NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
contains the active ingredient irbesartan/hydrochlorothiazide
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about ABISART HCTZ.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking ABISART HCTZ against the benefits expected for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What ABISART HCTZ is used for
ABISART HCTZ is used to treat hypertension (i.e. high blood pressure). ABISART HCTZ is a trade name (manufacturer’s name). ABISART HCTZ tablets contain two medicines, irbesartan and hydrochlorothiazide.
Your doctor measured your blood pressure and found it to be too high. Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) which means your blood pressure stays high even when you are calm and relaxed.
There are usually no symptoms of high blood pressure. The only way of knowing that you have hypertension is to have you r blood pressure checked on a regular basis. High blood pressure, if not treated, can damage blood vessels in several organs such as the heart, the kidneys, the brain and the eyes. This may lead to heart attacks, heart or kidney failure, strokes or blindness. There are usually no symptoms of high blood pressure before damage occurs, so your doctor needs to measure your blood pressure to see if it is too high.
High blood pressure can be treated and controlled with medicines such as ABISART HCTZ.
One of the active ingredients in ABISART HCTZ is irbesartan which belongs to a class of medicines called angiotensin-II receptor antagonists. Angiotensin II is a substance produced in the body which causes blood vessels to tighten.
Irbesartan blocks angiotensin-II and therefore relaxes your blood vessels. This helps to lower your blood pressure.
The other active ingredient in ABISART HCTZ is hydrochlorothiazide which belongs to a 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.
Your doctor may also have recommended that you adjust your life style to help to lower your high blood pressure (losing weight, avoiding smoking, reducing alcohol consumption and restricting the amount of salt in the diet). Your doctor may also have encouraged the practice of regular, mild (not strenuous) exercise such as walking, swimming, etc.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor’s prescription.
This medicine may affect your ability to drive a car or operate machinery.
Before you take ABISART HCTZ
When you must not take it
Do not take ABISART HCTZ if you are:
allergic to irbesartan or hydrochlorothiazide or to sulfonamide derived medicines
allergic to any of the ingredients listed at the end of this leaflet
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
Do not take this medicine if you are not producing urine.
Do not take this medicine if you are pregnant (or think you may be pregnant) or are planning to become pregnant.
It may affect your developing baby if you take it during pregnancy.
Do not breast-feed if you are taking this medicine.
It is not known if ABISART HCTZ passes into breast milk, therefore it is not recommended to be taken while you are breast-feeding.
Do not give this medicine to children.
Safety and effectiveness in children have not been established.
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.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
you have recently had excessive vomiting or diarrhea or think you are dehydrated
you suffer from any medical conditions especially –
kidney problems, or have had a kidney transplant or dialysis
liver problems, or have had liver problems in the past
gout or have had gout in the past
high or low levels of potassium or sodium or other electrolytes in your blood
you are strictly restricting your salt intake
you are lactose intolerant or have had any allergies to any other medicine or any other substances, such as foods, preservatives or dyes
have had a sympathectomy
you have been taking diuretics
you have a history of allergy or asthma
Be sure you tell your doctor about any of these things before you take any ABISART HCTZ.
If you have not told your doctor about any of the above, tell him/her before you start taking ABISART HCTZ.
Taking ABISART HCTZ with other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and ABISART HCTZ may interfere with each other. It is important that you tell your doctor if you are taking, or plan to take any of the following:
other tablets for high blood pressure
other water tablets or diuretics
lithium or lithium containing medicines (for example Lithicarb®)
potassium tablets (for example Span-K®, Slow-K®, Mag-K®)
potassium containing salt substitutes (for example Pressor-K®)
anti-inflammatory medicines (these are used to relieve pain, swelling and other symptoms of inflammation, including arthritis) and include nonsteroidal anti-inflammatory agents – NSAIDs (for example Voltaren®, Indocid®) and COX-2 inhibitors (for example Celebrex®). Taking a combination of ABISART® HCTZ with an anti-inflammatory medicine may damage your kidneys
strong pain killing medicines such as codeine or morphine
medicines for diabetes (oral tablets or capsules or insulins)
calcium supplements, medicines containing calcium or calcium sparing drugs (for example Vitamin D therapy).
medicines for gout.
powder or granules used to help reduce cholesterol (Questran Lite or Colestid Granules)
heart medicines such as digoxin or antiarrhythmic medicines (for example Sotacor®)
corticosteroid medicines such as prednisone, cortisone or ACTH
medicines used to treat cancer (cytotoxic medicines)
amantadine (Symmetrel), 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 (Tegretol), an anticonvulsant medication.
medicines used during surgery
medicines used in an emergency, such as adrenaline (epinephrine).
These medicines may be affected by ABISART HCTZ or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines or whether you should have check-ups or blood test more frequently.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take ABISART HCTZ
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 box, ask your doctor or pharmacist for help.
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 a day. The full blood pressure lowering effect should be reached 6-8 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.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How to take it
Swallow the tablets whole with a full glass of water.
When to take it
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.
It does not matter whether you take ABISART HCTZ tablets before or after food.
How long to take it
This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
Therefore ABISART HCTZ must be taken every day.
Continue taking ABISART HCTZ until your doctor tells you to stop.
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 it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
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 that you or anyone else may have taken too much ABISART HCTZ. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include feeling lightheaded or dizzy.
While you are taking ABISART HCTZ
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking ABISART HCTZ.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
It may interfere with the results of some tests.
Keep all of your doctor’s appointments so that your progress can be checked.
Get up slowly when getting out of bed or standing up.
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.
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 lightheaded 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.
If you have excessive vomiting and/or diarrhea while taking ABISART HCTZ, tell your doctor.
This can also mean that you are losing too much water and your blood pressure may become too low.
Things you must not do
Do not take ABISART HCTZ 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 stop taking your medicine or change the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen.
Things to be careful of
Be careful driving or operating machinery until you know how ABISART HCTZ affects you.
As with many other medicines used to treat high blood pressure, ABISART HCTZ may cause dizziness or light-headedness in some people. 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 lightheaded.
Be careful when drinking alcohol while you are taking this medicine.
If you drink alcohol, dizziness or light-headedness may be worse.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.
Hydrochlorothiazide contained in this medicine could produce a positive analytical result in antidoping test.
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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ABISART HCTZ.
This medicine helps most people with high blood pressure, 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.
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 if you notice any of the following and they worry you –
dizziness or light-headedness (vertigo)
unusual tiredness or weakness, fatigue
pain in the stomach or gut; nausea and/or vomiting
The above list includes the more common side effects of your medicine. They are usually mild and do not normally require treatment to be interrupted.
Tell your doctor immediately if you notice any of the following:
skin rash or itchiness
aching muscles or aching joints, not caused by exercise
muscle pain, weakness or paralysis of muscles
buzzing, ringing or other persistent noise in the ears
changes in heart rhythm
you are not urinating (passing water) as much as normal
numbness or tingling in fingers or toes
painful, swollen joints which may be symptoms of gout
yellowing of the skin and/or eyes, also called jaundice
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 change in heart rhythm
symptoms that 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 see haloes around lights) and eye pain.
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
If any of the following happen, stop taking ABISART HCTZ and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
swelling to the face, lips, tongue or throat which may cause difficulty in swallowing or breathing. If you have them, you may have a serious allergic reaction to ABISART HCTZ.
severe and sudden onset of pinkish, itchy swellings on the skin, also called hives or nettlerash. If you have them, you may have a serious allergic reaction to ABISART HCTZ.
symptoms that may indicate liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes and dark coloured urine.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
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.
If you notice any other unwanted effects, you should tell your doctor or pharmacist and ask for their advice.
After taking ABISART HCTZ
Keep your tablets in the blister 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 ABISART HCTZ 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.
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
ABISART HCTZ 150/12.5 tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide –
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.
ABISART HCTZ 300/12.5 tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide –
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.
ABISART HCTZ 300/25 tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide –
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.
ABISART HCTZ contains irbesartan and hydrochlorothiazide as the active ingredients.
It also contains the following inactive ingredients:
colloidal anhydrous silica
iron oxide yellow (300/12.5 mg only)
Opadry complete film coating system 03G54386 pink (ARTG no. 107731) (150/12.5 mg and 300/25 mg)
Opadry complete film coating system 03G52390 yellow (ARTG no. 107730) (300/12.5 mg)
ABISART HCTZ contains lactose.
ABISART HCTZ is supplied in Australia by:
Sun Pharma ANZ Pty Ltd.
Macquarie Park NSW 2113
Australian registration numbers:
ABISART HCTZ 150/12.5
Blister pack AUST R 302147
ABISART HCTZ 300/12.5
Blister pack AUST R 302148
ABISART HCTZ 300/25
Blister pack AUST R 302149
This leaflet was prepared on
12 August 2019.
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