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SUKKARTO SR 1000MG PROLONGED RELEASE TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sukkarto SR 1000 mg Prolonged Release Tablets
Metformin hydrochloride

inhibitors and angiotensin II receptor antagonists).

Sukkarto SR may cause a very rare (may affect up to 1 in 10,000 people),

especially if you have reduced kidney function (such as verapamil,
rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim,
vandetanib, isavuconazole, crizotinib, olaparib).

may lead to coma.

!
Medicines used to treat pain and inflammation (NSAID and COX-2but very serious side effect called lactic acidosis (see section “Warnings
inhibitors, such as ibuprofen and celecoxib).
and precautions”). If this happens you must stop taking Sukkarto SR and
!
Medicines that may change the amount of Sukkarto SR in your blood,
contact a doctor or the nearest hospital immediately, as lactic acidosis

Stop taking Sukkarto SR and see your doctor immediately if you notice
!
if you are a heavy drinker of alcohol.
This medicine is intended for adult patients only.
abnormal liver function tests and hepatitis (inflammation of the liver) which
!
if you are under the age of 18 years.
Read all of this leaflet carefully before you start taking this medicine
Sukkarto SR with food, drink and alcohol
may result in jaundice (yellowing of the eyes and/or skin).
because it contains important information for you.
The tablets should be swallowed whole with a glass of water during or
Warnings and precautions
!
Keep this leaflet. You may need to read it again.
immediately after meals.
The following other side effects have also been reported:
Talk to your doctor or pharmacist before taking Sukkarto SR.
!
If you have any further questions, ask your doctor or pharmacist.
Avoid excessive alcohol intake while taking Sukkarto SR since this may
!
This medicine has been prescribed for you only. Do not pass it on to
increase the risk of lactic acidosis (see section “Warnings and
Very common (may affect more than 1 in 10 people):
Risk of lactic acidosis
others. It may harm them, even if their signs of illness are the same as
precautions”).
!
Diarrhoea, nausea, vomiting, stomach ache or loss of appetite. If you
Sukkarto SR may cause a very rare, but very serious side effect called lactic
yours.
get these, do not stop taking the tablets as these symptoms will
acidosis, particularly if your kidneys are not working properly. The risk of
!
If you get any side effects, talk to your doctor or pharmacist. This
Pregnancy and breast-feeding
normally go away in about 2 weeks. If these do not get better after a
developing lactic acidosis is also increased with uncontrolled diabetes,
includes any possible side effects not listed in this leaflet. See section
Do not take Sukkarto SR if you are pregnant or breast-feeding. If you think
few days, tell your doctor.
serious infections, prolonged fasting or alcohol intake, dehydration (see
4.
you may be pregnant or are planning to have a baby, ask your doctor or
further information below), liver problems and any medical conditions in
pharmacist for advice before taking this medicine.
Common (may affect up to 1 in 10 people):
which a part of the body has a reduced supply of oxygen (such as acute
What is in this leaflet:
!
Taste disturbance.
severe heart disease).
1. What Sukkarto SR is and what it is used for
Driving and using machines
If any of the above apply to you, talk to your doctor for further instructions.
2. What you need to know before you take Sukkarto SR
Sukkarto SR taken on its own does not cause 'hypos' (symptoms of low
Very rare (may affect up to 1 in 10,000 people):
3. How to take Sukkarto SR
blood sugar or hypoglycaemia, such as faintness, confusion and increased
!
Skin rashes including redness, itching and hives.
Stop taking Sukkarto SR for a short time if you have a condition that
4. Possible side effects
sweating) and therefore should not affect your ability to drive or use
!
Decreased vitamin B12 levels.
may be associated with dehydration (significant loss of body fluids) such
5. How to store Sukkarto SR
machinery.
as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less
6. Contents of the pack and other information
You should be aware, however, that Sukkarto SR taken with other
Reporting of side effects
fluid than normal. Talk to your doctor for further instructions.
antidiabetic medicines can cause hypos, so in this case you should take
If you get any side effects, talk to your doctor, pharmacist or nurse. This
1. What Sukkarto SR is and what it is used for
