Sotalol Mylan Generics

Italy
Brand name Sotalol Mylan Generics
Form tablets
Active substance / Dosage
SOTALOL HYDROCHLORIDE
Prescription type Prescription only
ATC code
C07AA07
Registration number 035453
Manufacturer MYLAN S.P.A.

Table of Contents

Patient Information Leaflet

Sotalolo Mylan Generics 80 mg tablets

(sotalol hydrochloride)
Generic medicine
Read this entire 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. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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

1. What Sotalolo Mylan Generics is and what it is used for
The name of this medicine is Sotalolo Mylan Generics. Each tablet contains the active substance sotalol hydrochloride.
Sotalolo Mylan Generics belongs to a group of medicines called beta-adrenoceptor antagonists or "beta-blockers".
Sotalolo Mylan Generics is used to treat irregular heartbeats.

2. What you need to know before taking Sotalolo Mylan Generics

Do not take Sotalolo Mylan Generics:

  • if you are allergic to sotalol or to any of the excipients of this medicine (listed in section 6)
  • if you suffer from asthma, wheezing attacks, or any other lung disease
  • if you have very slow heart rate or low blood pressure
  • if you have a condition causing discoloration (white or purple) of hands and feet (Raynaud's syndrome)
  • if you have severe circulatory disorders
  • if you have suffered from certain heart diseases (such as untreated heart failure, heart block, sick sinus syndrome) or cardiogenic shock
  • if you have a condition called metabolic acidosis
  • if you have an untreated tumour of the adrenal gland (see section “Warnings and precautions”)
  • if you have renal failure
  • if you are scheduled for surgery or require anaesthesia, inform your anaesthetist or dentist that you are taking Sotalolo Mylan Generics
  • if you are receiving intravenous verapamil or diltiazem (medicines used to treat irregular heartbeat).

If you have any of the conditions listed above, speak with your doctor before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sotalolo Mylan Generics.

Your doctor may want to check your blood levels of potassium and magnesium before you start taking Sotalolo Mylan Generics. Patients with low levels should not take Sotalolo Mylan Generics.

Regular blood tests may be required during treatment with Sotalolo Mylan Generics.

You should talk to your doctor or pharmacist before taking Sotalolo Mylan Generics:

  • if you are pregnant, planning a pregnancy, or breastfeeding
  • if you have heart disease, an enlarged heart, are being treated for heart failure, or have recently had a heart attack
  • if you have an abnormal heart rhythm (seen on electrocardiogram (ECG), such as prolonged QT interval). In such cases, your doctor will be very careful when increasing the dose.
  • if you have kidney problems, as the dose of Sotalolo Mylan Generics may need adjustment
  • if you have diabetes, as your insulin or other diabetes medication dose may need to be changed. Sotalolo Mylan Generics may also mask or reduce warning signs of low blood sugar (hypoglycaemia)
  • if you have an overactive thyroid, as Sotalolo Mylan Generics tablets may mask symptoms or worsen them if sotalol treatment is stopped suddenly
  • if you are currently suffering from, or have recently had, diarrhoea, or have recently experienced severe or prolonged diarrhoea. This is because it may affect potassium and magnesium levels in your body, and you may not be able to take Sotalolo Mylan Generics
  • if you have psoriasis (a skin disease causing itching, red, painful patches of skin)
  • if you are allergic to a variety of allergens. While taking this medicine, you may have a more severe reaction upon repeated exposure. Sotalolo Mylan Generics may also reduce the effectiveness of medicines used to treat severe allergic reactions, such as adrenaline
  • if you have liver problems
  • if you have a tumour of the adrenal gland (pheochromocytoma, see section “Do not take this medicine”), alpha receptors must be blocked simultaneously with another medicine.

If you are scheduled for surgery

You must inform your doctor or anaesthetist that you are taking Sotalolo Mylan Generics, as it may affect the action of anaesthetics or muscle relaxants used during surgery. It may be necessary to stop taking Sotalolo Mylan Generics before surgery, and it should be gradually discontinued over a period of one week. Your doctor will advise you if this is necessary.

If you are undergoing laboratory tests, such as urine tests, inform your doctor that you are taking Sotalolo Mylan Generics.

