GLUCOPHAGE 500 mg Tabletki Powlekane

Treść ulotki

1. GLUCOPHAGE 1000 mg film-coated tablets
   1. What is Glucophage and what is it used for
   2. What you need to know before taking Glucophage
   3. How to take Glucophage
   4. Possible side effects
   5. How to store Glucophage
   6. Package contents and other information
2. GLUCOPHAGE 850 mg film-coated tablets
   1. What is Glucophage and what is it used for
   2. What you need to know before taking Glucophage
   3. How to take Glucophage
   4. Possible side effects
   5. How to store Glucophage
   6. Package contents and other information
3. GLUCOPHAGE 500 mg film-coated tablets
   1. What is Glucophage and what is it used for
   2. What you need to know before taking Glucophage
   3. How to take Glucophage
   4. Possible side effects
   5. How to store Glucophage
   6. Package contents and other information

GLUCOPHAGE 1000 mg film-coated tablets

metformin hydrochloride

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 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 is Glucophage and what is it used for

Glucophage contains metformin, a medicine to treat diabetes. It belongs to a group of
active substances called biguanides.
Insulin is a hormone produced by the pancreas that allows the body to absorb glucose
(sugar) from the blood. The body uses glucose to produce energy or stores it for future
use.
If you have diabetes, the pancreas does not produce enough insulin or your body is not
able to use the insulin it produces correctly. This causes high levels of glucose in
the blood. Glucophage helps to lower blood glucose, bringing it to a level as close as
normal as possible.
If you are an overweight adult, taking Glucophage for a long period of time also contributes
to reducing the risk of complications associated with diabetes. Glucophage has been associated with both
stabilization and modest body weight loss.
Glucophage is used to treat patients with type 2 diabetes (also called “non-
insulin-dependent diabetes”) when diet and exercise alone have not been sufficient to
control blood glucose levels. It is particularly used in overweight patients.
Adults can take Glucophage alone or in combination with other medicines to treat
diabetes (medicines administered orally or insulin).
Children aged 10 years and over and adolescents can take Glucophage alone
or in combination with insulin.

2. What you need to know before taking Glucophage

Do not take Glucophage

• if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (listed in section 6).
• if you have liver problems.
• if you have severely reduced kidney function.
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood glucose levels), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and can lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness and breath with an unusually fruity odor.
• if your body has lost too much water (dehydration), for example, due to prolonged or severe diarrhea or if you have vomited repeatedly. Dehydration can cause kidney problems that can expose you to the risk of lactic acidosis (see section “Warnings and precautions”).
• if you have a severe infection, such as an infection affecting the lungs or bronchial system or the kidneys. Severe infections can cause kidney problems, which can expose you to the risk of lactic acidosis (see section “Warnings and precautions”).
• if you are being treated for acute heart failure or have recently had a heart attack, if you have severe circulatory problems (such as shock) or difficulty breathing. This can cause oxygen deficiency in the tissues, which can expose you to the risk of lactic acidosis (see section “Warnings and precautions”).
• if you drink a lot of alcohol.

If you are in any of the above conditions, consult your doctor before starting to take this
medicine.
Make sure to ask your doctor for advice if:

• you need to undergo examinations such as X-rays or diagnostic scans that require the injection of iodine-containing contrast agents into the bloodstream
• you need to undergo surgery

You must stop taking Glucophage for a certain period of time before and after
the examination or surgery. Your doctor will decide if you need another treatment for that period of time. It is important that you carefully follow all of your doctor's instructions.

Warnings and precautions
Risk of lactic acidosis.
Glucophage can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased by the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for more information), liver problems and any other medical condition in which an area of the body is deprived of oxygen supply (such as severe acute heart disease).
If you have any of the medical conditions described above, consult your doctor for further
instructions.

Stop taking Glucophage for a short period of time if you have a medical condition
that may be associated with dehydration(significant loss of body fluids) such as severe
vomiting, diarrhea, fever, exposure to heat or if you drink less fluids than usual. Consult your
doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Glucophage and
seek immediate medical attention or go to the nearest hospital, as lactic acidosis can lead to coma.
The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of unwellness associated with severe fatigue
• difficulty breathing
• reduced body temperature (hypothermia) and slower heartbeat

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are to undergo major surgery, you must stop taking
Glucophage during the surgery and for a certain period of time afterwards. Your
doctor will decide when you should stop and when you should resume treatment with
Glucophage. Glucophage alone does not cause hypoglycemia (blood glucose levels too low).
However, if you take Glucophage together with other medicines to treat diabetes 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, visual disturbances or difficulty concentrating, it is usually helpful to eat
or drink something containing sugar.

Other medicines and Glucophage
If you are to receive an injection of iodine-containing contrast agents into the bloodstream, for
example as part of X-rays or diagnostic scans, you must stop taking
Glucophage before and after the examination. Your doctor will decide when you should stop and when
you can resume treatment with Glucophage.
Tell your doctor if you are taking, have recently taken or might take any other
medicines. You may need to have your blood glucose and
kidney function checked more frequently or your doctor may decide to adjust the dose of Glucophage. It is
particularly important to mention the use of

• medicines that increase urine production (diuretics).
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• some medicines for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• beta-2 agonists such as salbutamol or terbutaline (used to treat asthma).
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma).
• drugs that can alter the amount of Glucophage in the blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
• other medicines used to treat diabetes.

Glucophage with alcohol
Avoid excessive alcohol consumption and medicines containing alcohol during treatment with
Glucophage, as this may increase the risk of lactic acidosis (see section
“Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor for advice
before taking this medicine so that they can make changes to your treatment if necessary, or monitor
your blood glucose levels.
This medicine is not recommended if you are breastfeeding or intend to breastfeed your
baby.

Driving and using machines
Glucophage alone does not cause hypoglycemia (blood glucose levels too low). This means
that it does not impair your ability to drive vehicles or use machines.
However, be particularly careful if you are taking Glucophage together with other medicines for
treating diabetes that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). The
symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid
heartbeat, visual disturbances or difficulty concentrating. Do not drive vehicles and do not use
machines if you start to experience these symptoms.

3. How to take Glucophage

Always take this medicine exactly as your doctor has told you. If you have any doubts
consult your doctor or pharmacist.
Glucophage cannot replace the benefits of a healthy lifestyle. Continue to follow all the advice
on diet given to you by your doctor and exercise regularly.

Recommended dose
Children aged 10 years and over and adolescents usually start with 500 mg or 850
mg of Glucophage once a day. The maximum daily dose is 2000 mg taken in 2 or 3 separate doses.
Treatment of children between 10 and 12 years of age is recommended only on
specific medical advice, as experience in this age group is limited.
Adults usually start with 500 mg or 850 mg of Glucophage two or three times a day. The
maximum daily dose is 3000 mg taken in 3 separate doses.
If you have reduced kidney function, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will tell you how to start taking Glucophage.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust the dose of Glucophage to your blood sugar levels. See your doctor regularly. This is particularly important for children and adolescents or if you are an elderly person.
• Your doctor will also check at least once a year how well your kidneys are working. You may need more frequent checks if you are an elderly person or if your kidneys are not working normally.

How to take Glucophage
Take the tablets during or after a meal. This will help avoid unwanted effects that
disturb digestion.
Do not crush or chew the tablets. Swallow each tablet with a glass of water.

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

If, after a while, you think that the effect of Glucophage is too strong or too weak,
consult your doctor or pharmacist.

If you take more Glucophage than you should
If you have taken more Glucophage than you should, you may develop lactic acidosis. The symptoms
of lactic acidosis are non-specific such as vomiting, stomach pain (abdominal pain) with muscle cramps,
a general feeling of unwellness with extreme tiredness and difficulty breathing.
Further symptoms include a decrease in body temperature and heart rate. If
you experience any of these symptoms you should seek medical attention immediately, as
lactic acidosis can lead to coma. Stop taking Glucophage and contact
your doctor or the nearest hospital immediately.

