Primacor

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Primacor (Carmen), 20 mg, coated tablets

Lercanidipine hydrochloride
Primacor and Carmen are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Primacor and what is it used for
• 2. Important information before taking Primacor
• 3. How to take Primacor
• 4. Possible side effects
• 5. How to store Primacor
• 6. 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 channel blockers (dihydropyridine derivatives), which 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 taking Primacor

When not to take Primacor

• If the patient is allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• If the patient has certain heart diseases:
• narrowing of the blood vessel leaving the heart
• untreated heart failure
• unstable angina (chest pain at rest or with increasing severity)
• within 1 month of a heart attack
• If the patient has severe liver disease
• If the patient has severe kidney problems or is undergoing dialysis
• If the patient is taking certain medicines that are inhibitors of liver 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 cyclosporin (used after organ transplantation to prevent rejection)
• If the patient consumes grapefruit or drinks grapefruit juice

Warnings and precautions

Before starting treatment with Primacor, the patient should discuss it with their doctor or pharmacist:

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

The patient should tell their doctor about pregnancy, suspected pregnancy, or planning a pregnancy, as well as breastfeeding (see "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

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
If Primacor is taken with other medicines, its effect or the effect of other medicines may change, and the frequency of side effects may increase (see also section 2, subsection "When not to take Primacor").
In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• phenytoin, phenobarbital, or carbamazepine (medicines used to treat epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• astemizole or terfenadine (antihistamines)
• amiodarone, quinidine, or sotalol (medicines used to treat rapid heart rate)
• midazolam (a sedative)
• digoxin (a medicine used to treat heart conditions)
• beta-blockers, such as metoprolol (medicines used to treat high blood pressure, heart failure, and irregular heart rhythm)
• cimetidine (in doses greater than 800 mg per day; a medicine used to treat stomach ulcers, indigestion, or heartburn)
• simvastatin (a medicine used to lower cholesterol levels in the blood)
• other medicines used to treat high blood pressure

Taking Primacor with food, drink, and alcohol

• Eating a meal high in fat significantly increases the level of the medicine in the blood (see section 3).
• Alcohol may enhance the effect of Primacor. The patient should not drink alcohol while taking Primacor.
• The patient should not take Primacor with grapefruit or grapefruit juice (this may increase the blood pressure-lowering effect). See section 2, subsection "When not to take Primacor."

Pregnancy, breastfeeding, and fertility

Primacor should not be used during pregnancy and breastfeeding.
There are no data on the use of Primacor in pregnant or breastfeeding women. If the patient is pregnant or breastfeeding, if they are not using any contraceptive method, if they suspect they may be pregnant, or if they plan to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

If the patient experiences dizziness, weakness, or drowsiness while taking this medicine, they should not drive or operate machinery.

Primacor contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Primacor contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free."

3. How to take Primacor

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Adults

The recommended dose is 10 mg once a day, taken every day at the same time, preferably in the morning, at least 15 minutes before breakfast. If necessary, the doctor may recommend increasing the dose to one 20 mg Primacor tablet per day (see also section 2, subsection "Taking Primacor with food, drink, and alcohol").
Primacor 20 mg: the tablet can be divided into equal doses. The tablets should be swallowed whole, with a sufficient amount of water.

Use in children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Elderly patients

No dose adjustment is necessary. However, the patient should be monitored closely at the start of treatment.

Patients with liver or kidney problems

These patients should be monitored closely at the start of treatment and when increasing the daily dose to 20 mg.

Taking more than the recommended dose of Primacor

The patient should not take more than the recommended dose.
If the patient takes more than the recommended dose, they should immediately contact their doctor or go to the emergency department of the nearest hospital. They should take the medicine packaging with them.
Taking more than the recommended dose may cause excessive lowering of blood pressure and irregular or rapid heart rate.

Missing a dose of Primacor

If the patient forgets to take a dose, they should skip the missed dose and take the next dose the following day at the usual time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Primacor

If the patient stops taking Primacor, their blood pressure may rise again.
Before stopping treatment, the patient should consult their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Primacor can cause side effects, although not everybody gets them.
The following side effects may occur while taking this medicine:

Some side effects can be serious – if the patient experiences any of the following symptoms, they should contact their doctor immediately:

Rarely (may occur in less than 1 in 1000 people):angina (e.g., chest pain caused by insufficient blood flow to the heart), allergic reactions (with symptoms such as itching, rash, hives), fainting.
In patients who have previously experienced angina, the use of medicines from the same group as Primacor may cause an increase in frequency, duration, or severity of angina attacks. In rare cases, a heart attack may occur.

Other possible side effects:

Common (may occur in less than 1 in 10 people):headache, rapid heart rate, palpitations (feeling of rapid or irregular heart rate), sudden flushing of the face, neck, or upper chest, swelling of the ankles.
Uncommon (may occur in less than 1 in 100 people):dizziness, low blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, increased urination, weakness, fatigue.
Rare (may occur in less than 1 in 1000 people):drowsiness, vomiting, diarrhea, hives, frequent urination, chest pain.
Frequency not known (frequency cannot be estimated from the available data):gum swelling, liver function disorders (detected in blood tests), clouding of the 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Primacor

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Primacor 20 mg, coated tablets: Store in the original packaging to protect from light.
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 Primacor contains

Primacor 20 mg, coated tablets

• The active substance is lercanidipine hydrochloride. One coated tablet contains 20 mg of lercanidipine hydrochloride (which corresponds to 18.8 mg of lercanidipine).
• The other ingredients of the medicine are: Tablet core:lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (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 score line 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, the patient should 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 Cesky Tesin
Czech Republic

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellonska 76
03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa
ul. Dzialkowa 56
02-234 Warsaw
Medezin Sp. z o.o.
ul. Zbanszyńska 3
91-342 Lodz
Wytwornia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Zeleńskiego 45
31-353 Krakow
Marketing authorization number in Germany, country of export:48836.01.00

Parallel import authorization number: 24/22 Date of approval of the leaflet: 10.01.2022

[Information about the registered trademark]