Glucophage 500 mg

Leaflet accompanying the packaging: information for the user

GLUCOPHAGE 500 mg, 500 mg, film-coated 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 those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Glucophage and what is it used for

Glucophage 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 helps reduce blood glucose levels to values as close to normal as possible.
In adults with overweight, long-term use of Glucophage also reduces the risk of complications associated with diabetes. Taking Glucophage is associated with maintaining body weight or moderate weight loss.
Glucophage is used to treat patients with type 2 diabetes (also called "non-insulin-dependent" diabetes), in whom diet and physical exercise alone cannot achieve adequate blood glucose control. It is particularly used in patients with overweight.
Adults can take Glucophage as the only medicine or in combination with other anti-diabetic medicines (oral or insulin).
Children from 10 years of age and adolescents can take Glucophage as the only medicine or in combination with insulin.

2. Important information before taking Glucophage

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When not to take Glucophage:

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• in case of liver dysfunction,
• if the patient has significantly reduced kidney function,
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketosis. Ketosis 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 an unusual fruity odor from the mouth,
• in case of excessive fluid loss from the body (dehydration), e.g. due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney dysfunction, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of severe infection, e.g. pneumonia, bronchitis or kidney infection. Severe infections can lead to kidney dysfunction, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of treatment of acute heart failure or recent myocardial infarction, severe circulatory disorders (e.g. 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 any of the above situations apply, 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 bloodstream,
• perform major surgery.

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

Warnings and precautions

Risk of lactic acidosis

Glucophage 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 adequately 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 if they have 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.
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The patient should stop taking Glucophage 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,
• muscle cramps,
• general feeling of being unwell, accompanied by severe 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 for further instructions 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.
• they experience any of the following symptoms after starting metformin: seizures, cognitive impairment, difficulty moving, symptoms of nerve damage (e.g. pain or numbness), migraine, or hearing loss.

If the patient is to undergo major surgery, they should not take Glucophage during the surgery and for a period after it. The doctor will decide when the patient should stop and resume Glucophage treatment.
Glucophage does not cause hypoglycemia (low blood sugar).
However, if Glucophage is taken in combination 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 a sugary drink usually helps.

Glucophage and other medicines

If the patient is to be injected with a contrast agent containing iodine into the bloodstream, e.g. for an X-ray examination or computed tomography, they must stop taking Glucophage before or at the latest at the time of the injection. The doctor will decide when the patient should stop and resume Glucophage treatment.
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 need more frequent blood glucose monitoring and kidney function tests or dose adjustments of Glucophage by the 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), 3
• 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 in the blood, especially if the patient has kidney dysfunction (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat diabetes.

Glucophage and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Glucophage, 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 glucose monitoring may be necessary.
This medicine is not recommended for breastfeeding women or those planning to breastfeed.

Driving and using machines

Glucophage 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 in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, 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.

3. How to take Glucophage

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 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 from 10 years of age and adolescents: usually start with a dose of 500 mg or 850 mg of Glucophage once a day. The maximum daily dose is 2000 mg and is taken in 2 or 3 divided doses. Treatment of children from 10 to 12 years of age is only used in case of special recommendation by the doctor, as experience with Glucophage in this age group is limited.
Adults: usually start with a dose of 500 mg or 850 mg of Glucophage, 2 or 3 times a day. The maximum daily dose is 3000 mg and is taken in 3 divided doses.
If the patient has kidney dysfunction, the doctor may prescribe a lower dose.
If the patient is also taking insulin, the doctor will inform them how to start taking Glucophage.

Treatment monitoring

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• The doctor will order regular blood glucose tests and adjust the dose of Glucophage based on the glucose levels. The patient should regularly visit their doctor for check-ups. This is especially important in children and adolescents, as well as in elderly patients.
• The doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary in elderly patients or if the patient's kidneys are not functioning properly.

How to take Glucophage

Glucophage should be taken during 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 the patient takes one dose a day, they should take it in the morning (breakfast).
• If the patient takes two doses a day, they should take them in the morning (breakfast) and evening (dinner).
• If the patient takes three doses a day, they should take them in the morning (breakfast), at noon (lunch), and evening (dinner).

If the patient feels that the effect of the medicine is too strong or too weak after some time, they should consult their doctor or pharmacist.

Taking a higher dose of Glucophage than recommended

If the patient takes a higher dose of Glucophage than recommended, they may experience lactic acidosis. The symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps), muscle cramps, general feeling of being unwell, accompanied by severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If the patient experiences any of these symptoms, they should immediately seek medical help, as lactic acidosis can lead to coma. The patient should stop taking Glucophage and contact their doctor or the nearest hospital immediately.

Missing a dose of Glucophage

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 can cause side effects, although not everybody gets them.
The side effects that may occur are listed below.
Glucophage 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 and contact their doctor or the nearest hospital immediately, 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 Glucophage treatment. It may be helpful to divide the daily dose into several smaller doses taken throughout the day and take Glucophage with a meal or immediately after a meal. If the symptoms do not disappear, the patient should stop taking Glucophage and tell their doctor.

Glucophage and side effects

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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 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 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. The symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
• Abnormal liver function test results or symptoms of liver inflammation (accompanied by fatigue, loss of appetite, and weight loss, as well as yellowing or non-yellowing of the skin and whites of the eyes). If such symptoms occur, the patient should stop taking Glucophage and tell their doctor.
• Skin reactions, such as skin redness, itching, or itchy rash.

Children and adolescents

Limited data in children and adolescents indicate that the side effects are similar in nature and severity to those observed in adults.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 4921 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Glucophage

The medicine should be stored out of sight and reach of children. If Glucophage is used in children, it is recommended that the treatment be supervised by parents or caregivers.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton after the "EXP" label. The expiry date refers to the last day of the month stated.
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.
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6. Contents of the packaging and other information

What Glucophage contains

• The active substance of Glucophage is metformin hydrochloride. One film-coated tablet of Glucophage 500 mg contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin.
• The other ingredients are: povidone K 30, magnesium stearate, hypromellose.

What Glucophage looks like and contents of the pack

Glucophage 500 mg film-coated tablets are white, round, and convex.
Each pack contains 30 or 100 film-coated 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.
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

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

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom (Northern Ireland): Glucophage.
Hungary: Merckformin
Date of last revision of the leaflet: March 2025
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