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METFORMIN 850MG TABLETS

Active substance: METFORMIN HYDROCHLORIDE

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Metformin 500mg
and 850mg Tablets
Metformin hydrochloride
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for
you.
•  this leaflet. You may need to read it again.
Keep
•  have any further questions, ask your doctor or
If you
pharmacist or nurse.
•  medicine has been prescribed for you only. Do not pass
This
it on to others. It may harm them even if their signs of illness
are the same as yours.
•  get any side effects, talk to your doctor or pharmacist.
If you
This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet:
1  hat Metformin Tablets are and what they are
W
used for
2  hat you need to know before you take Metformin
W
Tablets
3  ow to take Metformin Tablets
H
4  ossible side effects
P
5  ow to store Metformin Tablets
H
6  ontents of the pack and other information
C
1  hat Metformin Tablets are and what they are
W

used for

Metformin 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 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.
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.
Adults can take Metformin 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 on
its own or together with insulin.

2  hat you need to know before you take Metformin
W

Do not take Metformin

• if you are allergic (hypersensitive) to metformin or any of the other
ingredients of this medicine (see ‘What Metformin Tablet contains’
in section 6)
• if you have kidney or liver problems
• 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
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• 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 ‘Take special care
with Metformin Tablets’ below).
• 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 ‘Take special care with Metformin Tablets below).
• if you are treated for 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
‘Take special care with Metformin Tablets’ 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.
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
You must stop taking Metformin 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
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, prolonged fasting or alcohol intake.
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.
Metformin on its own does not cause hypoglycaemia (a blood
glucose level which is too low). However, if you take Metformin
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, vision disorders or difficulty in concentration, it
usually helps to eat or drink something containing sugar.

Other medicines and Metformin Tablets

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 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 at the same time. You may need more frequent blood
glucose tests or your doctor may adjust the dosage of Metformin:
• 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 infl ammation of the skin or in asthma)
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• other medicines used to treat diabetes
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

Taking Metformin with food and drink

Do not drink alcohol when you take this medicine. Alcohol
may increase the risk of lactic acidosis especially if you have
liver problems or if you are undernourished. This also applies to
medicines that contain alcohol.

Pregnancy and breast-feeding

During pregnancy, you need insulin to treat your diabetes. Tell
your doctor if you are, you think you might be or are planning to
become pregnant, so that he or 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 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 heartbeat, vision disorders or difficulty in concentration. Do
not drive or use machines if you start to feel these symptoms.

3  ow to take Metformin Tablets
H
Always take Metformin exactly as your 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
500mg or 850mg Metformin once a day. The maximum daily dose
is 2000mg 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.
Adults usually start with 500mg or 850mg Metformin two or three
times a day. The maximum daily dose is 3000mg taken as 3 divided
doses.
If you take insulin too, your doctor will tell you how to start
Metformin.

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.

How to take Metformin

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

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 product, ask
your doctor or pharmacist.

4  ossible Side Effects
P
Like all medicines, this medicine 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)
• 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 the 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)
• changes in taste.
Very rare side effects (in less than 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 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.
• 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, 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
Website at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information
on the safety of this medicine.

5  ow to store Metformin Tablets
H
Keep out of the sight and reach of children.
Do not use Metformin Tablets after the expiry date which is stated
on the carton.
Do not store the tablets above 25°C.
6  ontents of the pack and other information
C

What Metformin Tablets contain

The active substance is 500mg or 850mg of metformin
hydrochloride.
The other ingredients are sodium starch glycollate, maize starch,
povidone, colloidal anhydrous silica, magnesium stearate. The
film coating is made up of hypromellose, titanium dioxide (E171),
propylene glycol, macrogol 6000 and purified talc.
What Metformin Tablets look like and contents of the pack
Metformin Tablets are white coloured, film coated round biconvex
tablets.
The tablets are supplied in blister packs of 28 and 84 tablets for the
500mg dose and packs of 56 tablets for the 850mg dose.
Metformin Tablets are also available in securitainers of 500 tablets
for the 500mg dose and 300 tablets for the 850mg dose.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited, Cheshire House, Gorsey Lane, Widnes,
Cheshire, WA8 0RP, UK
Date leaflet last revised: May 2015.
PL 20395/0027 and 0028

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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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