SOTALOL 80 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Sotalol Aurovitas, 40 mg, Tablets
3. Sotalol Aurovitas, 80 mg, Tablets
4. Sotalol Aurovitas, 160 mg, Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
5. What is Sotalol Aurovitas and what is it used for
6. Important information before taking Sotalol Aurovitas
   1. When Not to Take Sotalol Aurovitas
   2. Warnings and Precautions
   3. Sotalol Aurovitas and Other Medications
   4. Pregnancy, Breastfeeding, and Fertility
   5. Driving and Using Machines
   6. Sotalol Aurovitas Contains Lactose:
   7. Sotalol Aurovitas Contains Sodium:
7. How to Take Sotalol Aurovitas
   1. Adults (including elderly patients):
   2. Children:
   3. Taking a Higher Than Recommended Dose of Sotalol Aurovitas
   4. Missing a Dose of Sotalol Aurovitas
   5. Stopping Sotalol Aurovitas
8. Possible Side Effects
   1. Other Side Effects
   2. Reporting Side Effects
9. How to Store Sotalol Aurovitas
10. Contents of the Pack and Other Information
    1. What Sotalol Aurovitas Contains
    2. What Sotalol Aurovitas Looks Like and What the Pack Contains
    3. Marketing Authorization Holder:
    4. Manufacturer/Importer:
    5. This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:
    7. Date of Last Revision of the Leaflet: 10/2024

Package Leaflet: Information for the Patient

Sotalol Aurovitas, 40 mg, Tablets

Sotalol Aurovitas, 80 mg, Tablets

Sotalol Aurovitas, 160 mg, Tablets

Sotalol Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, 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 medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

Sotalol belongs to a group of medications called beta-blockers, which slow down the heart rate, making the heart's work more efficient. Sotalol is used to prevent severe heart rhythm disturbances from recurring.

2. Important information before taking Sotalol Aurovitas

When Not to Take Sotalol Aurovitas

• if the patient is allergic to sotalol or any of the other ingredients of this medication (listed in section 6);
• if the patient is allergic to sulfonamides, e.g., co-trimoxazole, sulfadiazine;
• if the patient has any heart disease other than those for which this medication was prescribed, in particular:
• abnormal heart rhythm called "long QT syndrome";
• congestive heart failure (NYHA class IV);
• ventricular tachycardia torsades de pointes;
• atrioventricular block;
• sick sinus syndrome (without a pacemaker);
• if the 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 anxiety);
• if the patient has any of the following diseases or disorders:
• asthma or other breathing difficulties;
• Prinzmetal's angina (chest pain and palpitations at rest, usually

at night);

• circulatory disorders (e.g., Raynaud's phenomenon or calf muscle pain when walking);
• pheochromocytoma (a benign adrenal gland tumor) that is not being treated;
• low blood pressure (not due to heart rhythm disturbances);
• severe kidney disease;
• metabolic acidosis (acidic blood reaction);
• if the patient is scheduled to receive general anesthesia;
• if the patient is also taking other medications to correct abnormal heart rhythms, e.g., quinidine, hydroquinidine, or disopyramide (so-called class Ia antiarrhythmic medications), amiodarone, dofetilide, or ibutilide (so-called class III antiarrhythmic medications);
• if the patient is also taking medications used to treat schizophrenia and other severe mental disorders, e.g., sulpiride, sultopride, amisulpride, tiorydazine, chlorpromazine, levomepromazine, trifluperazine, cyamemazine, tiapride, pimozide, haloperidol, droperidol (so-called neuroleptics);
• if the patient is receiving erythromycin injections (an antibiotic), vincamine (used to treat certain brain diseases, especially dementia), bepridil (used to treat angina pectoris), cisapride (used to treat certain gastrointestinal diseases), difemanyl (used to treat slow heart rate), mizolastine (used to treat hay fever), moxifloxacin (an antibiotic), or floctafenine (used to treat pain). If the patient is elderly, it is especially important not to take sotalol if any of the above conditions apply to the patient.