Children

Sotalolo Mylan Generics is not recommended for children and adolescents under 18 years of age.

Other medicines and Sotalolo Mylan Generics

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Some medicines may affect the effectiveness of each other.

Do not take Sotalolo Mylan Generics in combination with:

  • other medicines used to treat irregular heartbeat (e.g. verapamil, quinidine, diltiazem, disopyramide, procainamide, flecainide, amiodarone, bepridil)
  • other beta-blockers (medicines that may be used for angina, high blood pressure, or prevention of migraine)

It is particularly important that you inform your doctor if you are taking any of the following medicines:

  • medicines used to treat diabetes (e.g. metformin or insulin)
  • medicines used to treat asthma and other lung diseases (e.g. inhaled salbutamol, terbutaline, or isoprenaline)
  • medicines used to treat depression (e.g. imipramine, maprotiline), anxiety, nervous disorders, and mental disorders (e.g. haloperidol)
  • medicines used to treat allergies such as hay fever (some antihistamines such as astemizole and terfenadine)
  • diuretics
  • medicines used for high blood pressure or as adjuncts in the treatment of Raynaud's syndrome (e.g. amlodipine, nifedipine)
  • methyldopa, reserpine, or guanethidine (medicines used to control blood pressure)
  • medicines used to treat heart failure (e.g. digoxin)
  • a medicine called halofantrine (used to treat malaria)
  • certain antibiotics (e.g. pentamidine and "floxacin" antibiotics such as ciprofloxacin)

Or if you are taking:

  • a medicine called clonidine (sometimes used to treat hot flushes or headaches). If you are taking clonidine and sotalol at the same time and treatment with clonidine needs to be stopped, you must stop taking sotalol first, gradually reducing the dose, before stopping clonidine.
  • steroids
  • laxatives
  • a medicine called floctafénine (used to relieve pain and inflammation)
  • a medicine called amphotericin B (used to treat fungal infections)
  • medicines used to treat psychiatric disorders (phenothiazines, certain antidepressants), barbiturates, opioids, blood pressure-lowering medicines, diuretics, or vasodilators, which may cause excessive drop in blood pressure.

Sotalolo Mylan Generics and alcohol

Moderate amounts of alcohol do not affect Sotalolo Mylan Generics; however, you should consult your doctor to determine whether drinking alcohol is advisable for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Sotalolo Mylan Generics should not be administered during pregnancy unless your doctor considers it essential. If taken during pregnancy, sotalol should be discontinued 48–72 hours before the expected date of delivery. If this is not possible, the newborn must be closely monitored for 48–72 hours after birth.

You must not breastfeed while being treated with Sotalolo Mylan Generics.

Driving and using machines

Sotalolo Mylan Generics generally does not affect your ability to drive. However, if you feel tired, lightheaded, or dizzy, do not drive or operate machinery.

3. How to take Sotalolo Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Do not stop taking Sotalolo Mylan Generics without informing your doctor.

Adults
The recommended starting dose is 80 mg given as a single dose or divided into two doses. The dose will be gradually adjusted every 2–3 days. Most patients will take between 160 mg and 320 mg daily. Some patients may require doses up to 640 mg per day. Lower doses are often used in elderly patients or in those with kidney disease.

The tablet may be divided into equal doses. The tablets or divided doses (half a tablet) must not be chewed or crushed and should be swallowed whole with a glass of water. They may be taken before, during, or after meals, but always in the same way each day as instructed by your doctor.

The dose should be taken in two divided doses approximately 12 hours apart. Always take this medicine exactly as described in this leaflet or as prescribed by your doctor, pharmacist, or nurse. If you are unsure, check with your doctor, pharmacist, or nurse.

During the first few weeks after starting sotalol treatment, your doctor will need to see you regularly to monitor your response, and it may be necessary to adjust your dose to suit you best.

Use in children and adolescents
Sotalolo Mylan Generics is not recommended for children and adolescents under 18 years of age.

If you take more Sotalolo Mylan Generics than you should
If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.
Depending on the extent of the overdose, the following symptoms may occur: a marked drop in blood pressure, slow pulse, disturbances in heart rhythm, heart failure, breathing difficulties, narrowing/spasms of the airways, and symptoms of hypoglycaemia (feeling hungry, sweating, dizziness, tiredness, blurred vision, tremor or restlessness, anxiety or irritability, paleness, rapid pulse or palpitations).

If you forget to take Sotalolo Mylan Generics
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose, do not worry. Take it as soon as you remember, unless it is almost time for your next dose. In this case, skip the missed dose and continue with your regular schedule.

If you stop taking Sotalolo Mylan Generics
Treatment with beta-blockers must not be stopped abruptly. If treatment needs to be discontinued, the dose should always be gradually reduced over a period of at least 1 or 2 weeks.
Sudden discontinuation of beta-blockers may increase the risk of having a heart attack or irregular heart rhythm. It may also cause worsening symptoms of inadequate blood flow to the heart (angina), resulting in chest pain that occurs especially during movement or physical activity, or an increase in blood pressure.

If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

For those engaged in sports activities
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects

Immediately contact your doctor or go to the nearest hospital emergency department if you experience the following symptoms: swelling of the face, lips, tongue and/or throat, with difficulty swallowing or breathing. These may be signs of an allergic reaction, and tablet intake must be stopped.

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

  • Cardiac arrest (causing sudden collapse, absence of heartbeat, no breathing and loss of consciousness)

Other possible side effects

Common (may affect up to 1 in 10 people):

  • Irregular heartbeat, slow heartbeat, chest pain, hypotension, breathing difficulties, swelling, fainting and palpitations, disturbances in heart rhythm (Torsades de pointes, QT interval prolongation, AV conduction disorder, ventricular tachycardia), worsening of angina pectoris (causing chest pain)
  • Worsening of peripheral occlusive disease, cold extremities
  • Nausea and vomiting, indigestion, abdominal pain, flatulence, diarrhoea, cramps
  • Anxiety, depression, confusion, mood swings, headache, dizziness, vertigo, general weakness, fatigue, sleep problems, tingling in feet and hands (paraesthesia)
  • Sexual dysfunction, impotence, fever, skin rashes, skin reactions, hearing problems, vision problems, taste disturbances

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

  • Hallucinations, abnormal dreams
  • Blurred vision, conjunctivitis, inflammation of the cornea (keratoconjunctivitis), reduced tear production (especially when wearing contact lenses)
  • Dry mouth
  • Activation or worsening of psoriasis (a skin condition)
  • Increased blood lipids and decreased blood sugar (glucose) concentration

Patients taking this type of medicine have reported cold and/or blue fingers and toes, worsening leg pain when walking, skin rashes or dry eyes.

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.

You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sotalolo Mylan Generics

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 the words
"Expiry". The expiry date refers to the last day of that month.
Blister packs
Store in the original packaging to protect from light.
Safety bottles
Keep the container tightly closed to protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Sotalolo Mylan Generics contains

  • The active substance is sotalol hydrochloride. The 80 mg tablet contains 80 mg of sotalol hydrochloride.
  • The other excipients are: calcium hydrogen phosphate, corn starch, povidone, sodium glycolate starch, talc, magnesium stearate.

What Sotalolo Mylan Generics looks like and contents of the pack
The medicine is presented as white tablets with rounded corners. The Sotalolo Mylan Generics 80 mg tablets are marked with "SL | 80" on one side and nothing on the other.
Sotalolo Mylan Generics is available in safety bottles containing 20, 28, 30, 40, 50, 60, 100 and 300 tablets.
Sotalolo Mylan Generics is also available in blisters containing 20, 28, 30, 40, 50, 60, 90, 100 and 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan B.V., Dieselweg 26, 3752 LB Bunschoten, Netherlands
This medicinal product is authorized in European Economic Area (EEA) Member States under the following names:
Denmark: Sotalol Mylan Tabletter 80 mg, 160 mg
Greece: Sotalol/Mylan TAB 80mg/TAB, 160 mg/TAB
Ireland: Sotoger Tablets 80 mg, 160 mg
Italy: Sotalolo Mylan Generics 80 mg Compresse
Netherlands: Sotalol HCl Mylan 80 mg, 180 mg Tabletten
Belgium: Sotalol Mylan 160 mg tabletten
This leaflet was last approved on