Corectin 5

Leaflet accompanying the packaging: information for the user

CORECTIN 5

5 mg, film-coated tablets

CORECTIN 10

10 mg, film-coated tablets

Bisoprolol fumarate

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Corectin and what is it used for

The active substance of Corectin is bisoprolol fumarate. 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 heart's efficiency in pumping blood throughout the body.
Heart failure occurs when the heart muscle is weak and cannot pump enough blood to meet the body's needs.
Corectin is used to treat high blood pressure, angina pectoris, and stable, chronic heart failure (in combination with other medicines suitable for the treatment of heart failure, such as ACE inhibitors, diuretics, and cardiac glycosides).

2. Important information before taking Corectin

When NOT to take Corectin:

• if the patient is allergicto bisoprolol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has acute heart failureor acute exacerbation of heart failurerequiring hospital treatment;
• if the patient has severe heart function disordersthat cause low blood pressure and circulation disorders (cardiogenic shock);
• if the patient has severe heart rhythm disordersthat cause slow or irregular heartbeat;
• if the patient has slow heart rate(bradycardia) below 50 beats per minute before starting Corectin;
• if the patient has very low blood pressure(systolic blood pressure <90 mmhg);< li>
• if the patient experiences breathing difficultiesor wheezing(severe asthma or severe chronic obstructive pulmonary disease);
• if the patient has severe circulatory disorders in the limbsthat may cause tingling, pallor, or cyanosis of the fingers and toes (such as Raynaud's syndrome);
• if the patient has an untreated pheochromocytoma(a rare tumor in the adrenal gland that causes high blood pressure);
• if the patient has excessive acid accumulationin the body (metabolic acidosis) - the doctor will provide more information on this;
• if the patient is taking floctafenineor sultopride- see "Corectin and other medicines" for more information.

In case of doubts about the above conditions, consult a doctor.

Warnings and precautions

Before taking Corectin, consult a doctor:

• if the patient has severe liver or kidney function disorders. The doctor may recommend a lower dose of the medicine - see also section 3 "How to take Corectin";
• if the patient has heart failure. In these patients, bisoprolol treatment should be initiated with caution, under close medical supervision. Treatment starts with a low dose, which is then gradually increased to the appropriate dose for the patient;
• if the patient has diabetesand is taking medicines to lower blood sugar levels. Bisoprolol may mask the symptoms of low blood sugar;
• if the patient has or has had psoriasis(a recurring skin disease characterized by scaling, dryness, and rash);
• if the patient is being treated for allergic reactions(allergies). Bisoprolol may increase sensitivity to allergens and exacerbate allergic reactions;
• if the patient is or has been treated for pheochromocytoma;
• if the patient has hyperthyroidism. Bisoprolol may mask the symptoms of hyperthyroidism;
• if the patient has asthmaor chronic obstructive pulmonary disease;
• if the patient is not eating solid food (is on a strict fast);
• if the patient has any less severe heart rhythm disordersor slow heart rate;
• if the patient has Prinzmetal's angina(a type of chest pain caused by coronary artery spasm). Bisoprolol may increase the frequency and duration of angina attacks;
• if the patient has any less severe circulatory disorders in the limbs(hands and feet), as the medicine may worsen symptoms, especially at the start of treatment;
• if the patient is to undergo anesthesia- inform the doctor, hospital staff, or dentist about all medicines being taken.

The medicine contains an active substance that can give a positive result in doping tests for athletes.

Children and adolescents

The use of the medicine is not recommended due to the lack of experience with bisoprolol in children and adolescents.

Corectin and other medicines

Tell the doctor or pharmacist about all medicines currently being taken or recently taken, as well as any medicines planned to be taken.
In particular, inform the doctor about taking any of the following medicines:

• floctafenine(used for pain and inflammation of the joints) - in this case, do nottake Corectin at the same time.
• sultopride(used to treat severe mental disorders) - in this case, do nottake Corectin at the same time.
• medicines used to treat high blood pressure or heart disorders, such as other beta-adrenergic blockers, amiodarone, verapamil, diltiazem, amlodipine, nifedipine, clonidine, methyldopa, moxonidine, rilmenidine, disopyramide, lidocaine, quinidine, digoxin, dobutamine, isoprenaline, adrenaline;
• medicines used to treat diabetes(e.g., insulin, oral antidiabetic medicines);
• medicines used to treat depression and mental disorders, such as tricyclic antidepressants, phenothiazine derivatives, monoamine oxidase inhibitors (MAOIs), and barbiturates;
• anestheticsused during surgical or dental procedures, as well as contrast agentscontaining iodine used in radiological examinations;
• medicines used to treat Alzheimer's disease(e.g., tacrine, donepezil, rivastigmine) or myasthenia gravis(e.g., pyridostigmine, neostigmine);
• anti-inflammatory medicines, known as NSAIDs (non-steroidal anti-inflammatory drugs), such as diclofenac, ibuprofen, naproxen;
• antimalarial medicines, such as mefloquine;
• antimigraine medicines, such as ergotamine, dihydroergotamine;
• medicines used to treat glaucoma(e.g., beta-adrenergic blockers in the form of eye drops) or to dilate the pupil(e.g., physostigmine, atropine);
• medicines used to treat asthma(e.g., salmeterol, formoterol, budesonide);
• medicines used to treat nasal congestion(e.g., pseudoephedrine);
• corticosteroidsused to treat arthritis and inflammation of other organs(e.g., hydrocortisone, prednisone);
• baclofen- a muscle relaxant;
• rifampicin- an antibiotic (used, for example, in tuberculosis).

All of the above medicines may affect blood pressure and/or heart function.
Bisoprolol, when taken with insulin or other diabetes medicines, may mask the symptoms of low blood sugar.

Corectin with food, drink, or alcohol

Take the medicine in the morning, on an empty stomach or with food.
Swallow the tablets with water.
Alcohol may increase the dizziness and feeling of "emptiness" in the head caused by Corectin.
In this case, avoid consuming alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Corectin may harm the pregnancy and/or the fetus. There is an increased risk of premature birth, miscarriage, low blood sugar, and slow heart rate in the fetus or newborn. The medicine may also affect the development of the fetus or newborn.
For this reason, do not take Corectin during pregnancy unless absolutely necessary.
Breastfeeding
It is not known whether bisoprolol passes into breast milk, and therefore, breastfeeding should be avoided while taking Corectin.

Driving and using machines

The medicine may cause fatigue, drowsiness, or dizziness. If such effects occur, do not drive vehicles or operate machines. Be aware of the possibility of these effects, especially at the start of treatment, when changing the dose of the medicine, or when taking other medicines, and when consuming alcohol.

3. How to take Corectin

Always take this medicine exactly as the doctor has told you. If you are not sure, consult a doctor or pharmacist.
During treatment with Corectin, regular medical check-ups are necessary. This is especially important at the start of treatment, when increasing the dose, and when stopping treatment.

Dosage

Hypertension and angina pectoris
The doctor will determine the dose of the medicine suitable for the patient.
Adults

• Usually, treatment starts with a dose of 5 mg.
• If necessary, the doctor may gradually increase the dose of the medicine.
• In milder cases of hypertension (diastolic blood pressure up to 105 mmHg), a dose of 2.5 mg may be appropriate.
• The maximumrecommended dose is 20 mg.

Stable, chronic heart failure
Corectin treatment is usually long-term.
Adults, including the elderly
The doctor will start treatment with bisoprolol at a low dose, which will then be 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 the first week (to achieve this dose, other medicines must be used - it is not possible to achieve a dose of 1.25 mg with Corectin)
• 2.5 mg of bisoprolol once a day for the next week
• 3.75 mg of bisoprolol once a day for the next week (to achieve this dose, other medicines must be used - it is not possible to achieve a dose of 3.75 mg with Corectin)
• 5 mg of bisoprolol once a day for 4 weeks
• 7.5 mg of bisoprolol once a day for 4 weeks
• 10 mg of bisoprolol once a day for maintenance (chronic) treatment.

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how the medicine is tolerated, the doctor may recommend extending 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 maintenance dose lower than 10 mg of bisoprolol may be sufficient.
The doctor will determine the appropriate course of action.
In case of stopping treatment, the doctor usually recommends gradually reducing the dose of the medicine, otherwise, the disease may worsen.
Patient with kidney function disorders
Patient with severe kidney function disorders should not take a dose higher than 10 mg. Consult a doctor before starting treatment with this medicine.
Patient with liver function disorders
Patient with severe liver function disorders should not take a dose higher than 10 mg. Consult a doctor before starting treatment with this medicine.
Use in children and adolescents
The use of the medicine is not recommended due to the lack of experience with bisoprolol in children and adolescents.

Method of administration

• Take the tablets once a day, in the morning, on an empty stomach or with food.
• Swallow the tablets with water.
• The tablet can be divided into two equal doses.

Duration of treatment

The duration of treatment is not limited. It depends on the nature and severity of the disease.
The doctor will determine how long the patient should take Corectin.

