Zan-Extra®

Lercanidipine hydrochloride & Enalapril maleate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions about Zan-Extra. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

Please read this leaflet before you start taking Zan-Extra.

If you are helping someone else take Zan-Extra, please read this leaflet before you give the first dose.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Zan-Extra against the expected benefits this medicine 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 Zan-Extra is used for

The name of your medicine is Zan-Extra. It is also known as lercanidipine plus enalapril. Zan-Extra is a combination of the two medicines. Lercanidipine belongs to a group of medicines called calcium channel blockers, enalapril belongs to a group called Angiotensin Converting Enzyme (ACE) inhibitors.

Zan-Extra lowers high blood pressure, which doctors call hypertension.

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

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.

Zan-Extra helps to lower your blood pressure.

Zan-Extra cannot be obtained without a doctor's prescription.

There is no evidence that Zan-Extra is addictive.

Before you take Zan-Extra

When you must not take it

Do not take Zan-Extra if you have an allergy to:

• lercanidipine, ZANIDIP®, enalapril, Renitec®, Amprace® or any other brands of enalapril maleate, or any of the ingredients listed at the end of this leaflet
• any drugs closely related to lercanidipine (such as amlodipine, felodipine or nifedipine)

Symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath, swelling of the face, lips or tongue, muscle pain or tenderness or joint pain.

Do not take Zan-Extra if you:

• have severe liver or kidney disease
• are also taking another medicine called ciclosporin
• have a history of swelling of the face, lips, tongue, throat, hands or feet, for no apparent reason.

Ask your doctor or pharmacist if you are not sure.

Do not take Zan-Extra if you are pregnant, intend to become pregnant or if you are breastfeeding. Your baby may absorb this medicine in the womb or from breast milk and therefore there is a possibility of harm to the baby.

Tell your doctor immediately if you become pregnant while you are taking Zan-Extra.

Do not take Zan-Extra if:

• the packaging is torn or shows signs of tampering.
• the tablets show visible sign of deterioration (for example, are broken or discoloured).
• the expiry date printed on the pack has passed. 
  If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure whether you should start taking Zan-Extra, talk to your doctor.

Do not give Zan-Extra to a child under the age of 18 years. Zan-Extra is not recommended for use in children.

Before you start to take it

You must tell your doctor if:

1. you intend to get pregnant or intend to breastfeed.

Zan-Extra should not be used during pregnancy or while breastfeeding.

1. you are taking other drugs for high blood pressure, such as beta-blockers, diuretics, ACE-inhibitors or angiotensin II receptor antagonists.
2. you have or have ever had any other health problems/medical conditions, including:

• liver or kidney disease or are on dialysis
• certain other heart conditions such as:
  - uncontrolled heart failure,
  - an obstruction to flow of blood from the heart,
  - unstable angina (chest pain or tightness at rest or progressively increasing),
  - a heart attack in the last month,
  - if you require a pacemaker

1. you are following a very low salt diet.
2. you are allergic to any other medicine or any foods, dyes or preservatives.

If you have not told your doctor about any of the above or if you are not sure, tell them before you take Zan-Extra.

Taking other medicines

Tell your doctor 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 and Zan-Extra may interfere with each other. These include:

• other blood pressure medications
• ritonavir, ciclosporin, ketoconazole, itraconazole, erythromycin, fluoxetine, cimetidine (more than 800 mg daily)
• Diuretic tablets - also called fluid or water tablets
• Lithium, a medicine used to treat mood swings and some types of depression
• Potassium tablets
• Potassium-containing salt substitutes and
• Non-steroidal anti-inflammatory medicines, used to relieve pain, swelling and other symptoms of inflammation.
• Arthritis medicines including gold therapy
• Insulin or oral antidiabetic medicines. You should be closely monitored for low blood glucose levels, especially during the first month of treatment with Zan-Extra.

These medicines may be affected by Zan-Extra, or may affect how well it works. 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 any of these medicines.

Also ask your doctor or pharmacist what to do if you are taking, or are about to take the following medicines: phenytoin, carbamazepine, rifampicin, amiodarone, quinidine, digoxin, simvastatin, metoprolol or propranolol.

If you have not told your doctor about any of the medicines listed above, tell them before you start taking Zan-Extra.

How to take Zan-Extra

How much to take

Follow all directions given to you by your doctor carefully. These directions may differ from the information contained in this leaflet.

The usual dose is one tablet taken once daily.

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

How to take it

Swallow Zan-Extra whole with a glass of water.

When to take it

Take Zan-Extra at about the same time each day, at least 15 minutes before a meal. Zan-Extra will have the best effect if it is taken at the same time each day at least 15 minutes before meals. This will also help you remember when to take the tablets.

How long to take it

Zan-Extra helps control your condition, but does not cure it. Therefore you must take Zan-Extra every day. Continue taking the tablets for as long as your doctor tells you to.

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 but be sure to take the next day's dose when it is due.

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

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

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

If you have missed several doses, consult your doctor.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident & Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Zan-Extra. 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 Zan-Extra it may cause your blood pressure to become too low and you may feel your heart beats become irregular and faster. It may also lead to unconsciousness.

While you are using Zan-Extra

Things you must do

Use Zan-Extra exactly as your doctor has prescribed. If you do not follow your doctor's instructions correctly, your blood pressure may not be controlled.

Be sure to keep all of your doctor's appointments so that your progress can be checked.

If you become pregnant while you are taking Zan-Extra, tell your doctor.

If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Zan-Extra.

Tell all other doctors, dentists and pharmacists who are treating you that you are taking Zan-Extra.

If you have an operation, tell the anaesthetist that you are taking this medicine.

Things you must not do

Do not give Zan-Extra to anyone else, even if they have the same condition as you.

Do not use Zan-Extra to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how Zan-Extra affects you. Zan-Extra generally does not cause any problems with your ability to drive a car or operate machinery. However, as with other medicines used to treat high blood pressure, a few people may feel dizzy, light-headed or faint, especially when first taking Zan-Extra or when starting to take a different amount of medicine. Your doctor may also ask you to limit or stop your alcohol intake while taking medicines to control your blood pressure, such as Zan-Extra, 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.

As with some medicines used to treat high blood pressure such as Zan-Extra, you should avoid drinking grapefruit juice.

Grapefruit juice may increase the effects of these medicines.

Side Effects

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

Zan-Extra helps most people with high blood pressure, 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.

Possible side effects include:

• flushing
• swelling of the ankles, feet or lower legs
• headache
• dizziness
• gastrointestinal disturbances such as nausea, abdominal pain, taste alteration or diarrhoea
• fatigue or sleepiness
• swelling of the face, lips, tongue or throat
• difficulty in breathing
• dry cough

These effects when they occur are usually mild. However, should you experience any of these or other undesirable effects not mentioned above, you should consult your doctor or pharmacist.

Ask your doctor or pharmacist to answer any questions you may have.

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

• angina (chest pain or tightness)
• increased heart beat
• signs of allergy such as rash, itching or hives on the skin

These side effects are usually rare but may be serious and need urgent medical attention.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Zan-Extra

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 it in a cool dry place away from sunlight where the temperature stays below 25°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 window sills. 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 the tablets or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description

What it looks like

Zan-Extra is available as tablets of two separate strengths, Zan-Extra 10/10 and Zan-Extra 10/20 both containing lercanidipine 10 mg, and either enalapril 10 mg or 20 mg respectively.

Zan-Extra 10/10 tablets are white, circular, biconvex, film-coated tablets, and available in packs of 28 tablets and 7 (physician's sample) tablets in a blister pack.

Zan-Extra 10/20 tablets are yellow, circular, biconvex, film-coated tablets, and available in packs of 28 tablets and 7 (physician's sample) tablets in a blister pack.

Ingredients

Active Ingredients 
Lercanidipine hydrochloride 10 mg with either enalapril maleate 10 mg or 20 mg per tablet.

Excipient Ingredients 
Lactose monohydrate, microcrystalline cellulose, sodium starch glycollate Type A, povidone, sodium bicarbonate, magnesium stearate, hypromellose, titanium dioxide (E171), purified talc, macrogol 6000.

Additionally Zan-Extra10/20 tablets contain quinoline yellow aluminium lake (E104) and iron oxide yellow (E172).

Zan-Extra does not contain gluten, sucrose, tartrazine or any other azo dyes.

Sponsor

Zan-Extra is supplied in Australia by:

Mylan Health Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 314 527

Australian registration numbers:

10 mg/10 mg- AUST R 120955

10 mg/20 mg- AUST R 120961

This leaflet was prepared in October 2017.