SOTALOLO 80 mg Coated Tablet

Содержание инструкции

1. Sotalolo Hexal 80 mg tablets
   1. What is Sotalolo Hexal and what is it used for
   2. What you need to know before you take Sotalolo Hexal
   3. How to take Sotalolo Hexal
   4. Possible side effects
   5. How to store Sotalolo Hexal
   6. Contents of the pack and other information

Sotalolo Hexal 80 mg tablets

Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Sotalolo Hexal contains the active ingredient sotalol, which belongs to a group of medicines called
beta-blockers.
This medicine is indicated for the treatment of heart rhythm disturbances.

2. What you need to know before you take 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 suffer from asthma or diseases that prevent you from breathing properly (chronic obstructive respiratory diseases);
• if you have a serious heart problem, known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout your body;
• if you have undergone a particular type of anesthesia that causes a reduction in heart rate (myocardial depression);
• if you experience a reduction in heartbeats (symptomatic sinus bradycardia);
• if you suffer from certain heart diseases (sick sinus syndrome, second and third degree atrioventricular block, unless a pacemaker is installed, uncontrolled heart failure, long QT syndrome, congenital or acquired);
• if you have kidney problems (renal insufficiency, creatinine clearance <10 ml/min);
• if you have a high amount of acidic substances in your blood (metabolic acidosis);
• if you have a benign tumor of the adrenal gland and are not undergoing any therapy to treat it (untreated pheochromocytoma);
• if you have low blood pressure (hypotension);
• if you experience tingling and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon) or have other problems with blood circulation (severe peripheral circulatory disorders);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”);
• if the person who is to take this medicine is less than 18 years old (See section “Children and adolescents”).

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

• you have heart activity disorders (prolongation of the QT and QTc interval);
• you experience a reduction in heart function (reduction in heart rate);
• you have previously suffered from heart problems (cardiomegaly, heart failure);
• you have low levels of potassium or magnesium in your blood (hypokalemia, hypomagnesemia), for example following treatment with medicines that promote urine excretion (diuretics) or if you have suffered from severe and prolonged diarrhea;
• you suffer from kidney problems (renal insufficiency);
• you are taking medicines for the treatment of depression (antidepressants) or other medicines used to treat heart rhythm disturbances (Class I antiarrhythmics) (See section “Other medicines and Sotalolo Hexal”);
• you suffer from heart function problems (left ventricular dysfunction) and are undergoing therapy with medicines such as ACE inhibitors, diuretics, digoxin;
• you have recently had a heart attack and experience disturbances in heart function (left ventricular dysfunction);
• you have previously suffered from allergic reactions;
• you are to undergo surgery and are to be given particular medicines to induce anesthesia (e.g. cyclopropane, trichloroethylene);
• you suffer from diabetes or if you have previously had low blood sugar levels (spontaneous hypoglycemia);
• you think you have thyroid problems (hyperthyroidism);
• you have skin irritations (psoriasis). Tell your doctor if you are to undergo a laboratory examination (urinary metanephrines), used to identify a tumor of the adrenal gland (pheochromocytoma), as Sotalolo Hexal may alter its results.

For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in positive anti-doping tests.

Children and adolescents
This medicine is contraindicated in children and adolescents under the age of 18 years (See
section “Do not take Sotalolo Hexal”).

Other medicines and Sotalolo Hexal
Tell 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), for the treatment of heart rhythm disturbances;
• verapamil and diltiazem (calcium antagonists), used to lower blood pressure.

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

• medicines similar to Sotalolo Hexal (beta-blockers);
• potassium-depleting diuretics that promote urine excretion and reduce potassium levels in the blood;
• amphotericin B, used for the treatment of fungal infections by intravenous injection (i.v.);
• corticosteroids for the treatment of inflammation and allergies;
• certain laxatives that promote bowel movements;
• Class I antiarrhythmics that can cause alterations in heart activity;
• phenothiazines for the treatment of mental disorders;
• tricyclic antidepressants for the treatment of depression;
• terfenadine and astemizole for the treatment of allergies;
• quinolone antibiotics for the treatment of bacterial infections;
• digoxin used to treat certain heart problems;
• calcium antagonists for the treatment of high blood pressure;
• reserpine and guanethidine (adrenergic agents) used to lower blood pressure;
• insulin and oral hypoglycemic agents for the treatment of diabetes;
• salbutamol, terbutaline and isoprenaline used for the treatment of asthma;
• clonidine for the treatment of high blood pressure;
• tubocurarine-like medicines that reduce muscle contraction (neuromuscular blockers), used before surgery.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, do not take this medicine unless absolutely necessary and under the direct
supervision of your doctor.
Do not take this medicine if you are breastfeeding. The doctor will decide whether to discontinue
breastfeeding or stop taking the therapy, depending on the importance of the drug for
the mother.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.

Sotalolo Hexal contains lactose
This medicine contains lactose, a type of sugar. If you have been diagnosed with
lactose intolerance, contact your doctor before taking this medicine.

3. How to take Sotalolo Hexal

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Before and during treatment with Sotalolo Hexal, your doctor must check your health condition, in particular the activity of your heart (measurement of the QT interval on the electrocardiogram, heart rate), kidney function (renal function), the amount of fluids and salts in the blood (hydro-electrolytic balance) and evaluate any therapies with other medicines.
At the beginning of treatment, the recommended dose is 80 mg 2 times a day which can be taken in a single dose (160 mg) or in two doses, of 80 mg, 12 hours apart.
The doctor may decide to gradually increase the dose every 2-3 days, based on your health condition (monitoring of the QT interval duration).
In more severe cases (threatening ventricular arrhythmias), the doctor may prescribe up to 480-640 mg per day.

Use in people with kidney problems
If you suffer from kidney problems (renal insufficiency), inform your doctor as it is necessary to reduce the dose of the medicine to be taken.

If you take more Sotalolo Hexal than you should
Following the intake of an excessive dose of this medicine, the following symptoms have manifested: reduced heart rate (bradycardia), serious heart problems (heart failure), low blood pressure (hypotension), difficulty breathing (bronchospasm), reduced blood sugar levels (hypoglycemia), alterations in heart rhythm (prolongation of the QT interval, premature ventricular complexes, ventricular tachycardia, torsades de pointes).
In case of accidental ingestion/intake of an excessive dose of Sotalolo Hexal, immediately inform your doctor 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 suddenly stop therapy without consulting your doctor.
Any suspension of treatment must occur exclusively under the control of the doctor and gradually with decreasing doses, over a period of 1-2 weeks, to avoid serious heart problems (worsening of angina symptoms, arrhythmias and rarely myocardial infarction).
If you have any doubts about 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.
The following side effects may occur:

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

• fatigue, dizziness, muscle weakness (asthenia), lightheadedness, headache, sleep disorders, depression, tingling in the extremities (paresthesia), mood changes, anxiety;
• excessive slowing of the heartbeat (bradycardia) or low blood pressure (hypotension), difficulty breathing (dyspnea), chest pain, increased awareness of heartbeats (palpitations), swelling due to fluid retention (edema), altered 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, diarrhea, indigestion (dyspepsia), abdominal pain, flatulence;
• muscle cramps;
• sexual dysfunction;
• vision and hearing disturbances, altered taste, fever;
• unusually low levels of platelets, also known as thrombocytes, in the blood.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-
una-sospetta-reazione-avversa . By reporting side effects you can help to 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 any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sotalolo Hexal contains
Sotalolo Hexal 80 mg tablets

• The active ingredient is sotalol hydrochloride. Each tablet contains 80 mg of sotalol hydrochloride.
• The other ingredients are: corn starch, lactose, hydroxypropylcellulose, sodium carboxymethylcellulose, colloidal silica, magnesium stearate.

Description of the appearance of Sotalolo Hexal and contents of the pack
Pack containing 40 tablets.

Marketing Authorisation Holder
Sandoz SpA - Largo U. Boccioni, 1 - 21040 Origgio (VA) - Italy

Manufacturer
SALUTAS Pharma GmbH - Otto-von-Guericke-Allee 1 - 39179 Barleben - Germany