PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Primacor (Carmen 20 mg)
20 mg, coated tablets
Lercanidipini hydrochloridum
Primacor and Carmen 20 mg are different trade names of the same medicinal product.
Please read the leaflet carefully before using 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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Primacor is and what it is 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 Primacor is and what it is used for

Primacor contains as the active substance lercanidipine hydrochloride, which belongs to a group of medicines called calcium antagonists (dihydropyridine derivatives), which lower blood pressure.
Primacor is used in the treatment of 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 lerkanidipine 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 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 agents (such as ketoconazole or itraconazole)
macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
antiviral agents (such as ritonavir)
If the patient is taking another medicine called cyclosporine (used after organ transplantation to prevent rejection)
If the patient consumes grapefruit or drinks grapefruit juice

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

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

Inform 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 or has recently taken, as well as any medicines the patient plans to take.
If Primacor is used concomitantly with other medicines, its effect or the effect of other medicines may be altered, and the frequency 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 in the treatment of 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 greater 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

A high-fat meal significantly increases the drug concentration in 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 is planning to have a child, she should consult her 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 monohydrate
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
The 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 used exactly as recommended by your doctor. If in doubt, consult
your doctor or pharmacist.
Primacor is available in the following strengths: 10 mg, 20 mg.
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 once daily (see also section 2, subsection "Taking Primacor
with food, drink and alcohol").
The Primacor tablet (20 mg) 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
No adjustment of the daily dose is 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 in these patients.
Taking more Primacor than recommended
Do not take more than the recommended dose.
If you take more than the recommended amount, contact your doctor immediately or go to the
nearest hospital emergency department. Take the medicine package with you.
Taking more than the recommended dose may cause excessive lowering of blood pressure and
irregular or rapid heart rate.
Missed dose of Primacor
If you forget to take a dose, skip the missed dose and take the next dose at the usual time the
following day. 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 discontinuing treatment.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with this medicine:
Some side effects may be serious – if any of the following symptoms occur,
contact your doctor immediately:
Rare (may occur in less than 1 in 1,000 people): angina pectoris (e.g. chest pain caused by
insufficient 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 of the class
to which Primacor belongs may lead to an increase in frequency, duration, or severity of angina
attacks. In isolated cases, myocardial infarction may occur.
Other possible side effects:
Common (may occur in less than 1 in 10 people): headache, fast heartbeat, palpitations (awareness
of rapid or irregular heartbeat), sudden redness 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, passing large amounts of urine, weakness,
fatigue.
Rare (may occur in less than 1 in 1,000 people): drowsiness, vomiting, diarrhoea, urticaria,
passing urine more frequently than usual, chest pain.
Frequency not known (frequency cannot be estimated from available data): gum 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 side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions
at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. 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 helps to provide more information on the safety of this medicine.

5. How to store the medicine Primacor

Keep the medicine out of the sight and reach of 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.
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 help protect the environment.

6. Contents of the pack and other information

What Primacor contains
The active substance is lercanidipine hydrochloride.
Each coated tablet contains 20 mg of lercanidipine hydrochloride (equivalent to 18.8 mg of lercanidipine).
The other ingredients are:
monohydrate lactose, 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
Pink, round, biconvex coated tablets with a diameter of 8.5 mm, scored on one side.
The medicine is available in packs containing 30 or 60 coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Germany, the country of export:
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer:
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

German Marketing Authorisation Number (country of export): 48836.01.00
Parallel Import Licence Number: 266/20