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SUKKARTO SR 1000MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sukkarto SR 1000 mg Prolonged Release Tablets
Metformin Hydrochloride

Read all of this leaflet carefully before you start taking
!
if you have been treated for heart problems or have
this medicine
recently had a heart attack or have problems with your
!
Keep this leaflet. You may need to read it again.
circulation (e.g. frequent cramp in your calves or leg
!
If you have further questions, please ask your doctor or
ulcers that do not heal) or breathing difficulties.
pharmacist.
!
if you drink alcohol.
!
This medicine has been prescribed for you. Do not pass it
!
if you are under the age of 18 years.
on to others. It may harm them, even if their symptoms are
the same as yours.
Take special care with Sukkarto SR
!
If any of the side effects get serious or if you notice any
If you have diabetes you should have your blood or urine
side effects not listed on this leaflet, please tell your doctor
tested for sugar regularly. You should return to your doctor at
or pharmacist.
least once a year to check the function of your kidneys (more
often if you are elderly or if you have kidney problems).
In this leaflet:
1. What Sukkarto SR is and what it is used for
Sukkarto SR may cause a very rare, but serious complication
2. Before you take Sukkarto SR
called lactic acidosis, particularly if your kidneys are not
3. How to take Sukkarto SR
working properly. The risk of lactic acidosis is also increased
4. Possible side effects
with uncontrolled diabetes, prolonged fasting or alcohol
5. How to store Sukkarto SR
intake. Symptoms of lactic acidosis are vomiting, bellyache
6. Further information
(abdominal pain) with muscle cramps, a general feeling of not
being well with severe tiredness, and difficulty in breathing. If
1. What Sukkarto SR is and what it is used for
this happens to you, you may need immediate hospital
treatment, as lactic acidosis may lead to coma. Stop
Sukkarto SR 1000mg prolonged release tablets contain the
taking Sukkarto SR immediately and contact a doctor or
active ingredient metformin hydrochloride. Each tablet
the nearest hospital straight away (see also under '4.
contains 1000 mg of metformin hydrochloride. Metformin
Possible side effects').
belongs to a group of drugs called biguanides which are used
in the treatment of diabetes.
If you need to have an X-ray examination tell your doctor that
you take Sukkarto SR as you may need to stop taking it for few
Sukkarto SR is used for the treatment of Type 2 (non-insulin
days afterwards.
dependent) diabetes mellitus particularly in overweight
patients, where diet and exercise changes alone have not
Tell your doctor if surgery is planned. Treatment with Sukkarto
been sufficient to control it. In type 2 diabetes, there is too
SR should be stopped 2 days before surgery until at least 2
much sugar (glucose) in the blood because pancreas does
days following surgery.
not produce enough insulin or because it produces insulin
that does not work properly.
You should continue your diet during treatment with Sukkarto
SR with an even intake of carbohydrate over the day. If you
Insulin is a hormone that enables body tissues to take glucose
are overweight continue your energy-restricted diet under
from the blood and use it for energy or fat storage for future
medical supervision.
use. People with Type 2 diabetes do not make enough insulin
in their pancreas, or their body does not respond properly to
Normal kidneys are essential for the treatment with Sukkarto
the insulin it does make. This causes a build-up of glucose in
SR because of the risk of developing lactic acidosis. Tests will
the blood which can cause a number of serious long-term
be done to check your kidney function at least once a year or
problems so it is important that you continue to take your
more frequently if you are elderly, or when starting treatment
medicine, even though you may not have any obvious
for high blood pressure.
symptoms. Sukkarto SR makes the body more sensitive to
insulin and helps return to the normal way your body uses
Taking Sukkarto SR alone does not normally cause low blood
glucose.
sugar levels (hypoglycaemia). Taking Sukkarto SR in
combination with medicines called sulphonylureas,
Sukkarto SR Prolonged release tablets are specially made to
meglitinides, insulin or other treatments for diabetes may
release the drug slowly in your body and therefore are
cause low blood sugar levels with symptoms such as
different to many other types of tablet containing metformin.
sweating, fainting, dizziness or weakness, so in this case you
should take extra care when driving or operating machinery.
Adults
Your doctor can prescribe Sukkarto SR for you to take on its
You may see some remains of your tablets in your stools. Do
own, or in combination with other oral antidiabetic medicines,
not worry - this is normal for this type of tablet.
or insulin.
Do not stop taking this medicine without speaking to your
2. Before you take Sukkarto SR
doctor.

