Celipres 100

Package Leaflet: Information for the Patient

Celipres 100, 100 mg, Coated Tablets

Celiprolol Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, 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 medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Celipres and What is it Used For
• 2. Important Information Before Taking Celipres
• 3. How to Take Celipres
• 4. Possible Side Effects
• 5. How to Store Celipres
• 6. Package Contents and Other Information

1. What is Celipres and What is it Used For

The active substance of Celipres is celiprolol hydrochloride, which belongs to a group of medications called beta-adrenergic blockers.
Celipres is used to treat mild to moderate hypertension.
This medication lowers blood pressure and slows down heart activity during physical exertion, but has little effect on heart rate at rest.

2. Important Information Before Taking Celipres

When Not to Take Celipres:

• if the patient is allergic to celiprolol or other beta-adrenergic blockers (e.g., propranolol, atenolol) or any other component of this medication (listed in section 6) - an allergic reaction may manifest as a rash, itching, swelling of the face, lips, or hands/feet, or difficulty breathing;
• if the patient has uncontrolled heart failure;
• if the patient has slow (at rest below 45-50 beats per minute) or irregular heart activity;
• if the patient has conduction disorders in the heart (second- and third-degree atrioventricular block, sick sinus syndrome);
• if the patient has cardiogenic shock (insufficient blood flow to tissues);
• if the patient has severe metabolic acidosis;
• if the patient has low blood pressure;
• if the patient has severe kidney dysfunction;
• if the patient has severe asthma or other serious breathing difficulties;
• if the patient has a pheochromocytoma (a tumor that is not being treated);
• if the patient has advanced peripheral arterial disease (severe circulatory disorders in the legs caused by narrowing or blockage of blood vessels);
• if the patient has chronic obstructive pulmonary disease;
• if the patient is taking verapamil (for the treatment of hypertension and certain heart conditions);
• if the patient is taking theophylline (for the treatment of asthma or chronic bronchitis).

Warnings and Precautions

Before taking Celipres, consult a doctor:

• if the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child;
• if the patient has kidney or liver disease; the doctor may decide to reduce the dose of the medication;
• if the patient has a particular type of heart disease (with chest pain), known as Prinzmetal's angina;
• if the patient has coronary heart disease. Do not stop taking the medication, as this may lead to an increase in the frequency and severity of angina attacks (chest pain) or worsening of the overall condition of the heart muscle. If it is necessary to discontinue the medication, the doctor will recommend gradual reduction of the dose, usually over a period of 1-2 weeks;
• if the patient is taking medications for heart rhythm disorders, such as congestive heart failure;
• if the patient has hyperthyroidism (a condition caused by an overactive thyroid) - celiprolol may mask the symptoms of hyperthyroidism;
• if the patient has chronic obstructive pulmonary disease, asthma, wheezing;
• if the patient has slow heart activity, with a rate of less than 50-55 beats per minute at rest (bradycardia) or irregular heart activity;
• if the patient has conduction disorders in the heart (first-degree atrioventricular block);
• if the patient has conditions such as Raynaud's disease (impaired blood circulation in the hands and feet, manifested by transient changes in skin color (white to blue, to red) and a feeling of cold in the limbs, with or without pain and a burning sensation) or Buerger's disease (reduced blood circulation in the legs, manifested by muscle pain in the calves or thighs after walking a certain distance, pain usually subsides after a short rest);
• if the patient has diabetes (celiprolol may mask the symptoms of low blood sugar);
• if the patient has a skin condition called psoriasis; during treatment with celiprolol, psoriasis symptoms may worsen;
• if the patient has had previous allergic reactions or is undergoing desensitization therapy;
• if the patient is an athlete and is to undergo doping tests, as celiprolol may cause a positive test result. The use of beta-blockers is prohibited in some sports.

If the patient needs to undergo surgery or receive anesthesia, they should inform their doctor or dentist about taking Celipres.
Consult a doctor even if the above conditions have occurred in the past.

Children and Adolescents

The safety and efficacy of celiprolol in children have not been established.

Celipres and Other Medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Be cautious when taking the following medications:

• diltiazem, verapamil, or nifedipine (used to treat high blood pressure and certain heart conditions);
• medications used for shock or low blood pressure;
• disopyramide, quinidine, amiodarone, or sotalol (used to treat heart rhythm disorders);
• chlorthalidone or hydrochlorothiazide (diuretics);
• clonidine (used to treat hypertension). If clonidine and celiprolol are taken together, do not stop taking clonidine unless advised by a doctor. The doctor may recommend stopping celiprolol many days before stopping clonidine;
• monoamine oxidase inhibitors (MAOIs) used to treat depression, e.g., phenelzine, tranylcypromine, moclobemide, and isocarboxazid;
• reserpine, alpha-methyldopa, guanfacine (used to treat high blood pressure);
• digoxin or digitoxin (used to treat heart failure and certain heart rhythm disorders);
• insulin or oral antidiabetic medications (e.g., glibenclamide, metformin);
• noradrenaline or adrenaline (used to treat low blood pressure, heart failure, asthma, or allergies); noradrenaline and adrenaline are always used under medical supervision;
• phenylephrine, pseudoephedrine, or phenylpropanolamine (found in cough medications or nasal and eye drops);
• nonsteroidal anti-inflammatory medications (used for inflammatory conditions and pain), e.g., ibuprofen, indomethacin;
• mefloquine, as it may cause bradycardia (slow heart activity);
• medications used to treat mental illnesses, 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 up, one hour before a meal or two hours after a meal.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication.

Driving and Operating Machines

Celipres has a negligible effect on the ability to drive vehicles and operate machines. However, very rarely, during treatment, dizziness and fatigue may occur, as well as tremors, headache, or blurred vision. If such symptoms occur, do not drive vehicles, use tools, or operate machines.

Celipres Contains Yellow Tartrazine

The medication contains yellow tartrazine, which may cause allergic reactions.

Celipres Contains Mannitol

The medication may have a mild laxative effect.

Celipres Contains Sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Celipres

Always take this medication exactly as your doctor has told you. If you are not sure, ask 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 insufficient, the 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.
Patient with Kidney Disease
In patients with moderate kidney impairment (creatinine clearance from 15 to 40 ml/min), it may be necessary to reduce the dose by half. Celiprolol is contraindicated in patients with severe kidney impairment (creatinine clearance less than 15 ml/min).
Celipres should be swallowed whole with a glass of water. Tablets can be taken in the morning, immediately after waking up, once daily, one hour before a meal or two hours after a meal.
To remember to take the medication, take it at the same time every day.
Take the medication for as long as the doctor has prescribed. It is important not to stop taking the medication when the patient feels better, as the symptoms may return.
If the patient feels that the effect of Celipres is too strong or too weak, they should consult a doctor or pharmacist.

Taking a Higher Dose of Celipres Than Recommended

In case of taking a higher dose of Celipres than recommended, consult a doctor or the nearest hospital emergency department. If possible, take the remaining tablets, packaging, and leaflet, so the doctor can immediately see what medication was taken.

Missing a Dose of Celipres

If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, only take the next tablet according to the normal schedule. Do not take a double dose to make up for the missed dose.

Stopping Celipres Treatment

Do not stop taking Celipres without consulting a doctor first. Suddenly stopping Celipres may worsen the patient's condition. The doctor will recommend gradual discontinuation of Celipres over a period of 7 to 10 days.
In case of doubts about taking the medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Celipres can cause side effects, although not everybody gets them.
If any of the following side effects occur, stop taking Celipres and immediately inform a doctor or go to the nearest hospital emergency department.

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

These are very serious side effects. If they occur, the patient may have a severe allergic reaction to celiprolol. Immediate medical attention or hospitalization may be necessary.
If any of the following side effects occur, immediately inform a doctor or go to the nearest hospital emergency department:

• dizziness or a feeling of "emptiness" in the head, weakness, or fainting, especially when standing up from a lying position,
• fast, slow, or irregular heart activity,
• breathing difficulties,
• worsening of pre-existing heart failure,
• worsening of diabetes. Previously undiagnosed diabetes may be revealed (in the form of increased thirst, frequent urination, increased hunger, weight loss). Inform a doctor if any of these symptoms occur.

Inform a doctor if any of the following side effects are noticed:
Common(may occur in less than 1 in 10 patients):

• headache and dizziness, drowsiness, nightmares, and insomnia (sleep disorders); tremors and a feeling of cold in the limbs, sudden flushing (especially of the face);
• palpitations, slowed heart rate, significantly decreased blood pressure, including when standing up from a lying position;
• muscle cramps;
• fainting;
• nausea or vomiting, abdominal pain or discomfort.

Rare(may occur in less than 1 in 1000 patients):

• positive antinuclear antibody test (ANA), single and reversible cases of lupus;
• depression;
• paresthesia (sensory disturbances);
• tinnitus;
• diarrhea, constipation;
• skin symptoms (e.g., itching, redness, rash, pruritus, urticaria, erythema);
• conduction disorders in the heart;
• worsening of conduction disorders in the heart (in susceptible patients);
• worsening of 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 the hands/feet, manifested by transient changes in skin color (white to blue, to red) and a feeling of cold in the limbs, with or without pain and a burning sensation];
• fatigue;
• allergic pneumonitis, bronchospasm, especially in patients with asthma or asthmatic reactions in the past;
• muscle weakness;
• decreased libido, impotence (in men);
• decreased blood sugar levels (hypoglycemia), increased blood sugar levels (hyperglycemia);
• in patients with hyperthyroidism, clinical symptoms of thyrotoxicosis (tachycardia, tremors) may be masked.

Warning signs of hypoglycemia (tachycardia, tremors) may be weakened.
Very Rare(may occur in less than 1 in 10,000 patients):

• hallucinations, psychosis;
• confusion;
• psoriasis symptoms, worsening of pre-existing psoriasis;
• vision disturbances, decreased tear secretion (dry eyes).

Unknown(frequency cannot be estimated from the available data):

• abnormal liver function test results (aminotransferases - ALT, AST).

Reporting Side Effects

If any side effects occur, including any not listed in this leaflet, inform a doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Celipres

Keep out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medication after the expiration date stated on the label. The expiration date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Celipres Contains

• -The active substance of Celipres is celiprolol hydrochloride. One tablet contains 100 mg of celiprolol hydrochloride.
• 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, yellow tartrazine (E 104), and lacquer.

What Celipres Looks Like and What the Package Contains

Yellow, heart-shaped, coated tablets with "100" embossed on one side.
Celipres packages contain 30 coated tablets in blisters (3x10).

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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
Netherlands
Date of Last Revision of the Leaflet:May 2023