CONARET 3.75 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Conaret, 1.25 mg, tablets
3. Conaret, 2.5 mg, tablets
4. Conaret, 3.75 mg, tablets
5. Conaret, 5 mg, tablets
6. Conaret, 7.5 mg, tablets
7. Conaret, 10 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
8. What is Conaret and what is it used for
9. Important information before taking Conaret
   1. When not to take Conaret
   2. Warnings and precautions
   3. Children and adolescents
   4. Conaret and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
10. How to take Conaret
    1. Chronic heart failure
    2. High blood pressure (hypertension)
    3. Coronary heart disease (angina pectoris)
    4. High blood pressure (hypertension) and coronary heart disease (angina pectoris)
    5. Taking a higher dose of Conaret than recommended
    6. Missing a dose of Conaret
    7. Stopping Conaret treatment
11. Possible side effects
    1. The most serious side effects are related to heart function:
    2. Reporting side effects
12. How to store Conaret
13. Contents of the packaging and other information
    1. What Conaret contains
    2. What Conaret looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
    6. For more information, the patient should contact the representative of the marketing authorization holder in Poland:

Leaflet accompanying the packaging: patient information

Conaret, 1.25 mg, tablets

Conaret, 2.5 mg, tablets

Conaret, 3.75 mg, tablets

Conaret, 5 mg, tablets

Conaret, 7.5 mg, tablets

Conaret, 10 mg, tablets

Bisoprolol fumarate

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 Conaret and what is it used for
• 2. Important information before taking Conaret
• 3. How to take Conaret
• 4. Possible side effects
• 5. How to store Conaret
• 6. Contents of the packaging and other information

1. What is Conaret and what is it used for

The active substance of Conaret is bisoprolol. Bisoprolol belongs to a group of medicines called beta-adrenergic blockers. These medicines affect the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and increases the efficiency of the heart in pumping blood throughout the body. At the same time, it reduces the amount of blood needed by the heart and its oxygen consumption.
Conaret is used to treat stable, chronic heart failure. Heart failure occurs when the heart muscle is weak and cannot pump enough blood to meet the body's needs. It is used in combination with other medicines for the treatment of this disease (such as angiotensin-converting enzyme inhibitors, diuretics, and cardiac glycosides).
In addition, Conaret 5 mg and 10 mg are used to treat high blood pressure (hypertension) and chest pain caused by reduced blood flow in the coronary arteries (coronary heart disease: angina pectoris).

2. Important information before taking Conaret

When not to take Conaret

• if the patient is allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe asthma;
• if the patient has advanced vascular disease, causing reduced blood flow to the arms and legs (peripheral arterial occlusive disease);
• if the patient has severe circulatory disorders in the limbs (such as Raynaud's syndrome), which can cause tingling, pallor, or cyanosis of the fingers and toes;
• if the patient has an untreated pheochromocytoma (a rare tumor of the adrenal gland);
• if the patient has metabolic acidosis (a disorder that causes excessive accumulation of acids in the blood).

Conaret should not be taken if the patient has the following heart conditions:

• acute heart failure;
• worsening of heart failure requiring intravenous administration of medicines that increase the strength of heart contractions;
• slow heart rate (less than 50 beats per minute);
• low blood pressure (systolic blood pressure below 90 mmHg);
• certain heart rhythm disorders that cause very slow or irregular heartbeats;
• cardiogenic shock (severe heart condition that causes low blood pressure and circulatory failure). If in doubt about any of the above conditions, the patient should consult a doctor.

Warnings and precautions

If any of the following conditions occur, the patient should discuss them with their doctor or pharmacist before starting Conaret; the doctor or pharmacist may decide that special caution is necessary (e.g., additional medications or more frequent monitoring):

• diabetes;
• strict fasting;
• certain heart diseases, such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina);
• kidney or liver disorders;
• not very severe circulatory disorders in the limbs;
• chronic lung disease or not very severe asthma;
• the occurrence of scaly skin lesions (psoriasis), also in the past;
• adrenal gland tumor (pheochromocytoma).
• thyroid dysfunction.

