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CARDIOPLEN

Active substance(s): FELODIPINE / FELODIPINE / FELODIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cardioplen® XL 2.5 mg, 5 mg & 10 mg
Prolonged Release Tablets
Felodipine
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leafet. See section 4.

What is in this leaflet:
1. What Cardioplen is and what it is used for
2. What you need to know before you take Cardioplen
3. How to take Cardioplen
4. Possible side effects
5. How to store Cardioplen
6. Contents of the pack and other information
1. What Cardioplen is and what it is used for
Cardioplen XL Prolonged Release Tablets contain felodipine which belongs to a group of
medicines called calcium-channel blockers that act on the cardiovascular system (the
heart and blood vessels). Cardioplen has been prescribed by your doctor to treat your
high blood pressure or to reduce the frequency of your anginal attacks. They are called
prolonged release tablets because they are manufactured in a way that allows the
felodipine to be released and slowly absorbed by your body over a period of several
hours.
In high blood pressure, felodipine works by widening the blood vessels. This creates less
resistance to the blood flow, and results in lower blood pressure, which in turn reduces
the strain on your heart.
In angina, felodipine works by opening up the arteries supplying the heart muscle and
this allows more blood and oxygen to reach the muscle, decreasing the chances of angina
(chest pains) occurring when extra strain is placed upon the heart.

2. What you need to know before you take Cardioplen
Do not take Cardioplen:
• if you are allergic to felodipine, other calcium-channel blockers (e.g. amlodipine,
nisoldipine or nifedipine) or any of the other ingredients in Cardioplen (listed in
section 6)
• if you are pregnant or likely to become pregnant
• if you have been told that you have a narrowing of the aortic valve in your heart
• if you have experienced a collapse which was caused by a heart problem
• if the severity or frequency of your angina has rapidly worsened over a matter of
hours or days
• if you have had a heart attack during the last month or have other severe heart
problems
• if you suffer from uncompensated heart failure.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cardioplen if:
• you suffer from low blood pressure with abnormal rapid heartbeats. Symptoms of
excessive low blood pressure and inadequate blood supply to the heart itself
frequently include dizziness and chest pain. If you experience these symptoms, seek
emergency care immediately
• you have a poorly functioning left ventricle of your heart
• you suffer from liver problems
• your gums are swollen. Practice good oral hygiene to help avoid your gums from
swelling (see section 4).
Other medicines and Cardioplen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. If you have to go to a doctor, dentist or hospital for any reason, tell
them that you are taking Cardioplen. This is especially important if you are likely to have
an anaesthetic or an operation.
In particular, tell your doctor if you are taking:
• cimetidine, to treat stomach ulcers
• the antibiotic erythromycin, to treat bacterial infections
• Medicines to treat fungal infections, including itraconazole and Ketoconazole
• medicines to treat HIV, such as ritonavir (protease inhibitors), efavirenz and
nevirapine
• tacrolimus, used after kidney or liver transplants
• Any other medicines to lower blood pressure
• barbiturates, to treat anxiety, sleeping problems and epilepsy
• phenytoin or carbamazepine, to treat seizures or epilepsy. If you are already taking
any of these medicines, your doctor may prescribe higher than normal doses of
Cardioplen for you to take
• Medicines containing St John’s wort (Hypericum perforatum) (herbal product used to
treat depression) may reduce the effect of Cardioplen and should therefore be avoided.
Cardioplen with food and drink
Do not drink grapefruit juice at the same time or soon after taking Cardioplen
because grapefruit juice can increase the blood levels of felodipine and affect the way it
works. It is best to take your tablets on an empty stomach or after a light meal.
Pregnancy, breast-feeding and fertility
Pregnancy
Do not use Cardioplen if you are pregnant.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Cardioplen is
not recommended for mothers who are breast-feeding, and your doctor may choose
another treatment for you if you wish to breast-feed.
Driving and using machines:
Cardioplen can have minor or moderate influence on your ability to drive and use
machines. If you experience headache, nausea, dizziness or fatigue your ability to react
may be impaired. Caution is recommended especially at the start of treatment.
Cardioplen contains Lactose Monohydrate
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.

3. How to take Cardioplen
Always take Cardioplen exactly as your doctor has told you to. You should check with
your doctor or pharmacist if you are not sure.
The label on the carton will tell you how many tablets you should take and when. It is
very important that you take your tablets regularly. Do not stop treatment even if you
feel better unless told to do so by your doctor.
Cardioplen is formulated so that you only have to take your tablets once a day. It is
important that you take your tablets at the same time each day, preferably in the
morning on an empty stomach or after a light meal not high in fat or carbohydrates. Your
tablets must be swallowed whole with a glass of water and not with grapefruit juice. Do
not break, crush or chew your tablets.
Please read the back of this leaflet →

High blood pressure
Adults and the elderly: the usual dose is 5 mg once a day. Your doctor may decide to
increase your dose to a maximum of 20 mg of Cardioplen once a day or prescribe another
medicine to treat your high blood pressure for you to also take whilst you are taking
Cardioplen. The usual dose when treating this disease for a long time is 5-10 mg once a
day.
Angina
Adults: the usual dose is 5 mg once a day. Your doctor may decide to increase your
dose to a maximum of 10 mg of Cardioplen once a day.
Do not stop taking your medicine until your doctor tells you.
Children must not take this medicine.
If you have liver problems
The level of felodipine in your blood may be increased. Your doctor may lower the dose.
Elderly people
If you are elderly, your doctor may prescribe a lower starting dose of 2.5 mg for you to
take once a day.
If you take more Cardioplen than you should
If you accidentally take more Cardioplen than you should, you may suffer from very low
blood pressure and sometimes palpitations, high or, rarely, slow heart rate. Therefore, it
is very important that you take the number of doses prescribed by your doctor. If you
experience symptoms such as feeling faint, light-headedness or dizziness, contact your
nearest casualty department or tell your doctor or pharmacist immediately. Remember to
take the pack and any remaining tablets with you.
If you forget to take Cardioplen
Do not worry. Simply leave out that dose completely and then take your next dose at the
right time. Do not take a double dose to make up for a missed dose.
If you stop taking Cardioplen
If you stop taking this medicine your condition may return. Please consult your doctor and
seek advice before you stop taking Cardioplen. Your doctor will advise you how long to
take your medicine.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Cardioplen can cause side effects, although not everyone gets them.
Allergic reactions, although serious, have been reported in isolated cases. If you
experience any of the following, stop taking Cardioplen and contact your doctor or
casualty department immediately:
• raised lumps on your skin (weal) or swelling of the face, lips, mouth, tongue and throat
Mild enlargement of the gums has been reported in patients with an inflammation in the
mouth (gingivitis/periodontitis). The enlargement can be avoided or reversed by careful
oral hygiene.
If you experience chest pains when you first start taking Cardioplen, contact your doctor
immediately.
Other side effects
The following side effects do not usually last long and are most likely to occur when you
first start to take your medicine or if your dose has been increased. If they continue or if
you are worried, contact your doctor or pharmacist immediately.
Very common: may affect more than 1 in 10 people
• Ankle swelling
Common: may affect up to 1 in 10 people
• Headache
• Flushing
Uncommon: may affect up to 1 in 100 people
• Abnormally rapid heart rate
• Palpitations
• Too low blood pressure (hypotension)
• Nausea
• Abdominal pain
• Burning/prickling/numbness
• Rash or itching
• Fatigue
• Dizziness
Rare: may affect up to 1 in 1,000 people
• Fainting
• Vomiting
• Nettle rash
• Pain in joints
• Muscular pain
• Impotence/sexual dysfunction
Very rare: may affect up to 1 in 10,000 people
• Gingivitis (swollen gums)
• Increased liver enzymes
• Skin reactions due to increased sensitivity to sunlight
• Inflammation of small blood vessels of the skin
• A need to pass water frequently.
• Hypersensitivity reactions such as fever or swelling of the lips and tongue
If any of the side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist, or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via
the YellowCard Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this medicine.

5. How to store Cardioplen
• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Store in the original packaging.
• Do not use Cardioplen after the expiry date which is stated on the blister and carton.
The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information
What Cardioplen contains:
• The active substance in your tablets is felodipine. Each tablet contains 2.5 mg, 5 mg
or 10 mg of felodipine.
• The other ingredients are lactose monohydrate, cellulose microcrystalline, talc,
hypromellose, povidone, propyl gallate, silica colloidal anhydrous, magnesium stearate,
ferric oxide yellow (E172), ferric oxide red (E172), titanium dioxide (E171) and
propylene glycol.
What Cardioplen looks like and the contents of the pack:
Cardioplen XL Tablets are round and biconvex in shape and are available in blister packs
of 28 tablets. Each strength can be identified by its colour and marking.
2.5 mg tablets are yellow and marked with “2.5”
5 mg tablets are light pink and marked with “5”
10 mg tablets are reddish brown and marked with “10”
Marketing Authorisation Holder and Manufacturer:
The Marketing Authorisation holder and manufacturer is Chiesi Limited, 333 Styal Road,
Manchester, M22 5LG, UK.

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
This leaflet was last approved in 03/2017

FR00271.V6 / CP0025/6

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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