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Package leaflet: Information for the user

Metformin Colonis 1000mg/5ml
Oral Solution
Metformin hydrochloride
regular exercise program because
Read all of this leaflet carefully before
these measures can reduce the risk of
you start taking this medicine because it
lactic acidosis.
contains important information for you.
■ The onset of lactic acidosis can be
■ Keep this leaflet. You may need to
subtle and the symptoms can be nonread it again
specific such as:
■ If you have any further questions, ask
■ being sick (vomiting)
your doctor or pharmacist.
■ stomach ache (abdominal pain) with
■ This medicine has been prescribed for
muscle cramps
you only. Do not pass it on to others.
■ a general feeling of not being well
It may harm them, even if their signs
with severe tiredness
of illness are the same as yours.
■ difficulty in breathing
■ If you get any side effects, talk to your
■ further symptoms are reduced body
doctor or pharmacist. This includes any
temperature and heartbeat.
possible side effects not listed in this
leaflet. See section 4.
If you experience some of these
symptoms, stop taking this medicine
What is in this leaflet:
and seek medical attention immediately.
1. What Metformin Oral Solution is and
■ Talk to your doctor or pharmacist
what it is used for
before using Metformin Oral Solution
2. What you need to know before you take
Metformin Oral Solution
■ you need to have a diagnostic
3. How to take Metformin Oral Solution
examination such as X-ray or scan
4. Possible side effects
involving the injection of contrast
5. How to store Metformin Oral Solution
dyes that contain iodine into your
6. Contents of the pack and other
■ you need to have surgery in which
you will be given an anaesthetic
1. What Metformin Oral Solution
(put to sleep).
is and what it is used for
You must stop taking Metformin Oral
Solution for a certain period of time
■ Metformin Colonis 1000mg/5ml Oral
before and after the examination
Solution (referred to as Metformin
or surgery. Your doctor will tell you
Oral Solution in this leaflet) contains
what you need to do and will decide
metformin hydrochloride, a medicine
whether you need any other treatments
to treat diabetes. It belongs to a group
during this time. It is important that
of medicines called biguanides.
you follow your doctor’s instructions
■ After you have eaten, your body
converts the carbohydrates and sugar

its own this medicine does not
in your food into glucose, which travels
cause hypoglycaemia (a condition
in your blood to where it is needed.
when your blood glucose levels
Insulin is a hormone produced in your
become too low). However, if you take
pancreas which moves the glucose
Metformin Oral Solution together
from your blood into your body’s cells
with other medicines used to treat
where it is used as energy (fuel)
diabetes (such as sulphonylureas,
■ If you have type 2 diabetes, your
insulin, meglitinides), there is a risk
pancreas does not make enough insulin
of hypoglycaemia. If you experience
or your body is not able to use properly
symptoms such as weakness, dizziness,
the insulin it produces, (known as
increased sweating, fast heart beating,
insulin resistance). This leads to
vision disorders or difficulty in
high levels of glucose in your blood.
concentration, it usually helps to eat or
Metformin Oral Solution helps to lower
drink something containing sugar.
your blood glucose to as normal a level
as possible.
Children aged 10 and over and
■ This medicine is used to treat patients
with type 2 diabetes (also called ‘non■ This medicine may be used in children
insulin dependent diabetes’) when
aged 10 and over either by itself or in
diet and exercise alone have not been
combination with insulin.
enough to control your blood glucose

