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AMLO®

contains the active ingredient amlodipine (maleate)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about AMLO.

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 AMLO against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

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

What AMLO is used for

AMLO is used to treat:

  • high blood pressure (hypertension)
  • angina pectoris.

AMLO belongs to a group of medicines called calcium channel blockers or calcium ion antagonists. They work by opening up blood vessels in the body to lower blood pressure and improve the supply of blood and oxygen to the heart. Calcium channel blockers do not change the amount of calcium in your blood or bones.

Your doctor may have prescribed AMLO for another reason. Ask your doctor if you have any questions about why AMLO has been prescribed for you.

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

AMLO is not recommended for use in children as there have been no studies of its effects in children.

Before you take AMLO

When you must not take it

Do not take AMLO if you are allergic to:

  • amlodipine
  • other calcium channel blockers such as nifedipine, felodipine, israldipine or lercanidipine.
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not take AMLO if the expiry date (EXP) printed on the pack has passed.

Do not take AMLO if the packaging shows signs of tampering or the tablets do not look quite right.

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

Before you start to take it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • heart disease such as heart failure
  • liver problems.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss the risks and benefits of taking AMLO during pregnancy.

Tell your doctor if you are breastfeeding. Your doctor will discuss the risks and benefits of taking AMLO while breastfeeding.

If you have not told your doctor about any of the above, tell them before you start taking AMLO.

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 medicines and AMLO may interfere with each other.

Tell your doctor or pharmacist if you are taking any of the following:

  • other medicines used to treat angina, such as diltiazem
  • some antibiotics, such as erythromycin or rifampicin
  • some antifungals, such as ketoconazole or itraconazole
  • anti-proteases, medicines used to treat HIV infection, such as ritonavir
  • St John’s Wort
  • Grapefruit or grapefruit juice

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking AMLO.

How to take AMLO

How much to take

The dose varies from patient to patient.

The usual starting dose is 5 mg per day. Your doctor may increase this to 10 mg each day depending on how you respond to this medicine.

Follow all directions given to you by your doctor and pharmacist carefully.

How to take it

Swallow AMLO whole with a full glass of water.

How long to take it

AMLO helps control your condition, but does not cure it. Therefore you must take AMLO every day. Continue taking your medicine for as long as your doctor tells you.

If you forget to take AMLO

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 medicine as you would normally.

Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.

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

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much AMLO. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much AMLO, you may feel lightheaded, dizzy or faint and have an irregular heartbeat.

While you are taking AMLO

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you are taking AMLO.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking AMLO.

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

Have your blood pressure checked when instructed by your doctor, to make sure AMLO is working.

Things you must not do

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

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

Things to be careful of

Be careful driving or operating machinery until you know how AMLO affects you. AMLO may cause dizziness or drowsiness in some people and can affect alertness. Make sure you know how you react to AMLO before you drive, operate machinery or do anything else that could be dangerous if you are dizzy or drowsy.

If you are 65 years or older, you should be especially careful while taking AMLO. Report any side effects promptly to your doctor. Some people in this age group may be more likely to experience side effects such as swelling of the feet and ankles, muscle cramps and dizziness.

Things that may help your condition

Some self-help measures suggested below may assist your condition. Talk to your doctor about these for more information.

  • Weight - your doctor may suggest losing some weight. Some people may need a dietician's help to lose weight.
  • Exercise - regular exercise helps lower blood pressure and strengthen the heart. It is important not to overdo it. Before commencing regular exercise you should consult your doctor who will suggest the most suitable exercise for you. If you feel uncomfortable when exercising or experience symptoms such as unusual chest pain or breathlessness see you doctor.
  • Diet - eat a healthy low-fat diet that includes plenty of fresh vegetables, fruit, bread, cereals and fish. Also eat less fat and sugar. Again, some people may need a dietician's help to lose weight.
  • Alcohol - your doctor may advise you to limit your alcohol intake.
  • 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 at the table or in cooking.
  • Smoking - your doctor may advise you to stop smoking or at least cut down.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking AMLO. Like all other medicines, AMLO may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

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:

  • swelling of the ankles, face, feet or hands
  • headache
  • dizziness
  • flushing
  • rapid heart beat
  • fatigue
  • drowsiness
  • stomach pain or nausea

These side effects are usually mild but may be serious.

Tell your doctor if you notice any of the following:

  • muscle cramps or aches
  • sexual problems
  • swollen gums
  • constipation
  • weight gain
  • difficulty sleeping
  • feeling nervous, moody or depressed
  • changes in sight or vision
  • loss or thinning of hair
  • ringing in the ears.

These may or may not be due to AMLO but you should tell your doctor if they worry you.

Tell your doctor immediately if you notice any of the following:

  • changes in heart beat either fast or slow
  • chest pain
  • dizziness or lightheadedness on standing up from a sitting or lying position
  • shortness of breath
  • symptoms of allergy such as skin rash and/or itching
  • symptoms of liver disease such as itching, yellowing of the skin and eyes, and dark coloured urine.

These may be serious side effects that may need urgent medical attention. These side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

If you are 65 years or older, you should be especially careful while taking AMLO. Report any side effects promptly to your doctor. Some people in this age group may be more likely to experience side effects such as swelling of the feet and ankles, muscle cramps and dizziness.

After using AMLO

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store AMLO or any other medicine in the bathroom or near a sink.

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 or pharmacist tells you to stop taking AMLO or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

AMLO comes in 2 strengths of tablets:

  • AMLO 5 - white, round, biconvex tablet, marked with a break line on both sides.
  • AMLO 10 - white, round, biconvex tablet marked with 10, break line, MH on one side and a break line on the other side.

AMLO comes in blister packs of 30 tablets.

Ingredients

The active ingredient in AMLO is amlodipine (as maleate).

  • each AMLO 5 tablet contains 5 mg of amlodipine
  • each AMLO 10 tablet contains 10 mg of amlodipine.

Other ingredients:

  • lactose
  • povidone
  • microcrystalline cellulose
  • crospovidone
  • sodium stearylfumarate.

Sponsor

Spirit Pharmaceuticals Pty Ltd
117 Harrington Street, The Rocks
Sydney NSW 2000, Australia
Phone: 1800 065 772

Distributor

Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

Australian registration numbers
5 mgAUST R 96950
10 mgAUST R 96962

This leaflet was revised on 10 October 2011

® Registered Trade Mark

Published by MIMS February 2012

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