Package leaflet: Information for the patient

Sotalolo Hexal 80 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Sotalolo Hexal is and what it is used for
What you need to know before taking Sotalolo Hexal
How to take Sotalolo Hexal
Possible side effects
How to store Sotalolo Hexal
Contents of the pack and other information

1. What Sotalolo Hexal is and what it is used for

Sotalolo Hexal contains the active substance sotalol, which belongs to a group of medicines called beta-blockers.
This medicine is indicated for the treatment of irregularities in the heart's rhythm.

2. What you need to know before taking Sotalolo Hexal

Do not take Sotalolo Hexal

if you are allergic to sotalol hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
if you have asthma or diseases that impair your ability to breathe properly (chronic obstructive pulmonary disease);
if you have a severe heart condition known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
if you have undergone a particular type of anesthesia causing reduced heart rate (myocardial depression);
if you experience a reduced heart rate (symptomatic sinus bradycardia);
if you suffer from certain heart diseases (sick sinus syndrome, second- or third-degree atrioventricular block, unless a pacemaker is in place, uncontrolled heart failure, congenital or acquired long QT syndrome);
if you have kidney problems (renal failure, creatinine clearance <10 ml/min);
if you have high levels of acidic substances in the blood (metabolic acidosis);
if you have an untreated benign tumor of the adrenal gland (untreated pheochromocytoma);
if you have low blood pressure (hypotension);
if you experience tingling and pain in the fingers, followed by a sensation of heat and pain (Raynaud's phenomenon), or other blood circulation problems (severe peripheral circulatory disorders);
if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”);
if the person taking this medicine is under 18 years of age (See section “Children and adolescents”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sotalolo Hexal.
Take this medicine with caution and inform your doctor if:

you have heart rhythm disturbances (prolongation of QT and QTc intervals);
you experience reduced heart function (reduced heart rate);
you have previously had heart problems (cardiomegaly, heart failure);
you have low levels of potassium or magnesium in the blood (hypokalaemia, hypomagnesaemia), for example due to treatment with medicines that increase urine elimination (diuretics), or if you have had severe and prolonged diarrhoea;
you have kidney problems (renal failure);
you are taking medicines for depression (antidepressants) or other medicines used to treat heart rhythm disorders (Class I antiarrhythmics) (See section “Other medicines and Sotalolo Hexal”);
you have heart function problems (left ventricular dysfunction) and are being treated with medicines such as ACE inhibitors, diuretics, or digitalis;
you recently had a heart attack and have heart function disturbances (left ventricular dysfunction);
you have previously experienced allergic reactions;
you are scheduled for surgery and will be given specific medicines to induce anesthesia (e.g. cyclopropane, trichloroethylene);
you have diabetes or have previously experienced low blood sugar levels (spontaneous hypoglycaemia);
you suspect you have thyroid problems (hyperthyroidism);
you have skin irritations (psoriasis). Inform your doctor if you are scheduled for a laboratory test (urinary metanephrine), used to detect a tumor of the adrenal gland (pheochromocytoma), as Sotalolo Hexal may alter the test results.

For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
This medicine is contraindicated in children and adolescents under 18 years of age (See section “Do not take Sotalolo Hexal”).
Other medicines and Sotalolo Hexal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The use of Sotalolo Hexal together with the following medicines is not recommended:

other antiarrhythmics (disopyramide, quinidine, procainamide, amiodarone), used to treat heart rhythm disorders;
verapamil and diltiazem (calcium antagonists), used to lower blood pressure.

Take this medicine with particular caution and inform your doctor if you are taking:

medicines similar to Sotalolo Hexal (beta-blockers);
potassium-depleting diuretics, which increase urine elimination and reduce potassium levels in the blood;
amphotericin B, used to treat fungal infections via intravenous (i.v.) injection;
corticosteroids, used to treat inflammation and allergies;
certain laxatives that facilitate bowel movements;
Class I antiarrhythmics, which may cause disturbances in heart activity;
phenothiazines, used to treat mental disorders;
tricyclic antidepressants, used to treat depression;
terfenadine and astemizole, used to treat allergies;
quinolone antibiotics, used to treat bacterial infections;
digoxin, used to treat certain heart conditions;
calcium antagonists, used to treat high blood pressure;
reserpine and guanethidine (antiadrenergic agents), used to lower blood pressure;
insulin and oral hypoglycaemic agents, used in diabetes treatment;
salbutamol, terbutaline, and isoprenaline, used to treat asthma;
clonidine, used to treat high blood pressure;
tubocurarine-like medicines that reduce muscle contraction (neuromuscular blockers), used before surgery.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy, except in cases of absolute necessity and under direct medical supervision.
Do not take this medicine if you are breastfeeding. Your doctor will decide whether to discontinue breastfeeding or stop treatment, depending on the importance of the medicine for the mother.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Sotalolo Hexal contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Sotalolo Hexal

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before and during treatment with Sotalolo Hexal, your doctor must monitor your health status, particularly your heart activity (measurement of the QT interval on electrocardiogram, heart rate), kidney function (renal function), fluid and electrolyte levels in the blood (fluid and electrolyte balance), and assess any concomitant therapies with other medicines.
At the beginning of treatment, the recommended dose is 80 mg twice daily, which may be taken as a single dose (160 mg) or as two doses of 80 mg taken 12 hours apart.
Your doctor may decide to gradually increase the dose every 2–3 days, depending on your health condition (monitoring of QT interval duration).
In more severe cases (life-threatening ventricular arrhythmias), your doctor may prescribe up to 480–640 mg daily.
Use in patients with kidney problems
If you have kidney problems (renal insufficiency), inform your doctor, as it may be necessary to reduce the dose of the medicine.
If you take more Sotalolo Hexal than you should
Symptoms following an overdose of this medicine may include: slowing of the heartbeat (bradycardia), serious heart problems (heart failure), low blood pressure (hypotension), breathing difficulties (bronchospasm), low blood sugar levels (hypoglycaemia), disturbances in heart rhythm (QT interval prolongation, premature ventricular complexes, ventricular tachycardia, torsades de pointes).
If you or someone else has accidentally taken an excessive dose of Sotalolo Hexal, contact your doctor immediately or go to the nearest hospital.
If you forget to take Sotalolo Hexal
Do not take a double dose to make up for the missed tablet.
Take only the next dose at the scheduled time.
If you stop taking Sotalolo Hexal
Do not stop treatment abruptly without consulting your doctor.
Any discontinuation of treatment must occur exclusively under medical supervision and gradually, by progressively reducing the dose over a period of 1–2 weeks, to avoid serious heart problems (worsening of anginal symptoms, arrhythmias, and rarely myocardial infarction).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

fatigue, dizziness, muscle weakness (asthenia), lightheadedness, headache, sleep disorders, depression, tingling in the extremities (paraesthesiae), mood changes, anxiety;
excessive slowing of the heart rate (bradycardia) or lowering of blood pressure (hypotension), difficulty breathing (dyspnoea), chest pain, increased awareness of heartbeat (palpitations), swelling due to fluid accumulation (oedema), changes in heart activity (ECG abnormalities), heart rhythm problems (proarrhythmia, including torsade de pointes), fainting accompanied by temporary loss of consciousness (pre-syncope, syncope), serious heart problems (heart failure);
skin irritation (rash), hair loss, excessive sweating;
nausea, vomiting, diarrhoea, difficulty digesting (dyspepsia), abdominal pain, flatulence;
muscle cramps;
sexual dysfunction;
visual and hearing disturbances, taste alterations, fever;
abnormally low levels of platelets in the blood.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sotalolo Hexal

Keep this medicine out of the 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 that month.
No special storage conditions are required for this medicine.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sotalolo Hexal contains
Sotalolo Hexal 80 mg tablets

The active substance is sotalol hydrochloride. Each tablet contains 80 mg of sotalol hydrochloride.
The other components are: maize starch, lactose, hydroxypropylcellulose, sodium carboxymethylstarch, colloidal silicon dioxide, magnesium stearate.

Description of the appearance of Sotalolo Hexal and contents of the pack
Carton containing 40 tablets.
Marketing Authorization Holder
Sandoz SpA - Largo U. Boccioni, 1 - 21040 Origgio (VA) - Italy
Manufacturer
SALUTAS Pharma GmbH - Otto-von-Guericke-Allee 1 - 39179 Barleben - Germany