Consumer Medicine Information
WHAT IS IN THIS LEAFLETThis leaflet answers some common questions about Fosinopril / HCT Sandoz. 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 risk of you taking this medicine against the benefits it is expected to 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 want to read it again.
WHAT FOSINOPRIL / HCT SANDOZ IS USED FORThe name of your medicine is Fosinopril / HCT Sandoz. It contains the active ingredients fosinopril sodium and hydrochlorothiazide.It is used to treat high blood pressure. 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 your blood pressure is too high is having it checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems, such as stroke, heart disease or kidney disease.Ask your doctor if you have any questions about why this medicine was prescribed for you. Your doctor may have prescribed it for another reason.
How Fosinopril / HCT Sandoz worksThere are two different active ingredients in each Fosinopril / HCT Sandoz tablet, fosinopril sodium and hydrochlorothiazide. They both work by reducing blood pressure, but do so in different ways.Fosinopril sodium belongs to a group of medicines called ACE inhibitors. It works by widening the blood vessels and thereby reducing the blood pressure. This also reduces the resistance in the vessels and thus makes it easier for the heart to pump blood around your body.Hydrochlorothiazide is a diuretic. It works by increasing the amount of urine produced and thus reducing excess fluid that may be contained in the body. It also lowers high blood pressure, especially when combined with other blood pressure medicines such as ACE inhibitors.There is no evidence that this medicine is addictive.This medicine is available only with a doctor’s prescription.
The safety and effectiveness of Fosinopril / HCT Sandoz in children have not been established.BEFORE YOU TAKE FOSINOPRIL / HCT SANDOZWhen you must not take it
Do not take this medicine if:
you are allergic to either of the active ingredients (fosinopril sodium or hydrochlorothiazide) or any of the inactive ingredients mentioned at the end of this leaflet under Product Description.
you have taken another ACE inhibitor previously, and have had an allergic reaction to it. This could mean that you may also get an allergic reaction to Fosinopril / HCT Sandoz.
you have had an allergic reaction to another medicine which contains an ingredient with a name like 'sulphonamide' or '-thiazide' (like hydrochlorothiazide). Ask your doctor or pharmacist if you are not sure.
you are not producing any urine (are anuric).
you are pregnant or plan on becoming pregnant. This medicine may cause serious injury to your developing baby if you take it during pregnancy.
you are breastfeeding. This medicine passes into breast milk and may affect your baby.
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, for no apparent reason.
it is past its expiry date or the packaging appears to have been tampered with.
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, especially if they are in the same drug class as fosinopril sodium or hydrochlorothiazide
any other substances, including foods, preservatives or dyes.
Tell your doctor if you are going to have surgery (including dental surgery) involving a general anaesthetic, even if it is minor.
Tell your doctor if you have or have had any medical conditions, especially the following:
systemic lupus erythematosus (SLE), scleroderma or other autoimmune diseases
kidney problems, including dialysis
hypotension (low blood pressure)
high levels of potassium in your blood (hyperkalaemia)
problems passing urine.
If you have not told your doctor about any of the above, tell him/her before you start taking Fosinopril / HCT Sandoz.Taking other medicines
Tell your doctor if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.In particular, tell your doctor if you take any of the following:
diuretics, also called water tablets
other blood pressure lowering medicines
lithium or lithium-containing preparations
potassium-containing salt substitutes
medicines used to help you sleep
strong pain relievers
medicines used to treat diabetes, including insulin
medicines or other tablets containing calcium
medicines used to treat gout (e.g. allopurinol)
medicines used to treat high levels of cholesterol, such as cholestyramine and colestipol hydrochloride
some medicines used during surgery or in emergency situations, such as anaesthetics
medicines used to suppress the immune system, such as corticosteroids, cyclosporin or medicines used to treat cancer (including radiation therapy)
anti-inflammatory medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis. These include non-steroidal anti-inflammatory drugs (e.g. diclofenac or indomethacin) and COX-2 inhibitors (e.g. celecoxib). Taking a combination of Fosinopril / HCT Sandoz and an anti-inflamatory medicine may damage your kidneys.
These medicines may be affected by Fosinopril / HCT Sandoz, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.Your doctor and pharmacist may have more information on medicines to be careful with or avoid while you are taking this medicine.HOW TO TAKE FOSINOPRIL / HCT SANDOZFollow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet. Your doctor will tell you how many tablets you need to take each day.
The usual dose is one 10mg/12.5mg tablet once a day or one 20mg/12.5mg tablet once a day.Take the tablets about the same time each day, preferably in the morning. It does not matter if you take this medicine before or after food.If you need to take an antacid or cholesterol lowering medicine such as cholestyramine or colestipol hydrochloride, take it at least two hours before or two hours after your dose of Fosinopril / HCT Sandoz.If you have high blood pressure you will need to take this medicine for a long time. Continue taking your tablets for as long as your doctor recommends.If you forget to take your dose
Take your dose as soon as you remember, and continue to take it as you would normally.If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.If you take too much
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital, if you think you or anyone else has taken too much Fosinopril / HCT Sandoz.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
WHILE YOU ARE TAKING FOSINOPRIL / HCT SANDOZThings you must do
Always follow your doctor’s instructions carefully.
Tell any doctors, dentists or pharmacists who are treating you that you are taking Fosinopril / HCT Sandoz.
Tell your doctor immediately if you become pregnant, plan on becoming pregnant or will be breastfeeding while taking this medicine.
If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking this medicine.
Tell your doctor if you have excessive vomiting or diarrhoea or experience any of the following symptoms: light-headedness/dizziness, dry mouth/thirst, weakness, tiredness, drowsiness, muscle pain, cramps, fast heart beat, passing less urine than normal.
These symptoms may mean that you are dehydrated because you are losing too much water. This is more likely to occur when you begin to take this medicine or if your dose is increased.Make sure you drink enough water, especially during exercise and hot weather, or if you sweat a lot. If you do not drink enough water while taking this medicine, you may dehydrate and your blood pressure may drop suddenly.
If you are going to have surgery involving a general anaesthetic (even if it is minor), tell your dentist or doctor that you are taking this medicine. Your blood pressure may drop suddenly.
If you are about to have a blood test, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.
Have your blood pressure checked when your doctor says so, to make sure that this medicine is working.
Go to your doctor regularly for check-ups. Your doctor may do blood tests to see how this medicine is affecting you.
Things you must not do
Do not stop taking this medicine without your doctor’s permission.
Do not use Fosinopril / HCT Sandoz to treat any other complaint unless your doctor says so.
Do not give this medication to anyone else, even if their symptoms seem similar to yours.
Things to be careful of
You may feel light-headed or dizzy, especially when you first start to take this medicine. This is because your blood pressure is dropping suddenly. If you experience these symptoms, be careful when getting out of bed or standing up, especially if you are elderly.Be careful driving or operating machinery until you know how this medicine affects you. It may cause dizziness or light-headedness in some people, especially after the first dose. If you drink alcohol while taking this medicine, dizziness or light-headedness may be worse.General recommendations for your blood pressure
These are some suggestions which can assist 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 lower your blood pressure and help lessen the amount of work your heart has to do. A dietician may support you in doing so.
Diet: Eat a healthy diet which includes plenty of vegetables, fruit, cereals and fish. Try to limit your intake of fat and sugars.
Salt: It may be advisable to reduce the amount of salt in your diet.
Exercise: Regular exercise may help to reduce your blood pressure and help you get fitter. However, be careful not to overdo it. Walking is a good exercise to start with. Before you start any exercise, discuss with your doctor the best programme for you.
Smoking: Your doctor may advise you to stop smoking or at least cut down.
SIDE EFFECTSAll medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. Do not be alarmed by this list of possible side effects. You may not experience any of them.Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Fosinopril / HCT Sandoz.Tell your doctor if you notice any of the following and they worry you:
light-headedness, dizziness or faintness
tiredness, fatigue or weakness
sore throat or runny nose
feeling sick (nausea) or vomiting
upset stomach or heartburn
muscle cramps or pain
any problems urinating (passing water).
These are the more common side effects of the medicine. Mostly, these are mild and short-lived.Tell your doctor immediately if you notice any of the following:
changes to your heart rhythm
infections, e.g. of your urinary tract, or cold and flu symptoms
severe dizziness (vertigo)
problems with your sexual function
mild rash or itching
gout (painful or swollen joints)
diabetes (symptoms include excessive thirst, passing large amounts of urine, increased appetite with loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell)
sore throat and fever
yellowing of the skin and eyes or dark coloured urine (symptoms of hepatitis)
difficulty sleeping (insomnia), unusual dreams
seeing or hearing things that are not there (hallucinations).
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 Fosinopril / HCT Sandoz 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
fainting within a few hours of taking your dose of Fosinopril / HCT Sandoz tablets
you are not passing any urine
stomach pain with or without nausea.
These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are rare.Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.AFTER TAKING FOSINOPRIL / HCT SANDOZStorage
Keep your medicine in the original packaging until you need to take it.If you take it out of its original container it may not keep well.Keep your medicine in a cool dry place where the temperature stays below 25°C.Do not store Fosinopril / HCT Sandoz 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 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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.PRODUCT DESCRIPTIONWhat it looks like
Fosinopril / HCT Sandoz 10mg/12.5mg tablets: Light pink, biconvex round tablet, embossed “E” above “341” on one side and plain on the other side. Available in bottles of 30 tablets.
Fosinopril / HCT Sandoz 20mg/12.5mg tablets: Dark pink, biconvex round tablet, embossed “E” above “342” on one side and scored on the other side. Available in bottles of 30 tablets.
Each Fosinopril / HCT Sandoz 10mg/12.5mg tablet contains 10mg fosinopril sodium and 12.5mg hydrochlorothiazide.Each Fosinopril / HCT Sandoz 20mg/12.5mg tablet contains 20mg fosinopril sodium and 12.5mg hydrochlorothiazide.Inactive Ingredients
red iron oxide
Fosinopril / HCT Sandoz is supplied in Australia by:Sandoz Pty Ltd
Level 4, 100 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500
This leaflet was prepared in July 2009.Australian Register Numbers
Fosinopril / HCT Sandoz 10mg/12.5mg tablets: AUST R 124850
Fosinopril / HCT Sandoz 20mg/12.5mg tablets: AUST R 124852