METFORMIN HYDROCHLORIDE 100MG/ML ORAL SOLUTION

Active substance: METFORMIN HYDROCHLORIDE

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METFORMIN HYDROCHLORIDE
100 mg/ml ORAL SOLUTION
Read all of this leaflet carefully before you start taking this medicine.

It may harm them, even if their symptoms are the same as yours.
not listed in this leaflet, please tell your doctor or pharmacist.

need any other treatment for this time. It is important that you follow
your doctor’s instructions precisely.
Take special care with Metformin
Please note the following particular risk of lactic acidosis.
Metformin may cause a very rare, but serious complication called
lactic acidosis, particularly if your kidneys are not working properly.
The risk of lactic acidosis is also increased with uncontrolled diabetes,
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.

1. What Metformin Hydrochloride 100 mg/ml Oral Solution is and what it
is used for
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
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
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
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
blood glucose to as normal a level as possible.
If you are an overweight adult, taking metformin over a long period of
time also helps to lower the risk of complications associated with
diabetes.
Metformin is associated with either a stable body weight or modest
weight loss.
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.

inflammation of the skin or in asthma)
taken any other medicines, including medicines obtained without a
prescription.
Taking Metformin Hydrochloride Oral Solution with food and drink
the risk of lactic acidosis, especially if you have liver problems or if you
are undernourished. This also applies to medicines that contain alcohol.

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.

Children aged 10 years and over and adolescents can take Metformin on
its own or together with insulin.

doctor if you are, you think you might be or are planning to become
pregnant so that he or she may change your treatment.
are planning to breast-feed your baby.

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.

If you take insulin too, your doctor will tell you how to start Metformin.

Medicines should not be disposed of via wastewater or household waste.

Monitoring

These measures will help to protect the environment.

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

ORAL SOLUTION

Do not take Metformin Hydrochloride Oral Solution:
ingredients of this medicine (see ‘What Metformin Hydrochloride
100 mg/ml Oral Solution contains’ in Section 6)
(high blood glucose), nausea, vomiting, dehydration, rapid weight loss

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.

‘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

Important information about some of the ingredients of Metformin
Hydrochloride Oral Solution
This medicine contains:
long-lasting or severe diarrhoea, or if you have vomited several times in Methyl and propyl parahydroxybenzoates. These may cause an allergic
a row. Dehydration may lead to kidney problems, which can put you at reaction (possibly delayed), such as skin rash and difficulty in breathing. If
this happens talk to a doctor straight away.
risk for lactic acidosis (see ‘Take special care with Metformin’ below)
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)
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)
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
injection of contrast medicines that contain iodine into your
bloodstream

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

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.
(breakfast) and evening (dinner).
(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.

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.

What Metformin Hydrochloride 100 mg/ml Oral Solution looks like and
contents of the pack:
homogenous oral solution with a characteristic smell of orange.
The product is available in 100 ml and 150 ml bottles with a plastic
0.5 ml.

If you take more Metformin Hydrochloride Oral Solution than you should Marketing Authorisation Holder
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 Manufacturer
being well with severe tiredness, and difficulty in breathing. If this
Teva Czech Industries s.r.o.
happens to you, you may need immediate hospital treatment, as lactic
č
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.
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:

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):
Very rare side effects (in less than 1 in 10,000 people):
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.
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.
rash (hives)

doctor has told you.
Check with your doctor or pharmacist if you are not sure.

6 FURTHER INFORMATION
What Metformin Hydrochloride 100 mg/ml Oral Solution contains

Very common side effects (in more than 1 in 10 people):

2 BEFORE YOU TAKE METFORMIN HYDROCHLORIDE 100 mg/ml

ORAL SOLUTION

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.

Pregnancy and breast-feeding
treat diabetes (medicines taken by mouth or insulin).

5 HOW TO STORE METFORMIN HYDROCHLORIDE 100 MG/ML
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.

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.

This leaflet was last revised in: May 2011

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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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