Taking a higher dose of Corectin than recommended

In case of accidentally taking a higher dose of the medicine than recommended, consult a doctor immediately. Take the remaining tablets or this leaflet with you, so the medical staff knows what medicine was taken.
Symptoms of overdose include dizziness, feeling of "emptiness" in the head, fatigue, shortness of breath, and (or) wheezing. There may also be a slowing of the heart rate, a decrease in blood pressure, heart failure, and a decrease in blood glucose levels (which may cause feelings of hunger, sweating, and palpitations).

Missing a dose of Corectin

Do not take a double dose to make up for a missed dose.
If a dose is missed, take a tablet within the next 12 hours. If more than 12 hours have passed, do not take the missed dose, just take the next one at the usual time.

Stopping treatment with Corectin

Treatment with Corectin should NOTbe stopped suddenly, especially in patients with angina pectoris or after a heart attack. Abrupt cessation of treatment may worsen the patient's condition or increase blood pressure again. To avoid this, the dose of the medicine should be gradually reduced over several weeks, according to the doctor's instructions.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Corectin can cause side effects, although not everybody gets them.
To prevent serious side effects, consult a doctor if the side effects are severe, sudden, or worsening.
The most serious side effects are related to heart function:

• slow heart rate (very common - occurs in more than 1 in 10 people),
• worsening of heart failure causing increased shortness of breath and (or) fluid retention (common - occurs in 1 to 10 in 100 people),
• slow or irregular heart rate (uncommon - occurs in 1 to 10 in 1,000 people).

In case of dizziness, weakness, or breathing difficulties, consult a doctor as soon as possible.
Other side effects are presented below, according to their frequency.
Common(occurs in 1 to 10 in 100 people):

• feeling of fatigue, dizziness, headache (especially at the start of treatment - these symptoms are usually mild and often disappear within 1-2 weeks)
• feeling of coldness or numbness in the upper and (or) lower limbs
• pain, pallor, or cyanosis of the hands and (or) feet
• more frequent occurrence of leg cramps while walking - in patients with intermittent claudication
• nausea and vomiting
• diarrhea
• constipation
• low blood pressure
• feeling of weakness (exhaustion)

Uncommon(occurs in 1 to 10 in 1,000 people):

• sleep disorders
• depression
• decrease in blood pressure when changing body position from lying to standing or when getting up quickly (orthostatic hypotension)
• breathing difficulties - in patients with asthma or a history of breathing disorders
• muscle weakness, painful muscle cramps
• joint degeneration

Rare(occurs in 1 to 10 in 10,000 people):

• low blood sugar- a condition that may cause symptoms such as rapid or irregular heartbeat, increased sweating. Note: Corectin may mask the symptoms of low blood sugar (so-called masking of symptoms).
• nightmares
• hallucinations
• fainting
• dryness of the eyes caused by reduced tear secretion (may be very troublesome, especially if the patient wears contact lenses)
• hearing disorders
• inflammation of the nasal mucosa, causing a runny nose with irritation
• inflammation of the liver, causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the eyes and skin, as well as dark urine
• allergic reactions (itching, rash, sudden and temporary flushing of the face)
• decreased sexual potency
• changes in blood test results (increased triglyceride levels in the blood, increased liver enzyme activity)

Very rare(occurs in less than 1 in 10,000 people):

• inflammation of the conjunctiva (itching and redness of the eyes)
• worsening of psoriasis or development of a similar, dry, and scaly rash
• hair loss (alopecia)

Reporting side effects

If any side effects occur, including any not listed in this leaflet, tell a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, e-mail: [email protected]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Corectin

Store in the original packaging, at a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask a 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 Corectin contains

• The active substance of Corectin is bisoprolol fumarate. Corectin 5 One film-coated tablet contains 5 mg of bisoprolol fumarate. Corectin 10 One film-coated tablet contains 10 mg of bisoprolol fumarate.
• Other ingredients are:

tablet core:microcrystalline cellulose, pregelatinized starch, crospovidone, colloidal anhydrous silica, magnesium stearate;
coating:Aqua Polish white 010.12 C [hypromellose 6 cps, hypromellose 50 cps, macrogol 6000, polysorbate 20, talc, calcium carbonate, titanium dioxide (E 171)].
Corectin 10 also contains yellow iron oxide (E 172).

What Corectin looks like and contents of the packaging

Corectin 5
White, round, biconvex film-coated tablets with a smooth surface, with a dividing line on one side.
Corectin 10
Yellow, round, biconvex film-coated tablets with a smooth surface, with a dividing line on one side.
Tablets are packaged in PVC/PVDC/Aluminum blisters, placed in a cardboard box.
The packaging contains 30 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Responsible entity and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
[email protected]

Date of last revision of the leaflet: