Sotalol aurovitas

Package leaflet: Information for the patient

Sotalol Aurovitas, 40 mg, tablets
Sotalol Aurovitas, 80 mg, tablets
Sotalol Aurovitas, 160 mg, tablets
Sotalol hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

Sotalol belongs to a group of medicines called beta-blockers (antiarrhythmic agents).
Sotalol is used for:
➢ Life-threatening ventricular arrhythmias with increased heart rate (life-threatening symptomatic ventricular tachyarrhythmias)
➢ Symptomatic and treatment-requiring supraventricular arrhythmias with increased heart rate (symptomatic and treatment-requiring supraventricular tachyarrhythmias), in order to

• prevent chronic irregular heartbeat due to pathologically increased atrial excitation (prevention of chronic atrial fibrillation) after electrical cardioversion
• prevent paroxysmal irregular heartbeats resulting from abnormal increased atrial excitation (prevention of paroxysmal atrial fibrillation).

2. Important information before using Sotalol Aurovitas

When not to use Sotalol Aurovitas

• if the patient is allergic to sotalol or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to sulfonamides, e.g. co-trimoxazole, sulfadiazine;
• if the patient has any heart conditions other than those for which this medicine has been prescribed, in particular:
  • an abnormal heart rhythm known as "long QT syndrome";
  • congestive heart failure (NYHA class IV);
  • torsade de pointes tachycardia;
  • atrioventricular block;
  • sick sinus syndrome (without a pacemaker);
  • if heart rate is less than 50 beats per minute;
  • if the patient has uncontrolled heart failure;
  • if the patient has experienced cardiogenic shock (low blood pressure, cold skin, weak pulse, confusion and restlessness);
• if the patient has any of the following diseases or disorders:
  • asthma or other breathing difficulties;
  • circulatory disorders (e.g. Raynaud's phenomenon or leg muscle pain while walking);
  • phaeochromocytoma (a benign adrenal gland tumour) that is untreated;
  • low blood pressure (not caused by heart rhythm disorders);
  • severe kidney disease;
  • low blood potassium levels;
  • low blood magnesium levels;
  • metabolic acidosis (acidic blood);
• if general anaesthesia is planned for the patient;
• if the patient is also taking other medicines to treat irregular heart rhythm, such as quinidine, hydroquinidine or disopyramide (so-called class Ia antiarrhythmics), amiodarone, dofetilide or ibutilide (so-called class III antiarrhythmics);
• if the patient is also taking medicines used to treat schizophrenia and other serious psychiatric disorders, e.g. sulpiride, sultopride, amisulpride, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, tiapride, pimozide, haloperidol, droperidol (so-called neuroleptics);
• if the patient is also receiving intravenous erythromycin (an antibiotic), vinpocetine (used in the treatment of certain brain disorders, especially dementia), bepridil (used to treat angina pectoris), cisapride (used to treat certain gastrointestinal disorders), difeminal (used to treat slow heart rate), mizolastine (used to treat hay fever), moxifloxacin (an antibiotic), or flecainide (used to treat pain).
• intravenous administration of calcium channel blockers such as verapamil or diltiazem, or other antiarrhythmic drugs (such as disopyramide), is contraindicated in patients taking sotalol (except for drugs used in intensive care settings).

If the patient is elderly, it is particularly important not to take sotalol if any of the above conditions apply.

Warnings and precautions

Sotalol may sometimes worsen heart rhythm disorders or cause new heart rhythm disturbances.

Before starting treatment with Sotalol Aurovitas, discuss this with your doctor or pharmacist if the patient has:

• heart failure that is being treated, or first-degree atrioventricular block, or the patient has recently had a heart attack;
• slow heart rate (less than 50 beats per minute);
• certain abnormalities on electrocardiogram (ECG) (prolonged QT interval), cardiomegaly (enlarged heart muscle), or a history of heart failure;
• a recent heart attack, as sotalol may worsen existing arrhythmias or cause new heart rhythm disturbances;
• problems with excess thyroid hormones in the blood (thyrotoxicosis), because sotalol may mask symptoms or symptoms may worsen after abrupt discontinuation;
• psoriasis (red, flaky skin patches);
• diabetes treated with insulin or sulfonylurea derivatives, because warning signs of low blood sugar may be less noticeable than usual (hypoglycaemia);
  • particularly relevant in cases of strict fasting and in diabetics with unstable blood glucose levels or episodes of spontaneous hypoglycaemia;
• peripheral circulatory disorders, such as severe vasoconstriction in fingers or toes (Raynaud's syndrome) and peripheral arterial occlusive disease (PAOD); symptoms may occur especially in the initial phase of treatment;
• a hormone-secreting adrenal medulla tumour (phaeochromocytoma; see section "When not to use Sotalol Aurovitas"); alpha-adrenergic receptor activity should be blocked simultaneously with another medicine;
• Prinzmetal's angina; beta-blocking agents, including sotalol, may increase the risk of angina pectoris;
• kidney disease.

