Conaret

Package leaflet: information for the patient

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
Bisoprololum fumaricum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Conaret is and what it is 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 pack and other information

1. What Conaret is and what it is used for

The active substance in Conaret is bisoprolol. Bisoprolol belongs to a group of medicines called beta-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 thereby improves the heart's efficiency in pumping blood throughout the body. At the same time, it reduces the amount of blood required by the heart and its oxygen consumption.

Conaret is used in the treatment of stable chronic heart failure. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs. It is used in combination with other medicines for treating this condition (such as angiotensin-converting enzyme inhibitors, diuretics, and cardiac glycosides).

Additionally, Conaret tablets in 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 (ischaemic heart disease: angina pectoris).

2. Important information before taking Conaret

When not to take Conaret

• if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6);
• if you have severe bronchial asthma;
• if you have advanced-stage vascular disease causing reduced blood flow to the hands and feet (peripheral arterial occlusive disease);
• if you have severe circulatory disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, pallor, or blueness of the fingers and toes;
• if you have untreated phaeochromocytoma (a rare tumour of the adrenal glands);
• if you have metabolic acidosis (a disorder causing excessive accumulation of acids in the blood).

Do not take Conaret if you have any of the following heart conditions:

• acute heart failure;
• worsening heart failure requiring intravenous administration of drugs that increase the force 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 causing very slow or irregular heartbeat;
• cardiogenic shock (a severe heart disorder causing low blood pressure and circulatory failure). If you are unsure whether any of the above conditions apply to you, consult your doctor.

Warnings and precautions

If you have any of the following conditions, talk to your doctor or pharmacist before starting Conaret; your doctor or pharmacist may decide that special caution is needed (for example, additional medicines 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;
• mild circulatory disorders in the limbs;
• chronic lung disease or mild bronchial asthma;
• presence of psoriatic skin lesions (psoriasis), even in medical history;
• adrenal medulla tumour (phaeochromocytoma);
• thyroid dysfunction.

Additionally, tell your doctor if you are planning:

• allergen immunotherapy (e.g. to prevent hay fever), because Conaret may increase the likelihood of allergic reactions or increase their severity;
• surgery under general anaesthesia, because Conaret may alter the body's response to administered medicines.

If you have chronic lung disease or mild bronchial asthma, inform your doctor immediately if you develop new breathing difficulties, cough, or wheezing during physical exertion while taking Conaret.

Children and adolescents

Conaret is not recommended for use in children and adolescents.

Conaret with other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Do not take the following medicines together with Conaret without specific medical advice:

• certain medicines used to treat heart rhythm disorders (class I antiarrhythmics, 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, do not stop taking these medicines without consulting your doctor.

Before taking any of the following medicines together with Conaret, talk to your doctor, as more frequent medical checks may be needed:

• 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 antiarrhythmics such as amiodarone);
• locally applied beta-blockers (such as eye drops used to treat 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;
• agents used in general anaesthesia (e.g. during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat joint inflammation, relieve pain and inflammation (e.g. ibuprofen and diclofenac);
• all medicines that may lower blood pressure, either as a desired or an adverse effect, such as antihypertensive medicines, certain antidepressants (tricyclic antidepressants), certain antiepileptic medicines or those used during general anaesthesia (barbiturates such as phenobarbital), and certain medicines used in psychiatric disorders characterised by loss of contact with reality (phenothiazine derivatives such as levomepromazine);
• mefloquine, used to prevent and treat malaria;
• medicines used to treat depression, called monoamine oxidase inhibitors (MAOIs) (except MAO-B inhibitors), such as moklobemide.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Pregnancy

There is a risk that using Conaret during pregnancy may harm the unborn child.

If you are pregnant or planning to become pregnant, inform your doctor. Your doctor will decide whether you can take Conaret during pregnancy.

Breastfeeding

It is not known whether bisoprolol passes into breast milk; therefore, Conaret is not recommended during breastfeeding.

Driving and using machines

This medicine may impair the ability to drive or operate machinery, depending on how it is tolerated. Exercise particular caution at the beginning of treatment, after dose increases, or when changing medicines, and also if combining the medicine with alcohol.

3. How to take Conaret

Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.

Regular medical check-ups are necessary during treatment with Conaret. This is particularly important at the beginning of treatment, during dose escalation, and when discontinuing treatment.

Take the tablet in the morning with or without food, swallowing it with water. Do not crush or chew the tablets. The score line on the tablet is not intended for dividing the tablet.

Treatment with Conaret is usually long-term.

Chronic heart failure

Adults, including elderly people

Treatment with bisoprolol starts with low doses, which are then gradually increased. Your doctor will decide how to increase the dosage. Usually, this is done as follows:

• 1.25 mg bisoprolol once daily for one week
• 2.5 mg bisoprolol once daily for one week
• 3.75 mg bisoprolol once daily for one week
• 5 mg bisoprolol once daily for four weeks
• 7.5 mg bisoprolol once daily for four weeks
• 10 mg bisoprolol once daily for maintenance treatment (long-term use).

The maximum recommended dose is 10 mg bisoprolol per day.

If Conaret 1.25 mg, 3.75 mg, or 7.5 mg is not available in your country, these doses can be achieved using other available bisoprolol-containing products.

Depending on how the medicine is tolerated, your doctor may decide to extend the time between dose increases. If your condition worsens or if the medicine is not well tolerated, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose lower than 10 mg bisoprolol may be sufficient. Your doctor will determine the appropriate course of action.

If treatment needs to be discontinued, your doctor will usually recommend gradually reducing the dose. Otherwise, your condition may worsen.

High blood pressure (hypertension)

Adults, including elderly people

Unless otherwise directed by your doctor, the recommended dose is 5 mg bisoprolol once daily. In milder forms of hypertension (diastolic pressure up to 105 mmHg), 2.5 mg once daily may be appropriate, possibly combined with other medicines of suitable strength.

If necessary, the dose may be increased to 10 mg bisoprolol per day. Further dose increases are justified only in exceptional cases.

The maximum recommended dose is 20 mg once daily.

Ischaemic heart disease (angina pectoris)

Adults, including elderly people

Unless otherwise directed by your doctor, the recommended dose is 5 mg bisoprolol once daily.

If necessary, the dose may be increased to 10 mg bisoprolol per day. Further dose increases are justified only in exceptional cases.

The maximum recommended dose is 20 mg once daily.

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

Dosage in patients with impaired liver or kidney function

In patients with mild to moderate liver or kidney impairment, dosage adjustment is usually not necessary. In patients with severe kidney impairment (creatinine clearance < 20 ml/min) or severe liver impairment, doses higher than 10 mg bisoprolol fumarate per day should not be used.

Taking more Conaret than recommended

If you take more Conaret tablets than recommended, contact your doctor immediately. The doctor will decide what actions are necessary.

Symptoms of overdose may include slowed heart rate, breathing difficulties, dizziness, or tremors (caused by low blood sugar levels).

If you forget to take Conaret

Do not take a double dose to make up for a missed dose. Take your usual dose the next morning.

Stopping Conaret

Do not stop taking Conaret unless your doctor tells you to. Otherwise, it may cause a significant worsening of symptoms.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
To prevent serious reactions, you should contact your doctor if adverse effects are
severe, appear suddenly, or worsen rapidly.
The most serious adverse effects are related to heart function:

• slow heart rate (may occur in more than 1 in 10 people – in patients with chronic heart failure; may occur in no more than 1 in 100 people – in patients with hypertension or angina pectoris);
• worsening of heart failure (may occur in no more than 1 in 10 people);
• slow or irregular heartbeat (may occur in no more than 1 in 100 people).

If dizziness, weakness, or difficulty breathing occur, contact your doctor as soon as possible.
Other adverse effects are listed below, classified by frequency of occurrence.
Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

• feeling of weakness (in patients with hypertension or angina pectoris);
• sleep disturbances;
• depression;
• dizziness upon standing;
• breathing problems in patients with asthma or chronic lung disease;
• muscle weakness or cramps.

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

• hearing disturbances;
• allergic rhinitis;
• reduced tear production (important if the patient wears contact lenses);
• hepatitis, which may cause yellowing of the skin or whites of the eyes;
• changes in the results of certain blood tests assessing liver function or blood lipid levels;
• allergic reactions such as itching, facial flushing, rash. You should contact your doctor immediately if more severe allergic reactions occur, which may include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.
• reduced sexual function (impotence);
• nightmares, hallucinations;
• fainting.

Very rare (may affect up to 1 in 10,000 people):

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Conaret

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following the abbreviation: EXP. The expiry date refers to the last day of the specified month.
Tablets packed in OPA/Aluminium/PVC/Aluminium foil blisters:
Store below 30°C. Keep in the original packaging to protect from moisture.
Tablets packed in white blisters made of PVC/PVDC/Aluminium foil:
Store below 25°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Conaret contains
The active substance 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 are: microcrystalline cellulose (type 102), pregelatinized starch, corn starch,
crosspovidone (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
iron oxide yellow (E172);
Conaret 3.75 mg tablets, Conaret 10 mg tablets contain iron oxide brown (E172).

What Conaret looks like and contents of the pack
Conaret 1.25 mg tablets: white, round tablets, embossed with the number 1.25, diameter 6 mm ± 0.3 mm.
Conaret 2.5 mg tablets: white, round tablets, embossed with the number 2.5, with a division line, diameter
6 mm ± 0.3 mm. The division line on the tablet is not intended for splitting the tablet.
Conaret 3.75 mg tablets: white to light beige round tablets, embossed with the number 3.75, with randomly
distributed pigment spots, diameter 6 mm ± 0.3 mm.
Conaret 5 mg tablets: pale yellow to light yellow round tablets, embossed with the number 5, with a
division line and randomly distributed pigment spots, diameter 6 mm ± 0.3 mm. The division line on the
tablet is not intended for splitting the tablet.
Conaret 7.5 mg tablets: yellow to dark yellow round tablets, embossed with the number 7.5, with possible
darker or lighter spots, diameter 6 mm ± 0.3 mm.
Conaret 10 mg tablets: ochre-coloured round tablets, embossed with the number 10, with a division line
and possible darker or lighter spots, diameter 6 mm ± 0.3 mm. The division line on the tablet is not intended
for splitting the tablet.

1.25 mg tablets
Tablets are available in blisters made of OPA/Aluminium/PVC/Aluminium foil in a cardboard box.

2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg tablets
Tablets are available in blisters made of OPA/Aluminium/PVC/Aluminium or PVC/PVDC/Aluminium foil
in a cardboard box.

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

Manufacturer
Tablets 1.25 mg, 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 authorised 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, Slovak Republic: 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

To obtain further information, please contact the local representative of the Marketing Authorisation
Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00