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GLUCOPHAGE SR 1000 MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE

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Very rare (affects less than 1 person in 10,000):
• Decreased vitamin B12 levels
• Skin rashes including redness, itching and hives.

This leaflet was last revised in April 2017

TW1021381

6. Contents of the pack and other information

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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.
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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.
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. Content 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
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 buildup 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 liver problems
• you have severely reduced kidney function

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

Prolonged release tablets
metformin hydrochloride

MC-2004-2016

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.

Package leaflet: Information for the user

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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.

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

• 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’).
• 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.

• stomach ache (abdominal pain)

Warnings and precautions

Do not stop taking this medicine without speaking to your
doctor.

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

• 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.

Other medicines and Glucophage SR
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 II receptor
antagonists)
• Steroids such
beclometasone.

PAGE 2

as

prednisolone,

mometasone,

• 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.
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

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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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