Due to its beta-adrenergic receptor-blocking properties, sotalol hydrochloride may increase sensitivity to allergens and exacerbate acute generalized allergic reactions (anaphylactic reactions). If the patient has experienced severe hypersensitivity reactions or is undergoing treatment aimed at reducing or eliminating allergic tendencies (desensitisation therapy), there is an increased risk of excessive anaphylactic reactions. In such cases, the use of Sotalol Aurovitas should be carefully considered.

Proarrhythmic effects, involving changes in heart rhythm or worsening of arrhythmias, commonly occur and may lead to severe disturbances in heart function, potentially resulting in cardiac arrest. Worsening of arrhythmias (arrhythmogenic effect) may occur particularly in patients with life-threatening arrhythmias and left ventricular dysfunction.

Sotalol hydrochloride prolongs the QT interval (an ECG parameter), which may lead to irregular heartbeat (tachyarrhythmias; including torsade de pointes tachycardia), especially in cases of overdose, resulting in significant slowing of heart rate. Severe proarrhythmic events (persistent ventricular tachycardia or ventricular flutter/fibrillation or torsade de pointes) are generally dose-dependent and usually occur during the initial phase of treatment or after dose escalation.

Patients after myocardial infarction or with impaired heart function are particularly at risk of developing worsened arrhythmias (proarrhythmia) and require especially careful monitoring after starting sotalol.

Concomitant use with class I antiarrhythmic drugs that may widen the QRS complex (an ECG parameter) (especially those similar to quinidine) should be avoided, as this could lead to excessive QT prolongation and increased susceptibility to ventricular arrhythmias. Concomitant use with other class III antiarrhythmic drugs should also be avoided due to the risk of excessive QT prolongation. Based on experience with widely used antiarrhythmic drugs, the most dangerous adverse effect is considered to be worsening of existing arrhythmias or induction of new arrhythmias.

In case of severe or persistent diarrhoea, or if the patient is taking medicines that cause excessive excretion of magnesium and/or potassium, electrolyte balance and acid-base balance should be closely monitored. Sotalol should not be taken if the patient has low potassium levels (hypokalaemia) or low magnesium levels (hypomagnesaemia). Taking sotalol with potassium or magnesium deficiency may lead to undesirable changes in heart rhythm.

Other precautions to take:

• Inform medical or dental staff that the patient is taking sotalol if surgery requiring anaesthesia is planned or if radiological examination (using X-rays) is to be performed.
• Never stop taking sotalol abruptly (see section 3).

Sotalol Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Some medicines must not be taken together with sotalol. These are listed above under "When not to use Sotalol Aurovitas".

Tell your doctor if the patient is taking any of the medicines listed below. Sotalol Aurovitas should generally not be taken together with the following medicines due to the risk of further heart disturbances:

• flecainide (for pain treatment);
• medicines that may affect electrocardiogram results (prolong QT interval) or cause torsade de pointes tachycardia, such as certain antiarrhythmics, including quinidine, hydroquinidine, disopyramide, amiodarone, dofetilide, dronedarone, ibutilide; medicines used in the treatment of severe psychiatric disorders (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol); antibiotics (erythromycin, moxifloxacin, gatifloxacin); antihistamines (terfenadine, astemizole); gastroprokinetic/antiemetic medicines (cisapride, domperidone); protein kinase inhibitors (vandetanib); and others (methadone, bepridil, difemanil, intravenous erythromycin, mizolastine and intravenous vinpocetine).