extra care when driving or operating machinery.
includes any possible side effects not listed in this leaflet. You can also
Stop taking Sukkarto SR and contact a doctor or the nearest hospital
report side effects directly via the Yellow Card Scheme at:
Sukkarto SR 500mg prolonged release tablets contain the active ingredient
immediately if you experience some of the symptoms of lactic
3. How to take Sukkarto SR
www.mhra.gov.uk/yellowcard.
metformin hydrochloride and belongs to a group of medicines called
acidosis, as this condition may lead to coma. Symptoms of lactic acidosis
By reporting side effects, you can help provide more information on the
biguanides which are used in the treatment of diabetes.
include:
Always take this medicine exactly as your doctor or pharmacist has told
safety of this medicine.
!
vomiting,
you. Check with your doctor or pharmacist if you are not sure.
Sukkarto SR is used for the treatment of Type 2 (non-insulin dependent)
!
stomach ache (abdominal pain),
5. How to store Sukkarto SR
diabetes mellitus when diet and exercise changes alone have not been
!
muscle cramps,
Your doctor may prescribe Sukkarto SR for you to take on its own, or in
enough to control blood glucose (sugar).
!
a general feeling of not being well with severe tiredness,
combination with other oral antidiabetic medicines or insulin.
Keep this medicine out of the sight and reach of children.
!
difficulty in breathing,
Insulin is a hormone that enables body tissues to take glucose from the
!
reduced body temperature and heartbeat.
Swallow the tablets whole with a glass of water, do not chew.
Do not use this medicine after the expiry date which is stated on the blister
blood and use it for energy or for storage for future use. People with Type 2
and carton after EXP. The expiry date refers to the last day of that month.
diabetes do not make enough insulin in their pancreas or their body does
Lactic acidosis is a medical emergency and must be treated in a hospital.
The recommended dose is:
not respond properly to the insulin it does make. This causes a build-up of
Usually you will start treatment with 500 mg Sukkarto SR daily. After you
This medicinal product does not require any special storage conditions.
glucose in the blood which can cause a number of serious long-term
If you need to have major surgery you must stop taking Sukkarto SR during
have been taking Sukkarto SR for about 2 weeks, your doctor may
problems so it is important that you continue to take your medicine, even
and for some time after the procedure. Your doctor will decide when you
measure your blood sugar and adjust the dose. The maximum daily dose is
Do not throw away any medicines via wastewater or household waste. Ask
though you may not have any obvious symptoms. Sukkarto SR makes the
must stop and when to restart your treatment with Sukkarto SR.
2000 mg of Sukkarto SR.
your pharmacist how to throw away medicines you no longer use. These
body more sensitive to insulin and helps return to normal the way your body
measures will help protect the environment.
uses glucose.
Make sure you ask your doctor for advice if you need to have an
If you have reduced kidney function, your doctor may prescribe a lower
examination such as X-ray or scan involving the injection of contrast
dose.
6. Contents of the pack and other information
Sukkarto SR is associated with either a stable body weight or modest
medicines that contain iodine into your bloodstream (see section “Other
weight loss.
medicines and Sukkarto SR”).
Normally, you should take the tablets once a day, with your evening meal. In
What Sukkarto SR contains
Sukkarto SR prolonged release tablets are specially made to release the
some cases, your doctor may recommend that you take the tablets twice a
The active substance is metformin hydrochloride. Each prolonged release
drug slowly in your body and therefore are different to many other types of
After you have started taking your medicine:
day. Always take the tablets with food.
tablet contains 1000 mg of metformin hydrochloride.
tablet containing metformin.
During treatment with Sukkarto SR, your doctor will check your kidney
function at least once a year or more frequently if you are elderly and/or if
If you take more Sukkarto SR than you should
The other ingredients are stearic acid; shellac (refined bleached);
2. What you need to know before you take Sukkarto SR
you have worsening kidney function.
If you take extra tablets by mistake you need not worry, but if you have
povidone K-30; silica, colloidal anhydrous; magnesium stearate;
unusual symptoms, contact your doctor. If the overdose is large, lactic
