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METFORMIN 100 MG / ML ORAL SOLUTION

Active substance(s): METFORMIN HYDROCHLORIDE

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X-ray or scan, involving the injection of contrast
medicines into your bloodstream that contain
iodine;
• 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 or not you need any other treatment
during this period. 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, stomach
ache (abdominal pain) with muscle cramps, a
general feeling of being unwell, with severe
tiredness and difficulty in breathing. If this happens
to you, you may need immediate treatment in
hospital. Stop taking Metformin Oral Solution
immediately and contact your doctor or go to the
nearest hospital straight away.
Metformin Oral Solution 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
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 heartbeat, 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 into your bloodstream, that contain
iodine, 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);

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(continued overleaf)

• Sodium sulfite. This may rarely cause severe Monitoring
hypersensitivity
(allergic)
reactions
and • Your doctor will adapt your dose of Metformin
bronchospasm.
Oral Solution to your blood glucose levels. Make
• Ethanol. This medicinal product contains small
sure that you talk to your doctor regularly. This is
amounts of ethanol (alcohol), less than 100mg
particularly
important
for
children
and
per 10ml.
adolescents or if you are elderly.
• Your doctor will also check, at least once a year,
how well your kidneys work. You may need more
frequent checks if you are elderly or if your
3. How to take Metformin 100mg/ml
kidneys are not working normally.
Oral Solution
Always take Metformin Oral Solution exactly as your Directions for opening the bottle and using the
doctor has told you. You should check with your syringe
doctor or pharmacist if you are not sure.
Open the bottle by pressing the cap
Metformin Oral Solution cannot replace the
and turn it anticlockwise (Figure 1).
benefits of a healthy lifestyle. Continue to follow
any advice about diet that your doctor has given Insert the syringe into the bottle.
you and get some regular exercise.
Whilst holding the bottom ring, pull
the piston upwards to the graduation
How to take this medicine
• This solution contains 100mg of metformin in 1ml. mark corresponding to the quantity
• Taking this medicine with or just after food will in millilitres (ml) prescribed by the
avoid you having side effects affecting your doctor (Figure 2).
digestion.
Remove the oral syringe from the bottle and wipe
• If you take one dose a day, take it in the morning the body of the syringe with a tissue to remove
excess solution.
(breakfast).
• If you take two divided doses a day, take them in Empty the contents of the syringe onto a spoon or
the morning (breakfast) and evening (dinner).
directly into the mouth by pressing the plunger down.
• If you take three divided doses a day, take them Close the bottle with the plastic screw cap.
in the morning (breakfast), at noon (lunch) and in Wash the syringe with water after every use and
the evening (dinner).
leave it to air dry.
If, after some time, you think that the effect of If you take more Metformin Oral Solution than you
Metformin Oral Solution is too strong or too weak, should
talk to your doctor or pharmacist.
If you have taken more Metformin Oral Solution
Usual dose
than you should have, you may experience lactic
acidosis. Symptoms of lactic acidosis are vomiting,
Adults
• The usual starting dose is 500mg (5ml) or 850mg stomach ache (abdominal pain) with muscle
cramps, a general feeling of being unwell, with
(8.5ml) two or three times a day.
• The maximum daily dose is 3000mg (30ml) taken severe tiredness and difficulty in breathing. Contact
your doctor or go to the nearest hospital straight
as 3 divided doses.
If you take insulin too, your doctor will tell you how away.
If you forget to take Metformin Oral Solution
to start taking Metformin Oral Solution.
Elderly: Your doctor may prescribe a different dose. Do not take a double dose to make up for a
forgotten dose. Take the next dose at the usual time.
Children over 10 years and adolescents
If you stop taking Metformin Oral Solution
• The usual dose of metformin is 500mg (5ml) or Keep taking this medicine until your doctor tells you
850mg (8.5ml) once a day.
to stop.
• The maximium daily dose is 2000mg (20ml) taken If you have any further questions on the use of this
as 2 or 3 divided doses.
product, ask your doctor or pharmacist.
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
4. Possible side effects
limited.
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 (in more than 1 in 10 users)
• digestive problems, such as feeling sick (nausea),
being sick (vomiting), diarrhoea, stomach ache
(abdominal pain) and loss of appetite. These side
effects most often happen at the beginning of
treatment with Metformin Oral Solution. It helps if
you spread the doses over the day and if you
take the doses with or straight after a meal. If
symptoms continue, stop taking Metformin Oral
Solution and talk to your doctor.
Common side effects (in less than 1 in 10 users)
• changes in taste.
Very rare side effects (in less than 1 in 10,000 users)
• lactic acidosis. This is a very rare but serious
complication, particularly if your kidneys are not
working properly. Symptoms of lactic acidosis are
vomiting, stomach ache (abdominal pain) with
muscle cramps, a general feeling of being unwell,
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 contact
your doctor or go to the nearest hospital straight away.
• skin reactions such as redness of the skin
(erythema), itching or an itchy rash (urticaria).
• low vitamin B12 levels in the blood.
• 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 and inform your doctor immediately.
Children and adolescents
Limited data in children and adolescents showed
that adverse events 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 100mg/ml Oral
Solution

Once the medicine is opened, use within 28 days.
Do not use after the expiry date which is stated on
the bottle label and carton. 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
1ml of solution contains 100mg of metformin hydrochloride.
The other ingredients are: Sodium methyl parahydroxybenzoate (E219), Sodium propyl parahydroxybenzoate (E217), Sodium dihydrogen phosphate
dihydrate, Di-sodium hydrogen phosphate anhydrous
(E339), Liquid Maltitol (75%) (E965), Acesulfame
potassium (E950), Caramel colour (E150b) (containing
sucrose and sodium sulfite (E221)), Peppermint flavour,
Peach flavour (containing ethanol) and Purified water.
What Metformin Oral Solution looks like and
contents of the pack
Metformin Oral Solution is a clear brown solution
with characteristic odour.
It comes in an amber glass bottle, containing 150ml
of solution, with a child resistant screw-cap, along
with a 10ml oral syringe.
Marketing Authorisation Holder
Focus Pharmaceuticals Ltd., Capital House, 1st
Floor, 85 King William Street, London EC4N 7BL,
United Kingdom
Tel: 00 44 (0)1283 495280
Fax: 00 44 (0)1283 495290
Email: medinfo@focuspharma.co.uk
Manufacturer
Farmasierra Manufacturing, S.L.
Ctra. de Irún, Km 26,200,
28709 San Sebastián de los Reyes (Madrid), Spain
For any information about this medicinal product,
please contact the Marketing Authorisation Holder,
details provided above.

For information in large print, audio CD or
Braille please telephone
Keep out of the sight and reach of children. If a child is 00 44 (0)1283 495 280 or email
treated with Metformin Oral Solution, parents and carers medinfo@focuspharma.co.uk.
are advised to oversee how this medicine is used.
Do not store above 25°C.

This leaflet was last revised in 06/2015.

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BACK

• corticosteroids (used to treat a variety of
conditions, such as severe inflammation of the
skin or in asthma);
• other medicines 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 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.
It is not recommended to take Metformin Oral
Solution during breast-feeding. Your doctor will
decide whether you should stop breast-feeding
whilst you are treated with Metformin Oral Solution.
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, meglitinides). 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:
• Liquid maltitol (75%) and sucrose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product. Sucrose
may also be harmful to teeth.
• Sodium methyl and propyl parahydroxybenzoates.
These may cause allergic reactions (possibly
delayed).
• Sodium (7mg per 5ml dose). To be taken into
consideration by patients on a controlled sodium
diet.
• Potassium (14.5mg per 5ml dose). To be taken
into consideration by patients with reduced
kidney function or patients on a controlled
potassium diet.

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FRONT

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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
PACKAGE LEAFLET:
been enough to control your blood glucose levels.
INFORMATION FOR THE USER
It is used particularly in overweight patients.
Metformin 100mg/ml Oral Solution
Adults can take Metformin Oral Solution on its own
Metformin Hydrochloride
or together with other medicines to treat diabetes
Read all of this leaflet carefully before you start (medicines taken by mouth or insulin).
taking this medicine.
Children 10 years and over and adolescents can
• Keep this leaflet. You may need to read it again. take Metformin Oral Solution on its own or together
• If you have further questions, ask your doctor or with insulin.
your pharmacist.
• This medicine has been prescribed only for you.
Do not pass it on to others. It may harm them, 2. Before you take Metformin 100mg/ml
even if their symptoms are the same as yours.
Oral Solution
• If any of these side effects get serious, or if you Do not take Metformin Oral Solution:
notice any side effects not listed in this leaflet,
• If you are allergic (hypersensitive) to metformin or
please tell your doctor or pharmacist.
any of the other ingredients in this medicine (see
In this leaflet:
section 6, Further information).
1. What Metformin 100mg/ml Oral Solution is and • If you have kidney or liver problems.
what it is used for
• If you have uncontrolled diabetes, with severe
2. Before you take Metformin 100mg/ml Oral
hyperglycaemia (high blood glucose), nausea,
Solution
vomiting, dehydration, rapid weight loss or
3. How to take Metformin 100mg/ml Oral Solution
ketoacidosis. Ketoacidosis is a condition in which
4. Possible side effects
substances called 'ketone bodies' accumulate in
the blood. Symptoms include stomach pain, fast
5. How to store Metformin 100mg/ml Oral Solution
and deep breathing, sleepiness or unusual fruity
6. Further information
odour of the breath.
• If you have lost too much water from your body
1. What Metformin 100mg/ml Oral Solution
(dehydration), due to long-lasting or severe
is and what it is used for
diarrhoea, or if you have vomited several times in
a row. Dehydration may lead to kidney
Your medicine is called Metformin 100mg/ml Oral
problems, which can put you at risk of lactic
Solution (called Metformin Oral Solution throughout
acidosis (see 'Take special care with Metformin
the rest of this leaflet).
Oral Solution’ below).
What Metformin Oral Solution is:
• If you have a severe infection, such as an
Metformin Oral Solution contains metformin, a
infection affecting your lungs, bronchial system
medicine to treat diabetes. It belongs to a group of
or your kidneys. Severe infections may lead to
medicines called biguanides.
kidney problems, which can put you at risk of
Insulin is a hormone produced by the pancreas that
lactic acidosis (see 'Take special care with
makes your body take in glucose (sugar) from the
Metformin Oral Solution’ below).
blood. Your body uses glucose to produce energy
• If you are being treated for heart failure or have
or stores it for future use.
recently had a heart attack, have severe
If you have diabetes, your pancreas does not make
problems with your circulation (such as shock) or
enough insulin or your body is not properly able to
have breathing difficulties. This may lead to a
use the insulin that it produces. This leads to a high
lack in oxygen supply to tissue which can put you
level of glucose in your blood. Metformin Oral
at risk of lactic acidosis (see 'Take special care
Solution helps to lower your blood glucose to as
with Metformin Oral Solution’ below).
normal a level as possible.
• If you drink a lot of alcohol.
If you are an overweight adult, taking Metformin
Oral Solution over a long period of time also helps If any of the above applies to you, talk to your
to lower the risk of complications associated with doctor before you start taking this medicine.
diabetes. Metformin is associated with either a Make sure you ask your doctor for advice if:
• you need to have an examination such as an
stable body weight or modest weight loss.

tel:
01283 495280

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fax:
01283 495290

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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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