Consumer medicine information

Terry White Chemists Captopril Tablets

Captopril

BRAND INFORMATION

Brand name

Terry White Chemists Captopril Tablets

Active ingredient

Captopril

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Terry White Chemists Captopril Tablets.

What is in this leaflet

Read this leaflet carefully before taking your medicine. Ask your doctor or pharmacist if you do not understand anything or are worried about taking your medicine.

This leaflet answers some common questions about captopril.

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. Some more recent information on your medicine may be available. Speak to your pharmacist or doctor to obtain the most up-to-date information.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

Keep this leaflet with the medicine.

You may need to read it again.

What captopril is used for

The name of your medicine is Terry White Chemists Captopril. It contains the active ingredient, captopril.

Captopril is used to treat:

  • high blood pressure (hypertension)
  • heart failure
  • patients who have had a heart attack
  • kidney problems caused by diabetes.

These are long term (chronic) diseases so it is important that you continue to take your medicine every day.

How it works

Captopril 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.

By increasing the supply of oxygen to your heart, your heart does not have to work as hard which may reduce the risk of further damage to your heart after you have had a heart attack.

By reducing blood pressure, captopril may also slow down the kidney damage caused by type 1 (insulin-dependent) diabetes.

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. If you have hypertension (high blood pressure), it 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.

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.

Heart Attack:
A heart attack occurs when one of the major blood vessels supplying blood to your heart becomes blocked. This means that your heart can not receive the oxygen it needs and becomes damaged. This may lead to further problems, such as heart failure, irregular heart rhythms and blood clots.

Kidney Problems caused by Diabetes:
If you have type 1 (insulin-dependent) diabetes, you may develop kidney problems. The problems do not start at the same time as your diabetes is discovered; kidney problems develop slowly over several years. Good control of your blood sugar and blood pressure are important in keeping your kidneys healthy, but may not always prevent kidney damage from occurring.

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

Your doctor may have prescribed captopril for another reason.

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

There is no evidence that this medicine is addictive.

Use in children

Captopril is not recommended for use in children as there have not been enough studies of its effects in children. However, it may be necessary for a child with high blood pressure and kidney problems to take captopril. If this is the case, your doctor will discuss all possible risks and benefits to the child before starting therapy.

Before you take captopril

When you must not take it

Do not take this medicine if you have had an allergic reaction to captopril, any other ACE inhibitor (as you may be allergic to captopril) or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue , throat or other parts of the body; muscle pain or tenderness or joint pain; or rash, itching or hives on the skin.

Do not take captopril 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.

Do not take captopril if you are pregnant or trying to become pregnant.

Captopril may cause serious injury to your developing baby if you take it during pregnancy.

Do not take captopril if you are breast-feeding or intend to breast-feed.

Captopril can pass into breast milk.

Do not take this medicine after the expiry date (EXP) printed on the pack.

If you take this medicine after the expiry date has passed, it may not work as well.

Do not take this medicine if the packaging is torn, shows signs of tampering or if the tablets do not seem quite right.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you take it

Tell your doctor if you:

  1. have allergies to:
  • any other medicines
  • any other substances, such as, foods, preservatives or dyes.
  1. have a family history of swelling of the face, lips, tongue, throat that may cause difficulty in swallowing or breathing.
  2. have or have had any medical conditions, especially the following:
  • diabetes
  • systemic lupus erythematosus (SLE), scleroderma, any other auto immune 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 if you have taken other ACE inhibitors in the past.
  1. plan to become pregnant or breast-feed.

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

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 captopril may interfere with each other. These include:

  • any other medicine used to treat high blood pressure
  • water tablets or diuretics (e.g. Lasix®, Urex®, Natrilix®, Moduretic®)
  • arthritis/osteoarthritis medicines which are called non-steroidal anti-inflammatory drugs (NSAIDs), or COX-2 inhibitors to relieve pain, swelling and other symptoms of inflammation (e.g. Brufen®, Indocid®, Naprosyn® or Celebrex®). Taking a combination of captopril with a thiazide diuretic (water tablet) and an anti-inflammatory medicine may damage your kidneys.
  • potassium tablets (e.g. SPAN-K® SLOW-K® or K-MAG®)
  • potassium containing salt substitutes (e.g.PRESSOR-K®)
  • lithium, a medicine used to treat mood swings and some types of depression (e.g. Lithicarb®, Priadel®)
  • medicines used to treat diabetes, including insulin
  • antacids, medicines used to treat heartburn and indigestion
  • general anaesthetics
  • medicines used to treat gout, such as allopurinol
  • medicines which lower the immune system, such as azathioprine or medicines used to treat cancer
  • if you are taking captopril for high blood pressure do not take any medicine (including ones bought without a prescription) for appetite control, asthma, colds, coughs, hay fever or sinus problems unless you have discussed the medicine with your doctor or pharmacist.

These medicines may be affected by captopril, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking captopril.

Other interactions not listed above may also occur.

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully.

They may be different from the information contained in this leaflet.

If you do not understand any written instructions, ask your doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition and whether or not you are taking any other medicines.

Captopril is usually taken at a dose of 12.5 - 50 mg two or three times per day. Treatment may be started at low doses, particularly if you have heart failure. Your doctor will decide which dose is right for you.

How to take it

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

When to take it

Your medicine should be taken on an empty stomach, preferably, one hour before food - alternatively, two hours after food, unless your doctor has prescribed otherwise.

If you need to take an antacid, take it at least two hours before or two hours after your dose of captopril.

How long to take it

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

Captopril 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.

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 medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering 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) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much captopril.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much captopril, you may feel light-headed, dizzy or you may faint.

While you are taking captopril

Things you must do

If you become pregnant while taking captopril, 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 and salt and your blood pressure may drop too much. This is more likely to occur when you begin to take captopril or if your dose is increased.

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

If you do not drink enough water while taking captopril, you may feel faint, light-headed or sick. This is because your blood pressure may drop suddenly and you may dehydrate. If you experience any of the above symptoms, tell your doctor.

If you feel light-headed or dizzy after taking the first dose of your medicine, or when your dose is increased, tell your doctor immediately.

This is especially important if you are taking your medicine to treat heart failure.

Tell any other doctors, dentists and pharmacists who treat you that you are taking captopril.

If you are about to be started on a new medicine, tell your doctor, dentist or pharmacist that you are taking captopril.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking captopril because having a general anaesthetic while taking captopril may cause your blood pressure to drop suddenly.

Your doctor may like to do blood tests to see how captopril is affecting you.

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

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

Go to your doctor regularly for a check-up.

Your doctor may occasionally do a blood test to check your potassium levels and see how your kidneys are working.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not take your medicine to treat any other complaints unless your doctor tells you to.

Do not stop taking your medicine, or change 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 captopril 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 captopril, especially if you are elderly.

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

If you drink alcohol, dizziness or light-headedness may be worse.

Things to do to help lower your blood pressure or help 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. Alsoeat 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 of captopril

All medicines can have side effects. Sometimes they are serious, most of the time they are not.

Captopril helps most people with certain conditions, but it may have unwanted side effects in a few people.

If you are over 65 years of age you may have an increased chance of getting side effects.

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

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 thislist . 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
  • dry cough
  • headache
  • feeling sick (nausea) or vomiting
  • loss of appetite
  • stomach pain
  • diarrhoea
  • constipation
  • aching, tender or weak muscles not caused by exercise
  • muscle cramps
  • unusual tiredness or weakness, fatigue
  • ringing or buzzing in the ears
  • runny or blocked nose, or sneezing
  • taste disturbances or loss of taste
  • mouth or tongue ulcers
  • flushed or pale skin
  • fever
  • confusion or nervousness
  • if too much potassium builds up in your body, you may experience the following: irregular heartbeat, nervousness, numbness or tingling of the hands, feet or lips, shortness of breath or difficulty breathing, weakness or heaviness of legs.

These are the more common side effects of captopril. These are usually mild and short-lived.

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

  • disturbed vision
  • symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
  • itchy or raised skin rash, hives or nettle rash
  • signs of anaemia such as tiredness, being short of breath and looking pale
  • yellowing of the skin and/or eyes
  • swollen glands in the neck, armpit or groin
  • breast enlargement in men
  • fast or irregular heart beat
  • shortness of breath or tightness in the chest
  • tingling or numbness in the hands, feet or ankles
  • numbness, tingling and colour change (white, blue then red) in the fingers or toes when exposed to the cold
  • severe upper stomach pain, often with nausea and vomiting
  • signs of worrying or frequent infections such as fever, severe chills, sore throat or mouth ulcers
  • passing little or no urine
  • passing more urine than is normal for you
  • swelling of the hands, feet or ankles
  • bleeding or bruising more easily than normal

These may be serious side effects, which may need medical attention. They rarely occur.

If any of the following happen, stop taking your medicine 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
  • severe dizziness and confusion with visual disturbances and speech problems
  • collapse, numbness or weakness in the arms or legs
  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
  • wheezing or difficulty breathing
  • pink or red itchy spots on the skin which may blister and progress to form raised, red, pale-centred marks
  • severe flaking or peeling of the skin
  • severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
  • chest pain.

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

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

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

After taking this medicine

Storage

Keep your medicine in its original packaging until it is time to take them.

If you take the tablets out of their original packaging they will not keep well.

Keep your medicine in a cool dry place where the temperature stays below 30 degrees 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 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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

Product description

What Terry White Chemists Captopril looks like

12.5 mg tablets:
white, capsule-shaped tablets, one side engraved "12.5", other side engraved "APO".

25 mg tablets:
white, square tablets, one side engraved "APO" over "25".

50 mg tablets:
white, oval tablets engraved "APO-50" on one side, other side plain.

Each strength is available in a pack containing 90 tablets.

Ingredients

Each tablet contains captopril as the active ingredient.

It also contains the following inactive ingredients:

  • lactose
  • microcrystalline cellulose
  • croscarmellose sodium
  • magnesium stearate
  • colloidal silicon dioxide.

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

Australian Registration Numbers

  • Terry White Chemists Captopril 12.5 mg tablets:
    AUST R 73398.
  • Terry White Chemists Captopril 25 mg tablets:
    AUST R 74003.
  • Terry White Chemists Captopril 50 mg tablets:
    AUST R 74007.

Sponsor

Apotex Pty Ltd
ABN 52 096 916 418
66 Waterloo Road
North Ryde, NSW 2113
Australia

Distributor

Symbion Pharmacy Services Pty Ltd
ABN 25 000 875 034
48-58 Overseas Drive
Noble Park North VIC 3174
Australia

Terry White Chemists is a registered trade mark of Symbion Pharmacy Services Pty Ltd.

This leaflet was prepared in:
May 2008.

BRAND INFORMATION

Brand name

Terry White Chemists Captopril Tablets

Active ingredient

Captopril

Schedule

S4