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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

Sukkarto SR 500 mg Prolonged Release Tablets
Metformin Hydrochloride

Read all of this leaflet carefully before you start taking
Take special care with Sukkarto SR
this medicine
If you have diabetes you should have your blood or urine
!
Keep this leaflet. You may need to read it again.
tested for sugar regularly. You should return to your doctor at
!
If you have further questions, please ask your doctor or
least once a year to check the function of your kidneys (more
pharmacist.
often if you are elderly or if you have kidney problems). Your
!
This medicine has been prescribed for you. Do not pass it
doctor may also perform these tests when starting treatment
on to others. It may harm them, even if their symptoms are
for high blood pressure.
the same as yours.
!
If any of the side effects get serious or if you notice any
Sukkarto SR may cause a very rare, but serious complication
side effects not listed on this leaflet, please tell your doctor
called lactic acidosis, particularly if your kidneys are not
or pharmacist.
working properly. The risk of lactic acidosis is also increased
with uncontrolled diabetes, prolonged fasting or alcohol
In this leaflet:
intake. Symptoms of lactic acidosis are vomiting, bellyache
1. What Sukkarto SR is and what it is used for
(abdominal pain) with muscle cramps, a general feeling of not
2. Before you take Sukkarto SR
being well with severe tiredness, and difficulty in breathing. If
3. How to take Sukkarto SR
this happens to you, you may need immediate hospital
4. Possible side effects
treatment, as lactic acidosis may lead to coma. Stop
5. How to store Sukkarto SR
taking Sukkarto SR immediately and contact a doctor or
6. Further information
the nearest hospital straight away.
1. What Sukkarto SR is and what it is used for
Sukkarto SR prolonged release tablets contain the active
ingredient metformin hydrochloride. Each tablet contains 500
mg of metformin hydrochloride. Metformin belongs to a group
of drugs called biguanides which are used in the treatment of
diabetes.
Sukkarto SR is used for the treatment of Type 2 (non-insulin
dependent) diabetes mellitus particularly in overweight
patients, where diet and exercise changes alone have not
been sufficient to control it. In type 2 diabetes, there is too
much sugar (glucose) in the blood because pancreas does
not produce enough insulin or because it produces insulin
that does not work properly.
Your doctor can prescribe Sukkarto SR for you to take on its
own, or in combination with other oral antidiabetic medicines,
or insulin.

You should avoid drinking alcohol and using alcohol
containing medicines as this will increase the risk of lactic
acidosis.
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
days afterwards.
Tell your doctor if surgery is planned. Treatment with Sukkarto
SR should be stopped 2 days before surgery until at least 2
days following surgery.
You should continue your diet during treatment with Sukkarto
SR with an even intake of carbohydrate over the day. If you
are overweight continue your energy-restricted diet under
medical supervision.

Taking Sukkarto SR alone does not normally cause low blood
sugar levels (hypoglycaemia). Taking Sukkarto SR in
combination with medicines called sulphonylureas,
2. Before you take Sukkarto SR
meglitinides, insulin or other treatments for diabetes may
cause low blood sugar levels with symptoms such as
Do not take Sukkarto SR
sweating, fainting, dizziness or weakness, so in this case you
!
if you are allergic (hypersensitive) to metformin or to any
should take extra care when driving or operating machinery.
of the ingredients in this medicine.
!
if you have ketosis (this is a symptom of uncontrolled
Taking other medicines
diabetes in which substances called “ketone bodies”
Please tell your doctor or pharmacist if you are taking or have
accumulate in the blood); you may notice that your breath
recently taken any other medicines including medicines
has an unusual, fruity odour.
obtained without a prescription.
!
if you have had serious complications with your diabetes
The effects of Sukkarto SR may be altered by:
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 problems with your liver or kidneys.
heart attack or low blood pressure,
!
if you are suffering from severe infection or have recently
!
Diuretics (water tablets) such as bendroflumethiazide,
suffered a severe injury.
!
ACE inhibitors such as lisinopril, enalapril used for blood
!
if you have been treated for heart problems or have
pressure.
recently had a heart attack or have problems with your
circulation (e.g. frequent cramp in your calves or leg
Taking Sukkarto SR with food and drink
ulcers that do not heal) or breathing difficulties.
The tablets should be swallowed whole with a glass of water
!
if you are pregnant.
during or after meals. This can reduce some side effects.
!
if you drink alcohol.
Avoid drinking alcohol while taking Sukkarto SR.
!
if you are under the age of 18 years.

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.
Driving and using machines:
Sukkarto SR does not affect your ability to drive vehicles or
handle machinery, but if you are also taking other antidiabetic medicines it is possible that you may feel faint, dizzy
or weak. If this happens you should not drive or operate any
machinery until you have recovered.
3. How to take Sukkarto SR

The following side effects have also been reported:
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.

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):

Always take Sukkarto SR exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
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 and swallow
whole (without chewing or breaking), with a glass of water.
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.
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. Take the remaining doses at the
correct time.
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
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.

!
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.
Do not store above 30°C.
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
What Sukkarto SR contains
The active substance is metformin hydrochloride. Each
prolonged release tablet contains 500 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 500 mg tablets are off-white coloured, oval,
biconvex, film-coated tablets plain on both sides.
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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