Corsip

Package leaflet: Information for the patient

Corsib, 2.5 mg, tablets
Corsib, 5 mg, tablets
Corsib, 10 mg, tablets
Bisoprololum fumaras
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Corsib is and what it is used for
2. Important information before taking Corsib
3. How to take Corsib
4. Possible side effects
5. How to store Corsib
6. Contents of the pack and other information

1. What Corsib is and what it is used for

The active substance in Corsib 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 heart activity and thereby improves the heart's efficiency in
pumping blood throughout the body.
Corsib is used in combination with other medicines (ACE inhibitors, diuretics, and cardiac glycosides) for the treatment of stable heart failure.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.
Corsib is also used to treat high blood pressure (arterial hypertension) and angina pectoris (chest pain caused by blockage of the arteries supplying the heart muscle).

2. Important information before using Corsib

When not to use Corsib:

• if the patient is allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6)
• if the patient has severe asthma
• if the patient has severe circulatory disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness, or blueness of the fingers or toes
• if the patient has metabolic acidosis, a condition in which the concentration of acids in the blood is too high
• if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal (medulla)
• if the patient has acute heart failure, which suddenly worsens, and (or) which may require hospital treatment
• if the patient has a slow heart rate causing symptoms, or low blood pressure
• if the patient has certain heart diseases causing slow or irregular heartbeat
• if the patient has cardiogenic shock, i.e. severe heart problems leading to low blood pressure and circulatory failure.

Warnings and precautions
Before starting to take Corsib, consult a doctor or pharmacist,
especially if the patient has any of the following conditions:

• chronic bronchitis or milder forms of asthma
• diabetes
• strict fasting
• allergen immunotherapy (e.g. to prevent hay fever)
• certain heart diseases such as heart rhythm disorders or severe chest pain at rest (Prinzmetal's angina)
• kidney or liver problems
• circulatory disorders in the limbs
• general anaesthesia will be used during surgery
• if the patient currently suffers from (or has suffered in the past) psoriasis (a recurring skin condition characterised by skin scaling and dry rash)
• phaeochromocytoma of the adrenal medulla
• thyroid dysfunction.

Children and adolescents
Corsib is not recommended for use in children and adolescents, as there is no experience with the use of Corsib in this patient group.
Corsib and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
Do not take the following medicines together with Corsib without specific instructions from a doctor:

• 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, or heart rhythm disorders (calcium channel blockers, 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 first consulting a doctor. Before taking the following medicines together with Corsib, consult a doctor; the doctor may recommend more frequent medical checks:
• certain medicines used to treat high blood pressure or angina (calcium channel blockers, 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 - increased eye pressure)
• 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 (such as isoprenaline and dobutamine)
• medicines used to treat diabetes, including insulin
• agents used in general anaesthesia (e.g. during surgery)
• digoxin (used to treat heart failure)
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat joint inflammation, pain and swelling (such as ibuprofen and diclofenac)
• all medicines that may lower blood pressure, such as:
  • antihypertensive medicines,
  • certain antidepressants (such as imipramine or amitriptyline),
  • certain medicines used to treat epilepsy,
  • certain medicines used during anaesthesia (such as phenobarbital),
  • certain medicines used to treat psychiatric disorders (such as levomepromazine)
• mefloquine, used to prevent or treat malaria
• medicines used to treat depression, called monoamine oxidase inhibitors (MAOIs), except MAO-B inhibitors, such as moclobemide.

Corsib with food, drink and alcohol
Corsib is usually taken in the morning, with or without food.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There is a risk that using bisoprolol during pregnancy may harm the unborn child. The doctor will decide whether Corsib can be taken during pregnancy.
It is not known whether bisoprolol passes into breast milk. Therefore, breastfeeding is not recommended during treatment with bisoprolol.
Driving and operating machinery
Depending on how it is tolerated by the patient, Corsib may affect the ability to drive or operate machinery. Particular caution should be exercised at the beginning of treatment, after dose increases, or when changing medications, as well as when combining the medicine with alcohol.

3. How to use Corsib

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Corsib tablets should be taken in the morning with food or independently of meals, swallowed with water.
Tablets must not be crushed or chewed.

High blood pressure / Angina pectoris
Adults
Your doctor will start treatment with the lowest possible dose (5 mg). Your doctor will carefully
monitor your condition at the beginning of treatment and gradually increase the dose until reaching
the dose best tolerated by the patient. The recommended daily dose is 10 mg. The maximum daily
dose is 20 mg.
Treatment with Corsib is usually long-term.

Patients with impaired kidney or liver function
In patients with mild or moderate kidney or liver impairment, dose adjustment is usually not
required. Patients with severe kidney or liver impairment should not take more than 10 mg of
bisoprolol per day.

Heart failure (reduced ability of the heart to function as a pump)
Treatment with Corsib requires regular medical supervision, especially at the beginning of treatment
and during dose adjustment. Bisoprolol treatment should be initiated at a low dose and gradually
increased. Your doctor will decide how to increase the dose, which is usually done as follows:

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

The maximum recommended daily dose is 10 mg of bisoprolol. In some patients, a maintenance dose
lower than 10 mg of bisoprolol may be sufficient.
Tablets may be divided into equal doses.
Depending on how well the patient tolerates Corsib, your doctor may decide to extend the intervals
between dose increases. If the patient's condition worsens or the patient does not tolerate Corsib,
it may be necessary to reduce the dose again or discontinue treatment. If treatment must be
completely stopped, your doctor will usually recommend gradually reducing the dose, as otherwise
the patient's condition may deteriorate.

Use in children and adolescents
Corsib is not recommended for use in children and adolescents.

Use in elderly patients
Generally, no dose adjustment is necessary in elderly patients.

Taking more Corsib than recommended
If you take more Corsib than recommended, contact your doctor immediately. Your doctor will
decide what actions should be taken.
Symptoms of overdose may include: slowing of the heartbeat (bradycardia), acute narrowing of the
airways causing breathing difficulties (bronchospasm), a significant drop in blood pressure, acute
heart failure, or low blood sugar levels.

If you miss a dose of Corsib
Do not take a double dose to make up for a missed dose. Take your next dose as usual the following
morning.

Stopping Corsib
Never stop taking Corsib unless your doctor tells you to do so. Otherwise, your condition may
worsen significantly.
Treatment with bisoprolol must not be stopped suddenly. If you need to discontinue treatment, it
should be done gradually to avoid adverse effects. If any adverse effects occur, the dose should be
reduced more slowly.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If dizziness, weakness or difficulty breathing occurs, contact a doctor as soon as possible.
The following adverse reactions are listed below according to their frequency of occurrence:
Very common (may affect more than 1 in 10 people):

• bradycardia (slow heart rate)

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

• sensation of coldness or numbness in hands or feet
• low blood pressure
• worsening of existing heart failure
• nausea, vomiting, diarrhoea, constipation
• fatigue*, dizziness*, headache*, weakness (asthenia)

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

• sleep disorders
• depression
• atrioventricular conduction disorders
• drop in blood pressure upon standing causing dizziness
• breathing problems in patients with asthma or chronic lung disease
• muscle weakness, muscle cramps

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

• dry eyes due to reduced tear production (may be problematic if the patient wears contact lenses)
• hearing disturbances
• allergic rhinitis and nasal congestion
• hepatitis, which may cause yellowing of the skin or whites of the eyes
• increased levels of liver enzymes (AST, ALT), increased triglyceride levels
• allergic reactions such as itching, facial flushing, rash. Contact a doctor immediately if more severe allergic reactions occur, which may include: swelling of the face, neck, tongue, mouth or throat, or difficulty breathing.
• erectile dysfunction
• nightmares, hallucinations, fainting

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

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

* When treating high blood pressure or angina pectoris, these symptoms occur particularly at the beginning of treatment or when the dose is changed. They are usually mild and often resolve within 1 to 2 weeks.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store the medicine Corsib

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Corsib contains

• The active substance is bisoprolol fumarate. Corsib 2.5 mg contains 2.5 mg of bisoprolol fumarate. Corsib 5 mg contains 5 mg of bisoprolol fumarate. Corsib 10 mg contains 10 mg of bisoprolol fumarate.
• The other ingredients are microcrystalline cellulose (type 102), microcrystalline cellulose (type 101), crospovidone (type A), magnesium stearate, yellow iron oxide (E 172) (only in Corsib 2.5 mg and 10 mg), red iron oxide (E 172) (only in Corsib 10 mg).

What Corsib looks like and contents of the pack
Corsib 2.5 mg are yellow, round, flat tablets with a score line on one side, 7 mm in diameter.
The tablet can be divided into equal doses.
Corsib 5 mg are white, round, biconvex tablets with a score line, 7 mm in diameter.
The tablet can be divided into equal doses.
Corsib 10 mg are dark pink, round, flat tablets with a score line on one side and the number "10" embossed on the other, 7 mm in diameter.
The tablet can be divided into equal doses.
Pack sizes: 10, 20, 28, 30, 50, 60, 90, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer:
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovakia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Slovakia: Bisoprolol Medreg 2.5 mg
Bisoprolol Medreg 5 mg
Bisoprolol Medreg 10 mg
Czech Republic: Bisoprolol Medreg
Poland: Corsib
Romania: Bisoprolol Gemax Pharma 2.5 mg comprimate
Bisoprolol Gemax Pharma 5 mg comprimate
Bisoprolol Gemax Pharma 10 mg comprimate