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METFORMIN 1000MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

!
Medicines that may change the amount of Metabet SR in your blood,
Other possible side effects are listed by frequency as follows:
especially if you have reduced kidney function (such as verapamil,
rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim,
Very common (may affect more than 1 in 10 people):
vandetanib, isavuconazole, crizotinib, olaparib).
Diarrhoea, nausea, vomiting, stomach ache or loss of appetite. If you
!
Metformin hydrochloride
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
Metabet SR with food, drink and alcohol
or immediately after a meal.
The tablets should be swallowed whole with a glass of water during or
!
if you have been treated for acute heart problems or have recently had
This medicine is intended for adult patients only.
immediately after meals.
a heart attack or have severe circulatory problems or breathing
Read all of this leaflet carefully before you start taking this medicine
Common (may affect up to 1 in 10 people):
Avoid excessive alcohol intake while taking Metabet SR since this may
difficulties. This may lead to a lack in oxygen supply to tissue which can
because it contains important information for you.
Taste disturbance.
increase
the
risk
of
lactic
acidosis
(see
section
“Warnings
and
!
put
you
at
risk
for
lactic
acidosis
(see
section
“Warnings
and
Keep this leaflet. You may need to read it again.
!
precautions”).
precautions”).
If you have any further questions, ask your doctor or pharmacist.
!
Very rare (may affect up to 1 in 10,000 people):
!
if you are a heavy drinker of alcohol.
This medicine has been prescribed for you only. Do not pass it on to
!
Skin rashes including redness, itching and hives.
!
Pregnancy and breast-feeding
!
if you are under the age of 18 years.
others. It may harm them, even if their signs of illness are the same as
Decreased vitamin B12 levels.
!
Do
not
take
Metabet
SR
if
you
are
pregnant
or
breast-feeding.
If
you
think
yours.
you may be pregnant or are planning to have a baby, ask your doctor or
Warnings and precautions
If you get any side effects, talk to your doctor or pharmacist. This
!
Reporting of side effects
pharmacist for advice before taking this medicine.
Talk to your doctor or pharmacist before taking Metabet SR.
includes any possible side effects not listed in this leaflet. See section
If you get any side effects, talk to your doctor or pharmacist. This includes
4.
any possible side effects not listed in this leaflet. You can also report side
Driving and using machines
Risk of lactic acidosis
e f f e c t s d i r e c t l y v i a t h e Ye l l o w C a r d S c h e m e a t :
Metabet SR taken on its own does not cause 'hypos' (symptoms of low
Metabet SR may cause a very rare, but very serious side effect called lactic
What is in this leaflet:
www.mhra.gov.uk/yellowcard.
blood sugar or hypoglycaemia, such as faintness, confusion and increased
acidosis, particularly if your kidneys are not working properly. The risk of
1. What Metabet SR is and what it is used for
By reporting side effects, you can help provide more information on the
sweating) and therefore should not affect your ability to drive or use
developing lactic acidosis is also increased with uncontrolled diabetes,
2. What you need to know before you take Metabet SR
safety of this medicine.
machinery.
serious infections, prolonged fasting or alcohol intake, dehydration (see
3. How to take Metabet SR
You should be aware, however, that Metabet SR taken with other
further information below), liver problems and any medical conditions in
4. Possible side effects
antidiabetic medicines can cause hypos, so in this case you should take
5. How to store Metabet SR
which a part of the body has a reduced supply of oxygen (such as acute
5. How to store Metabet SR
extra
care
when
driving
or
operating
machinery.
severe heart disease).
6. Contents of the pack and other information
Keep this medicine out of the sight and reach of children.
If any of the above apply to you, talk to your doctor for further instructions.
3. How to take Metabet SR
1. What Metabet SR is and what it is used for
Do not use this medicine after the expiry date which is stated on the blister
Stop taking Metabet SR for a short time if you have a condition that
and carton after EXP. The expiry date refers to the last day of that month.
Always take this medicine exactly as your doctor or pharmacist has told
may be associated with dehydration (significant loss of body fluids) such
Metabet SR 1000mg prolonged release tablets contain the active
you. Check with your doctor or pharmacist if you are not sure.
as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less
ingredient metformin hydrochloride and belong to a group of medicines
This medicinal product does not require any special storage conditions.
fluid than normal. Talk to your doctor for further instructions.
called biguanides, used in the treatment of Type 2 (non-insulin dependent)
Your
doctor
may
prescribe
Metabet
SR
for
you
to
take
on
its
own,
or
in
diabetes mellitus.
