Consumer medicine information

Chemmart Enalapril

Contains the active ingredient, enalapril maleate

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before taking your medicine. This leaflet answers some common questions about enalapril. 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 Chemmart Enalapril. It contains the active ingredient enalapril.

It is used to treat:

  • high blood pressure
  • 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.

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, including stroke, heart disease and kidney failure.

Heart Failure:
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.

Your doctor may have prescribed enalapril for another reason.

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

This medicine is only available with a doctor’s prescription.

How it works

Enalapril 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.

This medicine is not addictive.

Use in children

There is not enough information to recommend the use of this medicine in children.

Before you take this medicine

When you must not take it

Do not take this medicine if:

  • 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.
  • You are pregnant or trying to become pregnant.
    Enalapril may cause serious injury to your developing baby if you take it during pregnancy.
  • You are hypersensitive to, or have had an allergic reaction to:
    – enalapril or any other medicine containing enalapril
    – any other ACE inhibitor, as you may be allergic to enalapril
    – lactose – this medicine contains lactose
    – 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 hay fever-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.
  1. You have a family history of swelling of the face, lips, tongue, throat that may cause difficulty in swallowing or breathing.
  2. You have or have had any medical conditions, especially the following:
  • diabetes
  • systemic lupus erythematosus (SLE), scleroderma, any other autoimmune diseases or are taking any immunosuppressant medicine
  • kidney problems, or have had kidney problems in the past, or are having dialysis
  • liver problems, or have had liver problems in the past
  • any conditions in which you are taking diuretics (water tablets) and/or potassium containing medicines
  • are following a very low salt diet
  • are dehydrated, or have recently suffered from excessive vomiting or diarrhoea
  • are going to have surgery (including dental surgery) involving a general anaesthetic, even if it is minor
  • coughing when you have taken other ACE inhibitors in the past.
  1. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant.
  2. You are currently breastfeeding or you plan to breast-feed. Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.
  3. You are planning to have surgery or an anaesthetic.
  4. You are currently receiving or are planning to receive dental treatment.
  5. 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.

Some medicines may interact with enalapril. These include:

  • water tablets or diuretics (for example Lasix®, Urex®, Natrilix®, Moduretic®)
  • potassium tablets (for example SPAN-K®, SLOW-K® or MAGK®)
  • potassium-containing salt substitutes (for example PRESSOR-K®)
  • lithium or lithium-containing preparations (for example Lithicarb®, Priadel®)
  • medicines used to treat diabetes
  • arthritis medicines, including gold therapy
  • 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 Voltaren®, Indocid®) and COX-2 inhibitors (for example Celebrex®). Taking a combination of enalapril with a thiazide diuretic (water tablet) and an anti-inflammatory medicine may damage your kidneys.

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 enalapril.

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.

For High Blood Pressure (Hypertension):
For most patients, the usual starting dose is 5 mg taken once a day. Some patients may need a lower starting dose. Most patients take between 10 mg to 40 mg each day. This dose may be taken once a day or divided into two doses per day.

For Heart Failure:
The usual starting dose is 2.5 mg taken once a day. Depending on your response, this dose may be increased up to 20 mg each day. This dose may be taken once a day or divided into two doses per day.

How to take it

Swallow the tablets with a glass of water. Do not chew or crush the tablets.

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.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.

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

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

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

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 enalapril or if your dose is increased.

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

If you do not drink enough water while taking enalapril, your blood pressure may drop suddenly and you may dehydrate. If you experience any of the above symptoms, tell your doctor.

Tell your doctor that you are taking this medicine if:

  • you are about to be started on any new medicine
  • you are breastfeeding or are planning to breast-feed
  • you are going to have surgery or an anaesthetic or are going into hospital.

Having a general anaesthetic while taking enalapril may cause your blood pressure to drop suddenly.

  • you are about to have any blood tests

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 enalapril 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 enalapril, especially if you are elderly.

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

As with other ACE inhibitor medicines, enalapril may cause dizziness or light-headedness in some people. Make sure you know how you react to enalapril 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 or heart failure

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.

Possible side effects

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

This list includes the more common side effects. Mostly, these are mild:

  • feeling light-headed, dizzy or faint
  • headache
  • tiredness, fatigue or weakness
  • dry cough
  • mild stomach upsets such as feeling sick (nausea), constipation or stomach pains
  • muscle cramps.

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

These may be serious side effects and you may need medical attention. Mostly, these side effects are rare:

  • fainting
  • symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
  • itchy skin rash or other skin problems
  • yellowing of the skin and/or eyes
  • fast or irregular heart beat
  • signs of worrying or frequent infections such as fever, severe chills, sore throat or mouth ulcers
  • passing less urine than is normal for you.

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 and you may need urgent medical attention or hospitalisation. These side effects are usually very rare:

  • collapse, numbness or weakness in the arms or legs
  • pinkish, itchy swellings on the skin (hives, nettlerash)
  • swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing
  • swelling of hands, feet or ankles
  • wheezing or difficulty in breathing
  • chest pain, angina.

Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to enalapril, 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, throat or other parts of the body
  • rash, itching or hives on the skin
  • fainting
  • hay fever-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 it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What Chemmart Enalapril looks like

Chemmart Enalapril comes in three strengths:

  • 5 mg – oval, convex, white snap tab tablets, with one side scored and marked EN 5.
  • 10 mg – oval, convex, red-brown snap tab tablets, with one side scored and marked EN 10.
  • 20 mg – oval, convex, orange snap tab tablets, with one side scored and marked EN 20.

All strengths are available in packs containing 30 tablets.

* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains enalapril as the active ingredient.

It also contains the following inactive ingredients:

  • Sodium bicarbonate
  • Lactose
  • Starch-maize
  • Talc
  • Magnesium stearate
  • Iron oxide yellow
  • Hydroxypropylcellulose (5 mg tablets only)
  • Iron oxide red (10 mg tablets only)
  • Iron oxide red (20mg tablets only)

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

  • Chemmart Enalapril 5mg Tablets (Blisters): AUST R 96333
  • Chemmart Enalapril 10mg Tablets (Blisters): AUST R 96334
  • Chemmart Enalapril 20mg Tablets (Blisters): AUST R 96335

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

Chemmart is a registered trademark of Symbion Pty Ltd.

This leaflet was last updated in November 2012.

Published by MIMS April 2013