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METFORMIN 850MG TABLETS

Active substance(s): METFORMIN / METFORMIN HYDROCHLORIDE / METFORMIN / METFORMIN HYDROCHLORIDE / METFORMIN / 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.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist or nurse.
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.

What is in this leaflet:
1 What Metformin Tablets are and what they are 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
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 What you need to know before you take Metformin

tablets

Do not take Metformin

if you are allergic to metformin or any of the other ingredients of this medicine
(see ‘What Metformin Tablet contains’ in section 6)
• if you have liver problems
• if you have severely reduced kidney function
• if you have uncontrolled diabetes, with, for example, severe hyperglycaemia
(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 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’ 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 ‘Warnings and
precautions’ below).
• 
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 precau tions’
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.

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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
Risk of lactic acidosis
Metformin may cause a very rare, but very serious side effect called
lactic acidosis, particularly if your kidneys are not working properly. The
risk of developing lactic acidosis is also increased with uncontrolled
diabetes, serious infections, prolonged fasting or alcohol intake,
dehydration (see further information below), liver problems and any
medical conditions in which a part of the body has a reduced supply of
oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further
instructions.
Stop taking Metformin 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 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.
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
Lactic acidosis is a medical emergency and must be treated in a
hospital.
If you need to have major surgery you must stop taking Metformin
during and for some time after the procedure. Your doctor will
decide when you must stop and when to restart your treatment with
Metformin.
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.
During treatment with Metformin, 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.

Other medicines and Metformin Tablets

If you need to have an injection of a contrast medium that contains iodine
into your bloodstream, for example in the context of an X-ray or scan, you
must stop taking Metformin before or at the time of injection. Your doctor
will decide when you must stop and when to restart your treatment with
Metformin.
Tell your doctor if you are taking, have recently taken or might take any other
medicines. You may need more frequent blood glucose and kidney function
tests, or your doctor may need to adjust the dosage of Metformin. It is
especially important to mention the following:
• medicines which increase urine production (diuretics).
• medicines used to treat pain and inflammation (NSAID and COX-2inhibitors, such as ibuprofen and celecoxib).
• certain medicines for the treatment of high blood pressure (ACE inhibitors
and angiotensin II receptor antagonists).
• 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).

continued over page

Metformin 500mg & 850mg Tablets PIL - UK
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Item no:

BBBA0524

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
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C.Grant
14/02/17
27.03.17
S.Anson

Dimensions:
180 x 280
Min Body Text Size: 8pts
Supplier:
Relonchem

Date sent:
14/02/17 + 21/02/17
Date received: 02.03.17

Colours

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* Please note that only Artwork Studio is permitted to make changes to the above artwork.
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• medicines that may change the amount of Metformin in your blood,
especially if you have reduced kidney function (such as verapamil,
rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprime,
vandetanib, isavuconazole, crizotinib, olaparib).
• other medicines used to treat diabetes.
Metformin with alcohol
Avoid excessive alcohol intake while taking Metformin since this may
increase the risk of lactic acidosis (see section ‘Warnings and precautions’).

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

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them. The following side effects may occur:
Serious side effect
Metformin may cause a very rare (may affect up to 1 user in 10,000), but
very serious side effect called lactic acidosis (see section ‘Warnings and
precautions’). If this happens you must stop taking Metformin and
contact a doctor or the nearest hospital immediately, as lactic
acidosis may lead to coma.
Stop taking Metformin tablets and see your doctor immediately if
you notice abnormal liver function tests and hepatitis (inflammation of
the liver) which may result in jaundice (yellowing of the eyes and/or skin).
Other side effects
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)
• skin reactions such as redness of the skin (erythema), itching or an itchy
rash (hives).
• low vitamin B12 levels in the blood.

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 take regular exercise.

Children and adolescents

Recommended dose

Reporting of side effects

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 have reduced kidney function, your doctor may prescribe a
lower dose. If you use 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 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 immediate
medical attention, as lactic acidosis may lead to coma. Stop taking
Metformin immediately and contact a doctor or the nearest hospital
straight away.

Limited data in children and adolescents showed that adverse events
were similar in nature and severity to those reported in adults.
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 How to store Metformin Tablets

Keep out of the sight and reach of children. If a child is treated with
Metformin tablets, parents and caregivers are advised to oversee how
this medicine is used.
Do not use Metformin Tablets after the expiry date which is stated on
the carton. Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the environment.
Do not store the tablets above 25°C.

6 Contents of the pack and other 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 approved: March 2017
PL 20395/0027 and 0028

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.

continued top of next column
BBBA0524

Metformin 500mg & 850mg Tablets PIL - UK
approved for print/date

Proof Round

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0524

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

C.Grant
14/02/17
27.03.17
S.Anson

Dimensions:
180 x 280
Min Body Text Size: 8pts
Supplier:
Relonchem

Date sent:
14/02/17 + 21/02/17
Date received: 02.03.17

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Expand Transcript

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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