hypromellose; hydroxy propyl cellulose; titanium dioxide; propylene glycol;
Do not take Sukkarto SR
You may see some remains of your tablets in your stools. Do not worry- this
acidosis is more likely. Symptoms of lactic acidosis are non-specific, such
macrogol 6000 and talc.
!
if you are allergic to metformin or any of the other ingredients of this
is normal for this type of tablet.
as vomiting, bellyache with muscle cramps, a general feeling of not being
medicine (listed in section 6).
well with severe tiredness, and difficulty in breathing. Further symptoms
What Sukkarto SR looks like and contents of the pack
!
if you have severely reduced kidney function.
You should continue to follow any dietary advice that your doctor has given
are reduced body temperature and heartbeat. If you experience some of
Sukkarto SR 1000 mg tablets are off-white coloured, oval, biconvex film!
if you have uncontrolled diabetes, with, for example, severe
you and you should make sure that you eat carbohydrates regularly
these symptoms, you should immediately seek medical attention, as lactic
coated tablets plain on one side and a score line on the other.
hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea,
throughout the day.
acidosis may lead to coma. Stop taking Sukkarto SR immediately and
rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or
contact a doctor or the nearest hospital straightaway.
Sukkarto SR is available in blister packs of 7, 10, 14, 20, 28, 30, 56, 60, 84,
ketoacidosis. Ketoacidosis is a condition in which substances called
Do not stop taking this medicine without speaking to your doctor.
90, 100 and 112 tablets.
'ketone bodies' accumulate in the blood and which can lead to diabetic
If you forget to take Sukkarto SR
pre-coma. Symptoms include stomach pain, fast and deep breathing,
Other medicines and Sukkarto SR
Take the missed dose as soon as you remember, unless it's nearly time for
Not all pack sizes may be marketed.
sleepiness or your breath developing an unusual fruity smell.
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. Take
!
if you have lost too much water from your body (dehydration).
into your bloodstream, for example in the context of an X-ray or scan, you
the remaining doses at the correct time.
Marketing Authorisation Holder
Dehydration may lead to kidney problems, which can put you at risk for
must stop taking Sukkarto SR before or at the time of the injection. Your
Morningside Healthcare Ltd.
lactic acidosis (see section "Warnings and precautions").
doctor will decide when you must stop and when to restart your treatment
If you stop taking Sukkarto SR
115 Narborough Road
!
if you have liver problems.
with Sukkarto SR.
If you stop taking Sukkarto SR, tell your doctor as soon as possible, as your
Leicester, LE3 0PA, UK
!
if you have a severe infection, such as an infection affecting your lung
diabetes will not be controlled.
or bronchial system or your kidney. Severe infections may lead to
Tell your doctor or pharmacist if you are taking, have recently taken or might
Manufacturer
kidney problems, which can put you at risk for lactic acidosis (see
take any other medicines. You may need more frequent blood glucose and
If you have any further questions on the use of this medicine, ask your
Morningside Pharmaceuticals Ltd.
section “Warnings and precautions”).
kidney function tests, or your doctor may need to adjust the dosage of
doctor or pharmacist.
5 Pavilion Way
!
if you have been treated for acute heart problems or have recently had
Sukkarto SR. It is especially important to mention the following:
Loughborough, LE11 5GW, UK
a heart attack or have severe circulatory problems or breathing
!
Steroids such as prednisolone, mometasone, beclometasone.
4. Possible side effects
difficulties. This may lead to a lack in oxygen supply to tissue which can
!
Sympathomimetic medicines including epinephrine and dopamine
This leaflet is available in large font or audio format upon request.
put you at risk for lactic acidosis (see section “Warnings and
used to treat heart attacks and low blood pressure. Epinephrine is also
Like all medicines, this medicine can cause side effects, although not
precautions”).
included in some dental anaesthetics.
everybody gets them.
This leaflet was last revised in March 2017.
!
Medicines which increase urine production (diuretics).
!
Certain medicines for the treatment of high blood pressure (ACE

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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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