Biosotal 40

Package Leaflet: Information for the Patient

BIOSOTAL 40,40 mg, tablets
BIOSOTAL 80,80 mg, tablets
Sotalol Hydrochloride

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

• Keep this leaflet, you may need to read it again.
• 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 side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Biosotal and what is it used for

Biosotal 40 and Biosotal 80 are available in tablet form and contain the active substance sotalol. Sotalol belongs to the group of non-selective beta-adrenergic blocking agents. Sotalol is used in heart rhythm disorders and has anti-arrhythmic effects characteristic of class II and III anti-arrhythmic drugs.
Sotalol slows down the accelerated heart rate, reduces the heart muscle's need for oxygen, and lowers blood pressure.
Biosotal is used in:

• life-threatening ventricular arrhythmias,
• supraventricular arrhythmias: atrial fibrillation and atrial flutter, supraventricular tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia,
• arrhythmias in Wolff-Parkinson-White syndrome.

2. Important Information Before Taking Biosotal

When Not to Take Biosotal:

• if the patient is allergic to sotalol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has an untreated pheochromocytoma,
• if the patient has experienced arrhythmias of the torsade de pointes type,
• if the patient has hypotension not caused by arrhythmia,
• if the patient has asthma or chronic obstructive pulmonary disease,
• if the patient has sick sinus syndrome (including sinoatrial block), in patients without a pacemaker,
• if the patient has bradycardia (heart rate below 45-50 beats/min),
• if the patient has atrioventricular block of second and third degree (in patients without a pacemaker),
• if the patient has congenital or acquired QT interval prolongation,
• if the patient has experienced cardiogenic shock,
• if the patient has experienced Raynaud's syndrome or severe peripheral circulatory disorders,
• if the patient has experienced metabolic acidosis,
• if the patient has severe renal impairment (creatinine clearance <10 ml min)< li>
• if the patient has experienced uncontrolled heart failure,
• if the patient has experienced Prinzmetal's angina,
• if the patient has been given anesthesia that causes cardiac inhibition,
• if the patient is taking medications that may cause torsade de pointes:
• class Ia anti-arrhythmic drugs (quinidine, procainamide, disopyramide),
• class III anti-arrhythmic drugs (amiodarone, dronedarone),
• drugs used to treat depression and anxiety disorders, such as citalopram, escitalopram,
• other drugs, such as difemanil, intravenous erythromycin, mizolastine, intravenous spiramycin, intravenous vincamine, intravenous dolasetron, domperidone, hydroxyzine, mequitazine, arsenic, moxifloxacin, piperacillin, prucalopride, toremifene, vandetanib (see section Biosotal and other medicines).

Warnings and Precautions

Before starting treatment with Biosotal, discuss it with your doctor or pharmacist.
Do not suddenly stop taking Biosotal, especially in patients with coronary heart disease. Suddenly stopping treatment may worsen coronary heart disease, disrupt heart rhythm, or even lead to myocardial infarction or death. Before stopping treatment, consult your doctor.
During long-term use, every 1-2 months, an ECG and electrolyte levels in the blood should be performed.
The most dangerous side effect of anti-arrhythmic drugs is the exacerbation of existing arrhythmias or the induction of new arrhythmias.
Drugs that prolong the QT interval, including Biosotal, may cause arrhythmias of the torsade de pointes type. The frequency of torsade de pointes is dose-dependent.
It usually occurs at the beginning of treatment and during dose increases. It occurs more frequently in women.
In patients with hypokalemia and hypomagnesemia (low potassium and magnesium levels) before taking Biosotal, the levels of the respective electrolytes should be corrected.
Caution should be exercised when treating patients with congestive heart failure with Biosotal. Treatment should be started with the lowest possible dose and increased cautiously.
Caution should be exercised when treating patients with Biosotal after myocardial infarction and with left ventricular dysfunction.
In case of bradycardia (slow heart rate) during treatment, consult your doctor.
Caution should be exercised in patients with first-degree atrioventricular block.
Beta-adrenergic blocking agents may enhance anaphylactic reactions. Patients may not respond to adrenaline doses used to treat allergic reactions.
In unstable diabetes, the drug may mask the initial symptoms of hypoglycemia, such as tachycardia (rapid heart rate), palpitations, and excessive sweating. At the beginning of treatment, blood glucose levels should be monitored more frequently.
Biosotal may mask the cardiovascular symptoms of hyperthyroidism.
The dose of the drug should be reduced in patients with renal impairment.
Before administering general anesthetics, inform the anesthesiologist about taking Biosotal.
Beta-adrenergic blocking agents may exacerbate psoriasis, so before taking Biosotal, consult your doctor.
In elderly patients, it is necessary to strictly follow the contraindications. Treatment should be started with a low dose and very close monitoring of the patient's condition is required.
Biosotal contains an active substance that may give positive results in doping tests for athletes.

