Metformin Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metformina DOC 500 mg film-coated tablets

Generic medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What METFORMINA DOC is and what it is used for

METFORMINA DOC 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 enables the human body to absorb
glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for
future use.
If you have diabetes, your pancreas does not produce enough insulin or your body is unable
to properly use the insulin it produces. This leads to high levels of glucose in the blood.
METFORMINA DOC helps lower the glucose level in your blood to as close to normal as
possible.
If you are overweight, taking METFORMINA DOC over a long period of time also helps reduce
the risk of diabetes-related complications. METFORMINA DOC is associated with stable body
weight or modest weight loss.
METFORMINA DOC is used to treat patients with type 2 diabetes (also known as
"non-insulin-dependent diabetes") when diet and exercise alone have not been sufficient to
control glucose levels in your blood. It is particularly used in overweight patients.
Adults may take METFORMINA DOC alone or in combination with other antidiabetic medicines
(oral medications or insulin).
Children from 10 years of age and adolescents may take METFORMINA DOC alone or in
combination with insulin.

2. What you need to know before taking METFORMIN DOC

Do not take METFORMIN DOC

• 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 associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or breath with an unusually fruity odour.
• If you have lost too much fluid from your body (dehydration), such as following prolonged or severe diarrhoea, or if you have vomited several times in succession. Dehydration may lead to kidney problems, which may put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you have a severe infection, such as infections of the lungs, bronchi or kidneys. Severe infections may lead to kidney failure, which may put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you are being treated for heart failure or have recently had a myocardial infarction, if you have serious circulation problems (such as shock) or breathing difficulties. These conditions may lead to insufficient oxygen supply to tissues, which may put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you consume large amounts of alcohol.

If you have any of the conditions listed above, consult your doctor before starting to take this medicine.
Make sure to ask your doctor if

• you are scheduled to undergo a diagnostic test such as X-rays or scanning requiring injection of an iodine-containing contrast agent into your bloodstream
• you are scheduled for surgery

Stop taking METFORMIN DOC for a certain period of time before and after the diagnostic test or surgical procedure. Your doctor will decide whether you need alternative treatment during this time. It is important that you follow your doctor’s instructions exactly.

Warnings and precautions
Risk of lactic acidosis
METFORMIN DOC may cause a very rare but serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterised by reduced oxygen supply to part of the body (such as severe heart disease).
If any of the above conditions apply to you, speak to your doctor before starting this medicine.

Temporarily stop taking METFORMIN DOC if you develop a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than normal. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking METFORMIN DOC and contact your doctor or go to the nearest hospital immediately, because lactic acidosis may lead to coma.
Symptoms of lactic acidosis include:

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

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are undergoing major surgery, you must stop taking METFORMIN DOC during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with METFORMIN DOC.

METFORMIN DOC alone does not cause hypoglycaemia (low blood sugar levels). However, if you take METFORMIN DOC together with other diabetes medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating, eating or drinking something containing sugar usually helps.

During treatment with METFORMIN DOC, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.

Other medicines and METFORMIN DOC
If you are scheduled to receive an injection of an iodinated contrast agent into your bloodstream, for example for an X-ray, you must stop taking METFORMIN DOC before or during the injection. Your doctor will decide when to stop and when to restart treatment with METFORMIN DOC.

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need to have your blood glucose and kidney function tested more frequently, or your doctor may decide to adjust the dose of METFORMIN DOC. It is particularly important to mention the following:

• 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 used to treat 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 a range of conditions, such as severe skin inflammation or asthma)
• medicines that may alter the amount of METFORMIN DOC 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

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

Pregnancy, breastfeeding and fertility
During pregnancy, insulin is required for the treatment of diabetes. If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine is not recommended during breastfeeding or if you are planning to breastfeed your baby.

Driving and using machines
METFORMIN DOC alone does not cause hypoglycaemia (low blood glucose levels). This means it does not affect your ability to drive or use machinery. However, exercise particular caution if you are taking METFORMIN DOC together with other diabetes medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, tachycardia, visual disturbances or difficulty concentrating. Do not drive or use machinery if these symptoms occur.

