SPASMOCTYL PEDIATRIC

Introduction

Package Leaflet: Information for the Patient

Sotalol Sandoz 80 mg Tablets EFG

Sotalol Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Sotalol Sandoz and what is it used for
2. What you need to know before you take Sotalol Sandoz
3. How to take Sotalol Sandoz
4. Possible side effects
5. Storage of Sotalol Sandoz
6. Contents of the pack and other information

1. What is Sotalol Sandoz and what is it used for

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

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

2. What you need to know before you take Sotalol Sandoz

Do not takeSotalol Sandoz

• if you are allergic to any of the ingredients of this medicine (listed in section 6),
• if you have any heart disease (such as untreated heart failure, heart block, sick sinus syndrome) or cardiogenic shock,
• if you have low blood pressure or a very slow heart rate,
• if you are to undergo treatment or surgical intervention that requires ambulatory anesthesia or narcosis that may suppress heart function,
• if you have an untreated pheochromocytoma (a tumor of the adrenal gland that can cause a sudden and severe increase in blood pressure, severe headache, excessive sweating, and rapid heart rate),
• if you have a disease that causes discoloration (white or purple) of hands and feet (poor circulation - Raynaud's syndrome),
• if you have any severe circulatory disorder,
• if you have asthma, wheezing attacks, or any other lung disease,
• if you have a disease 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 stopping treatment with sotalol. Treatment with this medicine should not be stopped abruptly. The dose should be gradually reduced (over a period of 2 weeks), sometimes it may be necessary to switch to a substitute treatment,
• if you have heart rhythm disorders (arrhythmias); as a side effect, the existing heart rhythm disorder (arrhythmia) may worsen or cause new heart rhythm disorders,
• if you have a low level of potassium in the blood, recognizable in its most severe form by muscle spasms or muscle weakness and fatigue (hypokalemia) or if you have a low level of magnesium in the blood (hypomagnesemia); certain heart conditions may occur if you take this medicine and have these conditions, for example, if you have severe diarrhea or if you are being treated at the same time with medicines that decrease magnesium and/or potassium (e.g., some diuretics); you will have a higher risk of developing certain heart conditions (prolongation of the QT interval and torsades de pointes),
• if you have altered heart function; symptoms may worsen,
• if you have recently suffered 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 suffered hypersensitivity reactions in the past and are also using certain medicines used to treat high blood pressure, certain heart conditions, or increased eye pressure (beta-blockers); you may not respond adequately to epinephrine (a medicine used to treat hypersensitivity reactions),
• if you are to undergo surgery or treatment with anesthesia; inform the specialist that you are taking this medicine if you have diabetes or episodes of low blood sugar accompanied by hunger, sweating, dizziness, palpitations (hypoglycemia); be more attentive to the signs of these conditions and check your blood glucose levels more frequently,
• if you have an overactive thyroid gland or are at risk of developing this disease; your doctor will closely monitor you during treatment and abrupt discontinuation of treatment should be avoided,
• if you have altered kidney function; your doctor will reduce the dose (see also "Posology"),
• if you have a recurrent 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 medicine.

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

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

Use in athletes

This medicine contains a substance that can produce a positive result in doping tests (see references in section 4.4 of the technical sheet).

Other medicines and Sotalol Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Sotalol and other medicines can affect each other's effects and side effects.

Do not use sotalol with:

