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METFORMIN HYDROCHLORIDE TABLETS 850MG

Active substance(s): METFORMIN HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Metformin Hydrochloride 850mg Tablets
(Metformin Hydrochloride)
Read all of this entire 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 your 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.

What is in this leaflet:
1
2
3
4
5
6

What Metformin Hydrochloride is and what it is used for
What you need to know before you take Metformin Hydrochloride
How to take Metformin Hydrochloride
Possible side effects
How to store Metformin Hydrochloride
Contents of the pack and other information

1 What Metformin Hydrochloride



is and what it is used for

Metformin Hydrochloride 850mg Tablets (also referred
to as Metformin Hydrochloride throughout this leaflet)
belong to a group of medicines called biguanide oral
anti−hyperglycaemic agents. It works by lowering your
blood−sugar level.
If your blood sugar levels are not controlled, it can
lead to serious problems such as kidney damage,
amputations and blindness. Metformin Hydrochloride
is thought to work by decreasing the amount of sugar
absorbed from food through the stomach, by helping
the body respond better to the insulin it makes
naturally and by decreasing the amount of sugar
produced by the liver and kidneys.
Metformin Hydrochloride is used to treat non−insulin
dependent diabetes (also called type 2 diabetes)
when an improvement in diet and exercise has failed
to reduce blood sugar levels, particularly if overweight.
It may be used alone as initial therapy or along with
other oral antidiabetic drugs or with insulin.
Children 10 years and over and adolescents can take
Metformin Hydrochloride on its own or together with
insulin.
Sometimes Metformin Hydrochloride is also used to
treat patients suffering from insulin dependent
diabetes, who are overweight (obese) and whose
symptoms are poorly controlled.

2

What you need to know before
you take Metformin Hydrochloride

Do not take Metformin Hydrochloride 850mg
Tablets if:

you are allergic to Metformin Hydrochloride or
any of the other ingredients of this medicine
(listed in section 6‘Contents of the pack and
other information‘).

you have very high blood sugar levels
(hyperglycaemia) or ketoacidosis, which can lead
to diabetic pre−coma. Diabetic ketoacidosis is a
condition in which substances called ’ketone
bodies’ accumulate in the blood, due to
consistently high blood glucose levels.
Symptoms include stomach pain, fast and deep
breathing, sleepiness or unusual fruity odour of
the breath

you have kidney or liver disease

you have heart complications such as heart
failure (even if the condition is under control) or
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’ below).

you regularly consume excess alcohol.

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).

you suffer from a loss or lack of water in the
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).
Warnings and precautions
Talk to your doctor before taking Metformin
Hydrochloride:

if you have diabetes and kidney problems as you
are more at risk of developing a rare but serious
side effect known as ’lactic acidosis’. The risk of
lactic acidosis is also increased with uncontrolled
diabetes, an increased level of ketones in your
blood (ketosis), prolonged fasting, drinking an
excessive amount of alcohol or liver problems.
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 (see Section
4 ’Possible side effects’)
If this happens to you, you may need
immediate hospital treatment, as lactic
acidosis may lead to coma. Stop taking
Metformin Hydrochloride immediately and
contact a doctor or the nearest hospital
straight away

if you are to undergo diagnostic tests (using
iodinated contrast media) or you need to have
major surgery, you must tell your doctor. You will
need to stop taking Metformin Hydrochloride for a
certain period of time before and after the
diagnostic tests or surgery

Hard to Read?




if you continuously use Metformin Hydrochloride. It
may reduce your vitamin B12 level and should be
annually monitored by your doctor
if you suffer from kidney problems, particularly if
elderly
if you are taking Metformin Hydrochloride together
with other medicines used to treat diabetes, such
as insulin, sulphonylureas or meglitinides

Monitoring kidney function and diabetes
Kidney function: As Metformin Hydrochloride is
excreted by the kidney your doctor will test your
kidney function This should be done before
starting treatment and regularly thereafter: once a
year for normal kidney function and two to four
times a year if you have kidney problems or you
are elderly

Diabetes: Usual laboratory tests for diabetes
monitoring should be performed regularly



Other medicines and Metformin Hydrochloride
Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other
medicines, including medicines obtained without
prescription.
If you are to undergo diagnostic tests (using iodinated
contrast media) or you need to have major surgery,
you must tell your doctor. You will need to stop taking
Metformin Hydrochloride for a certain period of time
before and after the diagnostic tests or surgery (see
’Warnings and precautions’ above)
Other medicines may interfere with the actions of
Metformin Hydrochloride. You should tell your doctor if
you are taking any of the following medicines and
Metformin Hydrochloride at the same time. You may
need more frequent blood glucose tests or your doctor
may adjust the dosage of Metformin Hydrochloride:

cimetidine, for stomach ulcers and indigestion

medicines to prevent clotting of the blood, such
as warfarin (anticoagulants)

medicines for high blood pressure, such as
captopril (ACE inhibitors)

medicines for depression, such as moclobemide
(MAO inhibitors)

diazoxide, for high blood pressure

medicines for lowering high blood pressure, such
as propanolol (beta−blockers)

medicines for inflammatory and allergic
conditions, such as beclometasone
(corticosteroids)

Oral contraceptives

medicines called ’diuretics’ that are used to treat
fluid retention or high blood pressure such as
furosemide

medicines for high cholesterol, such as
ezetimibe (clofibrates)

other medicines used to treat diabetes such as
glibenclamide (sulphonylureas) or insulin
Metformin Hydrochloride and alcohol
You should not drink alcohol whilst taking Metformin
Hydrochloride. Alcohol may increase the risk of lactic
acidosis especially if you have liver problems, you are
undernourished or you are fasting. This also applies to
medicines that contain alcohol.
Pregnancy and breast−feeding
If you are pregnant or breast−feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.
Pregnancy
If you are pregnant, think you may be pregnant or you
are planning to become pregnant as you should not
take Metformin Hydrochloride. However, your diabetes
needs to be controlled during pregnancy and this
should be done by taking insulin.
Breast−feeding
You should not take Metformin Hydrochloride whilst
breast−feeding unless your doctor thinks the benefits
outweigh the risks.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
If you are taking Metformin Hydrochloride on its own it
should not affect your ability to drive or operate
machinery.
However, if you are taking Metformin Hydrochloride
together with other medicines to treat diabetes (such
as sulphonylureas, insulin or meglitinides) it may
cause hypoglycaemia (low blood glucose level).
Symptoms of hypoglycaemia include weakness,
dizziness, increased sweating, fast heart beat, vision
disorders or difficulty in concentrating. If you have any
of these symptoms do not drive or use machinery.

Phone

continued....

0800 970 6115

for help
Till−Ipc−V.1sa

Important information about some of the
ingredients
This medicine contains lactose. If you have been told
by your doctor that you have intolerance to some
sugars, contact your doctor before taking this product.

3

5

How to take Metformin
Hydrochloride

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure. Do not
take more than the doctor has told you to. Read
and follow the instructions on the pharmacist’s
label.




These tablets are for oral administration
Metformin Hydrochloride 850mg Tablets should
be taken with or after food
The score line is only there to help you break the
tablet if you have difficulty swallowing it whole



The recommended dose is:
Adults
The usual dose is one 850mg tablet twice a day. This
medicine may take a few days to 2 weeks to control
your condition. Your doctor may increase the dosage
to a maximum of 3000mg per day taken as 3 divided
doses, until your condition is under control.
Older people
Your doctor will monitor your condition if you have
kidney problems, and will need to have regular
checkups to monitor your kidney function.
Use in children (10 years and above) and
adolescents:
The normal dose is 500mg or 850mg, once a day.
The maximum dose is 2000mg a day 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
If you take insulin too, your doctor will tell you how to
start Metformin Hydrochloride.
If you have taken more Metformin Hydrochloride
than you should
If you accidentally take too many tablets, contact your
doctor immediately or go to the nearest accident and
emergency department.
Remember to take this leaflet or any remaining
tablets with you.
An overdose of Metformin Hydrochloride may lead to
lactic acidosis (for symptoms see section 4 ’Possible
side effects’)
If you forget to take Metformin Hydrochloride
Take as soon as you remember. Do not take a double
dose to make up for the forgotten individual dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist

4

effects directly via the internet at
(www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the
safety of this medicine.

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Serious side effect:
Although very rare, some people have developed a
condition known as lactic acidosis whilst taking
Metformin Hydrochloride.

How to store Metformin
Hydrochloride

Keep this medicine out of the sight and reach of
children.
Store in the original package.
Do not use this medicine after the expiry date, which
is stated on the 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 Hydrochloride 850mg Tablets
contain:

The active ingredient is: Metformin
Hydrochloride. Each tablet contains 850mg of
Metformin Hydrochloride.
 The other ingredients are: microcrystalline
cellulose, copovidone, colloidal anhydrous silica
and magnesium stearate.
 The film coating is: talc, opadry white
OY−L−28900 consisting of lactose monohydrate,
hypromellose, titanium dioxide (E171) and
macrogol 4000.



This medicine contains lactose (see important
information about some of the ingredients at the
end of section 2)

What Metformin Hydrochloride 850mg Tablets
look like and the contents of the pack:
Metformin Hydrochloride 850mg Tablets are
approximately 22mm x 8.7mm, white, oblong, film−
coated tablets with a score notch on one side and
marked M850 on the other.
They are available in pack sizes of 28, 30, 56, 84 or
120 tablets.
Not all pack sizes may be marketed.
REMEMBER
This medicine is only for YOU. Do not offer it to
anybody else. It may harm them even if their
symptoms seem to be the same as yours.
This information applies only to Metformin
Hydrochloride 850mg Tablets.
Marketing Authorisation Holder and
Manufacturer:
Tillomed Laboratories Ltd
3 Howard Road.
Eaton Socon, St Neots
Cambridgeshire,
PE19 8ET
United Kingdom.
Product Licence Number:
Metformin Hydrochloride 850mg Tablets:
PL 11311/0096

Lactic acidosis is caused by a build up of lactic acid in
the blood (produced when glucose is turned into
energy without oxygen).
Date of approval May 2014

Possible symptoms of lactic acidosis:
unexplained weight loss
feeling sick (nausea
being sick (vomiting)
general feeling of being unwell
pain in the belly region
difficulty breathing
muscle cramp
severe weakness or loss of strength
feeling cold











If you have or think you may have lactic acidosis,
you should go to the hospital immediately as it is
a medical emergency.
Very common side effects (may affect more than 1
in 10 people)
 feeling sick (nausea)
 being sick (vomiting)
 diarrhoea
 weight loss
 abdominal pain
 loss of appetite
These side effects usually occur at the start of
treatment. You should continue to take your medicine
as they normally disappear after a short time. They
may be avoided by taking your medicine with or after
food and in 2 or 3 divided doses.
Common side effects (may affect up to 1 in 10
people)
 change in taste
Very rare side effects (may affect up to 1 in 10,000
people)
 skin reactions such as flushing of the skin, itching
or itchy rash
 decreased vitamin B12 absorption
 abnormal liver function test (detected through
blood test) or inflammation of the liver (hepatitis),
which may cause tiredness, loss of appetite,
weight loss or yellowing of the skin or whites of
the eyes. If this happens to you, stop taking
Metformin and talk to your doctor
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

Hard to Read?
Product Name
Strength / Form
Type
Dimensions
Typefaces
Rev #
Last updated
No. of Colours

Phone

Metformin
850mg Tablets
PIL
150 x 480 mm
Font SansSerif − Min. Text 8pt
Till−Ipc−V.1sa
11/06/2014
Pantone Black CVC

0800 970 6115

for help
Till−Ipc−V.1sa

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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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