SOTALOL 40 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 Medicines
   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 the elderly):
   2. Children:
   3. Taking a Higher Dose of Sotalol Aurovitas than Recommended
   4. Missing a Dose of Sotalol Aurovitas
   5. Stopping Treatment with 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 Contents of the Pack
    3. Marketing Authorization Holder:
    4. Manufacturer/Importer:
    5. This Medicinal Product is Authorized 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 medicines called beta-blockers, which slow down the heart rate, making the heart work more efficiently. Sotalol is used to prevent recurrence of severe heart rhythm disturbances.

2. Important information before taking Sotalol Aurovitas

When Not to Take Sotalol Aurovitas

• 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);
• 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);
• phaeochromocytoma (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);

Warnings and Precautions

Sotalol may sometimes worsen heart rhythm disturbances or cause new heart rhythm disturbances. Before starting treatment with Sotalol Aurovitas, you should discuss this with your doctor or pharmacist if you have:

• heart failure that is being treated or heart rhythm disturbances called atrioventricular block, or if you have 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, scaly 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:

• You should inform medical staff or your dentist that you are taking sotalol if you are scheduled to have surgery that requires anesthesia or if you are to have a radiological examination (using X-rays).
• Never stop taking sotalol suddenly (see section 3).
• In athletes, taking sotalol may cause a positive doping test result.

Sotalol Aurovitas and Other Medicines

Certain medicines must not be taken with sotalol. They are listed above, in the subsection "When not to take Sotalol Aurovitas". You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. Sotalol Aurovitas should not usually be taken with the following medicines 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 (medicines called calcium antagonists, used to treat heart rhythm disturbances);
• the reduction in heart rate and changes in electrical conduction in the heart tissue caused by sotalol hydrochloride may be increased by concomitant administration of reserpine, clonidine, alpha-methyldopa, guanfacine or digitalis glycosides;
• blood pressure may rise sharply after concomitant administration of sotalol hydrochloride and noradrenaline or MAO inhibitors, such as moclobemide, phenelzine, isocarboxazid, as well as after sudden discontinuation of concomitant administration of clonidine;
• concomitant use of sotalol hydrochloride with other beta-receptor blocking medicines may lead to a decrease in blood pressure and heart rate;
• when used with beta-agonists, it may be necessary to increase the dose of these medicines;
• nerve-muscle blockade caused by tubocurarine may be increased by the beta-adrenergic blocking effect of sotalol hydrochloride.

Pregnancy, Breastfeeding and Fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor may only recommend sotalol during pregnancy if it is absolutely necessary. If your doctor recommends taking sotalol, you should always follow the doctor's instructions. Breastfeeding is not recommended during treatment with sotalol.

Driving and Using Machines

Sotalol may cause vision disturbances or dizziness. If you experience these symptoms, do not drive, operate machinery or use tools.

Sotalol Aurovitas Contains Lactose:

If you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sotalol Aurovitas Contains Sodium:

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to Take Sotalol Aurovitas

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is:

Adults (including the elderly):

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 as needed. The usual dose is between 160 mg and 320 mg of sotalol per day, given in two or three divided doses. In some patients with life-threatening heart rhythm disturbances, your doctor may increase the dose to 480 mg or 640 mg of sotalol per day. Patients with kidney problems may need a lower dose. Sotalol hydrochloride should only be given to patients with severe kidney problems under close monitoring of the electrocardiogram and sotalol hydrochloride serum levels.

Children:

Due to the 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 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 Dose of Sotalol Aurovitas than Recommended

If you (or someone else) have taken too many tablets, or if a child has taken any tablets, you should contact your nearest hospital emergency department or doctor immediately. Take this leaflet, any remaining tablets and the packaging with you so that the doctor knows what has been taken.

Missing a Dose of Sotalol Aurovitas

If you miss a dose, take the missed dose as soon as possible, unless it is nearly time for your next dose. Never take a double dose to make up for a forgotten dose. Take your next dose at the usual time.

Stopping Treatment with Sotalol Aurovitas

Do not stop taking sotalol suddenly, as this may cause serious heart problems, including heart attack and death. Your doctor will decide when and how to stop taking Sotalol Aurovitas. Follow the doctor's instructions. If you have any further questions on the use of this product, 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 have been reported - you should tell your doctor immediately if you experience any of the following symptoms: blood disorders (such as changes in the number of white or red blood cells), which may be indicated by unusual bleeding or bruising, fever or chills, sore throat, mouth ulcers or throat ulcers. Side effects observed with sotalol 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, keratitis and conjunctivitis, decreased tear production (note: relevant 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, abdominal pain and bloating, dry mouth,
• muscle cramps, muscle pain or joint pain,
• edema, fatigue,
• sexual dysfunction, 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, reports of joint and connective tissue inflammation (e.g. tendons) with skin rash have been made. These symptoms usually disappear after the end of treatment. 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, you can help provide more information on the safety of this 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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: lactose monohydrate, microcrystalline cellulose, povidone (K-30), sodium carboxymethylcellulose (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-colored, 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 cream-colored, 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 cream-colored, 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.
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 (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 Medicinal Product is Authorized 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