Do not throw away any medicines via wastewater or household waste. Ask
combination with other oral antidiabetic medicines or insulin.
Stop taking Metabet SR and contact a doctor or the nearest hospital
your
pharmacist how to throw away medicines you no longer use. These
Metabet SR is used together with diet and exercise to lower the risk of
immediately if you experience some of the symptoms of lactic
measures will help protect the environment.
Swallow the tablets whole with a glass of water, do not chew.
developing Type 2 diabetes in overweight adults, when diet and exercise
acidosis, as this condition may lead to coma. Symptoms of lactic acidosis
alone for 3 to 6 months have not been enough to control blood glucose
include:
The recommended dose is:
6. Contents of the pack and other information
(sugar). You are at high risk of developing Type 2 diabetes if you have
!
vomiting,
Usually you will start treatment with 500 mg Metabet SR daily. After you
additional conditions like high blood pressure, age above 40 years, an
!
stomach ache (abdominal pain),
have been taking Metabet SR for about 2 weeks, your doctor may measure
What Metabet SR contains
abnormal amount of lipids (fat) in the blood or a history of diabetes during
!
muscle cramps,
your blood sugar and adjust the dose. The maximum daily dose is 2000 mg
The active substance is metformin hydrochloride. Each prolonged-release
pregnancy.
!
a general feeling of not being well with severe tiredness,
of Metabet SR.
tablet contains 1000 mg of metformin hydrochloride.
!
difficulty in breathing,
The other ingredients are stearic acid; shellac (refined bleached);
The medicine is particularly effective if you are aged below 45 years, are
!
reduced body temperature and heartbeat.
If you have reduced kidney function, your doctor may prescribe a lower
povidone K-30; silica, colloidal anhydrous; magnesium stearate;
very overweight, have high blood glucose levels after a meal or developed
dose.
hypromellose; hydroxy propyl cellulose; titanium dioxide; propylene glycol;
diabetes during pregnancy.
Lactic acidosis is a medical emergency and must be treated in a hospital.
macrogol-6000 and talc.
Normally, you should take the tablets once a day, with your evening meal. In
Metabet SR is used for the treatment of Type 2 diabetes when diet and
If you need to have major surgery you must stop taking Metabet SR during
some cases, your doctor may recommend that you take the tablets twice a
What Metabet SR looks like and contents of the pack
exercise changes alone have not been enough to control blood glucose
and for some time after the procedure. Your doctor will decide when you
day.
Always
take
the
tablets
with
food.
Metabet
SR 1000 mg tablets are off-white coloured, oval, biconvex film(sugar). Insulin is a hormone that enables body tissues to take glucose from
must stop and when to restart your treatment with Metabet SR.
coated tablets plain on one side and a score line on the other.
the blood and use it for energy or for storage for future use. People with
If you take more Metabet SR than you should
Type 2 diabetes do not make enough insulin in their pancreas or their body
During treatment with Metabet SR, your doctor will check your kidney
If you take extra tablets by mistake you need not worry, but if you have
Metabet SR is available in blister packs of 7, 10, 14, 20, 28, 30, 56, 60, 84,
does not respond properly to the insulin it does make. This causes a buildfunction at least once a year or more frequently if you are elderly and/or if
unusual
symptoms,
contact
your
doctor.
If
the
overdose
is
large,
lactic
90,
100 and 112 tablets.
up of glucose in the blood which can cause a number of serious long-term
you have worsening kidney function.
acidosis is more likely. Symptoms of lactic acidosis are non-specific, such
problems so it is important that you continue to take your medicine, even
as vomiting, bellyache with muscle cramps, a general feeling of not being
Not all pack sizes may be marketed.
though you may not have any obvious symptoms. Metabet SR makes the
If you are older than 75 years, treatment with Metabet SR should not be
well with severe tiredness, and difficulty in breathing. Further symptoms
body more sensitive to insulin and helps return to normal the way your body
started to lower the risk of developing type 2 diabetes.
are reduced body temperature and heartbeat. If you experience some of
Marketing Authorisation Holder
uses glucose.
these
symptoms,
you
should
immediately
seek
medical
attention,
as
lactic
Morningside
Healthcare Ltd.
