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GLUCOPHAGE SR 750 MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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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 the
Yellow Card Scheme 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 Glucophage SR
Keep Glucophage SR tablets out of the sight and reach of
children.
Do not use them after the expiry date that is printed on
the pack after “EXP:”. The expiry date refers to the last day
of that month.
This medicinal product does not require any special storage
conditions.
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.
6. Contents of the pack and other information
What the tablets contain
Each prolonged release tablet contains 500, 750 or
1000  milligrams of the active ingredient metformin
hydrochloride. The other ingredients are magnesium
stearate, carmellose sodium and hypromellose.
What Glucophage SR looks like and contents of the
pack
The 500 milligram tablets are white to off -white and
round with ‘500’ on one side.
The 750 milligram tablets are white to off -white and
capsule-shaped with ‘750’ on one side and ‘MERCK’ on the
other side.
The 1000 milligrams tablets are white to off-white and
capsule-shaped with ‘1000’ on one side and ‘MERCK’ on
the other side.
Glucophage SR is supplied in packs of 28 and 56 prolonged
release tablets.

Glucophage SR 500 mg, 750 mg and 1000 mg Prolonged
Release Tablets are manufactured for Merck Serono Ltd,
Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14
8NX, UK by Merck Santé s.a.s, 2 rue du Pressoir Vert,
­45400 Semoy, France.

Package leaflet: Information for the user

This leaflet was last revised in May 2015
Useful tips
• If you smoke, try to stop
• Take regular exercise
• Drink as little alcohol as possible
• Look after your feet. Ask about this at the surgery or
hospital
• Carry a card, bracelet or disk saying you are diabetic

Prolonged release tablets
metformin hydrochloride
This medicine is intended for adult patients only
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.

• Visit your diabetic clinic regularly

-- 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 you want more information about diabetes contact:

-- 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.

Diabetes UK Central Office
Macleod House
10 Parkway
London NW1 7AA Tel: 020 7424 1000

What is in this leaflet
1. What Glucophage SR is and what it is used for
2. What you need to know before you take Glucophage SR
3. How to take Glucophage SR
4. Possible side effects
5. How to store Glucophage SR

Glucophage SR is associated with either a stable body
weight or modest weight loss.

6. Content of the pack and other information

2. What you need to know before you take
Glucophage SR

1. What Glucophage SR is and what it is used for
Glucophage SR prolonged release tablets contain the
active ingredient metformin hydrochloride and belong
to a group of medicines called biguanides, used in the
treatment of diabetes.
Glucophage SR is used for the treatment of Type 2
(non-insulin dependent) diabetes mellitus when diet and
exercise changes alone have not been enough to control
blood glucose (sugar). Insulin is a hormone that enables
body tissues to take glucose from the blood and to use it
for energy or for storage for future use. People with Type
2 diabetes do not make enough insulin in their pancreas
or their body does not respond properly to the insulin it
does make. This causes a build-up of glucose in the blood
which can cause a number of serious long-term problems
so it is important that you continue to take your medicine,
even though you may not have any obvious symptoms.
Glucophage SR makes the body more sensitive to insulin
and helps return to normal the way your body uses glucose.

Glucophage SR Prolonged Release Tablets are specially
made to release the drug slowly in your body and therefore
are different to many other types of tablet containing
metformin.

Do not take Glucophage SR if:
• you are allergic to metformin or to any of the other
ingredients of this medicine (listed in section 6). An
allergic reaction may cause a rash, itching or shortness
of breath.
• you have ketosis (this is a symptom of uncontrolled
diabetes in which substances called ‘ketone bodies’
accumulate in the blood – you may notice that your
breath has an unusual, fruity odour).
• you have liver problems or kidney problems (glomerular
filtration rate (GFR) below 45 ml/min).
• you have had serious complications with your
diabetes or other serious conditions which resulted in
rapid weight loss, nausea, vomiting or dehydration.
Dehydration may lead to kidney problems, which
can put you at risk for lactic acidosis (see 'Warnings
and precautions).

TW781950 FR2581851

Reporting of side effects

• 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).
• you have been treated for acute heart problems or have
recently had a heart attack or have severe circulatory
problems or 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).
• you are a heavy drinker of alcohol.
• you are under 18 years of age.
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. (See below under
Other medicines and Glucophage SR)
• you need to have major surgery.
You must stop taking Glucophage SR 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.
After you have started taking your medicine:
If you have diabetes you should have your blood or urine
tested for sugar regularly. You should return to your
doctor at least once a year to check the function of your
kidneys (more often if you are elderly or if you have kidney
problems).
Please note the following particular risk of lactic
acidosis.
Glucophage SR 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).
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.

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 immediately
seek medical attention, as lactic acidosis may lead
to coma. Stop taking Glucophage SR immediately
and contact a doctor or the nearest hospital straight
away.
You may see some remains of the tablets in your stools. Do
not worry- this is normal for this type of tablet.
You should continue to follow any dietary advice that your
doctor has given you and you should make sure that you
eat carbohydrates regularly throughout the day.
Do not stop taking this medicine without speaking to your
doctor.
Other medicines and Glucophage SR
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without prescription.
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
Glucophage SR for a certain period of time before and
after (at least 48 hours) the examination (see ‘Make sure
you ask your doctor for advice’ above).
If you are taking any of the following medicines, your
blood sugar levels may need to be checked more often and
your dose adjusted:
• Steroids such
beclometasone.

as

prednisolone,

mometasone,

• Diuretics (water tablets) such as furosemide.
• Sympathomimetic medicines including epinephrine and
dopamine used to treat heart attacks and low blood
pressure. Epinephrine is also included in some dental
anaesthetics.
You should avoid drinking alcohol and using alcoholcontaining medicines as this will increase the risk of lactic
acidosis (see under ‘4. Possible side effects’).
Glucophage SR with food and drink:
You should take Glucophage SR with or immediately after
food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any
medicine.

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
immediately seek medical attention, as lactic acidosis may
lead to coma. Stop taking Glucophage SR immediately and
contact a doctor or the nearest hospital straightaway.

Driving and using machines

If you forget to take Glucophage SR

Glucophage SR taken on its own does not cause ‘hypos’
(symptoms of low blood sugar or hypoglycaemia, such as
faintness, confusion and increased sweating) and therefore
should not affect your ability to drive or use machinery.

Take it as soon as you remember with some food. Do not
take a double dose to make up for a forgotten dose.

You should be aware, however, that Glucophage SR taken
with other antidiabetic medicines can cause hypos, so
in this case you should take extra care when driving or
operating machinery.

Like all medicines, Glucophage SR can cause side effects,
although not everybody gets them. If you notice any of
the following, stop taking Glucophage SR and see your
doctor immediately:

3. How to take Glucophage SR

• unexpected weight loss

Your doctor may prescribe Glucophage SR for you to take
on its own, or in combination with other oral antidiabetic
medicines or insulin.

• very severe nausea or vomiting

Do not take Glucophage SR if you are pregnant or breast
feeding.

Always take Glucophage SR exactly as your doctor has told
you.
You should check with your doctor or pharmacist if you
are not sure.
Swallow the tablets whole with a glass of water, do not
chew.
Recommended dose
Usually you will start treatment with 500 milligrams
Glucophage SR daily. After you have been taking
Glucophage SR for about 2 weeks, your doctor may
measure your blood sugar and adjust the dose. The
maximum daily dose is 2000 milligrams of Glucophage SR.
In renal impaired patients with a GFR between 45 and 60 ml/
min, the starting dose is 500 mg or 750 mg Glucophage SR
once daily. The maximum dose is 1000 mg daily. The renal
function should be closely monitored (every 3 – 6 months).
Normally, you should take the tablets once a day, with your
evening meal.
In some cases, your doctor may recommend that you take
the tablets twice a day. Always take the tablets with food.
If you take more Glucophage SR than you should
If you take extra tablets by mistake you need not worry, but
if you have unusual symptoms, contact your doctor. If the
overdose is large, lactic acidosis is more likely. Symptoms of
lactic acidosis are non-specific, such as vomiting, bellyache
with muscle cramps, a general feeling of not being well

4. Possible side effects

• a general feeling of not being well with severe tiredness
• very fast breathing which you cannot stop
• reduced heart beat
• stomach pains with muscle cramps or feeling cold
These can be signs of serious problems with your diabetes
and may mean you have a very rare side effect called “lactic
acidosis” (too much acid in the blood). If this happens, see
a doctor as you will need treatment straight away.
• abnormal liver function tests and hepatitis
(inflammation of the liver) which may result in jaundice.
If you develop yellowing of the eyes and/or skin contact
your doctor immediately.
Other possible side effects are listed by frequency as
follows:
Very common (affects more than 1 person in 10):
• Diarrhoea, nausea, vomiting, stomach ache or loss
of appetite. If you get these, do not stop taking the
tablets as these symptoms will normally go away in
about 2 weeks. It helps if you take the tablets with or
immediately after a meal.
Common (affects less than 1 person in 10, but more than 1
person in 100):
• Taste disturbance
Very rare (affects less than 1 person in 10,000):
• Decreased vitamin B12 levels
• Skin rashes including redness, itching and hives.

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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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