Corectin 5

Package leaflet: Information for the user

CORECTIN 5
5 mg, film-coated tablets
CORECTIN 10
10 mg, film-coated tablets
Bisoprolol fumarate
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. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Corectin is and what it is used for

The active substance in 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, particularly in the heart. As a result, bisoprolol slows down the heart rate and improves the heart's efficiency in pumping blood throughout the body.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.
Corectin is used in the treatment of high blood pressure, angina pectoris, and stable chronic heart failure (in combination with other medicines appropriate for the treatment of heart failure, such as angiotensin-converting enzyme (ACE) inhibitors, diuretics, and cardiac glycosides).

2. Important information before using Corectin

When NOT TO USE Corectin:

• if the patient is allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has acute heart failure or sudden worsening of heart failure requiring hospital treatment;
• if the patient has severe heart function disorders causing low blood pressure and circulatory problems (cardiogenic shock);
• if the patient has serious heart rhythm disorders causing 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 pressure < 90 mmHg);
• if the patient has breathing difficulties or wheezing (severe bronchial asthma or severe chronic obstructive pulmonary disease);
• if the patient has severe circulatory disorders in the limbs that may cause tingling, paleness or blueness of fingers and toes (e.g. in Raynaud's syndrome);
• if the patient has untreated phaeochromocytoma (a rare tumour of the adrenal gland causing high blood pressure);
• if the patient has excessive accumulation of acids in the body (metabolic acidosis) – the doctor will provide detailed information on this;
• if the patient is concurrently taking floctafénine or sultopride – detailed information is provided in the section "Corectin and other medicines".

If in doubt about any of the above conditions, consult a doctor.
Warnings and precautions
Before starting treatment with Corectin, consult a doctor:

• if the patient has severe liver or kidney dysfunction. The doctor may recommend lower doses – see also section 3 "How to take Corectin";
• if the patient has heart failure. In such patients, treatment with bisoprolol should be initiated very carefully under strict medical supervision. Treatment starts with low doses, gradually increased to the appropriate dose for the patient;
• if the patient has diabetes and is taking blood sugar-lowering medicines. Bisoprolol tablets may mask 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. Bisoprolol may increase sensitivity to allergens and worsen allergic reactions;
• if the patient is or has been treated for adrenal phaeochromocytoma;
• if the patient has hyperthyroidism. Bisoprolol tablets may mask symptoms of hyperthyroidism;
• if the patient has bronchial asthma or chronic obstructive pulmonary disease;
• if the patient is not taking solid food (undergoing strict fasting);
• if the patient has any less serious heart rhythm disorders or slow heart rate;
• if the patient has Prinzmetal's angina (a type of chest pain caused by spasm of the coronary arteries supplying the heart muscle). Bisoprolol tablets 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 beginning of treatment;
• if the patient is scheduled for surgery under anaesthesia – inform the doctor, hospital staff or dentist about all medicines being taken.

The medicine contains an active substance that may produce positive results in anti-doping tests in athletes.
Children and adolescents
Use of the medicine is not recommended due to lack of experience with bisoprolol in children and adolescents.
Corectin and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor if you are taking any of the following medicines:

• floctafénine (used for pain and joint inflammation) – in this case, do not take Corectin simultaneously.
• sultopride (used to treat serious mental disorders) – in this case, do not take Corectin simultaneously.
• medicines used to treat high blood pressure or heart disorders, e.g.: other beta-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 drugs);
• medicines used for depression and mental disorders, such as tricyclic antidepressants, phenothiazine derivatives, monoamine oxidase inhibitors (MAO inhibitors) and barbiturates;
• anaesthetics used during surgical or dental procedures and iodine-containing contrast agents 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), e.g.: diclofenac, ibuprofen, naproxen;
• antimalarial medicines, e.g. mefloquine;
• anti-migraine medicines, e.g. ergotamine, dihydroergotamine;
• medicines used to treat glaucoma (e.g. beta-blocking agents in eye drops) or to dilate the pupil (e.g. physostigmine, atropine);
• medicines used for asthma (e.g. salmeterol, formoterol, budesonide);
• medicines used to treat nasal congestion (e.g. pseudoephedrine);
• corticosteroids used to treat joint inflammation and inflammatory conditions of other organs (e.g. hydrocortisone, prednisone);
• baclofen – a muscle relaxant;
• rifampicin – an antibiotic (e.g. used in tuberculosis treatment).

All the above medicines may affect blood pressure and/or heart function.
Bisoprolol, when taken together with insulin or other medicines used to treat diabetes, may mask 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 worsen dizziness and the sensation of "emptiness" in the head caused by Corectin.
In such cases, alcohol consumption should be avoided.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Corectin may harm the pregnancy and/or the foetus. There is an increased risk of premature birth, miscarriage, low blood sugar and slowed heart rate in the foetus or newborn. The medicine may also affect foetal or neonatal development.
Therefore, Corectin should not be taken during pregnancy unless absolutely necessary.
Breastfeeding
It is not known whether bisoprolol passes into breast milk, and therefore breastfeeding should not be undertaken during treatment with Corectin.
Driving and using machines
The medicine may cause fatigue, drowsiness or dizziness. If such adverse effects occur, do not drive or operate machinery. Be aware of the possibility of such effects, especially at the beginning of treatment, during dose changes, changes in other medicines taken, or when consuming alcohol.

3. How to use Corectin

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Regular medical check-ups are necessary during treatment with Corectin. This is particularly important at the beginning of treatment, when increasing the dose, and when stopping treatment.

