Corectin 10

Package Leaflet: Information for the User

CORECTIN 5

5 mg, film-coated tablets

CORECTIN 10

10 mg, film-coated tablets

Bisoprolol fumarate

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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Corectin is and what it is used for

The active substance of Corectin is bisoprolol fumarate. 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 increases the efficiency of the heart 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. Before you take Corectin

When NOT to take Corectin:

• if you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6);
• if you have acute heart failure or acute exacerbation of heart failure requiring hospital treatment;
• if you have severe heart conduction disorders, which cause low blood pressure and circulation disorders (cardiogenic shock);
• if you have severe rhythm disorders, which cause slow or irregular heartbeat;
• if you have a slow heart rate (bradycardia) below 50 beats per minute before starting treatment with Corectin;
• if you have very low blood pressure (systolic blood pressure <90 mmhg);< li>
• if you have difficulty breathing or wheezing (severe bronchial asthma or severe chronic obstructive pulmonary disease);
• if you have severe blood circulation disorders in the limbs, which may cause tingling, pallor, or cyanosis of the fingers and toes (such as Raynaud's syndrome);
• if you have an untreated phaeochromocytoma (a rare tumor of the adrenal gland that causes high blood pressure);
• if you have excessive acid accumulation in the body (metabolic acidosis) - your doctor will provide more information on this;
• if you are taking floctafenine or sultopride - see section "Corectin and other medicines" for more information.

If you are unsure about any of the above conditions, consult your doctor.

Warnings and precautions

Before starting treatment with Corectin, consult your doctor:

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

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

Children and adolescents

Corectin is not recommended for use in children and adolescents due to a lack of experience with bisoprolol in this age group.

Corectin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
In particular, tell your doctor about taking any of the following medicines:

• floctafenine(used for pain and inflammation of the joints) - in this case, do not takeCorectin at the same time.
• sultopride(used to treat severe mental disorders) - in this case, do not takeCorectin at the same time.
• medicines used to treat high blood pressure or heart disorders, such as other beta-blockers, amiodarone, verapamil, diltiazem, amlodipine, nifedipine, clonidine, methyldopa, moxonidine, rilmenidine, dyazoxide, lidocaine, quinidine, digoxin, dobutamine, isoprenaline, adrenaline;
• medicines used to treat diabetes(such as insulin or 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(such as tacrine, donepezil, rivastigmine) or myasthenia gravis(such as pyridostigmine, neostigmine);
• anti-inflammatory medicines, known as NSAIDs (non-steroidal anti-inflammatory drugs), such as diclofenac, ibuprofen, naproxen;
• antimalarial medicines, such as mefloquine;
• anti-migraine medicines, such as ergotamine, dihydroergotamine;
• medicines used to treat glaucoma(such as beta-adrenergic receptor blockers in the form of eye drops) or to dilate the pupil(such as physostigmine, atropine);
• medicines used to treat asthma(such as salmeterol, formoterol, budesonide);
• medicines used to treat nasal congestion(such as pseudoephedrine);
• corticosteroidsused to treat joint inflammation and other inflammatory conditions(such as 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 used with insulin or other medicines for diabetes, may mask the symptoms of low blood sugar.

Corectin with food, drink, and 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, you should avoid drinking alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Corectin may harm your 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 fetal development or the newborn.
For this reason, you should not take Corectin during pregnancy unless it is absolutely necessary.
Breastfeeding
It is not known whether bisoprolol passes into breast milk, and therefore, you should not breastfeed while taking Corectin.

Driving and using machines

The medicine may cause fatigue, drowsiness, or dizziness. If you experience these side effects, do not drive or operate machinery.
Be aware of the possibility of these side effects, especially at the start of treatment, when changing the dose of the medicine, or when taking other medicines, and when drinking alcohol.

3. How to take Corectin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your 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
Your doctor will determine the dose of Corectin that is right for you.
Adults

• Usually, treatment starts with a dose of 5 mg.
• If necessary, your 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 sufficient.
• The maximumrecommended dose is 20 mg.

Stable, chronic heart failure
Corectin treatment is usually long-term.
Adults, including the elderly
Your doctor will start treatment with bisoprolol at a low dose, which will then be gradually increased - your doctor will decide how to increase the dose. This is usually done as follows:

• 1.25 mg of bisoprolol once daily 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 daily for the next week
• 3.75 mg of bisoprolol once daily 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 daily for 4 weeks
• 7.5 mg of bisoprolol once daily for 4 weeks
• 10 mg of bisoprolol once daily for maintenance treatment (chronic).

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how the medicine is tolerated, your 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.
Your doctor will determine the appropriate course of action.
Patient with renal impairment
Patient with severe renal impairment should not take a dose higher than 10 mg. Consult your doctor before starting treatment with this medicine.
Patient with hepatic impairment
Patient with severe hepatic impairment should not take a dose higher than 10 mg. Consult your doctor before starting treatment with this medicine.
Use in children and adolescents
Corectin is not recommended for use in children and adolescents due to a lack of experience with bisoprolol in this age group.

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.
Your doctor will determine how long you should take Corectin.

Take more than the recommended dose of Corectin

If you accidentally take a higher dose than recommended, consult your doctor immediately. Take the remaining tablets or this leaflet with you so that the medical staff knows what medicine you have taken.
Symptoms of overdose are: dizziness, feeling of "emptiness" in the head, fatigue, shortness of breath, and (or) wheezing. There may also be a slow heart rate, low blood pressure, heart failure, and low blood sugar levels (which may cause hunger, sweating, and palpitations).

Miss a dose of Corectin

Do not take a double dose to make up for a missed dose.
If you miss a dose, 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 dose at the usual time.

Stop taking Corectin

Do not stop taking Corectin suddenly, especially if you have angina pectoris or have had a heart attack. Stopping treatment abruptly may worsen your condition or increase blood pressure. To avoid this, the dose of the medicine should be gradually reduced over several weeks, as advised by your doctor.
If you have any further questions about taking this medicine, ask your 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 your doctor if the side effects are severe, sudden, or get worse.
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 shortness of breath and (or) fluid retention (common - occurs in 1 to 10 in 100 people),
• slow or irregular heartbeat (uncommon - occurs in 1 to 10 in 1,000 people).

If you experience dizziness, weakness, or difficulty breathing, consult your doctor as soon as possible.
Other side effects are listed 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
• low blood pressure when changing position from lying down to standing or when getting up quickly (orthostatic hypotension)
• difficulty breathing - in patients with asthma or breathing difficulties in the past
• 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 heartbeat or palpitations, excessive 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 you wear 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 redness of the face)
• decreased sexual potency
• changes in blood test results (increased triglyceride levels in the blood, increased activity of liver enzymes)

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 you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring, 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: ndl@urpl.gov.pl. 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 package, 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 your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 pack

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.
The tablets are packaged in PVC/PVDC/Aluminum blisters, placed in a cardboard box.
The pack contains 30 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
biofarm@biofarm.pl

Date of last revision of the leaflet: