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 Lacidipine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
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).
2.
e Lacidipine
Do not take Lacidipine:
Talk to your doctor or pharmacist before taking Lacidipine:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3.
Lacidipine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Use in adults It is important to take the right number of tablets at the same time each day. • • • • •
The recommended starting dose is 2 mg every morning. After 3-4 weeks this may be increased to 4 mg every morning. If necessary, the dose may be increased again to 6 mg every morning which is the maximum daily dose. Swallow the tablets whole with a drink of water. Do not take with grapefruit juice.
The 4 mg tablet can be divided into equal doses. Patients with liver problems You may be given a lower dose by your doctor if you have severe liver problems. If you take more lacidipine than you should If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital emergency department straight away. You may have low blood pressure, or changes to your heart rate. Take the medicine pack with you, even if there are no tablets left. If you forget to take Lacidipine If you forget a dose in the morning, take it as soon as you remember it on the same day. However, if you remember the next day, take your normal dose on that morning. Do not take a double dose to make up for a forgotten dose. If you stop taking Lacidipine If you are considering or have stopped taking Lacidipine, speak to your doctor or pharmacist. If you have any further questions on the use of the medicine, ask your doctor or pharmacist.
4.
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)
5.
Lacidipine
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 pack after EXP.The expiry date refers to the last day of that month. This medicine does not require any special temperature storage conditions. Store in the original container in order to protect from light. Do not remove any tablets from the foil until you are ready to take them.
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.
6.
What Lacidipine contains The active substance is lacidipine. Each film-coated tablet contains 2 mg or 4 mg. The other ingredients are lactose monohydrate (see section 2 'Lacidipine contains lactose'), povidone, crospovidone and magnesium stearate. The film coating contains hypromellose, titanium dioxide (E171) and macrogol. What Lacidipine looks like and contents of the pack The 2 mg tablets are film-coated, round and white in colour. They have the logo '225' on the other side. The 4 mg tablets are film-coated, oval and white in colour. They have the logo and '24' separated by a break line on the other side.
on one side and on one side and '2'
Lacidipine is available in blister packs of 14 and 28 film-coated tablets and calendar packs of 28 filmcoated tablets. Not all pack sizes may be marketed
Marketing Authorisation Holder Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Manufacturer Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary. Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Viatris UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, United Kingdom This leaflet was last revised in 07/2023
Lacidipine 2 mg Film-coated Tablets comes as tablet containing 2mg. 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 2 mg Film-coated Tablets is lacidipine.
Medicines with the same active substance, strength and form include: Motens Tablets 2mg, Lacidipine 2 mg Film-Coated Tablets, Lacidipine 2mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Lacidipine 2 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.
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.
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.
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.
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.
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 2 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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