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METABET SR 500MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Metabet SR 500 mg Prolonged Release Tablets
Metformin hydrochloride
This medicine is intended for adult patients only.
Warnings and precautions
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
Risk of lactic acidosis
!
Keep this leaflet. You may need to read it again.
Metabet SR may cause a very rare, but very serious side effect called lactic
!
If you have any further questions, ask your doctor or pharmacist.
acidosis, particularly if your kidneys are not working properly. The risk of
!
This medicine has been prescribed for you only. Do not pass it on to
developing lactic acidosis is also increased with uncontrolled diabetes,
others. It may harm them, even if their signs of illness are the same as
serious infections, prolonged fasting or alcohol intake, dehydration (see
yours.
further information below), liver problems and any medical conditions in
!
If you get any side effects, talk to your doctor or pharmacist. This
which a part of the body has a reduced supply of oxygen (such as acute
includes any possible side effects not listed in this leaflet. See section
severe heart disease).
4.
If any of the above apply to you, talk to your doctor for further instructions.
What is in this leaflet:
1. What Metabet SR is and what it is used for
2. What you need to know before you take Metabet SR
3. How to take Metabet SR
4. Possible side effects
5. How to store Metabet SR
6. Contents of the pack and other information
1. What Metabet SR is and what it is used for
Metabet SR 500mg prolonged release tablets contain the active ingredient
metformin hydrochloride and belongs to a group of medicines called
biguanides which are used in the treatment of diabetes.
Metabet 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 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. Metabet SR makes the
body more sensitive to insulin and helps return to normal the way your body
uses glucose.
Metabet SR is associated with either a stable body weight or modest weight
loss.
Metabet 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 Metabet SR

Stop taking Metabet 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.

Metabet SR with food, drink and alcohol
The tablets should be swallowed whole with a glass of water during or
immediately after meals.
Avoid excessive alcohol intake while taking Metabet SR since this may
increase the risk of lactic acidosis (see section “Warnings and
precautions”).
Pregnancy and breast-feeding
Do not take Metabet SR if you are pregnant or breast-feeding. If you think
you may be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Metabet 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 Metabet 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 Metabet SR

Always take this medicine exactly as your doctor or pharmacist has told
Stop taking Metabet SR and contact a doctor or the nearest hospital
you. Check with your doctor or pharmacist if you are not sure.
immediately if you experience some of the symptoms of lactic
acidosis, as this condition may lead to coma. Symptoms of lactic acidosis
Your doctor may prescribe Metabet SR for you to take on its own, or in
include:
combination with other oral antidiabetic medicines or insulin.
!
vomiting,
!
stomach ache (abdominal pain),
Swallow the tablets whole with a glass of water, do not chew.
!
muscle cramps,
!
a general feeling of not being well with severe tiredness,
The recommended dose is:
!
difficulty in breathing,
Usually you will start treatment with 500 mg Metabet SR daily. After you
!
reduced body temperature and heartbeat.
have been taking Metabet SR for about 2 weeks, your doctor may measure
your blood sugar and adjust the dose. The maximum daily dose is 2000 mg
Lactic acidosis is a medical emergency and must be treated in a hospital.
of Metabet SR.
If you need to have major surgery you must stop taking Metabet SR during
and for some time after the procedure. Your doctor will decide when you
must stop and when to restart your treatment with Metabet SR.
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 section “Other
medicines and Metabet SR”).
After you have started taking your medicine:
During treatment with Metabet 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.
You may see some remains of your tablets in your stools. Do not worry- this
is normal for this type of tablet.

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 Metabet 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 heartbeat. If you experience some of
these symptoms, you should immediately seek medical attention, as lactic
acidosis may lead to coma. Stop taking Metabet SR immediately and
contact a doctor or the nearest hospital straightaway.

