Package Insert: Information for the Patient

Sotalol Sandoz 80 mg Tablets EFG

Sotalol Hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Sotalol belongs to a group of medications called beta blockers. These medications protect the heart from excessive activity.

This medication is indicated for the treatment of heart rhythm disturbances (ventricular and supraventricular arrhythmias).

Do not takeSotalol Sandoz

• if you are allergic to any of the components of this medication (listed in section 6),
• if you have any heart disease (such as untreated heart failure, some conduction disorders of the heart impulse (cardiac block), sick sinus syndrome (some heart rhythm disorders)), or cardiogenic shock,
• if you have low blood pressure or a very slow heart rate,
• if you are undergoing a surgical treatment or intervention that requires outpatient anesthesia or narcosis that may suppress cardiac function,
• if you have an untreated adrenal gland tumor, which may be accompanied by a sudden and severe increase in blood pressure, intense headache, intense sweating, and tachycardia (pheochromocytoma),
• if you have a disease that causes discoloration (white or blue) of hands and feet (Raynaud's syndrome),
• if you have a severe circulatory disorder,
• if you have asthma, bronchial spasms, or any other lung disease,
• if you have a condition called metabolic acidosis (when your body produces too much acid),
• if you have severe kidney failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take sotalol:

• when interrupting treatment with sotalol. Treatment with this medication should not be interrupted abruptly. The dose should be gradually reduced (over a period of 2 weeks), and sometimes a substitution treatment may be necessary,
• if you have heart rhythm disorders (arrhythmias); as a side effect, the existing heart rhythm disorder may worsen or cause new heart rhythm disorders,
• if you have low potassium levels in the blood, recognizable in its most severe form by muscle spasms or muscle weakness and fatigue (hypokalemia) or if you have low magnesium levels in the blood (hypomagnesemia); certain cardiac conditions may occur if you take this medication and have these conditions, for example, if you have severe diarrhea or if you are being treated at the same time with medications that decrease magnesium and/or potassium (e.g., some diuretics); you will have a higher risk of developing certain cardiac conditions (prolongation of the QT interval and torsades de pointes),
• if you have altered cardiac function; symptoms may worsen,
• if you have recently had a myocardial infarction; your doctor will closely monitor you and the dose will be carefully determined,
• if you have a slow heart rate; this increases the risk of developing certain cardiac arrhythmias,
• if you have had hypersensitivity reactions in the past and are also using certain medications used to treat high blood pressure, certain heart conditions, or increased intraocular pressure (beta-blockers); you may not respond adequately to epinephrine (a medication used to treat hypersensitivity reactions),
• if you are undergoing surgery or treatment with anesthesia; inform your specialist that you are taking this medication if you have diabetes or episodes of low blood sugar accompanied by hunger, sweating, dizziness, palpitations (hypoglycemia); be more aware of these symptoms and control your blood glucose levels more frequently,
• if you have an overactive thyroid gland or are at risk of developing this condition; your doctor will closely monitor you during treatment and abrupt discontinuation should be avoided,
• if you have altered renal function; your doctor will reduce the dose (see also "Posology"),
• if you have a recurring skin disease accompanied by a scaly and dry rash (psoriasis); symptoms may worsen,
• if your doctor has told you that you are hypersensitive to certain sugars; consult your doctor before taking this medication.

Consult your doctor if any of the above conditions affect or have affected you in the past.

Inform your doctor that you are taking this medication if you undergo any laboratory tests, such as a urine analysis.

Use in athletes

This medication contains substances that may produce a positive result in doping control tests (see references in the technical data sheet section 4.4).

Other medications and Sotalol Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Sotalol and other medications may affect each other's effects and side effects.

