Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using DIABEX?
DIABEX contains the active ingredient metformin hydrochloride. DIABEX is used to control
blood glucose (the amount of sugar in the blood) in people with diabetes mellitus.
For more information, see Section
1. Why am I using DIABEX? in the full CMI.
2. What should I know before I use DIABEX?
Do not use if you have ever had an allergic reaction to DIABEX or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use DIABEX? in the full CMI.
3. What if I am taking other medicines?
4. How do I use DIABEX?
The dose varies from person to person.
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. More instructions
can be found in Section
4. How do I use DIABEX? in the full CMI.
5. What should I know while using DIABEX?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using DIABEX.
Make sure that you, your friends, family and work colleagues can recognise the symptoms
of hypoglycaemia and hyperglycaemia and know how to treat them.
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|
Things you should not do
|
Do not take DIABEX to treat any other complaints unless your doctor tells you to.
Do not skip meals while taking DIABEX.
Do not stop taking your medicine or change the dosage without checking with your doctor.
|
|
Driving or using machines
|
DIABEX by itself is unlikely to affect how you drive or operate machinery.
Low blood glucose levels may slow your reaction time and affect your ability to drive
or operate machinery.
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Drinking alcohol
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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.
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|
Looking after your medicine
|
Keep the pack in a cool, dry place (below 25°C) in its original packaging.
Do not store DIABEX in the bathroom, near a sink, on a window sill or in the car.
Keep your tablets where children cannot reach it.
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6. Are there any side effects?
Tell your doctor or pharmacist if you notice any of the following and they worry you: nausea, vomiting, diarrhoea, stomach pain, taste disturbance, loss of appetite, skin
reactions such as redness of the skin or itching.
Tell your doctor immediately or go to Accident and Emergency at the nearest hospital
if you notice any of the following symptoms: trouble breathing, feeling weak, tired or generally unwell, unusual muscle pain,
sleepiness, dizziness, shivering, feeling extremely cold or slow heart beat. For more
information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
metformin hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DIABEX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using DIABEX.
Where to find information in this leaflet:
1. Why am I using DIABEX?
DIABEX contains the active ingredient metformin hydrochloride. 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 buildup of glucose in
the blood, which can lead to serious medical problems.
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).
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
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.
2. What should I know before I use DIABEX?
Warnings
Do not use DIABEX if:
you are allergic to any medicine containing metformin or any other biguanide, or 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.
Always check the ingredients to make sure you can use this medicine.
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 blood effectively)
severe breathing difficulties
blood clots in the lungs (symptoms include coughing,
shortness of breath, chest pain and a fast heart rate)
gangrene
inflammation of the pancreas (pancreatitis), symptoms include severe upper stomach
pain, often with nausea and vomiting
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 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 this medicine, talk to your doctor.
Check with your doctor if you:
are allergic to any other medicines or any foods, preservatives or dyes.
have or have had any of the following medical conditions:
heart failure
kidney problems
Your doctor may want to take special care if you have any of these conditions.
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.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
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.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your 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
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 or may affect how well it works. You may
need different amounts of your medicines or you may need to take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DIABEX.
4. How do I use 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 the dose.
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 DIABEX
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 DIABEX
DIABEX should be taken regularly at the same time each day.
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 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 use too much DIABEX
If you think that you have used too much DIABEX, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should 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.
5. What should I know while using DIABEX?
Things you should 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.
HYPOGLYCAEMIA
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
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 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:
uncontrolled diabetes
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:
become ill
become dehydrated
are injured
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 DIABEX.
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 should 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 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 vomit)
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.
Driving or using machines
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.
Drinking alcohol
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.
Looking after your medicine
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 on a window sill or in the car.
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.
Getting rid of any unwanted medicine
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.
6. Are there any side effects?
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. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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.
Serious side effects
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 else that may be making you
feel unwell.
Other side effects not listed here may 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.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DIABEX contains
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Active ingredient
(main ingredient)
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The tablets contain metformin hydrochloride as the active ingredient and are available
in three strengths 500 mg, 850 mg and 1000 mg.
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Other ingredients
(inactive ingredients)
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povidone
magnesium stearate
hypromellose (500 mg and 850 mg tablets only)
OPADRY complete film coating system YS-1-7472 (UK) (ARTG PI No: 4292) (1000 mg tablets
only)
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Potential allergens
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sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What DIABEX looks like
DIABEX tablets come in 3 strengths:
DIABEX 500 mg - white, oblong, convex, film-coated tablet. The tablet is embossed
with "DIABEX" on one side and is scored on the other. Each pack contains 100 tablets.
(AUST R 40806).
DIABEX 850 mg - white, circular, convex, film-coated tablet. The tablet has no embossing
and no score line. Each pack contains 60 tablets. (AUST R 57645).
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. (AUST R 81602).
Who distributes DIABEX
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
This leaflet was prepared in October 2022.
DIABEX_cmi\Oct22/00