Sotahexal 80

Leaflet attached to the packaging: patient information

SotaHEXAL 40, 40 mg, tablets

SotaHEXAL 80, 80 mg, tablets

SotaHEXAL 160, 160 mg, tablets

Sotalol hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is SotaHEXAL and what is it used for
• 2. Important information before taking SotaHEXAL
• 3. How to take SotaHEXAL
• 4. Possible side effects
• 5. How to store SotaHEXAL
• 6. Contents of the packaging and other information

1. What is SotaHEXAL and what is it used for

SotaHEXAL tablets contain the active substance sotalol hydrochloride, an antiarrhythmic medicine.
SotaHEXAL is used to treat supraventricular and ventricular arrhythmias, especially in the form of ventricular tachycardia.

2. Important information before taking SotaHEXAL

When not to take SotaHEXAL

if the patient is allergic to sotalol, sulfonamides, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include rash, itching, swelling of the face or lips, difficulty breathing.
if the patient's ECG (electrocardiogram) has shown a prolonged QT interval or the patient has life-threatening arrhythmias (such as torsade de pointes), or is taking medicines that may cause such arrhythmias.
if the patient has asthma, has had asthma attacks, or has chronic obstructive pulmonary disease (COPD).
if the patient has a slow heart rate (less than 45-50 beats per minute), low blood pressure, changes in skin color (pale or red), severe circulatory disorders, or heart disease (such as uncontrolled heart failure).
if the patient has recently had a heart attack.
if the patient has metabolic or diabetic ketoacidosis.
if the patient has kidney failure or untreated pheochromocytoma.
if the patient is taking an MAO-A inhibitor antidepressant or floctafenine (a non-steroidal anti-inflammatory drug).
If the patient is unsure whether any of the above applies to them, they should consult their doctor.
Before starting SotaHEXAL and during treatment, the doctor may recommend that the patient have their potassium and magnesium levels checked. If the patient's potassium and magnesium levels are low, the doctor may not prescribe SotaHEXAL.
During treatment, the patient should strictly follow the doctor's recommendations for regular check-ups and tests.

Warnings and precautions

Before taking SotaHEXAL, the patient should discuss it with their doctor or pharmacist if:
they have had kidney disease in the past, as the dose of SotaHEXAL may need to be adjusted.
they have diabetes, as the dose of their antidiabetic medicine may need to be adjusted. SotaHEXAL may mask or weaken the warning signs of low blood sugar (hypoglycemia).
they are taking any medicines for heart conditions or high blood pressure.
they have hyperthyroidism, as SotaHEXAL may mask some symptoms of the disease or worsen them if treatment is stopped suddenly.
they are to undergo surgery. The anesthesiologist should be informed about the use of SotaHEXAL.
they are allergic to various allergens, as SotaHEXAL may worsen an allergic reaction.
they have severe and/or prolonged diarrhea or are taking medicines that may reduce the amount of potassium and magnesium in the body (e.g., diuretics), as this may lead to serious heart rhythm disorders.
If the patient is to undergo tests for suspected pheochromocytoma, they should inform the laboratory staff about the use of SotaHEXAL.

SotaHEXAL and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
SotaHEXAL and other medicines may interact with each other (so-called interactions). This applies especially to medicines such as:
medicines used to treat high blood pressure;
medicines used to treat heart failure or arrhythmias;
antidiabetic medicines;
diuretics;
medicines used to treat asthma and other respiratory diseases;
medicines used to treat depression, anxiety, nervous system disorders, and mental illnesses;
antibacterial medicines (antibiotics and chemotherapeutics);
medicines used to treat allergies (e.g., hay fever);
corticosteroids;
non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation;
laxatives.
If the patient is to undergo surgery under general anesthesia, they should inform the anesthesiologist about the use of SotaHEXAL. It may be necessary to stop treatment before surgery by gradually reducing the dose of SotaHEXAL over a period of 1 week.

