Cardilopin

Package leaflet: Information for the patient

Cardilopin, 2.5 mg, tablets
Cardilopin, 5 mg, tablets
Cardilopin, 10 mg, tablets
Amlodipine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• 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 them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Cardilopin is and what it is used for
2. What you need to know 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 Cardilopin is and what it is used for

Cardilopin contains the active substance amlodipine, which belongs to a group of medicines called calcium channel blockers.
Cardilopin is indicated for the treatment of high blood pressure (hypertension) or chest pain known as angina pectoris, including its rare form called Prinzmetal's angina (vasospastic angina).
In patients with high blood pressure, the medicine relaxes blood vessels, allowing blood to flow more easily. In patients with ischemic heart disease, Cardilopin improves blood flow to the heart muscle by increasing oxygen supply, thereby helping to prevent chest pain. This medicine does not provide immediate relief of chest pain caused by ischemic heart disease.

2. Important information before using Cardilopin

When not to use Cardilopin

• if the patient is allergic to amlodipine or to any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonist – symptoms may include itching, redness of the skin, or difficulty in breathing,
• if the patient has very low blood pressure (hypotension),
• if the patient has aortic valve stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart cannot deliver enough blood to the body),
• if the patient has heart failure following a previous heart attack.

Warnings and precautions
Before starting treatment with Cardilopin, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or has previously had any of the following conditions:

• Recent heart attack
• Heart failure
• Acute increase in blood pressure (hypertensive crisis)
• Liver disease
• Need for dose adjustment in elderly patients

Children and adolescents
Studies on the use of Cardilopin in children under 6 years of age have not been conducted.
Cardilopin should only be used for arterial hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, please consult your doctor.

Cardilopin and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Cardilopin may affect the action of other medicines, or other medicines may affect the action of Cardilopin:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St John's wort
• verapamil, diltiazem (medicines used for heart conditions)
• dantrolene (used intravenously in severe disturbances of body temperature)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that suppress the patient's immune system)
• simvastatin (a medicine that lowers cholesterol levels)
• cyclosporine (an immunosuppressive medicine)

Cardilopin may lower blood pressure to a greater extent if the patient is taking other antihypertensive medicines.

Cardilopin with food and drink
Patients taking Cardilopin should not consume grapefruit juice or grapefruits, as they may increase the blood concentration of the active substance – amlodipine – which could consequently lead to an unexpected increase in the blood pressure-lowering effect of Cardilopin.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.

Pregnancy
There is a lack of data on the safety of amlodipine use during pregnancy. If the patient suspects she is pregnant or is planning a pregnancy, she should inform her doctor before taking Cardilopin.

Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or intends to breastfeed, she should inform her doctor before taking Cardilopin.

Effect on fertility
There are insufficient clinical data on the potential effect of amlodipine on fertility.

Driving and operating machinery
Cardilopin may affect the ability to drive and operate machinery. If the tablets cause nausea, dizziness, fatigue, or headache, the patient should not drive or operate machinery and should contact their doctor immediately.

Cardilopin contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Cardilopin

This medicine should always be used exactly as directed by the doctor. If in doubt, consult a 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 regardless of meals and drinks. It is recommended to take the medicine at the same time each day, with water. Cardilopin must not be taken with grapefruit juice.

Use in children and adolescents
In children and adolescents aged 6 to 17 years, the recommended starting dose is 2.5 mg per day.
The maximum recommended dose is 5 mg per day.
It is important to take the tablets continuously. Do not wait until all tablets are used up before visiting the doctor.

Taking more Cardilopin than recommended
Taking too many tablets may cause a reduction, or even a dangerous drop, in blood pressure. Dizziness, a feeling of emptiness in the head, fainting, or weakness may occur. If the drop in blood pressure is too severe, shock may occur.
The skin may become cold and clammy, and fainting may also occur.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary edema) may occur up to 24–48 hours after taking the medicine.
If too many tablets of Cardilopin have been taken, seek immediate medical help.

