PIP-LISINOPRIL lisinopril (as dihydrate) 2.5mg tablet blister pack

Main information

  • Trade name:
  • PIP-LISINOPRIL lisinopril (as dihydrate) 2.5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PIP-LISINOPRIL lisinopril (as dihydrate) 2.5mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 198011
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

198011

PIP-LISINOPRIL lisinopril (as dihydrate) 2.5mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Ipca Pharma (Australia) Pty Ltd

Postal Address

6 Morotai Avenue,ASHBURTON, VIC, 3147

Australia

ARTG Start Date

2/08/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. PIP-LISINOPRIL lisinopril (as dihydrate) 2.5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

18/06/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Hypertension: PIP-Lisinopril Tablets are indicated in the treatment of hypertension. It may be used alone or concomitantly with other classes of

antihypertensive agents. Sufficient data have not been provided to support the use of lisinopril (as dihydrate) in severe hypertension or renovascular

hypertension. Congestive heart failure: PIP-Lisinopril Tablets are also indicated in the treatment of heart failure. In such patients, it is recommended that

PIP-lisinopril tablets be administered with a diuretic. Acute myocardial infarction: PIP-Lisinopril Tablets are indicated for the treatment of acute

myocardial infarction in haemodynamically stable patients, defined as patients who are not in cardiogenic shock and who have a systolic blood pressure

greater than 100 mmHg. PIP-Lisinopril Tablets may be initiated within 24 hours of an acute myocardial infarction.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. PIP-LISINOPRIL lisinopril (as dihydrate) 2.5mg tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White to almost white, circular, biconvex, uncoated tablets with '2.5'

embossing on one side and 'BL' embossing on the other side.

Active Ingredients

Lisinopril dihydrate

QS

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

Public Summary

Page 1 of

Produced at 28.11.2017 at 11:38:20 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 28.11.2017 at 11:38:20 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PIP-LISINOPRIL

CONSUMER MEDICINE INFORMATION June 2013Version 1.3

COMMERCIAL-IN-CONFIDENCE

Lisinopril dihydrate

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about PIP-LISINOPRIL. 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 PIP-

LISINOPRIL 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 PIP-LISINOPRIL IS USED FOR

PIP-LISINOPRIL

lowers high blood pressure, which doctors call hypertension. It is

also used to treat heart failure and 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. You may feel fine and have no

symptoms, but eventually hypertension can cause stroke, heart disease and kidney failure.

PIP-Lisinopril 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 heart attack and 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.

PIP-Lisinopril helps to treat heart failure and may improve your symptoms.

PIP-LISINOPRIL

CONSUMER MEDICINE INFORMATION June 2013Version 1.3

COMMERCIAL-IN-CONFIDENCE

One of the ways PIP-Lisinopril helps heart failure is that it widens the blood vessels. This

means that blood is able to pass through them more easily and the heart does not have to

pump as hard to move the blood around the body. This also means that when you place extra

demands on your heart, such as during exercise, the heart may cope better so you may not

get short of breath as easily.

When used to treat heart failure, PIP-Lisinopril 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 is damaged. This damage may lead to further complications such

as heart failure, irregular heart rhythms and blood clots. In some patients, PIP-Lisinopril may

help to prevent some complications of heart attack, such as heart failure. PIP-Lisinopril

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

Your doctor may prescribe PIP-Lisinopril for another reason. Ask your doctor if you have

any questions about why PIP-Lisinopril has been prescribed for you.

PIP-Lisinopril is not addictive

BEFORE YOU TAKE PIP-LISINOPRIL

When you must not take it

Do not take PIP-LISINOPRIL if:

You have taken any medicines called ‘ACE- inhibitor’ 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 breath.

If you have had an allergic reaction to an ACE inhibitor before, you may be allergic to

PIP-LISINOPRIL.

If you have an allergy to lisinopril (as dihydrate)or any of the ingredients in PIP-

LISINOPRIL TABLETS listed at the end of this leaflet.

Some of the symptoms of an allergic reaction to PIP-Lisinopril may include skin rash,

itchiness, difficulty breathing or swallowing, or swelling of the face, lips, tongue or

throat.

You have a history of the 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

PIP-LISINOPRIL

CONSUMER MEDICINE INFORMATION June 2013Version 1.3

COMMERCIAL-IN-CONFIDENCE

You are pregnant or intend to become pregnant while taking PIP-Lisinopril

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 breast-feeding

Do not take PIP-Lisinopril 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 it to your pharmacist for disposal

you are undergoing haemodialysis.

