Cardilopin

Package Leaflet: Information for the Patient

Cardilopin, 2.5 mg, tablets

Cardilopin, 5 mg, tablets

Cardilopin, 10 mg, tablets

Amlodipine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Cardilopin and what is it used for

Cardilopin contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Cardilopin is used to treat high blood pressure (hypertension) or chest pain (angina pectoris) and its rare form called Prinzmetal's angina (vasospastic angina).
In patients with high blood pressure, the medicine widens the blood vessels so that the blood can flow more easily.
In patients with coronary heart disease, Cardilopin improves blood flow to the heart muscle, increasing the supply of oxygen, which prevents chest pain. The medicine does not provide immediate relief from chest pain caused by coronary heart disease.

2. Important information before taking Cardilopin

When not to take Cardilopin

• if you are allergic to amlodipine or any other ingredient of this medicine (listed in section 6), or to any other calcium antagonist - symptoms may include itching, skin rash, or difficulty breathing,
• if you have very low blood pressure (hypotension),
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart cannot supply enough blood to the body),
• if you have heart failure after a heart attack.

Warnings and precautions

Before taking Cardilopin, discuss it with your doctor or pharmacist.
Tell your doctor if you have or have had any of the following conditions:

• Recent heart attack
• Heart failure
• Sudden increase in blood pressure (hypertensive crisis)
• Liver disease
• Necessity to increase the dose in elderly patients

Children and adolescents

No studies have been conducted on the use of Cardilopin in children under 6 years of age.
Cardilopin should only be used in hypertension in children and adolescents from 6 to 17 years old (see section 3).
For further information, consult your doctor.

Cardilopin and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Cardilopin may interact with other medicines or other medicines may interact with Cardilopin:

• ketokonazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St. John's Wort
• verapamil, diltiazem (medicines used to treat heart conditions)
• dantrolene (used in severe body temperature disorders)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that suppress the patient's immune system)
• simvastatin (a medicine that lowers cholesterol levels)
• cyclosporin (an immunosuppressive medicine)

Cardilopin may lower blood pressure more when you take other antihypertensive medicines.

Cardilopin with food and drink

Patients taking Cardilopin should not consume grapefruit juice or grapefruit, as they may increase the levels of the active substance amlodipine in the blood, which may lead to an unexpected increase in the blood pressure-lowering effect of Cardilopin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Pregnancy
There are no data on the safety of amlodipine in pregnancy. If you are pregnant or plan to become pregnant, inform your doctor before taking Cardilopin.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Cardilopin.
Fertility
There are no sufficient clinical data on the potential impact of amlodipine on fertility.

Driving and using machines

Cardilopin may affect your ability to drive or operate machines. If the tablets cause nausea, dizziness, fatigue, or headache, do not drive or operate machines; consult your doctor immediately.
Cardilopin contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially 'sodium-free'.

3. How to take Cardilopin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended initial dose of Cardilopin is 5 mg once daily. The dose may be increased to 10 mg once daily.
This medicine can be taken with or without food and drinks. It is recommended to take the medicine at the same time every day, with a glass of water. Do not take Cardilopin with grapefruit juice.

Use in children and adolescents

In children and adolescents from 6 to 17 years old, the recommended initial dose is 2.5 mg once daily.
The maximum recommended dose is 5 mg once daily.
It is important to take the tablets continuously. Do not wait until you have taken all the tablets before visiting your doctor.

Taking more than the recommended dose of Cardilopin

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. You may experience dizziness, lightheadedness, fainting, or weakness. If the blood pressure drop is too severe, it may lead to shock.
The skin may become cool and moist, and fainting may occur.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.
If you have taken too many Cardilopin tablets, seek medical help immediately.

Missing a dose of Cardilopin

Stay calm. If you forget to take a tablet, skip it.
Take the next dose at the right time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Cardilopin

Your doctor will inform you about the duration of treatment with Cardilopin. If you stop taking the medicine before your doctor advises you to, your condition may worsen.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cardilopin can cause side effects, although not everybody gets them.
If you experience any of the following side effects after taking Cardilopin, contact your doctor immediately.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, and lips
• Swelling of the tongue and throat, causing severe difficulty breathing
• Severe skin reactions, including intense rash, hives, skin redness, itching, blisters, peeling, and skin swelling, as well as inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, arrhythmias
• Pancreatitis, which can cause severe abdominal and back pain with very poor general condition

Very common side effects:may affect more than 1 in 10 people

• Swelling (fluid retention)Common side effects:may affect up to 1 in 10 people
• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), sudden flushing (especially of the face)
• Abdominal pain, nausea, indigestion
• Changes in bowel movements (diarrhea, constipation)
• Fatigue, weakness
• Visual disturbances, double vision
• Swelling of the ankles,
• Muscle cramps

Other reported side effects are listed below. If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Uncommon side effects:may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting
• Numbness or tingling of limbs, lack of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Erectile dysfunction, discomfort or enlargement of the breasts in men
• Pain, poor general condition
• Joint or muscle pain, back pain
• Weight gain or loss

Rare side effects:may affect up to 1 in 1,000 people

• DisorientationVery rare side effects:may affect less than 1 in 10,000 people
• Decreased white blood cell count, decreased platelet count, which may lead to unusual bruising and bleeding
• High blood sugar levels (hyperglycemia)
• Nerve disorders, which can cause muscle weakness, numbness, or tingling
• Gum swelling
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect some test results
• Increased muscle tone
• Vasculitis, often with skin rash
• Sensitivity to light
• A disorder involving stiffness, tremors, and/or difficulty walking

Unknown(frequency cannot be estimated from available data)

• Tremors, stiffness, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cardilopin

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton after {EXP}. The expiry date refers to the last day of that month.
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 Cardilopin contains

The active substance is amlodipine.
Each tablet contains 2.5 mg, 5 mg, or 10 mg of amlodipine (as 3.475 mg, 6.95 mg, or 13.9 mg of amlodipine besylate).
The other ingredients are colloidal anhydrous silica, magnesium stearate, sodium carboxymethylcellulose (type A), microcrystalline cellulose.

What Cardilopin looks like and contents of the pack

2.5 mg tablets: white or almost white, round, flat, with beveled edges, odorless or almost odorless, with the inscription "E" on one side and the inscription "251" on the other side. The color of the fracture surface is white or almost white.
5 mg tablets: white or almost white, round, flat, with beveled edges, odorless or almost odorless, with the inscription "E" on one side and the inscription "252" on the other side. The color of the fracture surface is white or almost white.
10 mg tablets: white or almost white, round, flat, with beveled edges, odorless or almost odorless, with the inscription "E" on one side and the inscription "253" on the other side. The color of the fracture surface is white or almost white.
Packaging: 30 tablets (3x10) in aluminum/PVC/PVDC blisters in a cardboard box.

Marketing authorization holder

PROTERAPIA Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw

Manufacturer

Egis Pharmaceuticals PLC
1165 Budapest
Bökényföldi út 118-120
Hungary
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
PROTERAPIA Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D,
02-146 Warsaw,
Phone number: (22) 417 92 00

Date of last revision of the leaflet: 29.06.2022