SotaHEXAL with food and drink

Tablets should be taken before meals, with a drink. Meals, especially those containing milk, reduce the absorption of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
SotaHEXAL should only be used during pregnancy if the doctor considers it necessary.
Treatment should be stopped 2 to 3 days before planned delivery.
Breastfeeding
Do not breastfeed while taking SotaHEXAL.

Driving and operating machinery

The effect of SotaHEXAL on the ability to drive and operate machinery is not known.
Patients who experience dizziness, fatigue, or dizziness should not drive or operate machinery without consulting their doctor or pharmacist.

SotaHEXAL contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take SotaHEXAL

This medicine should be taken strictly according to the doctor's instructions. If in doubt, consult the doctor or pharmacist.
Adults
Usually, a dose of 80 mg to 320 mg per day is used. In some patients with life-threatening ventricular arrhythmias, a higher daily dose may be necessary, up to 480-640 mg.
The medicine can be taken in a single dose or in divided doses, as recommended by the doctor.
The doctor may recommend lower doses for elderly patients or patients with kidney function disorders.
Regular follow-up appointments and check-ups should be strictly followed as recommended by the doctor.
Use in children
SotaHEXAL is not intended for use in children.

Taking a higher dose of SotaHEXAL than recommended

If the patient has taken too many tablets, they should immediately consult their doctor or go to the nearest hospital. They should take the packaging or leaflet with them so that the medical staff knows which medicine has been overdosed.
Overdose symptoms may include slow heart rate, heart failure, low blood pressure, bronchospasm, low blood sugar, and arrhythmias.

Missing a dose of SotaHEXAL

If the patient forgets to take a dose, they should do so as soon as they remember, unless it is almost time for the next dose. In this case, they should take the tablet at the usual time. Never take a double dose of the medicine.
Taking the medicine at the same time every day helps to remember to take it.

Stopping SotaHEXAL treatment

Do not stop taking SotaHEXAL without consulting your doctor.
If treatment is stopped suddenly, life-threatening circulatory disorders may occur. If stopping treatment is necessary, the doctor will recommend gradually reducing the dose of SotaHEXAL over 1 to 2 weeks, including possible replacement therapy if necessary.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, SotaHEXAL can cause side effects, although not everybody gets them.
Side effects of SotaHEXAL are usually temporary, disappear after dose reduction, and rarely require treatment to be stopped.
The following side effects may occur during treatment with sotalol:
Common (may occur in less than 1 in 10 people): anxiety, sleep disorders, mood changes, depression, dizziness, fainting, headache, paresthesia, fainting, feeling of fainting, taste disorders, vision disorders, hearing disorders, arrhythmias, bronchospasm, chest pain, slow heart rate (bradycardia), palpitations, changes in the electrocardiogram (ECG), atrioventricular block, heart failure, low blood pressure, abdominal pain, nausea, vomiting, diarrhea, indigestion, bloating, dry mouth, muscle cramps, sexual dysfunction, feeling of tiredness, asthenia, fever, edema.
Uncommon (may occur in less than 1 in 100 people): bronchospasm in patients with asthma or a history of asthma.
Rare (may occur in less than 1 in 10,000 people): decreased tear secretion.
Frequency not known (cannot be estimated from the available data): abnormally low platelet count, Raynaud's disease, worsening of intermittent claudication, pain and coldness of the limbs, rash, exacerbation of psoriasis, hair loss, excessive sweating.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store SotaHEXAL

The medicine should be stored out of sight and reach of children.
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.
No special precautions for storage are necessary.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What SotaHEXAL contains

The active substance of the medicine is sotalol hydrochloride.
One tablet contains 40 mg, 80 mg, or 160 mg of sotalol hydrochloride.
The other ingredients are: lactose monohydrate, corn starch, hydroxypropyl cellulose, sodium carboxymethyl cellulose (type A), colloidal anhydrous silica, magnesium stearate.

What SotaHEXAL looks like and what the packaging contains

SotaHEXAL tablets are packaged in PP/Aluminum blisters in a cardboard box.
Packaging contains 20 or 30 tablets.

Marketing authorization holder

Sandoz GmbH.
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
To obtain more detailed information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of the last update of the leaflet:

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