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Package leaflet: Information for the user

Metformin Colonis 500mg/5ml
Oral Solution
Metformin hydrochloride
■ It is important you take your
Read all of this leaflet carefully before
medication as prescribed, follow
you start taking this medicine because it
dietary instructions and keep up your
contains important information for you.
regular exercise program because
■ Keep this leaflet. You may need to
these measures can reduce the risk of
read it again
lactic acidosis.
■ If you have any further questions, ask
■ The onset of lactic acidosis can be
your doctor or pharmacist.
subtle and the symptoms can be non■ This medicine has been prescribed for
specific such as:
you only. Do not pass it on to others.
■ being sick (vomiting)
It may harm them, even if their signs
■ stomach ache (abdominal pain) with
of illness are the same as yours.
muscle cramps
■ If you get any side effects, talk to your
■ a general feeling of not being well
doctor or pharmacist. This includes any
with severe tiredness
possible side effects not listed in this
■ difficulty in breathing
leaflet. See section 4.
■ further symptoms are reduced body
What is in this leaflet:
temperature and heartbeat.
1. What Metformin Oral Solution is and
If you experience some of these
what it is used for
symptoms, stop taking this medicine
2. What you need to know before you take and seek medical attention immediately.
Metformin Oral Solution
■ Talk to your doctor or pharmacist
3. How to take Metformin Oral Solution
before using Metformin Oral Solution
4. Possible side effects
5. How to store Metformin Oral Solution
■ you need to have a diagnostic
6. Contents of the pack and other
examination such as X-ray or scan
involving the injection of contrast
dyes that contain iodine into your
1. What Metformin Oral Solution
■ you need to have surgery in which
is and what it is used for
you will be given an anaesthetic
(put to sleep).
■ Metformin Colonis 500mg/5ml Oral
must stop taking Metformin Oral
Solution (referred to as Metformin
Solution for a certain period of time
Oral Solution in this leaflet) contains
before and after the examination
metformin hydrochloride, a medicine
or surgery. Your doctor will tell you
to treat diabetes. It belongs to a group
what you need to do and will decide
of medicines called biguanides.
whether you need any other treatments
■ After you have eaten, your body
during this time. It is important that
converts the carbohydrates and sugar
you follow your doctor’s instructions
in your food into glucose, which travels
in your blood to where it is needed.
Insulin is a hormone produced in your ■ On its own this medicine does not
cause hypoglycaemia (a condition
pancreas which moves the glucose
when your blood glucose levels
from your blood into your body’s cells
become too low). However, if you take
where it is used as energy (fuel)
Metformin Oral Solution together
■ If you have type 2 diabetes, your
with other medicines used to treat
pancreas does not make enough insulin
diabetes (such as sulphonylureas,
or your body is not able to use properly
insulin, meglitinides), there is a risk
the insulin it produces, (known as
of hypoglycaemia. If you experience
insulin resistance). This leads to
symptoms such as weakness, dizziness,
high levels of glucose in your blood.
increased sweating, fast heart beating,
Metformin Oral Solution helps to lower
vision disorders or difficulty in
your blood glucose to as normal a level
concentration, it usually helps to eat or
as possible.
drink something containing sugar.
■ This medicine is used to treat patients
with type 2 diabetes (also called ‘non- Children aged 10 and over and
insulin dependent diabetes’) when
diet and exercise alone have not been
■ This medicine may be used in children
enough to control your blood glucose
aged 10 and over either by itself or in
levels. It is often used in overweight
combination with insulin.
■ Regular monitoring of children taking
■ If you are an overweight adult, taking
this medicine is recommended
this medicine over a long period of
time can also help lower the risk
Other medicines and Metformin
Oral Solution
of complications associated with
diabetes. This medicine is associated
■ If you need to have an injection of a
with either a stable body weight or
contrast dye medicine that contains
modest weight loss.
iodine for a diagnostic examination
■ Adults can take this medicine on its
such as an X-ray or scan, you will need
own or together with other medicines
to stop taking Metformin Oral Solution
to treat diabetes or with insulin.
for a period of time both before and
■ Adolescents and children aged 10
after the examination (at least 48
years and over can take this medicine
hours). It is important that you discuss
on its own or together with insulin.
this with your doctor beforehand.
■ Tell your doctor or pharmacist if you
are taking, have recently taken or might
2. What you need to know before
take any other medicines, including
you take Metformin Oral Solution
those bought without a prescription.
■ You may need more frequent blood
Do not take Metformin Oral Solution
glucose tests or your doctor may adjust
the dosage of Metformin Oral Solution
■ if you are allergic (hypersensitive) to
if you are taking or have recently taken:
metformin hydrochloride or any of
■ diuretics (used to remove water from
the other ingredients of this medicine
the body by making more urine).
(listed in section 6)
■ beta-2 agonists such as salbutamol
■ if you have uncontrolled diabetes,
or terbutaline (used to treat asthma)
with e.g. severe hyperglycaemia (high
■ corticosteroids such as
levels of blood glucose in your blood),
prednisolone (used to treat a variety
nausea (feeling sick), vomiting (being
of conditions including asthma and
sick), dehydration or rapid weight loss
■ if you have symptoms of a condition
■ other medicines used to treat
called ketoacidosis in which
substances called ‘ketone bodies’
■ Non-Steroidal Anti-Inflammatories
accumulate in the blood and can lead to
(NSAIDS) such as diclofenac (used
diabetic pre-coma (unconsciousness).
to treat inflammation)
Symptoms include stomach pain, fast
and deep breathing, sleepiness and
Metformin Oral Solution with
unusual fruity odour of the breath
food and drink
(likened to the smell of pear drops)
■ if you have moderate or severe liver or Do not drink alcohol when you take
this medicine. Alcohol may increase
kidney problems
the risk of lactic acidosis especially if
■ if you become dehydrated (when
you have liver problems or if you are
you lose too much water from your
undernourished. This also applies to
body), due to long-lasting or severe
medicines that contain alcohol.
diarrhoea, or if you have been sick
several times in a short space of
Pregnancy and breast-feeding
time. Dehydration may lead to kidney
If you are pregnant or breastfeeding,
problems, which can put you at risk
think you may be pregnant or are
of lactic acidosis (see ‘Warnings and
planning to have a baby, ask your doctor
or pharmacist for advice before taking
■ if you have a severe infection,
this medicine.
such as an infection affecting your
■ During pregnancy, you need to use
lungs, airways or your kidneys.
insulin to treat your diabetes rather
Severe infections may lead to kidney
than Metformin Oral Solution. Tell your
problems, which can put you at risk
doctor if you are pregnant, think you
of lactic acidosis (see ‘Warnings and
may be pregnant or are planning to
precautions’ and Section 4 Possible
have a baby, so that they can change
side effects)
your treatment.
■ if you are treated for acute heart
■ This medicine is not recommended if
failure or have recently had a heart
you are breast-feeding or if you are
attack, have severe problems with
planning to breast-feed your baby.
your circulation (such as shock) or
Driving and using machines
have breathing difficulties. This may
lead to a lack of oxygen in your body
■ Taken on its own this medicine does
tissues which can put you at risk of
not cause hypoglycaemia (a condition
lactic acidosis (see “Warnings and
where your blood glucose levels
become too low). This means that it
■ if you drink a lot of alcohol
will not affect your ability to drive or
use machines.
If any of the above applies to you, talk to
■ If this medicine is taken with insulin
your doctor, before you start taking this
or other medicines used to treat
diabetes that can cause hypoglycaemia
Warnings and precautions
(such as sulphonylureas, insulin and
■ Metformin Oral Solution may cause a
meglitinides), it is possible that their
very rare, but very serious complication
combined effects may make you
called lactic acidosis, particularly if
feel faint or dizzy. Other symptoms
your kidneys are not working properly
of hypoglycaemia include weakness,
(kidney function may worsen when
increased sweating, fast heartbeat,
starting medication for high blood
vision disorders and difficulty
pressure, water retention and when
concentrating. If you experience any
starting treatment with Non-Steroidal
of these symptoms do not drive or
Anti-Inflammatory Drugs (NSAIDs).
operate machinery until you feel better.
■ The risk of developing lactic acidosis is
Important information about some
also increased with:
of the ingredients of Metformin
■ uncontrolled diabetes
Oral Solution
■ prolonged fasting or alcohol intake
This medicine contains Sodium propyl
■ loss of body fluid (dehydration)
due to severe diarrhoea or vomiting parahydroxybenzoate (E217) which
may cause allergic reactions (possibly
(being sick)
■ liver problems
■ any medical conditions in which a
region of the body is deprived of
oxygen (such as acute severe heart

