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GLUCIENT SR 1000 MG PROLONGED-RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET
INFORMATION FOR THE USER




Glucient ® SR 1000 mg
prolonged-release tablets
metformin hydrochloride

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
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.
In this leaflet:
1. What Glucient SR is and what is it used for
2. What you need to know before you take
Glucient SR
3. How to take Glucient SR
4. Possible side effects
5. How to store Glucient SR
6. Contents of the pack and other information
1. WHAT GLUCIENT SR IS AND WHAT IS IT
USED FOR
Glucient 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
Glucient SR is used for the treatment of Type 2
(non-insulin dependant) 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. Glucient SR makes the body
more sensitive to insulin and helps return to
normal the way your body uses glucose.
Glucient SR is associated with either a stable
body weight or modest weight loss.
Glucient 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 GLUCIENT SR
Do NOT take Glucient SR if:
• you are allergic to metformin or to any of the
other ingredients which are listed later on in
the leaflet (see under section ‘6. Further
information’).
• 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 long-term kidney or liver problems.

• you have had serious complications with your
diabetes or other serious conditions which
resulted in rapid weight loss, nausea, vomiting
or dehydration.
• you have a severe infection or have recently
suffered a severe injury
• you have been treated for heart problems or
have recently had a heart attack or have severe
circulatory problems or breathing difficulties.
• you are a heavy drinker of alcohol.
• you are under 18 years of age.
Warnings and precautions
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 the 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).
If you start to lose weight unexpectedly or
suffer severe nausea or vomiting, uncontrolled
rapid breathing or abdominal pains, stop
taking the medicine and tell your doctor
straight away. This can be a sign of a rare, but
serious, complication with your diabetes
called ‘ lactic acidosis’ which means there is
too much acid in the blood (see also under
section ‘4. Possible side effects’).
You may see some remains of the tablets in your
stools. Do not worry- this is normal for this type
of tablet. If you need to have an X-ray
examination involving the injection of a dye, tell
the doctor that you take Glucient SR as you may
need to stop taking it for a few days afterwards.
Tell your doctor if you are going to have an
operation under general anaesthetic, as you may
need to stop taking Glucient SR for a couple of
days before and after the procedure.
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 Glucient SR
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
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 section ‘4.
Possible side effects’).
Glucient SR with food and drink
You should take Glucient SR with or immediately
after food.

Pregnancy and breast-feeding
Do not take Glucient SR if you are pregnant or
breast-feeding.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Glucient 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 Glucient SR
taken with other antidiabetic medicines can
cause hypos, so in this case you should take
extra care when driving or operating machinery.
Glucient SR contains sodium
This medicinal product contains up to 1.9 mmol
(or 41.4mg) sodium per dose. To be taken into
consideration by patients on a controlled sodium
diet.
3. How to take Glucient SR
Your doctor may prescribe Glucient SR for you to
take on its own, or in combination with other oral
antidiabetic medicines or insulin.
Always take this medicine exactly as your doctor
or pharmacist 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. Usually you will start
treatment with 500 milligrams Glucient SR daily.
After you have been taking Glucient SR for about
2 weeks, your doctor may measure your blood
sugar and adjust the dose. The maximum daily
dose is 2000 milligrams of Glucient SR.
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 Glucient 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 and this is a medical
emergency requiring treatment in hospital (see
also under ‘4. Possible side effects’).
If you forget to take Glucient 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, this medicine can cause side
effects, although not everybody gets them.
If you notice any of the following side effects, you
may need urgent medical attention. Stop taking
Glucient SR and see your doctor immediately:
• unexpected weight loss
• very severe nausea or vomiting
• very fast breathing which you cannot stop
• stomach pains 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 (may affect more than 1 in 10
people):
• Nausea
• Vomiting
• Diarrhoea
• Abdominal pain (stomach pain)
• 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 (may affect up to 1 in 10 people):
• Taste disturbances.
Very rare (may affect up to 1 in 10,000 people):
• 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 Glucient SR
Keep this medicine out of the sight and reach of
children.
Do not store above 30 °C.
Do not use the tablets after the expiry date that is
printed on the pack. The expiry date refers to the
last day of the month. This medicinal product
does not require any special storage conditions.
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 Glucient SR contain:
Each prolonged-release tablet contains 1000
milligrams of the active ingredient metformin
hydrochloride. The other ingredients are,
carmellose sodium 2000, Hypromellose 100M,
colloidal anhydrous silica and magnesium
stearate.
What Glucient SR looks like and contents of
the pack:
Glucient SR 1000 mg prolonged-release tablets
are white, shallow, convex-shaped, 22.25 x 9mm
sized tablets marked “SR2” on one side.
The tablets are available in pack sizes of 28, 30,
56, 60 and 100 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Consilient Health Ltd.,
5th floor, Beaux Lane House,
Mercer Street Lower, Dublin 2, Ireland
Manufacturer
McGregor Cory Limited,
Middleton Close, Banbury, Oxfordshire,
OX16 4RS, United Kingdom
This leaflet was last revised in November 2014.

PL 24837/0060

P0183

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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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