KARNIDIN 20 mg Tablets

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET: USER INFORMATION
2. Karnidin, 10 mg, coated tablets
3. Karnidin, 20 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Karnidin and what is it used for
5. Important information before taking Karnidin
   1. When not to take Karnidin
   2. Warnings and precautions
   3. Children and adolescents
   4. Karnidin and other medicines
   5. Karnidin with food, drink, and alcohol
   6. Pregnancy, breast-feeding, and fertility
   7. Driving and using machines
6. How to take Karnidin
   1. Adults
   2. Use in children and adolescents
   3. Elderly patients
   4. Patients with liver or kidney problems
   5. Taking more than the recommended dose of Karnidin
   6. Missing a dose of Karnidin
   7. Stopping treatment with Karnidin
7. Possible side effects
   1. Some side effects can be serious. If you experience any of the following symptoms, contact your doctor immediately:
   2. Other possible side effects:
   3. Reporting side effects
8. How to store Karnidin
9. Contents of the pack and other information
   1. What Karnidin contains
   2. What Karnidin looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet:

PATIENT INFORMATION LEAFLET: USER INFORMATION

Karnidin, 10 mg, coated tablets

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

1. What is Karnidin and what is it used for

Karnidin belongs to a group of medicines called calcium antagonists (of the dihydropyridine type).
Karnidin is used to treat mild to moderate high blood pressure
(hypertension).

2. Important information before taking Karnidin

When not to take Karnidin

• if you are allergic (hypersensitive) to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have certain heart diseases:
• untreated heart failure
• obstruction of the outflow of blood from the heart
• unstable angina (chest pain at rest or with increasing severity)
• within one 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 or troleandomycin or clarithromycin)
• antiviral medicines (such as ritonavir)
• if you are taking a medicine called cyclosporin (used after organ transplantation to prevent rejection)
• if you consume grapefruit or grapefruit juice

Warnings and precautions

Before starting to take Karnidin, discuss it with your doctor or pharmacist if you:
have heart disease
have liver or kidney disease

• have heart disease
• have liver or kidney disease

Tell your doctor if you are pregnant, think you may be pregnant, or are planning 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 Karnidin in children and adolescents under 18 years of age have not been established.

Karnidin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. If Karnidin 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).

• 2)

Tell 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 a dose 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

Karnidin with food, drink, and alcohol

• Consuming a meal high in fat significantly increases the concentration of the medicine in the blood (see section 3).
• Alcohol may enhance the effect of Karnidin. Do not consume alcohol during treatment with Karnidin.
• Do not take Karnidin with grapefruit or grapefruit juice (may increase the blood pressure-lowering effect). See section 2.

Pregnancy, breast-feeding, and fertility

Karnidin should not be used during pregnancy and should not be used during breast-feeding. There are no data on the use of lercanidipine in pregnant or breast-feeding women. If you are pregnant or breast-feeding, if you do not use any contraceptive method, if you suspect 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.
Excipients
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Karnidin

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults

The recommended dose is one 10 mg Karnidin tablet 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 Karnidin tablet or two 10 mg Karnidin tablets. See section 2.
Swallow the tablet whole with a sufficient amount of liquid (e.g., one glass of water).
The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.

Use in children and adolescents

Do not use this medicine in children and adolescents under 18 years of age.

Elderly patients

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 than the recommended dose of Karnidin

Do not take more than the recommended dose. If you have taken more than the recommended dose, contact your doctor or go to the emergency department of the nearest hospital immediately. 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.

Missing a dose of Karnidin

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

Stopping treatment with Karnidin

If you stop taking Karnidin, your blood pressure may rise again.
Do not stop taking Karnidin without consulting your doctor.
If you have any further questions about 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:

Rarely ( may occur in less than 1 in 1000 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, the use of medicines from the same group as Karnidin 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, feeling of rapid or irregular heart rate (palpitations), 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, frequent urination, weakness, fatigue.
Rarely ( 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 you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 Karnidin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: Expiry date (EXP). The expiry date refers to the last day of the month stated.
Do not store above 25°C. Store in the original package to protect from light.
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 Karnidin contains

The active substance is lercanidipine hydrochloride.
Each coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine, or 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
The other ingredients are:
10 mg coated tablet
Core:
Cornstarch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, microcrystalline cellulose, poloxamer 188, sodium stearyl fumarate, macrogol 6000.
Coating:
Hypromellose, macrogol 6000, yellow iron oxide (E 172), titanium dioxide (E 171).
20 mg coated tablet
Core:
Microcrystalline cellulose, cornstarch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, povidone (K-30), sodium stearyl fumarate.
Coating:
Hypromellose, macrogol 6000, red iron oxide (E 172), titanium dioxide (E 171).

What Karnidin looks like and contents of the pack

Karnidin 10 mg is a yellow, round, biconvex coated tablet with a diameter of 6.5 mm, with a score line on one side and a smooth surface on the other.
Karnidin 20 mg is a pink, round, biconvex coated tablet with a diameter of 8.5 mm, with a score line on one side and a smooth surface on the other.
Pack sizes: 7, 14, 28, 35, 42, 50, 56, 98, 100, 280 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

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

Czech Republic:
Oridip 20 mg
Denmark:
Lercanidipine Orion 10 mg
Lercanidipine Orion 20 mg
Finland:
Oridip 10 mg tablet, coated
Oridip 20 mg tablet, coated
Lithuania:
Lercanidipin Orion 10 mg film-coated tablets
Norway:
Lercanidipine Orion 10 mg
Lercanidipine Orion 20 mg
Poland:
Karnidin
Sweden:
Lercanidipine Orion 10 mg
Lercanidipine Orion 20 mg

Date of last revision of the leaflet: