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METFORMIN HYDROCHLORIDE 1000MG POWDER FOR ORAL SOLUTION IN SACHETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucophage® 1000mg powder for oral solution in sachets /
Metformin hydrochloride 1000mg powder for oral solution in sachets
(metformin hydrochloride)
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any 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.
What is in this leaflet:
1) What Glucophage is and what it is used for
2) What you need to know before you take Glucophage
3) How to take Glucophage
4) Possible side effects
5) How to store Glucophage
6) Content of the pack and other 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.

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, vision 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 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:
 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

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.

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

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.

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.

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.

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.

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.

This medicine is not recommended if you are breast-feeding or if you are
planning to breast-feed your baby.

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 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’ below)
 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’ below)
 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’ below)
 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.

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.
Glucophage powder for oral solution contains aspartame, a source
of phenylalanine.
If you have phenylketonuria (a rare, hereditary disorder that unables
your body to use 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 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 500 mg or
850 mg Glucophage once a day. The maximum daily dose is 2000 mg
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 500 mg or 850 mg Glucophage two or three
times a day. The maximum daily dose is 3000 mg taken as 3 divided
doses.
If you take insulin too, your doctor will tell you how to start Glucophage.

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 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.

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 150 ml 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 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 affect up to 1 in 10,000
people) but a 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.
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 medicine does not require any special storage conditions.
 Do not use this medicine 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.
 Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away any medicines you no longer
use. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Glucophage contains
 The active substance 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 and pullulan PI-20.
What Glucophage looks like and contents of the pack
Glucophage 1000mg is a powder for oral solution in sachets, the powder
is white and odourless.
Each pack contains 30 or 60 single-dose sachets.
Manufacturer
Merck S.L., Poligono Merck, 08100 Mollet del Valles (Barcelona), Spain.
Procured from within the EU by the Product Licence holder
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER, UK.
Repackaged by MPT Pharma Ltd.
POM
PL: 33532/0472
Glucophage® 1000mg powder for oral solution in sachets /
Metformin hydrochloride 1000mg powder for oral solution in
sachets
Leaflet date: 05 February 2014
Leaflet code: XXXXXXXXXX
Glucophage® is a registered trademark of XXXXXXXXXXXXXXXXXXXX.

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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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