Celiprolol Vitabalans

Leaflet attached to the packaging: information for the patient user

Celiprolol Vitabalans, 200 mg, coated tablets

Celiprolol Vitabalans, 400 mg, coated tablets

Celiprolol 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Celiprolol Vitabalans and what is it used for

Celiprolol Vitabalans belongs to a group of medicines called beta-adrenergic blockers.
Celiprolol Vitabalans is used to treat high blood pressure and to prevent attacks of stable angina pectoris. Angina pectoris is chest pain caused by reduced oxygen supply to the heart muscle (ischemic heart disease). Celiprolol Vitabalans also widens blood vessels, which lowers blood pressure at rest and during physical exertion in patients with high blood pressure.

2. Important information before taking Celiprolol Vitabalans

When not to take Celiprolol Vitabalans

• if the patient is allergic to celiprolol hydrochloride or other beta-adrenergic blockers or any of the other ingredients of this medicine (listed in section 6);
• if the patient has heart failure or severe bradycardia (less than 50 beats per minute);
• if the patient has a pheochromocytoma (high blood pressure caused by a tumor, usually in the kidney area), which has not been previously treated;
• if the patient has metabolic acidosis (increased acid content in the blood);
• if the patient has attacks of angina pectoris at rest;
• if the patient has low blood pressure (hypotension);
• if the patient has kidney failure;
• if the patient has chronic obstructive pulmonary disease (irreversible airflow obstruction in the bronchi);
• if the patient has severe asthma attacks;
• if the patient has bronchospasm (sudden contraction of the bronchial muscles) or bronchial asthma;
• if the patient has conduction or rhythm disorders of the heart;
• if the patient has circulatory disorders in the blood vessels, which can cause tingling, pallor, or cyanosis of the fingers and toes;
• if the patient has acute liver failure;
• if the patient is taking medicines used to treat depression, so-called MAO inhibitors (except MAO-B inhibitors), e.g., phenelzine.

Warnings and precautions

Before starting treatment with Celiprolol Vitabalans, the patient should discuss it with their doctor or pharmacist

• if the patient has impaired kidney function (creatinine clearance between 15 and 40 ml/min);
• if the patient has liver failure;
• if the patient is elderly, the doctor will regularly monitor their condition during treatment with celiprolol;
• if the patient has ischemic heart disease;
• if the patient has peripheral circulation disorders (intermittent claudication);
• if the patient has had angina pectoris in the past (chest pain);
• if the patient has low heart rate (bradycardia);
• if the patient has first-degree heart block (disorder of electrical signal conduction that stimulates heart contraction);
• if the patient has diabetes or hyperthyroidism;
• if the patient has reversible obstructive pulmonary disease;
• if the patient has or has had psoriasis (skin disease);
• if the patient has had anaphylactic reactions (sudden, life-threatening allergic reactions);
• if the patient experiences eye dryness or rash without a clear reason, the use of celiprolol should be gradually discontinued.

If the patient is to undergo surgery or an operation under general anesthesia, they should inform the anesthesiologist about the use of Celiprolol Vitabalans.

Celiprolol Vitabalans and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Especially, the patient should inform their doctor if they are taking the following medicines:

• clonidine, hydrochlorothiazide, and other blood pressure-lowering medicines;
• calcium antagonists (medicines used to treat heart diseases or high blood pressure), e.g., verapamil, diltiazem, and nifedipine. Diltiazem, as it may increase the risk of depression;
• antiarrhythmic medicines (medicines used to treat arrhythmia), e.g., disopyramide, quinidine, flecainide, and amiodarone;
• cardiac glycosides (medicines used to treat heart diseases), e.g., digoxin;
• insulin and oral antidiabetic medicines (medicines that lower blood glucose levels);
• non-steroidal anti-inflammatory medicines (medicines used to treat inflammatory and painful conditions), e.g., ibuprofen, indomethacin;
• adrenaline (used to stimulate heart action in severe allergic reactions, including anaphylactic shock);
• theophylline (used to treat asthma or chronic bronchitis);
• tricyclic antidepressants (used to treat depression and anxiety disorders, as well as chronic pain), e.g., amitriptyline, nortriptyline, and doxepin;
• barbiturates (used to treat epilepsy), e.g., phenobarbital;
• phenothiazines (medicines used to treat certain mental illnesses, severe nausea, and painful conditions), e.g., levomepromazine, chlorpromazine, fluphenazine, perphenazine, and pimozide;
• MAO inhibitors (used to treat depression), e.g., phenelzine;
• cyclosporine (a medicine that prevents organ rejection after transplantation or is used to treat psoriasis, severe atopic dermatitis, or rheumatoid arthritis);
• medicines that affect the immune system, e.g., fingolimod;
• astemizole (an antihistamine medicine used to treat allergies);
• cisapride (used to treat heartburn and constipation);
• ergotamine, dihydroergotamine (medicines used to prevent and treat migraines);
• sirolimus, tacrolimus (medicines that prevent organ rejection after transplantation);
• terfenadine (an antihistamine medicine used to treat allergies);
• lithium (used to treat certain mental illnesses);
• HMG-CoA reductase inhibitors (statins, medicines used to lower cholesterol levels);
• antiepileptic medicines, e.g., phenytoin;
• warfarin (a medicine that reduces blood clotting);
• erythromycin, clarithromycin (antibiotics used to treat bacterial infections);
• ketoconazole and itraconazole (used to treat fungal infections);
• rifampicin (used to treat tuberculosis);
• St. John's Wort (a herbal medicine used to treat depression).

Taking Celiprolol Vitabalans with food and drink

Celiprolol Vitabalans should be taken half an hour before or two hours after a meal, with a glass of water.
The effect of celiprolol is reduced when taken with food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Taking celiprolol during pregnancy and breastfeeding is not recommended, as there is not enough data on the use of the medicine during pregnancy and its passage into breast milk.

Driving and operating machinery

The patient should consider that dizziness or fatigue may occasionally occur.
If the patient feels disoriented or tired, they should not drive vehicles, use tools, or operate machinery.

3. How to take Celiprolol Vitabalans

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Celiprolol Vitabalans is intended for use in adults.
Hypertension
The initial dose is 200 mg taken once a day. If the response to treatment is insufficient, the dose may be increased to 400 mg taken once a day after a period of 2 to 4 weeks. Blood pressure may decrease gradually, and it may take several weeks to achieve the expected values.
Stable angina pectoris
The recommended daily dose is 200 mg. If necessary, the doctor may increase it to 400 mg per day after a period of 2 to 4 weeks. In patients with circulatory disorders, it is recommended to gradually discontinue the medicine over 1-2 weeks. Abrupt cessation of treatment may cause heart disorders, especially in patients with ischemic heart disease.
The tablet can be divided into equal doses.

Use in children

Celiprolol Vitabalans is not indicated for use in children.

Taking a higher dose of Celiprolol Vitabalans than recommended

In case of taking a higher dose of the medicine than recommended, the patient should contact their doctor or go to the emergency department or the nearest hospital.
Symptoms of overdose include bradycardia (low heart rate), hypotension (low blood pressure), sudden and short-term loss of consciousness (syncope), palpitations, conduction disorders, and heart failure. Additionally, the heart may beat very slowly or stop beating.

Missing a dose of Celiprolol Vitabalans

The patient should not take a double dose to make up for a missed dose. The next tablet should be taken according to the established treatment schedule.

Stopping treatment with Celiprolol Vitabalans

Although no adverse effects have been observed in clinical trials after abrupt cessation of celiprolol, the dose should be gradually reduced over 1-2 weeks.
If necessary, other treatment should be started to prevent worsening of angina pectoris symptoms.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Celiprolol Vitabalans can cause side effects, although not everybody gets them.
Common (occurring in 1 to 10 patients out of 100):

• fatigue, dizziness, drowsiness
• headache, confusion, nervousness
• excessive sweating
• insomnia, nightmares
• depression, mental disorders, hallucinations
• numbness and decreased temperature of the limbs
• nausea, vomiting, flatulence, diarrhea
• low blood pressure (hypotension), low heart rate (bradycardia), sudden and short-term loss of consciousness (syncope), palpitations, conduction disorders, heart failure
• allergic skin reactions (redness, itching, rash) and hair loss

Uncommon (occurring in 1 to 10 patients out of 1,000):

• decreased platelet count (thrombocytopenia) or minor bleeding on the skin and mucous membranes (purpura)
• muscle weakness, extreme fatigue, muscle cramps
• dryness of the eye (important if the patient wears contact lenses), conjunctivitis
• dry mouth

Rare (occurring in 1 to 10 patients out of 10,000):

• bronchospasm, worsening of asthma symptoms, pneumonia (interstitial pneumonia)

Very rare (occurring in less than 1 to 10 patients out of 10,000):

• diabetes mellitus (latent diabetes) or worsening of existing diabetes
• worsening of existing muscle weakness and fatigue (myasthenia gravis
• keratoconjunctivitis (dry eye syndrome), vision disorders
• hearing loss, tinnitus
• worsening of angina pectoris attacks
• peripheral circulation disorders (intermittent claudication, Raynaud's disease)
• psoriasis, worsening of psoriasis symptoms, skin rashes similar to psoriasis
• chronic joint disorders (mono- and polyarthritis)
• worsening of kidney function in case of existing severe kidney failure
• sexual dysfunction and impotence
• abnormal liver function test results (transaminases, AlAT, AspAT)

Unknown (frequency cannot be estimated from available data):

• low blood sugar (hypoglycemia), high blood sugar (hyperglycemia)
• tremors, hot flashes
• dryness of the conjunctiva and cornea
• heart failure, arrhythmias
• sinus arrest (the heart beats very slowly or stops beating). This can occur especially in people over 65 years of age or those with other heart problems
• abdominal pain
• reversible lupus-like symptoms
• impotence
• antinuclear antibodies

In patients with hyperthyroidism, clinical symptoms of thyrotoxicosis (tachycardia, tremors) may be masked.
Prolonged, strict fasting or physical stress may lead to hypoglycemic conditions.
Warning signs of hypoglycemia (tachycardia, tremors) may be weakened.
Lipid metabolism may be impaired. With normal total cholesterol levels, a decrease in HDL cholesterol and an increase in triglyceride levels in the blood have been observed.
In patients with a tendency to bronchospasm (especially with obstructive pulmonary disease), shortness of breath may worsen.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Celiprolol Vitabalans

The medicine should be stored out of sight and reach of children.
There are no special recommendations for the storage temperature of the medicine.
Do not use this medicine after the expiration date stated on the container and carton after the words EXP. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Celiprolol Vitabalans contains

The active substance of the medicine is celiprolol hydrochloride.
One tablet contains 200 mg or 400 mg of celiprolol hydrochloride.
Other ingredients:
Tablet core: microcrystalline cellulose, mannitol (E 421), sodium croscarmellose, colloidal silica, magnesium stearate.
Tablet coating: polydextrose, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Celiprolol Vitabalans looks like and what the pack contains

Celiprolol Vitabalans 200 mg: white, coated, round, convex tablets with a dividing line on one side, 10 mm in diameter.
Celiprolol Vitabalans 400 mg: white, coated, round, convex tablets with a dividing line on one side, 12 mm in diameter.
Pack size:
30, 60, or 100 coated tablets in a container.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland
Phone: +358 3 615 600
Fax: +358 3 618 3130

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

Celiprolol Vitabalans 200 mg (CZ, FI, HU, LT, LV, PL, SK)
Celitin 200 mg (DE)
Celiprolol Vitabalans 400 mg (FI, LT, PL)
Celitin 400 mg (DE)

Date of last revision of the leaflet:

14.01.2021.