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Felodur(R) ER

CLICK TO BUY FELODUR-ER TAB-XR 2.5MG 30

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contains the active ingredient felodipine

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common questions about Felodur ER.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Felodur ER against the benefits expected 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 Felodur ER is used for

Felodur ER is used to treat high blood pressure (also known as hypertension).

The ER in Felodur ER stands for extended release. This means that the tablets are designed to work over a 24-hour period.

Felodur ER belongs to a group of medicines called calcium channel blockers or calcium antagonists. These medicines work by relaxing and widening small blood vessels, making it easier for the heart to pump blood around the body. This helps to lower high blood pressure. They do not change the amount of calcium in your blood or bones.

Felodur ER may also be used in combination with other medicines to treat high blood pressure.

Ask your doctor if you have any questions about why Felodur ER has been prescribed for you.

Your doctor may have prescribed Felodur ER for another reason.

There is not enough information available to recommend the use of Felodur ER in children.

Felodur ER is available only with a doctor`s prescription.

There is no evidence that Felodur ER is addictive.

Before you take Felodur ER

When you must not take it

Do not take Felodur ER if you are allergic to medicines containing felodipine (e.g. Agon SR, Plendil ER) or 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 Felodur ER if you are pregnant or plan to become pregnant.

Felodur ER may affect your developing baby if you take it during pregnancy.

Do not take Felodur ER if you have certain heart problems, including unstable angina (chest pain).

Do not take Felodur ER if the expiry date (Exp.) printed on the pack has passed.

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

Before you start to take it

Tell your doctor if you have allergies to:

• any other medicines used to treat high blood pressure
• any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are breastfeeding or wish to breastfeed.

Your doctor will discuss the risks and benefits of taking Felodur ER when breastfeeding.

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

• any heart problems, including angina
• liver problems.

Your doctor may want to take special care if you have any of these conditions.

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

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop, or order through the internet.

Some medicines may be affected by Felodur ER, or may affect how well it works. These include:

• medicines used to treat epilepsy, such as phenytoin (Dilantin), carbamazepine (Tegretol, Teril), and barbiturates (Phenobarbitone)
• certain antibiotics such as erythromycin (EES, Eryc, E-Mycin) and rifampicin (Rifadin, Rimycin)
• cimetidine (Tagamet, Magicul), a medicine used to treat stomach ulcers
• medicines used to treat fungal infections such as itraconazole (Sporanox), ketaconazole (Nizoral)
• tacrolimus (Prograf), a medicine used to prevent organ transplant rejection.

Tell your doctor if you are taking other medicines for high blood pressure because he/she may want to monitor your blood pressure more closely when you start Felodur ER.

This is to make sure that the combination does not cause a sudden and excessive drop in blood pressure.

Some examples of other medicines for high blood pressure include:

• diuretics or fluid tablets (Burinex, Lasix, Moduretic)
• beta-blockers (includes Betaloc, Inderal, Noten, Tenormin)
• ACE inhibitors (includes Accupril, Capoten, Monopril, Renitec, Zestril)
• angiotensin-II receptor antagonists (Avapro, Atacand, Karvea, Pritor).

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

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

How to take Felodur ER

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

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist.

How much to take

The usual starting dose is 2.5 mg or 5 mg once daily. Your doctor may increase this dose depending on how you respond to this medicine. Doses higher than 20 mg a day are not recommended.

If you are taking other medicines that lower blood pressure, your doctor may need to change the dose of them to obtain the best results for you.

Elderly people over 65 years and those with liver problems may need smaller doses.

How to take Felodur ER

Swallow the tablets whole with a glass of water.

Do not break, crush or chew the tablets.

If you crush or chew Felodur ER tablets they will not work as well.

When to take Felodur ER

Take your medicine at about the same time each day.

Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

Felodur ER can be taken with or without food, but not with grapefruit juice.

If you have to take more than one tablet, you must take them together.

How long to take Felodur ER for

Keep taking Felodur ER for as long as your doctor recommends.

To properly control your high blood pressure, Felodur ER must be taken every day on a long-term basis, even if you feel well.

If you forget to take Felodur ER

If it is more than 12 hours since your last dose or almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

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

If you are not sure what to do or you have any questions about this, ask your doctor or pharmacist.

If you take too much Felodur ER (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 Felodur ER. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much Felodur ER, you may feel dizzy, very tired, have a headache and a very slow heart rate.

While you are taking Felodur ER

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking Felodur ER.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Felodur ER.

If you become pregnant while taking Felodur ER, tell your doctor.

If you plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking Felodur ER.

If you have to have any blood or urine tests, tell your doctor that you are taking Felodur ER.

Felodur ER may affect the results of some tests.

Visit your doctor regularly so they can check on your progress.

Things you must not do

Do not take Felodur ER with grapefruit juice.

Grapefruit juice, but not other fruit juices, may increase the effects of Felodur ER.

Do not stop taking Felodur ER, or lower the dose, without checking with your doctor.

Do not use Felodur ER to treat any other conditions unless your doctor tells you to.

Do not give Felodur ER 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 Felodur ER affects you.

Felodur ER may cause dizziness or lightheadedness in some people, especially after the first dose. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Felodur ER.

Felodur ER helps most people with high blood pressure, but it may have unwanted side effects in some 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.

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:

• headache
• palpitations (rapid heart beat)
• dizziness
• tiredness
• swelling in the ankles or legs
• flushing (feeling of warmth)
• nausea, vomiting
• red or swollen gums.

These are the common and mild side effects. Most of these usually occur at the beginning of treatment or after an increase in dose. They usually go away or get less with time.

Tell your doctor as soon as possible if you notice any of the following:

• skin rash, itching.

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

• swelling of the face, tongue or back of the throat
• difficulty breathing
• chest pain.

These are very serious yet rare side effects which require urgent medical attention.

Tell your doctor if you notice anything that is making you feel unwell.

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

After taking Felodur ER

Storage

Keep Felodur ER 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.

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

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

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

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

Do not leave the tablets in the car or on window sills.

Heat and dampness can destroy some medicines.

Disposal

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

Product description

What it looks like

Felodur ER tablets are available in 3 strengths:

• Felodur ER 2.5 mg tablet – round, yellow, marked “A” over “FL” on one side and “2.5” on the other
• Felodur ER 5 mg tablet – round, pink, marked “A” over “Fm” on one side and “5” on the other
• Felodur ER 10 mg tablet – round, reddish-brown, marked “A” over “FE” on one side and “10” on the other.

Each blister pack contains 30 tablets.

Ingredients

The active ingredient in Felodur ER is felodipine. Each Felodur ER tablet contains 2.5 mg, 5 mg or 10 mg of felodipine.

The tablets also contain:

• hydrogenated castor oil
• propyl gallate
• hypromellose
• sodium aluminium silicate
• microcrystalline cellulose
• lactose anhydrous
• sodium stearylfumarate
• hydroxypropylcellulose.

The coating on each tablet contains:

• macrogol 6000
• titanium dioxide [E171]
• iron oxide yellow CI77492 [E172]
• iron oxide red CI77491 [E172] (5 mg and 10 mg tablets only)
• carnauba wax.

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Felodur ER is supplied in Australia by:

• Alphapharm Pty Limited
• (ABN 93 002 359 739)
• Chase Building 2
• Wentworth Park Road
• Glebe NSW 2037
• Phone: (02) 9298 3999
• www.alphapharm.com.au
• Medical Information
• Phone: 1800 028 365
• Australian registration numbers:
• Felodur ER 2.5 mg – AUST R 60980
• Felodur ER 5 mg – AUST R 60981
• Felodur ER 10 mg – AUST R 60982
• This leaflet was prepared on
• 16 June 2003.

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