Sotalol Aurovitas should not be taken together with the following medicines:

• Sotalol should be administered with extreme caution in combination with medicines that prolong the QT interval, such as:
  • antiarrhythmic drugs, such as procainamide, ajmaline, flecainide, cibenzoline, azimilide;
  • antidepressants, such as citalopram, escitalopram, fluoxetine, paroxetine, sertraline, fluvoxamine, clomipramine, amitriptyline, desipramine, imipramine, nortriptyline and maprotiline;
  • antipsychotics, such as mesoridazine, fluvoxamine and sertindole;
  • antihistamines, such as famotidine, promethazine and diphenhydramine;
  • gastroprokinetic/antiemetic drugs, such as ondansetron;
  • protein kinase inhibitors, such as sunitinib and sorafenib;
• other medicines such as arsenic trioxide, donepezil, trazodone, hydrocodone, probucol, ranolazine, hydroxyzine, fluconazole and papaverine;
• halofantrine, artemether and chloroquine (used to treat malaria);
• pentamidine (used to treat pneumonia);
• sparfloxacin (an antibiotic);
• methadone (which may be used to treat cough, pain and heroin addiction);
• ciprofloxacin or levofloxacin (antibiotics used to treat infections);
• diltiazem or verapamil (medicines known as calcium antagonists, used to treat heart rhythm disorders).

The reduction in heart rate and changes in electrical conduction in heart tissue caused by sotalol hydrochloride may be intensified by concomitant administration of:

• reserpine, clonidine, alpha-methyldopa, guanfacine or cardiac glycosides.

Blood pressure may rise sharply after concomitant administration of sotalol hydrochloride and noradrenaline or MAO inhibitors, e.g. moclobemide, phenelzine, isocarboxazid, or after abrupt discontinuation of concomitant clonidine administration.

Sotalol should be used with caution in patients taking:

• medicines that reduce potassium levels, such as diuretics (e.g. furosemide, hydrochlorothiazide), laxatives, glucocorticoids, tetracosactide, intravenous amphotericin B;
• concomitant use of sotalol hydrochloride with other medicines having beta-blocking properties may lead to reduced blood pressure and heart rate, such as diltiazem, verapamil; clonidine, reserpine, guanfacine; cardiac glycosides, including digoxin; mefloquine, alpha-methyldopa, cholinesterase inhibitors used, for example, in Alzheimer's disease, such as rivastigmine, tacrine, galantamine, neostigmine, pyridostigmine, ambenonium; pilocarpine;
• inhaled anaesthetics;
• medicines used to treat diabetes, such as insulin and hypoglycaemic sulfonylureas;
• propafenone (for treating heart rhythm disorders);
• baclofen (a muscle relaxant);
• intravenous lidocaine (local anaesthetic, treatment of arrhythmias);
• proton pump inhibitors (omeprazole, lansoprazole, pantoprazol or esomeprazole);
• antacids used to treat gastric ulcers and gastroesophageal reflux.

Combinations requiring attention:

• non-steroidal anti-inflammatory drugs, such as indomethacin;
• calcium channel blockers (dihydropyridines - nifedipine) used to treat high blood pressure, coronary artery disease and heart rhythm disorders;
• intravenous dipyridamole (an anticoagulant used prophylactically in the treatment of cardiovascular events and thrombosis);
• when used concomitantly with beta-agonists, an increased dose of these medicines may be necessary;
• neuromuscular blockade caused by tubocurarine may be intensified by the beta-adrenergic blocking effect of sotalol hydrochloride.

Interactions with laboratory tests:

When having blood tests, inform the doctor that the patient is taking sotalol, as this may affect the results of certain blood tests. The presence of sotalol in urine may interfere with urinary metanephrine measurements (a biomarker for phaeochromocytoma, a benign adrenal tumour).

Children and adolescents

The efficacy and safety of sotalol in patients under 18 years of age have not been adequately established.

Tell your doctor or pharmacist about all other medicines the patient is currently taking or has recently taken, including medicines available without a prescription.

Using Sotalol Aurovitas with food, drink and alcohol

While taking Sotalol Aurovitas, alcohol should be avoided, as combining this medicine with alcohol may cause heart rhythm disturbances.

Do not take Sotalol Aurovitas with milk and dairy products.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

The doctor may prescribe sotalol during pregnancy only if absolutely necessary.

Do not take sotalol unless prescribed by a doctor, and always take this medicine exactly as directed by the doctor.

Pregnancy

If the patient is pregnant, she may take sotalol hydrochloride, the active ingredient in Sotalol Aurovitas, only if the doctor considers it absolutely necessary, as experience with using this medicine in pregnant women is insufficient. Due to the risk of adverse effects in newborns (slow heart rate, low blood pressure, low blood sugar), treatment should be discontinued 48–72 hours before the expected delivery date. Newborns should be carefully monitored for an appropriate period after birth for signs of beta-blockade (slow heart rate, low blood pressure).

