2. What should I know before treatment with DIAFORMIN VIATRIS XR?
Do not use if you have ever had an allergic reaction to DIAFORMIN VIATRIS XR 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.
3. What if I am taking other medicines?
Some medicines may interfere with DIAFORMIN VIATRIS XR and affect how it works.
4. How is DIAFORMIN VIATRIS XR given?
Take your DIAFORMIN VIATRIS XR tablets once a day with a meal
5. What should I know during treatment with DIAFORMIN VIATRIS XR?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking DIAFORMIN VIATRIS
XR.
Call your doctor straight away if you if you become pregnant while taking DIAFORMIN
VIATRIS XR.
|
|
Things you should not do
|
Do not stop taking this medicine or change the dose without checking with your doctor.
Do not skip meals while taking DIAFORMIN VIATRIS XR.
|
|
Drinking alcohol
|
Alcohol can affect the control of your diabetes. Drinking excessive amounts of alcohol
while you are being treated with DIAFORMIN VIATRIS XR may also lead to serious side
effects.
|
|
Looking after your medicine
|
Keep your tablets in the pack until it is time to take them.
Store DIAFORMIN VIATRIS XR where the temperature stays below 25°C
|
6. Are there any side effects?
Common side effects include: nausea, vomiting, diarrhoea, stomach pain, taste disturbance
and loss of appetite.
Serious side effects that need to be noted are: lactic acidosis; trouble breathing;
feeling weak, tired or generally unwell; unusual muscle pain; sleepiness; dizziness
or lightheadedness; shivering, feeling extremely cold; slow heartbeat.
Active ingredient(s):
metformin hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DIAFORMIN VIATRIS XR. 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 DIAFORMIN VIATRIS XR.
Where to find information in this leaflet:
1. Why am I being treated with DIAFORMIN VIATRIS XR?
1. Why am I being treated with DIAFORMIN VIATRIS XR?
DIAFORMIN VIATRIS XR contains active ingredient: metformin. Metformin which belongs to a class of medicines called biguanides.
DIAFORMIN VIATRIS XR 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 VIATRIS XR has been
prescribed for you.
DIAFORMIN VIATRIS XR is not recommended in children as its safety and effectiveness
have not been established in this age group.
DIAFORMIN VIATRIS XR is available only with a doctor's prescription. There is no evidence
that DIAFORMIN VIATRIS 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.
2. What should I know before treatment with DIAFORMIN VIATRIS XR?
Warnings
Do not take DIAFORMIN VIATRIS 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.
Always check the ingredients to make sure you can use this medicine.
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.
Check with your doctor if you:
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 DIAFORMIN VIATRIS 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 VIATRIS 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.
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?
Before you start to take DIAFORMIN VIATRIS XR
Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.
Kidney function tests
Before starting DIAFORMIN VIATRIS 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.
Pregnancy and breastfeeding
DIAFORMIN VIATRIS XR is not recommended for use during pregnancy. Check with your doctor if you are pregnant or intend to become pregnant.
Insulin is more suitable for controlling blood glucose during pregnancy. Your doctor
will replace DIAFORMIN VIATRIS XR with insulin while you are pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed. You should not
take DIAFORMIN VIATRIS XR while breastfeeding or if planning to breastfeed.
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 DIAFORMIN VIATRIS
XR may also lead to serious side effects. Your doctor may suggest you stop drinking
or reduce the amount of alcohol you drink.
Children
Children and adolescents below 18 years should not use this medicine. DIAFORMIN VIATRIS
XR is not effective in children and adolescents 10 to 17 years of age with type 2
diabetes. DIAFORMIN VIATRIS XR has not been studied in children younger than 10 years
of age
If you have not told your doctor about any of the above, tell him/ her before you
start taking DIAFORMIN VIATRIS XR.
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 DIAFORMIN VIATRIS XR may interfere with each other.
These include:
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), spironolactone
(Aldactone, Spiractin).
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.
Feldene, Mobilis)
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 DIAFORMIN VIATRIS 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 DIAFORMIN VIATRIS XR.
4. How is DIAFORMIN VIATRIS XR given?
How much to take
The dose varies from person to person. 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 2 grams once per day.
The elderly and people with kidney problems may need smaller doses.
Follow the instructions provided and use DIAFORMIN VIATRIS XR until your doctor tells
you to stop.
How to take DIAFORMIN VIATRIS XR
Swallow the tablets whole with a glass of water.
Do not break, crush or chew the tablets.
If you break, crush or chew DIAFORMIN VIATRIS XR, they will not work as well. DIAFORMIN
VIATRIS 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 DIAFORMIN VIATRIS XR
Take your medicine everyday with the evening meal.
Taking DIAFORMIN VIATRIS 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 DIAFORMIN VIATRIS XR
Keep taking DIAFORMIN VIATRIS XR for as long as your doctor recommends.
DIAFORMIN VIATRIS XR will help control diabetes but will not cure it. Most people
will need to take DIAFORMIN VIATRIS XR for long periods of time.
When you start treatment with DIAFORMIN VIATRIS XR, it can take up to some weeks for
your blood glucose levels to be properly controlled.
If you forget to take DIAFORMIN VIATRIS XR
If you missed your dose at the usual time, take it as soon as you remember, and then
go back to taking your next dose when you are meant to.
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 DIAFORMIN VIATRIS XR
If you think that you have taken too much DIAFORMIN VIATRIS XR, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre (by calling 13 11 26 ), 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 DIAFORMIN VIATRIS 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 VIATRIS 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
tablets.
If you take too much DIAFORMIN VIATRIS XR, you may feel sick, vomit, have trouble
breathing and have stomach pain or diarrhoea. These may be the early signs of a serious
condition called lactic acidosis.
If you experience any of these symptoms, immediately get medical help
5. What should I know during treatment with DIAFORMIN VIATRIS XR?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking DIAFORMIN VIATRIS 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.
Call your doctor straight away if you:
are having surgery with general anaesthesia.
are having any x-ray procedures requiring an injection of an iodinated contrast agent
(dye).
Your doctor will advise you when to stop taking DIAFORMIN VIATRIS XR before you have
these procedures and when to start again.
HYPOGLYCAEMIA
DIAFORMIN VIATRIS XR does not normally cause hypoglycaemia (low blood sugar), although
you may experience it while taking other medicines for diabetes such as insulin, sulfonylureas
or glinide.
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
light-headedness, 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 VIATRIS 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);
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 DIAFORMIN VIATRIS 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 DIAFORMIN VIATRIS 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
and exercise.
Things you should not do
Do not use DIAFORMIN VIATRIS 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 VIATRIS XR.
Do not stop taking your medicine or change the dose without checking with your doctor.
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.
Be careful before you drive or use any machines or tools until you know how DIAFORMIN
VIATRIS XR affects you.
There is no information to suggest that DIAFORMIN VIATRIS XR affects your ability
to drive a car or operate machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
Things to be aware of
Make sure that you, your friends, family and work colleagues can recognise the symptoms
of hypoglycaemia and hyperglycaemia and know how to treat them.
Looking after your medicine
Store DIAFORMIN VIATRIS XR in a cool dry place away where the temperature stays below
25oC.
Keep your tablets in the pack until it is time to take them.
Follow the instructions on the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date
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 DIAFORMIN VIATRIS XR.
DIAFORMIN VIATRIS 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.
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.
Less serious side effects
These are generally mild side effects which disappear after the first few weeks. Taking
DIAFORMIN VIATRIS XR with meals can help reduce nausea and diarrhea.
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.
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 SEVERE 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. 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.
Reporting side effects
After you have received medical advice for any side effects you/your child 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 DIAFORMIN VIATRIS XR contains
|
Active ingredient
|
Metformin hydrochloride
|
|
Other ingredients
|
Microcrystalline cellulose
Magnesium stearate
Povidone
Hypromellose
|
Do not take this medicine if you are allergic to any of these ingredients.
What DIAFORMIN VIATRIS XR looks like
DIAFORMIN VIATRIS XR 500 extended release tablets: White to off-white coloured, capsule
shaped biconvex debossed with ‘500’ on one side and plain on other side.
DIAFORMIN VIATRIS XR 1000 extended release tablets: White to off-white coloured, oval
shaped biconvex tablets debossed with '1000 on one side and plain on other side.
Australian Registration Numbers are as follows:
Aust R 423411
Aust R 423390
Who distributes DIAFORMIN VIATRIS XR
Sponsor
Medreich Australia Pty Ltd
Unit 8, Homebush Business Village
11-21 Underwood Road,
Homebush, NSW 2140
Distributor
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet is prepared in May 2025.
DIAFORMIN® is a Viatris company trade mark