Glucophage Xr

Package Leaflet: Information for the Patient

GLUCOPHAGE XR, 1000 mg, prolonged-release tablets

Metformin hydrochloride

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

Glucophage XR contains metformin, a medicine used to treat diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that allows the body to take up glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for future use.
In diabetic patients, the pancreas does not produce enough insulin or the body is unable to use the insulin produced. This leads to an excessive increase in blood glucose levels. Glucophage XR helps to reduce blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of Glucophage XR also reduces the risk of complications associated with diabetes. Taking Glucophage XR is associated with either weight loss or no change in body weight.
Glucophage XR is used to treat patients with type 2 diabetes (also called non-insulin-dependent diabetes). It is particularly used in patients with overweight.
Adults can take Glucophage XR as the only medicine or in combination with other anti-diabetic medicines (oral or insulin).
In the prevention of type 2 diabetes in patients with a pre-diabetic state.
In polycystic ovary syndrome.

2. Important information before taking Glucophage XR

When not to take Glucophage XR:

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• in case of liver disease,
• if you have significantly 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 unusual fruity odor from the mouth,
• in case of excessive loss of body water (dehydration), for example, due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of severe infection, for example, pneumonia, bronchitis, or kidney infection. Severe infections can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of acute heart failure or recent myocardial infarction, severe circulatory disorders (such as shock) or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of alcohol abuse,
• if you are under 18 years old.

If any of the above situations occur, you should consult your doctor before taking this medicine.
It is essential to consult your doctor if it is necessary:

• to perform a radiological examination or an examination that requires the injection of a contrast agent containing iodine into the blood,
• to perform major surgery.

Glucophage XR must be discontinued for a period before and after the examination or surgery. Your doctor will decide whether other treatment is necessary during this time. It is essential to follow your doctor's instructions carefully.

Warnings and precautions

Risk of lactic acidosis

Glucophage 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 increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver disease, 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 circumstances apply to you, you should consult your doctor for more detailed instructions.

You should temporarily stop taking Glucophage XR if you have a condition that may lead to dehydration

(significant loss of body water), 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 Glucophage XR and contact your doctor or the nearest hospital immediately 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.

You should contact your doctor immediately for further instructions if:

• you have a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• you experience any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

If you are to undergo major surgery, you should not take Glucophage XR during and for some time after the surgery. Your doctor will decide when you should stop and restart Glucophage XR treatment.
Glucophage XR does not cause hypoglycemia (low blood sugar).
However, if Glucophage XR is taken with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, 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 a sugary drink usually helps.
During treatment with Glucophage 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.
You should follow your doctor's dietary recommendations.
It may happen that the tablet coating is visible in the stool. Do not worry, this is normal when taking this type of tablet.

Glucophage XR with other medicines

If you are to be injected with a contrast agent containing iodine into the bloodstream, for example, for an X-ray examination or computed tomography, you must stop taking Glucophage XR before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart Glucophage XR treatment.
Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood glucose checks and kidney function tests or a dose adjustment of Glucophage XR by your doctor. It is particularly important to inform your doctor about the following 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),
• 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 or asthma),
• medicines that may change the level of Glucophage XR in the blood, especially if you have kidney problems (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat diabetes.

Glucophage XR with alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and using machines

Glucophage XR does not cause hypoglycemia (low blood sugar). This means it does not affect your ability to drive or use machines.
However, you should be careful if you are taking Glucophage XR with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating. If you experience such symptoms, do not drive or use machines.

Glucophage XR contains sodium

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

3. How to take Glucophage XR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Glucophage XR does not replace the benefits of a healthy lifestyle.
You should continue to follow your doctor's recommendations regarding diet and regular physical activity.

