GLUCOPHAGE 850 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. GLUCOPHAGE 850 mg, 850 mg, film-coated tablets
   1. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
   2. Contents of the pack
3. What Glucophage is and what it is used for
4. What you need to know before you take Glucophage
   1. Do not take Glucophage:
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. You must stop taking Glucophage if you have any condition that may cause dehydration
   5. You must stop taking Glucophage and contact your doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis
   6. Glucophage with other medicines
   7. Glucophage with alcohol
   8. Pregnancy and breast-feeding
   9. Driving and using machines
5. How to take Glucophage
   1. Recommended dose
   2. Monitoring of treatment
   3. How to take Glucophage
   4. What to do if you take more Glucophage than you should
   5. What to do if you miss a dose of Glucophage
6. Possible side effects
   1. Very common side effects (may affect more than 1 in 10 people)
   2. Glucophage and tell your doctor.
   3. Common side effects (may affect up to 1 in 10 people)
   4. Very rare side effects (may affect up to 1 in 10,000 people)
   5. Children and adolescents
   6. Reporting of side effects
7. How to store Glucophage
8. Contents of the pack and other information
   1. What Glucophage contains
   2. What Glucophage looks like and contents of the pack
   3. Marketing Authorisation Holder
   4. Manufacturer
   5. This medicinal product is authorised in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: March 2025

Package Leaflet: Information for the User

GLUCOPHAGE 850 mg, 850 mg, film-coated tablets

(Metformin hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Glucophage is and what it is used for

Glucophage contains metformin, a medicine used to treat diabetes. It belongs to a group of medicines called biguanides.
Insulin, a hormone produced by the pancreas, allows the body to use glucose (sugar) from the blood for energy or to store it for future use.
In people with diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin produced. This leads to high blood glucose levels. Glucophage helps lower blood glucose levels to 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 maintains or slightly reduces body weight.
Glucophage is used to treat patients with type 2 diabetes mellitus (also called non-insulin-dependent diabetes), where diet and exercise alone are not enough to control blood glucose levels. It is particularly used in patients who are overweight.
Adults can take Glucophage alone or in combination with other oral anti-diabetic medicines or with insulin.
Children from 10 years of age and adolescents can take Glucophage alone or in combination with insulin.

2. What you need to know before you take Glucophage

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Do not take Glucophage:

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• if you have liver disease,
• if you have severely reduced kidney function,
• if you have uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a disease 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 a fruity odor from the mouth,
• if you have severe dehydration (loss of water from the body), 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),
• if you have a 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),
• if you have acute heart failure or have recently had a heart attack, severe circulatory problems (such as shock) or breathing difficulties. This can cause tissue hypoxia (lack of oxygen), which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• if you drink a lot of alcohol.

If any of the above apply to you, you should talk to your doctor before taking this medicine.
It is essential to consult your doctor if you need to:

• have an X-ray or a scan that involves the use of a contrast medium that contains iodine,
• have a major surgical operation.

Glucophage will need to be stopped for a certain period before and after the scan or surgery. Your doctor will decide whether you need another treatment during this time. It is essential to follow your doctor's instructions.

Warnings and precautions

Risk of lactic acidosis

Glucophage can cause a very rare but serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of lactic acidosis increases with uncontrolled diabetes, severe infection, prolonged fasting or alcohol intake, dehydration (see more information below), liver disease, and any conditions that may cause tissue hypoxia (such as acute heart failure).
If any of the above apply to you, you should talk to your doctor for further instructions.

You must stop taking Glucophage if you have any condition that may cause dehydration

(loss of water from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than you normally would. You should talk to your doctor for further instructions.
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You must stop taking Glucophage and contact your doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis

because this condition can lead to coma.
The symptoms of lactic acidosis are non-specific and include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, with severe fatigue,
• difficulty breathing,
• low body temperature and slow heart rate. Lactic acidosis is a medical emergency that requires immediate hospital treatment.

You should contact your doctor immediately if you:

• have a hereditary disease affecting the mitochondria (the energy-producing structures within 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, impaired cognitive function, difficulty moving, signs of nerve damage (such as pain or numbness), migraine, or hearing loss.

If you are going to have a major surgical operation, you should not take Glucophage during or for a certain period after the operation. Your doctor will decide when you should stop and restart taking Glucophage.
Glucophage does not cause hypoglycemia (low blood sugar).
However, if Glucophage 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, blurred vision, or difficulty concentrating, eating or drinking something containing sugar usually helps.

Glucophage with other medicines

If you are going to have an iodine-containing contrast medium injected into your bloodstream, for example for an X-ray or a scan, you should stop taking Glucophage before or at the time of the injection. Your doctor will decide when you should stop and restart taking Glucophage.
You should 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 monitoring of your blood glucose levels and kidney function, or your doctor may need to adjust your dose of Glucophage. It is particularly important to inform your doctor about:

• 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 allergies or asthma),
• medicines that may affect the levels of Glucophage in your blood, especially if you have kidney problems (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other anti-diabetic medicines.

