Package leaflet: Information for the patient

RYTMOBETA 80 mg tablets, 160 mg tablets

Sotalol hydrochloride
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 dangerous.
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 RYTMOBETA is and what it is used for
What you need to know before taking RYTMOBETA
How to take RYTMOBETA
Possible side effects
How to store RYTMOBETA
Contents of the pack and other information

1. What RYTMOBETA is and what it is used for

RYTMOBETA is a medicine used to treat heart rhythm disorders and belongs to a group of medicines known as antiarrhythmics.
RYTMOBETA is a class III antiarrhythmic agent that also inhibits beta receptors (a beta-blocking agent).
This medicine is used to treat cardiac arrhythmias, in particular:

symptomatic ventricular tachyarrhythmia (a fast heartbeat originating in the heart's ventricles);
symptomatic supraventricular tachyarrhythmia requiring treatment, such as: atrioventricular nodal tachycardia; supraventricular tachycardia with Wolff-Parkinson-White syndrome; paroxysmal atrial fibrillation.

2. What you must know before taking RYTMOBETA

Do not take RYTMOBETA if:

you are allergic (hypersensitive) to the active substance sotalol hydrochloride, sulfonamides, or to any of the other ingredients of this medicine (listed in section 6);
you have reduced heart function (NYHA class IV heart failure or congestive heart failure);
you have recently had a heart attack (acute myocardial infarction);
you are about to undergo surgery or receive anaesthetics that reduce cardiac output;
you are in a state of shock;
you have a severe disturbance in electrical conduction between the atria and ventricles of the heart (second- or third-degree atrioventricular block), unless a functioning pacemaker is present;
you have an electrical conduction block in the heart between the sinus node and the atrium (sinoatrial block);
you suffer from sinus node disease, a condition characterized by a slow heartbeat (less than 60 beats per minute), often interrupted by episodes of increased or irregular heartbeats or periods of sinus arrest;
you have a heart rate below 50 beats per minute (bradycardia);
you have a prolonged QT interval (an abnormality on the electrocardiogram);
you have low potassium levels in the blood (hypokalaemia);
you have low magnesium levels in the blood (hypomagnesaemia);
you suffer from low blood pressure (hypotension);
you have severe peripheral arterial occlusion (peripheral arterial blockage);
you have chronic obstructive airway disease, a condition characterized by reduced airflow, cough, wheezing, increased mucus production, and breathing difficulties;
you suffer from severe asthma;
you suffer from severe nasal inflammation due to allergy (severe allergic rhinitis);
you have breathing difficulties due to swelling of the throat (glottic oedema);
you have serious liver (severe hepatic insufficiency) or kidney problems (severe renal insufficiency);
you have increased blood acidity (metabolic acidosis);
you are being treated with calcium channel blockers (also called calcium antagonists), such as verapamil and diltiazem, administered intravenously for high blood pressure, or with other antiarrhythmic medicines (such as disopyramide);
you have an untreated tumour of the adrenal gland (called phaeochromocytoma).

Warnings and precautions
Talk to your doctor before taking RYTMOBETA if:

you have kidney problems (renal insufficiency). In such cases, your doctor will reduce the dose of RYTMOBETA (see section 3);
you have diabetes or unstable blood sugar levels (glycaemia), or are undergoing prolonged fasting, as treatment with RYTMOBETA may mask symptoms of low blood sugar (hypoglycaemia), especially tachycardia and tingling in the fingers;
you have a tumour of the adrenal gland (phaeochromocytoma). In such cases, your doctor will prescribe RYTMOBETA together with alpha-receptor antagonist drugs (alpha-blockers);
you suffer from hyperthyroidism;
you have a personal or family history of psoriasis. In such cases, your doctor will prescribe RYTMOBETA only after carefully evaluating the benefits and risks;
you have a prolonged PR interval (an abnormality on the electrocardiogram);
you have circulation problems in your hands and/or feet, for example, if you suffer from a condition called "Raynaud's phenomenon";
you are about to undergo surgery or receive anaesthetics;
you have a personal or family history of asthma;
you have experienced severe allergic reactions, or are currently undergoing or have undergone allergy treatments or therapies aimed at reducing the risk of allergies (desensitization therapy), as RYTMOBETA may increase sensitivity to allergens and worsen potential anaphylactic reactions. In such cases, your doctor will prescribe this medicine only after carefully evaluating the benefits and risks;
you have had a heart attack (myocardial infarction) or have heart problems, as you are at risk of worsening of these conditions (see "Do not take RYTMOBETA if");
you have low potassium (hypokalaemia) or magnesium (hypomagnesaemia) levels in the blood, or have taken medicines that reduce potassium or magnesium levels in the blood, or if you have severe or persistent diarrhoea.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and RYTMOBETA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. In particular, inform your doctor if you are taking one or more of the following medicines.

Calcium channel blockers (calcium antagonists)
Concomitant use of RYTMOBETA and calcium channel blockers such as verapamil and diltiazem (used to treat high blood pressure) may cause a marked drop in blood pressure, reduced heart rate (bradycardia), and severe atrioventricular conduction disturbances. Therefore, if you are being treated with calcium channel blockers such as verapamil and diltiazem administered intravenously for high blood pressure, treatment with RYTMOBETA is not recommended (see "Do not take RYTMOBETA if").

Antiarrhythmics
Combined treatment with antiarrhythmic medicines of type I (medicines used to treat heart rhythm disorders, particularly quinidine-like drugs, disopyramide) or type III may cause excessive prolongation of the QT interval on the electrocardiogram (ECG), increasing the risk of ventricular arrhythmias. To avoid excessive QT prolongation, the use of antiarrhythmics of types I and III should be avoided.
Concomitant use of sotalol hydrochloride with other medicines possessing beta-receptor blocking properties (beta-blockers) may lead to cumulative effects, resulting in reduced blood pressure and heart rate.

Other medicines capable of prolonging the QT interval
Concomitant use of RYTMOBETA and the following medicines, which may cause QT interval prolongation on the electrocardiogram (ECG), increases the risk of a heart rhythm disorder known as "torsades de pointes":

tricyclic or tetracyclic antidepressants (e.g. imipramine and maprotiline),
antihistamines (e.g. astemizole and terfenadine),
quinolone antibiotics (e.g. sparfloxacin),
macrolide antibiotics (e.g. erythromycin),
probucol (used to reduce cholesterol levels in the blood),
haloperidol (an antipsychotic),
halofantrine (used to treat malaria),
terodiline (used as a urinary tract antispasmodic).

Concomitant administration of RYTMOBETA and any of the following medicines may cause a rapid drop in blood pressure:

tricyclic antidepressants (medicines used to treat depression),
barbiturates (used to treat epilepsy),
phenothiazines (used as antihistamines or antipsychotics),
narcotics (used for general anaesthesia or as painkillers),
antihypertensives (medicines used to lower blood pressure),
diuretics (used to increase urine secretion),
vasodilators (used to widen blood vessels).

Noradrenaline, clonidine, and monoamine oxidase inhibitors (MAO inhibitors):
Concomitant administration of RYTMOBETA with noradrenaline or MAO inhibitors (used to treat depression), or abrupt discontinuation of clonidine (used to treat high blood pressure), may rapidly increase blood pressure.
The reduction in heart rate (cardiodepressive effect) caused by RYTMOBETA may be additive to the effects of narcotic drugs or medicines used to treat heart rhythm disorders.

Digitalis glycosides
In patients treated with sotalol who have also received digitalis glycosides, proarrhythmic events (appearance of new cardiac rhythm disturbances or worsening of pre-existing arrhythmias) were more common; however, these may also be related to the presence of chronic heart failure, a known risk factor for proarrhythmia in patients treated with digitalis glycosides.
Combining digitalis glycosides with beta-blockers may increase atrioventricular conduction time.

Concomitant use of antihypertensive agents such as reserpine, clonidine, or alpha-methyldopa, guanfacine (a medicine used in the treatment of attention deficit and hyperactivity disorders), or cardiac glycosides (used to treat heart muscle weakness) may enhance the effects of RYTMOBETA, further reducing heart rate or slowing impulse conduction through the heart.

Neuromuscular blocking agents such as tubocurarine
Neuromuscular blockade (blockade of nerve-muscle connection) caused by tubocurarine (agents used by anaesthesiologists during certain surgical procedures) may be enhanced by RYTMOBETA.

Insulin and oral antidiabetics
Concomitant administration of RYTMOBETA with insulin or oral antidiabetic medicines may lead to reduced blood sugar levels (hypoglycaemia), especially during periods of stress (e.g. physical exertion). Symptoms of hypoglycaemia (rapid breathing, increased heart rate, restlessness) may be masked by RYTMOBETA.

Diuretics that reduce potassium levels
Concomitant administration of diuretics with RYTMOBETA may alter potassium levels in the blood, increasing the risk of heart rhythm disturbances. Hypokalaemia or hypomagnesaemia may occur, increasing the risk of torsades de pointes.

Other medicines that reduce potassium levels
Amphotericin B (a medicine administered intravenously for certain severe fungal infections), systemic corticosteroids, and certain laxatives may also be associated with hypokalaemia. Potassium levels should be monitored and appropriately corrected during concomitant administration with RYTMOBETA.

Beta-2 receptor stimulants:
Beta-2 agonists (used in the treatment of asthma) may need to be administered at higher doses when used concomitantly with RYTMOBETA.

