Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Diabex 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
Diabex 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 Diabex XR is used for
Diabex 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.
Diabex 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
passing large amounts of urine
How Diabex XR works
Diabex 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
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 Diabex XR has been prescribed
Diabex XR is not recommended in children as its safety and effectiveness have not
been established in this age group.
Diabex XR is available only with a doctor's prescription.
There is no evidence that Diabex XR is addictive.
This medicine has been prescribed for you personally and you should not pass it onto
others even if their symptoms are the same as yours.
Before you take Diabex XR
When you must not take it
Do not take Diabex XR if you are allergic to:
medicines containing metformin (such as Diaformin, Glucophage) 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 Diabex 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 any type of metabolic acidosis such as
lactic acidosis, 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 Diabex 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 Diabex 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 Diabex XR with insulin while you are pregnant.
Do not take Diabex XR if you are breastfeeding.
Your doctor will discuss the options available to you.
Do not take this medicine after the expiry date (EXP) 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 Diabex 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 Diabex XR your doctor will ask you to have a blood test to check your
Tell your doctor if you have or have had any of the following medical conditions:
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 Diabex 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 Diabex 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 Diabex XR may interfere with each other.
other medicines used to treat diabetes such as insulin, glitinides (Novonorm), and
sulfonylureas (e.g. Amaryl, Daonil, Diamicron, Glimel, Glyade, Melizide, Minidiab)
iodinated contrast agents (dyes)
medicines that contain alcohol, such as cough and cold syrups
corticosteroids such as prednisone (Panafacort, Sone) and cortisone (Cortate)
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,
metoprolol (e.g. Betaloc, Minax), calcium channel blockers such as nifedipine (e.g.
Adalat, Adefin), ACE inhibitors such as captopril (e.g. Capoten, Acenorm), enalapril
(e.g. Alphapril, Amprace, Renitec) fosinopril (Monopril), lisinopril (e.g. Lisodur,
Prinivil, Zestril), perindopril (Coversyl), quinapril (Accupril, Asig).
Some medicines used to treat asthma such as salbutamol (Ventolin) or terbutaline (Bricanyl).
diuretics, also called fluid tablets, such as amiloride (Midamor, Kaluril), bumetanide
(Burinex), frusemide (Lasix, Uremide, Urex), hydrochlorothiazide (Dithiazide), spirinolactone
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, including arthritis such as aspirin (e.g. Disprin,
Solprin), diclofenac (e.g. Voltaren, Fenac), ibuprofen (e.g. Actiprofen, Brufen, Rafen),
meloxicam (Mobic), naproxen (e.g. Naprogesic, Naprosyn, Inza) and piroxicam (e.g.
medicines used to treat ulcers and reflux, such as cimetidine (e.g. Tagamet, Magicul)
medicines used to prevent blood clots such as warfarin (e.g. Coumadin, Marevan)
thyroid hormones, such as thyroxine (e.g. Oroxine, Eutroxsig)
medicines that are substrates/ inhibitors of organic cation transporters - OCT 1 such
as verapamil; OCT 2 such as dolutegravir, crizotinib, olaparib, daclatasvir or vandetanib
medicines that are inducers of OCT 1 such as rifampicin
medicines that may increase the risk of lactic acidosis when concomitantly used with
metformin hydrochloride such as topiramate and other carbonic anhydrase inhibitors
These medicines may be affected by Diabex 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 have more information on medicines to be careful with or
avoid while taking Diabex XR.
How to take Diabex 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
Diabex XR comes in two strengths
Diabex XR 500 (500 mg Tablets) and Diabex XR 1000 (1000 mg Tablets).
The dose varies from person to person. Your doctor will decide the right dose for
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 2 grams once per day.
The elderly and people with kidney problems may need smaller doses.
How to take Diabex XR
Swallow the tablets whole with a glass of water.
Do not break, crush or chew the tablets.
If you break, crush or chew Diabex XR, they will not work as well. Diabex 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 Diabex XR
Take your medicine everyday with the evening meal.
Taking Diabex XR during or with your evening meal will reduce the chance of a stomach
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 Diabex XR for
Keep taking Diabex XR for as long as your doctor recommends.
