Sotapor 80 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sotapor 80 mg tablets

Sotalol hydrochloride

Table of contents:

1. What Sotapor 80 mg tablets are and what they are used for
2. What you need to know before taking Sotapor 80 mg tablets
3. How to take Sotapor 80 mg tablets
4. Possible side effects
5. How to store Sotapor 80 mg tablets
6. Contents of the pack and other information

1. What Sotapor 80 mg tablets are and what they are used for

Sotapor is a medicine containing an active substance called sotalol, which belongs to a group of medicines known as beta-adrenergic blocking agents or beta-blockers.

Sotapor 80 mg tablets are indicated for the treatment of cardiac rhythm disorders:

• Ventricular arrhythmias:

• Treatment of life-threatening ventricular tachyarrhythmias.

• Treatment of symptomatic non-sustained ventricular tachyarrhythmias.

  • Supraventricular arrhythmias:

• Prophylaxis of paroxysmal atrial tachycardia, paroxysmal atrial fibrillation, paroxysmal A-V nodal re-entrant tachycardia, paroxysmal A-V re-entrant tachycardia involving accessory pathways, and paroxysmal supraventricular tachycardia following cardiac surgery.

• Maintenance of sinus rhythm after conversion from atrial fibrillation or atrial flutter.

2. What you need to know before taking Sotapor 80 mg tablets

Do not take Sotapor:

• If you are allergic (hypersensitive) to sotalol, sulfonamides, or any of the other components of Sotapor.
• If you have asthma, shortness of breath, or other chronic lung diseases (such as chronic obstructive pulmonary disease - COPD).
• If you have a very slow heart rate (less than 50 beats per minute).
• If you have any heart conditions, such as sinus disease (including sino-atrial block) without a pacemaker, second- or third-degree A-V heart block in patients without a pacemaker, long QT syndrome (hereditary or acquired), torsades de pointes (a serious heart rhythm disorder), cardiogenic shock, uncontrolled heart failure, or Prinzmetal's angina.
• If you have severe kidney disease.
• If you have untreated pheochromocytoma.
• If you have low blood pressure not associated with arrhythmia (abnormal heart rhythm).
• If you have severe peripheral circulatory disorders (Raynaud's syndrome).
• If you are scheduled for surgery with anesthesia, inform your doctor.
• If you have metabolic acidosis.
• If you are taking medications that may affect heart rhythm (cause torsades de pointes), such as certain antiarrhythmics (quinidine, hydroquinidine, disopyramide, amiodarone, dronedarone…), certain medications used to treat mental health conditions (chlorpromazine, levomepromazine, trifluoperazine, haloperidol, tiapride…), certain antidepressants, certain antibiotics (fluoroquinolones, macrolides…), or other medicines such as cisapride, domperidone, etc.
• If you are taking floctafénine (for pain treatment).

Warnings and precautions

Talk to your doctor or pharmacist before starting Sotapor.

Abrupt discontinuation of treatment should be avoided. The dose should be gradually reduced, especially if you have angina pectoris.

Take special care with Sotapor:

• If you have any heart conditions, such as a very slow heart rate, first-degree atrioventricular block, history of long QT interval, serious ventricular arrhythmias, or changes in the electrocardiogram (ECG).

• If you have congestive heart failure or have recently had a myocardial infarction.

• If you have low levels of potassium or sodium in the blood (especially if you are taking diuretics).

• If you have high blood levels of sotalol (due to overdose or impaired kidney function).

• If you are taking medications that may cause torsades de pointes (see Use of Sotapor with other medicines).

  • If you have a history of severe allergic reactions.

• If you have kidney disease, as dose adjustment of Sotapor may be required.

  • If you are diabetic, as you may need to adjust your insulin dose or that of any other medication prescribed for your diabetes. Sotapor may mask the early symptoms of hypoglycemia (low blood sugar).

• If you have psoriasis, as medicines in the same class as Sotapor may in some cases worsen your symptoms.

These factors require strict medical monitoring during Sotapor treatment.

Treatment with Sotapor should be interrupted during episodes of diarrhea or any condition causing electrolyte imbalance (low potassium or magnesium levels), but consult your doctor before stopping.

When discontinuing long-term treatment with Sotapor, you should be monitored, especially if you are at risk of developing thyrotoxicosis (excess circulating thyroid hormones).

If you are undergoing surgery requiring general anesthesia, inform your doctor and anesthesiologist that you are taking Sotapor, as it may increase the risk of hypotension. Similarly, inform your dentist before any dental procedure.

You will have periodic blood tests during your treatment with Sotapor.

Use in athletes

Athletes should be aware that this medicine contains a component that may lead to a positive result in doping control tests.

Use of Sotapor with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Sotapor. Combining Sotapor with other medicines is VERY DELICATE, if not contraindicated. In such cases, it may be necessary to adjust the dose or discontinue one of the treatments.

Do not take sotalol if you are taking any of the following medicines:

• Floctafénine (for pain treatment).
• Medicines that induce torsades de pointes (a type of heart rhythm disorder), such as certain antiarrhythmics (quinidine, hydroquinidine, disopyramide, amiodarone, dronedarone, dofetilide, ibutilide, etc.), neuroleptics (some medicines used to treat mental health conditions such as thioridazine, levomepromazine, trifluoperazine, ciamemazine, phenothiazines, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol…), certain antidepressants, certain antibiotics (fluoroquinolones, macrolides, etc.), certain non-sedating antihistamines (terfenadine, astemizole, etc.), bepridil, cisapride, difemanoil, cimetidine, mizolastine, or intravenous vincamine.

The use of sotalol is not recommended with the following medicines:

• Halofantrine (malaria treatment), pentamidine (infection treatment).
• Combination of sotalol with intravenous verapamil or diltiazem (medicines for high blood pressure) is generally not recommended.
• Sotapor should be used with extreme caution together with medicines that prolong the QT interval (a disturbance in the heart's electrical activity):
  • Antiarrhythmics for treating heart rhythm disorders: procainamide, ajmaline, flecainide, cibenzoline, azimilide;
  • Antidepressants for treating depression: citalopram, escitalopram, fluoxetine, paroxetine, sertraline, fluvoxamine, clomipramine, amitriptyline, desipramine, imipramine, nortriptyline;
  • Antipsychotics for treating psychological conditions: mesoridazine, thioridazine, chlorpromazine, fluvoxamine, sertindole;
  • Antibiotics for treating infections: ciprofloxacin, moxifloxacin, gatifloxacin, levofloxacin, sparfloxacin, azithromycin, clarithromycin, erythromycin, roxithromycin;
  • Antimalarials for treating malaria: chloroquine, artenimol;
  • Antihistamines: H1 antihistamines for treating allergies (promethazine, diphenhydramine), H2 antihistamines for treating stomach acidity (cimetidine, famotidine);
  • Gastroprokinetic/antiemetic agents for treating nausea: ondansetron;
  • Kinase inhibitor proteins for treating cancer: vandetanib, sunitinib, sorafenib;
  • Others: arsenic trioxide (cancer treatment), donepezil (dementia treatment), propofol (anesthetic), trazodone (psychological disorder treatment), hydrocodone (cough treatment), methadone, probucol (high cholesterol treatment), ranolazine (stable angina treatment), hydroxyzine (anxiety treatment), fluconazole (antifungal), papaverine (erectile dysfunction treatment, used in cardiac surgery), anagrelide (thrombocytosis treatment).

Sotalol should be administered with caution in patients taking:

• Medicines that reduce potassium levels in the blood, such as diuretics, laxatives, glucocorticoids, tetracosactide, intravenous amphotericin B.
• Medicines that act on the heart to reduce heart rate, such as diltiazem, verapamil; clonidine, guanfacine; digitalis glycosides including digoxin; mefloquine, alpha-methyldopa; cholinesterase inhibitors used in Alzheimer's disease (such as donepezil, rivastigmine, tacrine, galantamine, neostigmine, pyridostigmine, etc.), other beta-blockers, pilocarpine (used to treat glaucoma).
• Halogenated volatile anesthetics.
• Medicines used to treat diabetes, such as insulin and hypoglycemic sulfonamides.
• Propafenone (cardiac arrhythmia treatment).
• Baclofen (muscle relaxant).
• Intravenous lidocaine (local anesthetic, cardiac arrhythmia treatment).
• Proton pump inhibitors (omeprazole, lansoprazole, pantoprazole, esomeprazole) that reduce stomach acid, used to treat stomach ulcers and esophageal reflux.

Combinations that should be taken into account:

• Non-steroidal anti-inflammatory drugs such as aspirin and ibuprofen.
• Antidepressants of the imipramine group (tricyclics) and certain neuroleptics (to treat mental health conditions).
• Calcium channel blockers (dihydropyridines) for treating high blood pressure, coronary disease, and cardiac arrhythmia.
• Intravenous dipyridamole (anticoagulant for prophylactic treatment of cardiovascular events and thrombosis).

Interactions with laboratory tests: the presence of sotalol in urine may cause a false increase in urinary metanephrine levels.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking any medicine.

The use of Sotapor during pregnancy is not recommended. Sotapor should only be administered during pregnancy if the expected benefit justifies the potential risk. If you are pregnant and cannot discontinue Sotapor treatment 2–3 days before delivery, your newborn should be monitored for 48–72 hours after birth.

The use of Sotapor during breastfeeding is not recommended. Sotalol passes into breast milk and may cause effects in the infant. If your doctor discontinues your Sotapor treatment, do not start or resume breastfeeding until your doctor advises it.

Driving and use of machines

At the beginning of treatment with Sotapor, symptoms such as fatigue and dizziness may occur. Therefore, it is advisable not to perform tasks requiring special attention (such as driving vehicles or operating dangerous machinery) until the response to the medicine is satisfactory.

Sotapor contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Sotapor 80 mg tablets

Follow exactly the instructions for administration of this medicine as given by your doctor. If you are in doubt, consult your doctor or pharmacist.

The dose may be taken as a single dose or in divided doses.

Usually, the initial dose is one tablet (80 mg). The dose of Sotapor should be gradually adjusted, with intervals of 2–3 days between each dose increase. Therefore, it will be necessary to visit your doctor regularly during the first weeks after starting treatment with Sotapor, so that your response can be monitored and the dose adjusted if necessary.

Most patients respond to a daily dose of 160–320 mg/day, administered in two divided doses given 12 hours apart.

Some patients with life-threatening refractory ventricular arrhythmias may require doses of 480–640 mg/day.

You must not stop treatment with Sotapor abruptly.

Use in children and adolescents

The efficacy and safety of Sotapor have not been established in children under 18 years of age.

Use in elderly patients

In elderly patients with impaired renal function and other organic impairments, lower doses are usually used.

Renal impairment

In patients with renal impairment, lower doses are usually used.

If you take more Sotapor than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

The most frequent symptoms of overdose include bradycardia (slow heart rate), congestive heart failure, hypotension (low blood pressure), bronchospasm (spasms in the bronchi obstructing airflow to the lungs), hypoglycemia (low blood sugar levels), and seizures (including seizures caused by low blood sugar levels). It is recommended to seek immediate medical attention at the nearest hospital emergency department.

If you forget to take Sotapor 80 mg tablets

If you forget to take a dose, do not worry; if there is still time, take it as soon as possible. If it is already time for your next dose, simply continue with your regular dosing schedule. Never take a double dose to make up for a missed dose.

If you have any doubts about what to do or if you have missed more than one dose, ask your doctor or pharmacist.

If you stop taking Sotapor

Continue taking Sotapor tablets until your doctor advises otherwise. If you need to discontinue treatment with Sotapor, you must follow your doctor's instructions exactly. Treatment must never be stopped abruptly.

4. Possible adverse effects

Like all medicines, Sotapor may cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed:

Very common (may affect more than 1 in 10 people): bradycardia (slow heart rate), chest pain, palpitations, edema (swelling), abnormalities in the electrocardiogram, dyspnea (difficulty breathing), vomiting, diarrhea, dizziness, asthenia (weakness), drowsiness, headache, sleep disorders.

Common (may affect up to 1 in 10 people): arrhythmia (heart rhythm disorders), syncope (fainting), heart failure, presyncope (near-fainting), torsades de pointes (a type of arrhythmia), asthma, skin rash, pruritus (itching), alopecia (hair loss with itching), hyperhidrosis (excessive sweating), nausea, dyspepsia (digestive discomfort), stomach pain, flatulence, dysgeusia (taste disturbances), muscle cramps, myalgia (muscle pain), arthralgia (joint pain), fatigue, tingling, depression, anxiety, mood changes, sexual dysfunction, vision disorders, low blood pressure, fever, and hearing impairment.

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

• reduced number of cells that help blood clotting – this increases the risk of bleeding or bruising
• low blood sugar levels
• reduced blood flow to the extremities (resulting in cold and/or blue fingers and toes, leg pain when walking)
• raised areas of abnormally dry, itchy skin (psoriasis)
• chest tightness causing breathing difficulty (bronchospasm)
• pain or pressure in the center of the chest (angina pectoris)
• heart block

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sotapor 80 mg tablets

Keep out of the sight and reach of children.

Do not store above 30°C.

Store in the original container. Keep the container tightly closed, protected from light and moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sotapor 80 mg tablets

• The active substance is sotalol.
• The other components are: lactose monohydrate, corn starch, stearic acid, anhydrous colloidal silica, microcrystalline cellulose and magnesium stearate.

Appearance of the product and contents of the pack

Sotapor 80 mg tablets are presented as scored tablets. Each pack contains 30 tablets, each containing 80 mg of sotalol.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

Farmea

10 rue Bouché Thomas

ZAC d`Orgemont

49000 Angers

France

Local Representative

Laboratorios Rubió, S.A.

C/ Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Date of the most recent revision of this leaflet: September 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.