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SUKKARTO SR 500MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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