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METFORMIN HYDROCHLORIDE 1000MG POWDER

Active substance(s): METFORMIN HYDROCHLORIDE

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Package leaflet: Information for the user

Glucophage® 1000mg Powder
Powder for oral solution in sachets
(metformin hydrochloride)
Read all of this leaflet carefully before you start taking this
medicine

-

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Glucophage 1000mg Powder, but it will
be referred to as Glucophage throughout this leaflet.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Glucophage is and what it is used for
What you need to know before you take Glucophage
How to take Glucophage
Possible side effects
How to store Glucophage
Content of the pack and other information
1. What Glucophage is and What it is used for

Glucophage contains metformin, a medicine to treat diabetes. It
belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that makes your body
take in 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 make enough insulin or
your body is not able to use properly the insulin it produces. This leads
to a high level of glucose in your blood. Glucophage helps to lower
your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Glucophage over a long period of
time also helps to lower the risk of complications associated with
diabetes. Glucophage is associated with either a stable body weight or
modest weight loss.
Glucophage is used to treat patients with type 2 diabetes (also called
'non-insulin dependent diabetes') when diet and exercise alone have
not been enough to control your blood glucose levels. It is used
particularly in overweight patients.
Adults can take Glucophage on its own or together with other
medicines to treat diabetes (medicines taken by mouth or insulin).
Children 10 years and over and adolescents can take Glucophage on
its own or together with insulin.
2. What you need to know before you take Glucophage
Do not take Glucophage
if you are allergic to metformin or any of the other ingredients of
this medicine (listed in section 6)
if you have liver problems or kidney problems (glomerular filtration
rate below 45 ml/min)
if you have uncontrolled diabetes, with e.g. severe hyperglycaemia
(high blood glucose), nausea, vomiting, dehydration, rapid weight
loss or ketoacidosis. Ketoacidosis is a condition in which
substances called 'ketone bodies' accumulate in the blood and
which can lead to diabetic pre-coma. Symptoms include stomach
pain, fast and deep breathing, sleepiness or unusual fruity odour of
the breath
if you lost too much water from your body (dehydration), such as
due to long-lasting or severe diarrhoea, or if you have vomited
several times in a row. Dehydration may lead to kidney problems,
which can put you at risk for lactic acidosis (see ‘Warnings and
precautions’)
if you have a severe infection, such as an infection affecting your
lung or bronchial system or your kidney. Severe infections may
lead to kidney problems, which can put you at risk for lactic
acidosis (see ‘Warnings and precautions’)
if you are treated for acute heart failure or have recently had a
heart attack, have severe problems with your circulation (such as
shock) or have breathing difficulties. This may lead to a lack in
oxygen supply to tissue which can put you at risk for lactic acidosis
(see ‘Warnings and precautions’)
if you drink a lot of alcohol
If any of the above applies to you, talk to your doctor, before you start
taking this medicine.

Make sure you ask your doctor for advice, if:
you need to have an examination such as X-ray or scan involving
the injection of contrast medicines that contain iodine into your
bloodstream
you need to have major surgery
You must stop taking Glucophage for a certain period of time before
and after the examination or the surgery. Your doctor will decide
whether you need any other treatment for this time. It is important that
you follow your doctor’s instructions precisely.
Warnings and precautions
Please note the following particular risk of lactic acidosis.
Glucophage may cause a very rare, but very serious complication
called lactic acidosis, particularly if your kidneys are not working
properly. The risk of developing lactic acidosis is also increased with
uncontrolled diabetes, prolonged fasting or alcohol intake, body fluid
deficit (dehydration) due to severe diarrhoea or vomiting, liver
problems and any medical conditions in which a region of the body is
deprived with a lack of oxygen supply (such as acute severe heart
diseases)
It is important to you to comply with your medication intake, dietary
instructions and regular exercise program because this can reduce
the risk of lactic acidosis.
The onset of lactic acidosis can be subtle and the symptoms can be
non-specific such as vomiting, bellyache (abdominal pain) with
muscle cramps, a general feeling of not being well with severe
tiredness, and difficulty in breathing. Further symptoms are reduced
body temperature and heart beat.
If you experience some of these symptoms, you should seek
immediately medical attention, as lactic acidosis may lead to
coma. Stop taking Glucophage immediately and contact a
doctor or the nearest hospital straight away.
Glucophage on its own does not cause hypoglycaemia (a blood
glucose level which is too low). However, if you take Glucophage
together with other medicines to treat diabetes that can cause
hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is
a risk of hypoglycaemia. If you experience symptoms of
hypoglycaemia such as weakness, dizziness, increased sweating, fast
heart beating, visions disorders or difficulty in concentration, it usually
helps to eat or drink something containing sugar.
Other medicines and Glucophage
If you need to have an injection of contrast medicines that contain
iodine into your bloodstream, for example for examinations such as Xray or scan, you must stop taking Glucophage for a certain period
of time before and after (at least 48h) the examination (see 'Make
sure you ask your doctor for advice' above).
Tell your doctor if you take any of the following medicines and
Glucophage at the same time. You may need more frequent blood
glucose tests or your doctor may adjust the dosage of Glucophage:
diuretics (used to remove water from the body by making more
urine).
beta-2 agonists such as salbutamol or terbutaline (used to treat
asthma)
corticosteroids (used to treat a variety of conditions, such as
severe inflammation of the skin or in asthma)
other medicines used to treat diabetes
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Glucophage with food and drink
Do not drink alcohol when you take this medicine. Alcohol may
increase the risk of lactic acidosis especially if you have liver problems
or if you are undernourished. This also applies to medicines that
contain alcohol.
Pregnancy and breast-feeding
During pregnancy, you need insulin to treat your diabetes. Tell your
doctor if you are pregnant, think you may be pregnant or are planning
to have a baby, so that he or she may change your treatment.
This medicine is not recommended if you are breast-feeding or if you
are planning to breast-feed your baby.

