2. What should I know before I use SIDAPVIA?
Do not use if you have ever had an allergic reaction to dapagliflozin or sitagliptin
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 SIDAPVIA and affect how it works.
4. How do I use SIDAPVIA?
Swallow your SIDPAVIA tablet whole with a full glass of water.
The dose of SIDAPVIA is one tablet once a day. SIDAPVIA tablets can be taken with
or without food.
5. What should I know while using SIDAPVIA?
|
Things you should do
|
Make sure that you, your friends, family and work colleagues can recognise the symptoms
of hypoglycaemia (low blood sugar) and hyperglycaemia (high blood sugar) and know
how to treat them.
Talk to your doctor if you are having surgery (including dental surgery) to discuss
when to stop taking SIDAPVIA and when to start taking it again.
Remind any doctor, dentist or pharmacist you visit that you are using SIDAPVIA.
If you become pregnant while taking SIDAPVIA, tell your doctor immediately.
|
|
Things you should not do
|
Do not stop taking your medicine or change the dosage without checking with your doctor.
|
|
Driving or using machines
|
Make sure you know how you react to SIDAPVIA before you drive a car or use any machines
or tools. Although rare, SIDAPVIA may cause dizziness in some people. Low blood sugar
levels may slow your reaction time and affect your ability to drive or operate machinery.
|
|
Looking after your medicine
|
Keep your SIDAPVIA tablets in the blister until it is time to take them.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
|
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, some can
be minor and temporary. However, some side effects may be serious, and could require
urgent medical attention or hospitalisation. See Section
6. Are there any side effects? in the full CMI and, if you need to, ask your doctor if you have any further questions
about side effects. Tell your doctor if you experience any side effects, including
those not listed in this leaflet.
Active ingredients:
dapagliflozin (as propanediol monohydrate) and sitagliptin (as phosphate monohydrate)
Consumer Medicine Information (CMI)
This leaflet provides important information about using SIDAPVIA. 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 SIDAPVIA.
Where to find information in this leaflet:
1. Why am I using SIDAPVIA?
SIDAPVIA contains two active ingredients, dapagliflozin and sitagliptin. Dapagliflozin belongs to a class of medicines called SGLT-2 (Sodium Glucose Cotransporter-2)
inhibitors, and sitagliptin belongs to a class of medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4 inhibitors).
SIDAPVIA is used with diet and exercise to control the level of blood sugar (glucose)
in adults with type 2 diabetes mellitus.
Type 2 diabetes mellitus is a condition in which your body does not make enough insulin
and the insulin that your body produces does not work as well as it should. Your body
can also make too much sugar. When this happens, sugar (glucose) builds up in the
blood and can lead to serious medical problems.
The main goal of treating type 2 diabetes is to control your blood sugar to a normal
level. Lowering and controlling blood sugar may help prevent or delay complications
of diabetes, such as heart disease, kidney disease, blindness and amputation.
2. What should I know before I use SIDAPVIA?
Warnings
Do not use SIDAPVIA if:
you are allergic to dapagliflozin or sitagliptin, or 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:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue, or other parts of the body
rash, itching or hives on the skin or
you may feel faint.
Check with your doctor if you:
have any allergies to any other medicines, foods, dyes, or preservatives.
have, or have had, any of the following medical conditions:
type 1 diabetes mellitus
kidney, liver, or pancreas problems
frequently get genital or urinary tract infections (infections of the bladder, kidney,
or tubes that carry urine).
an illness that will make you dehydrated such as diarrhoea or a severe infection.
diabetic ketoacidosis. This is a symptom of uncontrolled diabetes, in which substances
called ketone bodies build up in the blood. You may notice this as rapid weight loss,
feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing,
confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet
or metallic taste in your mouth, or a different odour to your urine or sweat.
you are taking a medicine for high blood pressure or taking a water pill (diuretic).
take any medicines for any other condition.
Your doctor will do some tests for kidney function at the start of treatment and regularly
while you are on treatment.
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
Check with your doctor if you are pregnant or intend to become pregnant.
