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METFORMIN 500 MG FILM-COATED TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE

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Package leaflet: Information for the user

pressure (ACE inhibitors and angiotensin II receptor
antagonists)

Metformin 500 mg and 850 mg film‐coated Tablets
Metformin hydrochloride

1. What Metformin Tablets is and what it is used for
Metformin film-coated Tablets contain 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 use properly the insulin it
produces. This leads to 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 Tablets 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.
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Metformin Tablets is used to
treat patients with type 2
diabetes (also called 'noninsulin 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 Tablets 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 Tablets on its own or together with insulin.

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2. What you need to know before you take Metformin
Tablets
Do not take Metformin Tablets
• if you are allergic (hypersensitive) to metformin or any of
the other ingredients of this medicine (listed in
section 6).
• if you have liver problems or kidney problems
(glomerular filtration rate below 45 ml/min).
• if you have uncontrolled diabetes, with e.g. severe
hyperglycaemia (high blood glucose), nausea,
vomiting, dehydration, rapid weight loss or
ketoacidosis. Ketoacidosis is a condition in which
substances called '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.
• if you 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 kidney.
Severe infections may lead to kidney problems, which
can put you at risk for lactic acidosis (see ' Warnings and
precautions’).
• if you have severely reduced kidney function.
• if you have uncontrolled diabetes, with, for example,
severe hyperglycemia (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. Symptoms include stomach
pain, fast and deep breathing, sleepiness or your breath
developing an unusual fruity smell.
• 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 for lactic acidosis (see '
Warnings and precautions’)
• 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.

Pregnancy, breast- feeding and fertility
During pregnancy, you need insulin to treat your diabetes. If
you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

You must stop taking Metformin tablets 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.

This medicine is not recommended if you are breastfeeding or if you are planning to breast-feed your baby.

Warnings and precautions
Talk to your doctor or pharmacist before taking Metformin
Tablets.

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Please note the following particular risk of lactic acidosis.
Metformin may cause a very rare, but very 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,
prolonged fasting or alcohol intake, body fluid deficit
(dehydration) due to severe diarrhoea or vomiting, liver
problems and any medical conditions in which a region of the
body is deprived with a lack of oxygen supply (such as acute
severe heart diseases).

Metformin Tablets 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.
Recommended dose
Children 10 years and over and adolescents usually start
with 500 mg or 850 mg Metformin Tablets once a day. The
maximum daily dose is 2000 mg taken as 2 or 3 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.

Lactic acidosis is a medical emergency and must be treated
in a hospital.

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If you have reduced kidney function, your doctor may
prescribe a lower dose. The maximum dose is 1000 mg
daily, given as 2 divided doses. The renal function should
be closely monitored (every 3 - 6 months).
If you take insulin too, your doctor will tell you how to start
Metformin Tablets.
Monitoring
• Your doctor will perform regular blood glucose tests
and will adapt 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.
• 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.

Stop taking Metformin Tablets 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 Tablets 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.

How to take Metformin Tablets
Take Metformin Tablets with or after a meal. This will avoid
you having side effects affecting your digestion.

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
If you need to have major surgery you must stop taking
Metformin Tablets during and for some time after the
procedure. Your doctor will decide when you must stop and
when to restart your treatment with Metformin Tablets.
During treatment with Metformin Tablets, 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.

However, take special care if you take Metformin Tablets
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.

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.

The onset of lactic acidosis can be subtle and the symptoms
can be non-specific such as vomiting, bellyache (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 heart beat. If
you experience some of these symptoms, you should seek
immediately medical attention, as lactic acidosis may lead to
coma. Stop taking Metformin Tablets immediately and
contact a doctor or the nearest hospital straight away.

Metformin Tablets on its own does not cause hypoglycaemia
(a blood glucose level which is too low). However, if you take
Metformin Tablets together with other medicines to treat
diabetes that can cause hypoglycaemia (such as
sulphonylureas, insulin, meglitinides), there is a risk of
hypoglycaemia. If you experience symptoms of
hypoglycaemia such as weakness, dizziness, increased
sweating, fast heart beating, visions disorders or difficulty in
concentration, it usually helps to eat or drink something
containing sugar.

Driving and using machines
Metformin Tablets 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.

3. How to take Metformin Tablets

It is important to you to comply with your medication intake,
dietary instructions and regular exercise program because
this can reduce the risk of lactic acidosis.

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What is in this leaflet
1. What Metformin Tablets is and what it is used for
2. What you need to know before you take Metformin
Tablets
3. How to take Metformin Tablets
4. Possible side effects
5. How to store Metformin Tablets
6. Contents of the pack and other information

Metformin Tablets with food, drink and alcohol
Avoid excessive alcohol intake while taking Metformin
Tablets since this may increase the risk of lactic acidosis
(see section "Warnings and precautions").

Make sure you ask your doctor for advice, if:
• you need to have an examination such as X-ray or scan
involving the injection of contrast medicines that contain
iodine into your bloodstream
• you need to have major surgery

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Read all of this leaf let carefully before you start taking this
medicine.
− 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.

Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.

Do not crush or chew the tablets. Swallow each tablet with a
glass of water.
• 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, 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 Tablets than you should
If you have taken more Metformin Tablets that you should
have, you may experience lactic acidosis. Symptoms of
lactic acidosis are nonspecific such as vomiting, bellyache
(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 heart beat. If you experience some of
these symptoms, you should seek immediately medical
attention, as lactic acidosis may lead to coma. Stop taking
Metformin Tablets immediately and contact a doctor or the
nearest hospital straight away.

Other medicines and Metformin Tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
If you need to have an injection of contrast medicines that
contain iodine into your bloodstream, for example for
examinations such as X-ray or scan, you must stop taking
Metformin Tablets for a certain period of time before and
after (at least 48h) 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 Tablets at the same time. You may need more
frequent blood glucose tests or your doctor may adjust the
dosage of Metformin Tablets:
• diuretics (used to remove water from the body by
making more urine).
• 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)
• other medicines used to treat diabetes
• 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

If you forget to take Metformin Tablets
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 pharmacist.

Very common: may affect more than 1 in 10 people
• digestive problems, such as feeling sick (nausea),
being sick (vomiting), diarrhoea, bellyache
(abdominal pain) and loss of appetite. These side
effects most often happen at the beginning of the
treatment with Metformin. It helps if you spread the
doses over the day and if you take Metformin Tables
with or straight after a meal. If symptoms continue, stop
taking metformin and talk to your doctor.
Common: may affect up to 1 in 10 people
• changes in taste.
Very rare: 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 nonspecific such as vomiting, bellyache 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
heart beat. If you experience some of these symptoms,
you should seek immediately medical attention, as
lactic acidosis may lead to coma. Stop taking
metformin immediately and contact a doctor or the
nearest hospital straight away.
• 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 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.
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 or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via Yellow
Card Scheme, Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Metformin Tablets
Keep this medicine out of the sight and reach of children. If a
child is treated with Metformin, parents and caregivers are
advised to oversee how this medicine is used.
This medicinal product does not require any special storage
conditions.
Do not use this medicine after the expiry date which is stated
on the label and carton after 'EXP'. The expiry date refers to
the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information
What Metformin Tablets contain
Metformin 500 mg film-coated Tablets:
Each film-coated tablet contains 500 mg metformin
hydrochloride corresponding to 390 mg metformin base.
Metformin 850 mg film-coated Tablets:
Each film-coated tablet contains 850 mg metformin
hydrochloride corresponding to 662.9 mg metformin base.
The other ingredients are hydroxypropylmethyl cellulose,
povidone, sodium starch glycolate (type A), colloidal
anhydrous silica, magnesium stearate, Opadry White Y17000 H (HPMC 2910/hypromellose E464, titanium dioxide
E171, macrogol/PEG E1521)
What Metformin Tablets look like and contents of the
pack
Metformin 500 mg film-coated Tablets are White, round,
biconvex film coated tablet plain on one side and debossed
with 'E7' on other side with approximate 12 mm in diameter.
Metformin 850 mg film-coated Tablets are White, Capsule
shaped, biconvex film coated tablet, plain on one side and
debossed with 'E8' on other side with approximate length of
19 mm and width of 9 mm.
Metformin Tablets are available in HDPE bottle pack of
100 tablets, 300 tablets and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Ltd
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
United Kingdom.
This leaflet was last revised in MAY 2017

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The following side effects may
occur:
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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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