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METABET SR 500MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Metabet SR 500 mg Prolonged Release Tablets
Metformin Hydrochloride
Read all of this leaflet carefully before you start taking
this medicine
! Keep this leaflet. You may need to read it again.
! If you have further questions, please ask your doctor or
pharmacist.
! This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
! If any of the side effects get serious or if you notice any
side effects not listed on this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Metabet SR is and what it is used for
2. Before you take Metabet SR
3. How to take Metabet SR
4. Possible side effects
5. How to store Metabet SR
6. Further information
1. WHAT IS METABET SR AND WHAT IT IS USED FOR
Metabet SR prolonged release tablets contains 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.
Metabet 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 your blood because your pancreas
does not produce enough insulin or because it produces
insulin that does not work properly.
Your doctor can prescribe Metabet SR for you to take on its
own, or in combination with other oral antidiabetic medicines,
or insulin.

Take special care with Metabet SR
If you have diabetes you should have your blood or urine
tested for sugar regularly. You should return to your doctor at
least once a year to check the function of your kidneys (more
often if you are elderly or if you have kidney problems). Your
doctor may also perform these tests when starting treatment
for high blood pressure.
If you have kidney failure, blood levels of metformin can
increase, which can very rarely cause lactic acidosis. This
results in breathing problems, muscle pains or loss of
consciousness and if not treated this can be very dangerous
so needs urgent hospital attention. In this case you must
contact your doctor immediately or go to the nearest hospital
accident and emergency department.
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 Metabet SR as you may need to stop taking it for few
days afterwards.
Tell your doctor if surgery is planned. Treatment with Metabet
SR should be stopped 2 days before surgery until at least 2
days following surgery.
You should continue your diet during treatment with Metabet
SR with an even intake of carbohydrate over the day. If you
are overweight continue your energy-restricted diet under
medical supervision.
Taking Metabet SR alone does not normally cause low blood
sugar levels (hypoglycaemia). Taking Metabet SR in
combination with medicines called sulphonylureas, insulin or
other treatments for diabetes may cause low blood sugar
levels with symptoms such as sweating, fainting, dizziness or
weakness, so in this case you should take extra care when
driving or operating machinery.

2. BEFORE YOU TAKE METABET SR
Do not take Metabet SR
! if you are you allergic (hypersensitive) to metformin or to
any of the ingredients in this medicine.
! if you have ketosis (this is a symptom of uncontrolled
diabetes in which substances called “ketone bodies”
accumulate in the blood), you may notice that your breath
has an unusual, fruity odour.
! if you have had serious complications with your diabetes
or other serious conditions which resulted in rapid weight
loss, nausea, vomiting or dehydration and you have
fainted or suffered a coma due to your diabetes.
! if you have any problems with your liver or kidneys.
! if you are suffering from severe infection or have recently
suffered a severe injury.
! if you have been treated for heart problems or have
recently had a heart attack or have problems with your
circulation (e.g. frequent cramp in your calves or leg
ulcers that do not heal) or breathing difficulties.
! if you are pregnant or breast-feeding.
! if you are likely to have surgery or a scan or an X-ray.
! if you drink alcohol.
! if you are under the age of 18 years.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines including medicines
obtained without a prescription.
The effects of Metabet SR may be altered by;
! Steroids such as prednisolone, mometasone,
beclometasone
! Beta-2-agonist such as salbutamol used for asthma
! Diuretics (water tablets) such as bendroflumethiazide
! ACE inhibitors such as lisinopril, enalapril used for blood
pressure
Taking Metabet SR with food and drink
The tablets should be swallowed whole with a glass of water
during or after meals. This can reduce some side effects.
Avoid drinking alcohol while taking Metabet SR.
Pregnancy and breast-feeding
Do not take Metabet SR if you are pregnant or breast feeding.
Tell your doctor immediately if think you are pregnant.

Driving and using machines:
Metabet 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 METABET SR
Always take Metabet SR exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
The usual dose in:
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 Metabet 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 Metabet SR.
If you take more Metabet 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 Metabet 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 Metabet SR
If you stop taking Metabet 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 Metabet 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.
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 then one person in 10 but more than
one person in 100):
! Taste disturbance.
Very rare (affecting less than one in 10,000):
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
Metabet 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 METABET SR
Keep out of the reach and sight of children. Do not take
Metabet 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 Metabet 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 Metabet SR looks like and contents of the pack
Metabet SR 500 mg tablets are off-white coloured, oval,
biconvex, film coated tablets plain on both sides.
Metabet 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
United Kingdom.
Site responsible for batch release:
Morningside Pharmaceuticals Ltd
5 Pavilion Way, Loughborough, LE11 5GW
United Kingdom
This leaflet was last updated in:
June 2010

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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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