General Information
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking AVAPRO HCT. This
leaflet answers some common questions about AVAPRO HCT. It
does not contain all the available information. It does not take
the place of talking to your doctor or pharmacist. Do not throw
this leaflet away. You may need to refer to it again later.
Always follow the instructions that your doctor and pharmacist
give you about AVAPRO HCT. If you have any concerns about
taking AVAPRO HCT, ask your doctor or pharmacist.
What is AVAPRO HCT
AVAPRO HCT is a trade name (manufacturer's name). AVAPRO
HCT tablets contain two medicines, irbesartan and
hydrochlorothiazide. Both these medicines are in the tablets
your doctor has prescribed for you.
What AVAPRO HCT is used for AVAPRO HCT lowers high blood
pressure, which doctors call hypertension. 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 your 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
AVAPRO HCT. Your doctor may also have recommended that you
adjust your lifestyle 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. What
AVAPRO HCT does and how it works AVAPRO HCT contains
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 which causes
blood vessels to tighten. Irbesartan blocks angiotensin-II and
therefore relaxes your blood vessels. 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. Your doctor may have prescribed AVAPRO HCT for
another use. If you want more information, ask your doctor.
When you must not take AVAPRO HCT Do not take AVAPRO HCT
if :
you are pregnant (or think you may be pregnant) or are planning
to become pregnant.
Your baby may absorb this medicine in the womb and there is a
possibility of harm to the baby.
you are breast-feeding.
you are allergic to irbesartan or hydrochlorothiazide or to
sulfonamide derived medicines, or to any of the ingredients
listed under Product Description at the end of this leaflet.
you are not producing urine.
the packaging is torn or shows signs of tampering.
the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may
not work. If you are not sure if you should start taking AVAPRO
HCT, talk to your doctor. AVAPRO HCT should not be given to
children. Before you start to take AVAPRO HCT Tell your doctor
if:
you are or intend to become pregnant or plan to breast-feed
AVAPRO HCT should not be used during pregnancy or while
breast-feeding
you have recently had excessive vomiting or diarrhoea or think
you are dehydrated
you suffer from any medical conditions especially-
kidney problems, or have had a kidney transplant or dialysis
heart problems
liver problems, or have had liver problems in the past
diabetes
gout or have had gout in the past
lupus erythematosus
high or low levels of potassium or sodium or other electrolytes
in your blood
primary aldosteronism
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 AVAPRO HCT.
Taking AVAPRO HCT with other medicines Tell your doctor if you
are taking any other medicines, including medicines that you
buy without a prescription from your pharmacy, supermarket or
health food shop.
It is especially 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 Avapro HCT
and an anti-inflammatory medicine may damage your kidneys.
alcoholic drinks
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 (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.
medicines used during surgery.
medicines used in an emergency situation such as adrenaline.
Your doctor will decide whether your treatment needs to be
altered or whether you should have check ups more frequently.
How to take AVAPRO HCT The tablets should be taken regularly
as directed by your doctor. The tablets should be swallowed with
a drink of water. How much to take:
AVAPRO HCT 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 AVAPRO HCT.
The usual dose of AVAPRO HCT 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 AVAPRO HCT, your doctor may
prescribe another medicine to be taken with AVAPRO HCT. When
to take it:
You should always take your daily dose of AVAPRO HCT at about
the same time each day. Taking your AVAPRO HCT tablets at the
same time each day will have the best effect. To help you
remember to take your tablets each day, AVAPRO HCT 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". 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. It does not matter whether you
take AVAPRO HCT tablets before or after food. How long to take
it:
AVAPRO HCT helps to control your high blood pressure, but does
not cure it. Therefore AVAPRO HCT must be taken every day.
Continue taking AVAPRO HCT until your doctor tells you to stop.
If you miss a dose:
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. If you are not sure whether to skip the
dose, talk to your doctor or pharmacist. Do not take a double
dose to make up for the missed dose.
If you have trouble remembering to take your tablets, ask your
pharmacist for some hints. If you take too much AVAPRO HCT
(overdose) Immediately telephone your doctor or Poisons
Information Centre (telephone: 131126) or go to the Accident
and Emergency Department at your nearest hospital, if you or
anyone else may have taken too much AVAPRO HCT.
Do this even if there are no signs of discomfort or poisoning. If
you take too many AVAPRO HCT tablets, you will probably feel
lightheaded or dizzy. While you are using AVAPRO HCT Things
you must do:
If you become pregnant while taking AVAPRO HCT tell your
doctor immediately.
Have your blood pressure checked when your doctor tells you to,
to make sure AVAPRO HCT is working.
If you are about to start on any new medicine, tell your doctor
and pharmacist that you are taking AVAPRO HCT.
Get up slowly when getting out of bed or standing up.
You may feel light-headed or dizzy while taking AVAPRO HCT.
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 it occurs talk to your
doctor.
If you plan to have surgery or other treatment (even at the
dentist) that needs an anaesthetic, make sure that you tell your
doctor or dentist that you are taking AVAPRO HCT
Make sure you drink enough water during exercise and hot
weather when you are taking AVAPRO HCT, especially if you
sweat a lot.
If you do not drink enough water while taking AVAPRO HCT, 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.
If you have excessive vomiting and/or diarrhoea while taking
AVAPRO HCT, tell your doctor. This can also mean that you are
losing too much water and your blood pressure may become too
low.
Follow all directions given to you by your doctor 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. Things you must not do:
Do not give AVAPRO HCT tablets to anyone else, even if they
have the same condition as you.
Things to be careful of:
Be careful driving or operating machinery until you know how
AVAPRO HCT affects you. As with many other medicines used to
treat high blood pressure, AVAPRO HCT may cause dizziness or
light-headedness in some people. Make sure you know how you
react to AVAPRO HCT before you drive a car, operate machinery
or do anything else that could be dangerous if you are dizzy or
light-headed.
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 antidoping test.
Side effects AVAPRO HCT helps most people with high blood
pressure, but it may have unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious.
Most of the time they are not. Tell your doctor or pharmacist as
soon as possible if you do not feel well while you are taking
AVAPRO HCT. Tell your doctor if you notice any of the following
and they worry you -
headache
dizziness or light-headedness
unusual tiredness or weakness, fatigue
pain in the stomach or gut; nausea and/or vomiting
sexual problems
These are generally 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
fainting
yellowing of the skin and/or eyes, also known as 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 changes in
heart rhythm
These are serious side effects. Skin rash and itchiness may be
symptoms of an allergic reaction.
You may need medical attention. These side effects are not
common. If any of the following happen, stop taking AVAPRO
HCT and tell your doctor immediately or go to casualty 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 AVAPRO HCT
severe and sudden onset of pinkish, itchy swellings on the skin,
also called hives or nettle rash. If you have them, you may have
a serious allergic reaction to AVAPRO HCT
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.
These are serious side effects. You may need urgent medical
attention or hospitalisation. These side effects are very rare.
Other side effects not listed above may occur in some patients.
If you notice any other unwanted effects, you should tell your
doctor or pharmacist and ask for their advice. After using
AVAPRO HCT Storage:
Keep your AVAPRO HCT tablets in the blister pack until it is time
to take them.
If you take the tablets out of the blister pack they will not keep
well. Keep AVAPRO HCT tablets in a cool dry place where the
temperature stays below 25 °C. Do not store AVAPRO HCT or any
other medicine in the bathroom near a sink. Do not leave them
near a radiator, in a car on a hot day or on a window sill. Heat
and dampness can destroy some medicines. Keep all medicines
out of the reach of children. 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 AVAPRO HCT or the
tablets have passed their expiry date, ask your pharmacist what
to do with any tablets that are left over. Product description
What it looks like
Starting from January 2006 the manufacturer will be supplying a
new formulation of Avapro HCT tablets with some different
inactive ingredients. Therefore, until all stocks of the original
formulation have been used up, your pharmacist may give you
either the original formulation or the new one. There is only a
slight difference between the appearance of the original and the
new tablets (see below).
There is no difference between the two formulations in the
active ingredient or how well Avapro HCT tablets work. Original
formulation AVAPRO HCT 150/12.5 tablets - peach, oval tablet
with a heart shape on one side and "2775" on the other. Pack
size: 30 tablets. AUST R 68971 AVAPRO HCT 300/12.5 tablets -
peach, oval tablet with a heart shape on one side and "2776" on
the other. Pack size : 30 tablets. AUST R 68973 New formulation
AVAPRO HCT 150/12.5 tablets - peach, oval, film-coated tablet
with a heart shape on one side and "2875" on the other. Pack
size: 30 tablets. AUST R 102017 AVAPRO HCT 300/12.5 tablets
- peach, oval, film-coated tablet with a heart shape on one side
and "2876" on the other. Pack size : 30 tablets. AUST R 102086
New strength AVAPRO HCT 300/25 tablets - pink, oval, film-
coated tablet with a heart shape on one side and "2788" on the
other. Pack size: 30 tablets. AUST R 129436. Active Ingredients
AVAPRO HCT 150/12.5 tablets - 150 mg Irbesartan and 12.5 mg
Hydrochlorothiazide per tablet.
AVAPRO HCT 300/12.5 tablets - 300 mg Irbesartan and 12.5 mg
Hydrochlorothiazide per tablet. AVAPRO HCT 300/25 tablets -
300 mg Irbesartan and 25 mg Hydrochlorothiazide per tablet.
Other Ingredients
Original formulation
AVAPRO HCT tablets also contain microcrystalline cellulose,
croscarmellose sodium, lactose, magnesium stearate, silicon
dioxide, pregelatinised maize starch, and red and yellow iron
oxides
New formulation
AVAPRO HCT tablets also contain carnauba wax, croscarmellose
sodium, hypromellose, lactose, iron oxide red CI 77491, iron
oxide yellow CI 77492, macrogol 3000, magnesium stearate,
microcrystalline cellulose, silicon dioxide, and titanium dioxide.
New strength AVAPRO HCT 300/25 tablets also contain carnauba
wax, microcrystalline cellulose, croscarmellose sodium, lactose,
magnesium stearate, silicon dioxide, pregelatinised maize
starch, hypromellose, titanium dioxide, macrogol 3350 and red,
yellow & black iron oxides How current is this information This
leaflet was produced based on information known by Bristol-
Myers Squibb Australia Pty Ltd June 2007. You need to consult
your doctor regularly as your doctor has access to information
on any changes which may affect you. Who makes AVAPRO HCT
AVAPRO HCT is made available by
Bristol-Myers Squibb Australia Pty Ltd,
A.C.N. 004 333 322,
556 Princes Highway,
Noble Park VIC 3174,
Australia.
AVAPRO is a registered sanofi-aventis Trademark. This
information in no way replaces the advice of your doctor or
pharmacist. Version 4 June 2007