Plendil ER - Consumer Medicine Information
|Condition:||Hypertension (High Blood Pressure)|
|Class:||Calcium channel blocking agents|
|Ingredients:||felodipine, hydrogenated castor oil, propyl gallate (E 310), hypromellose, sodium aluminium silicate, microcrystalline cellulose (E 460), lactose anhydrous, sodium stearyl fumarate, hydroxypropyl cellulose, macrogol 6000, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172) (not in 2.5mg tablet), carnauba wax (E 903)|
What is in this leaflet
This leaflet answers some of the common questions people ask about Plendil ER. It does not contain all the information that is known about Plendil ER. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Plendil ER against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
What PLENDIL ER is for
Plendil ER lowers blood pressure by dilating (expanding) small blood vessels, letting the blood be pumped around the body more easily.
Your doctor will have explained why you are being treated with Plendil ER and told you what dose to take.
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 contains felodipine, which 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.
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.
Plendil ER is only available on a doctor’s prescription.
lendil ER is not addictive
Before you use PLENDIL ER
When you must not use it
Do not take Plendil ER if you have an allergy to any medicine containing felodipine or any of the ingredients listed at the end of the 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 or hives.
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
If you are not sure whether you have any of these conditions, ask your doctor.
Do not use Plendil ER if you are likely to become pregnant, are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved.
PLENDIL ER should not be used during pregnancy unless your doctor thinks that it is the appropriate drug for you. It may affect your baby if you take it during pregnancy.
Tell your doctor as soon as possible if you become pregnant while using Plendil ER.
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.
Do not give Plendil ER to children.
There is no information on its use in children.
Do not use after the use by (expiry) date printed on the pack.
Do not use Plendil ER if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Do not use it to treat any other complaint unless your doctor tells you to.
Do not give this medicine to anyone else.
Before you start to use it
You must tell your doctor if:
1. you have any allergies to
- any ingredients listed at the end of this leaflet
- any other medicine used to treat high blood pressure
- any other medicines, foods, preservatives or dyes.
If you have an allergic reaction, you may get a skin rash, hayfever, difficulty breathing or feel faint.v
2. you have any medical conditions such as:
- any heart problem, including angina
- liver problems
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
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Plendil ER may interfere with each other. 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
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.
Your doctor can tell you what to do if you are taking any of these medicines.
If you are taking other drugs which lower blood pressure, your doctor may need to change the dose of them to obtain the best results for you.
If you are unsure about any medicine you are taking you should check with your doctor or pharmacist. They will have more information on medicines to be careful with or avoid while taking Plendil ER.
If you have not told your doctor, dentist or pharmacist about any of these things, tell them before you take any Plendil ER.
Taking PLENDIL ER
How much to take
The usual starting dose of Plendil ER is one 2.5 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 20mg once a day.
If you have to take more than one tablet, you must take them together.
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.
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.
If you forget to take it
If you forget a dose, take it as soon as you remember, as long as it is more than 12 hours before the next dose is due.
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 that you missed. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
How long to take it
Take Plendil ER for as long as your doctor tells you to. Plendil ER must be taken every day.
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.
Telephone your doctor, the Poisons Information Centre (13 11 26) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much Plendil ER even if there are no signs of discomfort or poisoning.
If you take too much Plendil ER you may get a headache and feel sick (nausea), dizzy and very tired.
While you are using it
Things you must not do
Do not take Plendil ER with grapefruit juice
Grapefruit juice may increase the effect of Plendil ER.
Do not stop taking Plendil ER unless you have discussed it with your doctor.
Things to be careful of
Be careful driving or operating machinery 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.
Be careful when drinking alcohol while you are using Plendil ER.
Please talk to your doctor or pharmacist about these possibilities.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Plendil ER.
Plendil ER 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.
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
- palpitations (feeling of heart pounding)
- fatigue (tiredness)
These are all common side effects of Plendil ER.
These side effects usually go away or get less with time. If they do occur, it mostly happens at the beginning of treatment, or when the dose is increased.
Other side effects you should tell your doctor about if they worry you include:
- nausea (feeling sick)
- frequent urination
- impotence / sexual dysfunction
- stomach pain
- pain, swelling or redness in your gums
- increased sensitivity of the skin to sunlight
- sensation of burning, prickling, numbness, "'pins and needles"
- pain in joints or muscular pain These side effects are usually mild.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
- skin rash
- chest pain
- rapid heart beat
These are serious side effects. You may need urgent medical attention Serious side effects are rare.
If any of the following happen, stop taking Plendil ER and tell your doctor immediately or go to Accident and Emergency at your nearest hospital.
- swelling of the face, tongue or back of the throat
- harsh sounds or difficulty when breathing
These are very serious side effects. If you have them, you may have had a serious (allergic) reaction to Plendil ER. You may need urgent medical attention or hospitalisation.
All of these side effects are very rare.
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may get other side effects while taking Plendil ER.
After using it
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.
Keep it in a cool dry place where the temperature stays below 25° C.
Do not store Plendil ER or any other medicine in the bathroom or near a sink.
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.
Do not leave it in the car on hot days.
Ask your pharmacist what to do with any tablets you have left over if your doctor tells you to stop taking them, or you find that the expiry date has passed.
What Plendil ER looks like
Plendil ER 2.5mg
are yellow, circular tablets engraved A/FL on one side and 2.5 on the other. They are 8.5mm in diameter.
Plendil ER 5mgv
are pink, circular tablets engraved A/Fm on one side and 5 on the other. They are 9mm in diameter.
Plendil ER 10mg
are red-brown, circular tablets engraved A/FE on one side and 10 on the other. They are 9 mm in diameter.
All strengths are available in blister packs of 30 tablets.
Plendil ER tablets contain felodipine 2.5mg, 5mg or 10mg as the active ingredient, plus Hydrogenated castor oil Propyl gallate (E 310) Hypromellose Sodium aluminium silicate Microcrystalline cellulose (E 460) Lactose anhydrous Sodium stearyl fumarate Hydroxypropyl cellulose
The coating on each tablet contains: Macrogol 6000 Titanium dioxide (E 171) Iron oxide yellow (E 172) Iron oxide red (E 172) (not in 2.5mg tablet) Carnauba wax (E 903).
AstraZeneca Pty Ltd
ABN 54 009 682 311
NORTH RYDE NSW 2113
This leaflet was prepared in January 2013.
Australian Registration Number Plendil ER
2.5mg - 51774 5mg - 51775 10mg – 51776
®Trade Marks herein are the property of the AstraZeneca group