Metformin Pharmacare: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metformina Pharmacare

500 mg film-coated tablets
metformin hydrochloride
Equivalent 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What METFORMINA PHARMACARE is and what it is used for
What you need to know before taking METFORMINA PHARMACARE
How to take METFORMINA PHARMACARE
Possible side effects
How to store METFORMINA PHARMACARE
Contents of the pack and other information

1. What METFORMIN PHARMACARE is and what it is used for

METFORMIN PHARMACARE 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 later 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. METFORMIN PHARMACARE helps lower blood glucose levels to as near normal as possible.
If you are overweight, taking METFORMIN PHARMACARE over a long period of time also helps reduce the risk of diabetes-related complications. METFORMIN PHARMACARE is associated with stable body weight or modest weight loss.
METFORMIN PHARMACARE 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 may take METFORMIN PHARMACARE alone or in combination with other antidiabetic medicines (oral medications or insulin).
Children aged 10 years and older and adolescents may take METFORMIN PHARMACARE alone or in combination with insulin.

2. What you need to know before taking METFORMIN PHARMACARE

Do not take METFORMIN PHARMACARE

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 after prolonged or severe diarrhoea, or if you have vomited several times in succession. Dehydration may lead to kidney problems, which could 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 could 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 inadequate oxygen supply to tissues, which could 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 this medicine.
Make sure to seek medical advice if:

you are scheduled for a diagnostic test such as X-rays or scanning that requires injection of an iodine-containing contrast agent into your bloodstream
you are scheduled for surgery.

Stop taking METFORMIN PHARMACARE 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 PHARMACARE may cause a very rare but very 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 acute heart disease).
If any of the above conditions apply to you, consult your doctor before starting this medicine.
Stop taking METFORMIN PHARMACARE temporarily 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 PHARMACARE and contact your doctor or 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.
Contact your doctor immediately for further instructions if:

you know you have a hereditary genetic disease affecting mitochondria (the components that produce energy within cells), such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes, mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD, Maternal Inherited Diabetes and Deafness);
you experience any of the following symptoms after starting metformin: seizures, reduced cognitive abilities, movement difficulties, symptoms indicating nerve damage (e.g. pain or numbness), migraine and deafness.

If you are undergoing major surgery, you must stop taking METFORMIN PHARMACARE during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with METFORMIN PHARMACARE.
METFORMIN PHARMACARE alone does not cause hypoglycaemia (blood glucose level too low). However, if you take METFORMIN PHARMACARE together with other medicines for the treatment of diabetes that can cause hypoglycaemia (such as sulphonylureas, 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 PHARMACARE, 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 METFORMIN PHARMACARE
If you are scheduled to receive an injection of an iodinated contrast agent into your bloodstream, for example for an X-ray or diagnostic scan, you must stop taking METFORMIN PHARMACARE before or during the injection. Your doctor will decide when to stop and when to restart treatment with METFORMIN PHARMACARE.
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. 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 PHARMACARE. 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 amount of METFORMIN PHARMACARE 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 PHARMACARE and alcohol
Avoid excessive alcohol consumption during treatment with METFORMIN PHARMACARE, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy, breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor before taking this medicine so that necessary adjustments to your treatment can be made or your blood glucose levels monitored.
This medicine is not recommended if you are breastfeeding or intend to breastfeed your baby.

Driving and using machines
METFORMIN PHARMACARE alone does not cause hypoglycaemia (low blood glucose level). This means it does not affect your ability to drive or use machines.
However, exercise particular caution if you are taking METFORMIN PHARMACARE together with other medicines for the treatment of diabetes that can cause hypoglycaemia (such as sulphonylureas, 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 METFORMIN PHARMACARE

Take this medicine exactly as directed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
METFORMIN PHARMACARE 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
METFORMIN PHARMACARE 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
medical advice, as experience in this age group is limited.
Adults generally start with 500 mg or 850 mg of METFORMIN PHARMACARE 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 METFORMIN
PHARMACARE.

Monitoring

Your doctor will perform regular blood glucose tests and adjust your dose of METFORMIN PHARMACARE 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 METFORMIN PHARMACARE
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).

If, after some time, you feel that the effect of METFORMIN PHARMACARE is too strong or
too weak, consult your doctor or pharmacist.
If you take more METFORMIN PHARMACARE than you should
If you have taken more METFORMIN PHARMACARE than you should, lactic acidosis may
occur. Symptoms of lactic acidosis are non-specific and include vomiting, stomach pain
(abdominal pain) with muscle cramps, a general feeling of malaise with severe fatigue, and
difficulty breathing. Further symptoms include lowered body temperature and slowed heart rate.
If any of these symptoms occur, you must seek immediate medical attention,
as lactic acidosis can lead to coma. Stop taking METFORMIN PHARMACARE
immediately and contact a doctor or go to the nearest hospital immediately.
If you forget to take METFORMIN PHARMACARE
Do not take a double dose to make up for the forgotten dose. Take the next dose at your usual
scheduled 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 PHARMACARE 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 PHARMACARE and contact your doctor or go to the nearest hospital immediately, as 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 PHARMACARE. It may help to spread the doses throughout the day and take the tablets during or immediately after meals. If symptoms persist, stop taking METFORMINA PHARMACARE and consult 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 sensations (paraesthesias), or pale or yellowish skin). Your doctor may carry out certain tests to determine the cause of symptoms, as some of these may also be caused by diabetes or other unrelated health conditions.

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. 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 PHARMACARE and consult your doctor.
Skin reactions such as redness of the skin (erythema), itching, or skin 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 experience any side effect, 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 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 METFORMIN PHARMACARE

Keep this medicine out of the sight and reach of children.
If a child is being treated with METFORMIN PHARMACARE, 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 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 PHARMACARE 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 PHARMACARE 500 mg and pack sizes
Film-coated tablets.
METFORMINA PHARMACARE 500 mg:
METFORMINA PHARMACARE 500 mg film-coated tablets are film-coated, white to yellowish, round, biconvex tablets with "MA" engraved on one side.
METFORMINA PHARMACARE 500 mg is available in packs containing 30 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pharmacare srl
Via Marghera 29
20149 Milano
Italy

Manufacturer
SAG Manufacturing SLU
Ctra N-I, km. 36
28750 San Agustín del Guadalix
Madrid – Spain
Or
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Metformina Pharmacare

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Metformina Pharmacare

850 mg film-coated tablets
metformin hydrochloride
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as 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 others, even if their symptoms are the same as yours, as it may 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:

What METFORMINA PHARMACARE is and what it is used for
What you need to know before taking METFORMINA PHARMACARE
How to take METFORMINA PHARMACARE
Possible side effects
How to store METFORMINA PHARMACARE
Contents of the pack and other information

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

METFORMINA PHARMACARE 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 properly use the insulin it produces. This leads to high levels of glucose in the blood. METFORMINA PHARMACARE helps lower the level of glucose in your blood to as near normal as possible.
If you are overweight, long-term use of METFORMINA PHARMACARE may also help reduce the risk of diabetes-related complications. METFORMINA PHARMACARE is associated with stable body weight or modest weight loss.
METFORMINA PHARMACARE 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 PHARMACARE alone or in combination with other antidiabetic medicines (oral medications or insulin).
Children from the age of 10 years and adolescents may take METFORMINA PHARMACARE alone or in combination with insulin.

2. What you need to know before taking METFORMIN PHARMACARE

Do not take METFORMIN PHARMACARE

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 following prolonged or severe diarrhea, or if you have vomited repeatedly. Dehydration may lead to kidney problems, putting 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, putting 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 result in inadequate oxygen supply to tissues, putting 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 seek medical advice if

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

Warnings and precautions

Risk of lactic acidosis
METFORMIN PHARMACARE 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 characterized by reduced oxygen supply to part of the body (such as in cases of severe acute heart disease).
If any of the above conditions apply to you, speak to your doctor before starting this medicine.

Temporarily stop taking METFORMIN PHARMACARE 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 normal. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking METFORMIN PHARMACARE and contact your doctor or go to the nearest hospital immediately, as 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.

Seek immediate medical advice if:

you know you have a hereditary genetic disease affecting mitochondria (the components that produce energy within cells), such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes) or Maternal Inherited Diabetes and Deafness (MIDD);
you experience any of the following symptoms after starting metformin: seizures, cognitive decline, movement difficulties, symptoms indicating nerve damage (e.g., pain or numbness), headache, or hearing loss.

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

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

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 METFORMIN PHARMACARE. 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 METFORMIN PHARMACARE, 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.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor so that they can adjust 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
METFORMIN PHARMACARE alone does not cause hypoglycemia (low blood sugar). This means it does not affect your ability to drive or use machinery.
However, exercise particular caution if you are taking METFORMIN PHARMACARE together with other diabetes medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances, or difficulty concentrating. Do not drive or operate machinery if these symptoms occur.