Driving and using machines
Glucophage on its own does not cause hypoglycaemia (a blood
glucose level which is too low). This means that it will not affect your
ability to drive or use machines.
However, take special care if you take Glucophage together with other
medicines to treat diabetes that can cause hypoglycaemia (such as
sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia
include weakness, dizziness, increased sweating, fast heart beat,
vision disorders or difficulty in concentration. Do not drive or use
machines if you start to feel these symptoms.
Important information about some of the ingredients of
Glucophage
Glucophage contains aspartame, a source of phenylalanine.
If you have phenylketonuria (a rare, hereditary disorder that unables
your body to use phenylalanine), Glucophage may be harmful for you.
Talk to your doctor before you start taking this medicine.
3. How to take Glucophage
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Glucophage cannot replace the benefits of a healthy lifestyle. Continue
to follow any advice about diet that your doctor has given you and get
some regular exercise.
Recommended dose
Children 10 years and over and adolescents usually start with 500mg
or 850mg Glucophage once a day. The maximum daily dose is
2000mg taken as 2 or 3 divided doses. Treatment of children between
10 and 12 years of age is only recommended on specific advice from
your doctor, as experience in this age group is limited.
Adults usually start with 500mg or 850mg Glucophage two or three
times a day. The maximum daily dose is 3000mg taken as 3 divided
doses.
In renal impaired patients with a GFR between 45 and 60ml/min, the
starting dose is 500mg or 850mg metformin hydrochloride, once daily.
The maximum dose is 1000mg daily, given as 2 divided doses. The
renal function should be closely monitored (every 3 - 6 months).
If you take insulin too, your doctor will tell you how to start
Glucophage.
Monitoring
Your doctor will perform regular blood glucose tests and will adapt
your dose of Glucophage to your blood glucose levels. Make sure
that you talk to your doctor regularly. This is particularly important
for children and adolescents or if you are an older person.
Your doctor will also check at least once a year how well your
kidneys work. You may need more frequent checks if you are an
older person or if your kidneys are not working normally.
How to take Glucophage
Take Glucophage with or after a meal. This will avoid you having side
effects affecting your digestion.
Pour the powder into a glass and add 150ml water to get a clear to
slightly cloudy solution. Drink the solution immediately after
preparation. If necessary, stir the solution.
If you take one dose a day, take it in the morning (breakfast)
If you take two divided doses a day, take them in the morning
(breakfast) and evening (dinner)
If you take three divided doses a day, take them in the morning
(breakfast), at noon (lunch) and in the evening (dinner)
If, after some time, you think that the effect of Glucophage is too strong
or too weak, talk to your doctor or pharmacist.
If you take more Glucophage than you should
If you have taken more Glucophage that you should have, you may
experience lactic acidosis. Symptoms of lactic acidosis are nonspecific such as vomiting, bellyache (abdominal pain) with muscle
cramps, a general feeling of not being well with severe tiredness, and
difficulty in breathing. Further symptoms are reduced body
temperature and heart beat. If you experience some of these
symptoms, you should seek immediately medical attention, as
lactic acidosis may lead to coma. Stop taking Glucophage
immediately and contact a doctor or the nearest hospital straight
away.
If you forget to take Glucophage
Do not take a double dose to make up for a forgotten dose. Take the
next dose at the usual time.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Lactic acidosis
Lactic acidosis is a very rare side effect (may effect up to 1 in 10,000
people) but a serious complication particularly if your kidneys are not
working properly. Symptoms of lactic acidosis are non-specific such as
vomiting, bellyache (abdominal pain) with muscle cramps, a general
feeling of not being well with severe tiredness, and difficulty in
breathing. Further symptoms are reduced body temperature and heart
beat. If you experience some of these symptoms, you should seek
immediately medical attention, as lactic acidosis may lead to
coma. Stop taking Glucophage immediately and contact a doctor
or the nearest hospital straight away.
Liver function
Abnormalities 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) are very rare side
effects (may affect up to 1 in 10,000 people). If this happens to you,
stop taking Glucophage and talk to your doctor.
Digestive problems
Digestive problems, such as feeling sick (nausea), being sick
(vomiting), diarrhoea, bellyache (abdominal pain) and loss of appetite
are very common side effects (may affect more than 1 in 10 people).
These side effects most often happen at the beginning of the treatment
with Glucophage. It helps if you spread the doses over the day and if
you take Glucophage with or straight after a meal. If symptoms
continue, stop taking Glucophage and talk to your doctor.
Common side effects (may affect up to 1 in 10 people)
changes in taste.
Very rare side effects (may affect up to 1 in 10,000 people)
skin reactions such as redness of the skin (erythema), itching or an
itchy rash (hives).
low vitamin B12 levels in the blood.
Children and adolescents
Limited data in children and adolescents showed that side effects were
similar in nature and severity to those reported in adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. How to store Glucophage
Keep out of the sight and reach of children. If a child is treated with
Glucophage, parents and caregivers are advised to oversee how this
medicine is used.
This medicinal product does not require any special storage
conditions.
Do not take the powder after the expiry date which is stated on the
carton and sachet labels after 'Exp'. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other information

What Glucophage contains
The active ingredient in Glucophage is metformin hydrochloride.
Each sachet contains 1000mg metformin hydrochloride
corresponding to 780mg metformin base.
The other ingredients are acesulfame potassium, aspartame
(E951), citric acid anhydrous, erythritol, maize starch,
pullulan PI-20.
What Glucophage looks like and contents of the pack
Glucophage 1000mg is a white and odourless powder for oral solution
in sachets.
Each pack contains 30 single-dose sachets.
Manufactured by: Merck S.L. Poligono Merck, 08100 Mollet del
Valles (Barcelona), Spain.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Glucophage® 1000mg Powder
PL 18799/2005
POM
Leaflet date: 15.06.2016
Glucophage is a registered trademark of Merck

Package leaflet: Information for the user

Metformin hydrochloride 1000mg Powder
Powder for oral solution in sachets
Read all of this leaflet carefully before you start taking this
medicine