Do not take Sukkarto SR
Taking other medicines
!
if you are allergic (hypersensitive) to metformin or to any
Please tell your doctor or pharmacist if you are taking or have
of the ingredients in this medicine.
recently taken any other medicines including medicines
!
if you have ketosis (this is a symptom of uncontrolled
obtained without a prescription.
diabetes in which substances called “ketone bodies”
accumulate in the blood; you may notice that your breath
If you are taking any of the following medicines, your blood
has an unusual, fruity odour).
sugar levels may need to be checked more often and your
!
if you have had serious complications with your diabetes
dose adjusted:
or other serious conditions which resulted in rapid weight
!
Steroids such as prednisolone, mometasone,
loss, nausea, vomiting or dehydration and you have
beclometasone,
fainted or suffered a coma due to your diabetes.
!
Sympathomimetics such as epinephrine used to treat
!
if you have any long-term problems with your liver or
heart attack or low blood pressure,
kidneys.
!
Diuretics (water tablets) such as bendroflumethiazide,
!
if you are suffering from severe infection or have recently
!
ACE inhibitors such as lisinopril, enalapril, captopril.
suffered a severe injury.

Taking Sukkarto SR with food and drink
The tablets should be swallowed whole with a glass of water
during or immediately after meals. Avoid drinking alcohol
while taking Sukkarto SR, as this will increase the risk of lactic
acidosis (see under “4. Possible side effects”).

consciousness, you should stop taking the drug and, contact
your doctor immediately or go to the nearest hospital
accident and emergency department. These can be signs of
very rare condition called “lactic acidosis” which can be
dangerous and needs urgent hospital attention.

Pregnancy and breast-feeding
Do not take Sukkarto SR if you are pregnant or breastfeeding. Tell your doctor immediately if you think you are
pregnant or are breast-feeding.

The following side effects have also been reported:

Driving and using machines:
Sukkarto 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 Sukkarto SR taken with
other antidiabetic medicines can cause hypos, so in this case
you should take extra care when driving or operating
machinery.

Very common (affecting more than one person in 10):

!
Stomach pains or stomach upsets such as nausea,

vomiting, diarrhoea, loss of appetite.
These effects usually get better spontaneously and you
should continue to take the tablets. If these do not get better
after a few days, tell your doctor. It helps if you take your
tablets with or immediately after a meal.

Common (affecting less than one person in 10 but more than
one person in 100):
!
Taste disturbance.
Very rare (affecting less than one in 10,000):

3. How to take Sukkarto SR
Always take Sukkarto SR exactly as your doctor 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.
The usual dose is:
Adults: The usual starting dose is one 500 mg tablet daily with
your evening meals. After two weeks your doctor may
increase the dose to a maximum of 2000 mg per day. In some
cases, your doctor may recommend that you take the tablet
twice a day. Always take the tablets with food.
Combination with insulin: When taking Sukkarto SR with
insulin, the usual dose is one 500mg tablet once a day, while
insulin dosage is adjusted on the basis of blood sugar
measurements.
Elderly: The starting dose will be determined after tests have
been carried out on your kidney function.
Children and adolescents below 18 years: The use of the
medication is not recommended.
Your doctor will test your blood glucose and your kidney
function at intervals while you are taking Sukkarto SR to make
sure you are taking the right dose. This is especially important
when you start taking other new medicines at the same time
as Sukkarto SR.
If you take more Sukkarto SR than you should
Tell your doctor or contact the nearest hospital, taking the
medicine or this leaflet with you. 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 Sukkarto SR
Take the missed dose as soon as you remember, unless it's
nearly time for the next one. Do not take a double dose to
make up a forgotten dose.
If you stop taking Sukkarto SR
If you stop taking Sukkarto SR, tell your doctor as soon as
possible, as your diabetes will not be controlled.
If you have any further questions on the use of this product
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Sukkarto SR can cause side effects,
although not everybody gets them.
If you start to lose weight unexpectedly, feel sick with stomach
pains, have rapid uncontrolled breathing, or start to lose

!
Skin rash (redness and itching of the skin, hives).
!
Liver problems (hepatitis), possibly with jaundice

(yellowing of skin and eyes) which goes away on stopping
Sukkarto SR.
!
A decrease in vitamin B12 absorption, which can result in
anaemia, sore tongue, tingling and numbness.
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. How to store Sukkarto SR
Keep out of the sight and reach of children. Do not take
Sukkarto SR after the expiry date printed on the blister pack
and carton. The expiry date (EXP) refers to the last day of that
month.
This medicinal product does not require any special storage
conditions.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. Further information
The active substance is metformin hydrochloride. Each
prolonged release tablet contains 1000 mg of metformin
hydrochloride. The other ingredients in the tablets 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 Sukkarto SR looks like and contents of the pack
Sukkarto SR 1000 mg tablets are off-white coloured, oval,
biconvex, film-coated tablets plain on one side and a score
line on the other.
Sukkarto 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 UK
Manufacturer:
Morningside Pharmaceuticals Ltd
5 Pavilion Way, Loughborough, LE11 5GW UK
This leaflet is available in large font or audio format upon
request.
This leaflet was last revised in May 2016.

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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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