Warnings and Precautions

Sotalol may sometimes worsen heart rhythm disturbances or cause new heart rhythm disturbances. Before starting to take Sotalol Aurovitas, the patient should discuss this with their doctor or pharmacist if they have:

• heart failure that is being treated or heart rhythm disturbances called atrioventricular block first degree, or if the patient has recently had a heart attack;
• electrolyte imbalance (low potassium and magnesium levels in the blood);
• severe or prolonged diarrhea;
• frequent allergic reactions;
• hyperthyroidism;
• psoriasis (red, flaky patches on the skin);
• diabetes treated with insulin or sulfonylurea derivatives, as the warning signs of low blood sugar may be less noticeable than usual;
• kidney disease.

Other precautions to take:

• The patient should inform their medical personnel or dentist that they are taking sotalol if they are scheduled to have surgery that requires anesthesia or if they are to have a radiological examination (using X-rays).
• Sotalol should never be stopped abruptly (see section 3).
• In athletes, taking sotalol may result in a positive doping test.

Sotalol Aurovitas and Other Medications

Certain medications should not be taken at the same time as sotalol. They are listed above in the subsection "When Not to Take Sotalol Aurovitas". The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. Sotalol Aurovitas should not usually be taken at the same time as the following medications due to the risk of further heart problems:

• halofantrine (used to treat malaria);
• pentamidine (used to treat pneumonia);
• sparfloxacin (an antibiotic);
• methadone (which may be used to treat cough, pain, and heroin addiction);
• diltiazem or verapamil (medications called calcium antagonists, used to treat heart rhythm disturbances);
• the reduction in heart rate and changes in electrical conduction in heart tissue caused by sotalol hydrochloride may be increased by concurrent administration of reserpine, clonidine, alpha-methyldopa, guanfacine, or digitalis glycosides;
• blood pressure may rise sharply after concurrent administration of sotalol hydrochloride and norepinephrine or monoamine oxidase inhibitors, e.g., moclobemide, phenelzine, isocarboxazid, as well as after sudden cessation of concurrent administration of clonidine;
• concurrent use of sotalol hydrochloride with other medications that have beta-blocking properties may lead to low blood pressure and slow heart rate;
• when taken with beta-agonists, it may be necessary to increase the dose of these medications;
• neuromuscular blockade caused by tubocurarine may be increased by the beta-adrenergic blocking action of sotalol hydrochloride.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication. The doctor may only recommend taking sotalol during pregnancy if it is absolutely necessary. If the doctor recommends taking sotalol, it should always be taken strictly according to the doctor's instructions. Breastfeeding is not recommended during treatment with sotalol.

Driving and Using Machines

Sotalol may cause vision disturbances or dizziness. If such symptoms occur, the patient should not drive vehicles, operate machinery, or use tools.

Sotalol Aurovitas Contains Lactose:

If the patient has an intolerance to some sugars, they should contact their doctor before taking the medication.

Sotalol Aurovitas Contains Sodium:

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

3. How to Take Sotalol Aurovitas

This medication should always be taken according to the doctor's or pharmacist's instructions. If there are any doubts, the patient should consult their doctor or pharmacist. The recommended dose is:

Adults (including elderly patients):

The initial dose is 80 mg of sotalol once daily or in two divided doses every 12 hours. The doctor will then recommend gradually increasing the dose as needed. The usual dose is between 160 mg and 320 mg of sotalol per day, in two or three divided doses. In some patients with life-threatening heart rhythm disturbances, the doctor may increase the dose to 480 mg or 640 mg of sotalol per day. Patients with kidney function disorders may require a lower dose. Sotalol hydrochloride should only be administered to patients with severe kidney function disorders under close monitoring of the electrocardiogram and serum sotalol hydrochloride concentration.

Children:

Due to the lack of data, sotalol is not recommended for children. The patient should consult their 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 adjustment phase. Sotalol hydrochloride tablets should be taken whole and before meals, as the presence of food (especially milk and dairy products) may affect the absorption of the active substance. The 80 mg and 160 mg tablets can be divided into equal doses.

Taking a Higher Than Recommended Dose of Sotalol Aurovitas

In case the patient has taken too many tablets (or someone else has taken any number of tablets), or if a child has taken any number of tablets, they should immediately go to the emergency department of the nearest hospital or contact their doctor. They should bring this leaflet, the remaining tablets, and the packaging, so it is known which medication was taken.

Missing a Dose of Sotalol Aurovitas

If a dose is missed, the patient should take the missed dose as soon as possible, unless it is almost time for the next dose. The patient should never take a double dose to make up for a missed dose. They should take the next doses at the usual time.

Stopping Sotalol Aurovitas

Sotalol should not be stopped abruptly, as this may cause severe heart problems, including heart attack and death. The doctor will decide when and how to stop taking Sotalol Aurovitas. The patient should follow the doctor's instructions. If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Sotalol Aurovitas can cause side effects, although not everybody gets them. The following side effects have been reported - the patient should immediately tell their doctor if they experience any of the following symptoms: blood disorders (such as changes in the number of white or red blood cells), which may manifest as unusual bleeding or easy bruising, fever, or chills, sore throat, mouth ulcers, or throat ulcers. Side effects observed during treatment with sotalol in tablets are as follows (occurring in at least 1 in 100 patients):

• low blood sugar, increased total cholesterol and triglycerides, decreased HDL cholesterol,
• cold hands and (or) feet,
• vision disturbances, corneal and conjunctival inflammation, decreased tear production (note: this is important for contact lens wearers!), conjunctivitis,
• slow heart rate, shortness of breath, wheezing, chest pain, palpitations, swelling of the ankles, ECG abnormalities (electrocardiogram), low blood pressure, worsening of heart rhythm disturbances, fainting, heart failure, torsade de pointes,worsening of angina pectoris,
• skin rash, itching, increased sweating, sensitivity to light,
• nausea, vomiting, diarrhea, indigestion, stomach pain and bloating, dry mouth,
• muscle cramps, muscle pain or joint pain,
• swelling, fatigue,
• sexual disorders, including impotence,
• fatigue, dizziness of central origin, feeling of "emptiness" in the head, dizziness of labyrinthine origin, lethargy, headache, depression, difficulty sleeping, tingling, numbness, anxiety, fainting, pre-fainting conditions, confusion, sleep disturbances, mood swings, hallucinations, increased intensity of dreams.

In rare cases, joint and connective tissue inflammation (e.g., tendons) with skin rash have been reported. These symptoms usually disappear after treatment is stopped. In patients with psoriasis or intermittent claudication (cramping leg pain when walking), symptoms may worsen.

Other Side Effects

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

• Hair loss
• Excessive sweating
• Abnormally low number of platelets in the blood

Reporting Side Effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medication.

5. How to Store Sotalol Aurovitas

The medication should be stored out of sight and reach of children. Do not use this medication after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month. There are no special precautions for storing the medication. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Sotalol Aurovitas Contains

• The active substance of the medication 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.
• Other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone (K-30), sodium carboxymethylcellulose (Type A), colloidal anhydrous silica, magnesium stearate.

What Sotalol Aurovitas Looks Like and What the Pack Contains

Sotalol Aurovitas, 40 mg, tablets
White to creamy, round, biconvex, uncoated tablet with a diameter of 5.5 mm, with "40" embossed on one side and smooth on the other side.
Sotalol Aurovitas, 80 mg, tablets
White to creamy, round, biconvex, uncoated tablet with a diameter of 7.5 mm, with "80" and a score line embossed on one side and a score line on the other side. The tablet can be divided into equal parts.
Sotalol Aurovitas, 160 mg, tablets
White to creamy, round, biconvex, uncoated tablet with a diameter of 10 mm, with "160" and a score line embossed on one side and a score line on the other side. The tablet can be divided into equal parts.
Sotalol Aurovitas tablets are available in blisters and HDPE bottles, packaged in cardboard boxes.
Blisters(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 (only for dose dispensing) tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 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 Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

Netherlands:
Sotalol HCl Aurobindo 40 mg / 80 mg / 160 mg, tablets
Poland:
Sotalol Aurovitas
Portugal:
Sotalol Aurobindo

Date of Last Revision of the Leaflet: 10/2024