contains the active ingredient metformin hydrochloride
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about Diabex.
It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or diabetes
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Diabex against the benefits expected
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 is used for
Diabex is used to control blood glucose (the amount of sugar in the blood) in people with diabetes mellitus.
Diabex can be used in type 2 diabetes in adults and children over 10 years of age. It is especially useful in those who are
overweight, when diet and exercise are not enough to lower high blood glucose levels (hyperglycaemia). For adult patients,
metformin can be used alone, or in combination with other oral diabetic medicines or in combination with insulin in insulin
requiring type 2 diabetes.
Ask your doctor if you have any questions about why Diabex has been prescribed for you.
Your doctor may have prescribed Diabex for another reason.
Diabex is available only with a doctor's prescription.
There is no evidence that Diabex is addictive.
How Diabex works
Diabex belongs to a group of medicines called biguanides. Diabex lowers high blood glucose (hyperglycaemia) by helping your
body make better use of the insulin produced by your pancreas.
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, 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
Before you take Diabex
When you must not take it
Do not take Diabex 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 Diabex if you have any of the following conditions:
type 1 diabetes mellitus that is well controlled by insulin alone
type 2 diabetes that is already well controlled by diet alone
any type of metabolic acidosis such as lactic acidosis, diabetic ketoacidosis (a symptom of uncontrolled diabetes, in which
substances called ketone bodies build up in the blood - you may notice this as an unusual fruity odour on your breath, difficulty
breathing, confusion and frequent urination)
severe liver disease
excessive alcohol intake, binge drinking, alcohol dependence
kidney failure or severe kidney disease
dehydration, severe blood loss, shock
a severe infection
certain heart or blood vessel problems, including a recent heart attack or severe heart failure (when the heart fails to pump
severe breathing difficulties
blood clots in the lungs (symptoms include coughing, shortness of breath, chest pain and a fast heart rate)
inflammation of the pancreas (pancreatitis), symptoms include severe upper stomach pain, often with nausea and vomiting
Do not take Diabex 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 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.
The safety of Diabex in pregnant women has not been established.
Insulin is more suitable for controlling blood glucose during pregnancy. Your doctor will replace Diabex with insulin while
you are pregnant.
Do not take Diabex if you are breastfeeding.
Diabex is not recommended while 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 Diabex, ask your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.
Tell your doctor if you have or have had any of the following medical conditions:
Your doctor may want to take special care if you have any of these conditions.
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
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.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from
a pharmacy, supermarket or health food shop.
Some medicines and Diabex may interact with each other. These include:
other medicines used to treat diabetes
medicines that contain alcohol, such as cough and cold syrups
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
some medicines used to treat high blood pressure and some heart conditions, including beta-blockers, calcium channel blockers
and ACE inhibitors
medicines used to prevent blood clots, such as warfarin
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, a medicine used to treat reflux and ulcers
corticosteroids such as prednisone or cortisone
some medicines used to treat asthma such as salbutamol or terbutaline
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
These medicines may be affected by Diabex 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 this medicine.
How to take Diabex
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 for help.
How much to take
The dose varies from person to person. Your doctor will decide the right dose for you.
The usual starting dose for adults is 500 mg one to two times a day. Your doctor may increase or decrease the dose, depending
on your blood glucose levels. The maximum recommended dose is 1000 mg three times a day.
The elderly and people with kidney problems may need smaller doses.
Children & Adolescents:
The usual starting dose for children from 10 years of age and adolescents is one tablet of 500 mg or 850 mg once daily. Your
doctor may increase or decrease the dose, depending on your blood glucose levels.
The maximum recommended dose is 2 g taken as two or three divided doses.
If your child has diabetes that is resistant to insulin and is being treated in hospital, your child's doctor will decide
How to take it
Swallow the tablets with a glass of water.
The 1000 mg tablets can be divided in half along the breakline, if advised by your doctor or pharmacist.
When to take it
Take Diabex during or immediately after food.
This will reduce the chance of a stomach upset.
Take your medicine at about the same time each day.
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
Continue taking your medicine for as long as your doctor tells you to.
This medicine helps control diabetes but does not cure it. Most people will need to take Diabex on a long-term basis.
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 the missed dose as soon as you remember (with food), and then go back to taking your tablets as you would
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 Diabex. Do this even if there
are no signs of discomfort or poisoning.
If you take too much Diabex, you may feel sleepy, 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 Diabex
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 tablets.
While you are taking Diabex
Things you must do
Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia and hyperglycaemia
and know how to treat them.
Diabex does not normally cause hypoglycaemia, although you may experience it if you take other medicines for diabetes such
as sulfonylureas or repaglinide; or if you also use insulin.
Hypoglycaemia can occur suddenly. Initial signs may include:
weakness, trembling or shaking
lightheadedness, 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 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.
If you notice the return of any of the signs of hyperglycaemia, contact your doctor immediately.
Your doctor may need to consider additional or other treatments for your diabetes.
The risk of hyperglycaemia is increased in the following situations:
illness, infection or stress
taking less Diabex than prescribed
taking certain other medicines
too little exercise
eating more carbohydrates than normal.
Tell your doctor if you:
have a fever
have a serious infection
are having surgery (including dental surgery)
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 with insulin.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Diabex.
Tell all the other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you become pregnant while taking Diabex, tell your doctor immediately.
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 Diabex with insulin
Visit your doctor regularly for check-ups.
Your doctor may want to perform blood tests to check your kidneys, liver, heart and vitamin B12 level while you are taking
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.
When you start treatment with Diabex, it can take up to two weeks for your blood glucose levels to be properly controlled.
Carefully follow the advice of your doctor and dietician on diet, drinking alcohol and exercise.
Things you must not do
Do not take Diabex 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 Diabex.
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, Diabex 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.
When you are travelling, it is a good idea to:
wear some form of identification (e.g. bracelet) showing you have diabetes
carry some form of sugar to treat hypoglycaemia if it occurs, for example, sugar sachets or jelly beans
carry emergency food rations in case of a delay, for example, dried fruit, biscuits or muesli bars
bring enough Diabex with you, so you don't miss any doses
Lifestyle measures that help reduce heart disease risk
By following these simple measures, you can further reduce the risk from heart disease.
Quit smoking and avoid second-hand smoke
Limit alcohol intake
Enjoy healthy eating by:
eating plenty of vegetables and fruit;
reducing your saturated fat intake (eat less fatty meats, full fat dairy products, butter, coconut and palm oils, most take-away
foods, commercially-baked products)
Be active. Progress, over time, to at least 30 minutes of moderate-intensity physical activity on 5 or more days each week.
Can be accumulated in shorter bouts of 10 minutes duration. If you have been prescribed anti-angina medicine, carry it with
you when being physically active
Maintain a healthy weight
Discuss your lifestyle and lifestyle plans with your doctor
For more information and tools to improve your heart health, call Heartline, the Heart Foundation's national telephone information
service, on 1300 36 27 87 (local call cost)
Know warning signs of heart attack and what to do:
Tightness, fullness, pressure, squeezing, heaviness or pain in your chest, neck, jaw, throat, shoulders, arms or back
You may also have difficulty breathing, or have a cold sweat or feel dizzy or light headed or feel like vomiting (or actually
If you have heart attack warning signs that are severe, get worse or last for 10 minutes even if they are mild, call triple
zero (000). Every minute counts.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Diabex.
Diabex 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 attention
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.
Do not be alarmed by the following list of side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
feeling sick (nausea)
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 with meals can help reduce
stomach pain, nausea and diarrhoea. Skin reactions have been reported rarely.
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
slow heart beat
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 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
After taking Diabex
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store Diabex 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 it 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.
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.
What it looks like
Diabex tablets come in 3 strengths:
Diabex 500 mg - white, oblong, convex, film-coated tablet, marked "DIABEX" on one face and scored on the other. Each pack
contains 100 tablets.
Diabex 850 mg - white, circular, convex, film-coated tablet. Each pack contains 60 tablets.
Diabex 1000 mg - white, oval, biconvex, film-coated tablet, with a line on both sides and "1000" engraved on one side. Each
pack contains 90 tablets
The active ingredient in Diabex is metformin hydrochloride:
each Diabex tablet contains 500 mg of metformin hydrochloride
each Diabex 850 tablet contains 850 mg of metformin hydrochloride
each Diabex 1000 tablet contains 1000 mg of metformin hydrochloride
The tablets also contain the following inactive ingredients:
macrogol 400 (1000 mg tablets only)
macrogol 8000 (1000 mg tablets only)
The tablets are gluten free.
Diabex is 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:
Diabex 500 mg- AUST R 40806
Diabex 850 mg - AUST R 57645
Diabex 1000 mg - AUST R 81602
This leaflet was prepared on
16 September 2016.
* Registered trade mark of Merck Sante S.A.S.