Chemmart Irbesartan HCTZ

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Irbesartan and hydrochlorothiazide
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about irbesartan 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 risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.

What this medicine is used for

Irbesartan HCTZ is used to treat high blood pressure (hypertension).
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 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 your blood pressure checked on a regularly basis.

How it works

This product contains both irbesartan and hydrochlorothiazide (HCTZ). 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 which causes blood vessels to tighten. Irbesartan blocks angiotensin-II and therefore relaxes your blood vessels. This helps to lower your blood pressure.
HCTZ 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.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
This medicine is not addictive.
There is not enough information to recommend the use of this medicine for children.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:
irbesartan
hydrochlorothiazide
sulfonamide derived medicines,
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, throat or other parts of the body
itching or hives on the skin.
Do not take this medicine if you are pregnant or intend to become pregnant.
Irbesartan HCTZ may affect your developing baby if you take it during pregnancy.
Do not take this medicine if you are not producing urine.
Do not take this medicine if you are taking a medicine containing aliskiren and either have diabetes or moderate to severe kidney impairment.
Do not take this medicine if you have damage to your kidneys caused by diabetes, called 'diabetic nephropathy', and are on an ACE Inhibitor (used to treat high blood pressure).
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

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:
psoriasis or a history of psoriasis
kidney problems, kidney transplant or dialysis
heart problems
liver problems
diabetes
gout
lupus erythematosus
high or low levels of potassium or sodium or other electrolytes in your blood or you are restricting your salt intake
primary aldosteronism
sympathectomy
allergies or asthma
recent excessive vomiting or diarrhoea, dehydration
hypersensitivity to, or have had an allergic reaction to, penicillin.
Do not take this medicine if you are taking diuretics.
Do not take this medicine if you are breastfeeding until you and your doctor have discussed the risks and benefits involved.
Do not take this medicine if you are planning to have surgery, dental treatment or an anaesthetic.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

Tell your doctor and pharmacist if you are taking any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some medicines may interact with irbesartan HCTZ. These include:
medicines for the heart or high blood pressure (e.g. digoxin, sotalol, other fluid tablets or diuretics)
lithium, used for mood disorders
potassium tablets, potassium containing salt substitutes or other medicinal products that may increase potassium
anti-inflammatory medicines used to relieve pain. Taking a combination of irbesartan HCTZ and an anti-inflammatory medicine may damage your kidneys
alcohol
sleeping tablets
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 (e.g. Vitamin D therapy)
medicines for gout
powder or granules used to help reduce cholesterol
corticosteroid medicines such as prednisone, cortisone or ACTH
medicines used to treat cancer (cytotoxic medicines)
medicines used to treat Parkinson's disease (e.g. amantadine, anticholinergic medicines)
medicines used during surgery
medicines used in an emergency such as adrenaline.
If you are taking any of these, you may need a different dose, or you may need to take different medicines.
Other medicines not listed above may also interact with irbesartan HCTZ.

How to take this medicine

Follow carefully all directions given to you by your doctor.
They may differ to the information contained in this leaflet.

How much to take

Your doctor will tell you how much of this medicine you should take, depending on your condition and if you are taking any other medicines.
The usual dose is one tablet taken once a day. Depending on how your blood pressure responds, your doctor may increase your dose.

How to take it

The tablets should be swallowed whole with a drink of water.

When to take it

Take this 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.
To help you remember to take your tablets each day, Chemmart Irbesartan HCTZ tablets are supplied in a Calendar pack with the foil backing marked with the days of the week. This may help you to remember to take your tablets. All the tablets in the pack are the same.
When you start a new strip of tablets, take the tablet marked "START". On the next day, take the tablet marked with the relevant day of the week.
Continue taking your tablets each day until all the tablets are taken. Commence the next strip at "START" and continue as before.
It does not matter if you take this medicine before or after food.

How long to take it

Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time.
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 missed doses.
This may increase the chance of unwanted side effects.
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 the Emergency Department at your nearest hospital if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using this medicine

Things you must do

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine. If you become pregnant whilst taking this medicine, tell your doctor immediately.
Tell your doctor if you are about to have any blood tests, surgery or dental treatment.
Get up slowly when getting out of bed or standing up especially during the first few doses or if your dose is increased.
You may feel light-headed or dizzy while taking this medicine. This may become worse if you stand up quickly as your blood pressure may fall. 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 occurs, talk to your doctor.
Make sure you drink enough water during exercise and hot weather, especially if you sweat a lot.
If you do not drink enough water, 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 diarrhoea while taking this medicine, tell your doctor.
This can also mean that you are losing too much water and your blood pressure may become too low.
Go to your doctor regularly for a check-up.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as you.
Do not take your medicine to treat any other complaint unless your doctor tells you to.
Do not stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.
As with many other medicines used to treat high blood pressure, Irbesartan HCTZ may cause dizziness or light-headedness in some people. If you drink alcohol, dizziness or light-headedness may be worse.
The hydrochlorothiazide contained in this medicine could produce a positive analytical result in an anti-doping test.

Side effects

Tell your doctor and pharmacist as soon as possible if you do not feel well while you are taking irbesartan HCTZ.
All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Tell your doctor if you notice any of the following:
headache
dizziness or light-headedness
unusual tiredness or weakness, fatigue
pain in the stomach or gut; nausea and/or vomiting
sexual problems
Tell your doctor as soon as possible 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
blurred vision, eye pain
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
fainting
excessive thirst, passing greatly increased amounts of urine, increased appetite with weight loss, feeling tired, drowsy, weak, depressed, irritable and generally unwell (signs of diabetes)
passing little or no urine, drowsiness, nausea, vomiting, breathlessness, loss of appetite and weakness (signs of kidney disease)
nausea, diarrhoea, muscle weakness and changes in heart rhythm (signs of high potassium levels in the blood)
nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes (jaundice) and dark coloured urine (signs of liver disease)
exacerbation of psoriasis
increased tendency of bleeding or bruising
The above list includes serious side effects that may need medical attention:
If any of the following occur, tell your doctor immediately or go to the Emergency department at your nearest hospital:
cough, 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; fainting, hay fever-like symptoms (signs of an allergic reaction)
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients.

Storage and Disposal

Storage

Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, 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 this medicine 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.

Disposal

If your doctor tells you to stop taking this medicine or they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What it looks like

150/12.5 mg tablets: peach, oval, biconvex film-coated tablet debossed with "L183" on one side and plain on the other side. AUST R 216080.
300/12.5 mg tablets: peach, oval, biconvex film-coated tablet debossed with "L184" on one side and plain on the other side. AUST R 216081.
300/25 mg tablets: pinkish brown, oval, biconvex film-coated tablet debossed with "L185" on one side and plain on the other side.
AUST R 216082.
Available in blister packs of 30 tablets.
* Not all strengths may be available.

Ingredients

Each tablet contains either 150 mg or 300 mg of irbesartan and 12.5 mg or 25 mg of hydrochlorothiazide as the active ingredients.
It also contains the following inactive ingredients:
Lactose monohydrate
croscarmellose sodium
povidone
pigment blend PB-24899 (ARPING 107861 consisting of iron oxide red, iron oxide yellow and lactose)
magnesium stearate.
150/12.5 and 300/12.5 tablets also contain Opadry II complete film coating system 30F84418 pink (ARPING 107862 consisting of iron oxide yellow, iron oxide red, hypromellose, lactose, macrogol 4000 and titanium dioxide).
300/25 tablets also contain Opadry II complete film coating system 30F86974 brown (ARPING 107863 consisting of iron oxide yellow, iron oxide red, iron oxide black, hypromellose, lactose, macrogol 4000 and titanium dioxide)
This medicine does not contain gluten, tartrazine or any other azo dyes.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trademarks Apotex Inc.
This leaflet was prepared in June 2019.