Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using PLENDIL ER?
PLENDIL ER contains the active ingredient Felodipine. PLENDIL ER is used to treat
high blood pressure, also called hypertension.
2. What should I know before I take PLENDIL ER?
Do not use if you have ever had an allergic reaction to PLENDIL ER or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with PLENDIL ER and affect how it works.
4. How do I take PLENDIL ER?
The usual starting dose of PLENDIL ER is one 2.5 mg or 5 mg tablet taken once daily.
If you have to take more than one tablet, you must take them together.
Swallow tablets whole and wash them down with a glass of water. They must not be divided,
crushed or chewed.
It does not matter if you take PLENDIL ER with food or not, but you must not take
it with grapefruit juice.
5. What should I know while using PLENDIL ER?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using PLENDIL ER.
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Things you should not do
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Do not stop using this medicine suddenly unless you have discussed it with your doctor.
Do not take it with grapefruit juice.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how PLENDIL
ER affects you.
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Drinking alcohol
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Be careful when drinking alcohol while you are using PLENDIL ER, tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep your tablets in the blister pack until it is time to take them.
Keep it in a cool dry place, below 25°C.
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6. Are there any side effects?
Common side effects include: headache, swelling of the ankles, dizziness, flushing,
palpitations (feeling of heart pounding), fatigue (tiredness). Uncommon side effects
that may require medical attention include: swelling of the face, tongue or back of
throat, harsh sounds or difficulty when breathing, skin rash, fainting, chest pain,
rapid heart beat. For more information, including what to do if you have any side
effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
felodipine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PLENDIL ER. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using PLENDIL ER.
Where to find information in this leaflet:
1. Why am I using PLENDIL ER?
PLENDIL ER contains the active ingredient felodipine. PLENDIL ER is used to treat
high blood pressure, also called hypertension. PLENDIL ER lowers blood pressure by dilating (expanding) small blood vessels, letting
the blood be pumped around the body more easily. The ER in PLENDIL ER stands for Extended
Release. This means that the tablets are designed to work over a 24 hour period.
PLENDIL ER belongs to the family of medicines known as calcium channel blockers. These
medicines do not change the way the body takes in calcium from food.
PLENDIL ER helps control your high blood pressure, but does not cure it.
Treatment of high blood pressure is necessary in most people for the rest of their
lives. Ask your doctor to explain the reasons for this.
2. What should I know before I take PLENDIL ER?
Warnings
Do not use PLENDIL ER 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, tightness of the
chest, wheezing, coughing or difficulty breathing, swelling of the face, lips, tongue
or other parts of the body; rash, itching, hives, hayfever or feeling faint.
Always check the ingredients to make sure you can use this medicine.
Do not take PLENDIL ER if you have any of the following conditions:
uncompensated heart failure
acute myocardial infarction
cardiac valvular obstruction
dynamic cardiac outflow obstruction
unstable angina pectoris
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition, including other medicines to lower blood
pressure
have any heart problem, including angina
liver problems
have any allergies to any other medicine used to treat high blood pressure or any
other medicines, foods, preservatives, or dyes.
It may not be safe for you to take PLENDIL ER if you have any of these conditions.
Tell your doctor if you are lactose intolerant.
PLENDIL ER tablets contain lactose.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not use PLENDIL ER if you are pregnant or likely to become pregnant. Ask your doctor
about the risks and benefits involved.
Tell your doctor as soon as possible if you become pregnant while using PLENDIL ER.
PLENDIL ER should not be used during pregnancy. It may affect your baby if you take
it during pregnancy.
Your baby can take in PLENDIL ER from breast milk if you are breastfeeding, but it
is unlikely to affect the infant when the mother is taking doses within the normal
range for her treatment. Your doctor can discuss the risks and benefits involved.
Use in children
Do not give PLENDIL ER to children.
There is no information on its use in children.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with PLENDIL ER and affect how it works, these include:
cimetidine - a medicine used to treat stomach ulcers or heartburn
medicines used to treat infections such as erythromycin and rifampicin
treatment with PLENDIL ER may affect the level of tacrolimus (a medicine given to
prevent the body from rejecting a transplanted organ, e.g. kidney or liver) in your
blood.
medicines used to treat fungal infections such as itraconazole and ketoconazole
medicines used to treat epilepsy such as phenytoin and carbamazepine
medicines used to help you sleep such as barbiturates
St John's Wort - a herbal remedy used to treat mood disorders
other medicines which lower blood pressure. Your doctor may need to change the dose
of them to obtain the best results for you.
These medicines may be affected by PLENDIL ER or may affect the way PLENDIL ER works.
You may need different amounts of your medicines, or may need to take different medicines.
Medicines that may increase the effect of PLENDIL ER include:
Grapefruit juice.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PLENDIL ER.
4. How do I take PLENDIL ER?
How much to take
Once daily, at the same time each day.
The usual starting dose of PLENDIL ER is one 2.5 mg or 5 mg tablet taken once daily.
Your doctor will check your progress and if needed, increase your dose of PLENDIL
ER. Sometimes the dose will be as high as 20 mg once a day.
If you have to take more than one tablet, you must take them together.
Follow the instructions provided and use PLENDIL ER until your doctor tells you to
stop.
How to take PLENDIL ER
It does not matter if you take PLENDIL ER with food or not, but you must not take
it with grapefruit juice.
Grapefruit juice may increase the effect of PLENDIL ER.
Swallow PLENDIL ER tablets whole and wash them down with a glass of water. They must
not be divided, crushed or chewed.
If they are broken or crushed, they will not work over 24 hours as they are supposed
to.
If you forget to take PLENDIL ER
PLENDIL ER should be used regularly at the same time each day. If you miss your dose
at the usual time, take it as soon as you remember, as long as it is more than 12
hours before the next dose is due.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If it is less than 12 hours until your next dose, skip the dose you missed and take
your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you take too much PLENDIL ER
If you think that you have used too much PLENDIL ER, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much PLENDIL ER you may experience a headache, a slow heartbeat, very
low blood pressure, dizziness, tiredness or feel sick (nausea).
5. What should I know while using PLENDIL ER?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using PLENDIL ER.
Keep all of your doctor's appointments so that your progress can be checked.
Call your doctor straight away if you:
become pregnant while taking this medicine.
Things you should not do
Do not stop taking PLENDIL ER unless you have discussed it with your doctor.
Do not take PLENDIL ER with grapefruit juice. Grapefruit juice may increase the effect
of PLENDIL ER.
Do not use this medicine to treat any other complaint unless your doctor tells you
to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PLENDIL
ER affects you.
When you start taking PLENDIL ER, whether you are changing from another medicine for
high blood pressure or not, you may feel dizzy or faint due to the drop in your blood
pressure.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful when drinking alcohol while you are using PLENDIL ER. Please talk to your
doctor or pharmacist about these possibilities.
Looking after your medicine
Store below 25°C.
Keep your tablets in the blister pack until it is time to take them.
If you take PLENDIL ER out of the blister pack it will not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
When to discard your medicine
Do not use this medicine after the expiry date printed on the pack.
Do not use PLENDIL ER if the packaging is torn or shows signs of tampering.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What PLENDIL ER contains
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Active ingredient
(main ingredient)
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felodipine
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Other ingredients
(inactive ingredients)
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Hydrogenated castor oil
Propyl gallate (E 310)
Hypromellose
Sodium aluminium silicate
Microcrystalline cellulose (E 460)
Lactose
Sodium stearyl fumarate
Hyprolose
The coating on each tablet contains:
Macrogol 6000
Titanium dioxide (E 171)
Iron oxide yellow (E 172)
Iron oxide red (E 172) (not in 2.5 mg tablet)
Carnauba wax (E 903)
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Potential allergens
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Lactose
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Do not take this medicine if you are allergic to any of these ingredients.
PLENDIL ER is not addictive.
What PLENDIL ER looks like
PLENDIL ER tablets are available in 3 strengths:
PLENDIL ER 2.5 mg tablet - round, yellow, marked "A" over "FL" on one side and "2.5"
on the other (AUST R 51774).
PLENDIL ER 5 mg tablet - round, pink, marked "A" over "Fm" on one side and "5" on
the other (AUST R 51775).
PLENDIL ER 10 mg tablet - round, reddish-brown, marked "A" over "FE" on one side and
"10" on the other (AUST R 51776).
All strengths are available in blister packs of 30 tablets and 7 tablets. Not all
pack sizes are available.
Who distributes PLENDIL ER
Clinect Pty Ltd.
120 - 132 Atlantic Drive
Keysborough VIC 3173
Australia
Free Call Australia: 1800 899 005
This leaflet was prepared in July 2024.