If you forget to take Glucophage
Do not take a double dose to make up for a forgotten dose. Take the next dose
at the scheduled time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects can occur:
Glucophage may cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Glucophage and immediately contact yourdoctor or the nearest hospital, because lactic acidosis can lead to coma

• 10,000) but very serious called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Glucophage and immediately contact yourdoctor or the nearest hospital, because lactic acidosis can lead to coma

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

• digestive problems such as nausea, vomiting, diarrhoea, stomach pain (abdominal pain) and loss of appetite. These side effects are more likely to occur at the beginning of treatment with Glucophage. It may be helpful to divide the doses throughout the day and take Glucophage during or immediately after a meal. If symptoms persist, stop takingGlucophage and contact your doctor.

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

• altered taste.
• reduced or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), red and sore tongue (glossitis), tingling (paraesthesia) or pale or yellowish skin). Your doctor may prescribe some tests to find out the cause of the symptoms because some of these may also be caused by diabetes or other health problems not related to this medicine.

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

• lactic acidosis. This is a very rare but serious complication, particularly if your kidneys are not working properly. The symptoms of lactic acidosis are non-specific (see section “Warnings and precautions”)
• abnormalities in liver function tests or hepatitis (inflammation of the liver; can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or the whites of the eyes). If you experience such symptoms, stop taking Glucophage andcontact your doctor;
• skin reactions such as redness of the skin (erythema), itching or itchy rash (urticaria);

Children and adolescents
Limited data in children and adolescents have shown that adverse events were similar in
nature and severity to those reported in adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Glucophage

Keep this medicine out of the sight and reach of children. If a child is
treated with Glucophage, parents and those caring for the child must supervise the use of
this medicine.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack or the bottle or the
blister after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Glucophage contains

• The active ingredient is metformin hydrochloride. One film-coated tablet of Glucophage 1000 mg contains 1000 mg of metformin hydrochloride corresponding to 780 mg of metformin base.
• The other ingredients are povidone K 30, magnesium stearate ,hypromellose, macrogol 400 and macrogol 8000.

Description of the appearance of Glucophage and package contents
Glucophage 1000 mg film-coated tablets are white in colour, oval in shape
and biconvex, with a breaking line on both sides of the tablet and the inscription '1000' on one
side, with dimensions of 19 mm X 10.5 mm and a height of 6.4 mm. The tablet can be divided into two
equal doses.
The tablets are available in blister packs of 1 (x30), 20, 30, 50, 60, 90, 100, 120, 180 or
600 tablets or in plastic bottles with a child-resistant closure containing 20, 30, 50, 60, 90, 100,
120, 180 or 600 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bruno Farmaceutici S.p.A.
Via delle Ande, 15
00144 Rome
Italy

Manufacturer
Merck Santé s.a.s.
2 rue du Pressoir Vert
45400 Semoy
France
or
Merck Healthcare KGaA
Frankfurter Str. 250
64293 Darmstadt
Germany
or
Merck S.L.
Poligono Merck
Mollet Del Vallès 08100 Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland, Ireland,
Italy, Latvia, Norway, Poland, Romania, Slovakia, Slovenia, Sweden: Glucophage
Hungary: Merckformin
Portugal: Risidon

GLUCOPHAGE 850 mg film-coated tablets

metformin hydrochloride

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 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 is Glucophage and what is it used for

Glucophage contains metformin, a medicine to treat diabetes. It belongs to a group of
active substances called biguanides.
Insulin is a hormone produced by the pancreas that allows the body to absorb glucose
(sugar) from the blood. The body uses glucose to produce energy or stores it for future
use.
If you have diabetes, the pancreas does not produce enough insulin or your body is not
able to use the insulin it produces correctly. This causes high levels of glucose in
the blood. Glucophage helps to lower blood glucose, bringing it to as normal a level as
possible.
If you are an overweight adult, taking Glucophage for a long period of time also contributes
to reducing the risk of complications associated with diabetes. Glucophage has been associated with both
stabilization and modest weight loss.
Glucophage is used to treat patients with type 2 diabetes (also called “non-
insulin-dependent diabetes”) when diet and exercise alone have not been sufficient to
control blood glucose levels. It is particularly used in overweight patients.
Adults can take Glucophage alone or in combination with other medicines to treat
diabetes (medicines administered orally or insulin).
Children aged 10 years and over and adolescents can take Glucophage alone
or in combination with insulin.

2. What you need to know before taking Glucophage

Do not take Glucophage

• if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (listed in section 6);
• if you have liver problems;
• if you have severely reduced kidney function;
• if you have uncontrolled diabetes, with for example, severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and can lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness and breath with an unusually fruity odour;
• if your body has lost too much water (dehydration), for example, due to prolonged or severe diarrhoea or if you have vomited many times in a row. Dehydration can cause kidney problems which can expose you to the risk of lactic acidosis (see section “Warnings and precautions”);
• if you have a severe infection, such as an infection affecting the lungs or the bronchial system or the kidneys. Severe infections can cause kidney problems, which can expose you to the risk of lactic acidosis (see section “Warnings and precautions”);
• if you are being treated for acute heart failure or have recently had a heart attack, if you have severe circulatory problems (such as shock) or difficulty breathing. This can cause oxygen deficiency in the tissues which can expose you to the risk of lactic acidosis (see section “Warnings and precautions”);
• if you drink a lot of alcohol.

If you are in any of the above conditions, consult your doctor before starting to take this
medicine.
Make sure you ask your doctor for advice if:

• you need to undergo examinations such as X-rays or diagnostic scans that require the injection of iodine-containing contrast agents into the bloodstream;
• you need to undergo surgery.

You must stop taking Glucophage for a certain period of time before and after
the examination or surgery. Your doctor will decide if you need another treatment during that time. It is important that you follow your doctor's instructions precisely.

Warnings and precautions
Risk of lactic acidosis
Glucophage can cause a very rare but very serious side effect called lactic acidosis, particularly if your kidneys do not function properly. The risk of developing lactic acidosis is also increased by the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for more information), liver problems and any other medical condition in which an area of the
body is deprived of oxygen supply (such as severe acute heart disease).
If you have any of the medical conditions described above, consult your doctor for further
instructions.

Stop taking Glucophage for a short period of time if you have a medical condition
that may be associated with dehydration(significant loss of body fluids) such as severe
vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than usual. Consult your
doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Glucophage and
seek immediate medical attention or go to the nearest hospital,because lactic acidosis can lead to coma.
The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of unwellness with severe tiredness
• difficulty breathing
• reduced body temperature (hypothermia) and slower heartbeat.

Lactic acidosis is a medical emergency and requires treatment in hospital.
If you are to have major surgery, you must stop taking
Glucophage during the surgery and for a certain period of time afterwards. Your
doctor will decide when you should stop and when you should resume treatment with
Glucophage. Glucophage alone does not cause hypoglycaemia (blood glucose levels too low).
However, if you take Glucophage together with other medicines to treat diabetes that can
cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If
you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, rapid
heartbeat, vision disturbances or difficulty concentrating, it is usually helpful to eat or drink something that contains sugar.
During treatment with Glucophage, your doctor will check your kidney function at least
annually, more frequently if you are elderly and/or have impaired kidney function.

Other medicines and Glucophage
If you are to receive an injection of iodine-containing contrast agents into the bloodstream, for
example, as part of X-rays or diagnostic scans, you must stop taking
Glucophage before and after the examination. Your doctor will decide when you should stop and when
you can resume treatment with Glucophage.
Tell your doctor if you are taking, have recently taken or might take any other
medicines. You may need to have your blood glucose and kidney function checked more often or your doctor may decide to adjust the dose of Glucophage. It is
particularly important to mention the use of

• medicines that increase urine production (diuretics);
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib);
• some medicines for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists);
• beta-2 agonists such as salbutamol or terbutaline (used to treat asthma);
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma);
• medicines that can alter the amount of Glucophage in the blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib);
• other medicines used to treat diabetes.

