Kapizen

Package leaflet: Information for the user

KAPIZEN, 10 mg, coated tablets
KAPIZEN, 20 mg, coated tablets
Lercanidipini hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

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

Contents of the leaflet

1. What Kapizen is and what it is 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 Kapizen is and what it is used for

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

2. Important information before using Kapizen

When not to use Kapizen

• if the patient is allergic to lerkanidipine or any of the other ingredients of this medicine (listed in section 6)
• if the patient has certain heart conditions:
• untreated heart failure
• obstruction of the blood outflow tract from the heart
• unstable angina (chest pain occurring at rest or progressively worsening)
• myocardial infarction (heart attack) within the previous month
• if the patient has severe liver disease
• if the patient has severe kidney disease or is undergoing dialysis
• if the patient is taking medicines that inhibit liver metabolism (e.g. inhibitors of the CYP3A4 isoenzyme), such as:
• antifungal medicines (e.g. ketoconazole, itraconazole)
• macrolide antibiotics (e.g. erythromycin, troleandomycin, clarithromycin)
• antiviral medicines (e.g. ritonavir)
• if the patient is taking a medicine called cyclosporine (used to prevent organ rejection after transplantation)
• with grapefruit or grapefruit juice.

Warnings and precautions
Before taking Kapizen, discuss with your doctor:

• if the patient has a heart condition
• if the patient has liver or kidney problems
• if the patient is pregnant or breastfeeding.

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

Kapizen 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.
Taking Kapizen together with certain other medicines (see below) may alter the effect of these medicines or of Kapizen.
It is especially important to inform your doctor 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 used 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 conditions)
• beta-blockers, e.g. metoprolol (medicines used to treat high blood pressure, heart failure, and heart rhythm disorders)
• cimetidine at doses exceeding 800 mg (a medicine used for peptic ulcer, indigestion, or heartburn)
• simvastatin (a medicine used to lower 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 intensify the effect of Kapizen. Do not consume alcohol during treatment with Kapizen.
Kapizen should not be taken with grapefruit or grapefruit juice (as they may enhance the hypotensive effect); see section 2.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Use of Kapizen is not recommended during pregnancy. Kapizen should not be used during breastfeeding. There is a lack of data on the use of lerkanidipine in pregnant and breastfeeding women.

Driving and operating machinery
If the patient experiences dizziness, weakness, or drowsiness while taking this medicine, driving or operating machinery should be avoided.

Kapizen contains lactose monohydrate and sodium
This medicine contains lactose monohydrate. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicinal product is considered "sodium-free".

3. How to use Kapizen

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose is 1 Kapizen coated tablet of 10 mg once daily, taken at the same time each day, preferably in the morning, at least 15 minutes before breakfast, since a meal high in fat significantly increases the drug concentration in the blood. If necessary, the doctor may decide to increase the dose to 1 Kapizen coated tablet of 20 mg once daily.
The tablets should preferably be swallowed whole, with half a glass of water. The score line is intended only to facilitate breaking the tablet for easier swallowing, not for dividing into equal doses.
Use in children and adolescents
Kapizen must not be used in children and adolescents under 18 years of age.
Patients with hepatic or renal impairment
Particular caution is required when initiating treatment in these patients, and also when increasing the daily dose to 20 mg.
Elderly patients
There is no need to adjust the daily dose. However, particular caution is required at the beginning of treatment.
Taking more Kapizen than prescribed
Do not exceed the prescribed dose. If a higher than prescribed dose has been taken, contact your doctor immediately or go to the emergency room of the nearest hospital.
Bring the medicine packaging with you.
Taking a higher than prescribed dose may cause excessive lowering of arterial blood pressure and irregular or rapid heartbeat.
Missed dose of Kapizen
If the patient forgets to take a tablet, they should take it as soon as they remember, unless it is almost time for the next dose. Then continue according to the prescribed schedule.
Do not take a double dose to make up for a missed dose.
Stopping Kapizen treatment
If Kapizen treatment is stopped, arterial blood pressure may rise again.
Consult your doctor before discontinuing treatment.
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 everybody gets them.
Some adverse reactions can be serious.
If any of the following symptoms occur, contact your doctor immediately:
Rare (may affect up to 1 in 1,000 people): angina pectoris (chest pain caused by inadequate blood flow to the heart muscle), allergic reactions (with symptoms such as itching, rash, urticaria), fainting.
Patients with pre-existing angina pectoris may experience increased frequency, duration, or severity of attacks, with a possible risk of myocardial infarction (heart attack) after using the group of medicines to which Kapizen belongs.

Other possible adverse reactions:
Common (may affect up to 1 in 10 people): headache, rapid heartbeat, sensation of fast or irregular heartbeat (palpitations), sudden flushing of the face, neck, or upper chest, ankle swelling.
Uncommon (may affect up to 1 in 100 people): dizziness, low blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, passing large amounts of urine, feeling weak or tired.
Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.
Not known (frequency cannot be estimated from the available data): gum swelling, increased 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 in breathing or swallowing.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 container, blister pack,
or cardboard box after EXP. The expiry date refers to the last day of the stated month.
Storage conditions:
PVC/PVDC/Aluminum blister: Do not store above 30°C.
Keep in the original blister to protect from moisture.
HDPE container: This medicine does not require special storage conditions. Store in
the original tablet container. Keep the container tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Kapizen contains

• The active substance is lerkanidipine hydrochloride. Each 10 mg coated tablet contains 10 mg of lerkanidipine hydrochloride, equivalent to 9.4 mg of lerkanidipine. Each 20 mg coated tablet contains 20 mg of lerkanidipine hydrochloride, equivalent to 18.8 mg of lerkanidipine.
• Other ingredients are: Tablet core: magnesium stearate, povidone, sodium carboxymethyl starch (type A), monohydrate lactose, microcrystalline cellulose (PH-101). Coating: polyethylene glycol, partially hydrolysed 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 mark "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 mark "L" on the other side.
The score line is intended only to facilitate breaking the tablet for ease of swallowing and does not guarantee division into equal doses.
Pack sizes:
PVC/PVDC/Aluminium blisters:
7, 14, 28, 30, 35, 42, 50, 56, 90, 98, 100 tablets
HDPE bottle:
100 tablets
Not all pack sizes may be marketed.

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

Manufacturers
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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Estonia, Czech Republic, Slovak Republic, Hungary: Kapidin
Poland: Kapizen
Sweden: Lerkanidipin Zentiva

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00