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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.
− 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.
Your medicine is called Glucophage SR 500 mg Prolonged release
tablets but throughout this leaflet will be referred to as Glucophage
SR.
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
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 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.
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 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).
• 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 as prednisolone, mometasone, beclometasone.
• 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 alcohol-containing
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
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.
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 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. If you notice any of the
following, stop taking Glucophage SR and see your doctor
immediately:
• unexpected weight loss
• very severe nausea or vomiting
• 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.
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.
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.
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, hypromellose and microcrystalline cellulose.
What Glucophage SR looks like and contents of the pack
Glucophage SR tablets are white, oblong film-coated prolonged
release tablets, marked '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.
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 15.02.2016

E0351/7

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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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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