Do not use sotalol with:

• certain medications used to treat heart rhythm disorders; heart rhythm disorders may worsen,
• other medications used to treat high blood pressure, certain heart conditions, or increased intraocular pressure (beta-blockers),
• phenothiazines (anti-nausea medications), tricyclic antidepressants (medications used to treat depression), terfenadine and astemizol (medications used to treat allergic disorders), and quinolones (medications used to treat infections by certain pathogens), erythromycin (medication used to treat infections) administered intravenously, halofantrine (medication used to treat malaria), and pentamidine (medication used to treat infections). The combination of these medications with sotalol is not recommended due to a higher risk of developing a certain type of cardiac arrhythmia (torsades de pointes),
• fluctofenine (medication used to treat rheumatoid arthritis),
• calcium channel blockers (agents that protect the heart from excessive activity). The concomitant use with beta-blockers may cause reduced blood pressure, decreased heart rate, and cardiac problems; the combination with calcium channel blockers such as verapamil and diltiazem (a certain type of calcium antagonist) should be avoided.

Be cautious when using sotalol with:

• certain diuretics (urinary agents); a low level of potassium in the blood may occur, which may manifest as muscle cramps, diarrhea, nausea, dizziness, headache (hypokalemia), and a low level of magnesium in the blood, which may be accompanied by drowsiness, low blood pressure, low body temperature, and abnormal heart function (hypomagnesemia),
• amphotericin B (agent used to treat fungal infections) administered intravenously, corticosteroids (with anti-inflammatory effects, among others), and some laxatives; when these medications are combined with sotalol, a low level of potassium in the blood may occur, which may manifest as muscle cramps, diarrhea, nausea, dizziness, headache (hypokalemia),
• clonidine (agent used to treat high blood pressure and migraine); a recurrence of high blood pressure may occur after discontinuing clonidine treatment due to the combination of this medication with sotalol,
• digitalis glycosides (agents used to treat heart disorders); arrhythmias may occur,
• medications such as reserpine (medication for movement disorders, high blood pressure, and severe depression), guanethidine (medication for high blood pressure), or alpha-methyldopa (medication for high blood pressure); the combination with sotalol may cause muscle weakness; if you are treated with a combination of this type, you should be closely monitored for your blood pressure and heart rate,
• insulin or other oral hypoglycemic agents; your blood sugar levels may increase too much (hyperglycemia). Your doctor may decide to adjust the dose of these medications. Symptoms of low blood sugar accompanied by hunger, sweating, dizziness, palpitations (hypoglycemia) may be masked,
• certain muscle relaxants (such as tubocurarine); the effect of these medications may be prolonged,
• medications that stimulate the heart and/or blood vessels; you may need to increase the dose of these medications.

Taking Sotalol Sandoz with food and drinks

The absorption of sotalol in the body may be reduced if taken with food at the same time. Therefore, you should take this medication 30 minutes before meals.

Pregnancyandbreastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Sotalol should only be used during pregnancy if the potential benefit outweighs the risk to the fetus.

If taken during pregnancy, sotalol should be discontinued 48-72 hours before the calculated date of delivery. If this is not possible, the newborn should be closely monitored for 48-72 hours after birth.

Breastfeeding

Sotalol is excreted in breast milk. Do not breastfeed while taking this medication.

Driving and operating machinery

Sotalol may cause side effects such as dizziness and fatigue. This may negatively affect your reaction time. You should be aware of this when driving or operating machinery.

Sotalol Sandoz contains lactose and sodium

If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not stop taking these tablets without consulting your doctor first.

Dose

Your doctor has prescribed the amount of sotalol you should take. In general, the following doses are applied:

Adults

Initial dose:

80 mg once a day or 40 mg twice a day.

Your doctor may decide to gradually increase the dose at 3-day intervals.

Maintenance dose:

Between 80 and 160 mg twice a day.

For the prevention of certain types of heart rhythm acceleration (tachycardia), a maintenance dose of 160 mg twice a day is recommended. An exception is after cardiac surgery, in which case 120 mg twice a day is recommended.

Occasionally, the doctor may decide on a dose of up to 480-640 mg.

If you have kidney failure, your doctor will adjust the dose (depending on the severity of your kidney failure).

Administration form

The tablet or half the tablet should be taken 30 minutes before meals with water.

Maintain 12-hour intervals when taking the dose twice a day.

If you estimate that the action of sotalol is too strong or too weak, consult your doctor or pharmacist.

How to divide Sotalol Sandoz:

Place the tablet on a hard, flat surface, with the marked face upwards.

With your thumb, apply pressure to the center of the tablet to split it into two halves.

Treatment duration

Your doctor will indicate for how long you should take this medication. Do not interrupt treatment too soon or symptoms may reappear.

If you take more Sotalol Sandoz than you should

If you have taken more sotalol than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sotalol Sandoz

If you have forgotten to take a dose, you can take it when you remember, unless it is almost time for the next dose. In that case, follow your usual schedule.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sotalol Sandoz

Do not stop using this medication abruptly. The dose should be gradually reduced (in 2 weeks), sometimes it may be necessary to change to a substitute treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects:

Immediately inform your doctor or go to the nearest hospital if you experience any of the following symptoms: swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing. These may be signs of an allergic reaction and you should stop taking the tablets.

Unknown frequency: (cannot be estimated from available data):

• Insufficient heart pumping capacity (heart failure) (this causes sudden cessation of heartbeats, absence of breathing, and loss of consciousness).

Other side effects:

Frequent(may affect up to 1 in 10 people):

• Irregular heart rhythm, slow heart rhythm, heart failure, chest pain, low blood pressure, difficulty breathing, swelling, fainting, and palpitations, alterations in heart rhythm (torsade de pointes, prolongation of the QT interval, AV conduction disorder, ventricular tachycardia), exacerbation of pressure, heaviness, oppression, oppression or chest pain (angina pectoris),
• Exacerbation of decreased blood flow in arms and legs (peripheral vascular disease), cold extremities,
• Nausea and vomiting, indigestion, abdominal pain, flatulence, diarrhea, cramps,
• Anxiety, depression, confusion, mood changes, headache, dizziness, weakness, general fatigue, sleep problems, tingling in feet and hands (pins and needles),
• Sexual dysfunction, impotence, fever, skin rash, skin reactions, hearing problems, vision problems, changes in taste.

Unknown frequency(cannot be estimated from available data):

• Abnormally low platelet levels in the blood. (Thrombocytopenia) Platelets coagulate to form clots in wounds. If you do not have enough platelets, you may experience bruising, red spots on the skin, nasal bleeding, or wounds that bleed for longer,
• Perception (seeing, hearing, smelling, feeling) of things that do not exist (hallucinations), abnormal dreams,
• Blurred vision, inflammation of the ocular mucosa causing itching, tearing, or redness (conjunctivitis), inflammation of the cornea (keratoconjunctivitis), decreased tear flow (especially in people who wear contact lenses),
• Dry mouth,
• Recurring skin condition with scaly and dry rash (psoriasis) that may be triggered or exacerbated, hair loss, excessive sweating,
• Increased fats and decreased blood sugar.

Patients taking this type of medication have complained of cold and/or blue fingers and toes, worsening of leg pain when walking, skin rashes, or dry eyes.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store in the original packaging to protect it from light.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sotalol Sandoz

• The active ingredient is 80 mg of sotalol hydrochloride per tablet.
• The other excipients are cornstarch, lactose monohydrate, hydroxypropylcellulose (E463), carboxymethylcellulose sodium (type A), anhydrous colloidal silica (E551), and magnesium stearate (E470b).

Appearance of the product and contents of the packaging

The Sotalol Sandoz tablets are white, round, biconvex, scored on one side, and marked with "SOT" on the other.

The tablet can be divided into equal doses.

The tablets are presented in blisters within a cardboard box.

Packaging sizes: 30, 50, 60, 90, 100 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Last review date of this leaflet: February 2024

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