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.
• 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. Do not pass it on to
others. It may harm them even if their symptoms are the same
as yours.
•  If any of the side effects get serious, or if you notice any side effects
not listed in the leaflet, please tell your doctor or pharmacist.

In this leaflet:
1 What Metformin Tablets are and what they are used for
2 Before you take Metformin Tablets
3 How to take Metformin Tablets
4 Possible side effects
5 How to store Metformin Tablets
6 Further information

1 What Metformin Tablets are and what they are 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 Before you take Metformin
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
• 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
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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.

Take special care with Metformin Tablets
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.

Taking 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 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)
• other medicines used to treat diabetes
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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 How to take Metformin Tablets

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 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)
• 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.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

5 How to store Metformin Tablets

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 Further information

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: April 2014
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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