Lercanidipine APOTEX (lercanidipine) Drug / Medicine Information

Lercanidipine APOTEX (lercanidipine) Drug / Medicine Information

Contains the active ingredient lercanidipine (as hydrochloride)

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some of the common questions about lercanidipine. It does not
contain all the available information. It does not replace seeking advice from 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.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking
lercanidipine against the benefits this medicine is expected to have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with the medicine. You may need to read it again.

What this medicine is used for

The name of your medicine is Lercanidipine APOTEX. It contains the active ingredient
lercanidipine (as hydrochloride).

Lercanidipine belongs to a group of medicines called dihydropyridine calcium channel
blockers.

Lercanidipine helps lower high blood pressure, otherwise known as hypertension.

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

How it works

This medicine works by relaxing some of the blood vessels in the body and reducing
resistance to the flow of blood through the blood vessels.

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 your blood pressure stays higher than is needed, even
when you are calm and relaxed, you have hypertension (high blood pressure).

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 hypertension can cause stroke, heart disease and kidney
failure.

There is no evidence that this medicine is addictive.

Use in children

This medicine should not be used in children.

Before you take this medicine

When you must not take it

Do not take this medicine if:

You have or have had any of the following:

severe liver or kidney disease.

taking another medicine called cyclosporine.

You are hypersensitive to, or have had an allergic reaction to, lercanidipine or 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.

2. You have or have had any medical conditions, especially the following:

liver or kidney disease or you are on dialysis

other heart conditions such as: heart disease, uncontrolled heart failure, an obstruction
to the flow of blood from the heart (aortic stenosis), unstable angina (chest pain
or tightness at rest or progressively increasing) or you have had a heart attack (myocardial
infarction) one month ago or less and/or you require a pacemaker.

taking other drugs for high blood pressure, such as beta-blockers, diuretics, ACE-inhibitors
or angiotensin II receptor antagonists.

3. You are currently pregnant or plan to become pregnant. Do not take this medicine whilst
pregnant until you and your doctor have discussed the risks and benefits involved.

4. 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.

5. You are planning to have surgery or on an anaesthetic.

6. You are currently receiving or are planning to receive dental treatment.

7. 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.

Taking other medicines

Some medicines may interact with lercanidipine. These include:

cyclosporine

ritonavir

ketoconazole

itraconazole

erythromycin

fluoxetine

cimetidine

phenytoin

carbamazepine

rifampicin

amiodarone

quinidine

digoxin

simvastatin

metoprolol

propranolol

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 this medicine.

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.

The usual dose is one 10 mg tablet taken once daily, but may be increased to 20 mg
once daily.

Do not stop taking your medicine or change your dosage without first checking with
your doctor.

If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.

How to take it

Swallow the tablet whole with a glass of water.

When to take it

Take this medicine at about the same time each day, at least 15 minutes before a meal.

This medicine will have the best effect if it is taken at the same time each day.
This will also help you remember when to take the tablets.

How long to take it for

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

This medicine helps control your condition but does not cure it therefore you must
not stop taking it unless your doctor tells you to.

Make sure you have enough to last over weekends and holidays.

If you forget to take it

If you forget to take a dose but remember within 12 hours from when the dose was due,
take it straight away, then continue as normal the next day. Otherwise skip that day’s
dose and take the next day’s dose when it is due.

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

Do not take a double dose to make up for missed doses. This may increase the chance
of unwanted side effects.

If you have trouble remembering to take your tablets, ask your pharmacist for some
hints to help you remember.

If you have missed several doses, consult your doctor.

If you use 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. Keep telephone numbers of these places/services handy.

If you take too much of this medicine, it may cause your blood pressure to become
too low and you may feel your heart beat becomes irregular and faster. It may also
lead to unconsciousness.

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

You are about to be started on any new medicine

You are pregnant or are planning to become pregnant

You are breast-feeding or are planning to breast-feed

You are about to have any blood tests

You are going to have surgery or are going into hospital.

Your doctor may occasionally do tests to make sure the medicine is working and to
prevent side effects. Be sure to keep all of your doctor’s appointments so that your
progress can be checked.

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 a child under the age of 18 years.

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 or pharmacist tells
you to

Stop taking your medicine, or change the dosage, without first checking with your
doctor.

Things to be careful of

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

This medicine generally does not affect your ability to drive a car or operate machinery.
However, as with other medicines used to treat high blood pressure, some people may
feel dizzy, light-headed or faint, especially when first taking this medicine or changing
your dose.

Your doctor may also ask you to limit or stop your alcohol intake while taking medicines
used to control your blood pressure as alcohol may increase these effects.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.

Grapefruit juice can increase the effects of some medicines including lercanidipine.
If you are taking lercanidipine speak to your doctor or pharmacist before drinking
grapefruit juice or changing your intake of grapefruit juice. As with some medicines,
used to treat high blood pressure (such as lercanidipine), you should avoid drinking
grapefruit juice as grapefruit juice may increase the effects of these medicines.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking
lercanidipine 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:

flushing

swelling of the ankles, feet or lower legs

headache

dizziness

gastrointestinal disturbances such as heartburn, nausea, abdominal pain or diarrhoea

muscle weakness

fatigue or sleepiness.

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 are usually rare. You may need urgent medical
attention or hospitalisation:

angina (chest pain or tightness)

increased heart beat or heart palpitations

difficulty breathing

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

Allergic reactions

If you think you are having an allergic reaction to lercanidipine, 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, or other parts of the body

rash, itching or hives on the skin

fainting

hayfever-like symptoms.

Storage and disposal

Storage

Keep your medicine in the original packaging until it is time to take them. If you
take your medicine out of the original packaging, it may not keep well.

Keep your medicine in a cool dry place, away from sunlight, 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 they have passed their expiry
date, your pharmacist can dispose of the remaining medicine safely.

Product description

What Lercanidipine APOTEX looks like

Lercanidipine APOTEX is available in 10 mg or 20 mg tablets.

10 mg Tablets:

Round, biconvex, yellow, film coated tablets, scored on one side, marked “L” on the
other side.

Blister pack of 28 tablets.

20 mg Tablets:

Round, biconvex, pink, film coated tablets, scored on one side, marked “L” on the
other side.

Blister pack of 28 tablets.

Ingredients

Each tablet contains 10 mg or 20 mg of lercanidipine (as hydrochloride) as the active
ingredient.

It also contains the following inactive ingredients:

lactose monohydrate

microcrystalline cellulose

sodium starch glycollate

povidone

magnesium stearate

polyvinyl alcohol

titanium dioxide

macrogol 3350

purified talc

iron oxide yellow (10 mg only)

iron oxide red (20 mg only).

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

Australian Registration Numbers

Lercanidipine APOTEX 10 mg tablets: AUST R 172204

Lercanidipine APOTEX 20 mg tablets: AUST R 172206

 

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

 

APO and APOTEX are registered trade marks of Apotex Inc.

 

This leaflet was prepared in December 2019

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