-

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Metformin hydrochloride 1000mg
Powder, but it will be referred to as Metformin hydrochloride
throughout this leaflet.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Metformin hydrochloride is and what it is used for
What you need to know before you take Metformin hydrochloride
How to take Metformin hydrochloride
Possible side effects
How to store Metformin hydrochloride
Content of the pack and other information
1. What Metformin hydrochloride is and What it is used for

Metformin hydrochloride contains metformin, a medicine to treat
diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that makes your body
take in 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 make enough insulin or
your body is not able to use properly the insulin it produces. This leads
to a high level of glucose in your blood. Metformin hydrochloride helps
to lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Metformin hydrochloride over a
long period of time also helps to lower the risk of complications
associated with diabetes. Metformin hydrochloride is associated with
either a stable body weight or modest weight loss.
Metformin hydrochloride is used to treat patients with type 2 diabetes
(also called 'non-insulin dependent diabetes') when diet and exercise
alone have not been enough to control your blood glucose levels. It is
used particularly in overweight patients.
Adults can take Metformin hydrochloride on its own or together with
other medicines to treat diabetes (medicines taken by mouth or
insulin).
Children 10 years and over and adolescents can take Metformin
hydrochloride on its own or together with insulin.
2. What you need to know before you take Metformin
hydrochloride
Do not take Metformin hydrochloride
if you are allergic to metformin or any of the other ingredients of
this medicine (listed in section 6)
if you have liver problems or kidney problems (glomerular filtration
rate below 45 ml/min)
if you have uncontrolled diabetes, with e.g. severe hyperglycaemia
(high blood glucose), nausea, vomiting, dehydration, rapid weight
loss or ketoacidosis. Ketoacidosis is a condition in which
substances called 'ketone bodies' accumulate in the blood and
which can lead to diabetic pre-coma. Symptoms include stomach
pain, fast and deep breathing, sleepiness or unusual fruity odour of
the breath
if you lost too much water from your body (dehydration), such as
due to long-lasting or severe diarrhoea, or if you have vomited
several times in a row. Dehydration may lead to kidney problems,
which can put you at risk for lactic acidosis (see ‘Warnings and
precautions’)
if you have a severe infection, such as an infection affecting your
lung or bronchial system or your kidney. Severe infections may
lead to kidney problems, which can put you at risk for lactic
acidosis (see ‘Warnings and precautions’)
if you are treated for acute heart failure or have recently had a
heart attack, have severe problems with your circulation (such as
shock) or have breathing difficulties. This may lead to a lack in
oxygen supply to tissue which can put you at risk for lactic acidosis
(see ‘Warnings and precautions’)

