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METFORMIN HYDROCHLORIDE 500 MG/5 ML ORAL SOLUTION

Active substance(s): METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Metformin Hydrochloride 500 mg/5 ml Oral Solution
Metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
− 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 only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
− If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Metformin Oral Solution is and what it is used for
2. What you need to know 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. Contents of the pack and other information
1. WHAT METFORMIN ORAL SOLUTION IS AND WHAT IT IS USED FOR
What Metformin Oral Solution is
Your medicine is called ‘Metformin Hydrochloride 500 mg/5 ml Oral Solution’.
It will be referred to throughout this leaflet as ‘Metformin Oral Solution’.
Metformin Oral Solution contains metformin, a medicine to treat diabetes. It
belongs to a group of medicines called biguanides.
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 properly use the insulin it produces. This leads to a high
level of glucose in your blood. Metformin Oral Solution 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, it also helps to lower the risk of complications associated with
diabetes. Metformin Oral Solution is associated with either a stable body
weight or modest weight loss.
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. WHAT YOU NEED TO KNOW 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 solution (see section 6 and end of section 2)
− if you have liver problems
− if you have severely reduced kidney function
− if you have uncontrolled diabetes, with for example severe hyperglycaemia
(high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic
acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis
is a condition in which substances called ‘ketone bodies’ accumulate in the
blood and which can lead to diabetic pre-coma. The symptoms of
ketoacidosis include stomach pain, fast and deep breathing, sleepiness or
your breath developing an unusual fruity smell
− if 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 in
a row. Dehydration may lead to kidney problems, which can put you at risk
for lactic acidosis (see “Warnings and precautions”)
− if 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 for lactic acidosis (see “Warnings and
precautions”)
− if you are treated for acute 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 of lactic acidosis (see “Warnings and precautions”
below)
− if you drink a lot of alcohol.
If any of the above applies to you, talk to your doctor before you start taking
this medicine.
Talk to your doctor before taking Metformin Oral Solution if:
− you need to have an examination such as X-ray or scan involving iodine
contrast medicines that contain iodine in 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 for this time. It
is important that you follow your doctor’s instructions precisely.
Warnings and precautions
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
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 diseases).
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 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.
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 to restart your treatment with Metformin Oral
Solution.
Metformin Oral Solution on its own does not cause hypoglycaemia (low blood
glucose level). However, if you take Metformin Oral Solution with other
medicines to treat diabetes that can cause hypoglycaemia (such as
sulphonylureas e.g. gliclazide, insulin, meglitinides e.g. repaglinide), there is a
risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as
weakness, dizziness, increased sweating, fast heart beating, vision disorders
or difficulty in concentration, it usually helps to eat or drink something
containing sugar.
During treatment with Metformin Oral Solution, your doctor will check your
kidney function at least once a year or more frequently if you are elderly and/or
if you have worsening kidney function.
Patients with heart failure are more at risk of hypoxia and renal insufficiency.
If you have stable chronic heart failure, your doctor will check your heart and
kidney function regularly. Do not take Metformin Oral Solution if you have
acute or unstable heart failure.
The diagnosis of type II diabetes must be confirmed before children and
adolescents are treated with metformin. No effects of metformin on the growth
and puberty of children has been observed, however monitoring of children is
recommended.
Caution is recommended when prescribing to children aged between 10 and
12 years.
Other medicines and Metformin Oral Solution
If you need to have an injection of a contrast medium that contains iodine into
your bloodstream, for example in the context of an X-ray or scan, you must
stop taking Metformin Oral Solution before or at the same time of
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
medicine. You may need more frequent blood glucose and kidney function
tests, or your doctor may adjust the dosage of Metformin Oral Solution. It is
especially important to mention the following:
− medicines which increase urine production (diuretics)
− 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)
− beta-2 agonists 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)
− medicines that may change the amount of Metformin Oral Solution in your
blood, especially if you have reduced kidney function (such as verapamil,
rifampicin; cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib,
isavuconazole, crizotinib, olaparib)
− other medicines to treat diabetes mellitus.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Metformin Oral Solution with 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, including
those obtained without a prescription.
Pregnancy and breast-feeding
During pregnancy, insulin rather than metformin is used to treat diabetes.
Do not take Metformin Oral Solution and talk to your doctor if you are pregnant,
think you might be pregnant or are planning to become pregnant, so that
he/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
(low blood glucose). 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 e.g. gliclazide, insulin, meglitinides e.g. repaglinide).
Symptoms of hypoglycaemia include weakness, dizziness, increased sweating,
fast heart beat, vision disorders or difficulty in concentration. Do not drive or
use machines if you start to feel these symptoms.
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Date

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210 x 297 mm

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Metformin Oral Solution contains methyl and propyl
parahydroxybenzoate, liquid maltitol, sodium and ethanol
− Methyl and propyl parahydroxybenzoate – may cause allergic reactions
(possibly delayed).
− Liquid maltitol - if you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal
product. May have a mild laxative effect. Calorific value 2.3 kcal/g of maltitol.
− Sodium - 14.19 mg per 5 ml dose. This should be taken into consideration
for patients on a controlled sodium diet.
− Ethanol - This medicinal product contains small amounts of ethanol
(alcohol) less than 100 mg per 5 ml.

3. HOW TO TAKE METFORMIN ORAL SOLUTION
Always take this medicine exactly as your doctor 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 also take insulin, your doctor will tell you how to start taking Metformin
Oral Solution.
The recommended dose is
Adults
− The recommended starting dose of Metformin Oral Solution is 5 ml (500 mg)
or 8.5 ml (850 mg) two or three times a day
− The maximum daily dose is 30 ml (3000 mg) taken as 3 divided doses.
For the elderly (where decreased renal function is likely), the dosage should
be adjusted based on renal function.
If you have reduced kidney function, your doctor may prescribe a lower dose.
Use in Children 10 years and over and adolescents
− The recommended starting dose of Metformin Oral Solution is 5 ml (500 mg)
or 8.5 ml (850 mg) once a day
− The maximum daily dose is 20 ml (2000 mg) taken as two or three 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.
Directions for using the syringe:
1. Open the bottle
2. Insert the adaptor into the bottle neck and ensure it is well fixed.
3. Push the tip of the syringe firmly into the adaptor plug (hole) in the neck of
the bottle. When in position the tip should be partly visible. Do not force it
all the way in.
4. To fill the syringe, turn the bottle upside down. Whilst holding the syringe in
place, gently pull the plunger down slowly drawing the medicine to the
correct mark (5 ml, 8.5 ml or 10 ml) on the syringe.
5. Turn the bottle the right way up, and then gently twist the syringe to remove
from the adaptor plug.
6. Place the end of the syringe into your mouth, pressing the plunger down to
slowly and gently release the medicine.
After use replace the cap on the top of the bottle tightly. The adaptor should
remain in the bottle. Wash the syringe in warm water and allow to dry.
Monitoring
− Your doctor will perform regular blood glucose tests and 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 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.
How to take Metformin Oral Solution
Take Metformin Oral Solution with or after a meal. This will help to avoid any
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 you think that the effect of Metformin Oral Solution is too strong or too weak,
talk to your doctor or pharmacist.
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. Further symptoms are reduced
body temperature and heartbeat. If you experience some of these
symptoms, you should seek immediate medical attention, as lactic
acidosis may lead to coma. Stop taking Metformin Oral Solution and
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.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them. The following side effects may occur:
Serious side effects
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.
Other side effects
Very common side effects (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 occur most often at the beginning of the treatment with Metformin
Oral Solution. It helps if you spread the doses over the day and if you take
the medicine with or straight after a meal. If symptoms continue, stop
taking Metformin Oral Solution and talk to your doctor.
Common side effects (may affect up to 1 in 10 people)
− changes in taste
Very rare side effects (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
non-specific (see section “Warnings and precautions”)
− 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 Metformin Oral Solution and talk to your doctor.
− skin reactions such as redness of the skin (erythema), itching or an itchy
rash (hives)
− low vitamin B12 levels in the blood.
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 effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App store. By
reporting side effects you can help provide more information on the safety of
this medicine.
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 caregivers are advised to oversee
how this medicine is used.
Do not store above 25°C.
Do not take Metformin Oral Solution 60 days after opening the bottle and
discard any remaining medicine. Do not use this medicine after the expiry date
which is stated on the label and carton. The expiry date refers to the last day
of that month.
Do not use this medicine if you notice that the appearance or smell of your
medicine has changed. Talk to your pharmacist about this.
Do not throw away medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Metformin Oral Solution contains
− The active substance is: metformin hydrochloride. Each 5 ml dose of
Metformin Oral Solution contains 500 mg of metformin hydrochloride.
− The other ingredients are: liquid maltitol (E965), glycerol (E422), saccharin
sodium (E954), propylene glycol (E1520), propyl parahydroxybenzoate
(E216), methyl parahydroxybenzoate (E218), sodium dihydrogen phosphate
dihydrate, disodium phosphate dodecahydrate (E339), peppermint flavour
(contains ethanol), peach flavour (contains propylene glycol and ethanol),
hydrochloric acid (for pH adjustment) and purified water (See end of
Section 2 for further information).
What Metformin Oral Solution looks like and contents of the pack
Metformin Oral Solution is a clear, colourless peach and peppermint flavoured
oral solution presented in 100 ml and 150 ml amber glass bottles with
child-resistant closures. A 10 ml graduated dosing syringe is provided.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL Number: PL 04917/0094
This leaflet was last revised in 09/2017.

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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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