Consumer Medicine Information

CO-RENITEC^®

enalapril maleate and hydrochlorothiazide

20 mg/12.5 mg tablets

What is in this leaflet

This leaflet answers some common questions about CO-RENITEC. 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 CO-RENITEC 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 CO-RENITEC is used for

CO-RENITEC lowers high blood pressure, which doctors call 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) 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. CO-RENITEC helps to lower your blood pressure.

CO-RENITEC contains two active ingredients

One of these is enalapril maleate. It belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It works by widening your 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.

The other active ingredient is hydrochlorothiazide which is a fluid tablet or diuretic. It helps reduce the amount of fluid in the body by making your kidneys pass more water and salt. Both of these active ingredients help to lower high blood pressure.

Your doctor may have prescribed CO-RENITEC for another reason. Ask your doctor if you have any questions about why CO-RENITEC has been prescribed for you.

CO-RENITEC is not addictive.

Before you take CO-RENITEC

When you must not take it

Do not take CO-RENITEC if:

you have taken any other 'ACE inhibitor' medicines for high blood pressure or heart failure before, which caused your face, lips, tongue, throat, hands or feet to swell up, or made it hard for you to breathe
you have had an allergic reaction to an ACE inhibitor before, you may be allergic to CO-RENITEC.
you have a history of swelling of the face, lips, tongue, throat, hands or feet for no reason, or if you have been diagnosed with hereditary or idiopathic angioedema
you have an allergy to CO-RENITEC, RENITEC or any of the ingredients listed at the end of this leaflet
Symptoms of an allergic reaction may include skin rash, itchiness, hives, fever, shortness of breath, swelling of the face, lips or tongue, muscle pain or tenderness, or joint pain.
you have an allergy to sulfonamide derived medicines. One of the active ingredients in CO-RENITEC, hydrochlorothiazide, is a sulfonamide. Therefore, if you are allergic to sulfonamide medicines, such as some antibiotics, you are likely to be allergic to CO-RENITEC. Check with your doctor or pharmacist if you are not sure whether you are allergic to sulfonamide medicines.
you are pregnant or breast-feeding
Your baby may absorb this medicine in the womb or from breast milk and therefore there is a possibility of harm to the baby.
you are not passing urine
the packaging is torn or shows signs of tampering
the expiry date on the pack has passed.
If you take medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking CO-RENITEC, talk to your doctor.

Do not give CO-RENITEC to a child

The safety of CO-RENITEC in children has not been established.

Before you start to take it

Tell your doctor if:

you intend to become pregnant or intend to breast-feed
CO-RENITEC should not be used during pregnancy or while breast-feeding.
you have any medical conditions, especially the following:
- heart problems
- if you are undergoing dialysis or are being treated with diuretics (water tablets)
- passing less urine than is normal
- liver disease
- diabetes or any kidney problems, as these may lead to increased levels of potassium in the blood which can be serious
- gout
you are following a very low salt diet, are taking potassium supplements, potassium-sparing agents or potassium-containing salt substitutes
you have had an allergy to any other medicines or any other substances, such as foods, preservatives or dyes
you have recently suffered from excessive vomiting or diarrhoea.

In these cases, your doctor may need to adjust the dosage of CO-RENITEC or monitor your blood level of potassium. Tell your doctor if you have diabetes, as thiazides may necessitate a dosage adjustment of anti-diabetic medications, including insulin.

If you have not told your doctor about any of the above, tell them before you take any CO-RENITEC.

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 CO-RENITEC may interfere with each other. These include:

other fluid or water tablets (diuretics)
other medicines used to treat high blood pressure
lithium, used to treat severe mood swings and some types of depression
potassium tablets or potassium-containing salt substitutes
non-steroidal anti-inflammatory medicines (NSAIDs) (including gold therapy) used to treat inflammation, pain, arthritis
medicines used to relax muscles before or during surgery

These medicines may be affected by CO-RENITEC, 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 CO-RENITEC.

How to take CO-RENITEC

How much to take

Your doctor will tell you how many tablets you need to take each day. This depends on your condition and whether you are taking other medicines. Take CO-RENITEC only when prescribed by your doctor.

For most patients, the usual starting dose is half or one tablet a day. Depending on your blood pressure, the dose may need to be increased to two tablets taken once a day.

