Celipres 100

Package leaflet: Information for the patient

Celipres 100, 100 mg, film-coated tablets
Celiprolol hydrochloride
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Celipres is and what it is used for

The active substance in Celipres is celiprolol hydrochloride, which belongs to a group of medicines
called beta-blockers.
Celipres is used in the treatment of mild to moderate arterial hypertension.
This medicine lowers arterial blood pressure and reduces heart rate during physical exertion, while
exerting only a slight effect on resting heart rate.

2. Important information before using Celipres

When not to use Celipres:

• if the patient is allergic to celiprolol or other beta-blockers (e.g. propranolol, atenolol) or any of the other ingredients of this medicine (listed in section 6) – allergic reaction may manifest as rash, itching, swelling of the face, lips or hands/feet, or difficulty breathing;
• if the patient has uncontrolled heart failure;
• if the patient has a slow (at rest below 45-50 beats per minute) or irregular heartbeat;
• if the patient has conduction disorders of the heart (second- or third-degree atrioventricular block, sick sinus syndrome);
• if the patient has cardiogenic shock (inadequate blood flow to tissues);
• if the patient has excessive blood acidification (metabolic acidosis);
• if the patient has low blood pressure;
• if the patient has severe kidney function disorders;
• if the patient has severe asthma or other serious breathing difficulties;
• if the patient has been diagnosed with phaeochromocytoma (which is untreated);
• if the patient has been diagnosed with advanced peripheral arterial disease (severe circulation problems in the legs caused by narrowing or blockage of blood vessels);
• if the patient has been diagnosed with chronic obstructive pulmonary disease;
• if the patient is taking verapamil (for treatment of hypertension and certain heart conditions);
• if the patient is taking theophylline (for treatment of asthma or chronic bronchitis).

Warnings and precautions
Before use, consult a doctor:

• if the patient is pregnant or planning pregnancy, or breastfeeding;
• when the patient has kidney or liver disease; the doctor may decide to reduce the dose;
• if the patient has been diagnosed with a specific type of heart disease (with chest pain) called Prinzmetal's angina;
• if the patient has ischaemic heart disease. Do not discontinue the medicine abruptly, as this may lead to increased frequency and severity of angina attacks (worsening chest pain) or deterioration of overall heart muscle condition. If discontinuation is necessary, the doctor will recommend gradually reducing the dose, usually over a period of 1-2 weeks;
• if the patient is taking medicines used for heart function disorders, such as congestive heart failure;
• if the patient has thyrotoxicosis (a condition caused by overactive thyroid) – celiprolol may mask symptoms of thyrotoxicosis;
• if the patient has chronic obstructive pulmonary disease, asthma, wheezing – bronchospasm;
• if the patient has a slow heart rate of less than 50-55 beats per minute at rest (bradycardia) or irregular heartbeat;
• if the patient has conduction disorders of the heart (first-degree atrioventricular block);
• if the patient has conditions such as Raynaud's disease (impaired blood circulation in hands, feet, manifesting as transient skin color changes (from white to blue to red) and cold sensation in extremities, with or without pain and burning);
• or Buerger's disease (reduced blood circulation in legs causing calf or thigh muscle pain after walking a certain distance, usually relieved by rest);
• if the patient has diabetes (celiprol0l may mask symptoms of low blood sugar);
• if the patient has a skin condition called psoriasis; during celiprolol treatment, psoriasis symptoms may worsen;
• if the patient has previously experienced allergic reactions or is undergoing desensitization therapy;
• if the patient is an athlete and will undergo doping tests, as celiprolol may cause a positive test result. The use of beta-blockers in certain sports disciplines may be prohibited.

