Lecalpin

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Lecalpin (Lercanidipine Actavis), 10 mg, Film-Coated Tablets

Lercanidipine Hydrochloride
Lecalpin and Lercanidipine Actavis are different trade names for the same medicine.

Read the Leaflet Carefully Before Taking the Medicine, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Lecalpin and what is it used for

The active substance of Lecalpin, lercanidipine, belongs to a group of medicines called calcium antagonists. These medicines inhibit the influx of calcium ions into cardiac muscle cells and blood vessels leading from the heart to the rest of the body (arteries). The influx of calcium into these cells causes the heart muscle to contract and the arteries to constrict. By blocking the influx of calcium ions, calcium antagonists weaken the heart's contraction and dilate the arteries, resulting in a decrease in blood pressure. Lecalpin is used to treat high blood pressure (hypertension).

2. Important information before taking Lecalpin

When Not to Take Lecalpin

• if you are allergic to lercanidipine or any of the other ingredients of this medicine (listed in section 6)
• if you have certain heart diseases:
• uncontrolled heart failure
• obstruction of the outflow of blood from the heart
• unstable angina (angina at rest or progressively increasing)
• if you have had a heart attack within the last 4 weeks
• if you have severe liver disease
• if you have severe kidney disease or are undergoing dialysis
• if you are taking medicines that are inhibitors of the CYP3A4 enzyme:
• antifungal medicines (such as ketoconazole, itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin, or clarithromycin)
• antiviral medicines (such as ritonavir)
• when taking cyclosporine
• with grapefruit or grapefruit juice

Warnings and Precautions

Before taking Lecalpin, discuss with your doctor:

• if you have a heart condition called sick sinus syndrome and you do not have a pacemaker
• if you have other heart conditions or experience chest pain (angina pectoris)
• if you have liver or kidney disease or are undergoing dialysis therapy.

Lecalpin and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Taking Lecalpin with certain other medicines (see below) may change their effects or the effect of Lecalpin. It is especially important to inform your doctor if you are taking any of the following medicines:

• phenytoin, phenobarbital, or carbamazepine (medicines used to treat epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• midazolam (a medicine that helps you sleep)
• cimetidine at a dose greater than 800 mg/day (a medicine used to treat stomach ulcers, heartburn, or indigestion)
• digoxin (a medicine used to treat heart conditions)
• terfenadine or astemizole (medicines used to treat allergies)
• amiodarone, quinidine, or sotalol (medicines used to treat rapid heart rate)
• metoprolol (a medicine used to treat high blood pressure)
• simvastatin (a medicine that lowers cholesterol)
• other medicines used to treat high blood pressure.

Lecalpin with Food, Drink, and Alcohol

Do not consume grapefruits or grapefruit juice, as this may increase the effect of the medicine. Do not drink alcohol while taking Lecalpin. If you drink alcohol while taking Lecalpin, you may experience dizziness/fainting, feeling tired, or weakness, as alcohol may increase the effect of Lecalpin.

Pregnancy and Breastfeeding

Lecalpin is not recommended for pregnant women and should not be used during breastfeeding. If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and Using Machines

If you experience dizziness, weakness, or drowsiness while taking this medicine, do not drive or operate machinery.

Lecalpin Contains Lactose and Sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to Take Lecalpin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Lecalpin (10 mg) and Lecalpin (20 mg) are available. The recommended dose is one 10 mg Lecalpin tablet once daily. Take the tablet every day at the same time, preferably in the morning, at least 15 minutes before breakfast, as a meal high in fat can significantly increase the concentration of the medicine in the blood. If necessary, your doctor may decide to increase the dose of Lecalpin to one 20 mg tablet once daily. Swallow the tablets whole with half a glass of water. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.

Use in Children and Adolescents

Lecalpin is not recommended for children and adolescents under 18 years of age.

Overdose of Lecalpin

Immediately contact your doctor or go to the emergency department of your nearest hospital. Taking too much of this medicine may cause excessive lowering of blood pressure and irregular or rapid heart rate. It may also lead to headache and loss of consciousness.

Missed Dose of Lecalpin

If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, do not take the missed dose, just take the next one at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping Lecalpin Treatment

If you stop taking Lecalpin, your blood pressure may increase again. Before stopping treatment, consult your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some Side Effects Can Be Serious. If You Experience Any of the Following, Tell Your Doctor Immediately:

Rare (may affect up to 1 in 1,000 people):
angina pectoris (e.g., chest pain caused by reduced blood flow to the heart), allergic reactions (symptoms include itching, rash, urticaria), fainting.
In patients with pre-existing angina pectoris, an increased frequency, duration, or severity of these episodes may occur with the group of medicines to which Lecalpin belongs. Single cases of myocardial infarction may be observed.

Other Possible Side Effects:

Common (may affect up to 1 in 10 people):
headache, rapid heart rate, palpitations, flushing (sudden reddening of the face and neck), ankle swelling.
Uncommon (may affect up to 1 in 100 people):
dizziness, low blood pressure which may lead to fainting, nausea, abdominal pain, rash, itching, muscle pain, increased urination, weakness, fatigue.
Rare (may affect up to 1 in 1,000 people):
drowsiness, vomiting, diarrhea, increased frequency of urination, chest pain.
Frequency Not Known (cannot be estimated from the available data):
gingival swelling, increased liver enzyme activity in the blood, cloudy fluid (during dialysis with a catheter placed in the abdominal cavity), swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Lecalpin

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 packaging. The expiry date refers to the last day of the month. Store in a temperature below 30°C. Store in the original package to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Lecalpin Contains

• The active substance is lercanidipine hydrochloride. One film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.
• The other ingredients are: magnesium stearate, povidone (K-29/32), sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose coating:macrogol 3350, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Lecalpin Looks Like and Contents of the Pack

Yellow, round, biconvex film-coated tablets with a diameter of 6.5 mm, with a score line on one side and the marking "L" on the other side. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. Packs of 28, 30, 56, and 60 film-coated tablets. For more detailed information on this medicine, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Latvia, the Country of Export:

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer:

Balkanpharma - Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
Actavis Ltd., BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Actavis ehf., Reykjavikurvegur 78, 220 Hafnarfjörður, Iceland

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Latvia, the Country of Export:09-0290

Parallel Import Authorization Number: 400/24

This Medicine is Authorized in the Member States of the European Economic Area Under the Following Names:

Bulgaria
Lecalpin
Estonia
Lercanidipine Actavis 10 mg
Hungary
Lecalpin
Latvia
Lercanidipine Actavis
Lithuania
Lercanidipine Actavis 10 mg film-coated tablets
Poland
Lecalpin
Slovenia
Lecalpin

Date of Approval of the Leaflet: 19.11.2024

[Information about the Trademark]