This may cause:
■ tiredness
■ loss of appetite
■ weight loss
Always take this medicine exactly as your
■ possible yellowing of your skin or
doctor has told you. Check with your
the whites of your eyes
doctor or pharmacist if you are not sure.
If this happens to you, stop taking
Metformin Oral Solution cannot replace
Metformin Oral Solution and talk to
the benefits of a healthy lifestyle. You
your doctor straight away.
should continue to follow any advice
about diet that your doctor has given you Very Common Side effects
(may affect more than 1 in 10 people)
and take regular exercise.
These side effects happen most often
Recommended dose
at the beginning of treatment with
Children and adolescents aged
Metformin Oral Solution. It helps if you
10 years and over
spread the doses out over the day and if
■ The recommended starting dose for
you take this medicine with or straight
children is either 500mg (5ml) or
after a meal. If symptoms continue, stop
850mg Metformin Oral Solution once
taking Metformin Oral Solution and talk
a day.
to your doctor
■ The maximum daily dose is 2000mg
■ feeling or being sick
(20ml) taken as 2 or 3 divided doses.
■ diarrhoea
■ Treatment of children between 10 and
■ stomach ache (abdominal pain)
12 years of age is only recommended
■ loss of appetite
on specific advice from your doctor,
Common side effects
as knowledge of the effects of this
(may affect up to 1 in 10 people)
medicine in this age group is limited.
■ changes in taste
Very rare side effects
■ The recommended starting dose for
(may affect up to 1 in 10,000 people)
adults is either 500mg (5ml) or
■ skin reactions such as redness of the
850mg Metformin Oral Solution two
skin (erythema)
or three times a day.

or an itchy rash (hives).
■ The maximum daily dose is 3000mg
■ low levels of vitamin B12 in the blood
(30ml) taken as 3 divided doses.
which may cause anaemia
Adults with kidney problems
Children and adolescents
■ The recommended starting dose for
Limited data in children and adolescents
adults with kidney impairment is
500mg (5ml) or 850mg Metformin Oral showed that side effects were similar in
nature and severity to those reported in
Solution once a day.
■ The maximum dose is 1000mg (10ml)
daily, given as 2 divided doses.
Reporting of side effects
■ Kidney function should be closely
If you get any side effects, talk to your
monitored every 3 - 6 months
doctor or pharmacist. This includes any
Note: Metformin Oral Solution
possible side effects not listed in this
500mg/5ml is intended for the
leaflet. You can also report side effects
administration of doses of 500mg or
directly via the Yellow Card Scheme
multiples of 500mg.
850mg/5ml and 1000mg/5ml strengths
By reporting side effects you can help
are also available and can be used to
provide more information on the safety of
ensure the right dose to control your
this medicine.
symptoms is achieved. If you think this
would be beneficial to you talk to your
5. How to store Metformin
If you also take insulin your doctor will
Oral Solution
give you advice about how to take this
Keep this medicine out of the sight and
medicine with your insulin.
reach of children. If this medicine is
intended for use in a child, administration
■ Your doctor will perform regular blood of the medicine should be supervised by
glucose tests and will adapt your dose an adult.
of Metformin Oral Solution to your
■ Do not store above 25°C
blood glucose levels. Make sure that
■ Do not use this medicine after the
you talk to your doctor regularly. This
expiry date which is stated on the
is particularly important for children
bottle and carton after ‘EXP’.
and adolescents or if you are an older
The expiry date refers to the last day of
that month.
■ Your doctor will also check how well
your kidneys are working at least once ■ Once the bottle has been opened,
this medicine should be used within
a year. You may need more frequent
2 months
checks if you are an older person or if
your kidneys are not working normally. ■ Do not throw away any medicines
via wastewater or household waste.
Directions for use
Ask your pharmacist how to throw
■ Always take this medicine with or after
away medicines you no longer use.
a meal. This may help you avoid having
These measures will help protect the
some of the side effects
■ If you take one dose a day, take it in
the morning (breakfast)
6. Contents of the pack and
■ If you have been advised to take two
other information
doses a day, take them in the morning
(breakfast) and evening (dinner)
What Metformin Oral Solution
■ If you have been advised to take three
doses a day, take them in the morning contains
(breakfast), at noon (lunch) and in the
■ The active substance is metformin
evening (dinner)
hydrochloride. Each 5ml oral solution
■ If, after some time, you think that the
contains 500mg of metformin
effect of this medicine is too strong
or too weak, talk to your doctor or
■ The other ingredients are:
■ Sodium propyl parahydroxybenzoate
■ Use the graduated 10ml dosing spoon
provided to administer the correct dose
■ Sodium dihydrogen phosphate
dihydrate (E 339)
Method of administration
■ Disodium phosphate anhydrous
Metformin Oral Solution is for oral use
(E 339)
■ Sucralose
■ Peach flavour (contains propylene
glycol and ethanol)
If necessary, Metformin Oral Solution can
■ Sodium hydroxide (for pH
be administered via a gastric, duodenal,
and nasal feeding tube, that should
■ Purified water.
be rinsed twice with 10ml of water
immediately after administration.
What Metformin Oral Solution looks

3. How to take Metformin
Oral Solution

If you take more Metformin Oral
Solution than you should
If you have taken more Metformin Oral
Solution that you should have, you may
experience lactic acidosis, (see Section
4 Possible side effects). This is a very
serious medical condition and you should
stop taking this medicine and seek
medical advice immediately because it
can lead to a diabetic coma.
If you forget to take Metformin Oral
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
4. Possible side effects

like and contents of the pack
Metformin Oral Solution is a clear,
colourless solution with a peach flavour,
filled into 150ml or 300ml, amber glass
bottles fitted with a child-resistant,
tamper-evident screw cap. (Not all pack
sizes may be marketed)
A graduated 10ml dosing spoon is also
included in the pack.
Marketing Authorisation Holder and
Marketing Authorisation Holder:
Colonis Pharma Limited
Hanover Place
8 Church Road
Royal Tunbridge Wells
United Kingdom
Rafarm SA
Thesi Pousi-Xatzi,
Agiou Louka,
Paiania Attiki,
TO- 37,
Saneca Pharmaceuticals, a.s.
Nitrianska 100
920 27 Hlohovec
Slovak Republic
Marketed and Distributed by:
Quantum Pharmaceutical
Hobson Industrial Estate
County Durham
NE16 6EA
United Kingdom

Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Stop taking Metformin Oral Solution and
see a doctor or go to a hospital straight
away if you experience any of these very
rare side effects (may affect up to 1 in
10,000 people)
■ Lactic acidosis: lactic acidosis is a
very rare side effect (may affect up
to 1 in 10,000 people) but is a very
serious complication particularly if
your kidneys are not working properly.
Lactic acidosis can be subtle and the
symptoms can be non-specific such as:
■ being sick
■ stomach ache (abdominal pain) with
muscle cramps
■ a general feeling of not being well
with severe tiredness
This leaflet was last revised in July 2016
■ difficulty in breathing
■ reduced body temperature
■ slower heartbeat
If you experience these symptoms, you
should seek medical advice immediately,
because lactic acidosis may lead to
diabetic coma, even if you have not had
problems with this medicine before.
■ Liver function: abnormalities in
liver function tests or hepatitis
(inflammation of the liver).

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