Primacor

Package Leaflet: Information for the User

PRIMACOR, 10 mg, coated tablets

PRIMACOR, 20 mg, coated tablets

lercanidipine hydrochloride

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What is PRIMACOR and what is it used for
• 2. Before you take 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 aged 18 and over (the medicine is not recommended for use in children under 18).

2. Before you take PRIMACOR

When not to take PRIMACOR

• If you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• If you have certain heart diseases:
• narrowing of the blood vessels leaving the heart
• untreated heart failure
• unstable angina (chest pain at rest or worsening)
• within 1 month after a heart attack
• If you have severe liver disease
• If you have severe kidney problems or are undergoing dialysis
• If you are taking certain medicines that inhibit liver metabolism:
• antifungal medicines (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin or

clarithromycin)

• antiviral medicines (such as ritonavir)
• If you are taking another medicine called cyclosporin (used after organ transplantation to prevent rejection)
• If you consume grapefruit or drink grapefruit juice

Warnings and precautions

Before taking PRIMACOR, discuss with your doctor or pharmacist:

• if you have heart disease,
• if you have liver or kidney disease.

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, as well as if you are breast-feeding (see "Pregnancy, breast-feeding, 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 you are taking now or have recently taken, as well as any medicines you 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, inform your doctor or pharmacist 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)
• astemizole or terfenadine (antihistamines)
• amiodarone, quinidine, or sotalol (medicines used for rapid heart rate)
• midazolam (a sedative)
• digoxin (a medicine used to treat heart disease)
• beta-blockers, such as metoprolol (medicines used to treat high blood pressure, heart failure, and heart rhythm disorders)
• cimetidine (in doses greater than 800 mg per day; a medicine used to treat stomach ulcers, 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 meal high in fat significantly increases the concentration of the medicine in the blood (see section 3).
• Alcohol may enhance the effect of PRIMACOR. Do not drink alcohol during treatment with PRIMACOR.
• Do 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, breast-feeding, and fertility

PRIMACOR should not be used during pregnancy and should not be used during breast-feeding.
There are no data on the use of PRIMACOR in pregnant or breast-feeding women.
If you are pregnant or breast-feeding, if you do not use any contraceptive method, if you think you may be pregnant, or if you plan to have a child, consult your doctor or pharmacist 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.

PRIMACOR contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

PRIMACOR contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take PRIMACOR

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults

The recommended dose is 10 mg once daily, taken at the same time every day, preferably in the morning, at least 15 minutes before breakfast. If necessary, your doctor may increase the dose to one 20 mg PRIMACOR tablet per day (see also section 2, subsection "Taking PRIMACOR with food, drink, and alcohol").
PRIMACOR 10 mg: the score line on the tablet is only to facilitate breaking and not to divide into equal doses.
PRIMACOR 20 mg: the tablet can be divided into equal doses.
Tablets should be swallowed whole with a sufficient amount of water.

Children and adolescents

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

Elderly

No dose adjustment is necessary. However, caution should be exercised at the start of treatment.

Patients with liver or kidney problems

Caution should be exercised at the start of treatment and when increasing the daily dose to 20 mg.

Taking more PRIMACOR than prescribed

Do not take more than the prescribed dose.
If you have taken more than the prescribed dose, contact your doctor or go to the emergency department of your nearest hospital immediately. Take the medicine package with you.
Taking more than the prescribed dose may cause excessive lowering of blood pressure and irregular or rapid heart rate.

Missing a dose of PRIMACOR

If you forget to take a dose, skip the missed dose and take the next dose at the usual time the next day. Do not take a double dose to make up for a missed dose.

Stopping treatment with PRIMACOR

If you stop taking PRIMACOR, your blood pressure may rise again. Before stopping treatment, consult your doctor.
If you have any further questions about taking 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.
The following side effects may occur while taking this medicine:

Some side effects can be serious – if you experience any of the following, contact your doctor immediately:

Rare (may affect up to 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, hives), fainting.
In patients who have previously experienced angina pectoris, taking 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 affect up to 1 in 10 people):headache, rapid heart rate, palpitations (feeling of rapid or irregular heart rate), flushing of the face, neck, or upper chest, swelling of the ankles.
Uncommon (may affect up to 1 in 100 people):dizziness, low blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, frequent urination, weakness, fatigue.
Rare (may affect up to 1 in 1,000 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 dialysis 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, tell your doctor or 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
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PRIMACOR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
PRIMACOR, 10 mg, coated tablets: Store in the original package to protect from light.
PRIMACOR, 20 mg, coated tablets: Store in the original package to protect from light. Store below 25°C.
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 PRIMACOR contains

PRIMACOR, 10 mg, coated tablets

• The active substance is lercanidipine hydrochloride. One coated tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 9.4 mg of lercanidipine).
• The other ingredients are: Tablet core:lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (Type A), povidone, magnesium stearate. Tablet coating:hypromellose, talc, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172).

PRIMACOR, 20 mg, coated tablets

• The active substance is lercanidipine hydrochloride. One coated tablet contains 20 mg of lercanidipine hydrochloride (equivalent to 18.8 mg of lercanidipine).
• The other ingredients are: Tablet core:lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (Type A), povidone, magnesium stearate. Opadry 02F25077 coating:hypromellose, talc, titanium dioxide (E 171), macrogol 6000, red iron oxide (E 172).

What PRIMACOR looks like and contents of the pack

PRIMACOR, 10 mg: yellow, round, biconvex coated tablets with a diameter of 6.5 mm, with a score line on one side.
PRIMACOR, 10 mg is available in packs of 14, 28, 60, and 90 coated tablets.
Not all pack sizes may be marketed.
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 of 7, 14, 28, 35, 42, 50, 56, 60, 90, 98, and 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder (PRIMACOR, 10 mg, coated tablets)
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
Marketing authorization holder (PRIMACOR, 20 mg, coated tablets)
Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Manufacturer
Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
or
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1
20148 Milan
Italy
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01
Date of last revision of the leaflet:24.06.2021