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METFORMIN HYDROCHLORIDE 100MG/ML ORAL SOLUTION

Active substance(s): METFORMIN HYDROCHLORIDE

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METFORMIN HYDROCHLORIDE
100 mg/ml ORAL SOLUTION
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9OUMUSTSTOPTAKING-ETFORMINFORACERTAINPERIODOFTIMEBEFOREAND
AFTERTHEEXAMINATIONORTHESURGERY9OURDOCTORWILLDECIDEWHETHERYOU
need any other treatment for this time. It is important that you follow
your doctor’s instructions precisely.

Read all of this leaflet carefully before you start taking this medicine.
Take special care with Metformin
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOURDOCTORORPHARMACIST
Please note the following particular risk of lactic acidosis.
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOU$ONOTPASSITONTOOTHERS
Metformin may cause a very rare, but serious complication called
It may harm them, even if their symptoms are the same as yours.
lactic acidosis, particularly if your kidneys are not working properly.
s )FANYOFTHESIDEEFFECTSGETSSERIOUS ORIFYOUNOTICEANYSIDEEFFECTS
The risk of lactic acidosis is also increased with uncontrolled diabetes,
not listed in this leaflet, please tell your doctor or pharmacist.
vomiting, bellyache (abdominal pain) with muscle cramps, a general
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feeling of not being well with severe tiredness, and difficulty in
breathing. If this happens to you, you may need immediate hospital
1. What Metformin Hydrochloride 100 mg/ml Oral Solution is and what it
treatment, as lactic acidosis may lead to coma. Stop taking Metformin
is used for
immediately and contact a doctor or the nearest hospital straight away.
2. Before you take Metformin Hydrochloride 100 mg/ml Oral Solution
3. How to take Metformin Hydrochloride 100 mg/ml Oral Solution
Metformin on its own does not cause hypoglycaemia (a blood glucose
4. Possible side effects
level which is too low). However, if you take Metformin together with
5. How to store Metformin Hydrochloride 100 mg/ml Oral Solution
other medicines to treat diabetes that can cause hypoglycaemia (such as
6. Further information
sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia.

1 WHAT METFORMIN HYDROCHLORIDE 100 mg/ml ORAL
SOLUTION IS AND WHAT IT IS USED FOR

What Metformin Hydrochloride 100 mg/ml Oral Solution is
Metformin Hydrochoride 100 mg/ml 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
TAKEINGLUCOSESUGAR FROMTHEBLOOD9OURBODYUSESGLUCOSETO
produce energy or stores it for future use.

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.
Taking other medicines
If you need to have an injection of contrast medicines that contain iodine
INTOYOURBLOODSTREAM FOREXAMPLEFOREXAMINATIONSSUCHAS8 RAYOR
scan, you must stop taking Metformin 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
If you have diabetes, your pancreas does not make enough insulin or
ATTHESAMETIME9OUMAYNEEDMOREFREQUENTBLOODGLUCOSETESTSOR
your body is not able to use properly the insulin it produces. This leads to
your doctor may adjust the dosage of Metformin:
a high level of glucose in your blood. Metformin helps to lower your
s $IURETICSUSEDTOREMOVEWATERFROMTHEBODYBYMAKINGMOREURINE
blood glucose to as normal a level as possible.
s "ETA AGONISTSSUCHASSALBUTAMOLORTERBUTALINEUSEDTOTREATASTHMA
s #ORTICOSTEROIDSUSEDTOTREATAVARIETYOFCONDITIONS SUCHASSEVERE
If you are an overweight adult, taking metformin over a long period of
inflammation of the skin or in asthma)
time also helps to lower the risk of complications associated with
s /THERMEDICINESUSEDTOTREATDIABETES
diabetes.
s 0LEASETELLYOURDOCTORORPHARMACISTIFYOUARETAKINGORHAVERECENTLY
Metformin is associated with either a stable body weight or modest
taken any other medicines, including medicines obtained without a
weight loss.
prescription.
What Metformin Hydrochloride 100 mg/ml Oral Solution is used for
Metformin 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.

Taking Metformin Hydrochloride Oral Solution with food and drink
s $ONOTDRINKALCOHOLWHENYOUTAKETHISMEDICINE!LCOHOLMAYINCREASE
the risk of lactic acidosis, especially if you have liver problems or if you
are undernourished. This also applies to medicines that contain alcohol.

!DULTSCANTAKE-ETFORMINONITSOWNORTOGETHERWITHOTHERMEDICINESTO Pregnancy and breast-feeding
s $URINGPREGNANCY YOUNEEDINSULINTOTREATYOURDIABETES4ELLYOUR
treat diabetes (medicines taken by mouth or insulin).
doctor if you are, you think you might be or are planning to become
Children aged 10 years and over and adolescents can take Metformin on
pregnant so that he or she may change your treatment.
its own or together with insulin.
s 4HISMEDICINEISNOTRECOMMENDEDIFYOUAREBREAST FEEDINGORIFYOU
are planning to breast-feed your baby.

2 BEFORE YOU TAKE METFORMIN HYDROCHLORIDE 100 mg/ml
ORAL SOLUTION

Do not take Metformin Hydrochloride Oral Solution:
s )FYOUAREALLERGICHYPERSENSITIVE TOMETFORMINORANYOFTHEOTHER
ingredients of this medicine (see ‘What Metformin Hydrochloride
100 mg/ml Oral Solution contains’ in Section 6)
s )FYOUHAVEKIDNEYORLIVERPROBLEMS
s )FYOUHAVEUNCONTROLLEDDIABETES WITHEGSEVEREHYPERGLYCAEMIA
(high blood glucose), nausea, vomiting, dehydration, rapid weight loss
ORKETOACIDOSIS+ETOACIDOSISISACONDITIONINWHICHSUBSTANCESCALLED
‘ketone bodies‘ accumulate in the blood and which can lead to diabetic
pre-coma. Symptoms include stomach pain, fast and deep breathing,
sleepiness or unusual fruity odour of the breath
s )FYOULOSTTOOMUCHWATERFROMYOURBODYDEHYDRATION SUCHASDUETO
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 ‘Take special care with Metformin’ below)
s )FYOUHAVEASEVEREINFECTION SUCHASANINFECTIONAFFECTINGYOURLUNG
or bronchial system or your kidney. Severe infections may lead to
kidney problems, which can put you at risk for lactic acidosis (see ‘Take
special care with Metformin’ below)
s IFYOUARETREATEDFORHEARTFAILUREORHAVERECENTLYHADAHEARTATTACK
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 for lactic acidosis (see ‘Take special care with
Metformin’ below)
s )FYOUDRINKALOTOFALCOHOL
If any of the above applies to you, talk to your doctor, before you start
taking this medicine.
Make sure you ask your doctor for advice if
s 9OUNEEDTOHAVEANEXAMINATIONSUCHAS8 RAYORSCANINVOLVINGTHE
injection of contrast medicines that contain iodine into your
bloodstream
s 9OUNEEDTOHAVEMAJORSURGERY

!SKYOURDOCTORORPHARMACISTFORADVICEBEFORETAKINGANYMEDICINE
Driving and using machines
Metformin 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
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
heart beat, 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
Hydrochloride Oral Solution
This medicine contains:
Methyl and propyl parahydroxybenzoates. These may cause an allergic
reaction (possibly delayed), such as skin rash and difficulty in breathing. If
this happens talk to a doctor straight away.

3 HOW TO TAKE METFORMIN HYDROCHLORIDE 100 mg/ml ORAL
SOLUTION

!LWAYSTAKE-ETFORMIN(YDROCHLORIDE/RAL3OLUTIONEXACTLYASYOUR
doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Metformin 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.

Usual dose
Children 10 years and over and adolescents usually start with
500 mg (5 ml) or 850 mg (8.5 ml) Metformin once a day. The maximum
daily dose is 2000 mg (20 ml) 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.
Adults usually start with 500 mg (5 ml) or 850 mg (8.5 ml) Metformin
two or three times a day. The maximum daily dose is 3000 mg (30 ml)
taken as 3 divided doses.
If you take insulin too, your doctor will tell you how to start Metformin.
Monitoring
s 9OURDOCTORWILLPERFORMREGULARBLOODGLUCOSETESTSANDWILLADAPT
your dose of Metformin 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
s 9OURDOCTORWILLALSOCHECKATLEASTONCEAYEARHOWWELLYOURKIDNEYS
WORK9OUMAYNEEDMOREFREQUENTCHECKSIFYOUAREANOLDERPERSONOR
if your kidneys are not working normally.
How to take Metformin
Take Metformin with or after a meal. This will avoid you having side
effects affecting your digestion.
This solution contains 100 mg of metformin in one 1 ml measurement.
s )FYOUTAKEONEDOSEADAY TAKEITINTHEMORNINGBREAKFAST 
s )FYOUTAKETWODIVIDEDDOSESADAY TAKETHEMINTHEMORNING
(breakfast) and evening (dinner).
s )FYOUTAKETHREEDIVIDEDDOSESADAY TAKETHEMINTHEMORNING
(breakfast), at noon (lunch) and in the evening (dinner).
If, after some time, you think that the effect of Metformin is too strong or
too weak, talk to your doctor or pharmacist.
If you take more Metformin Hydrochloride Oral Solution than you should
If you have taken more Metformin than you should have, you may
experience lactic acidosis. Symptoms of lactic acidosis are vomiting,
bellyache (abdominal pain) with muscle cramps, a general feeling of not
being well 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. Contact a doctor or the nearest hospital
straight away.
If you forget to take Metformin Hydrochloride Oral Solution
Do not take a double dose to make up for a forgotten dose. Take the next
dose at the usual time.

5 HOW TO STORE METFORMIN HYDROCHLORIDE 100 MG/ML
ORAL SOLUTION

Keep out of the reach and sight of children. If a child is treated with
Metformin, parents and caregivers are advised to oversee how this
medicine is used.
Do not store above 30°C.
Do not use this medicine after the expiry date shown on the label and the
outer carton. The expiry date refers to the last day of the month. Once
opened use within 30 days.
Medicines should not be disposed of via wastewater or household waste.
!SKYOURPHARMACISTHOWTODISPOSEOFMEDICINESNOLONGERREQUIRED
These measures will help to protect the environment.

6 FURTHER INFORMATION
What Metformin Hydrochloride 100 mg/ml Oral Solution contains
s 4HEACTIVESUBSTANCEISMETFORMINHYDROCHLORIDE MGML
s 4HEOTHERINGREDIENTSAREPROPYLENEGLYCOL% METHYL
PARAHYDROXYBENZOATE% PROPYLPARAHYDROXYBENZOATE%
ORANGEFLAVOUR  GLYCEROL% DISODIUMPHOSPHATEDIHYDRATE
% SODIUMDIHYDROGENPHOSPHATEDIHYDRATE% SACCHARIN
SODIUMMONOHYDRATE% PURIFIEDWATER
What Metformin Hydrochloride 100 mg/ml Oral Solution looks like and
contents of the pack:
s -ETFORMIN(YDROCHLORIDEMGML/RAL3OLUTIONISACLEAR
homogenous oral solution with a characteristic smell of orange.
The product is available in 100 ml and 150 ml bottles with a plastic
,$0%03 PIPETTEWITHLUERTIP MLDOSEVOLUMEGRADUATEDEVERY
0.5 ml.
.OTALLPACKSIZESMAYBEMARKETED
Marketing Authorisation Holder
4%6!5+,IMITED %ASTBOURNE ".!'
Manufacturer
Teva Czech Industries s.r.o.
/STRAVSKÉ čP /PAVA +OMÉROV
#ZECH2EPUBLIC
This leaflet was last revised in: May 2011
0,

)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOFTHISPRODUCT ASKYOUR
doctor or pharmacist.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Metformin 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 people):
s $IGESTIVEPROBLEMS SUCHASFEELINGSICKNAUSEA BEINGSICKVOMITING
diarrhoea, bellyache (abdominal pain) and loss of appetite. These side
effects most often happen at the beginning of treatment with
Metformin. It helps if you spread the doses over the day and if you take
Metformin with or straight after a meal.
If symptoms continue, stop taking Metformin and talk to your doctor.
Common side effects (in less than 1 in 10 people):
s #HANGESINTASTE
Very rare side effects (in less than 1 in 10,000 people):
s ,ACTICACIDOSIS4HISISAVERYRAREBUTSERIOUSCOMPLICATIONPARTICULARLY
if your kidneys are not working properly. Symptoms of lactic acidosis
are vomiting, bellyache (abdominal pain) with muscle cramps, a general
feeling of not being well 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
immediately and contact a doctor or the nearest hospital straight away.
s !BNORMALITIESINLIVERFUNCTIONTESTSORHEPATITISINFLAMMATIONOFTHE
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 and talk to your doctor.
s 3KINREACTIONSSUCHASREDNESSOFTHESKINERYTHEMA ITCHINGORANITCHY
rash (hives)
s ,OWVITAMIN"12 levels in the blood.
Children and adolescents
Limited data in children and adolescents showed that adverse events
were similar in nature and severity to those reported in adults.
If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

,& !

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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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