Celipres 200

Package Leaflet: Information for the Patient

Celipres 200, 200 mg, Film-Coated Tablets

Celiprolol Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, please inform your 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. Contents of the pack 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 medicines called beta-blockers.
Celipres is used to treat mild to moderate high blood pressure and chest pain (angina pectoris) caused by reduced blood flow to the heart. The pain occurs when the heart muscle receives too little oxygen.
This medicine lowers blood pressure and slows down the heart rate during physical exertion, but has little effect on the heart rate at rest.

2. Important information before taking Celipres

When not to take Celipres:

Warnings and precautions

Before taking Celipres, consult your doctor:

If you need to have surgery or receive anesthesia, you should inform your doctor or dentist that you are taking Celipres.
Consult your doctor even if these conditions have occurred in the past.

Children and adolescents

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

Celipres and other medicines

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

• diltiazem, verapamil, or nifedipine (used to treat high blood pressure and certain heart conditions);
• medicines used to treat shock or low blood pressure;
• disopyramide, quinidine, amiodarone, or sotalol (used to treat heart rhythm disorders);
• chlorthalidone or hydrochlorothiazide (diuretics);
• clonidine (used to treat high blood pressure). If you are taking clonidine and celiprolol, do not stop taking clonidine unless advised to do so by your doctor. Your doctor may advise you to stop taking celiprolol several days before stopping clonidine;
• monoamine oxidase inhibitors (MAOIs used to treat depression), such as 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 hypoglycemic agents (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, phenylpropanolamine (found in cough medicines or nasal and eye drops);
• non-steroidal anti-inflammatory drugs (used to treat inflammation and pain), such as ibuprofen, indomethacin;
• mefloquine, as it may cause bradycardia (slow heart rate);
• medicines 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Celipres contains yellow pigment

The medicine contains yellow pigment, 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, which means it is considered "sodium-free".

3. How to take Celipres

Always take this medicine 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 inadequate, your doctor may increase the dose to 400 mg of celiprolol once daily.
If you have liver or kidney disease, your doctor may decide to start treatment with a lower dose and then increase it if necessary.
Stable angina pectoris
The usual dose is 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.
It is recommended to gradually stop taking the medicine over 1-2 weeks. Suddenly stopping treatment may cause heart problems, especially in patients with coronary heart disease.
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. The tablets can be taken in the morning, immediately after waking up, once daily, one hour before a meal or two hours after a meal.
The dividing line on the tablet is not intended for breaking the tablet.
To remember to take the medicine, take it at the same time every day.
Take the medicine for as long as your doctor has prescribed. It is important not to stop taking the medicine when you feel better, as this may cause the symptoms to return.
If you feel that the effect of Celipres is too strong or too weak, consult your doctor or pharmacist.

Overdose of Celipres

In case of overdose, consult your doctor or the nearest hospital emergency department. If possible, take the remaining tablets, packaging, and leaflet with you, so that the doctor can immediately see what medicine has been taken.

Missing a dose of Celipres

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, only take the next tablet as scheduled. Do not take a double dose to make up for a missed dose.

Stopping treatment with Celipres

Do not stop taking Celipres without consulting your doctor. Suddenly stopping Celipres may worsen your condition. Your doctor will advise you to gradually stop taking Celipres over a period of 7 to 10 days.
If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

These are very serious side effects. If they occur, you may have had a severe allergic reaction to celiprolol. You may need immediate medical attention or hospitalization.
If you experience any of the following side effects, immediately inform your doctor or go to the nearest hospital emergency department:

• dizziness or feeling of "emptiness" in the head, weakness or fainting, especially when standing up from a lying position,
• fast, slow, or irregular heart rate,
• 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 your doctor if you experience any of these symptoms.

Inform your doctor if you notice any of the following side effects:
Common(may affect up to 1 in 10 people):

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

Rare(may affect up to 1 in 1,000 people):

• 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);
• heart conduction disorders;
• worsening of pre-existing heart conduction disorders (in susceptible patients);
• worsening of heart failure with peripheral edema (swelling of the limbs) and (or) exertional dyspnea;
• pogorszenie wcześniej występujących zaburzeń krążenia, takich jak chromanie przestankowe, zespół Raynauda [pogorszone krążenie krwi w rękach/stopach objawiające się przemijającymi

zmianami zabarwienia skóry (biała do niebieskiej, do czerwonej) oraz odczuwaniem zimna w
kończynach, z występującym bólem i uczuciem pieczenia lub bez];

• fatigue;
• allergic pneumonia, bronchospasm, especially in patients with asthma or a history of asthmatic reactions;
• 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 affect up to 1 in 10,000 people):

• 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 - AlAT, AspAT).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Celipres

Keep out of the sight and reach of children.
Store in a temperature 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Celipres contains

• -The active substance of Celipres is celiprolol hydrochloride. One tablet contains 200 mg of celiprolol hydrochloride.
• The other ingredients are: microcrystalline cellulose, mannitol, sodium carboxymethylcellulose, colloidal anhydrous silica, magnesium stearate, and a coating containing hypromellose 2910 6cP, titanium dioxide (E 171), macrogol 400, yellow pigment (E 104), and lacquer.

What Celipres looks like and contents of the pack

The film-coated tablets are yellow, heart-shaped, with the inscription "200" on one side and a dividing line on the other. The dividing line on the tablet is not intended for breaking the tablet.
Celipres is available in packs containing 30 film-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