Apo-Lercanidipine

Contains the active ingredient, lercanidipine (as lercanidipine hydrochloride)
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Apo-Lercanidipine. It does not contain all the information that is known about Apo-Lercanidipine. 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 using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is APO-Lercanidipine. It contains the active ingredient, lercanidipine (as lercanidipine hydrochloride).
Lercanidipine belongs to a group of medicines called dihydropyridine calcium channel blockers.
Lercanidipine helps lowers high blood pressure, otherwise known as hypertension.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.

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.

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 are pregnant or intend to become pregnant.
Like most calcium channel blockers, lercanidipine is not recommended for use during pregnancy.
You are breast-feeding.
Like most calcium channel blockers, lercanidipine is not recommended while you are breast-feeding.
You have severe liver or kidney disease.
You are also taking another medicine called cyclosporine.
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.
The tablets show visible signs of deterioration (for example, are broken or discoloured).
You have had an allergic reaction to lercanidipine, any of the ingredients listed at the end of this leaflet or any drugs closely related to lercanidipine (such as amlodipine, felodipine or nifedipine).
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, itching or hives on the skin.
If you think you are having an allergic reaction, contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

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
certain 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.

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

4. You are currently pregnant or breastfeeding or you plan to become pregnant or breast-feed.

5. You are planning to have surgery.

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

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with the way lercanidipine works, or may be affected by lercanidipine. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist can tell you what to do if you are taking of these medicines.
Ask your doctor or pharmacist what to do if you are taking, or are about to take the following medicines:
cyclosporine
ritonavir
ketoconazole
itraconazole
erythromycin
fluoxetine
cimetidine
phenytoin
carbamazepine
rifampicin
amiodarone
quinidine
digoxin
simvastatin
metoprolol
propranolol.
If you have not told your doctor about any of the medicines listed above, tell them before you start taking lercanidipine.
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 or pharmacist. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor or pharmacist 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

Use this medicine exactly as your doctor has prescribed.
If you do not follow your doctor's instructions correctly, your blood pressure may not be well controlled.
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.
Lercanidipine is not recommended for use in children.
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 or pharmacist 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 or pharmacist if you notice any of the following and they worry you.
This list includes the more common side effects. Mostly, these are mild:
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 where the temperature will stay below 30°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 APO-Lercanidipine looks like

APO-Lercanidipine is available in 10 mg or 20 mg tablets.
10 mg Tablets:
Yellow coloured, film coated, round shaped, biconvex tablets, engraved 'APO' on one side and score line on the other side.
20 mg Tablets:
Pink coloured, film coated, round shaped, biconvex tablets, engraved 'APO' on one side and score line on the other side.
APO-Lercanidipine comes in blister packs of 14*, 28 and 30* tablets.
APO-Lercanidipine also comes in bottles* of 30, 100 & 500 tablets.
* not available.

Ingredients

Each tablet contains 10 mg or 20 mg of lercanidipine (as lercanidipine hydrochloride) as the active ingredient.
It also contains the following inactive ingredients:
microcrystalline cellulose
lactose
croscarmellose sodium
butylate hydroxytoluene
magnesium stearate
hypromellose
macrogol 8000
titanium dioxide
purified talc
yellow iron oxide (10 mg only)
red iron oxide (20 mg only).
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

APO-Lercanidipine 10 mg tablets (blister pack):
AUST R 163768.
 
APO-Lercanidipine 10 mg tablets (bottle):
AUST R 163765.
 
APO-Lercanidipine 20 mg tablets (blister pack):
AUST R 163769.
 
APO-Lercanidipine 20 mg tablets (bottle):
AUST R 163762.

Sponsor

Apotex Pty Ltd
66 Waterloo Road
North Ryde NSW 2113
Australia
 
Apotex Pty Ltd is the licensee of the registered trade marks APO and APOTEX from the registered proprietor, Apotex Inc.
 
This leaflet was prepared in:
August 2010.