Glucophage Xr

Leaflet attached to the packaging: patient information

GLUCOPHAGE XR, 500 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, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 later 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 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 diabetes complications. Taking Glucophage XR is associated with maintaining body weight or modest weight loss.
Glucophage XR is used to treat patients with type 2 diabetes (also known as 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 condition.
In polycystic ovary syndrome.

2. Important information before taking Glucophage XR

1

When not to take Glucophage XR:

If any of the above situations occur, the patient should consult their doctor before taking this medicine.
It is essential to consult a 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,
• perform a major surgical procedure.

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

Warnings and precautions

Risk of lactic acidosis

Glucophage XR may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney dysfunction. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver dysfunction, 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 circumstances apply to the patient, they should consult their doctor for more detailed instructions.

The patient should temporarily stop taking Glucophage XR if they have a condition that may be associated with dehydration

(significant fluid loss from the body), 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.
2

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

as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, accompanied by extreme fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate. Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.

The patient should contact their doctor immediately if they:

• 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.
• experience any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or hearing loss.

If the patient is to undergo a major surgical procedure, they must not take Glucophage XR during the procedure and for a period after it. The doctor will decide when the patient must stop and resume treatment with Glucophage XR.
Glucophage XR does not cause hypoglycemia (low blood sugar).
However, if Glucophage XR is taken in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, 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 a sugary drink usually helps.
During treatment with Glucophage XR, the doctor will monitor the patient's kidney function at least once a year or more frequently if the patient is elderly and (or) has impaired kidney function.
The patient should follow the dietary recommendations given by their doctor.
It may happen that the tablet coating is visible in the stool. The patient should not be concerned, as this is normal when taking this type of tablet.

Glucophage XR with other medicines

If the patient is to be injected with a contrast agent containing iodine into the blood, e.g. for an X-ray examination or computed tomography, they must stop taking Glucophage XR before or at the latest at the time of the injection. The doctor will decide when the patient must stop and resume treatment with Glucophage XR.
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 require more frequent blood glucose monitoring and kidney function assessments or dose adjustments of Glucophage XR by their doctor. It is particularly important to inform 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 the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat diabetes.

Glucophage XR with alcohol

The patient 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 the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor, as changes in treatment or blood sugar monitoring may be necessary.
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 the patient's ability to drive or use machines.
However, the patient should be careful if they 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 such symptoms occur, the patient should not drive or use machines.

Glucophage XR contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Glucophage XR

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Glucophage XR does not replace the benefits of a healthy lifestyle.
The patient should continue to follow their doctor's recommendations regarding diet and regular physical activity.

Recommended dose

Children: due to the lack of appropriate safety data, Glucophage XR 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. Gradual dose increase may improve gastrointestinal tolerance.
The doctor may increase the dose up to a maximum of 4 tablets per day (2000 mg), taken once daily during the evening meal.
In patients already treated with metformin, the initial dose of Glucophage XR 500 mg 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 500 mg, the doctor should discontinue the previously used medicine and use Glucophage XR 500 mg in the dose specified above.
If the patient has impaired kidney function, the 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 the patient is also taking insulin, the doctor will inform them how to start taking Glucophage XR.
In monotherapy (pre-diabetic condition)
Usually, a dose of 1000 to 1500 mg of metformin hydrochloride is used 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 used once daily during the evening meal.

Treatment monitoring

• The doctor will order regular blood glucose tests and adjust the dose of Glucophage XR based on blood glucose levels. The patient should regularly attend follow-up appointments with their doctor. This is especially important for elderly patients.
• The doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary for elderly patients or if the patient's kidneys are not functioning properly.

How to take Glucophage XR

Glucophage XR should be taken with a meal or immediately after a meal. This will help avoid gastrointestinal side effects.
The patient should not crush or chew the tablets. They should swallow the tablet with a glass of water.
If after some time the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Glucophage XR than recommended

In case of taking a higher dose of Glucophage XR than recommended, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps), general feeling of being unwell, accompanied by extreme 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 attention, as lactic acidosis can lead to coma. The patient should stop taking Glucophage XR and contact their doctor or the nearest hospital.

Missing a dose of Glucophage XR

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Glucophage XR can cause side effects, although not everybody gets them.
The side effects that may occur are listed below.
Glucophage XR may very rarely cause (may occur in up to 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Glucophage XR and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.

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

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

Glucophage XR and tell their doctor.

Common side effects (may occur in less than 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). The 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.

Very rare side effects (may occur in less than 1 in 10,000 people)

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

Reporting side effects

If the patient experiences any side effects, including any side effects 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 Glucophage XR

The medicine should be stored out of 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 the month.
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 Glucophage XR contains

• The active substance of Glucophage XR is metformin hydrochloride. One Glucophage XR tablet contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin.
• The other ingredients are magnesium stearate, sodium carmellose, hypromellose.

What Glucophage XR looks like and contents of the pack

Glucophage XR tablets are white or almost white, round, biconvex with the inscription "500" on one 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 leaflet: March 2025

8