General Information
Consumer Medicine Information
What is in
this leaflet
This leaflet answers some common
questions about Diaformin XR.
It does not
contain all 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 Diaformin XR
against the benefits expected 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 Diaformin XR is used for
Diaformin XR
is used to control blood glucose (sugar) in people
with Type 2 diabetes mellitus, especially in those
who are overweight. It is used when diet and
exercise are not enough to control high levels of
blood glucose.
Diaformin XR can be used
alone, or in combination with other medicines for
treating diabetes.
TYPE 2 DIABETES
MELLITUS
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 to 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 may
include:
tiredness or lack of
energy
headache
thirst
passing large
amounts of urine
blurred vision.
How
Diaformin XR works
Diaformin 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
Diaformin XR has been prescribed for you.
Diaformin XR is not recommended in children as
its safety and effectiveness have not been
established in this age group.
Diaformin XR
is available only with a doctor's prescription.
There is no evidence that Diaformin XR is
addictive.
After the active ingredient
metformin is absorbed into your body, you may see
the empty tablet shell in your faeces (bowel
motions). This is normal and does not affect the
way Diaformin XR works.
Before you take
Diaformin XR
When you must not take it
Do
not take Diaformin XR if you are allergic to:
medicines containing metformin or any other
biguanide
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an
allergic reaction may include skin rash, itching
or hives; swelling of the face, lips or tongue
which may cause difficulty in swallowing or
breathing, wheezing or shortness of breath.
Do not take Diaformin 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
well controlled by diet alone
serious
complications with your diabetes or diabetic
ketoacidosis (a symptom of uncontrolled diabetes,
in which substances called ketone bodies
accumulate in the blood - you may notice this as
an unusual fruity odour on your breath)
kidney
failure or severe kidney
disease
dehydration(for instance due to
persistent or severe vomiting or diarrhoea)
shock from severe injury or blood
loss
severe liver disease
acute alcohol
intoxication, chronic alcohol
dependence
certain heart or blood circulation
problems, including a recent heart attack or heart
failure (when the heart fails to pump blood
effectively)
blood clots in the lungs (symptoms
include coughing, shortness of breath, chest pain
and a fast heart rate), severe breathing
difficulties
inflammation of the pancreas
(symptoms include severe upper stomach pain, often
with nausea and vomiting) if associated with
severe infection or hypoxia (lack of oxygen)
a
severe infection or gangrene.
Do not take
Diaformin XR if you need to have major surgery or
an examination such as an X-ray or a scan
requiring an injection of iodinated contrast
(dye). You must stop taking Diaformin XR for a
certain period of time before and after the
examination or the surgery. Your doctor will
decide whether you need any other treatment for
this time. It is important that you follow your
doctor's instructions precisely.
Do not
take this medicine if you are pregnant or plan to
become pregnant. Insulin is more suitable for
controlling blood glucose during pregnancy. Your
doctor will replace Diaformin XR with insulin
while you are pregnant.
Do not take
Diaformin XR if you are breastfeeding. Your doctor
will discuss the options available to you.
Do not take this medicine after the expiry
date printed on the pack or if the packaging is
torn or shows signs of tampering. If it has
expired or is damaged, return it to your
pharmacist for disposal.
If you are not
sure whether you should start taking Diaformin XR,
ask your doctor.
Before you start to take
it
Tell your doctor if you have allergies to
any other medicines, foods, dyes or preservatives.
Before starting Diaformin XR your doctor
will ask you to have a blood test to check your
kidney function.
Tell your doctor if you
have or have had any of the following medical
conditions:
kidney problems
liver
problems
heart or blood vessel problems
including heart failure.
Tell your doctor if
you drink alcohol. Alcohol can affect the control
of your diabetes. Drinking excessive amounts of
alcohol while you are being treated with Diaformin
XR may also lead to serious side effects. Your
doctor may suggest you stop drinking or reduce the
amount of alcohol you drink.
If you have
not told your doctor about any of the above, tell
him/her before you start taking Diaformin XR.
Taking other medicines
Tell your doctor or
pharmacist if you are taking any other medicines,
including any that you get without a prescription
from a pharmacy, supermarket or health food shop.
