Skip to Content

UK Edition. Click here for US version.

METFORMIN 100 MG / ML ORAL SOLUTION

Active substance(s): METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

pharmacode read direction
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.
PACKAGE LEAFLET:
Adults can take Metformin Oral Solution on its own or
INFORMATION FOR THE USER
together with other medicines to treat diabetes
Metformin 100mg/ml Oral Solution
(medicines taken by mouth or insulin).
Children 10 years and over and adolescents can take
Metformin Hydrochloride
Read all of this leaflet carefully before you start taking Metformin Oral Solution on its own or together with insulin.
this medicine because it contains important
information for you.
2. What you need to know before you take Metformin
• Keep this leaflet. You may need to read it again.
Oral Solution
• If you have further questions, ask your doctor,
Do not take Metformin Oral Solution:
pharmacist or nurse.
• This medicine has been prescribed for you only. Do • If you are allergic to metformin or any of the other
ingredients of this medicine (listed in section 6)
not pass it on to others. It may harm them, even if
• If you have kidney or liver problems or if you have
their signs of illness are the same as yours.
severely reduced kidney function
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side • If you have uncontrolled diabetes, for example
severe hyperglycaemia (high blood glucose),
effects not listed in this leaflet. See section 4.
nausea, vomiting, diarrhoea, rapid weight loss,
Your medicine is called Metformin 100mg/ml Oral
lactate acidosis (see “Risk of lactic acidosis” below)
Solution (called Metformin Oral Solution throughout
or ketoacidosis. Ketoacidosis is a condition in which
the rest of this leaflet).
substances called 'ketone bodies' accumulate in
What is in this leaflet
the blood and which can lead to diabetic
1. What Metformin Oral Solution is and what it is used
pre-coma. Symptoms include stomach pain, fast
for
and deep breathing, sleepiness or your breath
2. What you need to know before you take Metformin
developing an unusual fruity smell
Oral Solution
• If you have lost too much water from your body
3. How to take Metformin Oral Solution
(dehydration), due to long-lasting or severe
4. Possible side effects
diarrhoea, or if you have vomited several times in a
5. How to store Metformin Oral Solution
row. Dehydration may lead to kidney problems,
6. Contents of the pack and other information
which can put you at risk of lactic acidosis (see 'Take
special care with Metformin Oral Solution’ below)
• If you have a severe infection, such as an infection
1. What Metformin Oral Solution is and what it is used
affecting your lungs, bronchial system or your
for
kidneys. Severe infections may lead to kidney
What Metformin Oral Solution is:
problems, which can put you at risk of lactic
Metformin Oral Solution contains metformin, a
acidosis (see 'Take special care with Metformin Oral
medicine to treat diabetes. It belongs to a group of
Solution’ below)
medicines called biguanides.
• If you are being treated for heart failure or have
recently had a heart attack, have severe problems
Insulin is a hormone produced by the pancreas that
with your circulation (such as shock) or have
makes your body take in glucose (sugar) from the
breathing difficulties. This may lead to a lack in
blood. Your body uses glucose to produce energy or
oxygen supply to tissue which can put you at risk of
stores it for future use.
lactic acidosis (see 'Take special care with
If you have diabetes, your pancreas does not make
Metformin Oral Solution’ below)
enough insulin or your body is not properly able to use
the insulin that it produces. This leads to a high level of • If you drink a lot of alcohol.
glucose in your blood. Metformin Oral Solution helps to If any of the above applies to you, talk to your doctor
lower your blood glucose to as normal a level as before you start taking this medicine.
possible.
Make sure you ask your doctor for advice if:
If you are an overweight adult, taking Metformin Oral • you need to have an examination such as an X-ray
Solution over a long period of time also helps to lower
or scan, involving the injection of contrast medicines
the risk of complications associated with diabetes.
into your bloodstream that contain iodine
Metformin is associated with either a stable body • you need to have major surgery.
weight or modest weight loss.
You must stop taking Metformin Oral Solution for a
What Metformin Oral Solution is used for:
certain period of time before and after the
Metformin Oral Solution is used to treat patients with 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.
Warning and precautions
Talk to your doctor, pharmacist or nurse before taking
Metformin Oral Solution.
Take special care with Metformin Oral Solution
Risk of lactic acidosis:
Metformin Oral Solution may cause a very rare, but very
serious side effect called lactic acidosis, particularly if
your kidneys are not working properly. The risk of
developing lactic acidosis is also increased with
uncontrolled diabetes, serious infections, prolonged
fasting or alcohol intake, dehydration (see further
information below), liver problems and any medical
conditions in which a part of the body has a reduced
supply of oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor
for further instructions.
Stop taking Metformin Oral Solution for a short time if
you have a condition that may be associated with
dehydration (significant loss of body fluids) such as
severe vomiting, diarrhoea, fever, exposure to heat or
if you drink less fluid than normal. Talk to your doctor
for further instructions.
Stop taking Metformin oral solution and contact a
doctor or the nearest hospital immediately possible if
you experience some of the symptoms of lactic
acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:
• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of not being well with severe
tiredness
• difficulty in breathing
• reduced body temperature and heartbeat.
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.
Lactic acidosis is a medical emergency and must be
treated in a hospital.
If you need to have major surgery you must stop
taking Metformin Oral Solution during and for some
time after the procedure. Your doctor will decide
when you must stop and when you can restart your
treatment with Metformin Oral Solution.
During treatment with Metformin Oral Solution your
doctor will check your kidney function at least once a
year and more frequently if you are elderly or if you
have worsening kidney function.
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

3. How to take Metformin Oral Solution
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Metformin Oral Solution 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.
If you have reduced kidney function, your doctor may
prescribe a lower dose.
How to take this medicine
• This solution contains 100mg of metformin in 1ml
• Taking this medicine with or just after food 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).
If, after some time, you think that the effect of
Metformin Oral Solution is too strong or too weak, talk
to your doctor or pharmacist.
The recommended dose is
Adults
• The usual starting dose is 500mg (5ml) or 850mg
(8.5ml) two or three times a day
• The maximum daily dose is 3000mg (30ml) taken as
3 divided doses.

(continued overleaf)

If you take insulin too, your doctor will tell you how to
start taking Metformin Oral Solution.
Elderly: Your doctor may prescribe a different dose.
Use in children and adolescents
• The usual dose of metformin is 500mg (5ml) or
850mg (8.5ml) once a day
• The maximum daily dose is 2000mg (20ml) 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.
Patients with kidney problems
• Your doctor will decide the best dose for you
depending on your kidney function
• Kidney function should be closely monitored (every
3-6 months).
Monitoring
• Your doctor will 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 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 kidneys
are not working normally.
Directions for opening the bottle and using the syringe
Open the bottle by pressing the cap
and turn it anticlockwise (Figure 1).
Insert the syringe into the bottle.
Whilst holding the bottom ring, pull the
piston upwards to the graduation mark
corresponding to the quantity in millilitres
(ml) prescribed by the doctor (Figure 2).
Remove the oral syringe from the bottle and wipe the
body of the syringe with a tissue to remove excess
solution.
Empty the contents of the syringe onto a spoon or
directly into the mouth by pressing the plunger down.
Close the bottle with the plastic screw cap.
Wash the syringe with water after every use and leave
it to air dry.
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, stomach
ache (abdominal pain) with muscle cramps, a
general feeling of being unwell, with severe tiredness
and difficulty in breathing. Contact your doctor or go
to 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.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

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.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Metformin Oral Solution may cause a very rare (may
affect up to 1 user in 10,000), but very serious side
effect called lactic acidosis (see section “Warnings
and precautions”). If this happens you must stop taking
Metformin Oral Solution and contact a doctor or the
nearest hospital immediately, as lactic acidosis may
lead to coma. The following side effects may occur:
Very common (may affect more than 1 in 10 people)
• 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 (may affect up to 1 in 10 people)
• changes in taste.
Very rare (may affect up to 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, 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.
Additional side effects in 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

5. How to store Metformin Oral Solution
Keep this medicine out of the sight and reach of
children. If a child is treated with Metformin Oral
Solution, parents and carers are advised to oversee
how this medicine is used.
Do not use this medicine after the expiry date which is
stated on the bottle label and carton after Exp. The
expiry date refers to the last day of that month.
Do not store above 25°C.
Once the medicine is opened, use within 28 days.
Do not use this medicine if you notice that the
appearance or smell of your medicine has changed.
Talk to your pharmacist.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other 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), Hydrochloric acid (for pH
adjustment) 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, 85 King
William Street, London EC4N 7BL, United Kingdom
Manufacturer
Farmasierra Manufacturing, S.L.,
Ctra. De Irún, Km 26,200,
28709 San Sebastián de los Reyes (Madrid), Spain
This leaflet was last revised in April 2017.
17626/3

pharmacode read direction

BACK

pharmacode read direction
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.
Metformin Oral Solution 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
• Sodium sulfite. This may rarely cause severe
hypersensitivity (allergic) reactions and bronchospasm
• Ethanol. This medicinal product contains small amounts
of ethanol (alcohol), less than 100mg per 10ml.

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.
Other medicines and Metformin Oral Solution
If you need to have an injection of contrast medium
that contains iodine into your blood stream, for
example for in the context of an X-ray or scan, you
must stop taking Metformin Oral Solution before or at
the time of the injection. Your doctor will decide when
you must stop and when to restart your treatment with
Metformin Oral Solution.
Tell your doctor if you are taking, have recently taken
or might take any other medicines.
You may need more frequent blood glucose and
kidney function tests or your doctor may need to
adjust the dosage of Metformin Oral Solution. It is
especially important to mention the following:
• medicines which increase urine production
(diuretics)
• 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 to treat diabetes
• medicines used to treat pain and inflammation
(NSAID and COX-2-inhibitors, such as ibuprofen and
celecoxib)
• certain medicines for the treatment of high blood
pressure (ACE inhibitors and angiotensin II receptor
antagonists).
Metformin Oral Solution with food, drink and alcohol
Avoid excessive alcohol intake while taking Metformin
Oral Solution since this may increase the risk of lactic
acidosis (see section “Warnings and precautions”).
This also applies to medicines that contain alcohol.
Pregnancy, breast-feeding and fertility
During pregnancy, you need insulin to treat your
diabetes.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine. 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

pharmacode read direction

FRONT

LF-102137-01

Version No.:
Product Name:
Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

LF-102137-01
Metformin 100mg/ml
Oral Solution
150ml
Leaflet
103471
UK
Farmasierra
Manufacturing S.L.
3
11/04/2017
PAT
PR 6037
AMCO.CRF.101.2016
310 x 200 mm
17626/3
354
N/A
N/A
302 C

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

11/04/2017
8 pt

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc.) and that Amdipharm have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

Signature ...................................................................
Name .........................................................................
Date ...........................................................................

PAGE 1 OF 1

Expand Transcript

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.

Hide