In addition, the patient should tell their doctor if they are planning:

• desensitization treatment (e.g., to avoid hay fever), as Conaret may increase the risk of an allergic reaction or worsen its severity;
• undergoing surgery under general anesthesia, as Conaret may alter the body's response to the medications administered.

If the patient has chronic lung disease or not very severe asthma, they should immediately tell their doctor if they experience new breathing difficulties, coughing, wheezing after physical exertion, etc. while taking Conaret.

Children and adolescents

Conaret is not recommended for use in children and adolescents.

Conaret 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.
Conaret should not be taken with the following medicines without special recommendation by the doctor:

• certain medicines used to treat heart rhythm disorders (class I anti-arrhythmic medicines, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain medicines used to treat high blood pressure, angina pectoris, or heart rhythm disorders (calcium antagonists, such as verapamil and diltiazem);
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, the patient should not stop taking these medicines without consulting their doctor.

Before taking the following medicines with Conaret, the patient should discuss them with their doctor, as the doctor may recommend more frequent medical check-ups:

• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine calcium antagonists, such as felodipine and amlodipine);
• certain medicines used to treat heart rhythm disorders (class III anti-arrhythmic medicines, such as amiodarone);
• locally applied beta-adrenergic blockers (such as eye drops for glaucoma treatment);
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics, such as tacrine or carbachol) or medicines used to treat acute heart disorders (sympathomimetics, such as isoprenaline, dobutamine, and orciprenaline); antidiabetic medicines, including insulin;
• agents used in general anesthesia (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, relieve pain and inflammation (e.g., ibuprofen and diclofenac);
• all medicines that can lower blood pressure, either as a desired or undesired effect, such as antihypertensive medicines, certain antidepressants (tricyclic antidepressants), certain antiepileptic medicines, or medicines used during general anesthesia (barbiturates, such as phenobarbital), and certain medicines used in psychiatric disorders characterized by loss of contact with reality (phenothiazine derivatives, e.g., levomepromazine);
• mefloquine, used to prevent and treat malaria;
• medicines used to treat depression, called monoamine oxidase inhibitors (except MAO-B inhibitors), such as moklobemide.

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.
Pregnancy
There is a risk that taking Conaret during pregnancy may harm the baby.
If the patient is pregnant or plans to become pregnant, they should tell their doctor. The doctor will decide whether Conaret can be taken during pregnancy.
Breastfeeding
It is not known whether bisoprolol passes into breast milk, so Conaret is not recommended during breastfeeding.

Driving and using machines

The medicine, depending on how it is tolerated, may impair the ability to drive or operate machines. The patient should be particularly careful at the beginning of treatment, after increasing the dose, or when changing medicines, as well as when combining the medicine with alcohol.

3. How to take Conaret

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
During treatment with Conaret, regular medical check-ups are necessary. This is especially important at the beginning of treatment, during dose increases, and when stopping treatment.
The tablet should be taken in the morning with food or on an empty stomach, washed down with water. The tablets should not be crushed or chewed. The score line on the tablet is not intended for breaking the tablet.
Conaret treatment is usually long-term.

Chronic heart failure

Adults, including the elderly
Bisoprolol treatment starts with small doses, which are then gradually increased.
The doctor will decide how to increase the dose. This is usually done as follows:

• 1.25 mg of bisoprolol once a day for a week
• 2.5 mg of bisoprolol once a day for a week
• 3.75 mg of bisoprolol once a day for a week
• 5 mg of bisoprolol once a day for four weeks
• 7.5 mg of bisoprolol once a day for four weeks
• 10 mg of bisoprolol once a day for maintenance treatment.

The maximum recommended dose is 10 mg of bisoprolol per day.
If Conaret 1.25 mg, 3.75 mg, or 7.5 mg is not available in the country, these doses can be achieved using other bisoprolol products available.
Depending on how the medicine is tolerated, the doctor may decide to extend the time between dose increases. If the disease worsens or the medicine is not tolerated, it may be necessary to reduce the dose again or stop treatment. In some patients, a lower maintenance dose than 10 mg of bisoprolol may be sufficient. The doctor will determine the appropriate course of action.
If treatment needs to be stopped, the doctor will usually recommend gradually reducing the dose of the medicine; otherwise, the disease may worsen.

High blood pressure (hypertension)

Adults, including the elderly
Unless the doctor recommends otherwise, the recommended dose is 5 mg of bisoprolol once a day. In milder cases of hypertension (diastolic blood pressure up to 105 mmHg), 2.5 mg once a day may be appropriate, using other medicines of suitable potency.
If necessary, the dose can be increased to 10 mg of bisoprolol per day. Further dose increases are only justified in exceptional cases.
The maximum recommended dose is 20 mg once a day.

Coronary heart disease (angina pectoris)

Adults, including the elderly
Unless the doctor recommends otherwise, the recommended dose is 5 mg of bisoprolol once a day.
If necessary, the dose can be increased to 10 mg of bisoprolol per day. Further dose increases are only justified in exceptional cases.
The maximum recommended dose is 20 mg once a day.

High blood pressure (hypertension) and coronary heart disease (angina pectoris)

Dosing in patients with liver or kidney impairment
Patients with mild to moderate liver or kidney impairment usually do not require dose adjustment. In patients with severe kidney impairment (creatinine clearance <20 ml min) or severe liver impairment, a dose greater than 10 mg of bisoprolol fumarate per day should not be used.< p>

Taking a higher dose of Conaret than recommended

In case of taking more tablets of Conaret than recommended, the patient should immediately contact their doctor. The doctor will decide what actions to take.
Overdose symptoms may include slow heart rate, breathing difficulties, dizziness, or tremors (caused by low blood sugar levels).

Missing a dose of Conaret

The patient should not take a double dose to make up for a missed dose. They should take their usual dose the next morning.

Stopping Conaret treatment

The patient should not stop taking Conaret unless their doctor recommends it. Otherwise, it may cause significant worsening of symptoms.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Conaret can cause side effects, although not everybody gets them.
To prevent serious reactions, the patient should contact their doctor if side effects are severe, occur suddenly, or worsen rapidly.

The most serious side effects are related to heart function:

• slow heart rate (may occur in more than 1 in 10 patients with chronic heart failure; may occur in less than 1 in 100 patients with hypertension or angina pectoris);
• worsening of heart failure (may occur in less than 1 in 10 patients);
• slow or irregular heart rate (may occur in less than 1 in 100 patients).

If the patient experiences dizziness, weakness, or breathing difficulties, they should contact their doctor as soon as possible.
Other side effects are presented below, according to their frequency.

Frequent(may occur in less than 1 in 10 patients):

• fatigue, weakness (in patients with chronic heart failure), dizziness, headaches;
• feeling of cold or numbness in the hands or feet;
• low blood pressure;
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, or constipation. These symptoms usually occur at the beginning of treatment and are generally mild and resolve within 1 to 2 weeks after starting treatment.

Uncommon(may occur in less than 1 in 100 patients):

• weakness (in patients with hypertension or angina pectoris);
• sleep disorders;
• depression;
• dizziness when standing up;
• breathing problems in patients with asthma or chronic lung disease;
• muscle weakness or cramps.

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

• hearing disorders;
• allergic rhinitis;
• reduced tear secretion (important if the patient wears contact lenses);
• liver inflammation, which can cause yellowing of the skin or whites of the eyes;
• changes in the results of some blood tests, related to liver function or fat levels in the blood;
• allergic reactions, such as itching, flushing, rash. The patient should immediately contact their doctor if they experience more severe allergic reactions, which may include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.
• reduced sexual potency;
• nightmares, hallucinations;
• fainting.

Very rare(may occur in less than 1 in 10,000 patients):

• eye irritation or redness (conjunctivitis);
• hair loss;
• the occurrence or worsening of scaly skin lesions (psoriasis), psoriasis-like changes.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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, phone: +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 this medicine.

5. How to store Conaret

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.
Tablets packaged in OPA/Aluminium/PVC/Aluminium blisters:
Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
Tablets packaged in white PVC/PVDC/Aluminium blisters:
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
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 packaging and other information

What Conaret contains

The active substance of Conaret is bisoprolol fumarate.
Conaret, 1.25 mg, tablets: each tablet contains 1.25 mg of bisoprolol fumarate.
Conaret, 2.5 mg, tablets: each tablet contains 2.5 mg of bisoprolol fumarate.
Conaret, 3.75 mg, tablets: each tablet contains 3.75 mg of bisoprolol fumarate.
Conaret, 5 mg, tablets: each tablet contains 5 mg of bisoprolol fumarate.
Conaret, 7.5 mg, tablets: each tablet contains 7.5 mg of bisoprolol fumarate.
Conaret, 10 mg, tablets: each tablet contains 10 mg of bisoprolol fumarate.
Other ingredients of the medicine are: microcrystalline cellulose (type 102), cornstarch, crospovidone (type A), colloidal anhydrous silica, magnesium stearate.
Conaret, 3.75 mg, tablets, Conaret, 5 mg, tablets, Conaret, 7.5 mg, tablets, Conaret, 10 mg, tablets contain yellow iron oxide (E172);
Conaret, 3.75 mg, tablets, Conaret, 10 mg, tablets contain brown iron oxide (E172).

What Conaret looks like and contents of the pack

Conaret 1.25 mg, tablets: white, round tablets, with the inscription 1.25, diameter 6 mm ± 0.3 mm.
Conaret, 2.5 mg, tablets: white, round tablets, with the inscription 2.5, with a score line, diameter 6 mm ± 0.3 mm. The score line on the tablet is not intended for breaking the tablet.
Conaret, 3.75 mg, tablets: white to light beige, round tablets, with the inscription 3.75 and randomly distributed spots of colorants, diameter 6 mm ± 0.3 mm.
Conaret, 5 mg, tablets: yellow to light yellow, round tablets, with the inscription 5, with a score line and randomly distributed spots of colorants, diameter 6 mm ± 0.3 mm. The score line on the tablet is not intended for breaking the tablet.
Conaret, 7.5 mg, tablets: yellow to dark yellow, round tablets, with the inscription 7.5 and possible darker or lighter spots, diameter 6 mm ± 0.3 mm.
Conaret, 10 mg, tablets: ochre-colored, round tablets, with the inscription 10, with a score line and possible darker or lighter spots, diameter 6 mm ± 0.3 mm. The score line on the tablet is not intended for breaking the tablet.
Tablets 1.25 mg
Tablets are available in OPA/Aluminium/PVC/Aluminium blisters in a carton.
Tablets 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg
Tablets are available in OPA/Aluminium/PVC/Aluminium or PVC/PVDC/Aluminium blisters in a carton.
Available pack sizes:
1.25 mg: 20, 28, 30, 60, 90, or 100 tablets.
2.5 mg: 15, 28, 30, 60, 90, or 100 tablets.
3.75 mg: 28, 30, 50, 90, or 100 tablets.
5 mg; 10 mg: 28, 30, 50, 56, 60, 90, or 100 tablets.
7.5 mg: 28, 30, 50, 56, 60, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s.
U kabelovny 130
Dolni Mĕcholupy
102 37 Prague 10
Czech Republic

Manufacturer

Tablets 1.25, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg
Zentiva k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Tablets 2.5 mg, 5 mg, 10 mg
S.C. Zentiva S.A.
B-dul Theodor Pallady nr 50, Sector 3
032266 Bucharest
Romania

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany, Czech Republic, Bulgaria, Poland, Romania, Slovakia: Conaret
Austria, Portugal, Spain, Estonia, Latvia, Denmark, Norway, Sweden, Ireland: Bisoprolol Zentiva
Lithuania, United Kingdom (Northern Ireland): Bisoprolol fumarate Zentiva
France: BISOPROLOL ZENTIVA K.S
Italy: Bisoprololo Zentiva Generics

For more information, the patient should contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:September 2023