METFORMIN HYDROCHLORIDE 500 MG/5 ML ORAL SOLUTION

Active substance: METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

METFORMIN HYDROCHLORIDE
500 MG/5 ML ORAL SOLUTION
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 becomes severe, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Metformin oral solution is and what it is used for
2. Before you take Metformin oral solution
3. How to take Metformin oral solution
4. Possible side effects
5. How to store Metformin oral solution
6. Further information
1. WHAT METFORMIN ORAL SOLUTION IS AND WHAT IT IS
USED FOR
The name of this medicine is Metformin hydrochloride 500 mg/5 ml
oral solution, referred to as Metformin oral solution throughout this
leaflet. It belongs to a group of medicines called biguanides.
Metformin is used for the treatment of "Type 2 diabetes"
(non-insulin dependent 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.
If you have diabetes, your pancreas does not make enough insulin
or your body is not able to use the insulin it produces properly. This
leads to a high level of glucose in your blood. Metformin helps to
lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Metformin oral solution over a
long period of time also helps to lower the risk of complications
associated with diabetes.
What Metformin oral solution is used for
Metformin oral solution 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 oral solution 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
oral solution on its own or together with insulin.
2. BEFORE YOU TAKE METFORMIN ORAL SOLUTION
Do not take Metformin oral solution if:
• you are allergic (hypersensitive) to metformin or any of the other
ingredients of this medicine (see 'What Metformin oral solution
contains' in section 6);
• you have kidney or liver problems;
• you have uncontrolled diabetes, such as severe hyperglycaemia
(high blood glucose) 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;
• you have lost too much water from your body (dehydration), such
as due to long-lasting or severe diarrhoea, or if you have vomited
several times. Dehydration may lead to kidney problems, which
can put you at risk of lactic acidosis (see 'Take special care with
Metformin oral solution below);
• you have a severe infection, such as an infection affecting your
lung or bronchial system or your kidneys. Severe infections may
lead to kidney problems, which can put you at risk of lactic acidosis
(see 'Take special care with Metformin oral solution below);
• 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 oral solution below);
• 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 an 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 oral solution for a certain period of
time before and after the examination or the surgery. Your doctor
will decide whether you need any other treatment during this time.
It is important that you follow your doctor’s instructions precisely.
Take special care with Metformin oral solution
Please note the following particular risk of lactic acidosis.
Metformin oral solution 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, 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 treatment as lactic acidosis may lead to
coma. Stop taking Metformin oral solution immediately and
contact a doctor or your nearest hospital straight away.
Metformin on its own does not cause hypoglycaemia (a blood glucose
level which is too low). However, if you take Metformin oral solution
together with other medicines to treat diabetes such as sulphonylureas,
insulin or glinides, there is a risk of hypoglycaemia. If you experience
symptoms of hypoglycaemia such as weakness, dizziness, increased
sweating, fast heartbeat, vision disorders or difficulty in concentration, it
usually helps to eat or drink something containing sugar.
Taking Metformin oral solution with other medicines
• Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
If you need to have an injection of contrast medicines that contain
iodine into your bloodstream, for example for examinations such as
an X-ray or scan, you must stop taking Metformin oral solution
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 oral solution at the same time. You may need more
frequent blood glucose tests or your doctor may adjust the dosage
of Metformin oral solution:
• diuretics (used to remove water from the body by making more
urine);
• sympathomimetics 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.
If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before taking metformin.
Taking Metformin oral solution 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.
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 oral solution 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 oral solution
together with other medicines to treat diabetes that can cause
hypoglycaemia (such as sulphonylureas, insulin or glinides).
Symptoms of hypoglycaemia include weakness, dizziness,
increased sweating, fast heartbeat, 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 oral solution
This medicine contains:
• sodium methyl and propyl hydroxybenzoates, propyl
p-hydroxybenzoate and methyl p-hydroxybenzoate. These may
cause an allergic reaction such as skin rash and difficulty in
breathing. If this happens talk to a doctor straight away;
• liquid maltitol. If your doctor has told you that you cannot tolerate
some sugars, talk to your doctor before taking this medicine;
• sodium (5.3 mg in a 5 ml dose). Take this into account if you are
on a low sodium diet;
• potassium (14.5 mg in a 5 ml dose). Take this into account if you
have kidney problems or are on a low potassium diet.

3. HOW TO TAKE METFORMIN ORAL SOLUTION
Always take this medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Metformin 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.
Taking this medicine
• This solution contains 500 mg of metformin hydrochloride in 5 ml.
Take Metformin oral solution with or just after a meal. This will avoid
you having side effects affecting your digestion.
• 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)
Adults
• The usual starting dose is 500 mg (5 ml) or 850 mg (8.5 ml) of
Metformin oral solution two or three times a day.
• The maximum daily dose is 3000 mg (30 ml) taken as 3 divided
doses.
If you take insulin too, your doctor will tell you how to start
Metformin oral solution.
Children over 10 years and adolescents
• The usual starting dose is 500 mg (5 ml) or 850 mg (8.5 ml) of
Metformin oral solution once a day.
• The maximum daily dose is 2000 mg (20 ml) 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.
Monitoring
• Your doctor will perform regular blood glucose tests and adapt
your dose of Metformin oral solution 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.
If you take more Metformin oral solution than you should
If you have taken more Metformin oral solution than you should
have, you may experience lactic acidosis. Symptoms of lactic
acidosis are vomiting, 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 oral solution
Do not take a double dose to make up for a forgotten dose. Take the
next dose at the usual time.
If you stop taking Metformin oral solution
Keep taking this medicine until your doctor tells you to stop. Do not
stop taking Metformin oral solution just because you feel better. If
you stop your illness may get worse.

• 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 this medicine.
• skin reactions such as redness of the skin (erythema), itching or
an itchy rash (urticaria);
• 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 becomes severe, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE METFORMIN ORAL SOLUTION
Keep your medicine in a safe place
Keep out of the reach and sight of children
If a child is treated with Metformin oral solution, parents and
caregivers are advised to oversee how this medicine is used.
Dispose of any remaining medicine 28 days after opening.
Do not use Metformin oral solution after the expiry date which is
stated on the label and carton EXP (month, year). The expiry date
refers to the last day of that month.
Do not use Metformin Oral Solution if you notice that the
appearance or smell of your medicine has changed. Talk to your
pharmacist.
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. FURTHER INFORMATION
What Metformin oral solution contains:
The active substance is metformin hydrochloride. Each 5 ml of oral
solution contains 500 mg metformin hydrochloride.
The other ingredients are sodium methyl parahydroxybenzoate
(E219), sodium propyl parahydroxybenzoate (E217), liquid maltitol
(E965), sodium dihydrogen phosphate dihydrate, disodium
hydrogen phosphate anhydrous (E339), acesulfame potassium
(E950), caramel (E150), peppermint flavour, peach flavour and
purified water.
What Metformin oral solution looks like and contents of the pack
Metformin oral solution is a clear brown liquid which is peach and
peppermint flavoured. It comes in a brown glass bottle holding
100 ml or 150 ml of solution with a child resistant screw off cap and
a plastic pipette (5ml dose volume graduated every 0.5ml).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
Manufacturer
ONE PHARMA INDUSTRIAL PHARMACEUTICAL SA, 60th km
National Road Athens-Lamia, Schimatari, P.O. 32009, Greece.
This leaflet was updated in July 2012

4. POSSIBLE SIDE EFFECTS
Like all medicines, Metformin oral solution can cause side effects,
although not everybody gets them. The following side effects may
occur:
Very common side effects (affects more than 1 user in 10):
• digestive problems, such as feeling sick (nausea), being sick
(vomiting), diarrhoea, abdominal pain and loss of appetite. These
side effects most often happen at the beginning of the treatment
with Metformin oral solution. It helps if you spread the doses over
the day and if you take this medicine with or straight after a meal.
If symptoms continue, stop taking Metformin oral solution
and talk to your doctor.
Common side effects (affects 1 to 10 users in 100):
• changes in taste.
Very rare side effects (affects less than 1 user in 10,000):
• lactic acidosis. This is a very rare but serious complication
particularly if your kidneys are not working properly.
Symptoms of lactic acidosis are vomiting, 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 oral
solution immediately and tell your doctor straight away;

MET.WINT.LEAF.02

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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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