Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Lacidipine tablets contain the active substance lacidipine which belongs to a group of medicines called 'calcium channel blockers'. Lacidipine helps to relax your blood vessels so that they get wider. This helps the blood to flow more easily and lowers the blood pressure. Lacidipine taken regularly as prescribed by your doctor will help to lower your blood pressure (to treat hypertension).
Talk to your doctor or pharmacist before taking Lacidipine: • if you have an uneven heart beat or any other heart problems • if you have or have ever had any liver problems. If you are having any blood tests, tell the person giving the test that you are taking this medicine. This is because Lacidipine can affect results relating to your liver. Children and adolescents Do not give this medicine to children under the age of 18 years because it is not recommended in this age group. Other medicines and Lacidipine Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Lacidipine can affect the way some other medicines work. Also some other medicines can affect the way Lacidipine works. In particular, tell your doctor or pharmacist if you are taking any of the following: • other medicines used to treat high blood pressure such as beta blockers (e.g. atenolol, propanolol), diuretics (called 'water tablets' e.g. bendroflumethiazide, furosemide) and ACE-inhibitors (e.g. enalapril, ramipril) • ciclosporin, a medicine used to stop rejection after an organ transplant • rifampicin, a medicine used to treat tuberculosis • itraconazole, a medicine used to treat fungal infections • medicines used to control your heart beat (called 'anti-arrhythmics' e.g. disopyramide, flecainide, amiodarone) • medicines used to treat depression called 'tricyclic antidepressants' (e.g. clomipramine, imipramine) • antibiotics, medicines used to treat infections (e.g. erythromycin) • antihistamines, medicines used to treat hayfever and other allergies (e.g. terfenadine) • cimetidine, a medicine used to treat stomach problems • tetracosactide, a medicine used to test the function of the adrenal glands • corticosteroids, a group of medicines used to reduce inflammation (e.g. prednisone, hydrocortisone). Lacidipine with food and drink Do not eat grapefruit or drink grapefruit juice whilst taking this medicine. Pregnancy and breast-feeding There is no data on the use of lacidpine during pregnancy. There may be a possibility of problems such as difficulty becoming pregnant, miscarriages or a difficult labour. Lacidipine may pass into breast milk. Lacidipine is not recommended unless your doctor advises that the benefit to you is greater than the possibility of risk to your baby. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines You may feel dizzy while taking Lacidipine. If this happens, do not drive or use any tools or machines. Lacidipine 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor straight away if you notice any of the following serious side effects or go to your nearest hospital emergency department – you may need urgent medical treatment: • chest pain or a pressing sensation on your chest, including chest pain that is getting worse. These may be signs of angina which may be more likely to occur when you start taking this medicine or if you already have heart problems
• serious allergic reactions such as rapid swelling of the face, mouth, lips, tongue or throat which may cause difficulty breathing or swallowing. Other possible side effects include: Common (may affect up to 1 in 10 people) • dizziness • headache • fast or uneven heart beat which you may feel as a thumping in your chest (also called palpitations) • flushing • swelling (water retention), particularly of the ankles • upset stomach • feeling sick (nausea) • rash, redness of the skin, itching • an increase in the amount of water (urine) that you pass • feeling weak • changes in results of blood tests relating to your liver Uncommon (may affect up to 1 in 100 people) • low blood pressure which may cause you to feel faint • fainting • bleeding, tender or swollen gums Rare (may affect up to 1 in 1,000 people) • nettle rash (urticaria) • muscle cramps Very rare (may affect up to 1 in 10,000 people) • shaking (tremor) • depression 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 Website: 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.
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 protect the environment.
Lacidipine 4 mg Film-coated Tablets comes as tablet containing 4mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Lacidipine 4 mg Film-coated Tablets is lacidipine.
Medicines with the same active substance, strength and form include: Motens Tablets 4mg, Lacidipine 4 mg Film-Coated Tablets, Lacidipine 4mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Lacidipine 4 mg Film-coated 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.
Lacidipine is indicated in adults for the treatment of hypertension either alone or in combination with other antihypertensive agents, including ß-adrenoceptor antagonists, diuretics, and ACE-inhibitors.
Posology Adults The treatment of hypertension should be adapted to the severity of the condition, and according to the individual response. The recommended initial dose is 2 mg once daily. The dose may be increased to 4 mg (and then, if necessary, to 6 mg) after adequate time has been allowed for the full pharmacological effect to occur. In practice, this should not be less than 3 to 4 weeks. Daily doses above 6 mg have not been shown to be significantly more effective. Lacidipine should be taken at the same time each day, preferably in the morning. Treatment with lacidipine may be continued indefinitely. Patients with hepatic impairment Lacidipine is metabolised primarily by the liver and therefore in patients with hepatic impairment the bioavailability of lacidipine may be increased and the hypotensive effect enhanced. These patients should be carefully monitored, and in severe cases, a dose reduction may be necessary. Patients with kidney disease As lacidipine is not cleared by the kidneys, the dose does not require modification in patients with kidney disease. Paediatric population The safety and efficacy of lacidipine in children and adolescents aged below 18 has not been established. No data are available. Method of administration For oral administration. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
Lacidipine tablets are contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Lacidipine should only be used with great care in patients with a previous allergic reaction to another dihydropyridine because there is a theoretical risk of cross-reactivity. As with other calcium antagonists, lacidipine should be discontinued in patients who develop cardiogenic shock and unstable angina. In addition, dihydropyridines have been shown to reduce coronary arterial blood-flow in patients with aortic stenosis and in such patients lacidipine is contraindicated. Lacidipine should not be used during or within one month of a myocardial infarction. In case of rare hereditary conditions that may be incompatible with an excipient of the product (see section 4.4) the use of the product is contraindicated. <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
In specialised studies lacidipine has been shown not to affect the spontaneous function of the SA node or to cause prolonged conduction within the AV node. However, the theoretical potential for a calcium antagonist to affect the activity of the SA and AV nodes should be noted, and therefore lacidipine should be used with caution in patients with pre-existing abnormalities in the activity of the SA and AV nodes. As has been reported with other dihydropyridine calcium channel antagonists, lacidipine should be used with caution in patients with congenital or documented acquired QT prolongation. Lacidipine should also be used with caution in patients treated concomitantly with medications known to prolong the QT interval such as class I and III antiarrhythmics, tricyclic antidepressants, some antipsychotics, antibiotics (e.g. erythromycin) and some antihistamines (e.g. terfenadine). As with other calcium antagonists, lacidipine should be used with caution in patients with poor cardiac reserve. There is no evidence that lacidipine is useful for secondary prevention of myocardial infarction. The efficacy and safety of lacidipine in the treatment of malignant hypertension has not been established. Lacidipine should be used with caution in patients with impaired liver function because antihypertensive effect may be increased. There is no evidence that lacidipine impairs glucose tolerance or alters diabetic control. This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
Co-administration of lacidipine with other agents recognised to have a hypotensive effect, including anti-hypertensive agents, (e.g. diuretics, beta-blockers or ACE-inhibitors), may have an additive hypotensive effect. However, no specific interaction problems have been identified in studies with common antihypertensive agents (e.g. beta-blockers and diuretics) or with digoxin, tolbutamide or warfarin. The plasma level of lacidipine may be increased by simultaneous administration of cimetidine. Lacidipine is highly protein-bound (more than 95%) to albumin and alpha-1-glycoprotein. As with other dihydropyridines, lacidipine should not be taken with grapefruit juice as bioavailability may be altered. In clinical studies in patients with a renal transplant treated with ciclosporin, lacidipine reversed the decrease in renal plasma flow and glomerular filtration rate induced by ciclosporin. Lacidipine is known to be metabolised by cytochrome CYP3A4 and, therefore, significant inhibitors and inducers of CYP3A4 (e.g. rifampicin, itraconazole) administered concurrently may interact with the metabolism and elimination of lacidipine. Concomitant use of lacidipine and corticoids or tetracosactide might decrease antihypertensive effect. <summary id="PREGNANCY" data-evt="smpcSectionOpen"
Pregnancy
Although some dihydropyridine compounds have been found to be teratogenic in animals, data in the rat and rabbit for lacidipine provide no evidence of a teratogenic effect. Using doses far above the therapeutic range, in animals lacidipine shows evidence of maternal toxicity resulting in increased pre- and post-implantation losses and possibly delayed ossification. Evidence from experimental animals has indicated that administration of lacidipine results in prolongation of gestational period and prolonged and difficult labour as a consequence of relaxation of uterine muscle.
There are no data on the safety of lacidipine in human pregnancy.
Lacidipine should only be used in pregnancy when the potential benefits for the mother outweigh the possibility of adverse effects in the foetus or neonate.
The possibility that lacidipine can cause relaxation of the uterine muscle at term should be considered.
Breast-feeding
Milk transfer studies in animals have shown that lacidipine (or its metabolites) are likely to be excreted into breast milk.
Lacidipine should only be used during breast-feeding when the potential benefits for the mother outweigh the possibility of adverse effects in the foetus or neonate.
Fertility
No data are available.
Lacidipine may cause dizziness. Patients should be warned not to drive or operate machinery if they experience dizziness or related symptoms.
Lacidipine is generally well tolerated. Some individuals may experience minor side effects which are related to its known pharmacological action of peripheral vasodilation. Such effects, indicated by a hash (#), are usually transient and usually disappear with continued administration of lacidipine at the same dosage. Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Psychiatric disorders Depression Nervous system disorders Dizziness#, Headache# Tremor Cardiac disorders Palpitations#, Tachycardia Syncope, Angina pectoris Vascular disorders Flushing# Hypotension Gastrointestinal disorders Abdominal discomfort, Nausea Gingival hyperplasia Skin and subcutaneous tissue disorders Rash, Erythema, Pruritus Angioedema, Urticaria Musculoskeletal and connective tissue disorders Muscle cramps Renal and urinary disorders Polyuria General disorders and administration site conditions Asthenia, Oedema# Investigations Blood alkaline phosphatase increased As with other dihydropyridines aggravation of underlying angina pectoris has been reported in a small number of individuals, especially at the start of treatment. This is more likely to happen in patients with symptomatic ischaemic heart disease. Lacidipine should be discontinued under medical supervision in patients who develop unstable angina. Reporting of suspected adverse reactions in UK: 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. <summary id="OVERDOSE" data-evt="smpcSectionOpen"
Symptoms:
There have been no recorded cases of lacidipine overdosage. The expected symptoms could comprise prolonged peripheral vasodilation associated with hypotension and tachycardia. Bradycardia or prolonged AV conduction could occur.
Therapy:
There is no specific antidote. Standard general measures for monitoring cardiac function and appropriate supportive and therapeutic measures should be used.
Ask anything about Lacidipine 4 mg Film-coated 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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