Glucophage with alcohol

You should avoid excessive alcohol intake while taking Glucophage because it can increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 use during breast-feeding or if you are planning to breast-feed.

Driving and using machines

Glucophage 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 with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, blurred vision, or difficulty concentrating. If you experience any of these symptoms, do not drive or operate machinery.

3. How to take Glucophage

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

Recommended dose

Children from 10 years of age and adolescents: the starting dose is usually 500 mg or 850 mg Glucophage once daily. The maximum daily dose is 2000 mg, taken in 2 or 3 divided doses. Treatment of children from 10 to 12 years of age is only recommended if your doctor considers it necessary, as experience in this age group is limited.
Adults: the starting dose is usually 500 mg or 850 mg Glucophage 2 or 3 times daily. The maximum daily dose is 3000 mg, taken in 3 divided doses.
If you have kidney problems, your doctor may prescribe a lower dose.
If you are taking insulin, your doctor will tell you how to start taking Glucophage.

Monitoring of treatment

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• -Your doctor will ask you to have regular blood glucose tests and will adjust your dose of Glucophage according to your blood glucose levels. You should have regular check-ups with your doctor. This is particularly important for children and adolescents and for older people.
• Your doctor will check your kidney function at least once a year. More frequent checks may be necessary for older people or if your kidneys are not working properly.

How to take Glucophage

Take Glucophage with or just after a meal. This will help reduce the risk of gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet with a glass of water.

• If you take one dose a day, take it in the morning (with breakfast).
• If you take two doses a day, take them in the morning (with breakfast) and in the evening (with dinner).
• If you take three doses a day, take them in the morning (with breakfast), at lunchtime (with lunch) and in the evening (with dinner).

If, after some time, you think that the effect of Glucophage is too strong or too weak, talk to your doctor or pharmacist.

What to do if you take more Glucophage than you should

If you take more Glucophage than you should, 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 difficulty breathing. Other symptoms include low body temperature and slow heart rate. If you experience any of these symptoms, you should seek medical attention immediately,
stop taking Glucophage and contact your doctor or the nearest hospital.

What to do if you miss a dose of Glucophage

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 on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Glucophage can cause side effects, although not everybody gets them.
The following side effects may occur with Glucophage:
Glucophage can very rarely cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens, you must stop taking Glucophage 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 most often occur at the start of treatment with Glucophage. It may help to divide the daily dose into several smaller doses, taken with meals or just after meals. If the symptoms do not improve, you should stop taking Glucophage and talk to your doctor.

Glucophage and tell your doctor.

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

• Taste disturbances.
• Decreased or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain and redness of the tongue, numbness or tingling, or pale or yellowish skin). Your doctor may order several tests to find the cause of your symptoms, as some of these may also be due to your diabetes or other health problems.

Very rare side effects (may affect up to 1 in 10,000 people)

• Lactic acidosis. This is a very rare but serious side effect, especially if your kidneys are not working properly. The symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
• Abnormal liver function tests or signs of liver inflammation (with fatigue, loss of appetite, weight loss, and jaundice or without jaundice). If you experience any of these symptoms, you should stop taking Glucophage and talk to your doctor.
• Skin reactions, such as redness, itching, or itchy rash (hives).

Children and adolescents

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for reporting side effects" section below.
You can also report side effects directly to the manufacturer.

5. How to store Glucophage

Keep this medicine out of the sight and reach of children.
If Glucophage is used in children, treatment should be supervised by a parent or other responsible adult.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date which is 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Glucophage contains

• The active substance is metformin hydrochloride. One film-coated tablet of Glucophage 850 mg contains 850 mg metformin hydrochloride, equivalent to 662.9 mg metformin.
• The other ingredients are: povidone K30, magnesium stearate, hypromellose.

What Glucophage looks like and contents of the pack

Glucophage 850 mg film-coated tablets are white, round, and convex.
Each pack contains 30 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck Sante s.a.s.
37, rue Saint-Romain
69008 Lyon
France
(logo of the Marketing Authorisation 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
(only for Greece)
Petsiavas S.A
Agion Anargiron 21, Kaliftaki
Kato Kifisia Attiki 14564
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Spain: Dianben
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, France, Germany, Greece, Iceland, Ireland,
Italy, Luxembourg, Norway, Poland, Romania, Slovakia, Slovenia, Sweden, United Kingdom (Northern Ireland): Glucophage.
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Hungary: Merckformin
Portugal: Risidon

Date of last revision of the leaflet: March 2025

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