If the patient requires surgery or anaesthesia,
the patient should inform the doctor or dentist about taking this medicine.
Consult a doctor even if any of the above conditions occurred in the past.
Children and adolescents
The safety and efficacy of celiprolol in children have not been established.
Celipres with other medicines
Tell your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Exercise caution when using the following medicines:

• diltiazem, verapamil, or nifedipine (used to treat high blood pressure and certain heart disorders);
• medicines used in shock or hypotension;
• disopyramide, quinidine, amiodarone, or sotalol (used to treat heart rhythm disorders);
• chlorothalidone or hydrochlorothiazide (diuretics);
• clonidine (used to treat hypertension). If clonidine and celiprolol are used simultaneously, do not discontinue clonidine unless advised by a doctor. The doctor may recommend stopping celiprolol several days before discontinuing clonidine;
• medicines known as monoamine oxidase inhibitors (MAO inhibitors used to treat depression), e.g. phenelzine, tranylcypromine, moclobemide, isocarboxazid;
• reserpine, alpha-methyldopa, guanfacine (used to treat high blood pressure);
• digitoxin or digoxin (used to treat heart failure and certain types of heart rhythm disorders);
• insulin or oral antidiabetic medicines (e.g. glibenclamide, metformin);
• noradrenaline or adrenaline (used to treat low blood pressure, heart failure, asthma, or allergy); noradrenaline and adrenaline are always administered under medical supervision;
• phenylephrine, pseudoephedrine, phenylpropanolamine (contained in cough medicines or nasal and eye drops);
• non-steroidal anti-inflammatory drugs (used for inflammatory conditions and pain), e.g. ibuprofen, indomethacin;
• mefloquine, as it may cause bradycardia (slow heart rate);
• medicines used to treat mental disorders, such as phenothiazines (e.g. chlorpromazine, trifluoperazine) or tricyclic antidepressants (e.g. imipramine, amitriptyline, clomipramine, desipramine).

Celipres with food and drink
Celipres should be taken in the morning, immediately after waking, one hour before a meal or two hours after a meal.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Celipres has negligible influence on the ability to drive motor vehicles
and operate machinery. However, very rarely during treatment dizziness and fatigue may occur, as well as tremor, headache, or blurred vision. If such symptoms occur, do not drive, use tools, or operate machinery.
Celipres contains quinoline yellow
The medicine contains quinoline yellow, which may cause allergic reactions.
Celipres contains mannitol
The medicine may have a mild laxative effect.
Celipres contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Celipres

This medicine should always be used exactly as prescribed by the doctor. In case of doubts, please
consult your doctor or pharmacist.
Hypertension
The usual dose is 100 mg to 200 mg once daily. If after 2 to 4 weeks of treatment the clinical response is inadequate, your doctor may increase the dose to 400 mg of celiprolol once daily.
If the patient has liver or kidney disease, the doctor may decide to start treatment with a lower dose and then increase it if necessary.
Patients with kidney disease
In patients with moderate renal impairment (creatinine clearance from 15 to 40 ml/min), the dose may need to be reduced by half. Celiprolol is contraindicated in patients with severe renal impairment (creatinine clearance less than 15 ml/min).
Celipres tablets should be swallowed whole with a glass of water. The tablets may be taken once daily in the morning, shortly after waking up, one hour before a meal or two hours after a meal.
To help remember to take the medicine, it should be taken every day at the same time.
The medicine should be used for as long as prescribed by the doctor. It is important not to stop using the medicine when the patient feels better, as symptoms may return.
If the patient feels that the effect of Celipres is too strong or too weak, they should consult their
doctor or pharmacist.
Taking more Celipres than prescribed
If more than the prescribed dose of the medicine is taken, seek immediate advice from a doctor or the nearest hospital emergency department. If possible, bring any remaining tablets, the packaging, and the leaflet, so the doctor can immediately identify which medicine was taken.
Missing a dose of Celipres
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, only take the next tablet according to the regular schedule. Do not take a double dose to make up for a missed dose.
Stopping treatment with Celipres
Do not stop using Celipres without first consulting your doctor. Abruptly stopping treatment with Celipres may worsen the patient's condition. The doctor will advise gradually discontinuing Celipres over a period of 7 to 10 days.
If in doubt about how to use the medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse symptoms occur, discontinue use of Celipres immediately and
contact a doctor or go to the nearest hospital emergency department straight away.

• Rash, hives, chest tightness, shortness of breath, or swelling of the face, lips, hands, feet, fainting, elevated temperature.

These are very serious adverse reactions. If they occur, the patient may have experienced a severe
allergic reaction to celiprolol. Immediate medical intervention or hospitalization may be required.
If any of the following adverse symptoms occur, contact a doctor or go to the nearest hospital
emergency department immediately:

• Dizziness or a "blank" feeling in the head, weakness or fainting, especially when standing up from a lying position,
• Rapid, slow, or irregular heartbeat,
• Difficulty breathing,
• Worsening of pre-existing heart failure,
• Worsening of diabetes. Previously undiagnosed diabetes may become apparent (manifesting as increased thirst, frequent urination, increased appetite, weight loss). Inform your doctor if any of these symptoms occur.

Inform your doctor if you notice any of the following adverse reactions:
Common (may occur in less than 1 in 10 patients):

• Headache and dizziness, drowsiness, nightmares and insomnia (sleep disturbances); tremor and cold sensation in the extremities, sudden flushing (especially of the face);
• Palpitations, slowed heart rate, significant drop in blood pressure, including upon standing from a lying position;
• Muscle cramps;
• Fainting;
• Nausea or vomiting, abdominal pain or discomfort.

Uncommon (may occur in less than 1 in 1,000 patients):

• Positive antinuclear antibody (ANA) titer, isolated and reversible cases of lupus-like syndrome;
• Depression;
• Paresthesia (sensory disturbances);
• Tinnitus;
• Diarrhea, constipation;
• Skin reactions (e.g., itching, redness, rash, pruritus, urticaria, purpura);
• Cardiac conduction disturbances;
• Worsening of cardiac conduction disturbances (in susceptible patients);
• Worsening of pre-existing heart failure with peripheral edema (swelling of limbs) and/or exertional dyspnea;
• Worsening of pre-existing circulatory disorders such as intermittent claudication, Raynaud's syndrome [impaired blood circulation in hands/feet, manifesting as transient skin color changes (from white to blue to red), cold sensation in extremities, with or without pain and burning sensation];
• Fatigue;
• Allergic pneumonitis, bronchospasm, especially in patients with bronchial asthma or history of asthmatic reactions;
• Muscle weakness;
• Decreased libido, impotence (in men);
• Decreased blood sugar (hypoglycemia), increased blood sugar (hyperglycemia);
• In patients with hyperthyroidism, clinical symptoms of thyrotoxicosis (tachycardia, tremor) may be masked.

Warning symptoms of hypoglycemia (tachycardia, tremors) may be attenuated.
Very rare (may occur in less than 1 in 10,000 patients):

• Hallucinations, psychoses;
• Confusion;
• Psoriasis-like symptoms, worsening of pre-existing psoriasis;
• Visual disturbances, reduced tear secretion (dry eyes).

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

• Abnormal liver function test results (aminotransferases - AlAT, AspAT).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of 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 provide more information on the safety of the medicine.

5. How to store Celipres

Keep out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the label. 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 what to do with medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

What Celipres contains

• The active substance is celiprolol hydrochloride. One tablet contains 100 mg of celiprolol hydrochloride.
• The other ingredients are: microcrystalline cellulose, mannitol, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, and a coating containing hypromellose 2910 6cP, titanium dioxide (E 171), macrogol 400, quinoline yellow (E 104), lac.

What Celipres looks like and contents of the pack
Yellow, heart-shaped coated tablets, embossed with the number "100" on one side.
Celipres packaging contains 30 coated tablets in blisters (3x10).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
Manufacturer
Sun Pharmaceutical
Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands