Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking ABISART HCTZ?
ABISART HCTZ contains the active ingredients irbesartan and hydrochlorothiazide. ABISART
HCTZ is used to treat high blood pressure, which doctors call hypertension. For more
information, see Section
1. Why am I taking ABISART HCTZ? in the full CMI.
2. What should I know before I take ABISART HCTZ?
Do not take if you have ever had an allergic reaction to ABISART HCTZ 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 take ABISART HCTZ? in the full CMI.
3. What if I am taking other medicines?
4. How do I take ABISART HCTZ?
Your doctor will tell you how many tablets to take each day. The usual dose is one
tablet per day.
Swallow the table whole with a glass of water and take ABISART HCTZ at about the same
time each day.
5. What should I know while taking ABISART HCTZ?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking ABISART HCTZ.
If you become pregnant while taking ABISART HCTZ tell your doctor immediately
Before starting on any new medicine, tell your doctor and pharmacist you are taking
ABISART HCTZ
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking ABISART HCTZ
Make sure you drink enough water during exercise and hot weather when you are taking
ABISART HCTZ
If you have excessive vomiting and/or diarrhoea while taking ABISART HCTZ, tell your
doctor.
If you feel light headed or dizzy after your dose is increased, tell your doctor immediately
Tell your doctor if you experience increased skin sensitivity
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Things you should not do
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Do not stop taking ABISART HCTZ or lower the dosage, without checking with your doctor.
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Driving or using machines
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Be careful driving or operating machinery until you know how ABISART HCTZ affects
you. ABISART HCTZ may cause dizziness or light- headedness in some people. If this
occurs do not drive.
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Drinking alcohol
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If you drink alcohol, dizziness or light-headedness may be worse
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Looking after your medicine
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Keep ABISART HCTZ tablets in a cool dry place where the temperature stays below 25°C
Keep your tablets in the packaging until it is time to take them
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6. Are there any side effects?
Common side effects: headache; dizziness or light-headedness (vertigo), unusual tiredness or fatigue,
pain in the stomach or gut nausea and/or vomiting, sexual problems.
Serious side effects: swelling of the face, lips, tongue or throat which may cause difficulty in swallowing
or breathing; severe and sudden onset of pinkish, itchy swellings on the skin (hives
or nettle rash). Refer to the CMI for the full list. 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):
irbesartan and hydrochlorothiazide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ABISART HCTZ. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking ABISART HCTZ.
Where to find information in this leaflet:
1. Why am I taking ABISART HCTZ?
ABISART HCTZ contains the active ingredient irbesartan and hydrochlorothiazide. Both medicines reduce blood pressure in different ways.
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Angiotensin II is a substance produced in the body that causes blood vessels to narrow.
Irbesartan blocks angiotensin-II and therefore widens your blood vessels, making it
easier for your heart to pump blood throughout your body. This helps to lower your
blood pressure.
Hydrochlorothiazide belongs to the class of medicines known as diuretics. Diuretics
cause an increase in the volume of urine. They also help with lowering blood pressure
particularly when combined with other blood pressure reducing medicines.
ABISART HCTZ is used to treat high blood pressure, which doctors call hypertension.
2. What should I know before I take ABISART HCTZ?
Warnings
Do not take ABISART HCTZ if:
you are allergic to irbesartan, hydrochlorothiazide or to sulfonamide derived medicines
(commonly known as sulfur drugs), or to any ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can take this medicine.
you are pregnant (or think you may be pregnant) or are planning to become pregnant.
you are breast-feeding
you have diabetes or have kidney problems and you are being treated with medicines
that lower blood pressure such as an ACE inhibitor, any aliskiren-containing medicines
that belong to a group of medicines known as AIIRAs (medicines also used to treat
high blood pressure)
you are not producing urine
Check with your doctor if you:
have any other medical conditions
have had recent excessive vomiting or diarrhea or think you are dehydrated
have kidney problems, or have had a kidney transplant or dialysis
have heart problems
have liver problems, or have had liver problems in the past
have diabetes
have gout or have had gout in the past
have lupus erythematosus
have high or low levels of potassium or sodium or other electrolytes in your blood
have primary aldosteronism. This is a condition which causes sodium retention and
an increase in blood pressure.
are strictly restricting your salt intake
have had a sympathectomy. This is a surgical procedure to cut or block a nerve in
your body.
have been taking diuretics. These are medicines that reduce fluid retention in your
body and are often used to treat high blood pressure.
have had skin cancer or you develop an unexpected skin lesion during the treatment.