Breastfeeding

Sotalol hydrochloride, the active ingredient in Sotalol Aurovitas, passes into and accumulates in the breast milk of breastfeeding women. If sotalol hydrochloride is taken during breastfeeding, the infant should be monitored for signs of beta-blockade (slow heart rate, low blood pressure).

Breastfeeding is not recommended during treatment with sotalol.

Driving and using machines

Sotalol may cause visual disturbances or dizziness. If such symptoms occur, do not drive, operate machinery or use tools.

Sotalol Aurovitas contains lactose:

If the patient has an intolerance to certain sugars, consult a doctor before using this medicine.

Sotalol Aurovitas contains sodium:

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Sotalol Aurovitas

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults (including elderly patients):
Ventricular tachyarrhythmias (heart rhythm disorders with rapid heartbeat of ventricular origin)
The initial dose is 80 mg of sotalol once daily or in two divided doses every 12 hours. Your doctor
will then recommend gradually increasing the dose, depending on individual needs.
The usual daily dose ranges from 160 mg to 320 mg of sotalol, given in two or three divided doses.
In certain patients with life-threatening arrhythmias, your doctor may increase the dose to 480 mg or
640 mg of sotalol per day. In such cases, the dose should only be increased if potential benefits
outweigh the increased risk of possible severe adverse effects.
Dose increases should only occur after at least 2–3 days have elapsed.
Dose adjustment and monitoring during treatment with Sotalol Aurovitas
Dose titration of sotalol-containing medicines for ventricular arrhythmias requires careful
cardiological monitoring and should only be performed when emergency cardiac equipment and
continuous monitoring are available. During treatment, regular control examinations must be
performed (e.g. standard ECG and, if necessary, long-term ECG monitoring). If any ECG parameters
worsen, e.g. QRS complex prolongation or QT interval prolongation by more than 25%, or PQ
interval prolongation by more than 50%, or QT interval prolongation exceeding 500 ms, or increased
frequency or severity of arrhythmias, the continued appropriateness of therapy should be evaluated.
Atrial fibrillation:
At the beginning of treatment, take one Sotalol Aurovitas 80 mg tablet twice daily (equivalent to 2
x 80 mg sotalol hydrochloride). If treatment is not sufficiently effective, the daily dose may be
increased to one Sotalol Aurovitas 80 mg tablet three times daily (equivalent to 3 x 80 mg sotalol
hydrochloride). This dose should not be exceeded in the case of paroxysmal atrial fibrillation.
If the dose is insufficient in patients with chronic atrial fibrillation, it may be increased to a maximum
of two Sotalol Aurovitas 80 mg tablets twice daily (equivalent to 2 x 160 mg sotalol hydrochloride).
Dose increases should only occur after at least 2–3 days have elapsed.
Dosage recommendations in patients with renal impairment
Patients with impaired renal function may require lower doses. After multiple dosing, the drug may
accumulate in the blood. Therefore, the dose should be adjusted according to renal excretion rate
(creatinine clearance), taking into account heart rate (not less than 50 beats/min) and clinical
efficacy.
Sotalol hydrochloride should be administered to patients with severe renal impairment only under
strict monitoring of the electrocardiogram and serum sotalol hydrochloride concentration.
If creatinine clearance (a measure of kidney function) decreases to 10–30 ml/min (serum creatinine
concentration 2–5 mg/dl), the dose should be reduced by one-quarter. If creatinine clearance falls
below 10 ml/min (serum creatinine concentration >5 mg/dl), Sotalol Aurovitas should not be used or
should be used with extreme caution.
Children:
Due to lack of data, sotalol is not recommended for use in children. Consult your doctor.
Method of administration
The tablet should be swallowed whole with a glass of water.
Patients with a history of myocardial infarction or severe heart failure require close medical
supervision during the dose titration phase.
Sotalol hydrochloride tablets should be taken whole and before meals, as food (especially milk and
dairy products) may affect the absorption of the active substance.
Tablets of 80 mg and 160 mg strength may be divided into equal doses.
Use of a higher than recommended dose of Sotalol Aurovitas
If a patient (or another person) takes too many tablets, or if any number of tablets are taken by a
child, seek immediate medical attention at the nearest hospital emergency department or contact
your doctor. Bring this leaflet, any remaining tablets, and the packaging so that it is clear which
medicine has been taken.
Depending on the degree of overdose, the following symptoms may occur: fatigue, loss of
consciousness, dilated pupils, convulsions (including convulsions due to hypoglycaemia), low blood
pressure, hypoglycaemia, slowed heart rate up to circulatory arrest, myocardial depression, rapid
heartbeat, signs of cardiogenic shock.
Missed dose of Sotalol Aurovitas
If you miss a dose, take the missed dose as soon as possible, unless it is almost time for the next
dose. Never take a double dose to make up for a missed dose. Continue taking subsequent doses
at your usual time.
Stopping treatment with Sotalol Aurovitas
Do not suddenly stop taking sotalol, as this may cause serious heart problems, including myocardial
infarction and death.
Your doctor will decide when and how to discontinue Sotalol Aurovitas. Follow your doctor's
instructions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported – tell your doctor immediately if any of the following symptoms occur:
blood disorders (such as changes in white or red blood cell counts), which may manifest as unusual bleeding or easy bruising, fever or chills, sore throat, ulceration of the mucous membranes of the mouth or throat.

Common
Anxiety, confusion, sleep disturbances, mood swings,
sexual dysfunction, hallucinations, increased dream activity, depressive mood, depression;
Weakness (asthenia), dizziness, fatigue, drowsiness, headache,
sensory disturbances (paraesthesia), transient loss of consciousness (fainting) or
near-fainting episodes (pre-syncope), taste disturbances, sensation of cold in the extremities;
Abdominal pain, nausea, vomiting, diarrhoea, indigestion, bloating, dry mouth;
Visual disturbances;
Hearing disturbances;
certain forms of tachycardia (torsade de pointes), cardiac arrhythmias,
dyspnoea, chest pain, undesired drop in blood pressure,
further weakening of the heart muscle (heart failure), slowing of the heartbeat (bradycardia), palpitations, abnormalities in ECG findings, atrioventricular conduction disturbances, fluid retention in tissues (oedema), hypotension; redness, itching, skin rash (erythema);
Muscle cramps or muscle weakness; fever

Uncommon
Conjunctivitis;
Occurrence of respiratory disorders in patients with airway obstruction or
lung diseases (obstructive ventilation disorders)

Rare
Keratitis (inflammation of cornea and conjunctiva), reduced tear secretion (important for people who wear contact lenses!);
Exacerbation of angina attacks and peripheral circulatory disorders;
allergic bronchitis with abnormal connective tissue proliferation

Frequency not known
Lipid metabolism disorders (increased levels of total cholesterol and triglycerides, decreased HDL cholesterol levels);
Abnormally low blood levels of platelets (thrombocytopenia);
Bronchospasm;
hair loss; excessive sweating (hyperhidrosis);
Psoriasis (psoriasis vulgaris), psoriasis-like skin rashes;
Hypoglycaemia

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sotalol Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Sotalol Aurovitas contains

• The active substance is sotalol hydrochloride. Each tablet contains 40 mg of sotalol hydrochloride. Each tablet contains 80 mg of sotalol hydrochloride. Each tablet contains 160 mg of sotalol hydrochloride.
• The other ingredients are: Monohydrate lactose, microcrystalline cellulose, povidone (K-30), sodium carboxymethyl starch (Type A), colloidal anhydrous silica, magnesium stearate.

What Sotalol Aurovitas looks like and contents of the pack
Sotalol Aurovitas, 40 mg, tablets
White to cream, round, biconvex, uncoated tablet with a diameter of 5.5 mm, embossed with
"40" on one side and plain on the other side.
Sotalol Aurovitas, 80 mg, tablets
White to cream, round, biconvex, uncoated tablet with a diameter of 7.5 mm, embossed with
"80" and a break line on one side and a break line on the other side. The tablet can be
divided into equal parts.
Sotalol Aurovitas, 160 mg, tablets
White to cream, round, biconvex, uncoated tablet with a diameter of 10 mm, embossed with
"160" and a break line on one side and a break line on the other side. The tablet can be
divided into equal parts.
Sotalol Aurovitas tablets are available in blisters and HDPE bottles, packed in cardboard
boxes.
Blister (40 mg, 80 mg and 160 mg):
20, 30, 50, 60, 90 and 100 tablets.
HDPE bottle (only 40 mg and 80 mg):
30, 50, 60, 90, 100 and 500 (dose dispensing only) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]
Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
This medicinal product is authorised in the European Economic Area countries under the
following names:
Netherlands: Sotalol HCl Aurobindo 40 mg / 80 mg / 160 mg, tabletten
Poland: Sotalol Aurovitas
Portugal: Sotalol Aurobindo