General Information
Metex XR
contains the active ingredient
metformin hydrochloride
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Consumer Medicine Information
What is in this leaflet
This leaflet
answers some common questions about METEX XR.
It does not contain all of the available
information. It does not take the place of talking
to your doctor, pharmacist or diabetes educator.
All medicines have benefits and risks.
Your doctor has weighed the risks of you taking
METEX XR against the benefits they expect it will
have for you.
If you have any concerns
about taking this medicine, talk to your doctor,
pharmacist or diabetes educator.
Keep this
leaflet with your medicine. You may need to read
it again.
What METEX XR is used
for
METEX XR is used to control blood glucose
in patients with Type 2 diabetes mellitus,
especially in those who are overweight. It is used
when diet and exercise are not enough to control
your blood glucose levels.
METEX XR can be
used alone, or in combination with other medicines
for treating diabetes.
Type 2 diabetes
mellitus is also called non-insulin dependent
diabetes mellitus (NIDDM) or maturity onset
diabetes.
Insulin is a hormone that enables
body tissues to take up glucose from the blood and
use it for energy or fat storage for future use.
People with type 2 diabetes are unable to
make enough insulin or their body does not respond
properly to the insulin it does make. This causes
a build up of glucose in the blood
(hyperglycaemia), which can lead to serious
medical problems.
Long term hyperglycaemia
can lead to heart disease, blindness, kidney
damage, poor blood circulation and gangrene.
Signs of hyperglycaemia include:
tiredness or lack of
energy
headache
thirst
passing large
amounts of urine
blurred vision.
METEX XR is
available only with a doctor's prescription.
There is no evidence that METEX XR is
addictive.
How METEX XR works
METEX XR
belongs to a group of medicines called biguanides.
It lowers high blood glucose levels by:
improving your body’s sensitivity to
insulin
and restoring the way it normally uses
glucose
reducing the amount of glucose your
liver makes
delaying the amount of glucose your
intestine absorbs.
Ask your doctor if you have
any questions about why METEX XR has been
prescribed for you.
Before you take METEX
XR
When you must not take it
Do not take
METEX XR if you are allergic to:
medicines
containing metformin or any other biguanide
any
of the ingredients listed at the end of this
leaflet.
Symptoms of an allergic reaction may
include shortness of breath, wheezing or
difficulty breathing; swelling of the face, lips,
tongue or other parts of the body; rash, itching
or hives on the skin.
Do not take METEX XR
if you have any of the following medical
conditions:
type 1 diabetes mellitus that
is well controlled by insulin alone
type 2
diabetes that is already controlled by diet
alone
diabetic ketoacidosis
kidney
disease
severe liver disease
certain heart
or blood vessel problems, including a recent heart
attack or severe heart failure
excessive
alcohol intake, binge drinking, alcohol
dependence
dehydration, severe blood loss,
shock
severe infection
certain heart or
blood circulation problems, including a recent
heart attack or heart failure
gangrene
blood
clots in the lungs, severe breathing
difficulties
inflammation of the pancreas.
If you are not sure whether you should start
taking METEX XR, ask your doctor.
Do not
take METEX XR if you are pregnant or plan to
become pregnant. Insulin is more suitable for
controlling blood glucose during pregnancy. Your
doctor will replace METEX XR with insulin while
you are pregnant.
Do not take METEX XR if
you are breastfeeding. Your doctor will discuss
the options available to you.
Do not take
METEX XR if the expiry date (Exp.) printed on the
pack has passed.
Do not take METEX XR if
the packaging shows signs of tampering or the
tablets do not look quite right.
Before you
start to take it
Tell your doctor if you are
allergic to any other medicines, foods, dyes or
preservatives.
Before starting METEX XR
your doctor will ask you to have a blood test to
check your kidney function.
Tell your
doctor if you drink alcohol in any amount. Alcohol
can affect the control of your diabetes. Drinking
excessive amounts of alcohol while you are being
treated with METEX XR may also lead to serious
side effects. Discuss this with your doctor.
Your doctor may suggest that you stop drinking
or reduce the amount of alcohol you drink.
If you have not told your doctor about any of
the above, tell them before you start taking METEX
XR.
Taking other medicines
Tell your
doctor if you are taking any other medicines,
including those you buy without a prescription
from a pharmacy, supermarket or health food shop.
Some medicines may be affected by METEX XR
or may affect how well it works. These include:
other medicines used to treat
diabetes
medicines used to treat high blood
pressure and some heart conditions
medicines
used to prevent blood clots such as
warfarin
diuretics, also called fluid
tablets
thyroid preparations such as
thyroxine
corticosteroids such as prednisone,
cortisone
medicines that contain alcohol, such
as cough and cold syrups
medicines used to
treat asthma such as salbutamol and
terbutaline
NSAIDs, medicines used to relieve
pain, swelling and other symptoms of inflammation,
including arthritis such as aspirin, diclofenac,
ibuprofen, meloxicam, naproxen and
piroxicam
medicines used to treat ulcers and
reflux, such as cimetidine.
Your doctor or
pharmacist can tell you what to do if you are
taking any of these medicines. They also have more
information on medicines to be careful with or
avoid while taking METEX XR.
If you are not
sure whether you are taking any of these
medicines, check with your doctor or pharmacist.
How to take METEX XR
Follow all
directions given to you by your doctor and
pharmacist carefully. They may differ from the
information contained in this leaflet.
How
much to take
The dose varies from patient to
patient. Your doctor will decide the right dose
for you.
The usual starting dose for adults
is 500 mg (one tablet) with the evening meal. Your
doctor may increase the dose, depending on your
blood glucose levels.
The maximum
recommended dose is 2 g (4 tablets) once a day.
The elderly and people with kidney
problems may need smaller doses.
How to
take METEX XR
Swallow the tablets with a glass
of water.
Do not break, crush or chew the
tablets. If you break, chew or crush the tablets,
they will not work as well.
Take METEX XR
with your evening meal. This will lessen the
chance of a stomach upset. Taking it at the same
time each day will also have the best effect.
How long to take METEX XR for
Keep taking
METEX XR for as long as your doctor recommends.
METEX XR will help control diabetes but will not
cure it. Most people will need to take METEX XR
for long periods of time.
When you first
start treatment with METEX XR it may take some
weeks before your blood glucose levels are
properly controlled.
If you forget to take
METEX XR
Do not take a double dose to make up
for the dose you missed.
Take the next dose
at the usual time.
If you are not sure what
to do, ask your doctor or pharmacist.
If
you take too much METEX XR (overdose)
Immediately telephone your doctor, or the
Poisons Information Centre (telephone 13 11 26),
or go to Accident and Emergency at the nearest
hospital, if you think you or anyone else may have
taken too much METEX XR. Do this even if there are
no signs of discomfort or poisoning.
If you
take too much METEX XR, you may feel sick, vomit,
have trouble breathing and have unusual muscle
pain, stomach pain or diarrhoea. These may be
early symptoms of a serious condition called
lactic acidosis (high level of lactic acid in the
blood).
You may also experience symptoms of
hypoglycaemia (low blood glucose). This usually
only happens if you take too much METEX XR
together with other medicines for diabetes or with
alcohol.
If you do experience any signs of
hypoglycaemia, raise your blood glucose quickly by
eating jelly beans, sugar or honey, drinking non-
diet soft drink or taking glucose tablets.
While you are taking METEX XR
Things you
must do
Before starting any new medicine, tell
your doctor or pharmacist that you are taking
METEX XR.
Tell all the doctors, dentists
and pharmacists who are treating you that you are
taking METEX XR.
If you become pregnant
while taking METEX XR, tell your doctor.
Tell your doctor if you plan to have surgery
that requires general anaesthesia. You doctor will
tell you when to temporarily stop METEX XR and
when to restart them.
Tell your doctor if
you plan to have any X-ray procedures that require
an injection of iodinated contrast (dye). Using
this type of contrast while you are taking METEX
XR can cause serious kidney problems and increase
the risk of lactic acidosis.
Make sure that
you, your friends, family and work colleagues can
recognise the symptoms of hypoglycaemia (low blood
sugar) and hyperglycaemia (high blood sugar), and
know how to treat them.
Hypoglycaemia
METEX XR does not normally cause hypoglycaemia
although you may experience if you are also taking
other medicines for diabetes such as insulin or
sulfonylureas.
Hypoglycaemia can occur
suddenly. Symptoms may include:
weakness,
trembling or shaking
sweating
light-
headedness, dizziness, headache or lack of
concentration
irritability, tearfulness or
crying
hunger
numbness around the lips and
tongue.
If not treated promptly, these symptoms
may progress to:
loss of co-
ordination
slurred speech
confusion
fits
or loss of consciousness.
If you experience any
of the symptoms of hypoglycaemia, you need to
raise your blood glucose immediately. You can do
this by doing one of the following:
eating
5 to 7 jelly beans
eating 3 teaspoons of sugar
or honey
drinking half a can of non-diet soft
drink
taking 2 to 3 concentrated glucose
tablets.
Unless you are within 10 to 15 minutes
of your next meal or snack, follow up with extra
carbohydrates such as plain biscuits, fruit or
milk. Taking this extra carbohydrate will prevent
a second drop in your blood glucose level.
Hyperglycaemia
If you experience any of the
symptoms of hyperglycaemia (high blood sugar),
contact your doctor immediately.
The risk
of hyperglycaemia is increased in the following
situations:
uncontrolled
diabetes
illness, infection or stress
taking
less METEX XR than prescribed
taking certain
other medicines
too little exercise
eating
more carbohydrates than normal.
Tell your
doctor if you:
become ill
become
dehydrated
are injured
have a
fever
become pregnant
have a serious
infection
having surgery (including dental
surgery)
having X-ray procedures that require
injection of iodinated contrast agents (dye).
Your blood glucose may become difficult to
control at these times. You may also be more at
risk of developing a serious condition called
lactic acidosis. At these times, your doctor may
replace METEX XR with insulin.
Visit your
doctor regularly for check ups. Your doctor may
want to check your kidneys, liver, heart and blood
while you are taking METEX XR.
Make sure
you check your blood glucose levels regularly.
This is the best way to tell if your diabetes is
being controlled properly. Your doctor or diabetes
educator will show you how and when to do this.
Carefully follow your doctor's and
dietician’s advice on diet, drinking
alcohol and
exercise.
Things you must not do
Do not
skip meals while taking METEX XR.
Do not
stop taking METEX XR or change the dose without
checking with your doctor.
Do not give
METEX XR to anyone else, even if they have the
same condition as you.
Things to be careful
of
If you have to be alert, for example when
driving, be especially careful not to let your
blood glucose levels fall too low. Low blood
glucose levels may slow your reaction time and
affect your ability to drive or operate machinery.
Drinking alcohol can make this worse. However,
METEX XR by itself is unlikely to affect how you
drive or operate machinery.
If you become
sick with a cold, fever or flu, it is very
important to continue eating your normal meals.
Your diabetes educator or dietician can give you a
list of foods to eat on sick days.
Side
effects
Tell your doctor or pharmacist as soon
as possible if you do not feel well while you are
taking METEX XR. METEX XR helps most people with
diabetes but it may have unwanted side effects in
some people.
All medicines can have side
effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment
if you get some of the side effects.
If you
are over 65 years of age, you may have an
increased chance of getting side effects. Report
any side effects to your doctor promptly.
Ask your doctor or pharmacist to answer any
questions you may have.
Do not be alarmed
by this list of possible side effects. You may not
experience any of them.
Tell your doctor if
you notice any of the following and they worry
you:
stomach upset such as feeling sick
(nausea), vomiting
diarrhoea
stomach
pain
skin rash, itching, hives
taste
disturbance, loss of appetite.
These are
generally mild side effects which usually occur
during the first few weeks. Taking METEX XR with
meals can help reduce nausea and diarrhoea. Skin
rash is rare and should go away in a few days.
TELL YOUR DOCTOR IMMEDIATELY OR GO TO ACCIDENT
AND EMERGENCY AT THE NEAREST HOSPITAL IF YOU
NOTICE ANY OF THE FOLLOWING SYMPTOMS OF LACTIC
ACIDOSIS (HIGH LACTIC ACID IN THE BLOOD):
nausea, vomiting, stomach pain
trouble
breathing
feeling weak, tired or generally
unwell
unusual muscle
pain
sleepiness
dizziness or light-
headedness
shivering, feeling extremely
cold
slow heart beat.
LACTIC ACIDOSIS IS A
VERY RARE, BUT SERIOUS SIDE EFFECT OF METEX XR
THAT REQUIRES URGENT MEDICAL ATTENTION OR
HOSPITALISATION. IF LACTIC ACIDOSIS DOES OCCUR, IT
CAN BE FATAL.
The risk of lactic acidosis
is higher in some patients including:
the
elderly
those drinking excessive amounts of
alcohol
those whose kidneys or liver are not
working properly
those whose diabetes is poorly
controlled
those with certain heart
conditions
those with prolonged fasting.
Other side effects not listed above may also
occur in some people. Tell your doctor if you
notice anything that is making you feel unwell. It
is very important that you speak to your doctor
immediately if a side effect is sever, occurred
suddenly or gets rapidly worse.
After
taking METEX XR
Storage
Keep METEX XR where
children cannot reach it. A locked cupboard at
least one-and-a-half metres above the ground is a
good place to store medicines.
Keep your
tablets in a cool dry place where the temperature
stays below 25 deg C.
Do not store METEX XR
or any other medicine in the bathroom or near a
sink.
Do not leave METEX XR in the car or
on window sills. Heat and dampness can destroy
some medicines.
Disposal
If your doctor
tells you to stop taking METEX XR, or your tablets
have passed their expiry date, ask your pharmacist
what to do with any that are left over.
Product description
What it looks
like
METEX XR is a white capsule shaped tablet,
marked XR5 on one side and ‘>’ on the
other.
Blister packs contain 90 tablets.
Bottles contain 90 tablets or 300 tablets.
Ingredients
The active ingredient in METEX
XR is metformin hydrochloride. Each tablet
contains 500 mg of metformin hydrochloride.
The tablets also contain:
carmellose
sodium
hypromellose
colloidal anhydrous
silica
microcrystalline cellulose
magnesium
stearate.
The tablets do not contain lactose,
gluten, sucrose, tartrazine or any other azo dyes.
Supplier
Sigma Pharmaceuticals
(Australia) Pty Ltd
(A.C.N. 004 118 594)
96
Merrindale Dve
Croydon Victoria
3136
Australia
Telephone: 03 -
9839 2800 03 - 9839 2800
Australian
registration number
AUST R 143465
Date
of preparation:
June 2007.
Published by
MIMS/myDr March 2009
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