Glucophage with alcohol
Avoid excessive alcohol consumption and medicines containing alcohol during treatment with
Glucophage as this may increase the risk of lactic acidosis (see section
“Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor for advice
before taking this medicine so that they can make adjustments to your treatment if necessary, or monitor
your blood glucose levels.
This medicine is not recommended if you are breastfeeding or intend to breastfeed your
baby.

Driving and using machines
Glucophage alone does not cause hypoglycaemia (blood glucose levels too low). This means
that it does not impair your ability to drive or operate machinery.
However, be particularly careful if you take Glucophage together with other medicines to
treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). The
symptoms of hypoglycaemia include weakness, dizziness, increased sweating, rapid
heartbeat, vision disturbances or difficulty concentrating. Do not drive or operate
machines if you start to experience these symptoms.

3. How to take Glucophage

Always take this medicine exactly as your doctor has told you. If you have any doubts
consult your doctor or pharmacist.
Glucophage cannot replace the benefits of a healthy lifestyle. Continue to follow all the advice
on diet given to you by your doctor and exercise regularly.

Recommended dose
Children aged 10 years and over and adolescents usually start with 500 mg or 850
mg of Glucophage once a day. The maximum daily dose is 2000 mg taken in 2 or 3 doses
separated. Treatment of children between 10 and 12 years of age is recommended only on
specific medical advice, as experience in this age group is limited.
Adults usually start with 500 mg or 850 mg of Glucophage two or three times a day. The
maximum daily dose is 3000 mg taken in 3 separate doses.
If you have reduced kidney function, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will tell you how to start taking Glucophage.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust the dose of Glucophage according to your blood sugar levels. Consult your doctor regularly. This is particularly important for children and adolescents or if you are an elderly person.
• Your doctor will also check at least once a year how well your kidneys are functioning. You may need more frequent checks if you are an elderly person or if your kidneys are not functioning normally.

How to take Glucophage
Take the tablets during or after a meal. This will help avoid unwanted effects that
disturb digestion.
Do not crush or chew the tablets. Swallow each tablet with a glass of water.

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

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

If you take more Glucophage than you should
If you have taken more Glucophage than you should, you may develop lactic acidosis. The symptoms
of lactic acidosis are non-specific such as vomiting, stomach pain (abdominal pain) with muscle cramps,
general feeling of unwellness with extreme fatigue and difficulty breathing.
Further symptoms include a decrease in body temperature and heart rate. If

you experience any of these symptoms you must seek medical attention immediately, as
lactic acidosis can lead to coma. Stop taking Glucophage and contact
your doctor or the nearest hospital immediately.

If you forget to take Glucophage
Do not take a double dose to make up for a forgotten dose. Take the next dose
at the scheduled time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects can occur:
Glucophage can cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Glucophage and immediately contact yourdoctor or the nearest hospital,because lactic acidosis can lead to coma.

• 10,000) but very serious called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Glucophage and immediately contact yourdoctor or the nearest hospital,because lactic acidosis can lead to coma.

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

• digestive problems such as nausea, vomiting, diarrhoea, stomach pain (abdominal pain) and loss of appetite. These side effects are more likely to occur at the beginning of treatment with Glucophage. It may be helpful to divide the doses throughout the day and take Glucophage during or immediately after a meal. If symptoms persist, stoptaking Glucophage and contact your doctor.

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

• taste alteration; reduced or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), red and sore tongue (glossitis), tingling (paresthesia) or pale or yellowish skin). Your doctor may prescribe some tests to find out the cause of the symptoms because some of these may also be caused by diabetes or other health problems not related to this medicine.