Diabex XR will help control diabetes but will not cure it. Most people will need
to take Diabex XR for long periods of time.
When you start treatment with Diabex XR, it can take up to some weeks for your blood
glucose levels to be properly controlled.
If you forget to take Diabex XR
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 Diabex XR (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 Diabex XR. Do this even if there
are no signs of discomfort or poisoning.
If you take too much Diabex 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
You may also experience symptoms of hypoglycaemia (low blood glucose). This usually
only happens if you take too much Diabex 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 a non-diet soft drink or taking glucose
While you are taking Diabex 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 Diabex XR .
Tell all the other doctors, dentists and pharmacists who are treating you that you
are taking this medicine.
If you become pregnant while taking this medicine, tell your doctor.
Tell your doctor if you plan to have:
surgery with general anaesthesia
any x-ray procedures requiring an injection of an iodinated contrast agent (dye).
Your doctor will advise you when to stop taking Diabex XR before you have these procedures
and when to start again.
Diabex XR does not normally cause hypoglycaemia (low blood sugar), although you may
experience it while taking other medicines for diabetes such as insulin, 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
light-headedness, dizziness, headache or lack of concentration
irritability, tearfulness or crying
numbness around the lips and tongue.
If not treated promptly, these may progress to:
loss of co-ordination
fits or loss of consciousness.
If you experience any of the symptoms of hypoglycaemia, you need to raise your blood
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.
If you experience any of the signs of hyperglycaemia (high blood sugar), contact your
The risk of hyperglycaemia is increased in the following situations:
illness, infection or stress
taking less Diabex 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
you are injured
you have a fever
you have a serious infection such an influenza, respiratory tract infection or urinary
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).
you become pregnant.
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 Diabex XR with insulin.
Visit your doctor regularly for check-ups.
Your doctor may want to check your kidneys, liver, heart and blood levels while you
are taking Diabex 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 the advice of your doctor and dietician on diet, drinking alcohol
Things you must not do
Do not use Diabex 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
Do not skip meals while taking Diabex XR.
Do not stop taking your medicine or change the dose 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, Diabex XR by
itself is unlikely to affect how you drive or operate machinery.
Things to be aware of
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 Diabex XR works.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Diabex XR.
Diabex XR helps most people with diabetes but it may have unwanted side effects in
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.
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
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 Diabex 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 (jaundice) 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
feeling weak, tired or generally unwell
unusual muscle pain
dizziness or lightheadedness
shivering, feeling extremely cold
LACTIC ACIDOSIS IS 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 SEVERE KIDNEY OR LIVER PROBLEMS.
Tell your doctor or pharmacist 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
severe, occurred suddenly or gets worse rapidly.
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 taking Diabex XR
Keep Diabex 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 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 Diabex XR tablets in a cool, dry place where the temperature stays below
Do not store Diabex XR or any other medicine in the bathroom or near a sink.
Do not leave Diabex XR in the car or on window sills.
Heat and dampness can destroy some medicines.
If your doctor tells you to stop taking this medicine, or your tablets have passed
their expiry date, ask your pharmacist what to do with any medicine that is left over.
What it looks like
Diabex XR comes in 2 strengths. Diabex XR 500 (500 mg Tablets) and Diabex XR 1000
(1000 mg Tablets).
Diabex XR 500 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.
Diabex XR 1000 is a white to off-white, capsule-shaped tablet, marked on one side
with "1000". It is available in blister packs of 60 tablets.
The active ingredient in Diabex XR 500 and Diabex XR 1000 is metformin hydrochloride.
each Diabex XR 500 extended release tablet contains 500 mg of metformin hydrochloride.
each Diabex XR 1000 extended release tablet contains 1000 mg of metformin hydrochloride.
The tablets also contain the following inactive ingredients:
microcrystalline cellulose (500 mg only)
The tablets do not contain sucrose, lactose, gluten, tartrazine or any other azo dyes.
Diabex XR 500 and Diabex XR 1000 are supplied in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
Australian registration numbers are:
Diabex XR 500 - AUST R 98982
Diabex XR 1000 - AUST R 153699
This leaflet was prepared on
19 October 2018
® Registered trade mark of
Merck Sante S.A.S.