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GLUCOPHAGE SR 500 MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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Package leaflet: Information for the user



Glucophage® SR 500 mg
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 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.
− 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 get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.




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
Risk of lactic acidosis
Glucophage SR 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).

Your medicine is called Glucophage SR 500 mg Prolonged release
tablets but throughout this leaflet will be referred to as Glucophage SR.

If any of the above apply to you, talk to your doctor for further
instructions.

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
6. Contents of the pack and other information

Stop taking Glucophage SR 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.

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 Type 2 (non-insulin dependent)
diabetes mellitus.
Glucophage SR is used together with diet and exercise to lower the
risk of developing Type 2 diabetes in overweight adults, when diet and
exercise alone for 3 to 6 months have not been enough to control
blood glucose (sugar). You are at high risk of developing Type 2
diabetes if you have additional conditions like high blood pressure, age
above 40 years, an abnormal amount of lipids (fat) in the blood or a
history of diabetes during pregnancy. The medicine is particularly
effective if you are aged below 45 years, are very overweight, have
high blood glucose levels after a meal or developed diabetes during
pregnancy.
Glucophage SR is used for the treatment of Type 2 diabetes 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 is associated with either a stable body weight or
modest weight loss.
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.

Stop taking Glucophage SR 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 Glucophage
SR during and for some time after the procedure. Your doctor will
decide when you must stop and when to restart your treatment with
Glucophage SR.
During treatment with Glucophage SR, 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.
If you are older than 75 years, treatment with Glucophage SR should
not be started to lower the risk of developing type 2 diabetes.
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

2. What you need to know before you take Glucophage SR
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 liver problems
• you have severely reduced kidney function
• 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.
• you have lost too much water from your body (dehydration).
Dehydration may lead to kidney problems, which can put you at
risk for lactic acidosis (see ‘Warnings and precautions’).
• 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’).

If you need to have an injection of a contrast medium that contains
iodine into your bloodstream, in the context of an X-ray or scan, you
must stop taking Glucophage SR before or at the time of injection.
Your doctor will decide when you must stop and when to restart your
treatment with Glucophage SR.
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
Glucophage SR. It is especially important to mention the following:
• Medicines which increase urine production (diuretics (water
tablets) such as furosemide).
• Medicines used to treat pain and inflammation (NSAID and
COX-2 inhibitors, such as ibuprofen and celecoxib)
• Certain medicines for the treatment of high blood pressure
(ACE inhibitors and angiotensin ll receptor antagonists)
• Steroids such as prednisolone, mometasone, beclometasone.
• Sympathomimetic medicines including epinephrine and dopamine
used to treat heart attacks and low blood pressure. Epinephrine is
also included in some dental anaesthetics.



Medicines that may change the amount of Glucophage SR in your
blood, especially if you have reduced kidney function (such as
verapamil, rifampicin, cimetidine, dolutegravir, ranolazine,
trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Glucophage SR with alcohol
Avoid excessive alcohol intake while taking Glucophage SR since this
may increase the risk of lactic acidosis (see section ‘Warnings and
precautions’).
Pregnancy and breast-feeding
Do not take Glucophage SR if you are pregnant or breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
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.
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.
3. How to take Glucophage SR
Your doctor may prescribe Glucophage SR for you to take on its own,
or in combination with other oral antidiabetic medicines or insulin.
Always take Glucophage SR exactly as your doctor has told you.

Very rare (affects less than 1 person in 10,000):
• Decreased vitamin B12 levels
• Skin rashes including redness, itching and hives.
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 effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
the Google Play or Apple App Store.
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 “Use before:” 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.
If your tablets become discoloured or show any signs of deterioration,
please seek the advice of your pharmacist who will advise you what to
do.

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.
If you have reduced kidney function, your doctor may prescribe a lower
dose.
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 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.
If you forget to take Glucophage SR
Take it as soon as you remember with some food. Do not take a
double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Glucophage SR can cause side effects, although
not everybody gets them. The following side effects may occur:
Glucophage SR 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
Glucophage SR and contact a doctor or the nearest hospital
immediately, as lactic acidosis may lead to coma.
Glucophage SR may cause abnormal liver function tests and hepatitis
(inflammation of the liver) which may result in jaundice (may affect up
to 1 user in 10,000). 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

6. Contents of the pack and other information
What the tablets contain
Each prolonged release tablet contains 500 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
Glucophage SR tablets are white to off-white and round with '500' on
one side and plain on the reverse.
Glucophage SR is supplied in blister packs of 30 and 60 prolonged
release tablets.
Manufacturers:
Merck Santé S.A.S, Centre de Production de Semoy,
2 rue du Pressoir Vert, 45400, Semoy, France.
and
Merck KGaA, Frankfurter Str, 250, 64293 Darmstadt, Germany.
and
Famar Lyon,29 avenue Charles de Gaulle, Saint-Genis-Laval,
France
Procured within the EU
Product Licence Holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD.
POM
PL 19065/0351
This leaflet was last revised 25.01.2018

E0351/10

If you are blind or partially sighted
and require this leaflet in a different
format, call 01355 574450 and ask
for the Regulatory Department.
GLUCOPHAGE® is a registered trade mark of MERCK SANTE

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
• Visit your diabetic clinic regularly
If you want more information about diabetes contact:
Diabetes UK Central Office
Macleod House
10 Parkway
London
NW1 7AA
Tel: 020 7424 1000

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