3. How to take METFORMINA DOC

Take this medicine exactly as directed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
METFORMINA DOC cannot replace the benefits of a healthy lifestyle. Continue to follow
all dietary advice given by your doctor and maintain regular physical activity.
The recommended dose is:
Children from 10 years of age and adolescents usually start with 500 mg or 850 mg of
METFORMINA DOC once daily. The maximum daily dose is 2000 mg, taken in 2 or
3 separate doses. Treatment in children aged between 10 and 12 years is recommended only on specific advice from the doctor, as experience in this age group is limited.
Adults usually start with 500 mg or 850 mg of METFORMINA DOC 2 or 3 times
daily. 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 advise you on how to start METFORMINA DOC.

Monitoring

• Your doctor will regularly check your blood glucose levels and adjust your dose of METFORMINA DOC accordingly. Make sure you see your doctor regularly. This is particularly important for children and adolescents, or if you are elderly.
• Your doctor will also check your kidney function at least once a year. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take METFORMINA DOC
Take the tablets during or after meals. This will help you avoid unwanted digestive side effects. Do not crush or chew the tablets. Swallow each tablet with a glass of water.

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

Metformina DOC 850 mg / 1000 mg has a score line. The score line is not intended for breaking the tablet.
If, after some time, you feel that the effect of METFORMINA DOC is too strong or too
weak, consult your doctor or pharmacist.
If you take more METFORMINA DOC than you should
If you have taken more METFORMINA DOC than you should, lactic acidosis may occur. Symptoms of lactic acidosis include vomiting, stomach pain (abdominal pain) with muscle cramps, a general feeling of being unwell with severe tiredness, and difficulty breathing. If any of these symptoms occur, you must seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking METFORMINA DOC immediately and contact a doctor or go to the nearest hospital immediately.
If you forget to take METFORMINA DOC
Do not take a double dose to make up for a forgotten dose. Take the next dose at your usual time.
If you have any further questions about the use of this medicine, consult 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 may occur:
METFORMINA DOC 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 METFORMINA DOC and seek immediate medical attention at a doctor's office or the nearest hospital, because lactic acidosis can lead to coma.

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

• Gastrointestinal problems such as nausea, vomiting, diarrhoea, stomach ache (abdominal pain), and loss of appetite. These side effects mostly occur at the beginning of treatment with METFORMINA DOC. It may help to spread the doses throughout the day and take the tablets during or after meals. If symptoms persist, stop taking METFORMINA DOC and consult your doctor.

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

• Altered taste.

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

• Lactic acidosis. This is a very rare but serious complication, especially if your kidneys are not functioning properly. The symptoms of lactic acidosis are non-specific (see section "Warnings and precautions").
• Changes in liver function tests or hepatitis (liver inflammation; this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking METFORMINA DOC and consult your doctor.
• Skin reactions such as redness of the skin (erythema), itching, or skin rash (urticaria).
• Low levels of vitamin B12 in the blood.

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 experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store METFORMINA DOC

Keep this medicine out of the sight and reach of children.
If a child is being treated with METFORMINA DOC, parents and caregivers must supervise the use of this medicine.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton, bottle or blister pack after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of medicines via 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 METFORMINA DOC 500 mg contains

• The active substance is metformin hydrochloride. Each film-coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
• The other components are: Povidone K90, magnesium stearate, hypromellose, macrogol 6000, macrogol 400.

Description of the appearance of METFORMINA DOC 500 mg and pack sizes
Film-coated tablets.
METFORMINA DOC 500 mg:
METFORMINA DOC 500 mg film-coated tablets are film-coated, white to yellowish, round, biconvex tablets with "MA" imprinted on one side.
METFORMINA DOC 500 mg is available in packs containing 30 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 - Milano
Italy

Manufacturer
SAG Manufacturing SLU
Ctra N-I, km. 36
28750 San Agustín del Guadalix
Madrid – Spain
or
Galenicum Health, S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla
Esplugues de Llobregat
08950 Barcelona
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Metformin DOC 500 mg comprimidos revestidos
Italy: Metformin DOC 500 mg compresse rivestite

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Metformina DOC 850 mg film-coated tablets

Equivalent medicinal product
Please 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 give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What METFORMINA DOC is and what it is used for