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

• lactic acidosis. This is a very rare but serious complication, particularly if the kidneys are not functioning properly; The symptoms of lactic acidosis are non-specific (see the section “Warnings and precautions”) ;
• abnormalities in liver function tests or hepatitis (inflammation of the liver; can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or the whites of the eyes). If you experience such symptoms, stop taking Glucophage andcontact your doctor;
• skin reactions such as skin redness (erythema), itching or itchy rash (urticaria);

Children and adolescents
Limited data in children and adolescents have shown that adverse events were similar in
nature and severity to those reported in adults.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Glucophage

Keep this medicine out of the sight and reach of children. If a child is
treated with Glucophage, parents and those caring for the child must supervise the use of
this medicine.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack or the bottle or the
blister after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Glucophage contains

• The active ingredient is metformin hydrochloride. One film-coated Glucophage 850 mg tablet contains 850 mg of metformin hydrochloride corresponding to 662.9 mg of metformin base;
• The other ingredients are povidone K 30, magnesium stearate ,hypromellose.

Description of the appearance of Glucophage and package contents
Glucophage 850 mg film-coated tablets are white, circular and convex in shape.
The tablets are available in blister packs of 1 (x100), 8, 9, 10, 14, 20, 21, 30, 40, 50, 56,
60, 84, 90, 100, 120, 300, 600 or 1000 tablets and in plastic bottles with child-resistant closures containing 30, 60, 200, 300 or 600 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bruno Farmaceutici S.p.A.
Via delle Ande, 15
00144 Roma
Italy

Manufacturer
Merck Santé s.a.s.
2 rue du Pressoir Vert
45400 Semoy
France
or
Merck Healthcare KGaA
Frankfurter Str. 250
64293 Darmstadt
Germany
or
Merck S.L.
Poligono Merck
Mollet Del Vallès
08100 Barcellona
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
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
Hungary: Merckformin
Portugal: Risidon

GLUCOPHAGE 500 mg film-coated tablets

metformin hydrochloride

Read this leaflet carefully before taking this medicinebecause it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 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 is Glucophage and what is it used for

Glucophage contains metformin, a medicine to treat diabetes. It belongs to a group of
active substances called biguanides.
Insulin is a hormone produced by the pancreas that allows the body to absorb glucose
(sugar) from the blood. The body uses glucose to produce energy or stores it for future
use.
If you have diabetes, the pancreas does not produce enough insulin or your body is not
able to use the insulin it produces correctly. This causes high levels of glucose in
the blood. Glucophage helps to lower blood glucose, bringing it to as normal a level as
possible.
If you are an overweight adult, taking Glucophage for a long period of time also contributes
to reducing the risk of complications associated with diabetes. Glucophage has been associated with both
stabilization and modest body weight loss.
Glucophage is used to treat patients with type 2 diabetes (also called “non-
insulin-dependent diabetes”) when diet and exercise alone have not been sufficient to
control blood glucose levels. It is particularly used in overweight patients.
Adults can take Glucophage alone or in combination with other medicines to treat
diabetes (medicines administered orally or insulin).
Children aged 10 years and over and adolescents can take Glucophage alone
or in combination with insulin.

2. What you need to know before taking Glucophage

Do not take Glucophage

• if you are allergic (hypersensitive) to metformin or to any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems
• if you have severely reduced kidney function.
• if you have uncontrolled diabetes, with for example, severe hyperglycemia (high blood glucose levels), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and can lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness and breath with an unusually fruity odor.
• if your body has lost too much water (dehydration), for example, due to prolonged or severe diarrhea or if you have vomited many times in a row. Dehydration can cause kidney problems that can expose you to the risk of lactic acidosis (see section “Warnings and precautions”).
• if you have a severe infection, such as an infection affecting the lungs or bronchial system or the kidneys. Severe infections can cause kidney problems, which can expose you to the risk of lactic acidosis (see section “Warnings and precautions”).
• if you are being treated for acute heart failure or have recently had a heart attack, if you have severe circulatory problems (such as shock) or difficulty breathing. This can cause oxygen deficiency in the tissues, which can expose you to the risk of lactic acidosis (see section “Warnings and precautions”).
• if you drink a lot of alcohol

