Consumer medicine information

Monoplus®

Fosinopril sodium/hydrochlorothiazide

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before taking Monoplus.

This leaflet answers some of the common questions about Monoplus. It does not contain all the available information. Some of the information it contains may not apply to you. It does not take the place of talking to your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

If you have any concerns about taking Monoplus, ask your doctor or pharmacist.

What Monoplus is used for

Monoplus 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), 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.

How Monoplus works

Monoplus tablets contain two medicines, fosinopril sodium and hydrochlorothiazide. Both medicines reduce blood pressure, but work different ways.

Fosinopril sodium belongs to a group of medicines called 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.

Hydrochlorothiazide is a diuretic (fluid tablet). It helps reduce the amount of excess fluid in the body by increasing the amount of urine produced. It also lowers high blood pressure, particularly when combined with other blood pressure reducing medicines such as ACE inhibitors.

Your doctor may have prescribed Monoplus for another reason.

Ask your doctor if you have any questions about why Monoplus has been prescribed for you.

Monoplus is not addictive. Monoplus is available only with a doctor’s prescription.

The safety and effectiveness of Monoplus in children have not been established.

Before you take Monoplus

When you must not take it

Do not take Monoplus if:

you have an allergy to fosinopril sodium or hydrochlorothiazide (the active ingredients in Monoplus), or to any of the inactive ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to Monoplus may include skin rash, itchiness, shortness of breath, swelling of the face, lips, tongue, throat, hands or feet.
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 medicine before, you may be allergic to Monoplus.
you have had an allergic reaction to another medicine which contains an ingredient with a name like ‘sulphonamide’ or a ‘-thiazide’ (like hydrochlorothiazide). Ask your doctor or pharmacist if you are not sure.
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.

Do not take Monoplus if you are pregnant or are trying to become pregnant. Monoplus may cause serious injury to your developing baby if you take it during pregnancy.

Do not take Monoplus if you are not producing any urine (anuric).

Do not take Monoplus after the expiry date printed on the pack. Do not take Monoplus 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 Monoplus, talk to your doctor.

Before you start to take Monoplus

Tell your doctor if you have allergies to:

any other medicines, especially the antibiotics known as sulfonamides or penicillins
any other substances, such as foods, preservatives or dyes.

Tell your doctor if you have a family history of swelling of the face, lips, tongue or throat that may cause difficulty in swallowing or breathing.

Tell your doctor if you have any medical conditions, especially the following:

kidney problems, or have had kidney problems in the past, or are having dialysis
liver problems, or have ever had liver problems in the past
low blood pressure, which you may notice as dizziness or light-headedness
diabetes
high levels of potassium in your blood (hyperkalaemia)
systemic lupus erythematosus (SLE), scleroderma or other autoimmune diseases
gout
have a problem passing urine
are going to have surgery (including dental surgery) involving a general anaesthetic, even if it is minor.

Tell your doctor if you are pregnant or plan to become pregnant or breastfeed.

If you have not told your doctor about any of the above, tell them before you start taking Monoplus.

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 Monoplus may interfere with each other. These include:

water tablets or diuretics (for example Lasix, Urex, Natrilix, Moduretic)
other medicines used to treat high blood pressure
lithium or lithium-containing medicine (for example Lithicarb, Priadel)
carbamazepine (a medicine used to treat epilepsy or seizures, for example Tegretol)
potassium tablets (for example Span-K, Slow-K or Mag-K)
potassium-containing salt substitutes (for example Pressor-K)
antacids
alcoholic drinks
sleeping tablets
strong pain relieving medicines
antidiabetic medicines (for example insulin)
medicines or other tablets containing calcium
antigout medicines (for example Anturan, Benamid, Capurate)
cholestyramine resin and colestipol hydrochloride medicines to treat high cholesterol (for example Questran Lite, Colestid Granules)
some medicines used during surgery or emergency situations, such as anaesthetics
medicines that lower your immune system, such as corticosteriods, cyclosporin and other medicines used to prevent rejection of transplant organs or medicines used to treat cancer (including radiation therapy).
anti-inflammatory medicines (these are used to relieve pain, swelling and other symptoms of inflammation, including arthritis) and include nonsteroidal anti-inflammatory agents – NSAIDs (for example Voltaren, Indocid) and COX-2 inhibitors (for example Celebrex).
Taking a combination of Monoplus and an anti-inflammatory medicine may damage your kidneys.

Your doctor will decide whether your treatment needs to be altered or whether you should have check-ups or blood tests more frequently.

How to take Monoplus

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information in this leaflet. Your doctor or pharmacist will tell you how many tablets you will need to take each day.

If you do not understand the instructions on the label on the pack, ask your doctor or pharmacist for help.

How much to take

Monoplus is usually taken at a dose of one 10 mg/12.5 mg tablet per day or one 20 mg/12.5 mg tablet per day. Your doctor may have prescribed a different dose for you.

When to take it

Take Monoplus at about the same time each day. Taking your tablet at about the same time each day will help you to remember when to take it. It does not matter if you take Monoplus before or after food.

If you need to take an antacid (or Questran Lite or Colestid Granules), take it at least 2 hours before or two hours after your dose of Monoplus.

How long to take it

Monoplus helps to control your condition but does not cure it. Therefore you must take Monoplus every day. Continue taking it for as long as your doctor tells you.

If you forget to take Monoplus

If you forget to take one or more doses of Monoplus, if it is almost time for your next dose, skip the dose you missed and take your next dose at the normal time and in the normal amount.

Otherwise take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed. Do not take any more than your doctor prescribed for you.

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 Monoplus

Immediately phone your doctor or Poisons Information Centre (telephone 13 11 26), or go to the Accident and Emergency Department at your nearest hospital, if you think that you or anyone else may have taken too much Monoplus. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking Monoplus

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you are taking Monoplus.

If you are about to be started on a new medicine, tell your doctor, dentist or pharmacist that you are taking Monoplus. 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 Monoplus or if your dose is increased.

Make sure you drink enough water during exercise and hot weather when you are taking Monoplus, especially if you sweat a lot. If you do not drink enough water while taking Monoplus, your blood pressure may drop suddenly and you may dehydrate. If you experience any of the above symptoms, tell your doctor.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking Monoplus. Having a general anesthetic while taking Monoplus may also cause your blood pressure to drop suddenly.

If you become pregnant while taking Monoplus, tell your doctor immediately.

If you are about to have blood tests, tell your doctor that you are taking Monoplus. Monoplus may interfere with the results of some tests.

Have your blood pressure checked when your doctor says, to make sure Monoplus is working.

Go to your doctor regularly for a check-up. Your doctor may like to do blood tests to see how Monoplus is affecting you.

Things you must not do

Do not give Monoplus to anyone else, even if they have the same condition as you.

Do not take Monoplus to treat any other complaints unless your doctor or pharmacist tells you to.

Do not stop taking Monoplus, or lower the dosage, without 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 Monoplus 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 Monoplus, especially if you are elderly.

Be careful driving or operating machinery until you know how Monoplus affects you.

As with other ACE inhibitor medicines, Monoplus may cause dizziness, or light-headedness in some people. Make sure you know how you react to Monoplus 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 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 low-fat diet which includes plenty of fresh vegetables, fruit, bread, cereals and fish. Also eat less fat and sugar.
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.
Exercise –
regular exercise helps to reduce blood pressure and helps to 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 programme for you.
Smoking –
your doctor may advise you to stop smoking or at least cut down.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Monoplus.

Monoplus helps most people with high blood pressure, 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.

Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

feeling light-headed, dizzy or faint
headache
tiredness, fatigue or weakness
dry cough
sore throat or runny nose
feeling sick (nausea) or vomiting
upset stomach (dyspepsia) or heartburn
diarrhoea
stomach pains
muscle cramps or pains
flushing
any problem urinating (passing water).

These are the more common side effects of Monoplus. Mostly these are mild and short lived.

Tell your doctor as soon as possible if you notice any of the following:

changes to your heart rhythm
infections of your urinary tract or upper respiratory tract (URTI, or 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)
problems with your eyes or vision, such as glaucoma, pain or blurred vision.

These are serious side effects. You may need medical attention. Serious side effects are rare.

If any of the following happen, stop taking Monoplus and either tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

fainting within a few hours of taking a dose of Monoplus
swelling to the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing; swelling of the hands or feet; severe itching and/or rash
difficulty breathing
not urinating (passing water)
chest pain
stomach pain with or without nausea.

These are very serious side effects. You may need urgent medical attention or hospitalisation. (These side effects are rare.)

Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that makes you feel unwell while you are taking Monoplus.

After using Monoplus

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they will not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store Monoplus or any other medicine in the bathroom or near a sink.

Do not leave it on a window sill or in a car on hot days. 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.

Disposal

If your doctor or pharmacist tells you to stop taking Monoplus or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Monoplus 10/12.5 tablets are peach coloured, round tablets with ‘1492’ engraved on one side.

Monoplus 20/12.5 tablets are peach coloured, oblong tablets with ‘MJ’ and ‘1493’ engraved on one side and ‘m’ engraved on the other.

Ingredients

Active ingredients:

Monoplus 10/12.5 tablets contain 10 mg of fosinopril sodium and 12.5 mg hydrochlorothiazide.

Monoplus 20/12.5 tablets contain 20 mg of fosinopril sodium and 12.5 mg hydrochlorothiazide.

Other ingredients:

Monoplus tablets also contain lactose, croscarmellose sodium, povidone, sodium stearyl fumarate and iron oxides (red & yellow).

Registration Numbers

Monoplus 10/12.5 tablets
Bottles – AUST R 68968

Monoplus 20/12.5 tablets
Bottles – AUST R 68970

Date of Preparation: July 2016.

Monoplus is a trademark of a Bristol-Myers Squibb Company.

AU_CMI_Monoplus_V9.0_19 July 2016.docx

Published by MIMS November 2016