Recommended dose

Children: due to the lack of appropriate data on the safety of Glucophage XR in children, it should not be used in children.
Adults: treatment usually starts with one 500 mg Glucophage XR tablet once daily during the evening meal. After 10-15 days, the dose is adjusted by the doctor based on blood glucose measurements. After the dose is established, the doctor will consider switching to Glucophage XR 1000 mg.
The maximum daily dose is 2000 mg and is taken once daily during the evening meal.
In patients already treated with metformin, the initial dose of Glucophage XR should be equivalent to the daily dose of metformin in the form of immediate-release tablets.
In the case of switching from another oral anti-diabetic medicine to Glucophage XR 1000 mg, the doctor should discontinue the previously used medicine and use Glucophage XR 1000 mg in the dose specified above.
If you have impaired kidney function, your doctor may prescribe a lower dose.
In patients treated with metformin at a dose above 2000 mg per day in the form of immediate-release tablets, it is not recommended to switch to Glucophage XR.
If you are also taking insulin, your doctor will tell you how to start taking Glucophage XR.
In monotherapy (pre-diabetic state)
The usual dose is 1000 to 1500 mg of metformin hydrochloride once daily during the evening meal. The doctor will assess whether treatment should be continued based on regular blood glucose tests and risk factors.
Polycystic ovary syndrome
The usual dose is 1500 mg of metformin hydrochloride once daily during the evening meal.

Treatment monitoring

• Your doctor will order regular blood glucose tests and adjust the dose of Glucophage XR based on the blood glucose values. You should regularly visit your doctor for check-ups. This is especially important for elderly patients.
• Your doctor will check your kidney function at least once a year. More frequent checks may be necessary for elderly patients or if your kidneys are not working properly.

How to take Glucophage XR

Glucophage XR should be taken with a meal or immediately after a meal to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet with a glass of water.
If after some time you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Glucophage XR than recommended

If you take a higher dose of Glucophage XR than recommended, you may experience lactic acidosis. The symptoms of lactic acidosis are non-specific and include vomiting, abdominal 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 Glucophage XR and contact your doctor or the nearest hospital immediately.

Missing a dose of Glucophage XR

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, loss of appetite. These side effects usually occur at the beginning of Glucophage XR treatment and in most cases, they disappear on their own. Taking Glucophage XR with a meal or immediately after a meal may help. If the symptoms do not disappear, you should stop taking Glucophage XR and tell your doctor.

Common side effects (may affect up to 1 in 10 people)

• Taste disorders.
• Decreased or low levels of vitamin B in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or pale or yellowish skin). Your doctor may order some tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other non-diabetes-related health problems.

Rare side effects (may affect up to 1 in 1,000 people)

• Lactic acidosis. This is a very rare but serious side effect, especially if your kidneys are not working properly. Symptoms of lactic acidosis - see "Warnings and precautions".
• Abnormal liver function test results or symptoms of liver inflammation (with accompanying fatigue, loss of appetite, weight loss, and yellowing or non-yellowing of the skin and whites of the eyes). If such symptoms occur, you should stop taking Glucophage XR and tell your doctor immediately.
• Skin reactions, such as skin redness, itching, or itchy rash.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform 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 Glucophage XR

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Glucophage XR contains

• The active substance is metformin hydrochloride. One Glucophage XR tablet contains 1000 mg of metformin hydrochloride, which corresponds to 780 mg of metformin.
• The other ingredients are magnesium stearate, sodium carmellose, hypromellose 100,000 cPs.

What Glucophage XR looks like and contents of the pack

Glucophage XR tablets are white or almost white, oblong, biconvex with the inscription "1000" on one side and "MERCK" on the other side.
Each pack contains 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sante s.a.s.
37 rue Saint-Romain
69008 Lyon
France
(logo of the marketing authorization holder)

Manufacturer

Merck Sante s.a.s.
Centre de Production de Semoy
2 rue du Pressoir Vert
45400 Semoy
France
Merck Healthcare KGaA
Frankfurter str.250
64293 Darmstadt
Germany
Merck, S.L.
Poligono Merck
Mollet Del Vallés, 08100 Barcelona
Spain

Date of last revision of the package leaflet: March 2025