If you are in any of the above conditions, consult your doctor before starting to take this
medicine.
Make sure to ask your doctor for advice if:

• you need to undergo examinations such as X-rays or diagnostic scans that require the injection of contrast agents containing iodine into the bloodstream
• you need to undergo surgery

You must stop taking Glucophage for a certain period of time before and after
the examination or surgery. The doctor will decide if you need another treatment for that period of time. It is important that you follow your doctor's instructions precisely.

Warnings and precautions
Risk of lactic acidosis
Glucophage can cause a very rare but very serious side effect called lactic
acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis
is also increased by the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for more
information), liver problems and any other medical condition in which an area of
the body is deprived of oxygen supply (such as severe acute heart disease).
If you have any of the medical conditions described above, consult your doctor for further
instructions.

Stop taking Glucophage for a short period of time if you have a medical condition
that may be associated with dehydration(significant loss of body fluids) such as
vomiting, diarrhea, fever, exposure to heat or if you drink less fluids than usual. Consult your
doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Glucophage and
seek immediate medical attention or go to the nearest hospital,because lactic acidosis can lead to coma.
The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of unwellness associated with severe fatigue
• difficulty breathing
• reduced body temperature (hypothermia) and slower heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are to undergo major surgery, you must stop taking
Glucophage during the surgery and for a certain period of time afterwards. The
doctor will decide when you should stop and when you should resume treatment with
Glucophage. Glucophage alone does not cause hypoglycemia (blood glucose levels too
low). However, if you take Glucophage together with other medicines to treat diabetes 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, visual disturbances or difficulty concentrating, it is usually helpful to eat
or drink something containing sugar.

During treatment with Glucophage, your doctor will check your kidney function at least
annually or more frequently if you are elderly and/or have impaired kidney function.

Other medicines and Glucophage
If you are to receive an injection of contrast agents containing iodine into the bloodstream, for
example as part of X-rays or diagnostic scans, you must stop taking
Glucophage before and after the examination. Your doctor will decide when you should stop and when
you can resume treatment with Glucophage.
Tell your doctor if you are taking, have recently taken or may take any other
medicines. You may need to have your blood glucose and
kidney function checked more often or your doctor may decide to adjust the dose of Glucophage. It is
particularly important to mention the use of:

• medicines that increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• some medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• beta-2 agonists such as salbutamol or terbutaline (used to treat asthma)
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma)
• drugs that can alter the amount of Glucophage in the blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
• other medicines used to treat diabetes

Glucophage with alcohol
Avoid excessive alcohol consumption and medicines containing alcohol while being treated with
Glucophage as this may increase the risk of lactic acidosis (see section
“Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor for advice
before taking this medicine so that they can make changes to your treatment if necessary, or monitor your
blood glucose levels.
This medicine is not recommended if you are breastfeeding or intend to breastfeed your
baby.

Driving and using machines
Glucophage alone does not cause hypoglycemia (blood glucose levels too low). This means
that it does not impair your ability to drive vehicles or use machines.
However, be particularly careful if you take Glucophage together with other medicines to
treat diabetes that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). The
symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid
heartbeat, visual disturbances or difficulty concentrating. Do not drive vehicles and do not use
machines if you start to experience these symptoms.

3. How to take Glucophage

Always take this medicine exactly as your doctor has told you. If you have any doubts
consult your doctor or pharmacist.
Glucophage cannot replace the benefits of a healthy lifestyle. Continue to follow all the advice
on diet given to you by your doctor and exercise regularly.

