Xuvelex Xr

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

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 or pharmacist.
• 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 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 pack 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 known as 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 used especially 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 patients with type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin produced properly. 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 no symptoms are present.
Xuvelex XR increases the body's sensitivity to insulin and helps restore normal glucose use.
If the patient is overweight, taking Xuvelex XR for a longer period also reduces the risk of complications associated with diabetes. Taking Xuvelex XR is associated with maintaining weight or moderate weight loss.
Xuvelex XR is available in the form of prolonged-release tablets, which are specially designed to release the medicine slowly in the body and therefore differ from many other types of metformin tablets.

2. Important information before taking Xuvelex XR

When not to take Xuvelex XR:

• if the patient is 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 the patient has liver problems.
• if the patient has significantly reduced kidney function.
• if the patient has 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 unusual fruity breath odor.
• 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 disorders, or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below).
• if the patient abuses alcohol.

If any of the above situations occur, the patient should consult a doctor before taking this medicine.
It is essential to consult a doctor if:

• a radiological examination or examination requiring the injection of a contrast agent containing iodine into the bloodstream is necessary,
• a major surgical procedure is necessary. The patient should stop taking Xuvelex XR for a while before the examination or surgical procedure and for some time after. The doctor will decide whether other treatment is necessary during this time. It is crucial to follow the doctor's instructions.

Warnings and precautions

The patient should talk to their 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 the patient has kidney problems. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, 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 the above conditions apply to the patient, they should consult their doctor for more detailed instructions.

The patient should stop taking Xuvelex XR for a short time if they experience a condition that may be associated with dehydration (significant fluid loss),

such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual.The patient should consult their doctor for more detailed instructions.

The patient should stop taking Xuvelex XR and contact their doctor or the nearest hospital immediately if they experience any symptoms of lactic acidosis,

as 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 hospital treatment.
If the patient is to undergo major surgery, they must stop taking Xuvelex XR during and for some time after the surgery. The doctor will decide when the patient should stop and resume 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 symptoms of hypoglycemia occur, 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, the doctor will check the patient's kidney function at least once a year or more often if the patient is elderly and/or has impaired kidney function.
Tablet residues may be visible in the stool. The patient should not be concerned, as this is normal when taking this type of tablet.
The patient should follow all dietary recommendations given by their doctor and ensure that the recommended amount of carbohydrates is distributed throughout the day.
The patient should not stop taking this medicine without consulting their 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 the patient is to be injected with a contrast agent containing iodine into the bloodstream, for example, for an X-ray examination or computed tomography, they must stop taking Xuvelex XR before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume Xuvelex XR treatment.
The patient should tell their doctor or pharmacist 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 Xuvelex XR by their doctor. It is especially important to inform 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 terbutalina (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 the patient has reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Taking Xuvelex XR with alcohol

The patient 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor in case any changes are needed in their treatment or blood sugar control.
This medicine is not recommended if the patient is breastfeeding or plans 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 the ability to drive or use machines.
However, the patient should remember that Xuvelex XR taken with other anti-diabetic medicines (such as sulfonylurea derivatives, insulin, meglitinides) may cause hypoglycemia, so in such cases, the patient should be particularly 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 the medicine is considered "sodium-free".

3. How to take Xuvelex XR

The 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 prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Xuvelex XR does not replace the benefits of a healthy lifestyle. The patient should continue to follow all dietary recommendations given by their doctor and exercise regularly.
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, the doctor may adjust the dose based on blood sugar measurements. The maximum daily dose of Xuvelex XR is 2000 mg.
If the patient has reduced kidney function, the doctor may prescribe a lower dose.
If the patient is also taking insulin, the doctor will inform them how to start taking Xuvelex XR.
Treatment control

• The doctor will order regular blood sugar tests and adjust the dose of Xuvelex XR based on blood sugar levels. The patient should ensure that they regularly discuss their treatment with their doctor. This is especially important if the patient is elderly.
• The doctor will also check the patient's kidney function at least once a year or more often if the patient is elderly and/or has impaired kidney function.

How to take Xuvelex XR
Usually, the tablets are taken once a day during the evening meal. This will help avoid gastrointestinal side effects.
In some cases, the 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, without crushing or chewing.

Taking a higher dose of Xuvelex XR than recommended

If a higher dose of Xuvelex XR than recommended is taken, lactic acidosis may occur. 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 any of these symptoms occur, the patient should immediately seek medical help, as lactic acidosis can lead to coma.
The patient should stop taking Xuvelex XR and contact their doctor or the nearest hospital immediately.

Missing a dose of Xuvelex XR

If a tablet is missed, the patient should take it as soon as they remember or take the next dose at the usual time with food. The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult their 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 occur in up to 1 in 10,000 patients) cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Xuvelex XR and contact their doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
Xuvelex XR may cause changes in liver function test results and hepatitis, which can cause jaundice (may occur in up to 1 in 10,000 patients). If the patient experiences yellowing of the eyes and/or skin, they should stop taking Xuvelex XR and contact their doctor immediately.
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 these symptoms occur, the patient 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 less than 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 pale or yellowish skin). The doctor may order several 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. 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
Phone: +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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Xuvelex XR

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 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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, equivalent to 389.938 mg of metformin.
Xuvelex XR, 750 mg prolonged-release tablets:
each prolonged-release tablet contains 750 mg of metformin hydrochloride, equivalent to 584.907 mg of metformin.
Xuvelex XR, 1000 mg prolonged-release tablets:
each prolonged-release tablet contains 1000 mg of metformin hydrochloride, equivalent to 779.876 mg of metformin.
Other ingredients are: povidone K-90F, colloidal anhydrous silica, sodium carmellose 2500-3500 mPa·s, hypromellose 10,000 cps, microcrystalline cellulose, magnesium stearate.

Description of Xuvelex XR and contents of the pack

Description
Xuvelex XR, 500 mg prolonged-release tablets: white or almost white, rounded, biconvex tablets with "500" embossed on one side and smooth on the other side.
The tablets have a diameter of approximately 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 approximately 20.0 mm and a width of 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 approximately 22.6 mm and a width of 10.6 mm.

Contents of the pack

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, the patient 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: