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METUXTAN SR 500 MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Metformin

Market

UK

Language

English

Size

170 x 550 mm PIL

Min. Font Size

9

Version No.

2 (Page 1 of 2)

Date

03/05/17 (Metformin (ACC-UK) PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Package leaflet: Information for the patient

Metuxtan SR 500 mg
prolonged release tablets

Approved By
Quality Assurance

Stop taking Metuxtan 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.

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 Metuxtan SR is and what it is used for
2. What you need to know before you take
Metuxtan SR
3. How to take Metuxtan SR
4. Possible side effects
5. How to store Metuxtan SR
6. Contents of the pack and other information

1. What Metuxtan SR is and
what it is used for
Metuxtan SR 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.
Metuxtan SR prolonged release tablet 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.
Metuxtan 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 to 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 long-term problems
so it is important that you continue to take your
medicine, even though you may not have any
obvious symptoms. Metuxtan SR makes the body
more sensitive to insulin and helps return to
normal the way your body uses glucose.
Metuxtan SR is associated with either a stable
body weight or modest weight loss.
Metuxtan 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 Metuxtan SR
Do not take Metuxtan SR if:
• you are allergic to metformin hydrochloride or to
any of the other ingredients of this medicine
(listed in section 6). An allergic reaction may
cause a rash, itching or shortness of breath.
• 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.
• you 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 'Warnings and precautions').
• you have liver problems.
• you have severely reduced kidney function.
• you 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 'Warnings and precautions).
• you 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 'Warnings and precautions).
• you are a heavy drinker of alcohol.
• you are under 18 years of age.
Warnings and precautions
Risk of lactic acidosis.
Metuxtan 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.

(675660) Date: 15-05-17, R-16_11_17

Stop taking Metuxtan 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 Metuxtan SR during and for some time
after the procedure. Your doctor will decide when
you must stop and when to restart your treatment
with Metuxtan SR.
During treatment with Metuxtan 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
Metuxtan SR prolonged release tablet 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 Metuxtan SR
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 < Metuxtan
SR before or at the time of injection. Your doctor
will decide when you must stop and when to
restart your treatment with Metuxtan 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 Metuxtan SR. It is especially
important to mention the following:
• Steroids such as prednisolone, mometasone,
beclometasone.
• Medicines which increase urine production
(diuretics (water tablets) such as furosemide).
• 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)
• Sympathomimetic medicines including
epinephrine and dopamine used to treat heart
attacks and low blood pressure. Epinephrine is
also included in some dental anaesthetics.
• Medicines that may change the amount of
Metuxtan SR in your blood, especially if you
have reduced kidney function (such as
verapamil, rifampicin, cimetidine, dolutegravir,
ranolazine, trimethoprim, vandetanib,
isavuconazole, crizotinib, olaparib).
Metuxtan SR with alcohol
Avoid excessive alcohol intake while taking
Metuxtan SR since this may increase the risk of
lactic acidosis (see section “Warnings and
precautions”).
Pregnancy and breast-feeding
Do not take Metuxtan SR if you are pregnant or
breast feeding, 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
Metuxtan 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 Metuxtan
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 Metuxtan SR
Your doctor may prescribe Metuxtan SR for you
to take on its own, or in combination with other
oral antidiabetic medicines or insulin.
Always take Metuxtan SR exactly as your doctor
has told you.
You should check with your doctor or pharmacist
if you are not sure. Swallow the tablets whole
with a glass of water, do not chew.
Recommended dose
Usually you will start treatment with 500
milligrams Metuxtan SR daily. After you have
been taking Metuxtan SR for about 2 weeks, your
doctor may measure your blood sugar and adjust
the dose. The maximum daily dose is 2000
milligrams of Metuxtan 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.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Metformin

Market

UK

Language

English

Size

170 x 550 mm PIL

Min. Font Size

9

Version No.

2 (Page 2 of 2)

Date

03/05/17 (Metformin (ACC-UK) PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

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 Metuxtan 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 heart beat. If you
experience some of these symptoms, you should
immediately seek medical attention, as lactic
acidosis may lead to coma. Stop taking Metuxtan
SR immediately and contact a doctor or the
nearest hospital straightaway.
If you forget to take Metuxtan SR
Take it as soon as you remember with some
food. Do not take a double dose to make up for a
forgotten dose.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. The
following side effects may occur:
Metuxtan SR may cause a very rare (may affect
up to 1 user in 10,000), but very serious side
effect called lactic acidosis (see section
“Warnings and precautions”). If this happens you
must stop taking Metuxtan SR and contact a
doctor or the nearest hospital immediately, as
lactic acidosis may lead to coma.
Metuxtan 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 (affects more than 1 person in 10):
• 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 (affects less than 1 person in 10, but
more than 1 person in 100):
• Taste disturbance
Very rare (affects less than 1 person in 10,000):
• Decreased vitamin B12 levels
• Skin rashes including redness, itching and
hives.
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 Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in the Google Play or
Apple App Store. By reporting side effects you
can help provide more information on the safety
of this medicine.

5. How to store Metuxtan SR
Keep this medicine out of the sight and reach of
children.
This medicine does not require any special
storage conditions.
Do not use this medicine after the expiry date
which is stated on the label and 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 to protect the environment.

6. Contents of the pack and
other information
What Metuxtan SR contains
Each prolonged release tablet contains 500 mg
of the active ingredient metformin hydrochloride.
The other ingredients are cellulose
microcrystalline, hypromellose K 100M, silica
colloidal anhydrous and magnesium stearate.
What Metuxtan SR looks like and contents of
the pack
Metuxtan SR 500 mg are white to off-white,
biconvex, capsule shaped, uncoated tablets,
approximately 19.2mm × 9.3mm, debossed with
‘FN1’ on one side and plain on other side.
Metuxtan SR is supplied in Alu-PVC/PVdC or
OPA/Alu/PVC-Alu blister packs of 28, 30, 50, 56,
60, 90 and 100 prolonged release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Accord Healthcare Limited
Sage house, 319 Pinner road,
North Harrow, Middlesex, HA1 4HF
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage house, 319 Pinner road,
North Harrow, Middlesex, HA1 4HF
United Kingdom
This leaflet was last revised in: 11/2017.

INP001
10 2094 0 675660

(675660) Date: 15-05-17, R-16_11_17

+ 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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