Recommended dose
Children aged 10 years and over and adolescents usually start with 500 mg or 850
mg of Glucophage once a day. The maximum daily dose is 2000 mg taken in 2 or 3 separate doses.
Treatment of children aged between 10 and 12 years is recommended only on
specific medical advice, as experience in this age group is limited.
Adults usually start with 500 mg or 850 mg of Glucophage two or three times a day. The
maximum daily dose is 3000 mg taken in 3 separate doses.
If you have reduced kidney function, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will tell you how to start taking Glucophage.

Monitoring

• Your doctor will subject you to regular blood glucose tests and adjust the dose of Glucophage to your blood sugar levels. Consult your doctor regularly. This is particularly important for children and adolescents or if you are an elderly person.
• Your doctor will also check at least once a year how your kidneys are functioning. You may need more frequent checks if you are an elderly person or if your kidneys are not functioning normally.

How to take Glucophage
Take the tablets during or after a meal. This will help you avoid undesirable effects that
disturb digestion.
Do not crush or chew the tablets. Swallow each tablet with a glass of water.

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

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

If you take more Glucophage than you should
If you have taken more Glucophage than you should, you may develop lactic acidosis. The symptoms
of lactic acidosis are non-specific such as vomiting, stomach pain (abdominal pain) with muscle cramps,
general feeling of unwellness with extreme fatigue and difficulty breathing.
Further symptoms include a reduction in body temperature and heart rate. If

you experience any of these symptoms you should seek medical attention immediately, as
lactic acidosis can lead to coma. Stop taking Glucophage and contact
your doctor or the nearest hospital immediately.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects can occur:
Glucophage can cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Glucophage and immediately contact adoctor or the nearest hospital,because lactic acidosis can lead to coma.

• 10,000) but very serious called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Glucophage and immediately contact adoctor or the nearest hospital,because lactic acidosis can lead to coma.

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

• digestive problems such as nausea, vomiting, diarrhoea, stomach pain (abdominal pain) and loss of appetite. These side effects are more likely to occur at the beginning of treatment with Glucophage. It may be helpful to divide the doses throughout the day and take Glucophage during or immediately after a meal. If symptoms persist, stoptaking Glucophage and contact your doctor.

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

• altered taste; reduced or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), red and sore tongue (glossitis), tingling (paraesthesias) or pale or yellowish skin). Your doctor may prescribe some tests to find out the cause of your symptoms because some of these may also be caused by diabetes or other health problems not related

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

• lactic acidosis. This is a very rare but serious complication, particularly if the kidneys are not functioning properly. The symptoms of lactic acidosis are non-specific (see section “Warnings and precautions”)
• abnormalities in liver function tests or hepatitis (inflammation of the liver; can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or the whites of the eyes). If you experience these symptoms, stop taking Glucophage andcontact your doctor;
• skin reactions such as redness of the skin (erythema), itching or itchy rash (urticaria);

Children and adolescents
Limited data in children and adolescents have shown that adverse events were similar in
nature and severity to those reported in adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Glucophage

Keep this medicine out of the sight and reach of children. If a child is
treated with Glucophage, parents and those who care for the child must supervise the use of
this medicine.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack or the bottle or the
blister after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Glucophage contains

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

Description of the appearance of Glucophage and package contents
Glucophage 500 mg film-coated tablets are white in colour, circular in shape
and convex.
The tablets are available in blister packs of 1 (x100), 9, 20, 21, 30, 40, 50, 56, 60, 84, 90,
100, 120, 200, 500, 600 or 1000 tablets and in plastic bottles with child-resistant closure
containing 21, 30, 40, 50, 60, 100, 120, 300, 400, 500, 600 or 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bruno Farmaceutici S.p.A.
Via delle Ande, 15
00144 Roma
Italy

Manufacturer
Merck Santé s.a.s.
2 rue du Pressoir Vert
45400 Semoy
France
or
Merck Healthcare KGaA
Frankfurter Str. 250
64293 Darmstadt
Germany
or
Merck S.L.
Poligono Merck
Mollet Del Vallès 08100 Barcellona
Spain

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