Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about PRINIVIL. 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 taking PRINIVIL 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 need to read it again.
What PRINIVIL is used for
PRINIVIL lowers high blood pressure, which doctors call hypertension. It is also used to treat heart failure and patients who have just had a heart attack.
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. You may feel fine and have no symptoms, but eventually hypertension can cause stroke, heart disease and kidney failure. PRINIVIL helps to lower your blood pressure.
Heart failure means that the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure is not the same as heart attack and does not mean that the heart stops working. Heart failure may start off with no symptoms, but as the condition progresses, patients may feel short of breath or may get tired easily after light physical activity such as walking. Some patients may wake up short of breath at night. Fluid may collect in different parts of the body, often first noticed as swollen ankles and feet.
PRINIVIL helps to treat heart failure and may improve your symptoms.
When used to treat heart failure, PRINIVIL is almost always used with other medicines called diuretics or fluid tablets. These medicines help the kidney get rid of excess fluid from the body.
A heart attack occurs when one of the major blood vessels supplying blood to the heart muscle becomes blocked.
As a result of the blockage, the heart does not receive the oxygen it needs and the heart muscle is damaged. This damage may lead to further complications, such as heart failure, irregular heart rhythms and blood clots.
In some patients, PRINIVIL may help to prevent some complications of heart attack, such as heart failure.
How PRINIVIL works
One of the ways PRINIVIL helps lower blood pressure and treat heart failure is that it widens blood vessels. This means that blood is able to pass through them more easily and the heart doesn’t have to pump as hard to move blood around the body. This also means that when you place extra demands on your heart, such as during exercise, the heart may cope better so you may not get short of breath as easily.
PRINIVIL belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors.
Your doctor may have prescribed PRINIVIL for another reason. Ask your doctor if you have any questions about why PRINIVIL has been prescribed for you.
PRINIVIL is not addictive.
Before you take PRINIVIL
When you must not take it
Do not take PRINIVIL if:
- you have taken any other ‘ACE inhibitor’ medicines for high blood pressure, heart failure or heart attack 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 PRINIVIL.
- you have an allergy to PRINIVIL or Zestril™ (which is another brand of lisinopril) or any of the ingredients listed at the end of this leaflet
Symptoms of an allergic reaction to PRINIVIL may include skin rash, itchiness, difficulty breathing or swallowing, or swelling of the face, lips, tongue or throat.
- you have a history of swelling of the face, lips, tongue, throat, hands or feet, for no apparent reason
- you have diabetes and are taking a medicine called aliskiren to reduce blood pressure.
Do not take PRINIVIL if:
- you are pregnant or intend to become pregnant while taking PRINIVIL
Your baby may absorb this medicine in the womb and therefore there is a possibility of serious harm to the baby.
- you are breast-feeding.
Do not take PRINIVIL if:
- 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 whether you should start taking PRINIVIL, talk to your doctor.
Before you start to take it
Tell your doctor if:
- you intend to become pregnant or plan to breast-feed
PRINIVIL should not be used during pregnancy or while breast-feeding.
- you have any medical conditions, especially the following:
- kidney disease, or are undergoing dialysis
- liver disease
- low blood pressure, which you may notice as light-headedness or dizziness, especially when standing
- heart problems.
- you have recently suffered from excessive vomiting or diarrhoea
- you are following a very low salt diet
- you have had an allergy to any other medicines or any other substances, such as foods, preservatives or dyes
- surgery and anaesthesia (even at the dentist office) are scheduled, as there may be a sudden fall in blood pressure associated with anaesthesia.
If you have not told your doctor about any of the above, tell them before you take any PRINIVIL.
Taking 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. Some medicines and PRINIVIL may interfere with each other. These include:
- other medicines used to treat high blood pressure
- diuretic tablets – also called fluid or water tablets
- lithium, a medicine used to treat mood swings and some types of depression
- potassium tablets
- potassium-containing salt substitutes
- potassium-sparing agents (e.g. spironolactone, eplerenone, triamterene, amiloride)
- non-steroidal anti-inflammatory medicines, such as indomethacin
- arthritis medicines including gold therapy
- insulin or oral antidiabetic medicines. You should be closely monitored for low blood glucose levels, especially during the first month of treatment with PRINIVIL
- mammalian target of rapamycin inhibitors (e.g. temsirolimus, sirolimus, everolimus).
These medicines may be affected by PRINIVIL, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking PRINIVIL.
How to take PRINIVIL
How much to take
Your doctor will tell you how many tablets you need to take each day.
The number will depend on your condition and whether you are taking other medicines.
Take PRINIVIL only when prescribed by your doctor.
For high blood pressure:
For most patients, the usual starting dose is 5 to 10 mg taken once a day. Some patients may need a lower starting dose. The dose may need to be increased depending on your blood pressure. Most patients take between 10 to 20 mg each day, taken once a day.
For heart failure:
The usual starting dose is 2.5 mg taken once a day. Depending on your response, this dose may need to be increased up to 20 mg each day, taken once a day.
For heart attack:
PRINIVIL may be started within 24 hours of the onset of the symptoms of heart attack. The usual starting dose is 5 mg, which is followed 24 hours later by another 5 mg dose. This is then followed 48 hours later by a 10 mg dose, and then 10 mg taken once a day thereafter. Some patients may need a lower starting and maintenance dose.
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.
How to take it
Take your PRINIVIL at about the same time each day. Taking your tablet(s) at the same time each day will have the best effect. It will also help you remember when to take the tablets.
Swallow PRINIVIL with a glass of water. It does not matter whether you take PRINIVIL before or after food.
How long to take it
PRINIVIL helps control your high blood pressure and helps improve your heart failure, but does not cure it. Therefore PRINIVIL must be taken every day. Continue taking PRINIVIL for as long as your doctor prescribes.
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 tablet(s) 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 dose that you missed.
If you have trouble remembering to take your tablets, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much PRINIVIL. Do this even if there are no signs of discomfort or poisoning.
If you take too many tablets, you will probably feel light-headed or dizzy, or you may faint.
While you are using PRINIVIL
Things you must do
Have your blood pressure checked when your doctor says, to make sure PRINIVIL is working.
If you feel any light-headedness or dizziness after you take your first dose of PRINIVIL or when your dose is increased, tell your doctor immediately. This is especially important if you are taking PRINIVIL for heart failure.
If you feel light-headed, dizzy or faint get up slowly when getting out of bed or standing up. You may feel light-headed or dizzy, especially if you are also taking a diuretic (fluid tablet). This may be because your blood pressure is falling suddenly. 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 gets worse or continues, talk to your doctor.
If you become pregnant while taking PRINIVIL tell your doctor immediately.
If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking PRINIVIL.
If you plan to have surgery (even at the dentist) that needs a general anaesthetic tell your doctor or dentist that you are taking PRINIVIL. Your blood pressure may drop suddenly.
Make sure you drink enough water during exercise and hot weather when you are taking PRINIVIL, especially if you sweat a lot. If you do not drink enough water while taking PRINIVIL, you may faint or feel light-headed or sick. This is because your blood pressure is dropping suddenly. If you continue to feel unwell, tell your doctor.
If you have excessive vomiting and/or diarrhoea while taking PRINIVIL tell your doctor. This can also mean that you are losing too much water and salt and may drop your blood pressure too much.
Go to your doctor regularly for a check-up. Your doctor may occasionally do a blood test to check your potassium level in the blood and to see how your kidneys are working.
Things you must not do
Do not give PRINIVIL 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 PRINIVIL affects you.
PRINIVIL may cause dizziness or light-headedness in some people, especially after the first dose or if the dose is increased. Make sure you know how you react to PRINIVIL 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.
Things that would be helpful for your blood pressure or heart failure
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.
- Diet –
eat a healthy diet which includes plenty of fresh vegetables, fruit, bread, cereals and fish. Also eat less fat and sugar.
- Exercise –
regular exercise helps to reduce blood pressure and helps the heart get fitter, but it is important not to overdo it. Walking is good exercise, but try to find a route that is fairly flat. Before starting any exercise, ask your doctor about the best kind of programme for you.
- 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.
- Smoking –
your doctor may advise you to stop smoking or at least cut down.
- 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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PRINIVIL.
PRINIVIL helps most people with high blood pressure and heart failure, 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. You may need medical treatment if you get some of the side effects.
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:
- light-headedness or dizziness
- dry cough
- mild stomach upsets such as feeling sick, diarrhoea, or stomach pains
- hair loss or thinning
These are usually mild side effects of PRINIVIL, but may be serious.
Tell your doctor immediately if you notice any of the following:
- changes in the way your heart beats, for example, if you notice it beating faster
- yellowing of the skin and/or eyes, also called jaundice
- skin problems including itchiness, rash, or painful areas
- signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
- bruising more easily than normal
- signs of anaemia, such as tiredness, being short of breath, and looking pale
- severe abdominal pain
- tingling or numbness of the hands or feet
- passing less urine than is normal for you
- swelling of the hands, feet, or ankles
- signs of dehydration such as nausea, vomiting, muscle cramps, headache, drowsiness and tiredness. If untreated, mental confusion and fits may develop. Your doctor may need to monitor your blood sodium levels.
These may be serious side effects. You may need urgent medical attention.
Serious side effects are rare.
If any of the following happen, stop taking PRINIVIL and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
- pinkish, itchy swellings on the skin, also called hives or nettle rash
- chest pain, angina
- wheeziness due to tightness in the chest
- collapse, numbness or weakness of arms or legs
- severe skin reaction which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell.
These are serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Other side effects not listed above may also occur in some patients.
Tell your doctor if you notice any other effects. Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using PRINIVIL
Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.
Keep it in a cool dry place where the temperature stays below 30°C.
Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Do not store the tablets in the freezer. Freezing can damage 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 the tablets or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
What it looks like
PRINIVIL comes in three types of tablets:
- PRINIVIL 5 – white, shield-shaped tablet with PRINIVIL marked on one side.
- PRINIVIL 10 – light yellow, shield-shaped tablet with PRINIVIL marked on one side.
- PRINIVIL 20 – peach, shield-shaped tablet with PRINIVIL marked on one side.
A box of PRINIVIL contains 30 tablets.
- PRINIVIL 5 – 5 mg lisinopril per tablet
- PRINIVIL 10 – 10 mg lisinopril per tablet
- PRINIVIL 20 – 20 mg lisinopril per tablet
- calcium hydrogen phosphate
- maize starch
- pregelatinised maize starch
- magnesium stearate
- iron oxide yellow CI77492 (PRINIVIL 10 mg and 20 mg)
- iron oxide red CI77491 (PRINIVIL 20 mg)
PRINIVIL does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.
PRINIVIL is supplied in Australia by:
Merck Sharp & Dohme (Australia) Pty Limited
Level 1 Building A, 26 Talavera Road, Macquarie Park NSW 2113
This leaflet was prepared in September 2015.
Australian Register Numbers:
PRINIVIL 5 – AUST R 34377
PRINIVIL 10 – AUST R 34378
PRINIVIL 20 – AUST R 34379
Published by MIMS November 2016