Prospect: information for the patient

Sotapor 80 mg tablets

Sotalol hydrochloride

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

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

3.How to take Sotapor 80 mg tablets

4.Possible adverse effects

5.Storage of Sotapor 80 mg tablets

6.Contents of the package and additional information

Sotapor is a medication that contains an active ingredient called sotalol, which belongs to a group of medications called beta-adrenergic blocking agents or beta-blockers.

Sotapor 80 mg tablets is indicated for the treatment of heart 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 nodal A-V reentrant tachycardia, paroxysmal A-V reentrant tachycardia incorporating accessory pathways, and paroxysmal supraventricular tachycardia after cardiac surgery.

-Maintenance of sinus rhythm after conversion of atrial fibrillation or atrial flutter.

Do not take Sotapor:

-If you are allergic (hypersensitive) to sotalol, sulfonamides, or any other component 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 disease, such as atrial fibrillation (including sino-auricular block) without a pacemaker, second- and third-degree atrioventricular block in patients without a pacemaker, long QT syndrome (hereditary or acquired), torsades de pointes (severe heart rhythm disorder), cardiogenic shock, uncontrolled heart failure, Prinzmetal's angina.

-If you have severe kidney disease.

-If you have untreated phaeochromocytoma.

-If you have low blood pressure that is not associated with arrhythmia.

-If you have severe peripheral circulatory disorders (Raynaud's syndrome).

-If you are to undergo surgery with general anesthesia, inform your doctor.

-If you have metabolic acidosis.

-If you are taking medications that can affect heart rhythm (cause torsades de pointes), such as some antiarrhythmics (quinidine, hydroquinidine, disopyramide, amiodarone, dronedarone…), some medications used to treat mental health problems (chlorpromazine, levomepromazine, trifluoperazine, haloperidol, tiapride…), some antidepressants, some antibiotics (fluoroquinolones, macrolides…), or other medications such as cisapride, domperidone, etc.

- If you are taking floctafenina (for pain treatment).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sotapor.

Do not stop treatment abruptly. The dose should be reduced gradually, especially if you have angina pectoris.

Be especially careful with Sotapor:

• If you have any heart condition, such as a very slow heart rate, sino-auricular block, long QT syndrome, severe ventricular arrhythmias, 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 and sodium in the blood (especially if you are taking diuretics).

-If you have high levels of sotalol in the blood (due to overdose or kidney malfunction).

-If you are taking medications that can cause torsades de pointes (seeUse of Sotapor with other medications).

• If you have a history of severe allergic reactions.

-If you have any kidney disease, as the dose of Sotapor may need to be adjusted.

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

-If you have psoriasis, as certain medications in the group to which Sotapor belongs may exacerbate your symptoms.

These factors require strict medical control during Sotapor administration.

Sotapor treatment should be interrupted during episodes of diarrhea or any episode that represents an electrolyte imbalance (low levels of potassium or magnesium), but before doing so, consult your doctor.

When chronic treatment with Sotapor is discontinued, you should be monitored, especially if you have a risk of developing hyperthyroidism (excessive levels of circulating thyroid hormones in the blood).

Inform your doctor and anesthesiologist if you are to undergo surgery that requires general anesthesia, as Sotapor may increase the risk of hypotension. Also, inform your dentist before a dental procedure.

Regular blood tests will be performed during your treatment with Sotapor.

Use in athletes

Inform athletes that this medication contains a component that can result in a positive test in doping control tests.

Use of Sotapor with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Certain medications may interact with Sotapor. The combination of Sotapor with other medications is VERY DELICATE, if not contraindicated. In these cases, it may be necessary to change the dose or discontinue treatment with one of them.

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

-Floctafenina (for pain treatment).

-Medications that induce torsades de pointes (a type of heart rhythm disorder), such as some antiarrhythmics (quinidine, hydroquinidine, disopyramide, amiodarone, dronedarone, dofetilide, ibutilide, etc), neuroleptics (some medications used to treat mental health problems such as thioridazine, levomepromazine, trifluoperazine, ciamemazine, phenothiazines, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol…), some antidepressants, some antibiotics (fluoroquinolones, macrolides, etc), some antihistamines (terfenadine, astemizole, etc), bepridil, cisapride, difemanil, cimetidine, mizolastine, and vincamine intravenously.

Do not recommend the use of sotalol with the following medications:

-Halofantrine (malaria treatment), pentamidine (infection treatment).

-Normally, do not recommend the combination of sotalol with intravenous verapamil or diltiazem (blood pressure medications).