Children and Adolescents

The safety and efficacy of Biosotal in children have not been established.

Biosotal and Other Medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of sotalol with the following is contraindicated:

• drugs that cause torsade de pointes, such as amiodarone, disopyramide, quinidine (except for antiparasitic, neuroleptic, methadone, hydroxychloroquine)

Concomitant use of sotalol with the following is not recommended:

• fingolimod (an immunomodulatory drug used to treat multiple sclerosis),
• neuroleptics that may cause torsade de pointes, such as amisulpride, haloperidol,
• calcium channel blockers, such as verapamil and diltiazem (drugs used to treat arrhythmias),
• antiparasitic drugs that may cause torsade de pointes, such as chloroquine, halofantrine (drugs used to treat malaria), pentamidine (a drug used to treat pneumonia), hydroxychloroquine (a drug used to treat musculoskeletal disorders),
• methadone (a drug used to treat cough, pain, and heroin addiction).

Caution should be exercised when taking sotalol with the following:

• inhaled halogenated anesthetics (agents used for general anesthesia), inform the anesthesiologist about taking Biosotal
• azithromycin (an antibiotic),
• drugs that cause bradycardia,
• propafenone (an anti-arrhythmic drug),
• centrally acting antihypertensive drugs (clonidine, methyldopa, moxonidine, rilmenidine): there may be a significant increase in blood pressure in case of sudden discontinuation of centrally acting antihypertensive treatment. Sudden discontinuation of centrally acting antihypertensive treatment should be avoided,
• drugs that cause potassium loss, such as diuretics, laxatives that stimulate peristalsis, intravenous amphotericin B (a drug used to treat fungal infections), systemic corticosteroids (anti-inflammatory drugs),
• insulin and oral hypoglycemic agents,
• intravenous lidocaine,
• fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin),
• beta-adrenergic blocking agents used in heart failure (bisoprolol, carvedilol, metoprolol, nebivolol),
• ondansetron (an antiemetic), anagrelide (a drug used to treat thrombocytosis), clarithromycin, roxithromycin (antibiotics).

Consider concomitant use of sotalol with:

• non-steroidal anti-inflammatory drugs (NSAIDs),
• dihydropyridine derivatives, such as amlodipine, felodipine,
• intravenous dipyridamole,
• alpha-adrenergic blocking agents used in urology, such as alfuzosin, tamsulosin,
• antihypertensive drugs that block alpha-adrenergic receptors (urapidil),
• drugs that cause orthostatic hypotension.

Pregnancy and Breastfeeding

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. The medicine should only be used if the expected benefits to the mother outweigh the risks to the fetus.
Breastfeeding
Before taking the medicine, consult your doctor. Breastfeeding is not recommended during treatment with sotalol.

Driving and Using Machines

The medicine may cause dizziness and headaches in some people, especially during the initial treatment period. This may temporarily impair the ability to drive vehicles and operate machinery.

Biosotal Contains Lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to Take Biosotal

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Swallow the tablets whole.
Treatment starts with 80 mg per day, increasing the daily dose every 2-3 days by 40 mg (the steady-state concentration of the drug in the blood is reached after 5-6 doses).
The daily dose of sotalol in arrhythmias is from 120 mg to 480 mg.
The daily dose is usually divided into two doses: the drug is best taken in the morning and evening, 1 hour before meals.
Dosing in renal impairment:
It is recommended to reduce the dose by increasing the intervals between doses. In case of creatinine clearance 30-60 ml/min, one daily dose should be omitted. In case of creatinine clearance 10-30 ml/min, doses are given every 36-48 hours.
In case of creatinine clearance below 10 ml/min, the drug should not be used.
Liver disease does not require dose adjustment.
In elderly patients, the half-life of the drug may be prolonged, which increases the drug concentration in the blood.
The drug should be discontinued gradually, by gradually reducing the dose (sudden discontinuation may be dangerous).
If you feel that the effect of Biosotal is too strong or too weak, consult your doctor.

Taking a Higher Than Recommended Dose of Biosotal

The most common symptoms are: bradycardia (slow heart rate), congestive heart failure, hypotension, bronchospasm, hypoglycemia (low blood sugar), and seizures (including hypoglycemic seizures).
In case of overdose, immediately consult a doctor or go to the emergency department of the nearest hospital.
In case of significant overdose, the following have been observed: bradycardia (slow heart rate), QT interval prolongation, torsade de pointes, ventricular tachycardia, cardiac arrest.
Treatment of overdose: immediately discontinue sotalol and remain under close medical supervision. Sotalol does not bind to plasma proteins and can be removed from the bloodstream by hemodialysis.
Close monitoring of the patient should be continued until the QT interval is normalized and the heart rate returns to >50/min.

Missing a Dose of Biosotal

In case of missing one dose, take it as soon as possible, unless it is close to the time of the next dose. Do not take a double dose to make up for the missed dose. If in doubt, consult your doctor.
In case of any further doubts about the use of this medicine, consult your doctor.

4. Possible Side Effects

Like all medicines, Biosotal can cause side effects, although not everybody gets them.
Side effects are usually temporary and do not require discontinuation of treatment, usually disappearing after dose reduction.
The most serious side effect of sotalol is the induction of arrhythmias, including torsade de pointes.
Common (less than 1 in 10 people)

• edema, fatigue, asthenia (chronic fatigue)
• dizziness, headache, insomnia, paresthesia (partial paralysis of a body part or skin surface), taste disturbances
• muscle cramps
• nausea, vomiting, diarrhea, dyspepsia, abdominal pain, bloating
• proarrhythmic effect, torsade de pointes, heart failure, bradycardia (slow heart rate), chest pain, palpitations, syncope, presyncope
• hypotension, Raynaud's syndrome, worsening of peripheral vascular disease
• depression, anxiety disorders
• skin changes similar to psoriasis or exacerbation of existing psoriasis symptoms
• dyspnea
• changes in ECG recording.

Frequency not known (frequency cannot be estimated from available data)

• abnormally low platelet count in the blood
• excessive hair loss
• excessive sweating
• fever
• sexual dysfunction
• vision disturbances.

In rare cases, the development of antinuclear antibodies has been reported, which are only occasionally accompanied by clinical symptoms of a lupus-like syndrome, disappearing after discontinuation of treatment.
Laboratory tests
The presence of sotalol in urine may increase the results of urinary metanephrine measurement by photometric method. Patients who are suspected of having a pheochromocytoma and are taking sotalol will be prescribed to measure metanephrine by liquid chromatography.

Reporting Side Effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Biosotal

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
There are no special precautions for storage.
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 Biosotal Contains

• The active substance of the medicine is sotalol. Each Biosotal 40 tablet contains 40 mg of sotalol (as hydrochloride). Each Biosotal 80 tablet contains 80 mg of sotalol (as hydrochloride).
• The excipients are: lactose monohydrate, potato starch, microcrystalline cellulose, povidone (K-25), magnesium stearate, talc.

What the Pack Contains

Biosotal 40: tablet, round, 6 mm in diameter, flat on both sides, white or almost white color
Biosotal 80: tablet, round, 8 mm in diameter, flat on both sides, white or almost white color
The pack contains 60 Biosotal 40 tablets or 30 Biosotal 80 tablets, packaged in PVC/Al blisters of 10 tablets each, in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Opella Healthcare Poland Sp. z o.o.
Rzeszów Branch
ul. Lubelska 52
35-233 Rzeszów, Poland
Temmler Pharma GmbH
Temmlerstrasse 2
35039 Marburg, Germany
To obtain more detailed information, contact:
Komtur Polska Sp. z o.o.
phv@komtur.com

Date of Last Revision of the Leaflet: