Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Felotens XL 5mg Prolonged Release Tablets
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
for Felotens XL Tablets belong to a group of medicines called dihydropyridine-type calcium channel blockers. These work by relaxing the smooth muscle in the blood vessel walls and opening the blood vessels. This then lowers the blood pressure. Felotens XL Tablets are used to:
- treat patients with high blood pressure (essential hypertension). 2. Before you take Felotens XL Tablets DO NOT take Felotens XL Tablets if you:
- are allergic (hypersensitive) to felodipine, other similar compounds (dihydropyridine-type calcium channel blockers) or any of the other ingredients in the tablets (see section 6. "Further information" at the end of this leaflet)
- have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
- have a very low pulse and blood pressure (cardiogenic shock)
- have severe narrowing (stenosis) of the heart valves (mitral or aortic valve)
- suffer from an enlarged heart muscle (obstructive hypertrophic cardiomyopathy)
- get chest pain (unstable angina pectoris)
- have suffered a heart attack within the last two months
- have untreated and/or decompensated heart failure, causing swelling of the extremities, weakness, and shortness of breath
- have severely reduced liver function
- are or may be pregnant
- suffer from acute porphyria (a disease that causes stomach problems and discolouration of the urine). Take special care with Felotens XL Tablets if you:
- have severely reduced kidney function
- have mild to moderate reduced liver function
- suffer with stable heart failure
- suffer with fast heartbeat (tachycardia)
- suffer with narrowing (stenosis) of the heart valves (mitral or aortic valve)
- have conduction disturbances in the heart (e.g. 2nd or 3rd degree atrioventricular block). Felodipine could cause an extensive fall in blood pressure resulting in fast heartbeat (tachycardia). This may lead to a restriction in blood supply (myocardial ischaemia) and stroke in sensitive patients. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines, or natural products. Especially:
- other medicines that lower blood pressure such as hydrochlorothiazide, beta blockers (to treat high blood pressure), nitrates (to control coronary heart disease and chest pain) or tricyclic antidepressants (to treat depression)
- amiodarone, diltiazem or verapamil (to treat heart problems)
- digoxin (to treat heart failure)
- fluconazole, itraconazole, ketoconazole, miconazole, or voriconazole (to treat fungal or yeast infections)
- erythromycin, clarithromycin, or telithromycin (macrolide antibiotics)
- rifampicin (to treat tuberculosis)
- ciclosporin, tacrolimus (to suppress immune system e.g. after organ transplantation)
- phenobarbital, phenytoin, or carbamazepine (to treat epilepsy)
- cimetidine (to treat heartburn and stomach ulcers)
- nevirapine, ritonavir, sakinavir (to treat HIV infection)
- herbal medicines containing St. John's wort (Hypericum perforatum). Taking Felotens XL Tablets with food and drink Take Felotens XL Tablets on an empty stomach or with a light meal. The tablets should not be taken with a high fat meal. Do not drink grapefruit juice during treatment with Felotens XL Tablets as this may make the tablets work too strongly. If you have any questions, please ask your doctor. Pregnancy and breast-feeding Felodipine must not be taken during the whole pregnancy. If you think you are pregnant, plan to get pregnant or become pregnant while using Felotens XL Tablets stop using the medicine immediately and consult your doctor as soon as possible. Felodipine is excreted in breast milk, therefore the use of Felotens XL Tablets is not recommended whilst breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Felotens XL Tablets can cause dizziness or tiredness. These effects are more likely to occur at the start of treatment, after dose increases, or after taking alcohol at the same time. If you are affected, do not drive or operate machinery. Important information about some of the ingredients of Felotens XL Tablets This medicine contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How to take it
Felotens XL Tablets Always take Felotens XL Tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. The usual doses are described below. Adults
Initially, 5mg once daily. If needed, the doctor may increase the dose to 10mg daily or may prescribe an additional medicine to lower blood pressure. The maximum daily dose is 10mg felodipine.
Elderly
The doctor will decide your starting dose.
Children Not recommended. Taking the tablets
- Swallow these tablets whole at the same time of the day (e.g. in the morning) with a glass of water. Do not crush or chew them.
- Do NOT take the tablets with grapefruit juice, as this may make Felotens XL Tablets work too strongly.
- Take the tablets on an empty stomach or with a light meal. The tablets should not be taken with a high fat meal.
- Take this medicine for as long as your doctor tells you to. It may be dangerous to stop without your doctor's advice. If you take more Felotens XL Tablets than you should Do not take more tablets than your doctor tells you to. If you ever take too many, go to the nearest hospital casualty department or tell your doctor immediately. Take the container and any remaining tablets with you to show to the doctor. An overdose may lead to light-headedness, fainting and dizziness caused by very low blood pressure and in rare cases slowed heartbeat (bradycardia). If you forget to take Felotens XL Tablets If you forget to take a dose, take one as soon as you remember. Then go on as before. Do not take two doses at the same time to make up for a forgotten dose. If you are worried, ask your pharmacist or doctor for advice. If you stop taking Felotens XL Tablets Do not stop treatment early because felodipine can be associated with withdrawal symptoms. Please read the back of this leaflet. *Trademark
24986402
GEN/FLT/PIL/331_04 18/05/2015
If you stop taking the tablets too quickly you may develop high blood pressure again. Talk to your doctor before you stop taking the tablets and follow the advice. 4. Possible side-effects Like all medicines, Felotens XL Tablets may cause side-effects, although not everyone gets them. Evaluation of the side-effects is based on the following frequencies: Very common: Common:
Uncommon:
Rare:
Very rare:
Not known:
In more than 1 in 10 patients treated In less than 1 in 10, but more than 1 in 100 patients treated In less than 1 in 100, but more than 1 in 1,000 patients treated In less than 1 in 1,000, but more than 1 in 10,000 patients treated In less than 1 in 10,000 patients treated, including single reports frequency cannot be estimated from the available data
Stop taking Felotens XL Tablets and contact your doctor if you have an allergic reaction such as swelling of the face, lips, tongue, mouth and throat, which may cause shortness of breath or difficulty swallowing. Tell your doctor if you notice any of the following side-effects. Very common:
- headache
- tinnitus (ringing or buzzing in the ears)
- flushing. These effects are more likely to occur at the start of treatment or after dose increases and may settle with continued use. Common:
- chest pain (angina pectoris) or worsening (increase in frequency, duration and severity) of chest pain in patients with pre-existing angina pectoris. This is more likely at the beginning of treatment
- swelling of extremities (in particular the ankles, the degree of ankle swelling is dose related). Uncommon:
- pins and needles (paraesthesia)
- dizziness
- fatigue
- restlessness
- palpitations
- fast heartbeat (tachycardia)
- very low blood pressure (hypotension)
- fainting (syncope)
- shortness of breath (dyspnoea)
- gastrointestinal complaints (e.g. feeling sick (nausea) or being sick (vomiting), diarrhoea, constipation, stomach pain)
- skin and hypersensitivity reactions such as itching skin (pruritus), hives (urticaria), rash (exanthema)
- sensitivity to light (photosensitization)
- increased sweating
- joint or muscle pain (myalgia and arthralgia)
- tremors
- weight gain. Rare:
- palpable, normally painful purple colouration of the skin (cutaneous vasculitis, very rarely leucocytoclastic vasculitis).
- rash and/or itching skin
- erection disorders or impotence
- inflammation or swelling of the gums (gum hyperplasia and gingivitis)
- increased need to pass urine (pollakiuria)
- fever.
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on safety of this medicine.
*Trademark
24986402
GEN/FLT/PIL/331_03 18/05/2015
How to store it
Felotens XL Tablets Keep out of the sight and reach of children. Do not store above 25°C. Do not take Felotens XL after the expiry ("use before") date, which is stated on the 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 to protect the environment. 6. Further information What Felotens XL contains
- The active substance is felodipine.
- Each 2.5mg prolonged-release tablet contains 2.5mg of felodipine.
- Each 5mg prolonged-release tablet contains 5mg of felodipine.
- Each 10mg prolonged-release tablet contains 10mg of felodipine.
- The other ingredients in the tablet core are:
- lactose monohydrate (2.5mg tablet contains 25.2mg lactose; 5mg tablet contains 22.75mg lactose; 10mg tablet contains 20.38mg lactose)
- microcrystalline cellulose
- hypromellose
- povidone
- propyl gallate
- colloidal anhydrous silica
- magnesium stearate.
- The other ingredients in the film coating are:
- hypromellose
- titanium dioxide (E171)
- red and yellow iron oxide (E172)
- talc
- propylene glycol What Felotens XL 2.5mg, 5mg and 10mg Prolonged-release Tablets look like and the contents of the pack Felotens XL 2.5mg: Yellow, round, biconvex, filmcoated prolonged-release tablet with imprint 2.5. Felotens XL 5mg: Light pink, round, biconvex, filmcoated prolonged-release tablet with imprint 5. Felotens XL 10mg: Reddish brown, round, biconvex, film-coated prolonged-release tablet with imprint 10. Blister packs with pack sizes of: 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 250, 500 and 1000 prolonged-release tablets. Not all pack sizes may be marketed. POM PL 06831/0225 PL 06831/0226 PL 06831/0227
Felotens XL 2.5mg Prolonged-release Tablets Felotens XL 5mg Prolonged-release Tablets Felotens XL 10mg Prolonged-release Tablets
Marketing Authorisation Holder and Manufacturer MA holder: Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK. Manufacturer: STADA Arzneimittel AG, Stadastraße 2-18, D-61118 Bad Vilbel, Germany. Centrafarm Services B.V., Nieuwe Donk 9, 4879 AC Etten-Leur, Netherlands. This leaflet was last revised in May 2015
Very rare:
- heart attack (myocardial infarction)
- liver function problems seen as raised transaminase levels in blood tests
- scaling skin reactions (exfoliative dermatitis)
- erection disorders
- enlargement of breast tissue in males (gynecomastia)
- heavy menstruation (menorrhagia)
- angio-oedema (serious allergic reaction which causes swelling of the face or throat). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
Frequently asked questions about Felotens XL 5mg Prolonged Release Tablets
How do I take Felotens XL 5mg Prolonged Release Tablets?
Felotens XL 5mg Prolonged Release Tablets comes as tablet containing 5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Felotens XL 5mg Prolonged Release Tablets?
The active substance in Felotens XL 5mg Prolonged Release Tablets is felodipine.
Are there equivalent medicines to Felotens XL 5mg Prolonged Release Tablets?
Medicines with the same active substance, strength and form include: Cardioplen XL 5 mg Prolonged Release Tablets, Delofine XL 5 mg Prolonged-Release Tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Felotens XL 5mg 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.
Can I get Felotens XL 5mg Prolonged Release Tablets without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: felodipine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
In the management of hypertension and prophylaxis of chronic stable angina pectoris.
4.2. Posology and method of administration
For oral administrationHypertension:Adults (including elderly): The dose should be adjusted to the individual requirements of the patient. The recommended starting dose is 5 mg once daily. If necessary the dose may be further increased or another antihypertensive agent added. The usual maintenance dose is 5-10 mg once daily. Doses higher than 20 mg daily are not usually needed. For dose titration purposes a 2.5 mg tablet is available. In elderly patients an initial treatment with 2.5 mg daily should be considered.Angina pectoris:Adults: The dose should be adjusted individually. Treatment should be started with 5 mg once daily and if needed be increased to 10 mg once daily.Administration: The tablets should regularly be taken in the morning without food or with a light meal. Felotens XL 5 mg Prolonged Release Tablets must not be chewed or crushed. They should be swallowed whole with half a glass of water.Children: The safety and efficacy of Felotens XL 5 mg Prolonged Release Tablets in children has not been established.Felotens XL 5 mg 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. In patients with severely impaired liver function the dose of felodipine should be low. The pharmacokinetics are not significantly affected in patients with impaired renal function.
4.3. Contraindications
Unstable angina pectoris.Pregnancy.Acute porphyriaPatient with a previous allergic reaction to Felotens XL 5 mg Prolonged Release Tablets or other dihydropyridines because of the theoretical risk of cross-reactivity.Felotens XL 5 mg Prolonged Release Tablets should not be used in patients with clinically significant aortic stenosis, uncontrolled heart failure, and during or within one month of a myocardial infarction.As with other calcium channel blockers, Felotens XL 5 mg Prolonged Release Tablets should be discontinued in patients who develop cardiogenic shock.
4.4. Special warnings and precautions for use
As with other vasodilators, Felotens XL 5 mg Prolonged Release Tablets may, in rare cases, precipitate significant hypotension with tachycardia which in susceptible individuals may result in myocardial ischaemia. Withdraw if ischaemic pain occurs or existing pain worsens shortly after initiating treatment.There is no evidence that Felotens XL 5 mg Prolonged Release Tablets are useful for secondary prevention of myocardial infarction.The efficacy and safety of Felotens XL 5 mg Prolonged Release Tablets in the treatment of malignant hypertension has not been studied.Felotens XL 5 mg Prolonged Release Tablets should be used with caution in patients with severe left ventricular dysfunction.Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
4.5. Interaction with other medicinal products and other forms of interaction
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 Felotens XL 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 Felotens XL 5 mg Prolonged Release Tablets doses may be required in patients taking the drugs.No dosage adjustment is required when Felotens XL 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 followed 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 Felotens XL 5 mg Prolonged Release Tablets.The anti-hypertensive effect of felodipine may be enhanced by other anti-hypertensives such as α-blockers (e.g. prazosin) or β-blockers (e.g. atenolol) and general anaesthetics.
4.6. Pregnancy and lactation
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.
4.7. Effects on ability to drive and use machines
None.
4.8. Undesirable effects
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 Felotens XL 2.5 mg 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.Skin: very rarely - leucocytoclastic vasculitis, rarely - rash and/or pruritus, cutaneous vasculitis and isolated cases of photosensitivity.Musculoskeletal: in isolated cases arthralgia and myalgia.Psychiatric: rarely impotence/sexual dysfunction. Central and peripheral nervous system: headache, dizziness. In isolated cases paraesthesia.Gastrointestinal: rarely - gum hyperplasia, very rarely – gingivitis, in isolated cases abdominal pain, nausea, vomiting, Hepatic: in isolated cases increased liver enzymes. Urinary system: rarely - urinary frequency. Cardiovascular: rarely - tachycardia, palpitations and syncope.Vascular (extracardiac): peripheral oedema, flush. Other: rarely – fever, fatigue, in isolated cases hypersensitivity reactions e.g. urticaria, angio-oedema. 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
4.9. Overdose
Symptoms: Overdosage may cause excessive peripheral vasodilatation with marked hypotension which may sometimes be accompanied by bradycardia.Management: Activated charcoal, induction of vomiting or gastric lavage, if appropriate or indicated. Severe hypotension should be treated symptomatically, with the patient placed supine and the legs elevated. Bradycardia, if present, should be treated with atropine 0.5-1 mg 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 about this leaflet
Ask anything about Felotens XL 5mg 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.
Medicines containing Felodipine
- Cardioplen XL 10 mg Prolonged Release Tablets
- Cardioplen XL 2.5 mg Prolonged Release Tablets
- Cardioplen XL 5 mg Prolonged Release Tablets
- Delofine XL 10 mg Prolonged-Release Tablets
- Delofine XL 2.5 mg Prolonged-Release Tablets
- Delofine XL 5 mg Prolonged-Release Tablets
- Felotens XL 10mg Prolonged Release Tablets
- Felotens XL 2.5mg Prolonged Release Tablets
- Pinefeld XL (felodipine) 10mg Tablets