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BOLAMYN SR 500 MG PROLONGED RELEASE TABLETS (METFORMIN HYDROCHLORIDE)

Active substance(s): METFORMIN HYDROCHLORIDE

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TEVA UK Ref:

Version:

86463-W LEA METFORMIN 500 MG SR TAB TUK

metformin hydrochloride

Package leaflet: Information
for the user
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 or nurse. This
includes any possible side effects not
listed in this leaflet, See section 4.

What is in this leaflet:

Pharma code 3313

1. What Bolamyn SR 500 mg Prolonged
Release Tablets are and what they are
used for
2. What you need to know before you
take Bolamyn SR 500 mg Prolonged
Release Tablets
3. How to take Bolamyn SR 500 mg
Prolonged Release Tablets
4. Possible side effects
5. How to store Bolamyn SR 500 mg
Prolonged Release Tablets
6. Contents of the pack and other
information

1

What Bolamyn SR 500 mg
Prolonged Release Tablets are
and what they are used for

Metformin, active substance of Bolamyn
SR 500mg Prolonged Release Tablets,
belongs to a group of active substances
called biguanides, which are used to
treat diabetes by regulating the level of
sugar in the blood.
• Bolamyn SR is used for patients who
have non-insulin-dependent (type 2)
diabetes, particularly in overweight
patients, where diet and exercise
alone have failed to control it.
Metformin can be given alone or in
combination with other oral
antidiabetic medicines or with insulin.
This is a prolonged release tablet which
a type of tablet that spreads the release
of the medication over a longer period of
time than an immediate release tablet.
Ask your doctor or pharmacist if you
need additional information.

2

What you need to know
before you take Bolamyn SR
500 mg Prolonged Release
Tablets

Do not take Bolamyn SR Tablets:
• If you are allergic to metformin
hydrochloride or any of the other
ingredients of this medicine (listed in
section 6)
• If you have diabetic ketoacidosis (a
complication of diabetes which may
be associated with frequent urination,
feeling and being sick, abdominal
(stomach) pain, lethargy and
sleepiness) or diabetic pre-coma
(altered mental state due to an
imbalance in blood sugar)
• If you have kidney or liver problems
• If you are dehydrated
• If you are suffering from a severe
infection
• If you are going to have a certain type
of X-ray with an injectable dye – see
below under “Taking other medicines”.
• If you have recently suffered from
heart failure
• If you have recently had a heart attack
or have circulatory problems or
breathing difficulties
• If you are a heavy drinker (either every
day or only from time to time)
• If you are breast-feeding.
Warnings and Precautions
Talk to your doctor or pharmacist before
taking Bolamyn SR Tablets
Bolamyn SR treatment may rarely cause
a serious condition called lactic acidosis
which requires urgent hospital treatment
to prevent it leading to coma. Other

illnesses, prolonged fasting, poor blood
sugar control, or alcohol intake can all
increase the risk of lactic acidosis
developing. You should be aware of the
warning symptoms which include
muscle cramps, abdominal pain,
breathlessness and a feeling of being
very weak and unwell. If you develop
these symptoms you must tell your
doctor immediately.
• Your doctor should check that your
kidneys are working properly at least
once a year or more often if needed
• If you are going to have an
anaesthetic, X-ray or scan, tell your
doctor that you are taking Bolamyn
SR. It is advised to stop taking
Bolamyn SR for 48 hours before and
after the procedure
• Continue to follow any dietary advice
your doctor has given you and get
some regular exercise while you are
taking this medicine
• Be careful if you are taking Bolamyn
SR with insulin or other antidiabetic
medicines, as the combination may
increase the risk of hypoglycaemia
("hypos", excessively low sugar in
your blood)
• Children and adolescents should not
take Bolamyn SR.
Other medicines and Bolamyn SR
Tablets
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
• Bolamyn SR must not be used at the
same time as some injectable dyes
used for certain kinds of X-rays or
scans, because there is a risk of
kidney failure. If you are going to
undergo these procedures, you must
tell your doctor you are taking
Bolamyn SR. It is advised to stop
taking Bolamyn SR for 48 hours
before and after the procedure.
• Glucocorticoids (e.g. budesonide,
beclomethasone or hydrocortisone,
which are sometimes used to
suppress inflammation caused by
allergic reactions and in asthma),
beta-2-agonists (e.g. salbutamol,
which are mostly used in the
treatment of asthma) and diuretics
(water tablets which increase urine
production and may be used to treat
high blood pressure) can all increase
blood sugar levels. You should check
your blood sugar more often if you
are taking Bolamyn SR with any of
these medicines.
• ACE (Angiotensin Converting Enzyme)
inhibitors (e.g. quinapril, captopril,
which are used to treat heart
problems) can reduce blood sugar
levels. Tell your doctor if you start
treatment with an ACE inhibitor.
• Be careful and tell your doctor if you
start treatment for high blood
pressure or start to take a diuretic
(water tablets which increase urine
production) or NSAID (non-steroidal
anti-inflammatory drugs, e.g.
ibuprofen) as you may be at increased
risk for kidney problems.
Bolamyn SR Tablets with food and drink
• Bolamyn SR must be taken during or
after your evening meal. Taking your
tablets with food can reduce
unwanted side effects.
• You must avoid consuming alcohol
and using alcohol-containing
medicines whilst on Bolamyn SR, as
you could be at greater risk of
developing lactic acidosis, a serious
complication which can be recognised
by muscle cramps, abdominal pain,
breathlessness and a feeling of being
very weak and unwell.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or planning
to have a baby, ask your doctor or
pharmacist for advice before taking this
medicine.
• Tell your doctor if you are, think you
might be or are planning to become
pregnant. During pregnancy, diabetes
should be treated with insulin. If you
find out that you are pregnant while
taking Bolamyn SR, consult your
doctor so that he/she may change
your treatment.

05 December 2014

Top of page cut-off to middle of registration mark: 44 mm.

BOLAMYN SR 500 mg
PROLONGED RELEASE
TABLETS

1

TEVA UK Ref:

Version:

86463-W LEA METFORMIN 500 MG SR TAB TUK

• You must not take Bolamyn SR if you
are breast-feeding or if you are
planning to breast feed your baby.
• Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Taking Bolamyn SR does not affect your
ability to drive or use machines.
However, there is an increased risk of low
blood sugar Bolamyn SR is taken with
other medicine for diabetes
(sulphonylureas, insulin, repaglinide).
This may cause dizziness and fainting. Do
not drive or operate machines unless you
are sure that you are not affected.

3

How to take Bolamyn SR
500 mg Prolonged Release
Tablets

Always take this medicine exactly as your
doctor or pharmacist has told you. You
should check with your doctor or
pharmacist if you are not sure. The
tablets should be swallowed whole with
a drink of water during or after your
evening meal. You may see the shell of
the tablet in your bowel motions. This is
normal.
The recommended doses are explained
below.
Adults
For patients taking Bolamyn SR by itself
or combined with other oral antidiabetic
medicines:
The usual starting dose is one tablet once
a day. After 10 to 15 days, your doctor
will adjust the dose on the basis of blood
glucose measurements. Your doctor may
increase the dose up to a maximum of
2,000 mg of metformin hydrochloride per
day (four of these 500 mg Bolamyn SR in
one day).
For patients already taking Metformin
and switching to Bolamyn SR:
The usual starting dose of Bolamyn SR
should be equal to your daily dose of
metformin immediate-release tablets.
For patients taking Bolamyn SR
combined with insulin:
When taking Bolamyn SR with insulin,
the usual starting dose is one tablet once
a day, while insulin dosage is adjusted on
the basis of blood sugar measurements.
Older people:
The starting dose will be determined
after tests have been carried out on your
kidney function.
Use in children:
This medicine is not recommended for
children.
You should continue to take these tablets
for as long as your doctor tells you to.
If you take more Bolamyn SR than you
should
If you (or someone else) swallow a lot of
the tablets all together, or if you think a
child has swallowed any of the tablets,
contact your nearest hospital casualty
department or your doctor immediately.

department or your doctor immediately:
• If you have symptoms which include
muscle cramps, stomach pain,
breathlessness and a feeling of being
very weak and unwell: these
symptoms could indicate you have
lactic acidosis, a serious but very rare
(may affect up to 1 in 10,000 people)
side effect of metformin.
The following side effects have been
reported at the approximate frequencies
shown:
Very common (may affect more than 1 in
10 people):
• Nausea (feeling sick)
• Vomiting
• Diarrhoea
• Abdominal pain (stomach pain)
• Loss of appetite.
Common (may affect up to 1 in 10
people):
• Taste disturbances.
Very rare (may affect up to 1 in 10,000
people):
• Decrease in vitamin B12. Over time
this may lead to anaemia, a sore
mouth or tongue or possibly
numbness or tingling in the limbs.
• Redness and itching of the skin, hives
(nettle rash)
• There have also been isolated reports
of liver problems, including hepatitis
(jaundice: yellowing of the skin or
eyes).
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist or nurse. 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 Bolamyn SR
500 mg Prolonged Release
Tablets

Keep this medicine out of the sight and
reach of children. This medicinal product
does not require any special storage
conditions. Do not use this medicine
after the expiry date which is stated on
the blister and the carton after EXP. The
expiry date refers to the last day of that
month.
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 Bolamyn SR contain:
• The active substance is metformin
hydrochloride. One prolonged-release
tablet contains 500 mg metformin
If you forget to take Bolamyn SR
hydrochloride corresponding to
If you forget to take a tablet, take one as
390 mg of metformin.
soon as you remember, unless it is nearly
• The other ingredients are
time to take the next one. Do not take a
hypromellose (E454), ethylcellulose,
double dose to make up for a forgotten
cellulose microcrystalline and
tablet. Take the remaining doses at the
magnesium stearate.
correct time.
If you stop taking Bolamyn SR Tablets
If you stop treatment with Bolamyn SR
without medical advice, you have to be
aware of uncontrolled blood sugar
increase. Late symptoms of diabetes,
such as damage of the eyes, kidneys and
vessels, may occur.
If you see another doctor or go into
hospital, let him or the staff know what
medicines you are taking.
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.
If you experience any of the following,
contact your nearest hospital casualty

What Bolamyn SR look like and contents
of the pack:
• Bolamyn SR 500 mg Prolonged
release Tablets are white to off white,
oval shaped tablets, with “93” on one
side and “7267” on the other side
• The tablets are available in pack sizes
of 1, 20, 28, 30, 56, 60, 90 & 120
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
TEVA UK Ltd, Eastbourne, East Sussex,
BN22 9AG
This leaflet was last approved in July
2014
PL 00289/1013

86463-W

1

05 December 2014

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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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