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BOLAMYN SR 500 MG PROLONGED RELEASE TABLETS (METFORMIN HYDROCHLORIDE)

Active substance(s): METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE

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TEVA UK Ref:

86463-X LEA METFORMIN (Bolamyn) 500mg SR TAB TUK

Bolamyn SR 500 mg
Prolonged Release Tablets
Package leaflet: Information
for the patient
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,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet,
See section 4.

Risk of lactic acidosis
Bolamyn 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.
• 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.

What is in this leaflet

Pharma code 3313

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

Metformin, the 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 is 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 severely reduced kidney function.
• If you have liver problems
• If you 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.
• 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.

Stop taking Bolamyn 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 Bolamyn 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 Bolamyn SR during and for some
time after the procedure. Your doctor will
decide when you must stop and when to
restart your treatment with Bolamyn SR.
During treatment with Bolamyn 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.
• 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
Children and adolescents should not take
Bolamyn SR.
Other medicines and Bolamyn SR Tablets
If you need to have an injection of a contrast
medium that contains iodine into your
bloodstream, for example in the context of an
X-ray or scan, you must stop taking Bolamyn
SR before or at the time of the injection. Your
doctor will decide when you must stop and
when to restart your treatment with Bolamyn SR.






Tell your doctor 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
Bolamyn SR. It is especially important to
mention the following:
medicines which increase urine production
(diuretics)
medicines used to treat pain and
inflammation (NSAID and COX-2-inhibitors,
such as ibuprofen and celecoxib)
certain medicines for the treatment of high
blood pressure (ACE inhibitors and
angiotensin II receptor antagonists)
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.

Bolamyn SR Tablets with alcohol
• Bolamyn SR must be taken during or after
your evening meal. Taking your tablets with
food can reduce unwanted side effects.

1

25 January 2017

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

Metformin hydrochloride

Version:

TEVA UK Ref:

86463-X LEA METFORMIN (Bolamyn) 500mg SR TAB TUK

• Avoid excessive alcohol intake while taking
Bolamyn SR since this may increase the risk
of lactic acidosis (see section “Warnings and
precautions”).
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.

4

Version:

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

• 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.
• 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.

The following is very serious and if you
experience it you should seek urgent medical
attention:
Very rare: may affect up to 1 in 10,000 people
• Bolamyn SR may cause a very rare, but very
serious side effect called lactic acidosis (see
section “Warnings and precautions”). If this
happens you must stop taking Bolamyn SR
and contact a doctor or the nearest hospital
immediately, as lactic acidosis may lead to
coma.
• Abnormalities in liver function tests or
hepatitis (inflammation of the liver; this may
cause tiredness, loss of appetite, weight loss,
with or without yellowing of the skin or whites
of the eyes).

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.

Very common: may affect more than 1 in 10
people
• Nausea (feeling sick)
• Vomiting
• Diarrhoea
• Abdominal pain (stomach pain)
• Loss of appetite

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 recommended 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 tablets in one day).
For patients already taking metformin and
switching to Bolamyn SR:
The recommended 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
recommended starting dose is one tablet once a
day, while insulin dosage is adjusted on the basis
of blood sugar measurements.
For patients with reduced kidney function:
If you have reduced kidney function, your doctor
may prescribe a lower dose.
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.
If you forget to take Bolamyn SR
If you forget to take a tablet, take one as soon as
you remember, unless it is nearly time to take the
next one. Do not take a double dose to make up
for a forgotten tablet. Take the remaining doses
at the 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.

The following other side effects have been
reported at the approximate frequencies shown:

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)
Reporting of side effects
If you get any side effects, talk to your doctor,
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 hydrochloride
corresponding to 390 mg of metformin.
• The other ingredients are hypromellose
(E454), ethylcellulose, cellulose
microcrystalline and magnesium stearate.
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 revised in 01/2017.
PL 00289/1013

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.
323 x 130
86463-X

1

25 January 2017

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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