Consumer medicine information

Lisinopril Ranbaxy

Lisinopril dihydrate


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Lisinopril Ranbaxy.

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 Lisinopril Ranbaxy 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 need to read it again.

What Lisinopril Ranbaxy is used for

Lisinopril Ranbaxy is used to:

  • lower high blood pressure (hypertension)
  • treat heart failure
  • treat patients who have just had a heart attack

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.

Lisinopril Ranbaxy is used to lower high blood pressure (hypertension).

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

Heart failure may start off with no symptoms, but as the condition progresses, people may feel short of breath or may get tired easily after light physical activity such as walking. Some people 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.

Lisinopril Ranbaxy may help to improve the symptoms of heart failure.

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

Heart Attack:

A heart attack occurs when one of the major blood vessels supplying blood to the heart muscle becomes blocked. As a result of the blockage, the heart does not receive the oxygen it needs and the heart muscle becomes damaged. This may lead to further complications such as heart failure, irregular heart rhythms and blood clots.

In some patients, Lisinopril Ranbaxy may help to prevent some of the further complications of heart attack, such as heart failure.

Your doctor may prescribe Lisinopril Ranbaxy for another reason.

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

How Lisinopril Ranbaxy works

Lisinopril Ranbaxy belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors.

These medicines work by widening your blood vessels, which reduces the pressure in the blood 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.

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.

There is no evidence that Lisinopril Ranbaxy is addictive.

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

Use in children

The safety and effectiveness of Lisinopril Ranbaxy in children has not been established.

Before you take Lisinopril Ranbaxy

When you must not take it

Do not take Lisinopril Ranbaxy if:

  • 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 before, you may be allergic to Lisinopril Ranbaxy.

  • you have had an allergic reaction to Lisinopril Ranbaxy 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 or other parts of the body, rash, itching or hives on the skin.

  • you have a history of swelling of the face, lips, tongue, throat, hands or feet, for no apparent reason, or your family has a history of these symptoms.
  • 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.

  • the tablets show visible signs of deterioration.
  • the date has passed the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering.

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

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

  • you are undergoing dialysis using polyacrylonitrile-metalylsulphonate high-flux membranes.

Check with your doctor or nurse if you undergo dialysis and you are not sure which type of membrane is used.

If you are not sure whether you should start taking Lisinopril Ranbaxy, talk to your doctor.

Before you start to take it

Your doctor must know about all of the following before you start to take Lisinopril Ranbaxy:

  1. If you intend to become pregnant or intend to breast-feed.

Lisinopril Ranbaxy should not be used during pregnancy or while breast-feeding.

  1. If you suffer from:
  • kidney disease, or are undergoing dialysis
  • low blood pressure (you may notice this as faintness or dizziness, especially when standing)
  • liver disease
  • aortic stenosis, or hypertrophic cardiomyopathy
  • any other medical conditions
  1. If you are following a very low salt diet.
  2. If you have had any allergy to any other medicines or any other substances, such as foods, preservatives or dyes.
  3. If you are going to receive desensitisation treatment for an allergy, e.g. to insect stings.

If you have not told your doctor about any of the above, tell him/her before you take any Lisinopril Ranbaxy.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you have bought from your pharmacy, supermarket or health food shop.

Some of the medicines in common use may interfere with Lisinopril Ranbaxy. These include:

  • other medicines used to treat high blood pressure
  • diuretic tablets – also called fluid or water tablets
  • lithium, a medicine used to treat mood swings and some types of depression
  • potassium tablets such as Slow-K, Span-K, KSR, K-Mag or Chlorvescent
  • potassium-containing salt substitutes such as Pressor K
  • any non-steroidal anti-inflammatory medicines (NSAIDs), medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis
  • other medicines used to treat diabetes
  • general anaesthetics

These medicines may be affected by Lisinopril Ranbaxy, 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 a more complete list of medicines to avoid while taking Lisinopril Ranbaxy.

How to take Lisinopril Ranbaxy

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 Lisinopril Ranbaxy only when prescribed by your doctor.

For high blood pressure:

For most patients, the usual starting dose is 5 to 10 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 and 20 mg, taken once a 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.

The usual dose is 5 to 20 mg each day, taken once a day.

For heart attack:

Lisinopril Ranbaxy may be started within 24 hours of the onset of the symptoms of heart attack and may be continued for six weeks or more.

The usual starting dose is 5 mg and then as directed by your doctor.

The usual maintenance dose is 10 mg once a day. Some people may need a lower starting and maintenance dose.

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 on the pack, ask your doctor or pharmacist for help.

How to take it

Swallow Lisinopril Ranbaxy with a glass of water or other liquid.

When to take it

Take your Lisinopril Ranbaxy 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.

It does not matter if you take Lisinopril Ranbaxy before or after food.

How long to take it

Lisinopril Ranbaxy helps control your high blood pressure and helps improve your heart failure, but does not cure it. Therefore it must be taken every day.

Continue taking Lisinopril Ranbaxy for as long as your doctor prescribes it.

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 what you should do, ask your doctor or pharmacist.

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 have trouble remembering to take your tablets, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone number 13  11  26) or go to the Accident & Emergency Department at your nearest hospital, if you think that you or anyone else may have taken too much Lisinopril Ranbaxy. 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 Lisinopril Ranbaxy

Things you must do

Have your blood pressure checked when your doctor says to make sure that the Lisinopril Ranbaxy is working.

Tell your doctor immediately, if you feel light-headed or dizzy after taking your first dose of Lisinopril Ranbaxy, or if your dose is increased. This is especially important if you are taking Lisinopril Ranbaxy for heart failure.

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 is because your blood pressure is suddenly falling.

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 continues or gets worse, talk to your doctor.

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

If you plan to have surgery (even at the dentist) that needs a general anaesthetic, tell your doctor or dentist that you are taking Lisinopril Ranbaxy. Your blood pressure may drop suddenly during surgery.

Make sure you drink enough water during exercise and hot weather when you are taking Lisinopril Ranbaxy, especially if you sweat a lot. If you do not drink enough water while taking Lisinopril Ranbaxy, you may feel faint, 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 diarrhoea while taking Lisinopril Ranbaxy, tell your doctor. This can result in your losing too much water and salt and your blood pressure may drop too much.

Go to your doctor regularly for a check-up. Your doctor may occasionally do a blood test to check the potassium level in your blood and see how your kidneys are working.

Things you must not do

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

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

Do not stop taking Lisinopril Ranbaxy, or lower the dosage, without checking with your doctor.

Things to be careful of

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

As with other ACE inhibitor medicines, Lisinopril Ranbaxy may cause dizziness or light-headedness in some patients, especially after the first dose or if the dose is increased. Make sure you know how you react to Lisinopril Ranbaxy 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.
  • 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 reasonably 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 dietitian’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 Lisinopril Ranbaxy.

Lisinopril helps most people with high blood pressure and heart failure, 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.

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

  • light-headedness or dizziness
  • headache
  • fatigue
  • dry cough
  • mild stomach upsets such as feeling sick, diarrhoea, constipation or stomach pains

These are usually mild side effects of lisinopril.

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

  • chest pain, angina
  • changes in the way your heart beats, for example, if you notice it beating faster
  • difficulty breathing
  • wheeziness due to tightness in the chest
  • itchy skin rash or other skin problems
  • signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
  • tingling or numbness of the hands and feet
  • passing urine less than is normal for you
  • bruising more easily than normal
  • severe abdominal pain
  • collapse, numbness or weakness of arms or legs

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

If any of the following happens, stop taking Lisinopril Ranbaxy and tell your doctor immediately or go to casualty at your nearest hospital:

  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • pinkish, itchy swellings on the skin, also called hives or nettle rash
  • fainting
  • yellowing of the skin and/or eyes, also called jaundice

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Lisinopril Ranbaxy. You may need urgent medical attention or hospitalisation. All of these side effects are rare.

Also tell your doctor if you notice:

  • hair loss or thinning
  • impotence
  • psoriasis and other serious skin conditions
  • changes in the way things taste
  • feeling sleepy or difficulty in going to sleep, strange dreams
  • running nose or sinus pain

These are other side effects that have been reported with lisinopril.

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

After using Lisinopril Ranbaxy

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 they may not keep well.

Keep Lisinopril Ranbaxy in a cool, dry place where the temperature stays below 25ºC.

Do not store Lisinopril Ranbaxy 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 your medicines in a safe place where children cannot reach them. 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 tablets that are left over.

Where to go to 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. You may also be able to find general information about your disease and its treatment from patient information groups.

Product Description

What it looks like

Lisinopril Ranbaxy 5 mg tablets – Round, light yellow, scored tablets marked with “5” on one side; in pack sizes of 30 tablets.

Lisinopril Ranbaxy 10 mg tablets – Round, light yellow scored tablets marked with “10” on one side; in pack sizes of 30 tablets.

Lisinopril Ranbaxy 20 mg tablets – Round, light peach, scored tablets marked with “20” on one side; in pack sizes of 30 tablets.

Ingredients

Active Ingredient:

  • Lisinopril Ranbaxy 5 mg tablets – contain 5 mg of lisinopril (as dihydrate) per tablet
  • Lisinopril Ranbaxy 10 mg tablets – contain 10 mg of lisinopril (as dihydrate) per tablet
  • Lisinopril Ranbaxy 20 mg tablets – contain 20 mg of lisinopril (as dihydrate) per tablet

Other Inactive Ingredients:

  • Mannitol
  • Calcium hydrogen phosphate anhydrous
  • Maize Starch
  • Pregelatinised maize starch
  • Magnesium stearate
  • Iron oxide yellow
  • Iron oxide red (20 mg tablets only)

Lisinopril Ranbaxy does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Australian Registration Numbers

Lisinopril Ranbaxy 5 mg tablets – AUST R 153189

Lisinopril Ranbaxy 10 mg tablets – AUST R 153190

Lisinopril Ranbaxy 20 mg tablets – AUST R 153191

Sponsor

Ranbaxy Australia Pty Ltd.
Suite 4.02, Level 4, Building D
12-24 Talavera Road
North Ryde, NSW 2113
Australia

Date of leaflet preparation:
February 2009

Published by MIMS May 2010