Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Accuretic?
Accuretic contains the active ingredients quinapril hydrochloride and hydrochlorothiazide.
Accuretic is used to lower high blood pressure (hypertension).
For more information, see Section
1. Why am I using Accuretic? in the full CMI.
2. What should I know before I use Accuretic?
Do not use if you have ever had an allergic reaction to Accuretic, any sulfonamide
or sulfur medicines 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 use Accuretic? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Accuretic and affect how it works.
4. How do I use Accuretic?
For most patients, the usual starting dose is one Accuretic 10 mg/12.5 mg tablet a
day. The dose may need to be increased to one Accuretic 20 mg/12.5 mg tablet a day,
then two Accuretic 10 mg/12.5 mg tablets a day if necessary.
5. What should I know while using Accuretic?
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using Accuretic.
Make sure you drink enough water during exercise and hot weather, especially if you
sweat a lot.
Tell your doctor if you have excess vomiting and/or diarrhoea while taking Accuretic.
Tell your doctor immediately if you feel light-headed or dizzy after taking your first
dose of Accuretic, or when your dose is increased.
Have your blood pressure checked when your doctor says, to make sure Accuretic is
working.
Regularly check your skin for any new or suspicious skin lesions.
|
Things you should not do
|
Do not stop using this medicine, or change the dosage, without checking with your
doctor.
|
Driving or using machines
|
Be careful driving or operating machinery until you know how Accuretic affects you.
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Drinking alcohol
|
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly. Drinking alcohol may make these symptoms worse. If it does, reduce your
consumption of alcohol.
Your doctor may advise you to limit your alcohol intake.
|
Looking after your medicine
|
Keep your tablets in a cool dry place where the temperature stays below 25°C.
|
6. Are there any side effects?
Side effects include feeling light-headed, dizzy or faint, dry cough, headache, nausea
or vomiting, stomach pain, diarrhoea, constipation, tiredness or weakness, fatigue,
sleepiness or drowsiness, impotence, runny or blocked nose, sneezing, loss of taste,
confusion, restlessness, back pain, indigestion, sore throat, rash. For more serious
side effects and further 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):
quinapril hydrochloride and hydrochlorothiazide (quin-a-pril hi-dro-clor-ride and hi-dro-clor-o-thigh-a-zide)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Accuretic. 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 Accuretic.
Where to find information in this leaflet:
1. Why am I using Accuretic?
Accuretic contains the active ingredients quinapril hydrochloride and hydrochlorothiazide. Accuretic is a combination of a medicine called angiotensin converting enzyme (ACE)
inhibitor and a diuretic "water tablet".
Accuretic is used to lower 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 hypertension (high blood pressure) when your blood pressure stays higher
than is needed, even when you are calm and relaxed.
There are usually no symptoms of hypertension. The only way of knowing that you have
hypertension is to have your blood pressure checked on a regular basis. If high blood
pressure is not treated it can lead to serious health problems, including stroke,
heart disease and kidney failure.
Accuretic works by:
widening your blood vessels, which reduces pressure in the vessels, making it easier
for your heart to pump blood around your body.
making your kidneys pass more water and salt and retain more potassium. This helps
reduce high blood pressure.
2. What should I know before I use Accuretic?
Warnings
Do not use Accuretic if:
1. you are allergic to quinapril hydrochloride or hydrochlorothiazide, any sulfonamide
or sulfur medicines, or any of the ingredients listed at the end of this leaflet
One of the active ingredients of Accuretic, hydrochlorothiazide, is a sulfur-containing
medicine (a sulfonamide). Therefore, if you are allergic to sulfur medicines, such
as some antibiotics, you are likely to be allergic to Accuretic. Check with your doctor
or pharmacist if you are not sure whether you are allergic to sulfur medicines.
Symptoms of an allergic reaction to Accuretic may include skin rash, itchiness, shortness
of breath, swelling of the face, lips or tongue, muscle pain or tenderness or joint
pain.
Always check the ingredients to make sure you can use this medicine
2. you have taken any other 'ACE inhibitor' medicine before, which caused your face,
lips, tongue, throat, hands or feet to swell up, or made it hard for you to breathe
If you have had an allergic reaction to an ACE inhibitor before, you may be allergic
to Accuretic.
3. you or your family have a history of swelling of the face, lips, tongue, throat, hands
or feet for no apparent reason
4. you have kidney problems or a condition called 'renal artery stenosis'
5. you have regular dialysis for blood filtration
6. you are currently taking a blood pressure lowering medicine containing aliskiren or
with medicines known as angiotensin receptor blockers (ARB) or other ACE inhibitors
and you have the following conditions:
diabetes
kidney problems
high levels of potassium in your blood
congestive heart failure.
7. you are currently taking a neutral endopeptidase inhibitor, used to treat high blood
pressure or heart failure
Taking Accuretic with a neutral endopeptidase inhibitor (e.g. sacubitril/ valsartan
combination) increases your risk of angioedma, rapid swelling of your face, lips,
mouth, tongue or throat and may result in difficulty in swallowing or breathing.
8. you are pregnant or breastfeeding
Accuretic may enter your womb or it may pass into the breast milk and there is the
possibility that your baby may be affected.
9. the expiry date printed on the pack has passed or if the packaging is torn or shows
signs of tampering.
Check with your doctor if you:
have any allergies to any other medicines, foods, preservatives or dyes
have any other medical conditions, especially the following:
kidney problems, or are having dialysis
liver problems
heart problems
low blood pressure, which you may notice as dizziness or light-headedness
diabetes
high levels of potassium in your blood
gout
high cholesterol
Systemic Lupus Erythematosus (SLE), scleroderma or other autoimmune diseases
non-melanoma skin cancer
psoriasis (red patches on your skin) or worsening of already existing psoriasis.
have previously had trouble breathing, fever, or low blood pressure after taking hydrochlorothiazide
are following a very low salt diet
are about to receive desensitisation therapy for an allergy
are about to undergo dialysis or lipoprotein apheresis
are about to have surgery or a general anaesthetic
take any medicines for any other condition.
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
If you become pregnant while taking Accuretic, tell your doctor immediately.
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Children
The safety and effectiveness of Accuretic in children have not been established.
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.
Some medicines may interfere with Accuretic and affect how it works.
Tell your doctor or pharmacist if you are taking any of the following:
other medicines used to treat high blood pressure
other medicines that work in a similar fashion to ACE inhibitors, such as Angiotensin
Receptor Blockers (these are used to treat high blood pressure and/or heart failure)
digoxin, a medicine used to treat heart failure
neutral endopeptidase inhibitor (e.g. sacubitril/valsartan combination), a medicine
used to treat high blood pressure or heart failure.
other diuretics, also known as fluid or water tablets
non-steroidal anti-inflammatory drugs (NSAIDs) or Cox-2 inhibiting medicines used
to relieve pain, swelling and other symptoms of inflammation, including arthritis
allopurinol, a medicine used to treat gout
potassium supplements or potassium-containing salt substitutes
lithium, a medicine used to treat mood swings and some types of depression
tetracycline antibiotics
trimethoprim or trimethoprim/sulfamethoxazole, medicines used to treat bacterial infections
any other antibiotics and medicines to treat infections
steroid medicines such as cortisone, prednisone
insulin and tablets used to treat diabetes
barbiturates, used to treat epilepsy, such as phenobarbitone
strong pain killers such as codeine, morphine, dextropropoxyphene
cholestyramine and colestipol, used to treat high cholesterol
medicines used to relax muscles before and during surgery
medicines used in emergency situations such as adrenaline.
Tell your doctor if you are taking any of the following blood pressure lowering medicines:
angiotensin II receptor blocker (ARB)
aliskiren.
For some patients, Accuretic should not be taken in combination with these medicines.
Your doctor may check your kidney function, blood pressure and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
Tell your doctor if you are taking any of the following medicines:
mTOR inhibitors (e.g. temsirolimus), used in the treatment of kidney cancer
DPP-IV inhibitors (e.g. vildagliptin), used in the treatment of diabetes.
Taking Accuretic in combination with these medicines may increase your risk of having
an allergic reaction.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Accuretic.
4. How do I use Accuretic?
How much to take
for most patients, the usual starting dose is one Accuretic 10 mg/12.5 mg tablet a
day
the dose may need to be increased to one Accuretic 20 mg/12.5 mg tablet a day, then
two Accuretic 10 mg/12.5 mg tablets a day if necessary
most patients take between 10 mg/12.5 mg to 20 mg/12.5 mg daily
each dose may be taken once a day
follow the instructions provided and use Accuretic until your doctor tells you to
stop.
When to take Accuretic
take Accuretic at about the same time each day, with or without food
Taking it at the same time each day will have the best effect. It will also help you
remember when to take the tablets.
It does not matter whether you take it with or without food.
How to take Accuretic
swallow the tablets whole with a full glass of water
do not chew the tablets.
If you forget to use Accuretic
Accuretic should be used regularly at the same time each day.
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 use too much Accuretic
If you think that you have used too much Accuretic, you may need urgent medical attention.
You should immediately:
telephone 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 Accuretic?
Things you should do
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are taking Accuretic.
Make sure you drink enough water during exercise and hot weather when you are taking
Accuretic, especially if you sweat a lot.
If you do not drink enough water while taking Accuretic, you may feel faint, light-headed
or sick. This is because your blood pressure is dropping suddenly. If you continue
to feel unwell, tell your doctor.
Tell your doctor if you have excess vomiting and/or diarrhoea while taking Accuretic,
or you have any of the following symptoms:
dry mouth, thirst
weakness, tiredness, drowsiness
muscle pains or cramps
fast heart beat
passing less urine than normal.
You may be dehydrated because you are losing too much water.
If you are going to have surgery that needs a general anaesthetic, tell your doctor
or dentist that you are taking Accuretic.
Your blood pressure may drop suddenly.
If you are about to have any blood tests, tell your doctor that you are taking Accuretic.
Accuretic may interfere with the results of some tests.
Have your blood pressure checked when your doctor says, to make sure Accuretic is
working.
Regularly check your skin for any new or suspicious skin lesions. It has been observed
that one of the ingredients in Accuretic may increase the risk of non-melanoma skin
cancer if used at a high dose, or for an extended period.
Limit sun exposure and use adequate sun protection to minimise risk.
Go to your doctor regularly for a check-up.
Your doctor may occasionally do a blood test to check your potassium levels and see
how your kidneys are working.
Call your doctor straight away if you feel light-headed or dizzy after taking your
first dose of Accuretic, or when your dose is increased.
Things you should not do
do not stop using this medicine suddenly, or change the dosage, without checking with
you doctor
do not give your medicine to anyone else, even if they have the same condition as
you
do not take Accuretic to treat any other complaints unless your doctor or pharmacist
tells you to.
Things that would be helpful for your blood pressure
Some self-help measures suggested below may help your condition.
Talk to your doctor or pharmacist about these measures and for more information.
Alcohol
Your doctor may advise you to limit your alcohol intake.
Weight
Your doctor may suggest losing some weight to help lower your blood pressure and help
lessen the amount of work your heart has to do. Some people may need a dietician's
help to lose weight.
Diet
Eat a healthy diet which includes plenty of fresh vegetables, fruit, bread (preferably
wholegrain), cereals and fish. Also eat less sugar and fat (especially saturated fat)
which includes sausages, fatty meats, full cream dairy products, biscuits, cakes,
pastries, chocolates, chips and coconut. Monounsaturated and polyunsaturated fats
from olive oil, canola oil, avocado and nuts are beneficial in small quantities.
Salt
Your doctor may advise you to watch the amount of salt in your diet. To reduce your
salt intake you should avoid using salt in cooking or at the table and avoid cooked
or processed foods containing high sodium (salt) levels.
Exercise
Regular exercise, maintained over the long term, helps to reduce blood pressure and
helps get the heart fitter. Regular exercise also improves your blood cholesterol
levels, helps reduce your weight and stress levels, and improves your sleep, mood
and ability to concentrate. However, it is important not to overdo it. Before starting
any exercise, ask your doctor about the best kind of programme for you.
Smoking
Your doctor may advise you to stop smoking or at least cut down. Ask your doctor or
pharmacist for further information and advice.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Accuretic
affects you.
As with other medicines in this class, Accuretic may cause dizziness, light-headedness
or tiredness in some people. Make sure you know how you react to Accuretic before
you drive a car, operate machinery, or do anything else that could be dangerous if
you are dizzy or light-headed. If this occurs do not drive. If you drink alcohol,
dizziness or light-headedness may be worse.
Drinking alcohol
Be careful if you feel light-headed, dizzy or faint when getting out of bed or standing
up. It is suggested you 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.
Drinking alcohol may make these symptoms worse. If it does, reduce your consumption
of alcohol.
Looking after your medicine
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Follow the instructions on 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.
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.
Mild side effects
Mild side effects
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What to do
|
feeling light-headed, dizzy or faint
dry cough
headache
feeling sick (nausea) or vomiting
stomach pain
diarrhoea
constipation
unusual tiredness or weakness, fatigue
sleepiness or drowsiness
difficulty in getting or maintaining an erection (impotence)
runny or blocked nose, or sneezing
taste disturbances or loss of taste
confusion or nervousness
restlessness
back pain
indigestion
sore throat and discomfort when swallowing
rash
|
Speak to your doctor if you have any of these mild side effects and they worry you.
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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 Accuretic contains
Active ingredients
(main ingredient)
|
Accuretic 10 mg/12.5 mg - 10 mg quinapril hydrochloride and 12.5 mg hydrochlorothiazide
per tablet
Accuretic 20 mg/12.5 mg - 20 mg quinapril hydrochloride and 12.5 mg hydrochlorothiazide
per tablet
|
Other ingredients
(inactive ingredients)
|
crospovidone
lactose monohydrate
magnesium carbonate hydrate
magnesium stearate
povidone
candelilla wax
Opadry Pink OY-S-6937
|
Do not take this medicine if you are allergic to any of these ingredients.
What Accuretic looks like
Accuretic 10 mg/12.5 mg - pink, oval, biconvex, film-coated tablets, scored on both
sides
AUST R 81930
Accuretic 20 mg/12.5 mg - pink, triangular, biconvex, film-coated tablets, scored
on one side
AUST R 81931
A box of Accuretic contains 30 tablets.
Who distributes Accuretic
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in July 2022.
© Pfizer Australia Pty Ltd 2022
®Registered Trade Mark