If you miss a dose of Cardilopin
Stay calm. If the patient forgets to take a tablet, the missed dose should be skipped. Take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Cardilopin
The doctor will inform the patient about the duration of therapy with this medicine. If the patient stops taking Cardilopin before the doctor advises, the disease may recur.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur after using Cardilopin, you should seek immediate medical advice.

• 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 breathing difficulties
• Severe skin reactions including intense rash, urticaria, generalized redness of the skin, severe itching, blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Myocardial infarction, cardiac arrhythmias
• Pancreatitis, which may cause acute abdominal and back pain accompanied by a very poor general condition

The following very common adverse reactions have been reported. If any of these adverse reactions are troublesome to the patient or last longer than one week, contact a doctor.

Very common adverse reactions: may occur in at least 1 out of 10 patients

• Fluid retention (oedema)

The following common adverse reactions have been reported. If any of these adverse reactions are troublesome to the patient or last longer than one week, you should contact a doctor.
Common adverse reactions: may occur in less than 1 out of 10 patients

• 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 habits (diarrhoea, constipation)
• Fatigue, weakness
• Visual disturbances, double vision
• Swelling around the ankles
• Muscle cramps

Other reported adverse reactions are listed below. If any of the adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Uncommon adverse reactions: may occur in less than 1 out of 100 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling of the limbs, loss of pain sensation
• Tinnitus
• Low blood pressure
• Sneezing/nasal congestion due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dryness of the oral mucosa, vomiting
• Hair loss, increased sweating, skin itching, red skin spots, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Erectile dysfunction, discomfort or breast enlargement in men
• Pain, malaise
• Joint or muscle pain, back pain
• Increase or decrease in body weight

Rare adverse reactions: may occur in less than 1 out of 1,000 patients

• Disorientation
  Very rare adverse reactions: may occur in less than 1 out of 10,000 patients
• Decreased number of white blood cells, decreased number of platelets, which may lead to unusual bruising and easier bleeding
• Increased blood glucose (hyperglycaemia)
• Nerve disorders which may cause muscle weakness, tingling or numbness
• Gum oedema
• Abdominal bloating (gastric mucosal inflammation)
• Liver function abnormalities, hepatitis, jaundice (yellowing of the skin), increased liver enzyme activity, which may affect certain laboratory test results
• Increased muscle tone
• Vasculitis, often with skin rash
• Photosensitivity
• Movement disorders involving rigidity, tremor and/or difficulty moving

Not known (frequency cannot be estimated from the available data)

• Tremor, postural rigidity, facial masking, slowed movements, shuffling gait with dragging of the feet, unsteady gait.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
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 Cardilopin

Keep this medicine out of sight and reach of children.
Store 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 the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. 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 amlodipine besylate, respectively).
The other ingredients are: colloidal anhydrous silica, magnesium stearate, sodium carboxymethyl starch (type A), microcrystalline cellulose.

What Cardilopin looks like and contents of the pack
Tablets 2.5 mg: white or almost white, round, flat tablets with bevelled edges, odourless or almost odourless, marked with "E" on one side and "251" on the other side. The colour of the fracture surface is white or almost white.
Tablets 5 mg: white or almost white, round, flat tablets with bevelled edges, odourless or almost odourless, marked with "E" on one side and "252" on the other side. The colour of the fracture surface is white or almost white.
Tablets 10 mg: white or almost white, round, flat tablets with bevelled edges, odourless or almost odourless, marked with "E" on one side and "253" on the other side. The colour of the fracture surface is white or almost white.
Packaging: 30 tablets (3x10) in blisters of Aluminium/PVC/PVDC, in a cardboard box.

Marketing Authorisation Holder
PROTERAPIA Spółka z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Poland

Manufacturer
Egis Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary

For further information, please contact the marketing authorisation holder's representative in Poland:
PROTERAPIA Spółka z o.o.
ul. Komitetu Obrony Robotników 45 D,
02-146 Warsaw, Poland
Telephone: (22) 417 92 00