Some medicines and Diaformin XR may
interfere with each other. These include:
other medicines used to treat
diabetes
iodinated contrast agents (dyes)
medicines that contain alcohol, such as cough
and cold syrups
corticosteroids such as
prednisone or cortisone
tetracosactrin, a
medicine used in people with multiple sclerosis,
and in young children to treat some types of
seizures (fits)
danazol, a medicine used to
treat endometriosis
medicines used to treat
high blood pressure and some heart conditions,
such as beta-blockers, calcium channel blockers or
ACE inhibitors
some medicines used to treat
asthma such as salbutamol or
terbutaline
diuretics, also called fluid
tablets
chlorpromazine, a medicine used to
treat schizophrenia and other mental
illnesses
NSAIDs (non-steroidal anti-
inflammatory drugs), medicines used to relieve
pain, swelling and other symptoms of inflammation,
such as aspirin, diclofenac, ibuprofen, meloxicam,
naproxen or piroxicam
cimetidine, used to treat
ulcers and reflux
medicines used to prevent
blood clots such as warfarin.
These medicines
may be affected by Diaformin XR or may affect how
well it works. You may need different amounts of
your medicines, or you may need to take different
medicines.
Your doctor and pharmacist also
have more information on medicines to be careful
with or avoid while taking Diaformin XR.
How to take Diaformin XR
Follow all
directions given to you by your doctor and
pharmacist carefully. They may differ from the
information contained in this leaflet.
If
you do not understand the instructions on the
pack, ask your doctor or pharmacist.
How
much to take
The dose varies from patient to
patient. Your doctor will decide the right dose
for you.
The usual starting dose is 1
tablet (500 mg) once daily with the evening meal.
Your doctor may increase the dose slowly,
depending on your blood glucose levels.
The
maximum recommended dose is 4 tablets (2 grams)
once per day.
Elderly patients and people
with kidney problems may need smaller doses.
How to take it
Swallow the tablets whole
with a glass of water.
Do not break, crush
or chew the tablets. If you break, crush or chew
Diaformin XR, they will not work as well.
Diaformin XR are extended release tablets. This
means they have a special coating which allows the
active ingredient, metformin, to be released
slowly over time.
When to take it
Take
your medicine everyday with the evening meal.
Taking Diaformin XR during or with your evening
meal will reduce the chance of a stomach upset.
Taking it at the same time each day will
have the best effect. It will also help you
remember when to take it.
How long to take
it for
Keep taking Diaformin XR for as long as
your doctor recommends. Diaformin XR will help
control diabetes but will not cure it. Most people
will need to take Diaformin XR for long periods of
time.
When you start treatment with
Diaformin XR, it can take up to some weeks for
your blood glucose levels to be properly
controlled.
If you forget to take it
If
it is almost time for your next dose, skip the
dose you missed and take your next dose when you
are meant to.
Otherwise, take it as soon as
you remember, and then go back to taking your
medicine as you would normally.
Do not take
a double dose to make up for the dose you missed.
If you are not sure what to do, ask your
doctor or pharmacist.
If you take too much
(overdose)
Immediately telephone your doctor or
the Poisons Information Centre (telephone 13 11
26) for advice, or go to Accident and Emergency at
the nearest hospital, if you think you or anyone
else may have taken too much Diaformin XR. Do this
even if there are no signs of discomfort or
poisoning.
If you take too much Diaformin
XR, you may feel very tired, sick, vomit, have
trouble breathing and have unusual muscle pain,
stomach pain or diarrhoea. These may be early
signs of a serious condition called lactic
acidosis (build up 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 Diaformin 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 Diaformin XR
Things
you must do
If you are about to be started on
any new medicine, remind your doctor and
pharmacist that you are taking Diaformin XR.
Tell all the other doctors, dentists and
pharmacists who treat you that you are taking this
medicine.
If you become pregnant while
taking this medicine, tell your doctor
immediately.
HYPOGLYCAEMIA
Diaformin XR
does not normally cause hypoglycaemia (low blood
sugar), although you may experience it while
taking other medicines for diabetes such as
insulin or sulfonylureas.
Make sure that
you, your friends, family and work colleagues can
recognise the symptoms of hypoglycaemia (low blood
sugar) and know how to treat them.
Hypoglycaemia can occur suddenly. Initial
signs may include:
weakness, trembling or
shaking
sweating
lightheadedness, dizziness,
headache or lack of concentration
irritability,
tearfulness or crying
hunger
numbness around
the lips and tongue.
If not treated promptly,
these 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 signs 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 Diaformin XR than prescribed
taking
certain other medicines
too little
exercise
eating more carbohydrates than normal.
Tell your doctor if any of the following
happen:
you become ill
you become
dehydrated (for instance due to persistent or
severe diarrhoea or recurrent vomiting)
you are
injured
you have a fever
you have a serious
infection such an influenza, respiratory tract
infection or urinary tract infection
you are
having major surgery
you are having an
examination such as an X-ray or a scan requiring
an injection of an iodinated contrast agent (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 Diaformin XR with insulin.
Visit
your doctor regularly for check ups. Your doctor
may want to check your kidneys, liver, heart and
vitamin B12 levels while you are taking Diaformin
XR.
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 the advice of
your doctor and dietician on diet, drinking
alcohol and exercise.
Things you must not
do
Do not use Diaformin XR to treat any other
complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even
if they have the same condition as you.
Do
not skip meals while taking Diaformin XR.
Do not stop taking your medicine or change the
dosage without checking with your doctor.
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, Diaformin XR by itself is unlikely
to affect how you drive or operate machinery.
Side effects
Tell your doctor or pharmacist
as soon as possible if you do not feel well while
you are taking Diaformin XR. Diaformin 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.
Do not be alarmed by the following
lists of side effects. You may not experience any
of them.
Tell your doctor if you notice any
of the following and they worry you:
feeling sick (nausea)
vomiting
diarrhoea
stomach pain
taste
disturbance
loss of appetite
skin reactions
such as redness of the skin, itching or an itchy
rash (urticaria).
These are generally mild side
effects which disappear after the first few weeks.
Taking Diaformin XR with meals can help reduce
nausea and diarrhoea.
Tell your doctor as
soon as possible if you notice any of the
following:
symptoms of liver disease such
as nausea, vomiting, loss of appetite, feeling
generally unwell, fever, yellowing of the skin and
eyes and dark coloured urine
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 (BUILD UP OF
LACTIC ACID IN THE BLOOD):
nausea,
vomiting, stomach pain
trouble
breathing
feeling weak, tired or generally
unwell
unusual muscle
pain
sleepiness
dizziness or
lightheadedness
shivering, feeling extremely
cold
slow heart beat.
LACTIC ACIDOSIS A VERY
RARE BUT SERIOUS SIDE EFFECT REQUIRING URGENT
MEDICAL ATTENTION OR HOSPITALISATION. ALTHOUGH
RARE, IF LACTIC ACIDOSIS DOES OCCUR, IT CAN BE
FATAL. THE RISK OF LACTIC ACIDOSIS IS HIGHER IN
THE ELDERLY, THOSE WHOSE DIABETES IS POORLY
CONTROLLED, THOSE WITH PROLONGED FASTING, THOSE
WITH CERTAIN HEART CONDITIONS, THOSE WHO DRINK
ALCOHOL AND THOSE WITH KIDNEY OR LIVER PROBLEMS.
Tell your doctor or pharmacist if you
notice anything that is making you feel unwell.
Other side effects not listed above may
also occur in some people. Some side effects (e.g.
reduced vitamin B12 level) can only be found when
your doctor does tests from time to time to check
your progress.
After using Diaformin
XR
Storage
Keep your tablets in the blister
pack until it is time to take them. If you take
the tablets out of the blister pack they may not
keep well.
Keep your tablets in a cool, dry
place where the temperature stays below 25 degrees
C.
Do not store Diaformin XR or any other
medicine in the bathroom or near a sink. Do not
leave it in the car or on a window sill. Heat and
dampness can destroy some medicines.
Keep
Diaformin 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.
Disposal
If your doctor tells
you to stop taking this medicine or the expiry
date has passed, ask your pharmacist what to do
with any medicine that is left over.
Product description
What it looks
like
Diaformin XR is a white to off-white,
capsule-shaped tablet, marked "500" on one side.
It is available in blister packs of 90 and 120
tablets.
Ingredients
The active
ingredient in Diaformin XR is metformin
hydrochloride.
Each extended release tablet
contains 500 mg of metformin hydrochloride.
The tablets also contain the following
inactive ingredients:
croscarmellose
sodium
hypromellose
microcrystalline
cellulose
magnesium stearate.
The tablets do
not contain sucrose, lactose, gluten, tartrazine
or any other azo dyes.
Supplier
Diaformin XR is supplied in
Australia by:
Alphapharm Pty Limited
(ABN 93
002 359 739)
Chase Building 2
Wentworth Park
Road
Glebe NSW 2037
Phone: (02) 9298
3999
Medical Information
Phone: 1800 028
365
www.alphapharm.com.au
Australian
registration numbers:
Diaformin XR - AUST R
120868
This leaflet was prepared on
5
May 2009.
* Registered trade mark of
Alphapharm Pty Limited.