Cordiax

Package leaflet: Information for the patient

CORDIAX 200 mg film-coated tablets

Celiprolol hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CORDIAX is and what it is used for

This medicinal product contains the active substance celiprolol hydrochloride, which belongs to a group of medicines called beta-blockers that act on the heart (cardioselective) to regulate its activity. CORDIAX is used for the treatment of high blood pressure (arterial hypertension) and chest pain caused by reduced oxygen supply to the heart (angina pectoris).

2. What you should know before taking CORDIAX

Do not take CORDIAX

• if you are allergic to celiprolol hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from acute asthma attacks;
• if you have decompensated heart failure;
• if you have second- or third-degree heart block (second- or third-degree atrioventricular block);
• if you have heart problems (heart failure) for which treatment with digitalis drugs has proven ineffective;
• if you have cardiogenic shock. This occurs when your heart does not pump enough blood throughout the body. Symptoms may include confusion, sweating, rapid heartbeat, and pale skin;
• if you have a very slow heart rate, less than 50 beats/minute (marked bradycardia);
• if you have low blood pressure (hypotension);
• if you have a highly irregular heartbeat (sino-auricular node disease);
• if you have an untreated tumor called "pheochromocytoma". It is usually located near the kidney and may cause high blood pressure;
• if you suffer from advanced peripheral arterial disease or advanced Raynaud's syndrome.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
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Temporarily discontinue use of CORDIAX if you experience symptoms of severe heart dysfunction (heart failure).
Pay special attention when taking this medicine and inform your doctor:

• if you have thyroid problems (thyrotoxicosis), because this medicine may mask symptoms such as rapid heartbeat (tachycardia);
• if you have diabetes mellitus or are predisposed to diabetes, as this medicine may alter the signs of low blood sugar (hypoglycemia);
• if you have diabetes and are taking antidiabetic medicines such as sulfonylureas;
• if you have impaired kidney function (renal insufficiency); in this case, a dose reduction of this medicine may be necessary;
• if you have previously suffered from impaired heart function (heart failure) or increased heart size (cardiac hypertrophy). In such cases, your doctor should monitor your health status, especially at the beginning of treatment, and may consider prescribing additional medicines to increase urine output (diuretics) and stimulate heart activity (digitalis drugs);
• if you have mild impairment of heart conduction (first-degree atrioventricular block);
• if you have Prinzmetal's angina;
• if you have breathing difficulties (asthma) or inflammation of the airways (chronic bronchitis);
• if you are being treated for a tumor called pheochromocytoma;
• if you suffer from circulatory disorders in arms and legs (peripheral circulatory disorders), as these may worsen.

Prescription of this medicine should be carefully evaluated in the following cases:

• if you have previously experienced severe allergic reactions (anaphylactic reactions) or are undergoing allergy treatment (desensitization therapy). In such cases, this medicine should only be used when strictly necessary; furthermore, this medicine may reduce the effectiveness of adrenaline, a drug used in severe allergic reactions (anaphylaxis);
• if you suffer from a skin disease (psoriasis).

If you are taking this medicine and are scheduled for anesthesia during surgery (general anesthesia), inform the anesthesiologist.
Do not abruptly stop treatment with this medicine, especially if you have heart circulation disorders (coronary disorders, angina), as sudden discontinuation may lead to more frequent or severe angina attacks, worsening of heart condition, serious heart rhythm disturbances, heart attack, or sudden death (see section 3).
If you are engaged in sports, using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
This medicine may also cause positive results in drug tests.

Other medicines and CORDIAX
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Avoid taking this medicine if you are also taking:

• theophylline, a medicine used to treat asthma;
• chlorthalidone or hydrochlorothiazide, medicines used to increase urine output (diuretic medicines);
• medicines used for high blood pressure (antihypertensive, non-dihydropyridine calcium antagonists) such as verapamil and diltiazem. Before taking CORDIAX, treatment with verapamil must be discontinued;
• medicines used to stimulate heart function (digitalis glycosides), as heart contraction problems may occur;
• floctafénine, an anti-inflammatory medicine;
• clonidine, a medicine used to treat high blood pressure. If both medicines are administered together, CORDIAX must be discontinued several days before stopping clonidine therapy;
• certain medicines used for depression (MAO inhibitors), to avoid excessive increase in blood pressure (hypertension);
• citrus fruit juices, as they may reduce the absorption of the medicine;
• medicines used to alter immune system function, e.g., fingolimod, cyclosporine;
• diltiazem, as it may increase the risk of depression.

Use this medicine with caution and inform your doctor if you are taking:

• medicines used to treat heart rhythm disorders (antiarrhythmics), such as amiodarone, disopyramide, quinidine, and dronedarone;
• medicines used to treat diabetes (oral antidiabetics and insulin), as dosage adjustments may be necessary;
• medicines used to induce anesthesia (halogenated volatile anesthetics);
• medicines used to treat high blood pressure (dihydropyridine calcium antagonists), such as nifedipine, as they may cause low blood pressure (hypotension) or severe loss of heart function (cardiac collapse), especially if you have impaired heart function (latent heart failure);
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and indomethacin;
• medicines used in specific emergency situations, such as adrenaline and other sympathomimetics, as they may counteract the effect of this medicine;
• certain antidepressants (tricyclic antidepressants);
• medicines used to treat epilepsy (barbiturates);
• medicines used to treat mental disorders (antipsychotics) such as phenothiazines;
• mefloquine (an antimalarial medicine);
• certain antibiotics (e.g., rifampicin, erythromycin, and clarithromycin);
• cyclosporine (a medicine used to prevent organ transplant rejection);
• certain antifungal medicines (e.g., ketoconazole and itraconazole);
• the herbal remedy St. John's wort.

CORDIAX with food
Taking this medicine with food may reduce its effectiveness.
Take this medicine preferably in the morning, 30 minutes before a meal or 2 hours after a meal.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, your doctor will prescribe this medicine only if absolutely necessary and under close supervision.
If you have taken this medicine during pregnancy, your baby will be monitored in a specialized center during the first 3–5 days of life, as there is a risk of slow heart rate, breathing difficulties, and low blood sugar (hypoglycemia).
Avoid taking this medicine during breastfeeding.

Driving and using machines
This medicine may affect your ability to drive or operate machinery, as it may cause adverse effects such as fatigue, dizziness, tremors, headache, and visual disturbances.
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Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to take CORDIAX

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is one tablet daily. If necessary, the dose may be increased to 400 mg once daily and subsequently up to 600 mg once daily.
If you are being treated for high blood pressure, your doctor may prescribe additional medicines to enhance the effect of this medicine (diuretic medicines).
If it becomes necessary to discontinue treatment with this medicine, do so gradually and under medical supervision (see section 3 "If you stop taking CORDIAX").

Use in children
CORDIAX must not be used in children.

Use in patients with liver or kidney problems
If you have liver problems or severe renal impairment, your doctor will not prescribe this medicine.

If you take more CORDIAX than you should
In case of overdose, symptoms such as slowing of the heartbeat (bradycardia), low blood pressure (hypotension), bronchospasm, and acute heart failure may occur. Your heartbeat may become very slow or may stop. In acute intoxication, slowing of the heartbeat (bradycardia) and low blood pressure (hypotension) may occur.
If you accidentally take too much of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take CORDIAX
Do not take a double dose to make up for the forgotten dose.

If you stop taking CORDIAX
If treatment discontinuation is necessary, a gradual withdrawal is recommended to avoid adverse effects, especially if you have heart problems (coronary disease, angina pectoris). In such cases, pay particular attention and consult your doctor, as abrupt discontinuation of treatment may lead to serious adverse effects on the heart (increased frequency or severity of angina attacks, worsening of heart condition, irregular heartbeat, heart attack, sudden death).

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Common side effects (may affect up to 1 in 10 people):

• depression;
• hot flushes;
• excessive sweating (hyperhidrosis);
• erythema, rash, itching;
• worsening of pre-existing movement difficulties (intermittent claudication);
• worsening of pre-existing numbness and finger pain followed by sensation of heat and pain (Raynaud's phenomenon);
• fatigue and feeling of tiredness (asthenia);
• dizziness;
• somnolence;
• headache;
• tremors;
• dry mouth;
• altered sensation (paresthesia);
• nausea, vomiting;
• upper abdominal pain;
• sexual impotence;
• increase in antinuclear antibodies, detectable through blood tests.

Uncommon side effects (may affect up to 1 in 100 people):

• insomnia;
• heightened awareness of heartbeat (palpitations);
• cold sensation in hands and feet;
• low blood pressure (hypotension);
• difficulty breathing (dyspnea);
• muscle spasms, joint pain (arthralgia).

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

• allergic reactions, even severe (anaphylaxis);
• decreased or increased blood sugar levels (hypoglycaemia or hyperglycaemia);
• reduced libido, seeing or hearing things that are not real (hallucinations), nightmares;
• loss of consciousness (syncope);
• altered sensation in arms and legs (peripheral paresthesia);
• excessive dryness of the eye (xerophthalmia), visual disturbances;
• reduced heart function (heart failure);
• severe disturbance in heart activity (atrio-ventricular block);
• severe slowing of heart rate (severe bradycardia);
• changes in heart rhythm (arrhythmias);
• narrowing of the bronchi causing breathing difficulties (bronchospasm) and interstitial pneumonia;
• diarrhoea, abdominal pain, excessive gas production (flatulence);
• skin disorders such as irritation, sometimes associated with itching (eczema, acne), inflammation (psoriasis and worsening of psoriasis, exfoliative dermatitis);
• hair loss (alopecia);
• systemic lupus erythematosus;
• increased liver transaminases, detectable through blood tests;
• sinus arrest (heart rate becomes very slow or stops beating). This may occur especially in people over 65 years of age or in those with other heart rhythm problems.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CORDIAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.".
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The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CORDIAX contains

• The active substance is celiprolol hydrochloride. Each tablet contains 200 mg of celiprolol hydrochloride.
• The other components are: mannitol, microcrystalline cellulose, hypromellose, sodium carmellose, magnesium stearate, titanium dioxide, macrogol 6000.

Description of the appearance of CORDIAX and contents of the pack
Pack containing 28 film-coated tablets.
Marketing Authorization Holder
S.F Group Srl
Via Tiburtina 1143, 00156 Rome
Italy
Manufacturer
DOPPEL FARMACEUTICI S.r.l., Via Volturno, 8 - Quinto de’ Stampi, Rozzano (MI) - Italy
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