You may see some remains of your tablets in your stools. Do not worry- this
acidosis may lead to coma. Stop taking Metabet SR immediately and
115 Narborough Road
Metabet SR is associated with either a stable body weight or modest weight
is normal for this type of tablet.
contact a doctor or the nearest hospital straightaway.
Leicester, LE3 0PA
loss.
United Kingdom
Metabet SR prolonged-release tablets are specially made to release the
You should continue to follow any dietary advice that your doctor has given
If you forget to take Metabet SR
drug slowly in your body and therefore are different to many other types of
you and you should make sure that you eat carbohydrates regularly
Take the missed dose as soon as you remember with some food, unless it's
Manufacturer
tablet containing metformin.
throughout the day.
nearly time for the next one. Do not take a double dose to make up a
Morningside Pharmaceuticals Ltd.
forgotten dose.
5 Pavilion Way, Loughborough, LE11 5GW
2. What you need to know before you take Metabet SR
Do not stop taking this medicine without speaking to your doctor.
United Kingdom
If
you
stop
taking
Metabet
SR
Do not take Metabet SR
Other medicines and Metabet SR
If you stop taking Metabet SR, tell your doctor as soon as possible, as your
This leaflet was last revised in February 2018.
if you are allergic to metformin or any of the other ingredients of this
!
If you need to have an injection of a contrast medium that contains iodine
diabetes
will
not
be
controlled.
medicine (listed in section 6). An allergic reaction may cause a rash,
into your bloodstream, for example in the context of an X-ray or scan, you
Useful tips
itching or shortness of breath.
must stop taking Metabet SR before or at the time of the injection. Your
If
you
have
any
further
questions
on
the
use
of
this
medicine,
ask
your
If you smoke, try to stop.
!
if you have severely reduced kidney function.
!
doctor will decide when you must stop and when to restart your treatment
doctor or pharmacist.
Take regular exercise.
!
if you have uncontrolled diabetes, with, for example, severe
!
with Metabet SR.
Drink as little alcohol as possible.
!
hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea,
4. Possible side effects
Look after your feet. Ask about this at the surgery or hospital.
!
rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or
Tell your doctor or pharmacist if you are taking, have recently taken or might
Carry a card, bracelet or disk saying you are diabetic.
!
ketoacidosis. Ketoacidosis is a condition in which substances called
take any other medicines. You may need more frequent blood glucose and
Like all medicines, this medicine can cause side effects, although not
Visit your diabetic clinic regularly.
!
'ketone bodies' accumulate in the blood and which can lead to diabetic
kidney function tests, or your doctor may need to adjust the dosage of
everybody gets them. The following side effects may occur:
pre-coma. Symptoms include stomach pain, fast and deep breathing,
Metabet SR. It is especially important to mention the following:
sleepiness or your breath developing an unusual fruity smell.
!
Steroids such as prednisolone, mometasone, beclometasone.
Metabet SR may cause a very rare (may affect up to 1 in 10,000 people),
if you have liver problems.
!
!
Sympathomimetic medicines including epinephrine and dopamine
but
very serious side effect called lactic acidosis (see section “Warnings
if you have lost too much water from your body (dehydration).
!
used to treat heart attacks and low blood pressure. Epinephrine is also
and precautions”). If this happens you must stop taking Metabet SR and
Dehydration may lead to kidney problems, which can put you at risk for
included in some dental anaesthetics.
contact a doctor or the nearest hospital immediately, as lactic acidosis
lactic acidosis (see section “Warnings and precautions”).
!
Medicines which increase urine production (diuretics (water tablets)
may lead to coma.
!
if you have a severe infection, such as an infection affecting your lung
such as furosemide).
or bronchial system or your kidney. Severe infections may lead to
!
Certain medicines for the treatment of high blood pressure (ACE
Metabet SR may cause abnormal liver function tests and hepatitis
kidney problems, which can put you at risk for lactic acidosis (see
inhibitors and angiotensin II receptor antagonists).
(inflammation of the liver) which may result in jaundice (may affect up to 1
section “Warnings and precautions”).
!
Medicines used to treat pain and inflammation (NSAID and COX-2user in 10,000). If you develop yellowing of the eyes and/or skin contact
inhibitors, such as ibuprofen and celecoxib).
your doctor immediately.

Metabet SR 1000 mg Prolonged Release Tablets

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