METFORMINA DOC 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 enables the human body to absorb
glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for
future use.
If you have diabetes, your pancreas does not produce enough insulin or your body is unable
to properly use the insulin it produces. This leads to high levels of glucose in the blood.
METFORMINA DOC helps lower the level of glucose in your blood to as near normal as
possible.
If you are overweight, taking METFORMINA DOC over a long period of time also helps reduce
the risk of diabetes-related complications. METFORMINA DOC is associated with stable body
weight or modest weight loss.
METFORMINA DOC is used in the treatment of patients with type 2 diabetes (also known as
“non-insulin-dependent diabetes”) when diet and exercise alone have not been sufficient to
control glucose levels in your blood. It is particularly used in overweight patients.
Adults may take METFORMINA DOC alone or in combination with other antidiabetic medicines
(oral medications or insulin).
Children from the age of 10 years and adolescents may take METFORMINA DOC alone or in
combination with insulin.

2. What you need to know before taking METFORMINA DOC

Do not take METFORMINA DOC

• 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 associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or breath with an unusual fruity odour.
• If you have lost too much fluid from your body (dehydration), such as following prolonged or severe diarrhoea, or if you have vomited repeatedly. Dehydration can lead to kidney problems, which may put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you have a severe infection, such as infections of the lungs, bronchi or kidneys. Severe infections may lead to kidney failure, which may put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you are being treated for heart failure or have recently had a myocardial infarction, if you have serious circulation problems (such as shock) or breathing difficulties. These conditions may lead to reduced oxygen supply to tissues, which may put you at risk of lactic acidosis (see “Warnings and precautions”).
• If you consume large amounts of alcohol.

If you have any of the conditions listed above, consult your doctor before starting to take this medicine.
Make sure to ask your doctor if

• you are scheduled to undergo a diagnostic test such as X-ray or scanning that requires injection of an iodine-containing contrast agent into your bloodstream
• you are scheduled to undergo surgery

Stop taking METFORMINA DOC for a certain period of time before and after the diagnostic test or surgical procedure. Your doctor will decide whether you need alternative treatment during this time. It is important that you follow your doctor’s instructions exactly.

Warnings and precautions
Risk of lactic acidosis
METFORMINA DOC may cause a very rare but serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterised by reduced oxygen supply to part of the body (such as severe heart disease).
If any of the conditions described above apply to you, speak to your doctor before starting this medicine.
Stop taking METFORMINA DOC temporarily if you develop 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 are drinking less fluids than usual. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking METFORMINA DOC and contact your doctor or go to the nearest hospital immediately, because lactic acidosis may lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of being unwell associated with severe fatigue
• difficulty breathing
• decreased body temperature and slower heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are undergoing major surgery, you must stop taking METFORMINA DOC during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with METFORMINA DOC.
METFORMINA DOC alone does not cause hypoglycaemia (low blood sugar level). However, if you take METFORMINA DOC together with other diabetes medicines that can cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating occur, it usually helps to eat or drink something containing sugar.
During treatment with METFORMINA DOC, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.

Other medicines and METFORMINA DOC
If you are scheduled to receive an injection of an iodinated contrast agent into your bloodstream, for example for an X-ray, you must stop taking METFORMINA DOC before or during the injection. Your doctor will decide when to stop and when to restart treatment with METFORMINA DOC.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need to monitor your blood glucose and kidney function more frequently, or your doctor may decide to adjust the dose of METFORMINA DOC. It is particularly important to mention the following:

• 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 used to treat 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 a range of conditions, such as severe skin inflammation or asthma)
• medicines that may alter the amount of METFORMINA DOC 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

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

Pregnancy, breastfeeding and fertility
During pregnancy, insulin is required for the treatment of diabetes. If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine is not recommended during breastfeeding or if you are planning to breastfeed your baby.

Driving and using machines
METFORMINA DOC alone does not cause hypoglycaemia (low blood glucose level). This means it does not affect your ability to drive or use machinery. However, take particular care if you are taking METFORMINA DOC together with other diabetes medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, tachycardia, visual disturbances or difficulty concentrating. Do not drive or operate machinery if these symptoms occur.

3. How to take METFORMINA DOC

Take this medicine exactly as prescribed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
METFORMINA DOC cannot replace the benefits of a healthy lifestyle. Continue to follow
all dietary advice provided by your doctor and maintain regular physical activity.
The recommended dose is:
Children from 10 years of age and adolescents usually start with 500 mg or 850 mg of
METFORMINA DOC once daily. The maximum daily dose is 2000 mg, taken in 2 or
3 separate doses. Treatment of children aged 10 to 12 years is recommended only on
specific advice of the doctor, as experience in this age group is limited.
Adults generally start with 500 mg or 850 mg of METFORMINA DOC 2 or 3 times
daily. 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 instruct you on how to start METFORMINA DOC.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust your dose of METFORMINA DOC according to your blood glucose levels. Make sure to consult your doctor regularly. This is particularly important for children and adolescents, or if you are elderly.
• Your doctor will also check your kidney function at least once a year. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take METFORMINA DOC
Take the tablets during or after meals. This will help you avoid gastrointestinal side effects. Do not crush or chew the tablets. Swallow each tablet with a glass of water.

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

Metformina DOC 850 mg / 1000 mg has a score line. The score line is not intended for breaking the tablet.
If, after some time, you feel that the effect of METFORMINA DOC is too strong or too weak, consult your doctor or pharmacist.

If you take more METFORMINA DOC than you should
If you have taken more METFORMINA DOC than prescribed, lactic acidosis may occur. Symptoms of lactic acidosis include vomiting, stomach pain (abdominal pain) with muscle cramps, a general feeling of malaise with severe fatigue, and difficulty breathing. If any of these symptoms occur, you must seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking METFORMINA DOC immediately and contact a doctor or the nearest hospital immediately.

If you forget to take METFORMINA DOC
Do not take a double dose to make up for the missed dose. Take the next dose at your usual time.
If you have any further questions about the use of this medicine, consult 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 may occur:

METFORMIN DOC 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 METFORMIN DOC and seek immediate medical advice from your doctor or the nearest hospital, because lactic acidosis can lead to coma.

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

• Gastrointestinal problems such as nausea, vomiting, diarrhoea, stomach ache (abdominal pain), and loss of appetite. These side effects mostly occur at the beginning of treatment with METFORMIN DOC. It may help to spread the doses throughout the day and to take the tablets during or after meals. If symptoms persist, stop taking METFORMIN DOC and consult your doctor.

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

• Altered taste.

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

• Lactic acidosis. This is a very rare but serious complication, especially if your kidneys are not functioning properly. The symptoms of lactic acidosis are non-specific (see section "Warnings and precautions").
• Changes in liver function tests or hepatitis (liver inflammation; this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking METFORMIN DOC and consult your doctor.
• Skin reactions such as redness of the skin (erythema), itching, or skin rash (urticaria).
• Low levels of vitamin B12 in the blood.

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 experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store METFORMIN DOC

Keep this medicine out of the sight and reach of children.
If a child is being treated with METFORMIN DOC, parents and caregivers must supervise the use of this medicine.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton, bottle, or blister pack after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of medicines via 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 METFORMINA DOC 850 mg contains

• The active substance is metformin hydrochloride. Each film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to 662.9 mg of metformin base.
• The other components are: Povidone K90, magnesium stearate, hypromellose, macrogol 6000, macrogol 400.

Description of the appearance of METFORMINA DOC 850 mg and pack contents
Film-coated tablets.
METFORMINA DOC 850 mg:
Metformin DOC 850 mg film-coated tablets are film-coated tablets of white to yellowish colour, biconvex, oval-shaped, with a score between the letters "M" and "B" on one side and a score on the opposite side.
METFORMINA DOC 850 mg is available in packs containing 30 or 40 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 - Milano
Italy

Manufacturer
SAG Manufacturing SLU
Ctra N-I, km. 36
28750 San Agustín del Guadalix
Madrid – Spain
or
Galenicum Health, S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla
Esplugues de Llobregat
08950 Barcelona
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Metformin DOC 850 mg comprimidos revestidos
Italy: Metformin DOC 850 mg compresse rivestite

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metformina DOC 1000 mg film-coated tablets

Generic medicine
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What METFORMINA DOC is and what it is used for

METFORMINA DOC 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 enables the body to absorb glucose (sugar) from the blood.
Your body uses glucose to produce energy or stores it for future use.
If you have diabetes, your pancreas does not produce enough insulin or your body is unable to use the insulin it produces effectively. This leads to high levels of glucose in the blood. METFORMINA DOC helps lower the level of glucose in your blood to as near normal as possible.
If you are overweight, long-term use of METFORMINA DOC also helps reduce the risk of diabetes-related complications. METFORMINA DOC is associated with stable body weight or modest weight loss.
METFORMINA DOC is used to treat patients with type 2 diabetes (also known as “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 may take METFORMINA DOC alone or in combination with other antidiabetic medicines (oral medications or insulin).
Children aged 10 years and older and adolescents may take METFORMINA DOC alone or in combination with insulin.

2. What you need to know before taking METFORMINA DOC

Do not take METFORMINA DOC

• 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 associated, for example, with severe hyperglycemia (high blood glucose levels), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or breath with an unusually fruity odor.
• If you have lost too much fluid from your body (dehydration), such as after prolonged or severe diarrhea, or if you have vomited repeatedly. Dehydration may lead to kidney problems, increasing your risk of lactic acidosis (see “Warnings and precautions”).
• If you have a severe infection, such as infections of the lungs, bronchi, or kidneys. Severe infections may lead to kidney failure, increasing your risk of lactic acidosis (see “Warnings and precautions”).
• If you are being treated for heart failure or have recently had a myocardial infarction, if you have serious circulation problems (such as shock) or breathing difficulties. These conditions may result in inadequate oxygen supply to tissues, increasing your risk of lactic acidosis (see “Warnings and precautions”).
• If you consume large amounts of alcohol.

If you have any of the conditions listed above, consult your doctor before starting to take this medicine.
Make sure to seek medical advice if:

• you are scheduled for a diagnostic test such as X-rays or scanning requiring injection of an iodinated contrast agent into your bloodstream
• you are scheduled for surgery

Stop taking METFORMINA DOC for a certain period of time before and after the diagnostic test or surgical procedure. Your doctor will decide whether you need alternative treatment during this time. It is important that you follow your doctor’s instructions exactly.

Warnings and precautions
Risk of lactic acidosis
METFORMINA DOC may cause a very rare but serious side effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterized by reduced oxygen supply to part of the body (such as severe heart disease).
If any of the above conditions apply to you, consult your doctor before starting this medicine.

Temporarily stop taking METFORMINA DOC if you develop a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking METFORMINA DOC and contact your doctor or the nearest hospital immediately, because lactic acidosis may lead to coma.
Symptoms of lactic acidosis include:

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

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are undergoing major surgery, you must stop taking METFORMINA DOC during the procedure and for a certain period afterward. Your doctor will decide when to stop and when to restart treatment with METFORMINA DOC.

METFORMINA DOC alone does not cause hypoglycemia (low blood sugar). However, if you take METFORMINA DOC together with other antidiabetic medicines that may 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, visual disturbances, or difficulty concentrating, eating or drinking something containing sugar usually helps.

During treatment with METFORMINA DOC, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.

Other medicines and METFORMINA DOC
If you are scheduled to receive an iodinated contrast agent injected into your bloodstream, for example for an X-ray, you must stop taking METFORMINA DOC before or during the injection. Your doctor will decide when to stop and when to restart treatment with METFORMINA DOC.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need to check your blood glucose and kidney function more frequently, or your doctor may decide to adjust the dose of METFORMINA DOC. It is particularly important to mention the following:

• medicines that increase urine production (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 agonists such as salbutamol or terbutaline (used to treat asthma)
• Corticosteroids (used to treat a range of conditions, such as severe skin inflammation or asthma)
• medicines that may alter the blood levels of METFORMINA DOC, 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

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

Pregnancy, breastfeeding, and fertility
During pregnancy, insulin is required for the treatment of diabetes. If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine is not recommended during breastfeeding or if you are planning to breastfeed your baby.

Driving and using machines
METFORMINA DOC alone does not cause hypoglycemia (low blood glucose). This means it does not affect your ability to drive or operate machinery. However, exercise particular caution if you are taking METFORMINA DOC together with other antidiabetic medicines that may cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, tachycardia, visual disturbances, or difficulty concentrating. Do not drive or operate machinery if these symptoms occur.

