Consumer medicine information

Enalapril-GA

enalapril maleate

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Enalapril-GA. 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 Enalapril-GA 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 IS ENALAPRIL-GA USED FOR

The name of your medicine is Enalapril-GA. It contains the active ingredient enalapril maleate. Enalapril-GA is used to lower high blood pressure (hypertension). It is also used to treat heart failure.

Hypertension

Everyone has blood pressure. This pressure helps to circulate the 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.

Enalapril-GA helps to lower your blood pressure.

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 a heart attack and it does not mean that the heart stops working. 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.

Enalapril-GA helps to treat heart failure, whether you have symptoms or not. In many patients with heart failure who have symptoms, Enalapril-GA may slow the progression of heart failure and reduce the need to go to hospital as a result of heart failure. Enalapril-GA may help some of these patients live longer.

In many patients with heart failure who have no symptoms, Enalapril-GA may help to stop the heart muscle from getting weaker.

Enalapril-GA may also slow down the development of symptoms, such as shortness of breath, tiredness after light physical activity, or swelling of the ankles and feet. These patients may be less likely to have hospital stays due to heart failure.

By taking Enalapril-GA, heart failure patients may have less chance of having a heart attack.

When used to treat heart failure, Enalapril-GA is almost always used with other medicines called diuretics or fluid tablets. These medicines help the kidney get rid of excess fluid from the body.

Your doctor may have prescribed Enalapril-GA for another reason.

Ask your doctor if you have any questions about why Enalapril-GA was prescribed for you.

How Enalapril-GA works

Enalapril-GA belongs to a group of medicines called angiotensin converting enzymes (ACE) inhibitors.

One of the ways Enalapril-GA helps lower blood pressure and treat heart failure is that it widens your blood vessels, which reduces pressure in the vessels, making it easier for your heart to pump blood around your body.

This helps increase 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 Enalapril-GA is addictive.

BEFORE YOU TAKE ENALAPRIL-GA

When you must not take Enalapril-GA

Do not take Enalapril-GA if:

  • You are allergic to the active ingredient or any of the inactive ingredients mentioned at the end of this leaflet under Product Description.

Symptoms of an allergic reaction to Enalapril-GA or other brands of enalapril maleate may include skin rash, itchiness, shortness of breath, swelling of the face, lips or tongue, muscle pain or tenderness or joint pain.

  • 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 to breathe.
  • You have a history or a family history of swelling of the face, lips, tongue, throat, hands or feet for no apparent reason.
  • You have diabetes and are taking a medicine called aliskiren to reduce blood pressure.

Do not take Enalapril-GA if you are pregnant, plan on becoming pregnant, or are 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.

Do not give Enalapril-GA to children without discussing with your child’s doctor. The safety and effectiveness of enalapril in children have not been established.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return to your pharmacist for disposal.

Before you start to take Enalapril-GA

Tell your doctor if you have allergies to:

  • Any other medicines, especially if they are in the same drug class as enalapril maleate.
  • Any other substances, including foods, preservatives or dyes.

Tell your doctor if you are pregnant, plan on becoming pregnant or will be breast feeding while you are using Enalapril-GA.

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

  • Kidney problems, or if you are undergoing dialysis treatment
  • Heart problems
  • Low blood pressure, which you may notice as dizziness and lightheadedness
  • High levels of potassium in your blood
  • Stroke
  • Diabetes
  • Problems with your bone marrow or your white blood cells

Tell your doctor if you are following a very low salt diet.

Tell your doctor if you have a history or family history of a condition known as angioedema which can involve swelling of the face, lips, tongue, throat, hands or feet.

Tell your doctor if you are about to receive desensitisation therapy for an allergy.

Tell your doctor if you plan to have surgery and anaesthesia (even at the dentist office), as there may be a sudden fall in blood pressure associated with anaesthesia.

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.

Some medicines and Enalapril-GA may interfere with each other. In particular, tell your doctor if you take any of the following:

  • Other medicines used to treat high blood pressure
  • Diuretics, also known as fluid or water tablets
  • Non-steroidal anti-inflammatory drugs (NSAIDs or COX-2 inhibitor) medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis
  • Potassium supplements or potassium-containing salt substitutes
  • Potassium-sparing agents (eg. Spironolactone, eplerenone, triamterene, amiloride)
  • Lithium, a medicine used to treat mood swings and some types of depression.
  • Arthritis medicines including gold therapy
  • Insulin or oral anti-diabetic medicines. You should be closely monitored for low blood glucose levels, especially during the first month of treatment with Enalapril-GA.

Tell your doctor or pharmacist if you are currently taking any NSAID or COX-2 medicine. Your doctor may advise a blood test to check your kidney function before you start to take Enalapril-GA.

These medicines may be affected by Enalapril-GA, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

HOW TO TAKE ENALAPRIL-GA

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help. Take your Enalapril-GA at about the same time each day. Taking your tablet(s) at the same time each day will have the best effect. It will also help you remember when to take the tablets.

If you need to break Enalapril-GA, hold tablet with both hands and snap along break line.

Swallow Enalapril-GA with a glass of water. It does not matter if you take Enalapril-GA before or after food.

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 Enalapril-GA only when prescribed by your doctor.

For high blood pressure:
For most patients, the usual starting dose is 5 mg taken once a day. Some patients may need a lower starting dose. The dose may need to be increased depending on your blood pressure. Most patients take between 10 to 40 mg per 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 need to be increased up to 20 mg each day. This dose may be taken once a day or divided into two doses per day.

How long to take it

Enalapril-GA helps control your high blood pressure and helps improve your heart failure, but does not cure it. Therefore this medicine must be taken every day.

Continue taking the medicine for as long as your doctor prescribes.

If you forget to take it

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 (overdose)

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 Enalapril-GA. 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, or you may faint.

WHILE YOU ARE USING ENALAPRIL-GA

Things you must do

  • Always follow your doctor’s instructions carefully
  • Have your blood pressure checked when your doctor says to make sure Enalapril-GA is working
  • If you feel any light-headedness or dizziness after you take your first dose of Enalapril-GA or if your dose is increased, tell your doctor immediately. This is especially important if you are taking Enalapril-GA for heart failure
  • If you become pregnant, or plan on becoming pregnant while taking Enalapril-GA, tell your doctor immediately
  • If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking Enalapril-GA
  • If you plan to have surgery (even at the dentist) that needs a general anesthetic, tell your doctor or dentist that you are taking Enalapril-GA. Your blood pressure may drop suddenly.
  • If you are about to have any blood tests, tell your doctor that you are taking Enalapril-GA.

If you feel light-headed, dizzy or faint, get up slowly when getting out of bed or standing up. You may feel light-headed or dizzy, especially if you are also taking a diuretic (fluid tablet). This may be because your blood pressure is falling suddenly. Standing up slowly, especially when you get up from bed or a chair, 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.

Make sure you drink enough water during exercise and hot weather when you are taking Enalapril-GA, especially if you sweat a lot. If you do not drink enough water while taking Enalapril-GA, 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 have excessive vomiting and/or diarrhea while taking Enalapril-GA, tell your doctor. This can also mean that you are losing too much water and salt, and may drop your blood pressure too much.

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 stop taking Enalapril-GA without your doctor’s permission
  • Do not use Enalapril-GA 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

Be careful driving or operating machinery until you know how Enalapril-GA affects you. Enalapril-GA may cause dizziness or lightheadedness in some people, especially after the first dose or if the dose is increased.

Make sure you know how you react to Enalapril-GA before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or lightheaded.

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.
  • 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.

SIDE EFFECTS

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

All 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. Ask your doctor or pharmacist to answer any questions you may have.

While taking Enalapril-GA

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

  • Light-headedness or dizziness because your blood pressure is too low
  • Headache
  • Fatigue
  • Dry cough
  • Mild stomach upsets such as feeling sick, diarrhea, or stomach pains
  • Muscle cramps

These are the more common side effects of Enalapril-GA. Mostly, these are mild and short-lived.

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
  • Fainting
  • Yellowing of the skin and eyes, also called jaundice
  • itchy skin rash or other skin problems
  • Signs of worrying or frequent infections such as fever, severe chills, sore throat or mouth ulcers
  • Passing less urine than is normal for you
  • Signs of dehydration such as nausea, vomiting, muscle cramps, headache, drowsiness and tiredness. If untreated, mental confusion and fits may develop. Your doctor may need to monitor your blood sodium levels.

These may be serious side effects of Enalapril-GA. You may need urgent medical attention or hospitalisation. Serious side effects are rare.

If any of the following happen, stop taking Enalapril-GA, 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
  • Swelling of the hands, feet or ankles
  • Pinkish, itchy swelling on the skin, also called hives or nettlerash
  • Chest pain, angina
  • Wheeziness due to tightness in the chest
  • Collapse, numbness or weakness of arms or legs

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

All of these side effects are very rare.

Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.

AFTER USING ENALAPRIL-GA

Storage

Keep Enalapril-GA in the original packaging until you need to take it. If you take it out of its original packaging it may not keep well.

Store below 25°C in a dry place, protected from light and moisture.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on a window sill. Heat and dampness can destroy some medicines.

Keep Enalapril-GA 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 the tablets or the tablets have passed their expiry date, ask your pharmacist what to do with any unused medicine.

PRODUCT DESCRIPTION

What Enalapril-GA looks like

  • Enalapril-GA 5 mg – oval, convex, white snap tab tablets, with one side scored and marked EN 5, packed in blisters of 30’s.
  • Enalapril-GA 10 mg – oval, convex, red-brown snap tab tablets, with one side scored and marked EN 10, packed in blisters of 30’s.
  • Enalapril-GA 20 mg – oval, convex, orange snap tab tablets, with one side scored and marked EN 20, packed in blisters of 30’s.

Ingredients

Active Ingredient
Enalapril maleate

Inactive Ingredients

  • sodium bicarbonate
  • lactose
  • starch-maize
  • talc – purified
  • magnesium stearate
  • hydroxypropylcellulose (Enalapril 5 mg)
  • iron oxide red (Enalapril 10 mg and 20 mg)
  • iron oxide yellow (Enalapril 20 mg).

Australian Registration Number

  • Enalapril-GA 5 mg tablets:
    AUST R 121953 (blister pack)
  • Enalapril-GA 10 mg tablets:
    AUST R 121954 (blister pack)
  • Enalapril-GA 20 mg tablets:
    AUST R 121955 (blister pack)

Supplier

www.ascentpharma.com.au

Ascent Pharma Pty Ltd
151-153 Clarendon St
South Melbourne Vic. 3205

For further information call 1800 554 414

This leaflet was prepared in July 2013.

Published by MIMS September 2013