if you drink a lot of alcohol
If any of the above applies to you, talk to your doctor, before you start
taking this medicine.
Make sure you ask your doctor for advice, if:
you need to have an examination such as X-ray or scan involving
the injection of contrast medicines that contain iodine into your
bloodstream
you need to have major surgery
You must stop taking Metformin hydrochloride for a certain period of
time before and after the examination or the surgery. Your doctor will
decide whether you need any other treatment for this time. It is
important that you follow your doctor’s instructions precisely.
Warnings and precautions
Please note the following particular risk of lactic acidosis.
Metformin hydrochloride may cause a very rare, but very serious
complication called lactic acidosis, particularly if your kidneys are not
working properly. The risk of developing lactic acidosis is also
increased with uncontrolled diabetes, prolonged fasting or alcohol
intake, body fluid deficit (dehydration) due to severe diarrhoea or
vomiting, liver problems and any medical conditions in which a region
of the body is deprived with a lack of oxygen supply (such as acute
severe heart diseases)
It is important to you to comply with your medication intake, dietary
instructions and regular exercise program because this can reduce
the risk of lactic acidosis.
The onset of lactic acidosis can be subtle and the symptoms can be
non-specific such as vomiting, bellyache (abdominal pain) with
muscle cramps, a general feeling of not being well with severe
tiredness, and difficulty in breathing. Further symptoms are reduced
body temperature and heart beat.
If you experience some of these symptoms, you should seek
immediately medical attention, as lactic acidosis may lead to
coma. Stop taking Metformin hydrochloride immediately and
contact a doctor or the nearest hospital straight away.
Metformin hydrochloride on its own does not cause hypoglycaemia (a
blood glucose level which is too low). However, if you take Metformin
hydrochloride together with other medicines to treat diabetes that can
cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides),
there is a risk of hypoglycaemia. If you experience symptoms of
hypoglycaemia such as weakness, dizziness, increased sweating, fast
heart beating, visions disorders or difficulty in concentration, it usually
helps to eat or drink something containing sugar.
Other medicines and Metformin hydrochloride
If you need to have an injection of contrast medicines that contain
iodine into your bloodstream, for example for examinations such as Xray or scan, you must stop taking Metformin hydrochloride for a
certain period of time before and after (at least 48h) the
examination (see 'Make sure you ask your doctor for advice' above).
Tell your doctor if you take any of the following medicines and
Metformin hydrochloride at the same time. You may need more
frequent blood glucose tests or your doctor may adjust the dosage of
Metformin hydrochloride:
diuretics (used to remove water from the body by making more
urine).
beta-2 agonists such as salbutamol or terbutaline (used to treat
asthma)
corticosteroids (used to treat a variety of conditions, such as
severe inflammation of the skin or in asthma)
other medicines used to treat diabetes
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Metformin hydrochloride with food and drink
Do not drink alcohol when you take this medicine. Alcohol may
increase the risk of lactic acidosis especially if you have liver problems
or if you are undernourished. This also applies to medicines that
contain alcohol.
Pregnancy and breast-feeding
During pregnancy, you need insulin to treat your diabetes. Tell your
doctor if you are pregnant, think you may be pregnant or are planning
to have a baby, so that he or she may change your treatment.
This medicine is not recommended if you are breast-feeding or if you
are planning to breast-feed your baby.

