BIOSOTAL 40,40 mg, tablets
BIOSOTAL 80,80 mg, tablets
Sotalol hydrochloride
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 cardiac arrhythmias and has anti-arrhythmic activity characteristic of Class II and III anti-arrhythmic agents.
Sotalol slows down the accelerated heart rate, reduces the heart muscle's demand for oxygen, and lowers blood pressure.
Biosotal is used in:
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 serum should be performed.
The most dangerous side effect of anti-arrhythmic medications is the exacerbation of existing arrhythmias or the induction of new arrhythmias.
Medications that cause QT interval prolongation, 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 a history of myocardial infarction and left ventricular dysfunction with Biosotal.
If bradycardia (slow heart rate) occurs 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 medication may mask the initial symptoms of hypoglycemia, such as tachycardia (rapid heart rate), palpitations, and increased 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 medication 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 consult your doctor before taking Biosotal.
In elderly patients, it is essential to strictly follow the contraindications. Treatment should be started with a low dose, and the patient's condition should be closely monitored.
Biosotal contains an active substance that may give positive results in doping tests for athletes.
The safety and efficacy of Biosotal in children have not been established.
Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Concomitant use of sotalol with the following medications is contraindicated:
Concomitant use of sotalol with the following medications is not recommended:
Caution should be exercised when concomitantly using sotalol with the following medications:
Consider concomitant use of sotalol with:
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medication. The medication should only be used when the expected benefits to the mother outweigh the risks to the fetus.
Breastfeeding
Consult your doctor before taking the medication. Breastfeeding is not recommended during treatment with sotalol.
The medication may cause dizziness and headaches in some individuals, especially during the initial treatment period. This may temporarily impair the ability to drive vehicles and operate machinery.
If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medication.
Always take this medication exactly as your doctor has told you. If you are unsure, consult 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 medication in the blood is reached after 5-6 doses).
The daily dose of sotalol for arrhythmias is between 120 mg and 480 mg.
The daily dose is usually divided into two doses: the medication is best taken in the morning and evening, 1 hour before meals.
Dosing in renal impairment:
The dose should be reduced 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 administered every 36-48 hours.
In case of creatinine clearance below 10 ml/min, the medication should not be used.
Liver disease does not require dose adjustments.
In elderly patients, the half-life of the medication may be prolonged, increasing the concentration of the medication in the blood.
The medication should be discontinued gradually, by gradually reducing the dose (abrupt discontinuation may be hazardous).
If you feel that the effect of Biosotal is too strong or too weak, consult your doctor.
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 your 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.
In case of missing a dose, take it as soon as possible, unless it is close to the time for the next dose. Do not take a double dose to make up for the missed dose. If you have any doubts, consult your doctor.
In case of any further doubts about taking this medication, consult your doctor.
Like all medications, Biosotal can cause side effects, although not everybody gets them.
Side effects are usually temporary and do not require discontinuation of treatment; they usually resolve after reducing the dose of the medication.
The most serious side effect of sotalol is the induction of arrhythmias, including torsade de pointes.
Common (less than 1 in 10 people)
Frequency not known (frequency cannot be estimated from available data)
In rare cases, the development of antinuclear antibodies has been reported, which are only occasionally accompanied by clinical symptoms of a lupus-like syndrome, resolving after discontinuation of treatment.
Laboratory tests
The presence of sotalol in urine may falsely elevate the results of urinary metanephrine measurement by photometric methods. Patients suspected of having a pheochromocytoma and receiving sotalol should have metanephrine measured by liquid chromatography.
If you experience any side effects, including any side effects not listed in this 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 this medication.
Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging after "Expiration Date (EXP)". The expiration date refers to the last day of the specified month.
There are no special precautions for storing the medication.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.
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:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszow
ul. Lubelska 52
35-233 Rzeszow, Poland
Temmler Pharma GmbH
Temmlerstrasse 2
35039 Marburg, Germany
For more detailed information, please contact:
Komtur Polska Sp. z o.o.
phv@komtur.com
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