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 CO-RENITEC at about the same time each day. This is best in the morning, for example, at breakfast time.

Taking CO-RENITEC at the same time each day will have the best effect. It will also help you remember when to take the tablets.

Swallow CO-RENITEC with a glass of water.

When to take it

CO-RENITEC helps control your high blood pressure but does not cure it. Therefore CO-RENITEC must be taken every day. Continue taking CO-RENITEC 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 National Poisons Centre (telephone 0800 POISON or 0800 764 766), or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much CO-RENITEC. 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, your level of consciousness may decrease or you may faint. You may also become very thirsty, confused, have a change in the amount of urine passed or have a fast heart beat.

While you are using CO-RENITEC

Things you must do

Have your blood pressure checked when your doctor says, to make sure CO-RENITEC is working.

If you feel any light-headedness or dizziness after you take your first dose of CO-RENITEC or if your dose is increased, tell your doctor immediately.

If you feel light-headed, dizzy or faint, get up slowly when getting out of bed or standing up.

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 CO-RENITEC, tell your doctor immediately.

If you have excessive vomiting and/or diarrhoea while taking CO-RENITEC, or you have any of the following symptoms, tell your doctor:

dry mouth, thirst
weakness, tiredness, drowsiness
muscle pains or cramps
fast heart beat
passing less urine than normal

You may be dehydrated because you are losing too much water. This may also drop your blood pressure too much.

Make sure you drink enough water during exercise and hot weather when you are taking CO-RENITEC, especially if you sweat a lot.

If you do not drink enough water while taking CO-RENITEC, 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 plan to have surgery (even at the dentist) that needs a general anaesthetic, tell your doctor or dentist that you are taking CO-RENITEC. Your blood pressure may drop suddenly.

If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking CO-RENITEC.

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 CO-RENITEC 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 CO-RENITEC affects you. CO-RENITEC 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 CO-RENITEC 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

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.

Adverse Effects

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

CO-RENITEC helps most people with high blood pressure, but it may have unwanted adverse effects in a few people. All medicines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse 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 because blood pressure is too low
headache
tiredness or weakness
dry cough
nausea, vomiting
diarrhoea, constipation, stomach upset, pains or cramps
impotence (inability to get or maintain an erection)

These are usually mild adverse effects of CO-RENITEC, 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
swelling of the feet, hands and ankles
fainting
severe dizziness, spinning sensation
skin rash or itchiness
muscle cramps
signs of worrying or frequent infections such as fever, severe chills, sore throat or mouth ulcers
passing less urine than is normal for you
bruising or bleeding more easily than normal
numbness or tingling in the hands or feet

These may be serious adverse effects. You may need urgent medical attention.

Serious adverse effects are rare.

If any of the following happen, stop taking CO-RENITEC and tell your doctor immediately or go to accident and emergency at your nearest hospital

swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing
chest pain, angina
wheeziness due to chest tightness
collapse, numbness or weakness of arms and legs

These are serious adverse effects. You may need urgent medical attention or hospitalisation.

All of these adverse effects are rare.

Other adverse 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 adverse effects. You may not experience any of them.

After using CO-RENITEC

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack and store them in another container they will not keep well and they may become soft and pliable.

Keep CO-RENITEC 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.

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 tells you to stop taking CO-RENITEC 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

CO-RENITEC 20/12.5 - yellow, capsule-shaped tablet marked with MSD 718 on one side and scored on the other.

A box of CO-RENITEC contains 30 tablets.

Ingredients

Active ingredients

CO-RENITEC 20/12.5 - enalapril maleate 20 mg and hydrochlorothiazide 12.5 mg per tablet.

Inactive ingredients

sodium bicarbonate
lactose
maize starch
pregelatinised maize starch
iron oxide yellow CI77492
magnesium stearate

CO-RENITEC does not contain gluten, sucrose, tartrazine or any other azo dyes.

Supplier

CO-RENITEC is supplied in New Zealand by:

Merck Sharp & Dohme (New Zealand) Limited
P O Box 99851
Newmarket
Auckland
NEW ZEALAND
Tel: 0800 500 673

This leaflet was prepared in April 2008

CP-CRN-0408(290408)

INFORMATION FOR CONSUMERS