Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Felodipine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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.
e Cardioplen Do not take Cardioplen:
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.
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. 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. Please read the back of this leaflet →
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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.
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:
Cardioplen
What Cardioplen contains:
CP0025/8
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Cardioplen XL 2.5 mg Prolonged Release Tablets comes as tablet containing 2.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Cardioplen XL 2.5 mg Prolonged Release Tablets is felodipine.
Medicines with the same active substance, strength and form include: Delofine XL 2.5 mg Prolonged-Release Tablets, Felotens XL 2.5mg Prolonged Release Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Cardioplen XL 2.5 mg Prolonged Release Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
In the management of hypertension and prophylaxis of chronic stable angina pectoris.
For oral administration
Hypertension:
Adults (including older people): The dose should be adjusted to the individual requirements of the patient. The recommended starting dose is 5mg once daily. If necessary the dose may be further increased or another antihypertensive agent added. The usual maintenance dose is 5-10mg once daily. Doses higher than 20mg daily are not usually needed. In older patients an initial treatment with 2.5mg daily should be considered.
Angina pectoris:
Adults: The dose should be adjusted individually. Treatment should be started with 5mg once daily and if needed be increased to 10mg once daily.
Elderly population: Initial treatment with lowest available dose should be considered.
Administration: The tablets should regularly be taken in the morning without food or with a light meal. Cardioplen XL 2.5mg Prolonged Release Tablets must not be chewed or crushed. They should be swallowed whole with half a glass of water.
Paediatric Population: The safety and efficacy of Cardioplen XL 2.5mg Prolonged Release Tablets in children has not been established.
Cardioplen XL 2.5mg Prolonged Release Tablets can be used in combination with β-blockers, ACE inhibitors or diuretics. The effects on blood pressure are likely to be additive and combination therapy will usually enhance the antihypertensive effect. Care should be taken to avoid hypotension. Patients with impaired hepatic function may have elevated plasma concentrations of felodipine and may respond to lower doses. The pharmacokinetics are not significantly affected in patients with impaired renal function.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Unstable angina pectoris.
Pregnancy.
Patient with a previous allergic reaction to Cardioplen XL 2.5mg Prolonged Release Tablets or other dihydropyridines because of the theoretical risk of cross-reactivity.
Cardioplen XL 2.5mg Prolonged Release Tablets should not be used in patients with clinically significant aortic stenosis, and during or within one month of a myocardial infarction.
As with other calcium channel blockers, Cardioplen XL 2.5mg Prolonged Release Tablets should be discontinued in patients who develop cardiogenic shock.
Decompensated heart failure.
Haemodynamically significant cardiac valvular obstruction.
Dynamic cardiac outflow obstruction.
As with other vasodilators, Cardioplen XL 2.5mg Prolonged Release Tablets may, in rare cases, precipitate significant hypotension with tachycardia which in susceptible individuals may result in myocardial ischaemia.
There is no evidence that Cardioplen XL 2.5mg Prolonged Release Tablets are useful for secondary prevention of myocardial infarction.
The efficacy and safety of Cardioplen XL 2.5mg Prolonged Release Tablets in the treatment of malignant hypertension and hypertensive emergencies has not been studied.
Cardioplen XL 2.5mg Prolonged Release Tablets should be used with caution in patients with severe left ventricular dysfunction.
Felodipine is cleared by the liver. Consequently higher therapeutic concentrations and response can be expected in patients with clearly reduced liver function.
Concomitant administration of drugs that strongly induce or inhibit CYP3 A4 enzymes result in extensively decreased or increased plasma levels of felodipine, respectively. Therefore such combinations should be avoided (see section 4.5).
Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis. The enlargement can be avoided or reversed by careful oral hygiene.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Concomitant administration of substances which interfere with the cytochrome P450 system may affect plasma concentrations of felodipine. Enzyme inhibitors such as cimetidine, erythromycin, itraconazole, ketoconazole and ritonavir impair the elimination of felodipine, and Cardioplen XL 2.5 mg Prolonged Release Tablets dosage may need to be reduced when drugs are given concomitantly. Conversely, powerful enzyme inducing agents such as some anticonvulsants (phenytoin, carbamazepine, phenobarbitone) can increase felodipine elimination and higher than normal Cardioplen XL 2.5 mg Prolonged Release Tablets doses may be required in patients taking the drugs.
No dosage adjustment is required when Cardioplen XL 2.5 mg Prolonged Release Tablets are given concomitantly with digoxin.
Felodipine does not appear to affect the unbound fraction of other extensively plasma protein bound drugs such as warfarin.
Felodipine may increase the concentration of tacrolimus. When used together, the tacrolimus serum concentration should be monitored and the tacrolimus dose may need to be adjusted.
Grapefruit juice results in increased peak plasma levels and bioavailability possibly due to an interaction with flavonoids in the fruit juice. This interaction has been seen with other dihydropyridine calcium antagonists and represents a class effect. Therefore grapefruit juice should not be taken together with Cardioplen XL 2.5 mg Prolonged Release Tablets.
The anti-hypertensive effect of felodipine may be enhanced by other anti-hypertensive such as alpha-blockers (e.g. prazosin) or beta-blockers (e.g. atenolol) and general anaesthetics.
Felodipine should not be given during pregnancy.
In a study on fertility and general reproductive performance in rats, a prolongation of parturition resulting in difficult labour, increased foetal deaths and early postnatal deaths were observed in the medium- and high-dose groups. Reproductive studies in rabbits have shown a dose-related reversible enlargement of the mammary glands of the parent animals and dose-related digital abnormalities in the foetuses when felodipine was administered during stages of early foetal development.
Felodipine has been detected in breast milk, but it is unknown whether it has harmful effects on the new-born.
Felodipine has minor or moderate influence on the ability to drive and use machines. If patients taking felodipine suffer from headache, nausea, dizziness or fatigue and ability to react may be impaired. Caution is recommended especially at the start of treatment.
As with other calcium antagonists, flushing, headache, palpitations, dizziness and fatigue may occur. These reactions are usually transient and are most likely to occur at the start of treatment or after an increase in dosage.
As with other calcium antagonists ankle swelling, resulting from precapillary vasodilation, may occur. The degree of ankle swelling is dose related.
In patients with gingivitis/periodontitis, mild gingival enlargement has been reported with Cardioplen XL 2.5mg Prolonged Release Tablets, as with other calcium antagonists. The enlargement can be avoided or reversed by careful dental hygiene.
As with other dihydropyridines, aggravation of angina has been reported in a small number of individuals especially after starting treatment. This is more likely to happen in patients with symptomatic ischaemic heart disease.
The following adverse events have been reported from clinical trials and from Post Marketing Surveillance. In the great majority of cases a causal relationship between these events and treatment with felodipine has not been established.
The following definitions of frequencies are used:
Very common ≥1/10
Common ≥1/100 to <1/10
Uncommon ≥1/1,000 to <1/100
Rare ≥1/10,000 to <1/1,000
Very rare <1/10,000
System organ class
Frequency
Adverse reaction
Nervous system disorders
Common
Uncommon
Headache
Dizziness, paraesthesia
Cardiac disorders
Uncommon
Tachycardia, palpitations
Vascular disorders
Common
Uncommon
Rare
Flush
Hypotension
Syncope
Gastrointestinal disorders
Uncommon
Rare
Very rare
Nausea, abdominal pain
Vomiting
Gingival hyperplasia, gingivitis
Hepatobiliary disorders
Very rare
Increased liver enzymes
Skin and subcutaneous tissue disorders
Uncommon
Rare
Very rare
Rash, pruritus
Urticaria
Photosensitivity reactions, leukocytoclastic vasculitis
Musculoskeletal and connective tissue disorders
Rare
Arthralgia, myalgia
Renal and urinary disorders
Very rare
Pollakisuria
Reproductive system and breast disorders
Rare
Impotence/sexual dysfunction
General disorders and administration site conditions
Very common
Uncommon
Very rare
Peripheral oedema
Fatigue
Hypersensitivity reactions, e.g. angio-oedema, fever
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
Symptoms: Overdosage may cause excessive peripheral vasodilatation with marked hypotension which may sometimes be accompanied by bradycardia.
Management: If justified: activated charcoal, gastric lavage if performed within one hour after ingestion. Severe hypotension should be treated symptomatically, with the patient placed supine and the legs elevated. Bradycardia, if present, should be treated with atropine 0.5-1mg i.v. If this is not sufficient, plasma volume should be increased by infusion of e.g. glucose, saline or dextran. Sympathomimetic drugs with predominant effect on the (α1-adrenoceptor may be given e.g. metaraminol or phenylephrine.
Ask anything about Cardioplen XL 2.5 mg Prolonged Release Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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