Dosage

Hypertension and angina pectoris
Your doctor will determine the appropriate dose for you.

Adults

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

Chronic stable heart failure
Treatment with Corectin is usually long-term.

Adults, including elderly patients
Your doctor will start bisoprolol treatment at a low dose and gradually increase it – your doctor will decide how to adjust the dose. Typically, this is done as follows:

• 1.25 mg bisoprolol once daily for the first week (to achieve this dose, other medications must be used – a dose of 1.25 mg cannot be obtained with Corectin)
• 2.5 mg bisoprolol once daily for the next week
• 3.75 mg bisoprolol once daily for the following week (to achieve this dose, other medications must be used – a dose of 3.75 mg cannot be obtained with Corectin)
• 5 mg bisoprolol once daily for 4 weeks
• 7.5 mg bisoprolol once daily for 4 weeks
• 10 mg bisoprolol once daily for long-term (chronic) maintenance treatment.

The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how well the medicine is tolerated, your doctor may decide to extend the interval before the next dose increase. If your condition worsens or if the medicine is not well tolerated, it may be necessary to reduce the dose again or discontinue treatment. For 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 stopped, your doctor will usually recommend gradually reducing the dose. Otherwise, your condition may worsen.

Patients with impaired kidney function
Patients with severe kidney dysfunction should not take more than 10 mg. Consult your doctor before starting this medicine.

Patients with impaired liver function
Patients with severe liver dysfunction should not take more than 10 mg. Consult your doctor before starting this medicine.

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

Method of administration

• Tablets should be taken once daily, in the morning, on an empty stomach or with food.
• Swallow the tablets with water.
• The tablet may be divided into two equal doses.

Duration of treatment
The length of treatment is not limited. It depends on the nature and severity of the condition.
Your doctor will determine how long you should take Corectin.

Taking more than the recommended dose of Corectin
If you accidentally take more than the recommended dose, contact your doctor immediately. Take any remaining tablets or this leaflet with you so that medical personnel know which medicine has been 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, low blood pressure, heart failure, and decreased blood glucose levels (which may manifest as hunger, sweating, and palpitations).

Missed dose of Corectin
Do not take a double dose to make up for a missed dose.
If you miss a dose, take the tablet within the next 12 hours. If more than 12 hours have passed, do not take the missed dose; instead, take the next dose at the usual time.

Stopping treatment with Corectin
Treatment with Corectin MUST NOT be stopped suddenly, especially in patients with angina pectoris or after a heart attack. Abruptly stopping treatment may worsen the patient's condition or cause blood pressure to rise again. To avoid this, the dose must be gradually reduced over several weeks, as directed by your doctor.

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 will experience them.
To prevent serious adverse reactions, you should contact your doctor if adverse symptoms
are severe, occur suddenly, or worsen rapidly.
The most serious adverse reactions are related to heart function:

• Slowing of 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 heartbeat (uncommon – occurs in 1 to 10 in 1,000 people).

If dizziness, weakness, or difficulty breathing occurs, you should contact your doctor as
quickly as possible.
Other adverse reactions are listed below, according to their frequency of occurrence.
Common (occur in 1 to 10 in 100 people):

• Feeling of fatigue, dizziness, headache (especially at the beginning of treatment – these symptoms are usually mild and often resolve within 1-2 weeks)
• Sensation of coldness or numbness in the upper and/or lower limbs
• Pain, paleness, or blueness of hands and/or feet
• Increased occurrence of leg cramps during walking – in patients with intermittent claudication
• Nausea and vomiting
• Diarrhoea
• Constipation
• Low blood pressure
• Feeling of weakness (exhaustion)

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

• Sleep disturbances
• Depression
• Drop in blood pressure when changing position from lying down to standing up or upon sudden rising (orthostatic hypotension)
• Breathing difficulties – in patients with bronchial asthma or a history of breathing disorders
• Muscle weakness, painful muscle cramps
• Joint degeneration

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

• Low blood sugar levels – a condition which may manifest, among others, as increased heart rate or palpitations, excessive sweating. Note: Corectin may cause lack of awareness of these symptoms (so-called symptom masking).
• Nightmares
• Hallucinations
• Fainting
• Dry eyes due to reduced tear production (can be very bothersome if the patient wears contact lenses)
• Hearing disturbances
• Inflammation of the nasal mucosa causing runny nose with irritation
• Liver inflammation causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of eyes and skin, and dark urine
• Allergic reactions (itching, rash, transient and sudden flushing of the face)
• Reduced sexual performance
• Changes in blood test results (increased levels of triglycerides (fats) in the blood, increased liver enzyme activity)

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

• Conjunctivitis (itching and redness of the eyes)
• Worsening of psoriasis or development of similar dry, scaly rash
• Hair loss (alopecia)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can 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
e-mail: [email protected]
Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. How to store Corectin

Store in the original packaging, at a temperature not exceeding 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Corectin contains

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

tablet core: microcrystalline cellulose, pregelatinized starch, crospovidone, colloidal anhydrous silica, magnesium stearate;
coating composition: 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 additionally contains yellow iron oxide (E 172).

What Corectin looks like and contents of the pack
Corectin 5
White, round, biconvex coated tablets with a smooth surface, scored on one side.
Corectin 10
Yellow, round, biconvex coated tablets with a smooth surface, scored on one side.
The tablets are packed in PVC/PVDC/Aluminium blisters placed in a cardboard box.
Pack sizes contain either 30 or 60 coated tablets.
Not all pack sizes may be marketed.

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