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.
Pinefeld XL (felodipine) 10mg 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 The active ingredient in Pinefeld XL is felodipine which belongs to a group of medicines called calcium channel blockers. These work by blocking the effects of calcium on the blood vessels (narrowing of the blood vessels) which helps the blood vessels to relax and widen, increasing the blood flow and supply of oxygen to the heart, reducing the heart's workload. Pinefeld is used to treat the following:
- High blood pressure (hypertension)
- To prevent angina (chest pain) The name of this medicine is Pinefeld XL 10mg Prolonged-Release Film-Coated Tablets (felodipine) and is referred to as Pinefeld throughout this leaflet.
What you need to know before you take it
e Pinefeld Do not take Pinefeld if:
- You are allergic to felodipine, other calcium channel blockers or any of the other ingredients of this medicine (listed in section 6)
- You suffer from an insufficient blood supply to the heart muscle which can cause chest pain (unstable angina pectoris)
- You have had a severe heart attack within the last month (acute myocardial infarction)
- You suffer from heart failure or heart disease
- You are pregnant, think you may be pregnant or are planning to have a baby (see "Pregnancy and breastfeeding" section) Warnings and precautions Talk to your doctor before taking Pinefeld:
- If you suffer from heart problems such as: o Low blood pressure (hypotension) o Faster heartbeat (tachycardia) o Reduced blood flow to the heart muscle by a partial or complete blockage of the arteries (myocardial ischaemia)
- If you suffer from liver disorders
- If you suffer from swelling of the gums (gingivitis) or a serious gum infection that damages the soft tissue and destroys the bone that supports the teeth (periodontitis). Mild enlargement of the gums can be avoided or reversed by careful dental hygiene.
Other medicines and Pinefeld Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines. Medicines which may interact with or be affected by Pinefeld:
- Medicines used to treat stomach ulcers such as cimetidine (H2-receptor antagonists)
- Medicines used to treat fungal infections such as itraconazole, ketoconazole (azole antifungals)
- Medicines used to treat bacterial infections such as erythromycin, rifampicin (antibiotics)
- Medicines used to treat HIV infection (HIV protease inhibitors) such as ritonavir and efavirenz, nevirapine (Non-Nucleoside Reverse Transcriptase Inhibitors [NNRTIs])
- Medicines used to control seizures and epilepsy such as carbamazepine, phenytoin (anticonvulsant)
- St John's Wort, a herbal remedy used to treat depression
- Medicines used to treat anxiety and sleep disorders such as phenobarbital (barbiturates)
- Medicines used to reduce the body's immunity when receiving organ transplant such as tacrolimus (immunosuppressants) Taking Pinefeld with food and drink
- During treatment with Pinefeld, a low-fat, low-carbohydrate diet should be followed.
- These tablets may be taken with or without food.
- Grapefruit juice should be avoided during treatment with Pinefeld. Grapefruit juice can affect the amount of felodipine (the active ingredient in Pinefeld) in the blood. Pregnancy and breastfeeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Pregnancy If you are pregnant, think you may be pregnant or are planning to have a baby, Pinefeld must not be taken. Breast feeding If you are breast−feeding, Pinefeld should not be taken as felodipine (the active ingredient in Pinefeld) is passed into breast milk. Driving and using machines Pinefeld may cause headache, feeling sick (nausea), dizziness or tiredness (fatigue). This is more likely to occur at the start of treatment. If any of these symptoms are experienced, it may be necessary to avoid driving or operating machinery. Pinefeld contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Information about the sodium content of Pinefeld This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodiumfree'.
How to take it
Pinefeld Always take Pinefeld exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. • • • • •
These tablets are to be taken orally, in the morning, with water. These tablets should be swallowed whole. Do not break, chew or crush these tablets because they will be absorbed into the body too quickly. During treatment with Pinefeld, a low-fat, low-carbohydrate diet should be followed. These tablets may be taken with or without food. Grapefruit juice should be avoided during treatment with Pinefeld. Grapefruit juice can affect the amount of felodipine (the active ingredient in Pinefeld) in the blood.
Adults
- The recommended starting dose is 5mg once daily.
- The standard maintenance dose is 5-10mg once daily.
- Doses higher than 20mg daily are not usually required.
- Depending on the therapeutic response, the dose can be decreased to 2.5mg if applicable.
- Depending on the therapeutic response, the dose can be increased to 10mg once daily
- Another antihypertensive medicine may be added if necessary.
- Dose increases should occur at intervals of at least 2 weeks. Elderly Treatment should be started with the lowest available dose. Patients with kidney disorders
- Dose adjustment is not required for patients with impaired kidney function.
- Caution should be taken in patients with severely impaired kidney function. Patients with liver disorders
- Patients with impaired liver function may have increased concentrations of felodipine (the active ingredient in Pinefeld) in their blood and may require a lower dose.
- In patients with mild to moderately impaired liver function, the recommended starting dose should be the lowest minimum dose of Pinefeld.
- The dose should only be increased after balancing the benefits against the risks.
- Pinefeld should not be used in patients with severely impaired liver function. Use in children Pinefeld Tablets are not recommended for children. If you take more Pinefeld than you should: If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. The symptoms of overdose are; excessive widening of the veins and arteries of the outer parts of the body (peripheral vasodilatation) with low blood pressure (hypotension) and rarely a slower heartbeat (bradycardia). If you forget to take Pinefeld Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose do not take a double dose to make up for a forgotten dose. If you stop taking Pinefeld
- It is important that you keep taking Pinefeld for as long as your doctor has told you to.
- If treatment with Pinefeld is stopped abruptly, a hypertensive crisis (severe increase in blood pressure that may cause irreversible organ damage and/or stroke) may occur. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Pinefeld can cause side effects, although not everybody gets them. Seek medical advice immediately if you develop the following symptoms:
- Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness
- Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)
- Swelling of parts of the body (peripheral oedema) Common side effects (may affect up to 1 in 10 people)
- Headache. This is usually only temporary and appears at the start of treatment or following a dose increase
- Reddening of the face (flushing). This is usually only temporary and appears at the start of treatment or following a dose increase
Uncommon side effects (may affect up to 1 in 100 people)
- Dizziness. This is usually only temporary and appears at the start of treatment or following a dose increase
- Tingling or numbness in the hands or feet (paraesthesia)
- Low blood pressure (hypotension)
- Faster heartbeat (tachycardia)
- Feeling your heartbeat (palpitations)
- Stomach pain
- Feeling sick (nausea)
- Skin rashes
- Severe itching (pruritis)
- Tiredness, weakness or lack energy (fatigue). This is usually only temporary and appears at the start of treatment or following a dose increase Rare side effects (may affect up to 1 in 1000 people)
- Fainting (syncope)
- Inability to have or maintain an erection (impotence) or sexual problems
- Skin rashes with the formation of wheals (urticaria)
- Being sick (vomiting)
- Muscle pain (myalgia)
- Pain or swelling in the joints (arthralgia) Very rare side effects (may affect up to 1 in 10,000 people)
- Swelling/inflammation of gums [gingival hyperplasia/gingivitis] (can be prevented/reversed by careful dental hygiene)
- Liver function disorders (detected by blood tests)
- Frequent need to urinate (pollakisuria)
- Abnormal sensitivity of the skin to sunlight (photosensitivity)
- Inflammation of the blood vessels (leukocycoclastic vasculitis) 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 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. 5. • • • •
How to store it
Pinefeld Keep this medicine out of the sight and reach of children. Store in the original package. Do not use this medicine after the expiry date which is stated on the carton/blister after EXP. The expiry date refers to the last day of that month. 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 Pinefeld contains: Each prolonged-released film-coated tablet contains 10mg of felodipine. The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium laurilsulfate, hypromellose, magnesium stearate, macrogol 4000, iron oxide (E172) and titanium dioxide (E171). What Pinefeld looks like and contents of the pack: Pinefeld are grey−red, round, biconvex, prolonged-release, film-coated tablets with an approximate diameter of 9mm, with the imprint F10 on one side. Pinefeld is available in: Pinefeld Tablets are available in packs of 7, 14, 28 or 98 tablets.
Not all pack sizes may be marketed. Product Licence Number: PL 11311/0342 Marketing Authorisation Holder: Tillomed Laboratories Ltd 220 Butterfield Great Marlings Luton LU2 8DL United Kingdom Manufacturer: Kleva Pharmaceutcials S.A. 189, Parnithos AVE. 136 75 Acharnai – Attiki Greece This leaflet was last revised in October 2021 Till-Ver.7.1
Frequently asked questions about Pinefeld XL (felodipine) 10mg Tablets
How do I take Pinefeld XL (felodipine) 10mg Tablets?
Pinefeld XL (felodipine) 10mg Tablets comes as tablet containing 10mg. 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 Pinefeld XL (felodipine) 10mg Tablets?
The active substance in Pinefeld XL (felodipine) 10mg Tablets is felodipine.
Are there equivalent medicines to Pinefeld XL (felodipine) 10mg Tablets?
Medicines with the same active substance, strength and form include: Cardioplen XL 10 mg Prolonged Release Tablets, Delofine XL 10 mg Prolonged-Release Tablets, Felotens XL 10mg 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 Pinefeld XL (felodipine) 10mg 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 Pinefeld XL (felodipine) 10mg 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
Essential hypertension and prophylaxis of chronic 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. Dose increases should occur at intervals of at least 2 weeks. The standard maintenance dose is 5-10 mg once daily. Doses higher than 20 mg daily are not usually required.
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.
Pinefeld XL can be used in combination with β-blockers, ACE inhibitors or diuretics. Combination therapy will usually enhance the antihypertensive effect. Care should be taken to avoid hypotension.
Different prolonged-release preparations do not necessarily have the same effect. When changing therapy from different prolonged-release preparations of felodipine to Pinefeld XL, blood pressure should be checked and the dosage changed as appropriate (see section 5.2).
Elderly population
Initial treatment with lowest available dose should be considered.
Renal impairment
Caution should be taken in patients with severe renal impairment (see section 5.2). 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). In mild to moderate hepatic impairment, the recommended starting dose should be lowered to the minimum therapeutic effective dose. The dose should only be increased after balancing the benefits against the risks (see section 5.2). Felodipine is contraindicated in patients with severe hepatic impairment.
Paediatric population
There is limited clinical trial experience of the use of felodipine in hypertensive paediatric patients (see sections 5.1 and 5.2). Felodipine should not be used in children.
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. Pinefeld XL should NOT be taken with grapefruit juice (see section 4.5).
4.3. Contraindications
• Hypersensitivity to felodipine or any of the excipients listed in section 6.1.
• Unstable angina pectoris
• Acute myocardial infarction
• Decompensated heart failure
• Pregnancy
• 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).
Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis. The enlargement can be avoided or reversed by careful dental hygiene.
Pinefeld XL contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take Felodipine.
Pinefeld XL 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 co-administered with the strong CYP3A4 inhibitor itraconazole. When felodipine and erythromycin were co-administered, 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 is 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, 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 reactions are dose-dependent and appear at the start of treatment or after a dose increase. Should such 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 and <1/10
Uncommon ≥1/1000 and <1/100
Rare ≥1/10000 and <1/1000
Very rare <1/10000
Table 1 Undesirable effects
System Organ Class
Frequency
Adverse reaction
General disorders and administration site conditions
Very common
Uncommon
Very rare
Peripheral oedema
Fatigue
Hypersensitivity reactions e.g. angio-oedema, fever
Nervous system disorders
Common
Uncommon
Headache
Dizziness, paraesthesia
Vascular disorders
Common
Uncommon
Rare
Flushing
Hypotension
Syncope
Cardiac disorders
Uncommon
Tachycardia, palpitations
Gastrointestinal disorders
Uncommon
Rare
Very rare
Abdominal pain, nausea,
Vomiting
Gingival hyperplasia, gingivitis
Skin and subcutaneous system disorders
Uncommon
Rare
Very rare
Rash, pruritus
Urticaria
Photosensitivity reactions, leukocytoclastic vasculitis
Reproductive system and breast disorders
Rare
Impotence/sexual dysfunction
Musculoskeletal and connective tissue disorders
Rare
Myalgia, arthralgia
Hepatobilliary disorders
Very rare
Increased liver enzymes
Renal and urinary disorders
Very rare
Pollakisuria
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
Overdose 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 (0.5–1mg) 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 Pinefeld XL (felodipine) 10mg 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
- Felotens XL 5mg Prolonged Release Tablets