NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
APO-FOSINOPRIL
Contains the active ingredient fosinopril sodium
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about fosinopril. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
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.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want to read it again.
What this medicine is used for
The name of your medicine is APO-Fosinopril. It contains the active ingredient fosinopril.
It is used to treat:
high blood pressure (hypertension)
heart failure.
Both of these are long term (chronic) diseases so it is important that you continue to take your medicine every day.
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.
If you have hypertension (high blood pressure), this means that your blood pressure stays higher than is needed, even when you are 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.
Heart Failure:
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. Heart failure may start off with no symptoms, but as the condition progresses, patients 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.
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.
How it works
Fosinopril belongs to a class of medicines known as Angiotensin Converting Enzyme (ACE) inhibitors. It works by widening your blood vessels, reducing the pressure in the vessels (reducing ‘blood pressure’) and by making it easier for your heart to pump blood around your body. This helps your heart to work better by increasing 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.
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 are pregnant.
Fosinopril may affect your developing baby if you take it during pregnancy.
You have a history of angioedema or angioneurotic oedema, which is swelling of the face, lips, tongue, throat (which may cause difficulty in swallowing or breathing), hands or feet, associated with previous treatment of ACE inhibitors.
You take aliskiren-containing medications (for high blood pressure) and have diabetes or kidney problems.
You have had an allergic reaction to fosinopril, any other ACE inhibitor or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body, rash, itching or hives on the skin; fainting or hayfever-like symptoms
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
1.You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2.You have or have had any medical conditions, especially the following:
family history of swelling of the face, lips, tongue, throat that may cause difficulty in swallowing or breathing
diabetes
are undertaking any immunosuppressive therapy
are taking trimethoprim containing medicines
kidney problems, or are having dialysis
liver problems
low blood pressure, which you may notice as dizziness or lightheadedness
you are following a very low salt diet
you are dehydrated, or have recently suffered from excessive vomiting or diarrhoea.
coughing or skin reactions if you have taken other ACE inhibitors in the past.
3.You are currently breastfeeding or you plan to breastfeed. Do not take this medicine whilst breastfeeding.
4.You are planning to have surgery or an anaesthetic.
5.You are currently receiving or are planning to receive dental treatment.
6.You are taking or are planning to take any other medicines, This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Taking other medicines
Some medicines may interact with fosinopril. These include:
water tablets or diuretics (for example frusemide, indapamide, amiloride and hydrochlorothiazide)
potassium tablets (for example potassium chloride
potassium-containing salt substitutes
angiotensin II receptor blockers (e.g. irbesartan, valsartan, telmisartan) or aliskiren-containing medications
diabetes medication
lithium or lithium-containing preparations (for example lithium carbonate)
antacids
if you are taking fosinopril for high blood pressure do not take any medicine (including ones bought without prescription) for appetite control, asthma, colds, coughs, hayfever or sinus problems unless you have discussed the medicine with your doctor
anti-inflammatory medicines (these are used to relieve pain, swelling and other symptoms of inflammation, including arthritis) and include non-steroidal anti-inflammatory agents – NSAIDS (for example diclofenac and aspirin) and COX-2 inhibitors (for example celecoxib). Taking a combination of fosinopril with a thiazide diuretic (water tablet) and an anti-inflammatory medicine may damage your kidneys
medicines that lower your immune system, such as medicines used to prevent rejection of transplant organs
trimethoprim containing medicines used to treat certain types of injections
injectable gold or sodium aurothiomalate.
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 fosinopril.
How to take this medicine
Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
How to take it
Most people will initially start taking a 10 mg dose once daily. Fosinopril is then usually taken at a dose of 10 mg to 40 mg once a day. Your doctor may have prescribed a different dose for you.
When to take it
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It does not matter if you take it before, with or after food.
If you need to take an antacid, take it at least 2 hours before or 2 hours after your dose of fosinopril.
How long to take it for
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 you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are taking this medicine
Things you must do
Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you are pregnant or are planning to become pregnant
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
Tell your doctor if you have excessive vomiting or diarrhoea or experience any of the following symptoms:
light-headed or dizzy
dry mouth or thirst
weakness, tiredness or drowsiness
muscle pain or cramps
fast heart beat
passing less urine than normal.
If you experience these symptoms, you may be dehydrated because you are losing too much water. This is more likely to occur when you begin to take fosinopril or if your dose is increased.
Make sure you drink enough water during exercise and hot weather when you are taking fosinopril, especially if you sweat a lot.
If you do not drink enough water while taking fosinopril, your blood pressure may drop suddenly and you may dehydrate. If you experience any of the above symptoms, tell your doctor.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Things you must not do
Do not:
Give this medicine to anyone else, even if their symptoms seem similar to yours
Take your medicine to treat any other condition unless your doctor tells you to
Stop taking your medicine, or change the dosage, without first checking with your doctor.
Things to be careful of
As with other ACE inhibitor medicines, you may feel light-headed or dizzy when you begin to take fosinopril or after your dose is increased. This is because your blood pressure is dropping suddenly.
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. Be careful the first time you take fosinopril, especially if you are elderly.
Be careful when driving or operating machinery until you know how this medicine affects you.
If you drink alcohol, dizziness or light-headedness may be worse.
Possible side effects
Tell your doctor as soon as possible if you do not feel well while you are taking fosinopril or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following:
feeling light-headed, dizzy or faint
headache
tiredness, fatigue or weakness
dry cough
feeling sick (nausea) or vomiting
upset stomach (dyspepsia) or heartburn
diarrhoea
stomach pains
muscle cramps or pains
taste disturbance.
Tell your doctor as soon as possible if you notice any of the following: These may be serious side effects. You may need medical attention.
changes to your heart rhythm
infections of your urinary tract, upper respiratory tract, cold or flu symptoms
severe dizziness (vertigo)
impotence (inability to get or maintain an erection)
mild rash or itching
gout (painful, swollen joints)
diabetes (symptoms include excessive thirst, greatly increased amount of urine, increase of appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell)
sore throat and fever
hepatitis (symptoms include nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes and dark coloured urine)
confusion; irregular heartbeat; nervousness; numbness or tingling of the hands, feet or lips; shortness of breath or difficulty breathing; weakness or heaviness of legs (you may experience these symptoms if too much potassium builds up in your body).
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
fluid filled blisters or itchy rash, especially if it appears quickly
if you faint or if your skin turns yellow
sore throat and fever
chest pain
not urinating (passing water) as much as usual
stomach pain with or without nausea.
Other side effects not listed above may occur in some patients.
Allergic reactions
If you think you are having an allergic reaction to fosinopril, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
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
hayfever-like symptoms.
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 APO-Fosinopril looks like
10 mg tablets:
White, capsule shaped biconvex tablets with indents, engraved APO on one side and FOS-10 on the side.
20 mg tablets:
White, oval, biconvex tablets, engraved APO on one side and FOS-20 on the side.
Fosinopril 10mg and 20mg tablets are packaged in blister packs and bottles of 30 tablets*.
* Not all strengths, pack types and/or pack sizes may be available.
Ingredients
Each tablet contains 10 mg or 20 mg of Fosinopril sodium as the active ingredient.
It also contains the following inactive ingredients:
lactose
crospovidone
zinc stearate.
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
Australian Registration Numbers
APO-Fosinopril 10 mg tablet blister pack: AUST R 119874
APO-Fosinopril 10 mg tablet bottle: AUST R 119875
APO-Fosinopril 20 mg tablet blister pack: AUST R 119876
APO-Fosinopril 20 mg tablet bottle: AUST R 119877
Sponsor
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Australia
Tel: (02) 8877 8333
Web: www1.apotex.com/au
APO and APOTEX are registered trade marks of Apotex Inc.
This leaflet was prepared in:
March 2020.
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