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METABET SR 750 MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Metabet SR

750mg Prolonged-Release Tablets

Metformin hydrochloride
This medicine is intended for adult patients only.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Metabet SR is and what it is used for
2. What you need to know before you take Metabet SR
3. How to take Metabet SR
4. Possible side effects
5. How to store Metabet SR
6. Contents of the pack and other information
1. What Metabet SR is and what it is used for
Metabet SR 750mg prolonged-release tablets contain the active
ingredient metformin hydrochloride and belong to a group of
medicines called biguanides, used in the treatment of Type 2
(non-insulin dependent) diabetes mellitus.
Metabet SR is used together with diet and exercise to lower the
risk of developing Type 2 diabetes in overweight adults, when diet
and exercise alone for 3 to 6 months have not been enough to
control blood glucose (sugar). You are at high risk of developing
Type 2 diabetes if you have additional conditions like high blood
pressure, age above 40 years, an abnormal amount of lipids (fat)
in the blood or a history of diabetes during pregnancy.
The medicine is particularly effective if you are aged below 45 years,
are very overweight, have high blood glucose levels after a meal
or developed diabetes during pregnancy.
Metabet SR is used for the treatment of Type 2 diabetes when
diet and exercise changes alone have not been enough to control
blood glucose (sugar). Insulin is a hormone that enables body
tissues to take glucose from the blood and use it for energy or for
storage for future use. People with Type 2 diabetes do not make
enough insulin in their pancreas or their body does not respond
properly to the insulin it does make. This causes a build-up of
glucose in the blood which can cause a number of serious longterm problems, so it is important that you continue to take your
medicine, even though you may not have any obvious symptoms.
Metabet SR makes the body more sensitive to insulin and helps
return to the normal way your body uses glucose.
Metabet SR is associated with either a stable body weight or
modest weight loss.
Metabet SR prolonged-release tablets are specially made to
release the drug slowly in your body and therefore are different to
many other types of tablet containing metformin.
2. What you need to know before you take Metabet SR
Do not take Metabet SR if you:
• are allergic to metformin or any of the other ingredients of this
medicine (listed in section 6). An allergic reaction may cause a
rash, itching or shortness of breath.
• have liver problems.
• have severely reduced kidney function.
• have uncontrolled diabetes, with, for example, severe
hyperglycaemia (high blood glucose), nausea, vomiting,
diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic
acidosis” below) or ketoacidosis. Ketoacidosis is a condition
in which substances called ‘ketone bodies’ accumulate in the
blood and which can lead to diabetic pre-coma. Symptoms
include stomach pain, fast and deep breathing, sleepiness or
your breath developing an unusual fruity smell.
• have lost too much water from your body (dehydration).
Dehydration may lead to kidney problems, which can put you at
risk for lactic acidosis (see section “Warnings and precautions”).

• have a severe infection, such as an infection affecting your lung
or bronchial system or your kidney. Severe infections may lead
to kidney problems, which can put you at risk for lactic acidosis
(see section “Warnings and precautions”).
• have been treated for acute heart problems or have recently
had a heart attack or have severe circulatory problems or
breathing difficulties. This may lead to a lack in oxygen supply to
tissue which can put you at risk for lactic acidosis (see section
“Warnings and precautions”).
• are a heavy drinker of alcohol.
• are under the age of 18 years.
Warning and precautions
Talk to your doctor or pharmacist before taking Metabet SR.
Risk of lactic acidosis
Metabet SR may cause a very rare, but very serious side effect
called lactic acidosis, particularly if your kidneys are not working
properly. The risk of developing lactic acidosis is also increased
with uncontrolled diabetes, serious infections, prolonged fasting
or alcohol intake, dehydration (see further information below),
liver problems and any medical conditions in which a part of the
body has a reduced supply of oxygen (such as acute severe heart
disease).
If any of the above apply to you, talk to your doctor for further
instructions.
Stop taking Metabet SR for a short time if you have a
condition that may be associated with dehydration (significant
loss of body fluids) such as severe vomiting, diarrhoea, fever,
exposure to heat or if you drink less fluid than normal. Talk to your
doctor for further instructions.
Stop taking Metabet SR and contact a doctor or the
nearest hospital immediately if you experience some of the
symptoms of lactic acidosis, as this condition may lead to
coma. Symptoms of lactic acidosis include:
• vomiting,
• stomach ache (abdominal pain),
• muscle cramps,
• a general feeling of not being well with severe tiredness,
• difficulty in breathing,
• reduced body temperature and heartbeat.
Lactic acidosis is a medical emergency and must be treated in a
hospital.
If you need to have major surgery you must stop taking Metabet
SR during and for some time after the procedure. Your doctor will
decide when you must stop and when to restart your treatment
with Metabet SR.
During treatment with Metabet SR, your doctor will check your
kidney function at least once a year or more frequently if you are
elderly and/or if you have worsening kidney function.
If you are older than 75 years, treatment with Metabet SR should
not be started to lower the risk of developing type 2 diabetes.
You may see some remains of the tablets in your stools. Do not
worry - this is normal for this type of tablet.
You should continue to follow any dietary advice that your
doctor has given you and you should make sure that you eat
carbohydrates regularly throughout the day.
Do not stop taking this medicine without speaking to your doctor.
Other medicines and Metabet SR
If you need to have an injection of contrast medium that contains
iodine into your bloodstream, for example in context of an X-ray
or scan, you must stop taking Metabet SR before or at the time of
injection. Your doctor will decide when you must stop and when to
restart your treatment with Metabet SR.
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. You may need more
frequent blood glucose and kidney function tests, or your doctor
may need to adjust the dosage of Metabet SR. It is especially
important to mention the following:
• Steroids such as prednisolone, mometasone, beclometasone.

• Sympathomimetic medicines including epinephrine and
dopamine used to treat heart attacks and low blood pressure.
Epinephrine is also included in some dental anaesthetics.
• Medicines which increase urine production (diuretics (water
tablets) such as furosemide).
• Certain medicines for the treatment of high blood pressure
(ACE inhibitors and angiotensin II receptor antagonists).
• Medicines used to treat pain and inflammation (NSAID and
COX-2-inhibitors, such as ibuprofen and celecoxib).
• Medicines that may change the amount of Metabet SR in your
blood, especially if you have reduced kidney function (such
as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine,
trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
Metabet SR with food, drink and alcohol
The tablets should be swallowed whole with a glass of water
during or immediately after meals.
Avoid excessive alcohol intake while taking Metabet SR since this
may increase the risk of lactic acidosis (see section “Warnings
and precautions”).
Pregnancy and breast-feeding
Do not take Metabet SR if you are pregnant or breast-feeding.
If you think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
Metabet 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 Metabet SR taken with other
antidiabetic medicines can cause hypos, so in this case you
should take extra care when driving or operating machinery.
3. How to take Metabet SR
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
Your doctor may prescribe Metabet SR for you to take on its own,
or in combination with other oral antidiabetic medicines or insulin.
Swallow the tablets whole with a glass of water, do not chew.
The recommended dose is:
Usually you will start treatment with 500 mg Metabet SR daily.
After you have been taking Metabet SR for about 2 weeks, your
doctor may measure your blood sugar and adjust the dose. The
maximum daily dose is 2000 mg of Metabet SR.
If you have reduced kidney function, your doctor may prescribe a
lower dose.
Normally, you should take the tablets once a day, with your
evening meal. In some cases, your doctor may recommend that
you take the tablets twice a day. Always take the tablets with food.
If you take more Metabet SR than you should
If you take extra tablets by mistake you need not worry, but if you
have unusual symptoms, contact your doctor. If the overdose is
large, lactic acidosis is more likely. Symptoms of lactic acidosis
are non-specific, such as vomiting, bellyache with muscle
cramps, a general feeling of not being well with severe tiredness,
and difficulty in breathing. Further symptoms are reduced body
temperature and heartbeat. If you experience some of these
symptoms, you should immediately seek medical attention,
as lactic acidosis may lead to coma. Stop taking Metabet
SR immediately and contact a doctor or the nearest hospital
straightaway.
If you forget to take Metabet SR
Take the missed dose as soon as you remember with some food,
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 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 medicine ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them. The following side effects may occur:
Metabet SR may cause a very rare (may affect up to 1 in 10,000
people), but very serious side effect called lactic acidosis
(see section “Warnings and precautions”). If this happens you

must stop taking Metabet SR and contact a doctor or the
nearest hospital immediately, as lactic acidosis may lead to
coma.
Metabet SR may cause abnormal liver function tests and hepatitis
(inflammation of the liver) which may result in jaundice (may affect
up to 1 user in 10,000). If you develop yellowing of the eyes and/
or skin contact your doctor immediately.
Other possible side effects are listed by frequency as follows:
Very common (may affect more than 1 in 10 people):
• Diarrhoea, nausea, vomiting, stomach ache or loss of appetite.
If you get these, do not stop taking the tablets as these
symptoms will normally go away in about 2 weeks. It helps if
you take the tablets with or immediately after a meal.
Common (may affect up to 1 in 10 people):
• Taste disturbance.
Very rare (may affect up to 1 in 10,000 people):
• Skin rashes including redness, itching and hives.
• Decreased vitamin B12 levels.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Metabet SR
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the blister and carton after EXP. The expiry date refers to the last
day of that month.
This medicinal product does not require any special storage
conditions.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Metabet SR contains
The active substance is metformin hydrochloride. Each prolongedrelease tablet contains 750 mg of metformin hydrochloride.
The other ingredients are carmellose sodium, magnesium
stearate, hypromellose, cellulose microcrystalline and silica
colloidal anhydrous.
What Metabet SR looks like and contents of the pack
Metabet SR 750 mg tablets are white to off-white, capsule shaped
tablets, plain on both the 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
Manufacturer
Morningside Pharmaceuticals Ltd.
5 Pavilion Way,
Loughborough, LE11 5GW
United Kingdom
This leaflet was last revised in August 2017.
Useful tips
• If you smoke, try to stop.
• Take regular exercise.
• Drink as little alcohol as possible.
• Look after your feet. Ask about this at the surgery or hospital.
• Carry a card, bracelet or disk saying you are diabetic.
• Visit your diabetic clinic regularly.

M0277LAMUKNA-P-002
180/S/L/0517/1

Expand Transcript

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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