Glucophage Xr

Package Leaflet: Information for the Patient

GLUCOPHAGE XR, 750 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

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 people with diabetes, the pancreas does not produce enough insulin or the body is not able to use the insulin it produces properly. This leads to high blood glucose levels. Glucophage XR helps lower 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 mellitus (also called non-insulin-dependent diabetes). It is particularly used in patients with overweight.
Adults can take Glucophage XR alone or in combination with other anti-diabetic medicines (oral or insulin).
In the prevention of type 2 diabetes in patients with prediabetes.
In polycystic ovary syndrome.

2. Important information before taking Glucophage XR

When not to take Glucophage XR:

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

Glucophage XR must be discontinued for a certain 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 cases 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, consult your doctor for more detailed instructions.

Temporary discontinuation of Glucophage XR is recommended 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. Consult your doctor for more detailed instructions.

Discontinue Glucophage XR and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis

as it 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.

Consult your doctor immediately if you:

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

If you are to undergo major surgery, you must not take Glucophage XR during and for some time after the surgery. Your doctor will decide when you should stop and restart Glucophage XR.
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.
Follow your doctor's dietary recommendations.
It is not uncommon for the tablet coating to appear in the stool. Do not be concerned, as this is normal when taking this type of tablet.

Glucophage XR with other medicines

If you are to receive an iodine-containing contrast agent into your 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.
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 monitoring 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 levels 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

Avoid excessive alcohol consumption while taking Glucophage XR, as it may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor, as your treatment or blood sugar monitoring may need to be adjusted.
This medicine is not recommended for breastfeeding women or those 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, be cautious if you take 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 operate machinery.

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.
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 750 mg Glucophage XR tablet once daily, taken during the evening meal. After 10-15 days, the dose is adjusted by the doctor based on blood glucose measurements. Gradual dose increase may improve gastrointestinal tolerance.
Your doctor may increase the dose up to a maximum of 2 Glucophage XR 750 mg tablets, taken once daily during the evening meal.
In patients already treated with metformin, the initial dose of Glucophage XR 750 mg should be equivalent to the daily dose of metformin in the form of immediate-release tablets.
When switching from another oral anti-diabetic medicine to Glucophage XR 750 mg, the doctor should discontinue the previously used medicine and use Glucophage XR 750 mg at the dose specified above.
If you have kidney problems, 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 inform you how to start taking Glucophage XR.
In monotherapy (prediabetes)
Usually, a dose of 1000 to 1500 mg of metformin hydrochloride is taken once daily during the evening meal. The doctor will assess whether treatment should be continued based on regular blood glucose testing and risk factors.
Polycystic ovary syndrome
Usually, a dose of 1500 mg of metformin hydrochloride is taken once daily during the evening meal.

Monitoring of treatment

• Your doctor will prescribe 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

Take Glucophage XR with a meal or just 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 Glucophage XR is too strong or too weak, consult your doctor or pharmacist.

Overdose of Glucophage XR

In case of overdose, Glucophage XR may cause lactic acidosis. 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, seek medical help immediately, as lactic acidosis can lead to coma. Stop taking Glucophage XR and contact your doctor or the nearest hospital immediately.

Missed 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 with Glucophage XR:
Glucophage XR may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, stop taking Glucophage XR and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

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 treatment with Glucophage XR and in most cases, they disappear on their own. Taking Glucophage XR with a meal or just after a meal may help. If the symptoms do not disappear, 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, or numbness 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.

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 of the skin and whites of the eyes, with or without jaundice). If such symptoms occur, stop taking Glucophage XR and tell your doctor immediately.
• Skin reactions, such as redness, itching, or itchy rash (hives).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 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 750 mg of metformin hydrochloride, which corresponds to 585 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 "750" engraved on one side and "MERCK" on the other side.
Each pack contains 30, 60, 90, or 120 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sante s.a.s., 37 rue Saint-Romain, 69008 Lyon, France

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 leaflet: March 2025