METFORMIN HYDROCHLORIDE 500MG POWDER

Active substance: METFORMIN HYDROCHLORIDE

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Glucophage® 500mg Powder
(metformin hydrochloride)

Powder for oral solution in sachets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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. Do not pass it on to others. It may harm them, even if their symptoms are the
same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

The name of your medicine is Glucophage 500mg Powder, but it will be referred to as Glucophage throughout the
remainder of this leaflet.
In this leaflet:
1. What Glucophage is and what it is used for
2. Before you take Glucophage
3. How to take Glucophage
4. Possible side effects
5. How to store Glucophage
6. Further information

1. WHAT GLUCOPHAGE IS AND WHAT IT IS
USED FOR
What Glucophage is
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.
What Glucophage is used for
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. BEFORE YOU TAKE GLUCOPHAGE
Do not take Glucophage
• if you are allergic (hypersensitive) to metformin or any
of the other ingredients of this medicine (see 'What
Glucophage contains' in section 6)
• if you have kidney or liver problems
• 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 'Take special care with
Glucophage')
• 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 'Take special
care with Glucophage')
• if you are treated for 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 'Take special care
with Glucophage')
• if you drink a lot of alcohol
• if you are breast-feeding
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.

Take special care with Glucophage
Glucophage may cause a very rare, but serious complication
called lactic acidosis, particularly if your kidneys are not
working properly. The risk of lactic acidosis is also increased
with uncontrolled diabetes, prolonged fasting or alcohol
intake. Symptoms of lactic acidosis are vomiting, bellyache
(abdominal pain) with muscle cramps, a general feeling of not
being well with severe tiredness, and difficulty in breathing.If
this happens to you, you may need immediate hospital
treatment, 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, repaglinide), there is a risk of hypoglycaemia. If you
experience symptoms of hypoglycaemia such as weakness,
dizziness, increased sweating, fast heart beating, vision
disorders or difficulty in concentration, it usually helps to eat
or drink something containing sugar.
Taking other medicines
If you need to have an injection of contrast medicines that
contain iodine into your bloodstream, for example for
examinations such as X-ray or scan, you must stop taking
Glucophage for a certain period of time before and after
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:
• angiotensin-converting enzyme inhibitors (used to treat a
variety of heart and blood vessel conditions, such as high
blood pressure or heart failure)
• 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
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Taking 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, you think you might be or are
planning to become pregnant, so that he or she may change
your treatment.
Do not take this medicine 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,
repaglinide). 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 powder for oral solution contains aspartame, a
source of phenylalanine. If you have phenylketonuria (a
rare, hereditary disorder that prevents your body from using
phenylalanine), Glucophage powder for oral solution may be
harmful for you. Talk to your doctor before you start
taking this medicine.

3. HOW TO TAKE GLUCOPHAGE
Always take Glucophage 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.

Usual 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.
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 vomiting, bellyache (abdominal pain) with
muscle cramps, a general feeling of not being well with
severe tiredness, and difficulty in breathing. If this happens
to you, you may need immediate hospital treatment, as
lactic acidosis may lead to coma. 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 product,
ask your doctor or pharmacist.

Very rare side effects (in less than 1 in 10,000 people)
• lactic acidosis. This is a very rare but serious complication
particularly if your kidneys are not working properly.
Symptoms of lactic acidosis are vomiting, bellyache
(abdominal pain) with muscle cramps, a general feeling of
not being well with severe tiredness, and difficulty in
breathing. If this happens to you, you may need
immediate hospital treatment, as lactic acidosis may
lead to coma. Stop taking Glucophage immediately
and contact a doctor or the nearest hospital straight
away.
• 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). If this happens to you, stop taking
Glucophage and talk to your doctor straight away.
• 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 adverse
events were similar in nature and severity to those reported in
adults.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
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 use Glucophage after the expiry date which is stated
on the carton or the sachet 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.
If your medicine gets discoloured or shows any other signs of
deterioration, take it to your doctor or pharmacist for advice.

6. FURTHER INFORMATION
What Glucophage contains
• The active substance is metformin hydrochloride. Each
sachet contains 500mg metformin hydrochloride
corresponding to 390mg metformin base.
• The other ingredients are acesulfame potassium,
aspartame (E951), citric acid anhydrous, erythritol, maize
starch, pullulan PI-20.
Warning Aspartame: Contains a source of phenyalanine.
May be harmful for people with phenylketonuria.
What Glucophage looks like and contents of the pack
Glucophage 500mg is a white 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 500mg Powder, PL: 18799/2004

4. POSSIBLE SIDE EFFECTS

Glucophage is a registered trademark of Merck.

Like all medicines, Glucophage can cause side effects,
although not everybody gets them. The following side
effects may occur:

Leaflet date: 16.12.2013

Very common side effects (in more than 1 in 10
people)
• digestive problems, such as feeling sick (nausea), being
sick (vomiting), diarrhoea, bellyache (abdominal pain)
and loss of appetite. 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 (in less than 1 in 10 people)
• changes in taste.

POM

Metformin hydrochloride 500mg Powder
Powder for oral solution in sachets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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. Do not pass it on to others. It may harm them, even if their symptoms are the
same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

The name of your medicine is Metformin hydrochloride 500mg Powder, but it will be referred to as Metformin
hydrochloride throughout the remainder of this leaflet.
In this leaflet:
1. What Metformin hydrochloride is and what it is used for
2. Before you take Metformin hydrochloride
3. How to take Metformin hydrochloride
4. Possible side effects
5. How to store Metformin hydrochloride
6. Further information

1. WHAT METFORMIN HYDROCHLORIDE IS
AND WHAT IT IS USED FOR
What Metformin hydrochloride is
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.
What Metformin hydrochloride is used for
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. BEFORE YOU TAKE METFORMIN
HYDROCHLORIDE
Do not take Metformin hydrochloride
• if you are allergic (hypersensitive) to metformin or any
of the other ingredients of this medicine (see 'What
Metformin hydrochloride contains' in section 6)
• if you have kidney or liver problems
• 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 'Take special
care with Metformin hydrochloride')
• 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 'Take special
care with Metformin hydrochloride')
• if you are treated for 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
'Take special care with Metformin hydrochloride')
• if you drink a lot of alcohol
• if you are breast-feeding
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.

Take special care with Metformin hydrochloride
Metformin hydrochloride may cause a very rare, but serious
complication called lactic acidosis, particularly if your kidneys
are not working properly. The risk of lactic acidosis is also
increased with uncontrolled diabetes, prolonged fasting or
alcohol intake. Symptoms of lactic acidosis are vomiting,
bellyache (abdominal pain) with muscle cramps, a general
feeling of not being well with severe tiredness, and difficulty
in breathing.If this happens to you, you may need
immediate hospital treatment, 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,
repaglinide), there is a risk of hypoglycaemia. If you
experience symptoms of hypoglycaemia such as weakness,
dizziness, increased sweating, fast heart beating, vision
disorders or difficulty in concentration, it usually helps to eat
or drink something containing sugar.
Taking other medicines
If you need to have an injection of contrast medicines that
contain iodine into your bloodstream, for example for
examinations such as X-ray or scan, you must stop taking
Metformin hydrochloride for a certain period of time
before and after 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:
• angiotensin-converting enzyme inhibitors (used to treat a
variety of heart and blood vessel conditions, such as high
blood pressure or heart failure)
• 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
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Taking 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, you think you might be or are
planning to become pregnant, so that he or she may change
your treatment.
Do not take this medicine 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, repaglinide). 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 powder for oral solution contains
aspartame, a source of phenylalanine. If you have
phenylketonuria (a rare, hereditary disorder that prevents
your body from using phenylalanine), Metformin
hydrochloride powder for oral solution may be harmful for
you. Talk to your doctor before you start
taking this medicine.

3. HOW TO TAKE METFORMIN
HYDROCHLORIDE
Always take Metformin hydrochloride 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.

Usual 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.
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 vomiting, bellyache
(abdominal pain) with muscle cramps, a general feeling of
not being well with severe tiredness, and difficulty in
breathing. If this happens to you, you may need immediate
hospital treatment, as lactic acidosis may lead to coma.
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 product,
ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Metformin hydrochloride can cause side
effects, although not everybody gets them. The following
side effects may occur:

Very common side effects (in more than 1 in 10
people)
• digestive problems, such as feeling sick (nausea), being
sick (vomiting), diarrhoea, bellyache (abdominal pain)
and loss of appetite. 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 (in less than 1 in 10 people)
• changes in taste.
Very rare side effects (in less than 1 in 10,000 people)
• lactic acidosis. This is a very rare but serious
complication particularly if your kidneys are not working
properly.
Symptoms of lactic acidosis are vomiting, bellyache
(abdominal pain) with muscle cramps, a general feeling
of not being well with severe tiredness, and difficulty in
breathing. If this happens to you, you may need
immediate hospital treatment, as lactic acidosis may
lead to coma. Stop taking Metformin hydrochloride
immediately and contact a doctor or the nearest
hospital straight away.
• 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). If this happens to you, stop
taking Metformin hydrochloride and talk to your
doctor straight away.
• 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
adverse events were similar in nature and severity to those
reported in adults.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

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 use Metformin hydrochloride after the expiry date
which is stated on the carton or the sachet 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.
If your medicine gets discoloured or shows any other signs
of deterioration, take it to your doctor or pharmacist for
advice.

6. FURTHER INFORMATION
What Metformin hydrochloride contains
• The active substance is metformin hydrochloride. Each
sachet contains 500mg metformin hydrochloride
corresponding to 390mg metformin base.
• The other ingredients are acesulfame potassium,
aspartame (E951), citric acid anhydrous, erythritol, maize
starch, pullulan PI-20.
Warning Aspartame: Contains a source of
phenyalanine. May be harmful for people with
phenylketonuria.
What Metformin hydrochloride looks like and
contents of the pack
Metformin hydrochloride 500mg is a white 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 500mg Powder, PL: 18799/2004
POM

Leaflet date: 16.12.2013

Expand view ⇕

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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