SIDAPVIA is not recommended for use during pregnancy. The safety of SIDAPVIA in pregnant
women has not been established. If you become pregnant, stop taking SIDAPVIA and speak
with your doctor immediately about the best way to control your blood glucose during
pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
SIDAPVIA should not be used while breastfeeding or if planning to breastfeed. It is
not known if the active ingredients in SIDAPVIA will pass into your breast milk. Talk
with your doctor about the best way to feed your baby if you are taking SIDAPVIA.
Children
SIDAPVIA is not recommended for use in children.
It has not been studied in children younger than 18 years old.
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.
Discard any other medicines containing dapagliflozin or sitagliptin that your doctor
might have prescribed to you in the past and that you may still have in your possession.
SIDAPVIA contains dapagliflozin and sitagliptin. If you have more than one medicine
containing dapagliflozin or sitagliptin in your possession, you may accidentally take
too much (overdose).
Ask your doctor or pharmacist if you are unsure if you have any other medicines containing
dapagliflozin or sitagliptin.
Dapagliflozin and sitagliptin are sold separately as FORXIGA and JANUVIA in Australia.
Your doctor or pharmacist will know which other medicines also contain dapagliflozin
and sitagliptin and can tell you what to do.
Tell your doctor or pharmacist if you are taking any of the following:
lithium
sulfonylureas
insulin.
SIDAPVIA may interfere with or affect how these medicines work, or these medicines
may affect how SIDAPVIA works. Your doctor may need to adjust your dose of these medicines
or change to a different medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SIDAPVIA.
4. How do I use SIDAPVIA?
How to take SIDAPVIA
Follow all directions given to you by your doctor or 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.
Swallow your SIDAPVIA tablet whole with a full glass of water.
How much to take
The dose of SIDAPVIA is one tablet once a day.
When to take SIDAPVIA
SIDAPVIA should be taken at approximately the same time each day. Taking your tablets
at the same time each day will have the best effect. It will also help you remember
when to take the tablets.
SIDAPVIA tablets can be taken with or without food.
How long to take
Continue taking SIDAPVIA for as long as your doctor tells you. Make sure you keep
enough SIDAPVIA to last over weekends and holidays.
SIDAPVIA helps control your condition, but does not cure it. Therefore, you must take
SIDAPVIA every day.
If you forget to use SIDAPVIA
SIDAPVIA should be used regularly at the same time each day. If you miss your dose
at the usual time, take it as soon as you remember, and then go back to taking your
medicine as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much SIDAPVIA
If you think that you have used too much SIDAPVIA, 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.
5. What should I know while using SIDAPVIA?
Things you should do
If you are about to be started on any new medicines, tell your doctor, dentist or
pharmacist that you are taking SIDAPVIA.
Make sure that you, your friends, family and work colleagues can recognise the symptoms
of hypoglycaemia and hyperglycaemia and know how to treat them.
It is important to have regular check-ups with your doctor or diabetes centre.
If you have diabetes, it is important to check your feet regularly and adhere to any
other advice regarding foot care given by your doctor.
Tell your doctor if you experience rapid weight loss, feeling sick or being sick,
stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness
or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth,
or a different odour to your urine or sweat. These symptoms could be a sign of diabetic
ketoacidosis.
Talk to your doctor if you are having surgery (including dental surgery) to discuss
when to stop taking SIDAPVIA and when to start taking it again.
If you need to have any medical tests while you are taking SIDAPVIA, tell your doctor.
SIDAPVIA may affect the results of some tests.
Visit your doctor regularly for checkups.
Your doctor may want to perform blood tests to check your kidneys, liver, heart, and
levels of cholesterol and fats in your blood while you are taking SIDAPVIA.
Hypoglycaemia
SIDAPVIA does not normally cause hypoglycaemia, although you may experience it if
you take certain other medicines, such as insulin or a sulfonylurea.
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
forgetting to take SIDAPVIA
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.
If you become pregnant while taking SIDAPVIA, tell your doctor immediately.
Remind any doctor, dentist or pharmacist you visit that you are using SIDAPVIA.
Things you should not do
Do not stop taking your medicine without checking with your doctor.
Do not take SIDAPVIA to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else, even if their symptoms seem similar or they
have the same condition as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SIDAPVIA
affects you.
Low blood sugar levels may slow your reaction time and affect your ability to drive
or operate machinery.
Make sure you know how you react to SIDAPVIA before you drive a car, operate machinery
or do anything else that could be dangerous if you are dizzy or lightheaded.
Looking after your medicine
Keep your SIDAPVIA tablets in the blister until it is time to take them. If you take
SIDAPVIA out of the blister it will not keep well.
Keep it in a cool dry place where the temperature stays below 30°C.
Follow the instructions in 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 use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
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.
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
Serious side effects
|
Serious side effects
|
What to do
|
|
Allergic reaction:
Shortness of breath, wheezing or severe difficulty in breathing; shock, swelling of
the face, lips, tongue or other parts of the body; skin rash, itching or hives on
the skin, hayfever, or you may feel faint.
Hypoglycaemia:
Low blood sugar (hypoglycaemia) may become worse in people who already take another
medication to treat diabetes, such as sulfonylureas or insulin.
Signs of low blood sugar may include weakness, trembling or shaking, sweating, light-headedness,
headache, dizziness, rapid heartbeat, lack of concentration, tearfulness or crying,
irritability, hunger and numbness around the lips and fingers. Do not drive a car
if you have signs of low blood sugar.
Skin-related:
develop blisters or the breakdown of your skin (erosion). These symptoms could be
a sign of a skin reaction called bullous pemphigoid that can require treatment in
a hospital.
Dehydration:
Volume depletion (loss of needed fluids from the body; dehydration).
If you are unable to keep fluids down or if you have any of these symptoms of too
much loss of body fluids while taking SIDAPVIA: dry sticky mouth, severe thirst, severe
diarrhoea or vomiting, dizziness, or urinating less often than normal or not at all.
Infections-related:
Genital infections. If you experience painful urination, soreness and more severe
irritation or redness and swelling of your genitals, or an unpleasant odour or discharge
associated with your genitals.
Urinary tract infection. If you have symptoms, such as burning or pain when you pass
urine, more frequent or urgent need to urinate, fever, chills, or blood in the urine.
If you experience pain or tenderness, redness, swelling of the genitals or the area
from the genitals to the rectum, fever, and generally feeling unwell. These may be
symptoms of a rare but serious and potentially life-threating infection called Necrotising
fasciitis of the perineum (Fournier’s gangrene) and you will require prompt treatment.
Diabetic Ketoacidosis:
In rare cases dapagliflozin, the active ingredient in SIDAPVIA, may cause a serious
condition called diabetic ketoacidosis.
Symptoms of diabetic ketoacidosis may include feeling sick or being sick, difficulty
breathing, severe thirst, feeling weak and tired, confusion, a sweet smell to your
breath, a sweet or metallic taste in your mouth, a strange odour to your urine or
sweat and frequent urination.
The risk of developing diabetic ketoacidosis may be increased with prolonged fasting,
excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or
a higher need of insulin due to major surgery or serious illness.
Diabetes ketoacidosis is a life-threatening condition.
Pancreatitis:
Severe and persistent stomach pain, often with nausea and vomiting. These may be symptoms
of pancreatitis.
Pancreatitis can be a serious, potentially life-threatening medical condition.
Kidney-related:
Kidney problems (sometimes requiring dialysis)
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
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.
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 SIDAPVIA contains
|
Active ingredient
(main ingredient)
|
dapagliflozin 10 mg
sitagliptin 100 mg
|
|
Other ingredients
(inactive ingredients)
|
Core tablet:
croscarmellose sodium
crospovidone
microcrystalline cellulose
mannitol
magnesium stearate
calcium hydrogen phosphate
sodium stearylfumarate
Film coating:
polyvinyl alcohol
titanium dioxide
macrogol 3350
purified talc
iron oxide yellow
|
|
Potential allergens
|
Not applicable
|
Do not take this medicine if you are allergic to any of these ingredients.
What SIDAPVIA looks like
SIDAPVIA 10/100 tablets are yellow, oval shaped, approximately 8 mm x 15 mm, biconvex,
film-coated tablets with “F M” debossed on one side and plain on the other side.
Available in blister packs of 7 (sample pack) and 28 tablets. (Aust R 405540).
Who distributes SIDAPVIA
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared in June 2024.
SIDAPVIA is a trade mark of the AstraZeneca group of companies.
© AstraZeneca, 2024
VV-RIM-06210689 v1.0