Driving and using machines
Metformin hydrochloride on its own does not cause hypoglycaemia (a
blood glucose level which is too low). This means that it will not affect
your ability to drive or use machines.
However, take special care if you take Metformin hydrochloride
together with other medicines to treat diabetes that can cause
hypoglycaemia (such as sulphonylureas, insulin, meglitinides).
Symptoms of hypoglycaemia include weakness, dizziness, increased
sweating, fast heart beat, vision disorders or difficulty in concentration.
Do not drive or use machines if you start to feel these symptoms.
Important information about some of the ingredients of Metformin
hydrochloride
Metformin hydrochloride contains aspartame, a source of
phenylalanine.
If you have phenylketonuria (a rare, hereditary disorder that unables
your body to use phenylalanine), Metformin hydrochloride may be
harmful for you. Talk to your doctor before you start taking this
medicine.
3. How to take Metformin hydrochloride
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Metformin hydrochloride cannot replace the benefits of a healthy
lifestyle. Continue to follow any advice about diet that your doctor has
given you and get some regular exercise.
Recommended dose
Children 10 years and over and adolescents usually start with 500mg
or 850mg Metformin hydrochloride once a day. The maximum daily
dose is 2000mg taken as 2 or 3 divided doses. Treatment of children
between 10 and 12 years of age is only recommended on specific
advice from your doctor, as experience in this age group is limited.
Adults usually start with 500mg or 850mg Metformin hydrochloride two
or three times a day. The maximum daily dose is 3000mg taken as 3
divided doses.
In renal impaired patients with a GFR between 45 and 60ml/min, the
starting dose is 500mg or 850mg metformin hydrochloride, once daily.
The maximum dose is 1000mg daily, given as 2 divided doses. The
renal function should be closely monitored (every 3 - 6 months).
If you take insulin too, your doctor will tell you how to start Metformin
hydrochloride.
Monitoring
Your doctor will perform regular blood glucose tests and will adapt
your dose of Metformin hydrochloride to your blood glucose levels.
Make sure that you talk to your doctor regularly. This is particularly
important for children and adolescents or if you are an older
person.
Your doctor will also check at least once a year how well your
kidneys work. You may need more frequent checks if you are an
older person or if your kidneys are not working normally.
How to take Metformin hydrochloride
Take Metformin hydrochloride with or after a meal. This will avoid you
having side effects affecting your digestion.
Pour the powder into a glass and add 150ml water to get a clear to
slightly cloudy solution. Drink the solution immediately after
preparation. If necessary, stir the solution.
If you take one dose a day, take it in the morning (breakfast)
If you take two divided doses a day, take them in the morning
(breakfast) and evening (dinner)
If you take three divided doses a day, take them in the morning
(breakfast), at noon (lunch) and in the evening (dinner)
If, after some time, you think that the effect of Metformin hydrochloride
is too strong or too weak, talk to your doctor or pharmacist.
If you take more Metformin hydrochloride than you should
If you have taken more Metformin hydrochloride that you should have,
you may experience lactic acidosis. Symptoms of lactic acidosis are
non-specific such as vomiting, bellyache (abdominal pain) with muscle
cramps, a general feeling of not being well with severe tiredness, and
difficulty in breathing. Further symptoms are reduced body
temperature and heart beat. If you experience some of these
symptoms, you should seek immediately medical attention, as
lactic acidosis may lead to coma. Stop taking Metformin
hydrochloride immediately and contact a doctor or the nearest
hospital straight away.
If you forget to take Metformin hydrochloride
Do not take a double dose to make up for a forgotten dose. Take the
next dose at the usual time.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Lactic acidosis
Lactic acidosis is a very rare side effect (may effect up to 1 in 10,000
people) but a serious complication particularly if your kidneys are not
working properly. Symptoms of lactic acidosis are non-specific such as
vomiting, bellyache (abdominal pain) with muscle cramps, a general
feeling of not being well with severe tiredness, and difficulty in
breathing. Further symptoms are reduced body temperature and heart
beat. If you experience some of these symptoms, you should seek
immediately medical attention, as lactic acidosis may lead to
coma. Stop taking Metformin hydrochloride immediately and
contact a doctor or the nearest hospital straight away.
Liver function
Abnormalities 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) are very rare side
effects (may affect up to 1 in 10,000 people). If this happens to you,
stop taking Metformin hydrochloride and talk to your doctor.
Digestive problems
Digestive problems, such as feeling sick (nausea), being sick
(vomiting), diarrhoea, bellyache (abdominal pain) and loss of appetite
are very common side effects (may affect more than 1 in 10 people).
These side effects most often happen at the beginning of the treatment
with Metformin hydrochloride. It helps if you spread the doses over the
day and if you take Metformin hydrochloride with or straight after a
meal. If symptoms continue, stop taking Metformin hydrochloride
and talk to your doctor.
Common side effects (may affect up to 1 in 10 people)
changes in taste.
Very rare side effects (may affect up to 1 in 10,000 people)
skin reactions such as redness of the skin (erythema), itching or an
itchy rash (hives).
low vitamin B12 levels in the blood.
Children and adolescents
Limited data in children and adolescents showed that side effects were
similar in nature and severity to those reported in adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. How to store Metformin hydrochloride
Keep out of the sight and reach of children. If a child is treated with
Metformin hydrochloride, parents and caregivers are advised to
oversee how this medicine is used.
This medicinal product does not require any special storage
conditions.
Do not take the powder after the expiry date which is stated on the
carton and sachet labels after 'Exp'. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other information

What Metformin hydrochloride contains
The active ingredient in Metformin hydrochloride is metformin
hydrochloride. Each sachet contains 1000mg metformin
hydrochloride corresponding to 780mg metformin base.
The other ingredients are acesulfame potassium, aspartame
(E951), citric acid anhydrous, erythritol, maize starch,
pullulan PI-20.
What Metformin hydrochloride looks like and contents of the pack
Metformin hydrochloride 1000mg is a white and odourless powder for
oral solution in sachets.
Each pack contains 30 single-dose sachets.
Manufactured by: Merck S.L. Poligono Merck, 08100 Mollet del
Valles (Barcelona), Spain.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Metformin hydrochloride 1000mg Powder
PL 18799/2005
POM
Leaflet date: 15.06.2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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