contains the active ingredient felodipine
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about FELODIL XR.
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 FELODIL XR 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 FELODIL XR is used for
FELODIL XR is used to treat high blood pressure.
FELODIL XR belongs to a group of medicines called calcium channel blockers. 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.
Your doctor may have prescribed FELODIL XR for another reason. Ask your doctor if you have any questions about why FELODIL XR has been prescribed for you.
FELODIL XR is available only with a doctor's prescription.
There is no evidence that FELODIL XR is addictive.
Before you take FELODIL XR
When you must not take it
Do not take FELODIL XR if you are allergic to felodipine 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 FELODIL XR if you are pregnant or plan to become pregnant. FELODIL XR may affect your developing baby if you take it during pregnancy.
Do not take FELODIL XR if you have certain heart problems, including unstable angina (chest pain).
Do not take FELODIL XR if the expiry date (Exp.) printed on the pack has passed. It may not work as well if you do.
Do not take FELODIL XR 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 are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor will discuss the risks and benefits of taking FELODIL XR while breastfeeding.
Tell your doctor if you have, or have had, any medical conditions, especially the following:
any heart problems
If you have not told your doctor about any of the above, tell them before you start taking FELODIL XR.
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. Some medicines may be affected by FELODIL XR, or may affect how well it works. These include:
medicines used to treat epilepsy such as phenytoin, carbamazepine and barbiturates
certain antibiotics such as erythromycin and rifampicin
cimetidine, a medicine commonly used to treat reflux and ulcers
medicines used to treat fungal infections such as itraconazole and ketoconazole
warfarin, a medicine used to treat and prevent blood clots
tacrolimus, 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 FELODIL XR. 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 FELODIL XR.
You should not eat grapefruit or drink grapefruit juice while you are taking FELODIL XR because this may affect how well the tablets work.
How to take FELODIL XR
How much to take
The usual starting dose is 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. An alternate brand of felodipine extended release tablets will be required if a 2.5 mg dose is prescribed as FELODIL tablets must not be broken in half.
Follow all directions given to you by your doctor and pharmacist carefully.
How to take FELODIL XR
Swallow the tablets whole with a glass of liquid. FELODIL XR should not be chewed or broken up.
If you forget to take FELODIL XR
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 the missed dose as soon as you remember (if less than 12 hours to the next dose), and then go back to taking your tablets as you would normally.
Do not take more than one dose at a time to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
How long to take FELODIL XR for
FELODIL XR helps control your condition, but does not cure it. Therefore you must take it every day. Continue taking your tablets for as long as your doctor tells you to.
If you take too much FELODIL XR (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 FELODIL XR. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of overdosage may include feeling dizzy and fainting due to a drop in blood pressure, irregular or rapid heart beats, shortness of breath and even loss of consciousness.
While you are taking FELODIL XR
Things you must do
Before starting any new medicine, tell your doctor or pharmacist that you are taking FELODIL XR.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking FELODIL XR.
If you become pregnant while taking FELODIL XR, tell your doctor immediately.
If you plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking FELODIL XR.
If you have to have any blood or urine tests, tell your doctor that you are taking FELODIL XR. FELODIL XR 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 use FELODIL XR to treat any other conditions unless your doctor tells you to.
Do not give FELODIL XR 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 FELODIL XR affects you. FELODIL XR may cause dizziness or light-headedness in some patients, especially when they first start taking the medicine. Make sure you know how you react to FELODIL XR before driving a car, operating machinery, or doing anything else that could be dangerous if you are affected.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking FELODIL XR.
FELODIL XR helps most people with high blood pressure, but it may have unwanted side effects in some people.
All medicines 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:
dizziness or light-headedness
swelling in the ankles or legs
feeling sick, vomiting
red or swollen gums
These are the more common side effects of FELODIL XR. They are usually mild and occur at the beginning of treatment or after an increase in the dose.
If any of the following happen, either tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
swelling of the face, tongue or back of the throat which may cause difficulty in swallowing or breathing
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.
After using FELODIL XR
Keep FELODIL XR 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 a cool dry place where the temperature stays below 25°C.
Do not store FELODIL XR or any other medicine in the bathroom or near a sink.
Do not leave FELODIL XR in the car or on window sills. Heat and dampness can destroy some medicines.
Keep the tablets in their blister pack until it is time to take them. If you take the tablets out of the box or the blister pack they may not keep well.
If your doctor tells you to stop taking FELODIL XR, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
What it looks like
FELODIL XR comes in 2 strengths of tablets:
FELODIL XR 5 - round, pale pink tablet.
FELODIL XR 10 - round reddish-brown tablet.
Each blister pack contains 30 tablets.
The active ingredient in FELODIL XR is nifedipine.
each FELODIL XR 5 tablet contains 5 mg of felodipine
each FELODIL XR 10 tablet contains 10 mg of felodipine
The tablets also contain:
colloidal anhydrous silica
iron oxide red CI77491
iron oxide yellow CI7492.
The tablets are gluten free.
Arrow Pharmaceuticals Pty Ltd
(a member of the Sigma group of companies)
96 Merrindale Drive
Croydon Vic 3136
Tel: 03 - 9839 2800 03 - 9839 2800
Australian registration numbers:
FELODIL XR 5: AUST R 128793
FELODIL XR 10: AUST R 128795
Date of preparation:
Published by MIMS/myDr May 2008
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