Pharmacological interaction with laboratory tests:
The presence of sotalol (RYTMOBETA) in urine may cause falsely elevated urinary metanephrine levels (a test used in the diagnosis of phaeochromocytoma) when measured by photometric methods.

RYTMOBETA with food
RYTMOBETA should not be taken with meals, particularly with milk and dairy products, as this may affect the absorption of the active substance.

Fertility, pregnancy, and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Fertility
There are no clinical data on fertility from the use of this medicine. Animal fertility data are not available.

Pregnancy
Since sotalol hydrochloride, the active ingredient in RYTMOBETA, crosses the placenta and sufficient studies on the effects of sotalol hydrochloride in pregnant women are not currently available, your doctor will prescribe RYTMOBETA only after carefully evaluating the benefits and risks of treatment.
The medicine diffuses through the placenta and reaches pharmacologically active concentrations in the fetus. Therefore, bradycardia, hypotension, and hypoglycaemia may occur in the fetus or newborn. Treatment with RYTMOBETA should therefore be discontinued 48–72 hours before the expected date of delivery. For a corresponding period after birth, newborns should be closely monitored for signs of RYTMOBETA activity (signs of beta-blockade).

Breastfeeding
Sotalol hydrochloride, the active ingredient in RYTMOBETA, passes into breast milk (20%–23% of the dose administered to the mother). Breastfeeding is therefore not recommended during treatment with RYTMOBETA. If RYTMOBETA is taken during breastfeeding, infants should be monitored for signs of beta-blockade.

Driving and using machines
This medicine may affect a person's ability to drive vehicles and use machinery and may reduce a person's safety at work. This is particularly likely at the beginning of treatment, when the dose is increased, or when RYTMOBETA is used together with alcohol.

RYTMOBETA contains lactose and sodium

Lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Sodium (as sodium glycolate starch)
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take RYTMOBETA

Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Symptomatic ventricular tachycardia (tachycardia generating impulses in the heart's ventricles)
The initial dose is 80 mg of sotalol hydrochloride, twice daily (equivalent to 1 tablet of 80 mg RYTMOBETA, twice daily).
If this dose is ineffective, your doctor may increase it to 80 mg of sotalol hydrochloride three times daily (equivalent to 1 tablet of 80 mg RYTMOBETA, three times daily) or 160 mg of sotalol hydrochloride, twice daily (equivalent to 2 tablets of 80 mg or 1 tablet of 160 mg of RYTMOBETA, twice daily).
If you suffer from life-threatening heart rhythm disorders and the current dose is ineffective, your doctor may increase your dose up to 480 mg of sotalol hydrochloride in 2 or 3 divided doses (equivalent to 6 tablets of 80 mg or 3 tablets of 160 mg of RYTMOBETA). In such cases, your doctor will increase the dose only if the potential benefits outweigh the increased risk of side effects (particularly heart rhythm disturbances).
Your doctor may increase the dose only after 2–3 days of treatment.
Symptomatic supraventricular tachycardia requiring treatment
The initial dose is 80 mg of sotalol hydrochloride, twice daily (equivalent to 1 tablet of 80 mg RYTMOBETA, twice daily).
If the initial dose is well tolerated but not sufficiently effective, your doctor may increase the dose to 80 mg of sotalol hydrochloride, three times daily (equivalent to 1 tablet of 80 mg RYTMOBETA, three times daily). If you have paroxysmal atrial fibrillation, this dosage should not be exceeded.
If you have chronic atrial fibrillation and the initial dose is not effective enough but is well tolerated, your doctor may increase the dose up to a maximum of 160 mg of sotalol hydrochloride (equivalent to 2 tablets of 80 mg or 1 tablet of 160 mg of RYTMOBETA).
Your doctor may increase the dose only after 2–3 days of treatment.
Recommended doses for patients with renal impairment
If you have renal impairment, RYTMOBETA accumulates after prolonged use. Therefore, your doctor will adjust the dose based on kidney function (by measuring a value called creatinine clearance), monitoring heart rate (which should not fall below 50 beats per minute), and clinical response.
If you have severe renal impairment, your doctor may prescribe RYTMOBETA only if electrocardiograms (ECG) and blood ion levels are frequently monitored.
If creatinine clearance is greater than 60 millilitres/minute (i.e. above 1 millilitre/second), the dose is the same as that used for adults.
If creatinine clearance is between 30 and 60 millilitres/minute (i.e. between 0.5 and 1 millilitre/second), the dose is half that used for adults.
If creatinine clearance is between 10 and 30 millilitres/minute (i.e. between 0.17 and 0.5 millilitre/second), the dose is one-quarter that used for adults.
If creatinine clearance is less than 10 millilitres/minute (i.e. below 0.17 millilitre/second), RYTMOBETA must not be used (see section “Do not take RYTMOBETA if”).
Children and adolescents
There are insufficient studies on the effects of sotalol hydrochloride in children and adolescents up to 18 years of age. Therefore, the use of RYTMOBETA is not recommended in children and adolescents up to 18 years of age.
Elderly patients
In elderly patients, the doctor will assess possible kidney dysfunction and adjust the dose according to renal excretion rate (creatinine clearance).
Method of administration
Take the tablets whole with some liquid (e.g. a glass of water) before meals.
Do not break the tablets to make swallowing easier.
Do not take the tablets during meals, as food (particularly milk and dairy products) may affect drug absorption.
If you take more RYTMOBETA than you should
If you take more RYTMOBETA than prescribed, contact your doctor immediately, as appropriate countermeasures are necessary.
Symptoms of overdose depend on heart function (left ventricular function, presence of heart rhythm disorders).
Depending on the extent of the overdose, the following symptoms may occur: fatigue, loss of consciousness, dilated pupils, occasionally generalized myoclonic seizures (convulsions), bronchospasm (acute narrowing of the bronchi causing breathing difficulties), hypoglycaemia, dizziness, low blood pressure (hypotension), reduced heart rate (bradycardia), disturbances in heart rhythm such as torsades de pointes (a specific type of tachycardia), or asystole.
Additional symptoms related to cardiovascular shock may also occur, such as hypotension, abnormal heartbeats (bradycardia or tachycardia), dizziness, fainting (pre-syncope or syncope), sweating, cold and bluish extremities, pallor, reduced urine output (oliguria, anuria), and feeling of weakness (asthenia).
If you experience one or more of these symptoms, contact your doctor immediately or go to the nearest hospital.
If you forget to take RYTMOBETA
Do not take a double dose to make up for a missed dose; continue taking the medicine as prescribed.
If heart rhythm disturbances recur, contact your doctor.
If you stop taking RYTMOBETA
Do not stop or discontinue treatment with RYTMOBETA without consulting your doctor.
If you have had a heart attack (myocardial infarction) and/or continue to have heart rhythm disturbances, or if you have been taking RYTMOBETA for a long time, the medicine must be discontinued gradually, as sudden discontinuation may worsen your condition.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor if, during treatment with RYTMOBETA, you notice:

Common side effects (may affect up to 1 in 10 people)

worsening of heart failure, decreased heart rate (bradycardia), conduction disorders, chest pain (angina pectoris);
heart rhythm disorders or worsening of such disorders (especially in patients with life-threatening cardiac arrhythmias or left ventricular dysfunction), such as ventricular tachycardia (including atypical tachycardia or torsades de pointes);
reduction in blood pressure;
stomach or intestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain, dyspepsia (indigestion), flatulence;
skin reactions;
feeling of tiredness (asthenia), fatigue, fever, oedema (for example, swelling of the legs);
worsening of blood vessel blockages in the legs and arms, feeling of coldness in the legs and arms;
confusion, sleep disorders, mood changes, depression;
sensory disturbances such as tingling (paraesthesia), fainting, dizziness, headache;
muscle spasms, muscle weakness;
transient sexual dysfunction.

Other side effects (frequency cannot be estimated)

reduction in blood sugar levels (hypoglycaemia);
disturbances in fat metabolism: increase in total cholesterol, increase in triglycerides, decrease in HDL cholesterol;
hallucinations, abnormal dreams;
inflammation of the cornea (keratitis), conjunctivitis, blurred vision, decreased tear production (may occur particularly if you wear contact lenses);
cardiac arrest;
breathing difficulties (dyspnoea);
dry mouth;
psoriasis or worsening of existing psoriasis.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.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 RYTMOBETA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 RYTMOBETA contains
The active substance is: sotalol hydrochloride.
One tablet of RYTMOBETA 80 and 160 mg contains: 80 and 160 mg of sotalol hydrochloride.
The other components are: maize starch, sodium glycolate starch, hydroxypropylcellulose, lactose,
magnesium stearate, colloidal silicon dioxide.

Description of the appearance of RYTMOBETA and contents of the pack
RYTMOBETA is available as tablets.
This medicine is available in packs containing 20 or 50 tablets of 80 mg or 160 mg.

Marketing Authorization Holder
BGP Products S.r.l. - Viale Giorgio Ribotta 11, 00144 Roma (RM)

Manufacturer
AbbVie Deutschland GmbH & Co. KG, Knollstrasse 50, Ludwigshafen – Germany
AbbVie S.r.l. – S.R. 148 Pontina km 52 snc - 04011 - Campoverde di Aprilia (LT)

Rytmobeta