• certain medicines used to treat heart rhythm disorders; heart rhythm disorders may worsen,
• other medicines used to treat high blood pressure, certain heart conditions, or increased eye pressure (beta-blockers),
• phenothiazines (anti-emetic medicines), tricyclic antidepressants (medicines used to treat depression), terfenadine and astemizole (medicines used to treat allergic disorders) and quinolones (medicines used to treat infections caused by certain pathogens), erythromycin (a medicine used to treat infections) administered intravenously, halofantrine (a medicine used to treat malaria) and pentamidine (a medicine used to treat infections). It is not recommended to combine these medicines with sotalol due to an increased risk of developing a certain type of cardiac arrhythmia (torsades de pointes),
• floctafenine (a medicine used to treat rheumatoid arthritis),
• calcium channel blockers (agents that protect the heart from excessive activity). Concomitant use with beta-blockers may cause a reduction in blood pressure, a decrease in heart rate, and heart problems; 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 level of potassium in the blood that is too low may occur, which sometimes manifests as muscle cramps, diarrhea, nausea, dizziness, headache (hypokalemia) and a level of magnesium in the blood that is too low, which sometimes accompanies drowsiness, low blood pressure, low body temperature, and abnormal heart function (hypomagnesemia),
• amphotericin B (an agent used to treat fungal infections) administered intravenously, corticosteroids (with anti-inflammatory effects, among others) and some laxatives; when these medicines are combined with sotalol, a level of potassium in the blood that is too low may sometimes occur, which manifests as muscle cramps, diarrhea, nausea, dizziness, headache (hypokalemia),
• clonidine (an agent used to treat high blood pressure and migraine); a recurrence of high blood pressure may occur after stopping treatment with clonidine due to the combination of this medicine with sotalol,
• digitalis glycosides (agents used to treat heart disorders); arrhythmias may occur,
• medicines such as reserpine (a medicine for movement disorders, high blood pressure, and severe depression), guanethidine (a medicine for high eye pressure) or alpha-methyldopa (a medicine for high blood pressure); the combination with sotalol may decrease muscle tension; if you are treated with such a combination, your blood pressure and heart rate should be closely monitored,
• insulin or other oral hypoglycemic agents; your blood sugar level may increase too much (hyperglycemia). Your doctor may decide to adjust the dose of these medicines. The symptoms of low blood sugar accompanied by a feeling of hunger, sweating, dizziness, palpitations (hypoglycemia) may be masked,
• certain medicines that relax muscles (such as tubocurarine); the effect of these medicines may be prolonged,
• medicines that stimulate the heart and/or blood vessels; it may be necessary to increase the dose of these medicines.

Taking Sotalol Sandoz with food and drinks

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

Pregnancy and breast-feeding

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

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 delivery date. If this is not possible, the newborn should be closely monitored for 48-72 hours after birth.

Breast-feeding

Sotalol is excreted in breast milk. You should not breast-feed while being treated with this medicine.

Driving and using machines

Sotalol may cause side effects such as dizziness and fatigue. This may negatively affect your reaction ability. You should keep this in mind when driving or operating machines.

Sotalol Sandoz contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Sotalol Sandoz

Follow exactly the administration instructions of this medicine 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 intervals of 3 days.

Maintenance dose:

From 80 to 160 mg twice a day.

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

Occasionally, your 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).

Method of administration

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

Maintain intervals of 12 hours when taking the dose twice a day.

If you think the effect 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 up.

With your thumb, exert pressure in the center of the tablet to break it into two halves.

Duration of treatment

Your doctor will indicate for how long you should take this medicine. Do not stop 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine 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 make up for forgotten doses.

If you stop taking Sotalol Sandoz

The use of this medicine should not be stopped abruptly. The dose should be gradually reduced (over 2 weeks), sometimes it may be necessary to switch to a substitute treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Inform your doctor or go to the nearest hospital immediately 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.

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

• Insufficient heart pumping capacity (heart failure) (this causes the heart to stop beating suddenly, absence of breathing, and loss of consciousness).

Other side effects:

Common(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, heart rhythm disorders (torsades de pointes, prolonged QT interval, AV conduction disorder, ventricular tachycardia), exacerbation of pressure, heaviness, oppression, or pain in the chest (angina pectoris),
• exacerbation of decreased blood flow in arms and legs (peripheral occlusive disease), cold extremities,
• nausea and vomiting, indigestion, abdominal pain, flatulence, diarrhea, cramps,
• anxiety, depression, confusion, mood changes, headache, dizziness, drowsiness, general weakness, 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.

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

• abnormally low levels of platelets in the blood (thrombocytopenia) the platelets clot to form scabs on wounds. If you do not have enough platelets, you may develop bruises, red spots on the skin, nosebleeds, 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 mucous membrane of the eye that causes itching, tearing, or redness (conjunctivitis), inflammation of the cornea (keratoconjunctivitis), decreased tear flow (especially in people who wear contact lenses),
• dry mouth,
• a recurrent skin disease with a scaly and dry rash (psoriasis) that may be triggered or worsen, hair loss, excessive sweating,
• increased fats and decreased sugar in the blood.

Patients taking this type of medicine have reported cold hands and/or feet, worsening of leg pain when walking, skin rashes, or dry eyes.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sotalol Sandoz

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

Store in the original package to protect from light.

Do not use this medicine after the expiry date stated on the package and blister after CAD/EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition ofSotalol Sandoz

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

Appearance of the Product and Packaging Contents

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 inside a cardboard box.

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Date of the Last Revision of this Leaflet:February 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.