3. How to take METFORMIN PHARMACARE

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
METFORMIN PHARMACARE 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 METFORMIN PHARMACARE 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 on specific medical advice, as experience in this age group is limited.
Adults generally start with 500 mg or 850 mg of METFORMIN PHARMACARE 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 a lower dose.
If you are also taking insulin, your doctor will advise you on how to start METFORMIN PHARMACARE.

Monitoring

Your doctor will perform regular blood glucose tests and adjust your dose of METFORMIN PHARMACARE 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 METFORMIN PHARMACARE
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).

Metformin Pharmacare 850 mg tablets have a score line. The score line is not intended to facilitate breaking the tablet.

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

If you take more METFORMIN PHARMACARE than you should
If you have taken more METFORMIN PHARMACARE than you should, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, stomach pain (abdominal pain) with muscle cramps, a general feeling of illness 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 METFORMIN PHARMACARE immediately and contact a doctor or go to the nearest hospital immediately.

If you forget to take METFORMIN PHARMACARE
Do not take a double dose to make up for the forgotten dose. Take the next dose at your usual scheduled 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 everyone experiences them. The following side effects may occur:
METFORMINA PHARMACARE 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 PHARMACARE and contact your doctor or go to the nearest hospital immediately, 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 PHARMACARE. It may help to spread the doses throughout the day and take the tablets during or after meals. If symptoms persist, stop taking METFORMINA PHARMACARE and consult 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 sensations (paraesthesias), or pale or yellowish skin). Your doctor may carry out some tests to determine the cause of the symptoms, as some of these may also be caused by diabetes or other unrelated health problems.

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. 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 tiredness, 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 PHARMACARE and consult your doctor.
Skin reactions such as redness of the skin (erythema), itching, or skin 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 experience any side effect, 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 website
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 METFORMINA PHARMACARE

Keep this medicine out of the sight and reach of children.
If a child is being treated with METFORMINA PHARMACARE, 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 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 PHARMACARE 850 mg contains

The active substance is metformin hydrochloride. One 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 PHARMACARE 850 mg and contents of
the pack
Film-coated tablets.
METFORMINA PHARMACARE 850 mg:
METFORMINA PHARMACARE 850 mg film-coated tablets are film-coated tablets, white to yellowish in colour, biconvex, oval-shaped, with a score between the letters M and B on one side and a break line on the other side.
METFORMINA PHARMACARE 850 mg is available in packs containing 30 or 40 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pharmacare srl
Via Marghera 29
20149 Milano
Italy

Manufacturer
SAG Manufacturing SLU
Ctra N-I, km. 36
28750 San Agustín del Guadalix
Madrid – Spain
or
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain

This medicinal product is authorized in the European Economic Area countries under
the following names:
Italy: Metformina Pharmacare

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metformina Pharmacare

1000 mg film-coated tablets
metformin hydrochloride
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 other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What METFORMINA PHARMACARE is and what it is used for
What you need to know before taking METFORMINA PHARMACARE
How to take METFORMINA PHARMACARE
Possible side effects
How to store METFORMINA PHARMACARE
Contents of the pack and other information

1. What METFORMIN PHARMACARE is and what it is used for

METFORMIN PHARMACARE contains metformin, a medicine used for the treatment of
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
later 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.
METFORMIN PHARMACARE helps lower blood glucose levels to as near normal as possible.
If you are overweight, long-term use of METFORMIN PHARMACARE also helps reduce the
risk of diabetes-related complications. METFORMIN PHARMACARE is associated with stable
body weight or modest weight loss.
METFORMIN PHARMACARE 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 METFORMIN PHARMACARE alone or in combination with other antidiabetic
medicines (oral medications or insulin).
Children from the age of 10 years and adolescents may take METFORMIN PHARMACARE
alone or in combination with insulin.

2. What you should know before taking METFORMINA PHARMACARE

Do not take METFORMINA PHARMACARE

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 your diabetes is uncontrolled and 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 after prolonged or severe diarrhoea, 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 lead to reduced 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 above conditions, consult your doctor before starting 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 iodine-containing contrast medium into your bloodstream
you are scheduled for surgery.

Stop taking METFORMINA PHARMACARE 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 PHARMACARE may cause a very rare but very serious side effect called lactic acidosis, particularly 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 acute heart disease).
If any of the above conditions apply to you, consult your doctor before starting this medicine.

Temporarily stop taking METFORMINA PHARMACARE if you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as 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 METFORMINA PHARMACARE 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.

Contact your doctor immediately for further instructions if:

you know you have a hereditary genetic disease affecting mitochondria (the components that produce energy within cells), such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes) or maternally inherited diabetes and deafness (MIDD, Maternal Inherited Diabetes and Deafness);
you experience any of the following symptoms after starting metformin: seizures, reduced cognitive abilities, movement difficulties, symptoms indicating nerve damage (e.g. pain or numbness), headache or hearing loss.

If you are undergoing major surgery, you must stop taking METFORMINA PHARMACARE during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with METFORMINA PHARMACARE.

METFORMINA PHARMACARE alone does not cause hypoglycaemia (blood glucose level too low). However, if you take METFORMINA PHARMACARE together with other antidiabetic medicines that can cause hypoglycaemia (such as sulphonylureas, 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 METFORMINA PHARMACARE, 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 PHARMACARE
If you are scheduled to receive an injection of iodinated contrast medium into your bloodstream, for example for an X-ray or diagnostic scan, you must stop taking METFORMINA PHARMACARE before or during the injection. Your doctor will decide when to stop and when to restart treatment with METFORMINA PHARMACARE.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. You may need to have more frequent blood glucose and kidney function tests, or your doctor may decide to adjust the dose of METFORMINA PHARMACARE. 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 levels of METFORMINA PHARMACARE in the blood, especially if kidney function is reduced (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
other medicines used to treat diabetes.

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

Pregnancy, breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine so that your treatment can be adjusted if necessary, or your blood glucose levels monitored.
This medicine is not recommended if you are breastfeeding or intend to breastfeed your baby.

Driving and using machines
METFORMINA PHARMACARE alone does not cause hypoglycaemia (low blood glucose level). This means it does not affect your ability to drive or use machines.
However, exercise particular caution if you are taking METFORMINA PHARMACARE together with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, 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 PHARMACARE

Take this medicine exactly as prescribed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
METFORMINA PHARMACARE cannot replace the benefits of a healthy lifestyle.
Continue to follow all dietary advice provided 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 PHARMACARE once daily. 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 METFORMINA PHARMACARE 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 you a lower dose.
If you are also taking insulin, your doctor will advise you on how to start METFORMINA
PHARMACARE.

Monitoring

Your doctor will perform regular blood glucose tests and adjust your dose of METFORMINA PHARMACARE according to your blood glucose levels. Be 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 require more frequent checks if you are elderly or if your kidneys do not function normally.

How to take METFORMINA PHARMACARE
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 Pharmacare 1000 mg tablets have a score line. The score line is not intended for breaking the tablet.
If, after some time, you feel that the effect of METFORMINA PHARMACARE is too strong or too weak, consult your doctor or pharmacist.

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

If you forget to take METFORMINA PHARMACARE
Do not take a double dose to make up for the missed dose. Take the next dose at your usual scheduled 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 everyone experiences them. The following side effects may occur:

METFORMIN PHARMACARE 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 PHARMACARE and contact your doctor or go to the nearest hospital immediately, 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 PHARMACARE. It may help to spread the doses throughout the day and to take the tablets during or just after meals. If symptoms persist, stop taking METFORMIN PHARMACARE and consult 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 sensations (paraesthesias), or pale or yellowish skin). Your doctor may carry out certain tests to determine the cause of the symptoms, as some of these may also be caused by diabetes or other unrelated health problems.

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. 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 METFORMIN PHARMACARE and consult your doctor.
Skin reactions such as redness of the skin (erythema), itching or skin 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 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: 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 METFORMINA PHARMACARE

Keep this medicine out of the sight and reach of children.
If a child is being treated with METFORMINA PHARMACARE, 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 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 PHARMACARE 1000 mg contains

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

Description of the appearance of METFORMINA PHARMACARE 1000 mg and pack contents
Film-coated tablets.
METFORMINA PHARMACARE 1000 mg:
METFORMINA PHARMACARE 1000 mg film-coated tablets are film-coated tablets, white to yellowish in colour, biconvex, oval-shaped, with "MC" imprinted on one side and a score line on the other side.
METFORMINA PHARMACARE 1000 mg is available in packs containing 60 tablets.
Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 - Milan
Italy
Manufacturer
SAG Manufacturing SLU
Ctra N-I, km. 36
28750 San Agustín del Guadalix
Madrid – Spain
or
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Metformina Pharmacare