APO-Ramipril Capsules

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

contains the active ingredient ramipril
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about this medicine. 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 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 need to read it again.

What this medicine is used for

The name of your medicine is APO-Ramipril. It contains the active ingredient, ramipril.
Ramipril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors.
Ramipril is used to treat:
high blood pressure (hypertension)
some heart conditions, such as heart failure after a heart attack
kidney problems in some patients
Ramipril is also used to reduce the risk of cardiovascular problems and complications in patients aged 55 years or more with heart or blood vessel disease, or diabetes.
High Blood Pressure (Hypertension)
Ramipril 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 and can be influenced by how busy or worried you are. You have 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 high blood pressure. The only way of knowing that you have high blood pressure 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.
Heart Failure after a Heart Attack
Ramipril may be used after a heart attack. A heart attack occurs when one of the major blood vessels supplying blood to your heart becomes blocked. This means that your heart muscle cannot receive the oxygen it needs and becomes damaged. This may lead to further problems, such as heart failure, irregular heart rhythms and blood clots.
Heart failure means that the heart muscle is weak and 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. 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.
Kidney Problems
Ramipril may be used to treat some kidney problems. Some conditions, such as diabetes and high blood pressure, can lead to kidney problems. These problems develop slowly over several years. Good control of your blood sugar and blood pressure are important in keeping your kidneys healthy but may not always prevent kidney damage from occurring.
Prevention of Cardiovascular Problems and Complications
Ramipril may be used to reduce the risk of some of the problems and complications that may arise in patients aged 55 years or more who have problems such as coronary artery disease (heart disease caused by poor blood flow in the blood vessels of the heart), peripheral vascular disease (poor circulation in the hands or feet) or stroke.
Patients with Diabetes
Ramipril may also be used to reduce the risk of cardiovascular problems and complications in patients with diabetes aged 55 years or more who may be considered at risk because they have one or more additional risk factors (e.g. high blood pressure, high cholesterol levels, kidney problems, a current smoker or previous disease of the blood vessels).

How it works

Ramipril works by widening the blood vessels, which then reduces the pressure in the vessels, making it easier for your heart to pump blood around your body. This helps increase the supply of oxygen to your heart, so that when you place extra demands on your heart (such as during exercise), your heart may cope better, and you may not get short of breath as easily.
By increasing the supply of oxygen to your heart, your heart does not have to work as hard and it is under less stress, which may reduce the risk of further damage occurring to it following a heart attack.
Ramipril also improves blood flow through the small blood vessels found in the kidneys, which helps the kidneys to work more efficiently. This in turn can help to slow down the progression of kidney damage that might result from having diabetes or high blood pressure.
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.
There is no evidence that this medicine is addictive.

Use in children

This medicine should not be used in children.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:
any medicine containing ramipril
any other ACE-inhibitor
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 ramipril if you are intolerant or allergic to lactose.
This medicine contains lactose.
Do not take ramipril if you are also taking:
aliskiren-containing medications and have kidney problems or Type 2 diabetes
angiotensin II receptor antagonists (e.g. candesartan, irbesartan, olmesartan etc.), and have kidney problems caused by diabetes
Do not take ramipril if you have or have had any of the following medical conditions:
you or your family have a history of swelling of the face, lips, tongue, throat, intestines, hands or feet, for no apparent reason
kidney problems or a condition called 'renal artery stenosis'
problems or conditions affecting the flow of blood in and out of your heart (e.g. aortic or valvular stenosis)
low blood pressure
you undergo dialysis using certain high-flux membranes or LDL apheresis with dextran sulfate
Do not take this medicine if you are pregnant or intend to become pregnant.
Ramipril may affect your developing baby if you take it during pregnancy.
Do not take this medicine if you are breastfeeding.
Ramipril may pass into breast milk and affect your baby.
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:
kidney problems, or are having dialysis (your doctor may give you ramipril because of your kidney problems)
liver problems
heart problems (your doctor may give you ramipril because of your heart problems)
low blood pressure, which you may notice as dizziness or light-headedness
low white blood cell counts
diabetes (note: your doctor may give you ramipril because of your diabetes)
high levels of potassium in your blood
Systemic Lupus Erythematosus (SLE), scleroderma or other autoimmune conditions.
Tell your doctor if you are following a very low or very high salt diet.
Tell your doctor if you are dehydrated, or have had a recent bout of vomiting or diarrhoea
Tell your doctor if you are pregnant or plan to become pregnant or start breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
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 or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and ramipril may interfere with each other. These include:
other medicines used to treat high blood pressure especially sacubitril/valsartan
diuretics, also known as fluid or water tablets
lithium, used to treat mood swings and some types of depression
potassium supplements, potassium-containing salt substitutes or any medicine that may increase your potassium levels
non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain, swelling and other symptoms of inflammation
insulin and tablets used to treat diabetes
heparin
general anaesthetics
medicines which may affect the blood cells, such as allopurinol, procainamide, corticosteroids, immunosuppressants or medicines used to treat cancer
if you are taking ramipril for high blood pressure, do not take any medicines (including the ones bought without a prescription) for appetite control, asthma, colds, coughs, hay fever or sinus problems unless you have discussed it with your doctor or pharmacist
These medicines may be affected by ramipril or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell you how many capsules you will need to take.
This depends on your condition and whether you are taking any other medicines.
Some patients may need a lower starting dose. The usual dose is:
for high blood pressure, 2.5 mg to 10 mg per day
for heart failure, 5 mg to 10 mg per day
for kidney problems, 1.25 mg to 5 mg per day
for cardiovascular risk, 2.5 mg to 10 mg per day.
Depending on your response, your doctor may adjust the dose.
If two capsules are prescribed, your doctor may want you to take both together or at different times.
This will depend on the condition being treated and how you respond to ramipril.

How to take it

The capsules should be swallowed whole with plenty of fluid.

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 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.
Ramipril helps to control your condition but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is almost time to take 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 that 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 of this medicine. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much ramipril, you may feel light-headed, dizzy or you may faint. You may also experience a slow heartbeat.

While you are taking this medicine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
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.
Your blood pressure may drop suddenly.
Ramipril may also affect other medicines used during surgery.
If you become pregnant or start to breastfeed while taking this medicine, tell your doctor immediately.
Make sure you drink enough water during exercise and hot weather when you are taking ramipril, especially if you sweat a lot.
If you do not drink enough water while taking ramipril, 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.
If you have excess vomiting or diarrhoea while taking ramipril, tell your doctor.
You may lose too much water and salt and your blood pressure may drop too much.
If you feel light-headed or dizzy after taking your first dose of ramipril, or when your dose is increased, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
Ramipril may interfere with the results of some tests.
Have your blood pressure checked when your doctor says, to make sure ramipril is working.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Go to your doctor regularly for a check-up.

Things you must not do

Do not take this medicine 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 lower the dosage without checking with your doctor.

Things to be careful of

If you feel light-headed, dizzy or faint when getting out of bed or standing up, 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.
Be careful while driving or operating machinery until you know how ramipril affects you.
As with other ACE inhibitor medicines, ramipril may cause dizziness, light-headedness, tiredness or drowsiness in some people. Make sure you know how you react to ramipril 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.

Things that may help your condition

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 low-fat 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 get the heart fitter, but it is important not to overdo it.
Walking is good exercise but try to find a route that is reasonably flat. Before starting any exercise, ask your doctor about the best kind of exercise 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, or at least cut down smoking.
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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine.
Ramipril helps most people, but it may have unwanted side effects in a few people. All medicines may have some unwanted 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.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
feeling light-headed, dizzy or faint
persistent dry cough and/or tickling cough
headache
feeling sick (nausea) or vomiting
reflux
stomach pain
diarrhoea
taste disturbance
unusual tiredness or weakness, fatigue
skin reactions
ringing or buzzing in the ears
forgetfulness or confusion
increase in nasal congestion or asthma symptoms
The above list includes the more common side effects.
Tell your doctor as soon as possible if you notice any of the following:
disturbed vision
changes to your sleeping pattern, including drowsiness
symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
itchy or raised skin rash, hives or nettle rash
yellowing of the skin and/or eyes
severe upper stomach pain, often with nausea and vomiting
fast or irregular heart beat
shortness of breath or tightness in the chest
signs of anaemia such as tiredness, being short of breath and looking pale
numbness, tingling and colour change (white, blue then red) in the fingers or toes when exposed to the cold
frequent infections such as fever, severe chills, sore throat or mouth ulcers
passing little or no urine or more urine than is normal for you
bleeding or bruising more easily than normal
mood changes
These may be serious side effects. You may need medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
fainting within a few hours of taking a dose
severe dizziness and confusion with visual disturbances and speech problems
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
pink or red itchy spots on the skin which may blister and progress to form raised, red, pale-centred marks
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
chest pain
signs of allergic reaction which 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
These are 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.

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 capsules in a cool dry place where the temperature is below 25°C.
Do not store this 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 the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What APO-Ramipril Capsules looks like

1.25 mg Capsules
Yellow cap and white body; they are imprinted with "APO 1.25" in black ink. AUST R 179033. AUST R 179010.
2.5 mg Capsules
Orange cap and white body; they are imprinted with "APO 2.5" in black ink. AUST R 179026. AUST R 179015.
5 mg Capsules
Red cap and white body; they are imprinted with "APO 5" in black ink. AUST R 179028. AUST R 179012.
10 mg Capsules
Blue cap and white body; they are imprinted with "APO 10" in black ink. AUST R 179034. AUST R 179011.
The 1.25 mg, 2.5 mg and 5 mg capsules are supplied as 30 capsules packed in blisters or bottles.
The 10 mg capsules are supplied as 7, 10, 14, 28 or 30 capsules packed in blisters or bottles.

Ingredients

Active Ingredient:
Ramipril (1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril in each capsule).
It also contains the following inactive ingredients:
lactose
magnesium stearate
gelatin (sulfites)
titanium dioxide
OPACODE Monogramming ink S-1-17822 BLACK (PI 12390)
OPACODE Monogramming ink S-1-17823 BLACK (PI 12108)
iron oxide yellow CI 77492 (1.25 mg & 2.5 mg strengths only)
erythrosine CI 45430 (2.5 mg, 5 mg and 10 mg strengths only)
indigo carmine CI 73015 (5 mg and 10 mg strengths only)
iron oxide black CI 77499 (10 mg strength only).
This medicine contains sulfites and is gluten-free, sucrose-free, tartrazine-free and other azo dyes-free.

Sponsor

Apotex Pty Ltd
16 Giffnock Ave
Macquarie Park, NSW 2113
 
APO and APOTEX are registered trade marks of Apotex Inc.
 
This leaflet was last updated in August 2019.