Do not stop taking this medicine without speaking to your doctor.
Do not take Metabet SR
If you forget to take Metabet SR
if you are allergic to metformin or any of the other ingredients of this
!
Other medicines and Metabet SR
Take the missed dose as soon as you remember, unless it's nearly time for
medicine (listed in section 6).
If you need to have an injection of a contrast medium that contains iodine
the next one. Do not take a double dose to make up a forgotten dose.
if you have severely reduced kidney function.
!
into your bloodstream, for example in the context of an X-ray or scan, you
if you have uncontrolled diabetes, with, for example, severe
!
must stop taking Metabet SR before or at the time of the injection. Your
If you stop taking Metabet SR
hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea,
doctor will decide when you must stop and when to restart your treatment
If you stop taking Metabet SR, tell your doctor as soon as possible, as your
rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or
with Metabet SR.
diabetes will not be controlled.
ketoacidosis. Ketoacidosis is a condition in which substances called
'ketone bodies' accumulate in the blood and which can lead to diabetic
Tell your doctor or pharmacist if you are taking, have recently taken or might
If you have any further questions on the use of this medicine, ask your
pre-coma. Symptoms include stomach pain, fast and deep breathing,
take any other medicines. You may need more frequent blood glucose and
doctor or pharmacist.
sleepiness or your breath developing an unusual fruity smell.
kidney function tests, or your doctor may need to adjust the dosage of
if you have liver problems.
!
Metabet SR. It is especially important to mention the following:
4. Possible side effects
if you have a severe infection, such as an infection affecting your lung
!
Steroids such as prednisolone, mometasone, beclometasone.
!
or bronchial system or your kidney. Severe infections may lead to
Sympathomimetic medicines including epinephrine and dopamine
!
Like all medicines, this medicine can cause side effects, although not
kidney problems, which can put you at risk for lactic acidosis (see
used to treat heart attacks and low blood pressure. Epinephrine is also
everybody gets them.
section “Warnings and precautions”).
included in some dental anaesthetics.
if you have been treated for acute heart problems or have recently had
!
Medicines which increase urine production (diuretics).
!
Metabet SR may cause a very rare (may affect up to 1 in 10,000 people),
a heart attack or have severe circulatory problems or breathing
Certain medicines for the treatment of high blood pressure (ACE
!
but very serious side effect called lactic acidosis (see section “Warnings
difficulties. This may lead to a lack in oxygen supply to tissue which can
inhibitors and angiotensin II receptor antagonists).
and precautions”). If this happens you must stop taking Metabet SR and
put you at risk for lactic acidosis (see section “Warnings and
Medicines used to treat pain and inflammation (NSAID and COX-2!
contact a doctor or the nearest hospital immediately, as lactic acidosis
precautions”).
inhibitors, such as ibuprofen and celecoxib).
may lead to coma.
if you are a heavy drinker of alcohol.
!
Medicines that may change the amount of Metabet SR in your blood,
!
if you are under the age of 18 years.
!
especially if you have reduced kidney function (such as verapamil,
rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim,
vandetanib, isavuconazole, crizotinib, olaparib).

Stop taking Metabet SR and see your doctor immediately if you notice
abnormal liver function tests and hepatitis (inflammation of the liver) which
may result in jaundice (yellowing of the eyes and/or skin).
The following other side effects have also been reported:

Very common (may affect more than 1 in 10 people):
!
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 your tablets with
or immediately after a meal.

Common (may affect up to 1 in 10 people):
!
Taste disturbance.

Very rare (may affect up to 1 in 10,000 people):
!
Skin rashes including redness, itching and hives.
!
Decreased vitamin B12 levels.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Metabet SR
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister
and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Metabet SR contains
The active substance is metformin hydrochloride. Each prolonged release
tablet contains 500 mg of metformin hydrochloride.
The other ingredients are stearic acid; shellac (refined bleached);
povidone K-30; silica, colloidal anhydrous; magnesium stearate;
hypromellose; hydroxy propyl cellulose; titanium dioxide; propylene glycol;
macrogol 6000 and talc.
What Metabet SR looks like and contents of the pack
Metabet SR 500 mg tablets are off-white coloured, oval, biconvex filmcoated tablets plain on both sides.
Metabet SR is available in blister packs of 7, 10, 14, 20, 28, 30, 56, 60, 84,
90, 100 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd.
115 Narborough Road
Leicester, LE3 0PA
United Kingdom
Manufacturer
Morningside Pharmaceuticals Ltd.
5 Pavilion Way, Loughborough, LE11 5GW
United Kingdom
This leaflet was last revised in January 2017.

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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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