Conaret

Leaflet attached to 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 intended for the treatment of this disease (such as angiotensin-converting enzyme inhibitors, diuretics, and cardiac glycosides).
In addition, Conaret tablets at doses of 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 problems:

• 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 disorder that causes low blood pressure and circulatory failure). If in doubt, whether any of the above conditions apply to the patient, they 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 to take Conaret; the doctor or pharmacist may decide that special caution is required (e.g., additional medication or more frequent monitoring):

• diabetes;
• strict fasting;
• certain heart diseases, such as arrhythmias 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;
• psoriasis (a skin condition), including a history of psoriasis;
• pheochromocytoma (a tumor of the adrenal gland).
• 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;
• surgery under general anesthesia, as Conaret may alter the body's response to the administered medicines.

If the patient has chronic lung disease or not very severe asthma, they should immediately tell their doctor if they experience new breathing difficulties, cough, wheezing, or other symptoms 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 arrhythmias (class I anti-arrhythmic medicines, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain medicines used to treat hypertension, angina pectoris, or arrhythmias (calcium channel blockers, such as verapamil and diltiazem);
• certain medicines used to treat hypertension, 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 consult their doctor, as they may need more frequent medical check-ups:

• certain medicines used to treat hypertension or angina pectoris (dihydropyridine calcium channel blockers, such as felodipine and amlodipine);
• certain medicines used to treat arrhythmias (class III anti-arrhythmic medicines, such as amiodarone);
• locally used beta-adrenergic blockers (e.g., eye drops for glaucoma);
• 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;
• medicines used for 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 reduce 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 for 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 for 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 should not be taken 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, when increasing the dose, and when stopping treatment.
The tablet should be taken in the morning with food or on an empty stomach, with a glass of water. The tablets should not be crushed or chewed. The dividing 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 marketed in the country, these doses can be achieved using other available bisoprolol products.
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.

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 sufficient, using other medicines of appropriate 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.

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 need to modify their dosing. 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 Conaret tablets 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 a significant worsening of symptoms.
If the patient has any further doubts about taking this medicine, they 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, sudden, or worsening.

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 rhythm (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.
The other side effects are listed below, according to their frequency.

Common(may affect up to 1 in 10 people):

• 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 affect up to 1 in 100 people):

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

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

• hearing disorders;
• allergic rhinitis;
• reduced tear production (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 blood lipid levels;
• 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 affect up to 1 in 10,000 people):

• eye irritation or redness (conjunctivitis);
• hair loss;
• psoriasis or psoriasis-like skin 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, 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 to 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.
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.
The 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, with a diameter of 6 mm ± 0.3 mm.
Conaret, 2.5 mg, tablets: white, round tablets, with the inscription 2.5, with a dividing line, with a diameter of 6 mm ± 0.3 mm. The dividing 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 color, with a diameter of 6 mm ± 0.3 mm.
Conaret, 5 mg, tablets: yellow to light yellow, round tablets, with the inscription 5, with a dividing line and randomly distributed spots of color, with a diameter of 6 mm ± 0.3 mm. The dividing 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, with a diameter of 6 mm ± 0.3 mm.
Conaret, 10 mg, tablets: ochre-colored, round tablets, with the inscription 10, with a dividing line and possible darker or lighter spots, with a diameter of 6 mm ± 0.3 mm. The dividing 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 cardboard box.
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 cardboard box.
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 further information, please contact 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