1000mg, Comprimat cu eliberare prelungită
To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:
EGIS Polska sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet: