Patient Information Leaflet: Read this leaflet carefully before using the medicine

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Primacor (Carmen), 20 mg, coated tablets
Lercanidipini hydrochloridum
Primacor and Carmen are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What is Primacor and what is it used for
Important information before taking Primacor
How to take Primacor
Possible side effects
How to store Primacor
Contents of the pack and other information

1. What is Primacor and what is it used for

Primacor contains the active substance lercanidipine hydrochloride, which belongs to a group of medicines called calcium antagonists (dihydropyridine derivatives) that lower blood pressure.
Primacor is used to treat high blood pressure (hypertension) in adults over 18 years of age (the medicine is not recommended for use in children under 18 years of age).

2. Important information before using Primacor

When not to use Primacor

If the patient is allergic to leracanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
If the patient has certain heart diseases:
- obstruction of the left ventricular outflow tract
- untreated heart failure
- unstable angina (chest pain at rest or with increasing severity)
- within 1 month following a myocardial infarction
If the patient has severe liver disease
If the patient has severe renal impairment or is undergoing dialysis
If the patient is taking the following medicines, which are inhibitors of hepatic metabolism:
- antifungal medicines (such as ketoconazole or itraconazole)
- macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
- antiviral medicines (such as ritonavir)
- If the patient is taking another medicine called cyclosporine (used after organ transplantation to prevent organ rejection)
- If the patient consumes grapefruit or drinks grapefruit juice

Warnings and precautions
Before starting treatment with Primacor, discuss this with your doctor or pharmacist:

if the patient has heart diseases,
if the patient has liver or kidney disease.

Tell your doctor if you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding
(see section “Pregnancy, breastfeeding and fertility”).
Children and adolescents
The safety and efficacy of Primacor in children and adolescents under 18 years of age have not been established.
Primacor and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
If Primacor is taken together with other medicines, its effect or the effect of other medicines may be altered, and the risk of adverse reactions may increase
(see also section 2, subsection “When not to use Primacor”).
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

phenytoin, phenobarbital or carbamazepine (medicines used in the treatment of epilepsy)
rifampicin (a medicine used to treat tuberculosis)
astemizole or terfenadine (antihistamines)
amiodarone, quinidine or sotalol (medicines used in the treatment of rapid heart rate)
midazolam (a sedative)
digoxin (a medicine used in the treatment of heart diseases)
beta-blockers, e.g. metoprolol (medicines used in the treatment of high blood pressure, heart failure and cardiac arrhythmias)
cimetidine (at doses higher than 800 mg per day; a medicine used in peptic ulcer disease, indigestion or heartburn)
simvastatin (a medicine that lowers blood cholesterol levels)
other medicines used to treat high blood pressure

Taking Primacor with food, drink and alcohol

Eating a high-fat meal significantly increases the concentration of the medicine in the blood (see section 3).
Alcohol may enhance the effect of Primacor. Alcohol should not be consumed during treatment with Primacor.
Do not take Primacor together with grapefruit or grapefruit juice (this may enhance the blood pressure-lowering effect). See section 2, subsection “When not to use Primacor”.

Pregnancy, breastfeeding and fertility
Primacor is not recommended during pregnancy and should not be used during breastfeeding.
There are no data on the use of Primacor in pregnant or breastfeeding women. If the patient is pregnant or breastfeeding, not using any contraceptive method, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
If the patient experiences dizziness, weakness or drowsiness while taking this medicine, driving and operating machinery should be avoided.
Primacor contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Primacor contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Primacor

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Adults
The recommended dose is 10 mg once daily, taken every day at the same time, preferably in the morning, at least 15 minutes before breakfast. If necessary, your doctor may recommend increasing the dose to one tablet of Primacor 20 mg per day (see also section 2, subsection "Taking Primacor with food, drink and alcohol").
Primacor 20 mg: the tablet may be divided into equal doses. Tablets should preferably be swallowed whole, with sufficient water.
Use in children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
Elderly patients
Adjustment of the daily dose is not necessary. However, particular caution should be exercised at the beginning of treatment.
Patients with impaired liver or kidney function
Particular caution should be exercised at the beginning of treatment and when increasing the daily dose to 20 mg.
Taking a higher than recommended dose of Primacor
Do not take a higher dose than recommended.
If you take more than the recommended dose, contact your doctor immediately or go to the emergency department of your nearest hospital. Take the medicine pack with you.
Taking more than the recommended dose may cause excessive lowering of blood pressure and irregular or rapid heartbeat.
Missed dose of Primacor
If you forget to take a dose, skip the missed dose and take the next dose the following day at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Primacor
If you stop taking Primacor, your blood pressure may rise again. Consult your doctor before stopping the medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Some adverse reactions may be serious – if any of the following symptoms occur,
contact a doctor immediately:
Rare (may occur in less than 1 in 1,000 people): angina pectoris (e.g. chest tightness due to inadequate blood flow to the heart), allergic reactions (with symptoms such as itching, rash, urticaria), fainting.
In patients who have previously experienced angina pectoris, treatment with medicines from the same class as Primacor may lead to an increased frequency, prolonged duration, or worsening of angina attacks. In isolated cases, myocardial infarction may occur.
Other possible adverse reactions:
Common (may occur in less than 1 in 10 people): headache, rapid heartbeat, palpitations (sensation of fast or irregular heartbeat), sudden flushing of the face, neck, or upper chest, swelling of the ankle area.
Uncommon (may occur in less than 1 in 100 people): dizziness, low blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, passing large amounts of urine, weakness, fatigue.
Rare (may occur in less than 1 in 1,000 people): drowsiness, vomiting, diarrhoea, urticaria, more frequent urination than usual, chest pain.
Frequency not known (frequency cannot be estimated from the available data): gingival swelling, liver function abnormalities (detected in blood tests), clouding of the fluid (during dialysis using a catheter placed in the abdominal cavity), swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Primacor

The medicine should be stored in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Primacor 20 mg, coated tablets: Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Primacor contains
Primacor 20 mg, coated tablets

The active substance is lerkanidipine hydrochloride. One coated tablet contains 20 mg of lerkanidipine hydrochloride (equivalent to 18.8 mg of lerkanidipine).
Other components of the medicine are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), povidone K 30, magnesium stearate. Coating: hypromellose, talc, titanium dioxide (E 171), macrogol 6000, iron oxide red (E 172).

What Primacor looks like and contents of the pack
Primacor 20 mg: pink, round, biconvex coated tablets with a diameter of 8.5 mm, with a dividing groove on one side.
Primacor 20 mg is available in packs containing 30 and 60 coated tablets.
Not all pack sizes may be marketed.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in Germany, country of export, and manufacturer:
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
Parallel importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Český Těšín
Czech Republic
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Manufacturing site: Euceryn Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Marketing authorization number in Germany, country of export: 48836.01.00
Parallel import authorization number: 24/22
[Information about registered trademark]