Regular monitoring of children taking
levels. It is often used in overweight
this medicine is recommended
■ If you are an overweight adult, taking
Other medicines and Metformin
this medicine over a long period of
Oral Solution
time can also help lower the risk
■ If you need to have an injection of a
of complications associated with
contrast dye medicine that contains
diabetes. This medicine is associated
iodine for a diagnostic examination
with either a stable body weight or
such as an X-ray or scan, you will need
modest weight loss.
to stop taking Metformin Oral Solution
■ Adults can take this medicine on its
for a period of time both before and
own or together with other medicines
after the examination (at least 48
to treat diabetes or with insulin.
hours). It is important that you discuss
■ Adolescents and children aged 10
with your doctor beforehand.
years and over can take this medicine ■ this
Tell your doctor or pharmacist if you
on its own or together with insulin.
are taking, have recently taken or might
take any other medicines, including
2. What you need to know before
those bought without a prescription.
you take Metformin Oral Solution ■ You may need more frequent blood
glucose tests or your doctor may adjust
Do not take Metformin Oral Solution
the dosage of Metformin Oral Solution
if you are taking or have recently taken:
■ if you are allergic (hypersensitive) to
■ diuretics (used to remove water from
metformin hydrochloride or any of
the body by making more urine).
the other ingredients of this medicine
■ beta-2 agonists such as salbutamol
(listed in section 6)
or terbutaline (used to treat asthma)
■ if you have uncontrolled diabetes,
■ corticosteroids such as
with e.g. severe hyperglycaemia (high
prednisolone (used to treat a variety
levels of blood glucose in your blood),
of conditions including asthma and
nausea (feeling sick), vomiting (being
sick), dehydration or rapid weight loss
■ other medicines used to treat
■ if you have symptoms of a condition
called ketoacidosis in which
■ Non-Steroidal Anti-Inflammatories
substances called ‘ketone bodies’
(NSAIDS) such as diclofenac (used
accumulate in the blood and can lead to
to treat inflammation)
diabetic pre-coma (unconsciousness).
Symptoms include stomach pain, fast Metformin Oral Solution with
and deep breathing, sleepiness and
food and drink
unusual fruity odour of the breath
Do not drink alcohol when you take
(likened to the smell of pear drops)
■ if you have moderate or severe liver or this medicine. Alcohol may increase
the risk of lactic acidosis especially if
kidney problems
you have liver problems or if you are
■ if you become dehydrated (when
undernourished. This also applies to
you lose too much water from your
medicines that contain alcohol.
body), due to long-lasting or severe
diarrhoea, or if you have been sick
Pregnancy and breast-feeding
several times in a short space of
If you are pregnant or breastfeeding,
time. Dehydration may lead to kidney
think you may be pregnant or are
problems, which can put you at risk
planning to have a baby, ask your doctor
of lactic acidosis (see ‘Warnings and
or pharmacist for advice before taking
this medicine.
■ if you have a severe infection,
■ During pregnancy, you need to use
such as an infection affecting your
insulin to treat your diabetes rather
lungs, airways or your kidneys.
than Metformin Oral Solution. Tell your
Severe infections may lead to kidney
doctor if you are pregnant, think you
problems, which can put you at risk
may be pregnant or are planning to
of lactic acidosis (see ‘Warnings and
have a baby, so that they can change
precautions’ and Section 4 Possible
your treatment.
side effects)
■ This medicine is not recommended if
■ if you are treated for acute heart
you are breast-feeding or if you are
failure or have recently had a heart
planning to breast-feed your baby.
attack, have severe problems with
your circulation (such as shock) or
Driving and using machines
have breathing difficulties. This may
■ Taken on its own this medicine does
lead to a lack of oxygen in your body
not cause hypoglycaemia (a condition
tissues which can put you at risk of
where your blood glucose levels
lactic acidosis (see “Warnings and
become too low). This means that it
will not affect your ability to drive or
■ if you drink a lot of alcohol
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
(such as sulphonylureas, insulin and
Warnings and precautions
meglitinides), it is possible that their
■ Metformin Oral Solution may cause a
combined effects may make you
very rare, but very serious complication
feel faint or dizzy. Other symptoms
called lactic acidosis, particularly if
of hypoglycaemia include weakness,
your kidneys are not working properly
increased sweating, fast heartbeat,
(kidney function may worsen when
vision disorders and difficulty
starting medication for high blood
concentrating. If you experience any
pressure, water retention and when
of these symptoms do not drive or
starting treatment with Non-Steroidal
operate machinery until you feel better.
Anti-Inflammatory Drugs (NSAIDs).
■ 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)
parahydroxybenzoate (E217) which
due to severe diarrhoea or vomiting may cause allergic reactions (possibly
(being sick)
■ liver problems
■ any medical conditions in which a
3. How to take Metformin
region of the body is deprived of
Oral Solution
oxygen (such as acute severe heart
Always take this medicine exactly as your
■ It is important you take your
doctor has told you. Check with your
medication as prescribed, follow
doctor or pharmacist if you are not sure.
dietary instructions and keep up your

Metformin Oral Solution cannot replace
the benefits of a healthy lifestyle. You
should continue to follow any advice
about diet that your doctor has given
you and take regular exercise.

■ 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.
Recommended dose

Liver function: abnormalities in
Children and adolescents aged
liver function tests or hepatitis
10 years and over
(inflammation of the liver).
■ The recommended starting dose for
This may cause:
children is either 500mg (2.5ml)
■ tiredness
or 850mg (4.25ml) Metformin Oral
■ loss of appetite
Solution once a day.
■ weight loss
■ The maximum daily dose is 2000mg
■ possible yellowing of your skin or
(10ml) taken as 2 or 3 divided doses.
the whites of your eyes
■ Treatment of children between 10 and
If this happens to you, stop taking
12 years of age is only recommended
Metformin Oral Solution and talk to
on specific advice from your doctor,
your doctor straight away.
as knowledge of the effects of this
medicine in this age group is limited.
Very Common Side effects
(may affect more than 1 in 10 people)
■ The recommended starting dose
These side effects happen most often
for adults is either 500mg (2.5ml)
at the beginning of treatment with
or 850mg (4.25ml) Metformin Oral
Metformin Oral Solution. It helps if you
Solution two or three times a day.
spread the doses out over the day and if
■ The maximum daily dose is 3000mg
you take this medicine with or straight
(15ml) taken as 3 divided doses.
after a meal. If symptoms continue, stop
Adults with kidney problems
taking Metformin Oral Solution and talk
■ The recommended starting dose for
to your doctor
adults with kidney impairment is
■ feeling or being sick
500mg (2.5ml) or 850mg (4.25ml)
■ diarrhoea
Metformin Oral Solution once a day.
■ stomach ache (abdominal pain)
■ The maximum dose is 1000mg (5ml)
■ loss of appetite
daily, given as 2 divided doses.
side effects
■ Kidney function should be closely
up to 1 in 10 people)
monitored every 3 - 6 months
■ changes in taste
If you also take insulin your doctor will
Very rare side effects
give you advice about how to take this
(may affect up to 1 in 10,000 people)
medicine with your insulin.
■ skin reactions such as redness of the
skin (erythema)
■ Your doctor will perform regular blood ■ itching or an itchy rash (hives).
glucose tests and will adapt your dose ■ low levels of vitamin B12 in the blood
of Metformin Oral Solution to your
which may cause anaemia
blood glucose levels. Make sure that
Children and adolescents
you talk to your doctor regularly. This
Limited data in children and adolescents
is particularly important for children
showed that side effects were similar in
and adolescents or if you are an older
nature and severity to those reported in
■ Your doctor will also check how well
your kidneys are working at least once
Reporting of side effects
a year. You may need more frequent
If you get any side effects, talk to your
checks if you are an older person or if
your kidneys are not working normally. doctor or pharmacist. This includes any
possible side effects not listed in this
Directions for use
leaflet. You can also report side effects
■ Always take this medicine with or after directly via the Yellow Card Scheme
a meal. This may help you avoid having Website:
some of the side effects
By reporting side effects you can help
■ If you take one dose a day, take it in
provide more information on the safety
the morning (breakfast)
of this medicine.
■ If you have been advised to take two
doses a day, take them in the morning
5. How to store Metformin
(breakfast) and evening (dinner)
Oral Solution
■ If you have been advised to take three
doses a day, take them in the morning Keep this medicine out of the sight and
(breakfast), at noon (lunch) and in the reach of children. If this medicine is
evening (dinner)
intended for use in a child, administration
■ If, after some time, you think that the
of the medicine should be supervised by
effect of this medicine is too strong
an adult.
or too weak, talk to your doctor or
■ Do not store above 25°C
■ Do not use this medicine after the
■ Use either the graduated 10ml dosing
expiry date which is stated on the
spoon provided or the syringe (using
bottle and carton after ‘EXP’.
the instructions below) to administer
The expiry date refers to the last day of
the correct dose
that month.
Method of administration
■ Once the bottle has been opened,
this medicine should be used within
Metformin Oral Solution is for oral use only.
2 months
A graduated oral syringe and a Press-In
■ Do not throw away any medicines
Bottle Adapter (PIBA) are provided with
via wastewater or household waste.
the product. The press in bottle adapter
Ask your pharmacist how to throw
must be used only if the product is
away medicines you no longer use.
administered by the use of the oral syringe.
These measures will help protect the
1. Open the bottle by pressing down on
the child-resistant cap very firmly
and turning it anti-clockwise. At first
6. Contents of the pack and
use insert the Press-In Bottle Adapter
other information
(PIBA) firmly into the neck of the bottle
ensuring that it fits well enough to
What Metformin Oral Solution contains
prevent any spillages.
■ The active substance is metformin
2. Insert the syringe into the PIBA
hydrochloride. Each 5ml oral solution
contains 1000mg of metformin
3. Turn the bottle upside down and fill the
syringe with a small amount of solution
■ The other ingredients are:
by pulling the plunger down.
■ Sodium propyl parahydroxybenzoate
4. Push the plunger back up to remove
any possible bubbles.
■ Sodium dihydrogen phosphate
5. Pull the plunger down to the graduation
dihydrate (E 339)
mark corresponding to the quantity
■ Disodium phosphate anhydrous
inml prescribed by your doctor.
(E 339)
6. Remove the filled syringe from the
■ Sucralose
bottle in the upright position.
■ Peach flavour (contains propylene
7. Discharge the syringe contents into the
glycol and ethanol)
mouth. Repeat steps 2 to 7 as needed
■ Sodium hydroxide (for pH
to achieve the required dose prescribed
by your doctor.
■ Purified water.
8. Rinse the syringe and replace the cap
on the bottle (PIBA remains in place).
Let the syringe dry before using again. What Metformin Oral Solution looks
like and contents of the pack
Oral Solution is a clear,
If necessary, Metformin Oral Solution can Metformin
with a peach flavour,
be administered via a gastric, duodenal,
filled into 150ml or 300ml, amber glass
and nasal feeding tube, that should
bottles fitted with a child-resistant,
be rinsed twice with 10ml of water
tamper-evident screw cap. (Not all pack
immediately after administration.
sizes may be marketed)
If you take more Metformin Oral
A 5ml LDPE oral syringe with
Solution than you should
intermediate graduations of 0.25ml and a
If you have taken more Metformin Oral
graduated dosing spoon of 10ml are also
Solution that you should have, you may
included in the package.
experience lactic acidosis, (see Section
Marketing Authorisation Holder and
4 Possible side effects). This is a very
serious medical condition and you should Manufacturer
Marketing Authorisation Holder:
stop taking this medicine and seek
medical advice immediately because it
Colonis Pharma Limited
can lead to a diabetic coma.
Hanover Place, 8 Church Road
Royal Tunbridge Wells
If you forget to take Metformin Oral
Kent TN1 1JP
United Kingdom
Do not take a double dose to make up
for a forgotten dose. Take the next dose at Manufacturer:
the usual time.
Rafarm SA
Thesi Pousi-Xatzi,
If you have any further questions on the
Agiou Louka,
use of this medicine, ask your doctor or
Paiania Attiki,
TO- 37,
4. Possible side effects
Like all medicines, this medicine
Saneca Pharmaceuticals, a.s.
can cause side effects, although not
Nitrianska 100
everybody gets them.
27 Hlohovec
Stop taking Metformin Oral Solution and 920
see a doctor or go to a hospital straight
away if you experience any of these very Marketed and Distributed by:
rare side effects (may affect up to 1 in
Quantum Pharmaceutical
10,000 people)
Hobson Industrial Estate
■ Lactic acidosis: lactic acidosis is a
very rare side effect (may affect up
County Durham
to 1 in 10,000 people) but is a very
NE16 6EA
serious complication particularly if
United Kingdom
your kidneys are not working properly.
Lactic acidosis can be subtle and the
This leaflet was last revised in July 2016
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
■ difficulty in breathing
■ reduced body temperature

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