KAPIZEN 10 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Kapizen and what is it used for
3. Important information before taking Kapizen
   1. When not to take Kapizen
   2. Warnings and precautions
   3. Children and adolescents
   4. Kapizen and other medicines
   5. Kapizen with food, drink and alcohol
   6. Pregnancy, breastfeeding and fertility
   7. Driving and using machines
   8. Kapizen contains lactose monohydrate and sodium
4. How to take Kapizen
   1. Use in children and adolescents
   2. Patients with liver or kidney impairment
   3. Elderly patients
   4. Overdose of Kapizen
   5. Missed dose of Kapizen
   6. Stopping treatment with Kapizen
5. Possible side effects
   1. Some side effects can be serious.
   2. If you experience any of the following symptoms, contact your doctor immediately:
   3. Other possible side effects:
   4. Reporting side effects
6. How to store Kapizen
7. Contents of the pack and other information
   1. What Kapizen contains
   2. What Kapizen looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. For further information on this medicine, please contact the representative of the marketing authorization holder in Poland:

Leaflet accompanying the packaging: information for the user

KAPIZEN, 10 mg, coated tablets
KAPIZEN, 20 mg, coated tablets
Lercanidipine hydrochloride

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 only. 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Kapizen and what is it used for

Kapizen belongs to a group of medicines called calcium channel blockers. Calcium channel blockers prevent calcium from entering the muscle cells of the heart and blood vessels carrying blood from the heart (arteries). The entry of calcium into these cells causes the heart to contract and the arteries to narrow. By blocking the entry of calcium, calcium channel blockers reduce the contraction of the heart and widen the arteries, lowering blood pressure.
Kapizen has been prescribed to treat high blood pressure, also known as hypertension.

2. Important information before taking Kapizen

When not to take Kapizen

• 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:
• untreated heart failure
• narrowing of the outflow tract from the heart
• unstable angina (chest pain occurring at rest or worsening over time)
• heart attack within the last month
• if you have severe liver disorders
• if you have severe kidney disorders or are undergoing dialysis
• if you are taking medicines that inhibit liver metabolism, (e.g. CYP3A4 isoenzyme inhibitors), such as:
• antifungal medicines (such as ketoconazole, itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
• antiviral medicines (such as ritonavir)
• if you are taking a medicine called cyclosporin (used to prevent rejection of a transplanted organ after transplantation)
• with grapefruit or grapefruit juice.

Warnings and precautions

Before taking Kapizen, discuss with your doctor:

• if you have heart disease
• if you have liver or kidney disorders
• if you are pregnant or breastfeeding.

Children and adolescents

The safety and efficacy of lercanidipine in children under 18 years of age have not been established.

Kapizen and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about any medicines you plan to take.
Taking Kapizen with certain other medicines (see below) may change the effect of these medicines or Kapizen.
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)
• astemizole or terfenadine (medicines for allergies)
• amiodarone, quinidine or sotalol (medicines used to treat rapid heartbeat)
• midazolam (a medicine used to treat insomnia)
• digoxin (a medicine used to treat heart disease)
• beta-blockers, e.g. metoprolol (a medicine used to treat high blood pressure, heart failure and heart rhythm disorders)
• cimetidine in doses greater than 800 mg (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.

Kapizen with food, drink and alcohol

A high-fat meal significantly increases the concentration of the medicine in the blood (see section 3).
Alcohol may enhance the effect of Kapizen. Do not drink alcohol during treatment with Kapizen.
Do not take Kapizen with grapefruit or grapefruit juice (may enhance the hypotensive effect), see section 2.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Kapizen should not be used during pregnancy. Kapizen should not be used during breastfeeding. There are no data on the use of lercanidipine in pregnant or breastfeeding women.

Driving and using machines

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

Kapizen contains lactose monohydrate and sodium

This medicine contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered to be essentially 'sodium-free'.

3. How to take Kapizen

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one 10 mg Kapizen tablet, once a day, every day at the same time, preferably in the morning, at least 15 minutes before breakfast, as a high-fat meal significantly increases the concentration of the medicine in the blood. If necessary, your doctor may decide to increase the dose to one 20 mg Kapizen tablet once a day.
Tablets should be swallowed whole with half a glass of water. The score line is only to facilitate breaking to make swallowing easier, and not to divide into equal doses.

Use in children and adolescents

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

Patients with liver or kidney impairment

Special care should be taken when starting treatment in these patients and caution should be exercised when increasing the daily dose to 20 mg.

Elderly patients

No dose adjustment is necessary. However, special care should be taken at the beginning of treatment.

Overdose of Kapizen

Do not exceed 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 heartbeat.

Missed dose of Kapizen

If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Then continue as before.
Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Kapizen

If you stop taking Kapizen, your blood pressure may rise 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 symptoms, contact your doctor immediately:

Rare (may affect up to 1 in 1000 people):angina (chest pain caused by lack of blood flow to the heart muscle), allergic reactions (such as itching, rash, hives), fainting.
Patients with pre-existing angina may experience increased frequency, duration or severity of these attacks, with the possibility of a heart attack (myocardial infarction) after taking a group of medicines to which Kapizen belongs.

Other possible side effects:

Common (may affect up to 1 in 10 people):headache, rapid heartbeat, feeling of rapid or irregular heartbeat (palpitations), sudden reddening 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, excessive urination, feeling of weakness or fatigue.
Rare (may affect up to 1 in 1000 people):drowsiness, vomiting, diarrhea, hives, increased urination, chest pain.
Unknown (frequency cannot be estimated from the available data):gum swelling, elevated liver enzyme activity (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 breathing or swallowing.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor 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, tel.: +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 Kapizen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, blister or carton after EXP. The expiry date refers to the last day of that month.
Storage conditions:
PVC/PVDC/Aluminium blister: Do not store above 30°C.
Store in the original blister to protect from moisture.
HDPE container: This medicine does not require any special storage conditions. Store in the original container. Store the container tightly closed 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 Kapizen contains

• The active substance is lercanidipine hydrochloride. Each 10 mg coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine. Each 20 mg coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
• The other ingredients are: Core:magnesium stearate, povidone, sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose (PH-101). Coating:macrogol, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172). Kapizen 20 mg:red iron oxide (E172).

What Kapizen looks like and contents of the pack

Kapizen, 10 mg, coated tablets are yellow, round, biconvex coated tablets with a diameter of 6.5 mm, with a score line on one side and the marking "L" on the other side.
Kapizen, 20 mg, coated tablets are pink, round, biconvex coated tablets with a diameter of 8.5 mm, with a score line on one side and the marking "L" on the other side.
The score line is only to facilitate breaking to make swallowing easier, and not to divide into equal doses.
Pack sizes:
PVC/PVDC/Aluminium blisters:
7, 14, 28, 30, 35, 42, 50, 56, 90, 98, 100 tablets
HDPE container:
100 tablets
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10, Czech Republic

Manufacturer

Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Estonia, Czech Republic, Slovak Republic, Hungary
Kapidin
Poland
Kapizen
Sweden
Lercanidipine Zentiva

For further information on this medicine, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
Phone: (22) 375 92 00
Date of last revision of the leaflet:August 2022