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.
Delofine XL 5 mg 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
Pregnancy Do not take Delofine XL if you are pregnant.
Delofine XL Prolonged-Release Tablets contain the active substance felodipine. This belongs to a group of medicines called calcium antagonists. It lowers blood pressure by dilating small blood vessels. It does not negatively affect the heart function.
Breast-feeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Delofine XL is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Delofine XL is used in the treatment of high blood pressure (hypertension) and heart and chest pain brought on by for example exercise or stress (angina pectoris).
What you need to know before you take it
e Delofine XL Prolonged-Release Tablets Do not take Delofine XL Prolonged-Release Tablets:
- if you are pregnant. You should tell your doctor as soon as possible if you become pregnant while using this medicine,
- if you are allergic to felodipine or any of the other ingredients of this medicine
- (listed in section 6),
- if you suffer from uncompensated heart failure,
- if you have acute myocardial infarction (heart attack),
- if you have chest pain of recent onset, or angina pectoris that is lasting for more than 15 minutes or longer or is more severe than usual,
- if you have disease of a heart valve or heart muscle, until you have talked to your doctor. Warnings and precautions
Driving and using machines Delofine XL 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. Delofine XL Prolonged-Release Tablets contain lactose, castor oil and sodium Delofine XL Prolonged-Release Tablets contain lactose that is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Delofine XL Prolonged-Release Tablets contain castor oil, which may cause stomach upset and diarrhoea. Delofine XL Prolonged-Release Tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
How to take it
Delofine XL Prolonged-Release Tablets
Delofine XL, like other blood-pressure lowering medicinal products, may in rare cases lead to pronounced low blood pressure which in some patients may result in an inadequate supply of blood to the heart. 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.
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Talk to your doctor before taking Delofine XL, especially if you have problems with your liver.
Hypertension Treatment should be started with 5 mg once a day. If necessary, your doctor may increase the dose or add another blood-pressure lowering medicine. The usual dose when treating this disease for a long time is 5-10 mg once a day. In elderly patients, a starting dose of 2.5 mg daily may be considered.
Taking Delofine XL may cause your gums to become swollen. Practice good oral hygiene to help avoid your gums from swelling (see section 4). Children The use of Delofine XL is not recommended in children. Other medicines and Delofine XL ProlongedRelease Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines as
Delofine XL Prolonged-Release Tablets should be taken in the morning and be swallowed with water. The tablet must not be divided, crushed or chewed. This medicine can be taken without food or following a light meal not high in fat or carbohydrates.
Stable angina pectoris Treatment should be started with 5 mg once a day and if needed, your doctor may increase the dose to 10 mg once a day.
If you have liver problems The level of felodipine in your blood may be increased. Your doctor may lower the dose. Elderly people Your doctor may initiate treatment with the lowest available dose. If you take more Delofine XL Prolonged-Release Tablets than you should If you take more than the recommended number of doses of Delofine XL, 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 doctor immediately. If you forget to take Delofine XL Prolonged-Release Tablets If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose. If you stop taking Delofine XL Prolonged-Release Tablets If you stop taking this medicine your condition may return. Please consult your doctor and seek advice before you stop taking Delofine XL. Your doctor will advise you how long to take your medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following happen to you, stop taking Delofine XL and tell a doctor straight away:
- Hypersensitivity and allergic reactions: The signs may include raised lumps on your skin (weals) or swelling of your face, lips, mouth, tongue or throat. The following undesirable effects have been identified. Most of these reactions appear at start of treatment or after a dose increase. Should such reactions occur, they are usually brief and diminish in intensity with time. If you experience any of the following symptoms and they persist, please tell your doctor. 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. 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. Other undesirable effects may occur. If you have any bothersome or unusual reaction while taking Delofine XL, check with your doctor right away. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Delofine XL Prolonged-Release Tablets Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister foil after "EXP". The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Delofine XL Prolonged-Release Tablets contain Each prolonged-release tablet contains either 2.5 mg, 5 mg or 10 mg of felodipine as the active ingredient. The other excipients are: Tablet core: hydroxypropylcellulose (E463), hypromellose (E464), lactose monohydrate, macrogolglycerol hydroxystearate, aluminium magnesium silicate and sodium stearyl fumarate. Tablet coating: Delofine XL 2.5 mg and 5 mg: hypromellose (E464), titanium dioxide (E171), macrogol and iron oxide yellow (E172). Delofine XL 10 mg: hypromellose (E464), titanium dioxide (E171) and macrogol. What Delofine XL Prolonged-Release Tablets look like and contents of the pack Delofine XL 2.5 mg Prolonged-Release Tablets are yellow circular, biconvex film-coated tablets debossed with 'L26' on one side and plain on the other side. Delofine XL 5 mg Prolonged-Release Tablets are light yellow circular, biconvex film-coated tablets debossed with 'L27' on one side and plain on the other side. Delofine XL 10 mg Prolonged-Release Tablets are white circular, biconvex film-coated tablets debossed with 'L28' on one side and plain on the other side. The tablets are packaged in PVC/PE/PVDC-aluminium blister in packs of 14, 20, 28, 30, 50, 90, 98 and 100 tablets are available. Not all pack sizes may be marketed. Marketing Authorisation Holder Morningside Healthcare Ltd. Unit C, Harcourt Way Leicester LE19 1WP UK Manufacturer Morningside Pharmaceuticals Ltd. 5 Pavilion Way, Loughborough, Leicestershire, LE11 5GW UK For information in large print, tape, CD or Braille, please contact medical enquiries on 0116 478 0322. This leaflet was last revised in October 2021.
M0397LAMUKNAB1-P1-001
Frequently asked questions about Delofine XL 5 mg Prolonged-Release Tablets
How do I take Delofine XL 5 mg Prolonged-Release Tablets?
Delofine XL 5 mg 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 Delofine XL 5 mg Prolonged-Release Tablets?
The active substance in Delofine XL 5 mg Prolonged-Release Tablets is felodipine.
Are there equivalent medicines to Delofine XL 5 mg Prolonged-Release Tablets?
Medicines with the same active substance, strength and form include: Cardioplen XL 5 mg Prolonged Release Tablets, Felotens XL 5mg 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 Delofine XL 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.
Can I get Delofine XL 5 mg 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
Hypertension.
Stable angina pectoris.
4.2. Posology and method of administration
Posology
Hypertension
The dose should be adjusted individually. Treatment can be started with 5 mg once daily. Depending on the patient's response, the dosage can, where applicable, be decreased to 2.5 mg or increased to 10 mg daily. If necessary, another antihypertensive agent may be added. The standard maintenance dose is 5 mg once daily.
Angina pectoris
The dose should be adjusted individually. Treatment should be initiated with 5 mg once daily and, if needed, increased to 10 mg once daily.
Elderly population
Initial treatment with lowest available dose should be considered.
Renal impairment
Dose adjustment is not needed in patients with impaired renal function.
Hepatic impairment
Patients with impaired hepatic function may have elevated plasma concentrations of felodipine and may respond to lower doses (see section 4.4).
Paediatric population
There is limited clinical trial experience of the use of felodipine in hypertensive paediatric patients (see sections 5.1 and 5.2).
Method of administration
The tablets should be taken in the morning and be swallowed with water. In order to keep the prolonged-release properties, the tablets must not be divided, crushed or chewed. The tablets can be administered without food or following a light meal not rich in fat or carbohydrate.
4.3. Contraindications
• Pregnancy.
• Hypersensitivity to felodipine or any of the excipients listed in section 6.1.
• Decompensated heart failure.
• Acute myocardial infarction.
• Unstable angina pectoris.
• Haemodynamically significant cardiac valvular obstruction.
• Dynamic cardiac outflow obstruction.
4.4. Special warnings and precautions for use
The efficacy and safety of felodipine in the treatment of hypertensive emergencies has not been studied.
Felodipine may cause significant hypotension with subsequent tachycardia. This may lead to myocardial ischaemia in susceptible patients.
Felodipine is cleared by the liver. Consequently, higher therapeutic concentrations and response can be expected in patients with clearly reduced liver function (see section 4.2).
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).
Felodipine/Delofine XL tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Felodipine/Delofine XL tablets contains castor oil, which may cause stomach upset and diarrhoea.
Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis. The enlargement can be avoided or reversed by careful oral hygiene.
Sodium content: Felodipine/Delofine XL tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Felodipine is metabolised in the liver by cytochrome P450 3A4 (CYP3A4). Concomitant administration of substances which interfere with CYP3A4 enzyme system may affect plasma concentrations of felodipine.
Enzyme interactions
Enzyme inhibiting and enzyme inducing substances of cytochrome P450 isoenzyme 3A4 may exert an influence on the plasma level of felodipine.
Interactions leading to increased plasma concentration of felodipine
CYP3A4 enzyme inhibitors have been shown to cause an increase in felodipine plasma concentrations. Felodipine Cmax and AUC increased 8-fold and 6-fold, respectively, when felodipine was coadministered with the strong CYP3A4 inhibitor itraconazole. When felodipine and erythromycin were coadministered, the Cmax and AUC of felodipine were increased by about 2.5-fold. Cimetidine increased the felodipine Cmax and AUC by approximately 55%. The combination with strong CYP3A4 inhibitors should be avoided.
In case of clinically significant adverse events due to elevated felodipine exposure when combined with strong CYP3A4 inhibitors, adjustment of felodipine dose and/or discontinuation of the CYP3A4 inhibitor should be considered.
Examples:
• Cimetidine
• Erythromycin
• Itraconazole
• Ketoconazole
• Anti-HIV/protease inhibitors (e.g. ritonavir)
• Certain flavonoids present in grapefruit juice
Felodipine tablets should not be taken together with grapefruit juice.
Interactions leading to decreased plasma concentration of felodipine
Enzyme inducers of the cytochrome P450 3A4 system have been shown to cause a decrease in plasma concentrations of felodipine. When felodipine was co-administered with carbamazepine, phenytoin or phenobarbital, the Cmax and AUC of felodipine were decreased by 82% and 96% respectively. The combination with strong CYP3A4 inducers should be avoided.
In case of lack of efficacy due to decreased felodipine exposure when combined with potent inducers of CYP3A4, adjustment of felodipine dose and/or discontinuation of the CYP3A4 inducer should be considered.
Examples:
• Phenytoin
• Carbamazepine
• Rifampicin
• Barbiturates
• Efavirenz
• Nevirapine
• Hypericum perforatum (St. John's wort)
Additional interactions
Tacrolimus: 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.
Cyclosporin: Felodipine does not affect plasma concentrations of cyclosporin.
4.6. Fertility, pregnancy and lactation
Pregnancy
Felodipine should not be given during pregnancy. In non-clinical reproductive toxicity studies there were foetal developmental effects, which are considered to be due to the pharmacological action of felodipine.
Breast-feeding
Felodipine has been detected in breast milk, and due to insufficient data on potential effect on the infant, treatment is not recommended during breast-feeding.
Fertility
There are no data on the effects of felodipine on patient fertility. In a non-clinical reproductive study in the rat (see section 5.3), there were effects on foetal development but no effect on fertility at doses approximating to therapeutic.
4.7. Effects on ability to drive and use machines
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.
4.8. Undesirable effects
Summary of the safety profile
Felodipine can cause flushing, headache, palpitations, dizziness and fatigue. Most of these adverse reactions are dose- dependent and appear at the start of treatment or after a dose increase. Should such adverse reactions occur, they are usually transient and diminish with time.
Dose-dependent ankle swelling can occur in patients treated with felodipine. This results from precapillary vasodilatation and is not related to any generalised fluid retention.
Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis. The enlargement can be avoided or reversed by careful oral hygiene.
Tabulated list of adverse reactions
The adverse reactions listed below have been identified from clinical trials and from post marketing surveillance. 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
Table 1: Undesirable effects
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Overdosage may cause excessive peripheral vasodilatation with marked hypotension and sometimes bradycardia.
Management
If justified: activated charcoal, gastric lavage if performed within one hour after ingestion. If severe hypotension occurs, symptomatic treatment should be instituted.
The patient should be placed supine with the legs elevated. In case of accompanying bradycardia, atropine 0.5-1 mg should be administered intravenously. If this is not sufficient, plasma volume should be increased by infusion of e.g. glucose, saline, or dextran. Sympathomimetic medicinal products with predominant effect on the α1-adrenoceptor may be given if the above-mentioned measures are insufficient.
💬 Ask about this leaflet
Ask anything about Delofine XL 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.
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
- Felotens XL 10mg Prolonged Release Tablets
- Felotens XL 2.5mg Prolonged Release Tablets
- Felotens XL 5mg Prolonged Release Tablets
- Pinefeld XL (felodipine) 10mg Tablets