Treatment with hydrochlorothiazide, particularly long term use with high doses, may
increase the risk of some types of skin and lip cancer (non- melanoma skin cancer).
Protect your skin from sun exposure and UV rays while taking ABISART HCTZ.
take any medicines for any other condition
are pregnant or intend to become pregnant
if you are breast-feeding or plan to breastfeed
plan to have surgery (even at the dentist) that needs a general anaesthetic
have a history of allergy or asthma
have allergies to any substances, such as foods, preservatives or dyes.
have a decrease in your vision or pain in one or both of your eyes. If so, you should
discontinue ABISART HCTZ tablet treatment and seek prompt medical attention, as these
could be symptoms of fluid accumulation in the eye (choroidal effusion) or an increase
of pressure in your eye (glaucoma) and can happen within hours to weeks of taking
ABISART HCTZ tablets. This can lead to permanent vision loss, if not treated. If you
have had a penicillin or sulfonamide (sulfur drug) allergy, you can be at higher risk
of developing this.
experienced breathing or lung problems (including inflammation or fluid in the lungs)
following hydrochlorothiazide intake in the past.
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?
Use in children
ABISART HCTZ should not be given to children.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. Do not take
ABISART HCTZ if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Do not take
ABISART HCTZ if you are breastfeeding.
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.
Tell your doctor if you are taking or plan to take any of the following:
other medicines to treat high blood pressure
other diuretics
lithium or lithium-containing medicines (for example lithium carbonate)
potassium tablets
potassium-containing salt tablets
non-steroidal anti- inflammatory medicine such as diclofenac, ibuprofen) and COX-
2 inhibitors (for example celecoxib) These medicines may be used to relieve pain,
swelling and other symptoms of inflammation including arthritis. Taking irbesartan
and an anti- inflammatory medicine alone or with a thiazide diuretic (fluid tablet)
may damage your kidneys. It may also reduce the effect irbesartan has on lowering
blood pressure.
alcoholic drinks
sleeping tablets
strong pain medicines such as codeine or morphine
medicines to treat diabetes, such as repaglinide. ABISART HCTZ might induce hypoglycaemia;
low blood sugar.
calcium supplements or medicines containing calcium
medicines containing Vitamin D
medicines for gout
powder or granules used to help reduce cholesterol (cholestyramine or colestipol hydrochloride)
heart medicines such as digoxin or medicines to treat abnormal heart rhythm such as
sotalol hydrochloride
corticosteroid medicines such as prednisone, cortisone or adrenocorticotropic hormone
(ACTH)
medicines used to treat cancer
amantadine, a medicine used to treat Parkinson's disease or to prevent influenza
anticholinergic medicines, these can be used to treat Parkinson's disease, to relieve
stomach cramps or spasms or used to prevent travel sickness
carbamazepine, a medicine used to treat convulsion
medicines used during surgery
medicines used in an emergency such as adrenaline
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ABISART HCTZ.
4. How do I take ABISART HCTZ?
How much to take
ABISART HCTZ will usually be prescribed by your doctor if previous treatment does
not produce a sufficient drop in your blood pressure. Your doctor will tell you how
to switch from your previous treatment to ABISART HCTZ
The usual dose of ABISART HCTZ is one tablet once a day.
The full blood pressure lowering effect should be reached 6 to 8 weeks after beginning
treatment.
If your blood pressure is not satisfactorily reduced with ABISART HCTZ, your doctor
may prescribe another medicine to be taken with ABISART HCTZ
Ask your doctor or pharmacist if you are unsure of the correct dose for you. They
will tell you exactly how much to take.
Follow the instructions provided and take ABISART HCTZ until your doctor tells you
to stop.
When to take ABISART HCTZ
Take ABISART HCTZ at about the same time each day.
How to take ABISART HCTZ
Swallow the tablet whole with a glass of water. It does not matter whether you take
ABISART HCTZ tablets before or after food.
Continue taking ABISART HCTZ until your doctor tells you to stop.
To help you remember to take your tablets each day, ABISART HCTZ tablets are supplied
in a Calendar pack with the foil backing marked with the days of the week. This is
just a way to help you to remember to take your tablets. All of the tablets in the
pack are the same.
When you start a new strip of tablets, take the tablet marked "START" at the end of
the blister strip. On the next day, take the tablet marked with the relevant day of
the week. Continue taking your tablets each day until all of the tablets are taken.
Commence the next strip at "START" and continue as before.
If you forget to take ABISART HCTZ
ABISART HCTZ should be used regularly at the same time each day.
If you miss your dose at the usual time and 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 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 take too much ABISART HCTZ
If you think that you have used too much ABISART HCTZ, 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 many ABISART HCTZ tablets you will probably feel light-headed or dizzy.
5. What should I know while taking ABISART HCTZ?
Things you should do
Tell any other doctors, dentists, and pharmacists who are treating you that you are
taking ABISART HCTZ
Tell your doctor immediately if you become pregnant while taking ABISART HCTZ
Have your blood pressure checked when your doctor tells you to, to make sure ABISART
HCTZ is working
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking ABISART HCTZ
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking ABISART HCTZ. Your blood pressure may drop suddenly
Make sure you drink enough water during exercise and hot weather when you are taking
ABISART HCTZ, especially if you sweat a lot. If you do not drink enough water while
taking ABISART HCTZ, you may faint or feel light-headed or sick. This is because your
body does not have enough fluid and your blood pressure is low. If you continue to
feel unwell, tell your doctor.
Tell your doctor if you have excessive vomiting and/or diarrhoea while taking ABISART
HCTZ. You may lose too much water and salt and your blood pressure may drop too much.
Tell your doctor immediately if you feel lightheaded or dizzy after taking your first
dose of ABISART HCTZ, or when your dose is increased.
Tell your doctor if you experience an increased sensitivity of the skin to the sun
with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring
more quickly than normal.
If you develop any shortness of breath or difficulty breathing after taking ABISART
HCTZ, seek medical attention immediately.
Things you should not do
Do not give ABISART HCTZ tablets to anyone else, even if they have the same condition
as you
Do not take ABISART HCTZ to treat any other complaints unless your doctor or pharmacist
tells you to
Do not stop taking ABISART HCTZ, or lower the dosage, without checking with your doctor
Things to be careful of
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to the change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
The hydrochlorothiazide contained in this medicine could produce a positive analytical
result in an antidoping test
Driving or using machines
Be careful before you drive or use any machines or tools until you know how [medicine
name] affects you.
As with many other medicines used to treat high blood pressure, ABISART HCTZ, may
cause dizziness or light- headedness in some people. If this occurs do not drive.
Make sure you know how you react to ABISART HCTZ before you drive a car, operate machinery
or do anything else that could be dangerous if you are dizzy or light-headed.
Drinking alcohol
Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
Keep ABISART HCTZ tablets in a cool dry place where the temperature stays below 25°C
Keep your tablets in the blister pack until it is time to take them
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
do not store it in the car or on window sills.
Do not use this medicine after the expiry date.
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.
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
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Serious side effects
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What to do
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skin rash or itchiness (this may be a symptom of an allergic reaction).
aching muscles, not caused by exercise
muscle pain or weakness
blood tests may show raised levels of an enzyme that measures breakdown of muscle
(creatine phosphokinase)
buzzing, ringing or other persistent noise in the ear
changes in heart rhythm
you are not urinating (passing water) as much as normal
numbness or tingling in fingers or toes
painful, swollen joints that may be symptoms of gout
fainting
symptoms that may indicate low platelet count such as easy or excessive bruising,
bleeding from gums or nose, prolonged bleeding from cuts and blood in urine or stools
disturbances in your vision (such as blurred vision and seeing haloes around lights)
and eye pain
symptoms that may occur if you have developed diabetes, such as excessive thirst,
passing greatly increased amounts of urine, increased appetite with weight loss, feeling
tired, drowsy, weak, depressed, irritable and generally unwell
symptoms that may indicate kidney disease such as passing little or no urine, drowsiness,
nausea, vomiting, breathlessness, loss of appetite and weakness
symptoms that may indicate high potassium levels in the blood such as nausea, diarrhoea,
muscle weakness and changes in heart rhythm
yellowing of the skin and/or eyes, also known as jaundice
symptoms that may indicate liver disease such as nausea, vomiting, loss of appetite,
feeling generally unwell, fever, itching, yellowing of the skin and eyes and dark
coloured urine
swelling of the face, lips, tongue or throat which may cause difficulty in swallowing
or breathing
severe and sudden onset of pinkish, itchy swellings on the skin, also called hives
or nettle rash
acute respiratory distress (signs include shortness of breath, fever, weakness, and
confusion)
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Stop taking ABISART HCTZ and call your doctor straightaway, or go straight to the
Emergency Department at your nearest hospital if you notice any of these serious side
effects.
These are very serious side effects. You may need urgent medical attention or hospitalization.
These side effects are very rare
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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 ABISART HCTZ contains
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Active ingredient
(main ingredient)
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Each ABISART HCTZ 150/12.5 tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide
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Other ingredients
(inactive ingredients)
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croscarmellose sodium
hypromellose
lactose monohydrate
magnesium stearate
microcrystalline cellulose
colloidal anhydrous silica
OPADRY II complete film coating system 03G54386 pink (ARTG no. 107731)
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Potential allergens
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lactose monohydrate
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Active ingredient
(main ingredient)
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Each ABISART HCTZ 300/12.5 tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide
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Other ingredients
(inactive ingredients)
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iron oxide yellow
croscarmellose sodium
hypromellose
lactose monohydrate
magnesium stearate
microcrystalline cellulose
colloidal anhydrous silica
OPADRY II complete film coating system 03G52390 yellow (ARTG no. 107730)
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Potential allergens
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lactose monohydrate
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Active ingredient
(main ingredient)
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Each ABISART HCTZ 300/25 tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide
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Other ingredients
(inactive ingredients)
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hypromellose
croscarmellose sodium
colloidal anhydrous silica
lactose monohydrate
magnesium stearate
microcrystalline cellulose
Opadry complete film coating system 03G54386 pink (ARTG no. 107731)
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Potential allergens
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lactose monohydrate
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Do not take this medicine if you are allergic to any of these ingredients.
What ABISART HCTZ looks like
ABISART HCTZ 150/12.5 tablets: A pink to red, film-coated, oval-shaped tablet debossed with "IH1" on one side of
the tablet and plain on the other side. Available in blister packs of 30 tablets (Aust
R 302147).
ABISART HCTZ 300/12.5 tablets: A yellow film-coated, oval-shaped tablet debossed with "IH3" on one side of the tablet
and plain on the other side. Available in blister packs of 30 tablets (Aust R 302148).
ABISART HCTZ 300/25 tablets: A pink to red film-coated, oval-shaped tablet debossed with "IH2" on one side of
the tablet and plain on the other side. Available in blister packs of 30 tablets (Aust
R 302149).
Who sponsors ABISART HCTZ
Sun Pharma ANZ Pty Ltd.
12 Waterloo Road
Macquarie Park NSW 2113
Who distributes ABISART HCTZ
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This CMI was prepared in March 2023.
ABISART HCTZ is a Viatris company trademark
Abisart HCTZ CMI March 2023