If you are not sure whether you should start taking PIP-Lisinopril, talk to your doctor

Before you start to take it:

Your doctor must know about all of the following before you start to take PIP-Lisinopril.

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

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

2)

If you suffer from:

Kidney disease or are undergoing dialysis

Diabetes

Low blood pressure (you may notice this as faintness or dizziness, especially when

standing)

Liver disease

Heart problems

Aortic stenosis or hypertrophic cardiomyopathy

Any other medical condition

3) you have recently suffered from excessive vomiting or diarrhea

4) you are following a very low salt diet

5)

if you have had an allergy to any other medicines or any other substances, such as

foods, preservatives or dyes.

6)

surgery and anaesthesia (even at the dentist office) are scheduled, as there may be a

sudden fall in blood pressure associated with anaesthesia

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

PIP-Lisinopril.

PIP-LISINOPRIL

CONSUMER MEDICINE INFORMATION June 2013Version 1.3

COMMERCIAL-IN-CONFIDENCE

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy

without a prescription from your pharmacy,supermarket or health food shop.

Some of

the medicines in common use that may interfere with PIP-LISINOPRIL include:

Arthritis medicines including gold therapy

Other medicines used to treat high blood pressure

Diuretic tablets also called fluid or water tablets

Lithium a medicine used to treat some types of depression

Potassium tablets

Potassium-containing salt substitutes.

Potassium –sparing agents(e.g. spironolactone, eplerenone, triamterene, amiloride)

Any non-steroidal anti-inflammatory medicines (such as indomethacin)

Insulin or oral antidiabetic medicines. You shuld be closely monitored for low blood

glucose levels, especially during the first month of treatment with PIP-Lisinopril

These medicines may be affected by PIP-LISINOPRIL, 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 PIP-

Lisinopril

HOW TO TAKE PIP-LISINOPRIL

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

(as dihydrate)

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 to 20 mg each day, taken once a day

For Heart Failure:

The usual setting is 2.5 mg taken once a day

Depending on your response, this dose may need to be increased.

PIP-LISINOPRIL

CONSUMER MEDICINE INFORMATION June 2013Version 1.3

COMMERCIAL-IN-CONFIDENCE

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

For Heart attack:

PIP-Lisinopril may be started within 24 hours of the onset of the symptoms of heart attack.

The usual starting dose is 5 mg, which is followed 24 hours later by another 5 mg dose.

This is then followed 48 hours later by a 10 mg dose and then 10 mg taken once a day

thereafter. Some patients may need a lower starting and maintenance dose.

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 PIP-Lisinopril 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

Swallow PIP-Lisinopril with a glass of water or other liquid.

It does not matter whether you take PIP-LISINOPRIL with food or not.

How long to take it

PIP-LISINOPRIL helps control your high blood pressure and helps improve your heart

failure, but does not cure it. PIP-LISINOPRIL must be taken every day.

Take PIP-LISINOPRIL for as long as your doctor says to.

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 it as you would normally.

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

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

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 Poisons Information Center (telephone 131126) or go

to the Accident or Emergency centers at the nearest hospital, if you think that you or anyone

else may have taken too much PIP-LISINOPRIL. Do this even if there are no signs of

discomfort of poisoning. Keep telephone numbers for these places handy.

If you take too many tablets, you will probably feel light headed or dizzy, or you may faint.

PIP-LISINOPRIL

CONSUMER MEDICINE INFORMATION June 2013Version 1.3

COMMERCIAL-IN-CONFIDENCE

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

WHILE YOU ARE USING PIP-LISINOPRIL

Things you must do:

Have your blood pressure checked when your doctor says to make sure PIP-Lisinopril

is working.

Tell your doctor immediately if you feel any light-headedness or dizziness after you

take your first dose of PIP-LISINOPRIL or if your dose is increased.

This is especially important if you are taking PIP-LISINOPRIL 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 tablets).

This is 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 PIP-Lisinopril tell your doctor immediately.

If you are about to be started on any new medicine tell your doctor and pharmacist that

you are taking PIP-Lisinopril.

If you plan to have surgery (even at the dentist) that needs a general anaesthetic, tell

your doctor or dentist that you are taking PIP-Lisinopril.

Your blood pressure may drop suddenly during surgery.

Make sure you drink enough water during exercise and hot weather when you are

taking PIP-Lisinopril, especially if you sweat a lot.

If you do not drink enough water while taking PIP-Lisinopril, 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 diarrhoea while taking PIP-Lisinopril, tell your

doctor.

This can result in you losing too much water 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

see how your kidneys are working.

PIP-LISINOPRIL

CONSUMER MEDICINE INFORMATION June 2013Version 1.3

COMMERCIAL-IN-CONFIDENCE

Things you must not do

Do not give PIP-LISINOPRIL 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 PIP-LISINOPRIL affects

you.

PIP-Lisinopril

cause

dizziness

(lightheadedness)

tiredness

some

patients,

especially after the first dose or if the dose is increased. Make sure you know how you react

to PIP-Lisinopril before you drive a car, operate machinery, or do anything else that could be

dangerous

dizzy

light-headed.

drink

alcohol,

dizziness

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

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 PIP-LISINOPRIL.

PIP-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

PIP-LISINOPRIL

CONSUMER MEDICINE INFORMATION June 2013Version 1.3

COMMERCIAL-IN-CONFIDENCE

fatigue

dry cough

mild stomach upsets such as feeling sick, diarrhoea, or stomach pains

These are usually mild side effects of PIP-Lisinopril, but may be serious

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 our heart beats, for example, if you notice it beating faster

difficulty breathing

fainting

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 less urine than is normal for you

bruising more easily than normal

signs of anaemia, such as tiredness, being short of breath and looking pale.

severe abdominal pain

collapse, numbness or weakness of arms or legs

swelling of the hands, feet, or ankles

signs if 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 are all serious side effects. You may need urgent medical attention

Serious side effects are rare.

If

any

of

the

following

happen,

stop

taking

PIP-Lisinopril

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

severe skin reactions which starts with painful red areas, then large blisters and ends with

peeling of layers of skin. This is accompanied by fever and chills, aching muscles and

generally feeling unwell.

These are all very serious side effects. If you have them, you may have had a serious allergic

reaction to PIP-Lisinopril. 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

PIP-LISINOPRIL

CONSUMER MEDICINE INFORMATION June 2013Version 1.3

COMMERCIAL-IN-CONFIDENCE

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

changes in the way things smell

These are other side effects that have been reported with PIP-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 PIP-LISINOPRIL

Storage

Keep your tablets in the blister pack until it is time to take them. I

f you take the tablets out of the blister pack they may not keep well.

Keep in a cool, dry place where the temperature stays below 25 degrees 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 windowsills.

Heat and dampness can destroy some medicines.

Keep your tablets in a safe place where children cannot see or 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.

Further information

This is not all the information that is available on PIP-Lisinopril. If you have any more

questions or are not sure about anything, ask your doctor or pharmacist.

PRODUCT DESCRIPTION

Availability

PIP-LISINOPRIL comes in 2.5 mg, 5 mg, 10 mg and 20 mg tablet strengths

.

PIP-LISINOPRIL comes in pack sizes of 10, 14, 28, 30, 50, 56, 84 and 100 tablets.

PIP-LISINOPRIL

CONSUMER MEDICINE INFORMATION June 2013Version 1.3

COMMERCIAL-IN-CONFIDENCE

2.5 mg: white, circular, biconvex, uncoated tablets with “2.5” embossing on one side and

“BL” embossing on other side.

5 mg: light pink coloured, circular, biconvex, uncoated tablets with “5” embossed and break

line on one side and “BL” embossing on other side

10 mg: light pink coloured, circular, biconvex, uncoated tablets with “10” embossing on one

side and “BL” embossing on the other side.

20 mg: pink coloured, circular, biconvex, uncoated tablets with “20” embossing on one side

and “BL” embossing on the other side.

Ingredients

Active ingredient:

Lisinopril (as dihydrate)

Inactive ingredients:

Calcium Hydrogen Phosphate

Mannitol

Starch - Maize

Magnesium Stearate

The 5mg, 10mg and 20mg tablets also contains the colouring agent Iron Oxide Red CI77491

(E code 172)

Sponsor

IPCA PHARMA (AUSTRALIA) PTY. LTD

6 Morotai Avenue

Ashburton VIC 3147

AUSRALIA

AUST R

PIP-Lisinopril 2.5 mg Tablets: AUST R 198011

PIP-Lisinopril 5 mg Tablets:

AUST R 198012

PIP-Lisinopril 10 mg Tablets:

AUST R 198013

PIP-Lisinopril 20 mg Tablets: AUST R 198014

Date of TGA approval

29

th

July 2013