3. How to take METFORMINA DOC

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
METFORMINA DOC cannot replace the benefits of a healthy lifestyle. Continue to follow all dietary advice given by your doctor and maintain regular physical activity.

Recommended dose:
Children from 10 years of age and adolescents usually start with 500 mg or 850 mg of METFORMINA DOC once daily. The maximum daily dose is 2000 mg, taken in 2 or 3 divided doses. Treatment of children aged 10 to 12 years is recommended only under specific medical indication, as experience in this age group is limited.
Adults generally start with 500 mg or 850 mg of METFORMINA DOC 2 or 3 times daily. The maximum daily dose is 3000 mg, taken in 3 divided doses.
If you have reduced kidney function, your doctor may prescribe you a lower dose.
If you are also taking insulin, your doctor will advise you on how to start METFORMINA DOC.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust your dose of METFORMINA DOC according to your blood glucose levels. Make sure to see your doctor regularly. This is particularly important for children and adolescents, or if you are elderly.
• Your doctor will also check your kidney function at least once a year. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take METFORMINA DOC
Take the tablets during or after meals. This will help you avoid gastrointestinal side effects. Do not crush or chew the tablets. Swallow each tablet with a glass of water.

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

Metformina DOC 850 mg / 1000 mg has a score line. The score line is not intended for breaking the tablet.
If, after some time, you feel that the effect of METFORMINA DOC is too strong or too weak, consult your doctor or pharmacist.

If you take more METFORMINA DOC than you should
If you have taken more METFORMINA DOC than you should, lactic acidosis may occur. Symptoms of lactic acidosis include vomiting, stomach pain (abdominal pain) with muscle cramps, a general feeling of malaise with severe fatigue, and difficulty breathing. If any of these symptoms occur, you must seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking METFORMINA DOC immediately and contact a doctor or the nearest hospital immediately.

If you forget to take METFORMINA DOC
Do not take a double dose to make up for the forgotten dose. Take the next dose at your usual time.

If you have any further questions about 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 may occur:
METFORMINA DOC 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 METFORMINA DOC and seek immediate medical attention at the nearest doctor or hospital, because lactic acidosis can lead to coma.

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

• Gastrointestinal problems such as nausea, vomiting, diarrhoea, stomach ache (abdominal pain), and loss of appetite. These side effects mostly occur at the beginning of treatment with METFORMINA DOC. It may help to spread the doses throughout the day and take the tablets during or after meals. If symptoms persist, stop taking METFORMINA DOC and consult your doctor.

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

• Altered taste.

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

• Lactic acidosis. This is a very rare but serious complication, especially if your kidneys are not functioning properly. The symptoms of lactic acidosis are non-specific (see section "Warnings and precautions").
• Changes in liver function tests or hepatitis (inflammation of the liver; this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking METFORMINA DOC and consult your doctor.
• Skin reactions such as redness of the skin (erythema), itching, or skin rash (urticaria).
• Low levels of vitamin B12 in the blood.

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 experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store METFORMINA DOC

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

6. Package contents and other information

What METFORMINA DOC 1000 mg contains

• The active substance is metformin hydrochloride. Each film-coated tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.
• The other components are: Povidone K90, magnesium stearate, hypromellose, macrogol 6000, macrogol 400.

Description of the appearance of METFORMINA DOC 1000 mg and package contents
Film-coated tablets.
METFORMINA DOC 1000 mg:
Metformin DOC 1000 mg film-coated tablets are film-coated tablets, white to yellowish in colour, biconvex, oval-shaped, with "MC" engraved on one side and a break line on the other side.
METFORMINA DOC 1000 mg is available in packages containing 60 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 - Milano
Italy

Manufacturer
SAG Manufacturing SLU
Ctra N-I, km. 36
28750 San Agustín del Guadalix
Madrid – Spain
or
Galenicum Health, S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla
Esplugues de Llobregat
08950 Barcelona
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Metformin DOC 1000 mg comprimidos revestidos
Italy: Metformin DOC 1000 mg compresse rivestite