Lacipil

Package Leaflet: Information for the Patient

Lacipil, 2 mg, coated tablets

Lacipil, 4 mg, coated tablets

Lacipil, 6 mg, coated tablets

Lacidipine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Lacipil and what is it used for
• 2. Important information before taking Lacipil
• 3. How to take Lacipil
• 4. Possible side effects
• 5. How to store Lacipil
• 6. Contents of the pack and other information

1. What is Lacipil and what is it used for

Lacipil contains lacidipine, which is a specific, potent calcium antagonist of the dihydropyridine derivative group. Lacidipine acts almost exclusively on vascular smooth muscle. By dilating peripheral arterioles, it reduces peripheral resistance and, as a result, lowers blood pressure. Lacipil is intended for the treatment of hypertension. It can be used as monotherapy (as the only medicine) or in combination with other antihypertensive medicines, such as beta-adrenergic blockers, diuretics, or angiotensin-converting enzyme (ACE) inhibitors.

2. Important information before taking Lacipil

When not to take Lacipil:

• if the patient is allergic to lacidipine or any of the other ingredients of this medicine (listed in section 6).
• similar to other dihydropyridine derivatives, lacidipine is contraindicated in patients with severe aortic stenosis.

Warnings and precautions:
In specialized studies, no effect of Lacipil on the function of the sinoatrial node or on the prolongation of the atrioventricular node conduction time has been demonstrated. There is a theoretical possibility, similar to that of other calcium antagonists, of an effect on the function of the sinoatrial node and the atrioventricular node. Therefore, caution should be exercised when administering Lacipil to patients who have previously been diagnosed with rhythm and conduction disorders.
Similar to other dihydropyridine calcium antagonists, caution should be exercised when administering lacidipine to patients with congenital or documented acquired QT interval prolongation. Caution should also be exercised when administering lacidipine to patients being treated simultaneously with medicines that prolong the QT interval, such as antiarrhythmic drugs of class I and III, tricyclic antidepressants, certain antipsychotics, antibacterial drugs (e.g., erythromycin), and certain antihistamines (e.g., terfenadine).
Like other calcium antagonists, Lacipil should be used with caution in patients with borderline heart failure.
Similar to other dihydropyridine calcium antagonists, Lacipil should be used with caution in patients with previously diagnosed unstable angina pectoris, as well as in patients who have experienced unstable angina pectoris during treatment.
Caution should be exercised when administering Lacipil to patients after a recent myocardial infarction.
There is no evidence of the effectiveness of Lacipil in preventing a new myocardial infarction.
The efficacy and safety of Lacipil have not been established in the treatment of severe hypertension (so-called malignant hypertension).
The medicine should be used with caution in patients with liver function disorders due to the possibility of a stronger blood pressure-lowering effect.

Children and adolescents

There is no experience with the use of Lacipil in children.

Lacipil and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as about medicines they plan to take. This also applies to medicines that are available without a prescription.
Taking Lacipil and other medicines that lower blood pressure, including those used to treat hypertension (e.g., beta-adrenergic blockers, diuretics, or ACE inhibitors), may enhance the hypotensive effect. No specific interactions have been found with commonly used antihypertensive medicines (i.e., beta-adrenergic blockers, diuretics), digoxin, tolbutamide, or warfarin.
The concentration of lacidipine in the blood may be increased when cimetidine is administered simultaneously.
Lacidipine is strongly bound to proteins (over 95%): with albumin and alpha-1-glycoprotein.
In clinical studies conducted in patients who have undergone kidney transplantation and are being treated with cyclosporine, it has been found that lacidipine normalizes the decreased glomerular filtration rate and renal blood flow caused by cyclosporine administration.
Lacidipine is metabolized by CYP3A4, and therefore, medicines that are strong inhibitors (e.g., itraconazole) or inducers (e.g., rifampicin) of CYP3A4, when used simultaneously with lacidipine, may affect its metabolism and excretion.
Taking lacidipine with corticosteroids or tetracosactide may reduce its hypotensive effect.

Lacipil with food and drink

The medicine can be taken independently of meals.
During treatment with Lacipil, the patient should not drink grapefruit juice.

Pregnancy, breastfeeding, and fertility

There are no adequate studies on the safety of Lacipil in human pregnancy. In animal studies, no teratogenic effects or adverse effects on fetal development have been found.
Lacipil may be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus or child.
Lacipil may cause a weakening of uterine contractions during labor.
Lacipil may be used during breastfeeding only if the expected benefit to the mother outweighs the potential risk to the child.
If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.
There are no data on the effects of Lacipil on human fertility.

Driving and using machines

Due to the lack of relevant data, it is not known whether the medicine affects the ability to drive and use machines.
In case of side effects such as dizziness, the patient should consult their doctor.
Lacipil contains lactose.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Lacipil

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The initial dose is 2 mg per day, given in a single dose at the same time, preferably in the morning, and not necessarily in relation to meals.
The dose of the medicine, depending on the severity of the disease and the individual patient's response to treatment, may be increased by the doctor to 4 mg, and if necessary, to 6 mg per day.
Dose escalation may occur after the time necessary to achieve the full pharmacological effect. In practice, this period should not be less than 3-4 weeks, unless the patient's clinical condition requires faster dose escalation.
There are no restrictions on the duration of treatment with Lacipil.
Administration of Lacipil in patients with renal and/or hepatic impairment:
No dose adjustment of Lacipil is required in patients with renal and/or hepatic impairment.
Administration of Lacipil in elderly patients (over 65 years of age):
No dose adjustment of Lacipil is required in elderly patients.

Overdose of Lacipil

So far, no cases of overdose with Lacipil have been reported.
Symptoms:
The most likely consequence of an overdose is prolonged vasodilation, associated with prolonged hypotension and tachycardia.
Bradycardia or prolongation of the atrioventricular conduction time may also occur.
Procedure:
In case of an overdose, the patient should immediately consult their doctor or go to the emergency department of the nearest hospital.
There is no specific antidote. In case of an overdose, symptomatic treatment and close monitoring of heart function are recommended.

4. Possible side effects

Like all medicines, Lacipil can cause side effects, although not everybody gets them.
The frequency of side effects reported frequently, infrequently, and rarely was determined based on data from large clinical trials (both internal and published).
Lacipil is generally well-tolerated. Some people may experience slight exacerbation of symptoms related to vasodilation. These symptoms, marked with the symbol #, are usually transient and disappear during continued treatment with the same dose of Lacipil.
Common side effects(may occur in 1 to 10 out of 100 patients):

• headache, dizziness,
• palpitations, very rapid heart rate (tachycardia),
• sudden flushing (especially of the face),
• nausea, symptoms of indigestion,
• rash (including erythema and skin itching),
• polyuria,
• weakness, edema,
• transient increase in alkaline phosphatase activity (clinically significant increase occurs infrequently).

Uncommon side effects(may occur in 1 to 10 out of 1000 patients):

• exacerbation of existing angina pectoris - as with other dihydropyridine derivatives, exacerbation of existing angina pectoris has been observed in individual cases, especially at the beginning of treatment. The greater likelihood of such an effect occurs in patients with symptomatic coronary heart disease.
• fainting, hypotension,
• gingival hyperplasia.

Rare side effects(may occur in 1 to 10 out of 10,000 patients):

• angioedema, urticaria.

Very rare side effects(may occur in less than 1 out of 10,000 patients):

• tremor,
• depression.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Lacipil

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Tablets should be protected from light and removed from the blister pack immediately before administration. If, according to the recommended dosage, 2 mg of Lacipil should be taken, i.e., half a 4 mg tablet, the unused half should be left in the blister pack and taken within 48 hours.
Do not use this medicine after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lacipil contains

The active substance of Lacipil is lacidipine.
Each coated tablet contains 2 mg, 4 mg, or 6 mg of lacidipine.
The other ingredients are: lactose monohydrate, povidone K30, magnesium stearate.
Coating:
Lacipil, 2 mg and 4 mg: Opadry White YS-1-18043 (hypromellose, titanium dioxide (E171), PEG 400, polysorbate 80) or Opadry White OY-S-7335 (hypromellose, titanium dioxide (E171)).
Lacipil, 6 mg: Opadry White YS-1-18043 (hypromellose, titanium dioxide (E171), PEG 400, polysorbate 80).

What Lacipil looks like and contents of the pack

Lacipil, 2 mg: round, white, coated tablets with the number "2" embossed.
Lacipil, 4 mg: white, oval, coated tablets. The tablet may have the marking "GS" on one side and "3MS" on the other. The tablets can be divided into two equal doses.
Lacipil, 6 mg: white, oval, biconvex, coated tablets with the marking "GX CX3".
The pack contains:
Lacipil, 2 mg - 28 coated tablets in blisters in a cardboard box.
Lacipil, 4 mg - 28 coated tablets in blisters in a cardboard box.
Lacipil, 6 mg - 14 or 28 coated tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

Manufacturer:

Delpharm Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
{2 mg, 4 mg tablets}
or
Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos, Spain
{2 mg, 4 mg, 6 mg tablets}

Marketing authorization holder:

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
To obtain more detailed information, please contact the representative of the marketing authorization holder.
GSK Services Sp. z o.o.
Warsaw Office
ul. Rzymowskiego 53
02-697 Warsaw
Phone: +48 22 576 9000
Date of last revision of the leaflet:January 2025
(GSK logo)