-Sotapor should be given with extreme caution with medications that prolong the QT interval (alteration of heart activity):

•Antiarrhythmics for heart rhythm disorders: procainamide, ajmaline, flecainide, cibenzoline, azimilide;

•Antidepressants for depression: citalopram, escitalopram, fluoxetine, paroxetine, sertraline, fluvoxamine, clomipramine, amitriptyline, desipramine, imipramine, nortriptyline;

•Antipsychotics for mental health disorders: mesoridazine, thioridazine, chlorpromazine, fluvoxamine, sertindole;

•Antibiotics for infections: ciprofloxacin, moxifloxacin, gatifloxacin, enoxacin, sparfloxacin, azithromycin, clarithromycin, erythromycin, roxithromycin;

•Antimalarials for malaria treatment: chloroquine, artemol;

•Antihistamines: H1antihistamines for allergies (promethazine, diphenhydramine), H2antihistamines for stomach acid treatment (cimetidine, famotidine);

•Gastrokinetic/antiemetic medications for nausea treatment: ondansetron;

•Protein kinase inhibitors for cancer treatment: vandetanib, sunitinib, sorafenib;

•Others: arsenic trioxide (cancer treatment), donepezil (dementia treatment), propofol (anesthetic), trazodone (mental health disorders 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:

-Medications that decrease potassium levels in the blood, such as diuretics, laxatives, glucocorticoids, tetracosactide, amphotericin B intravenously.

-Medications that act on the heart, reducing 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).

-Anesthetic volatile halogenated compounds.

-Medications used to treat diabetes, such as insulin and sulfonylurea hypoglycemics.

-Profafenone (heart rhythm disorder treatment).

-Baclofen (muscle relaxant).

-Lidocaine intravenously (local anesthetic, heart rhythm disorder treatment).

-Proton pump inhibitors (omeprazole, lansoprazole, pantoprazole, esomeprazole) used to treat stomach ulcers and gastroesophageal reflux.

Associations to be taken into account:

-Nonsteroidal anti-inflammatory drugs such as aspirin and ibuprofen.

-Tricyclic antidepressants and some neuroleptics (used to treat mental health disorders).

-Calcium channel blockers (dihydropyridines) for high blood pressure, coronary artery disease, and heart rhythm disorders.

-Dipyridamole intravenously (anticoagulant for the prophylactic treatment of cardiovascular accidents and thrombosis).

Interactions with laboratory tests: the presence of sotalol in the urine may result in a false increase in the substance called metanephrine.

Pregnancy, lactation, and fertility

Consult your doctor or pharmacist before taking a medication.

Do not recommend the use of Sotapor during pregnancy. Sotapor should only be administered during pregnancy if the expected benefit justifies the possible risk. If you are pregnant and it is not possible to discontinue Sotapor treatment within 2-3 days before delivery, your child should be monitored in the 48-72 hours after birth.

Do not recommend the use of Sotapor during lactation. Sotalol passes into breast milk and may cause effects in the infant. If your doctor discontinues Sotapor treatment, do not start or resume breastfeeding until the date indicated by your doctor.

Driving and operating machinery

At the beginning of treatment with Sotapor, symptoms of fatigue and dizziness may appear, so it is advisable not to perform tasks that require special attention (driving, operating hazardous machinery) until the response to the medication is satisfactory.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The dose can be taken as a single dose or divided doses.

Usually, the initial dose is one tablet (80 mg). The Sotapor dose should be adjusted gradually, at intervals of 2-3 days between each dose increase, with the need to visit your doctor regularly during the first weeks after starting treatment with Sotapor, to check your response and if necessary, adjust the dose.

Most patients respond to a daily dose of 160-320 mg/day, administered in 2 divided doses at intervals of 12 hours.

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

Do 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.

Use in elderly patients

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

Renal insufficiency

In patients with renal impairment, usually lower doses are 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, phone 91 562 04 20, indicating the medication and the amount ingested.

The most frequent symptoms of overdose include bradycardia (slow heart rate), congestive heart failure, hypotension (low blood pressure), bronchospasm (bronchial spasms that prevent air from reaching the lungs), hypoglycemia (low blood sugar levels), and seizures (including seizures caused by low blood sugar levels). It is recommended to go quickly to the doctor or the nearest hospital Emergency Service.

If you forgot to take Sotapor 80 mg tablets

If you forget to take a dose, do not worry; if it is time, take it as soon as possible or if it is already time for the next dose, continue with the treatment. Never take a double dose to compensate for the missed one.

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

If you interrupt treatment withSotapor

Continue taking Sotapor tablets until your doctor advises otherwise. If you are going to interrupt treatment with Sotapor, you must follow exactly your doctor's instructions. Never interrupt treatment abruptly.

Like all medications, Sotapor may have adverse effects, although not everyone will experience 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), electrocardiogram abnormalities, dyspnea (difficulty breathing), vomiting, diarrhea, dizziness, asthenia (weakness), drowsiness, headache, sleep disturbances.

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

Unknown frequency (frequency cannot be estimated with available data)

• Reduced number of cells that help blood coagulation – this increases the risk of bleeding or hematomas
• Low blood sugar levels
• Decreased blood flow to extremities (causing hands and feet to be cold and/or blue, pain in legs when walking),
• Abnormally dry and itchy skin areas (psoriasis)
• Chest cramps causing difficulty breathing (bronchospasm)
• Pain or pressure in the center of the chest (angina pectoris)
• Cardiac block

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not store above30°C.

Store in the original packaging. Keep the packaging perfectly closed, protected from light and moisture.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Sotapor 80 mg tablets

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

Appearance of the product and content of the packaging

Sotapor 80 mg tablets are presented in the form of scored tablets. Each package contains 30 tablets with 80 mg of sotalol each.

Holder of the marketing authorization and responsible for manufacturing

Holder of the manufacturing authorization

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing

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

Last review date of this leaflet: September 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.