PATIENT INFORMATION LEAFLET

Sotalol Hydrochloride 40mg, 80mg and 160mg Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

■    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 signs of illness are the same as yours.

■    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What Sotalol is and what it is used for

Sotalol Hydrochloride belongs to a group of medicines called Beta-Blockers and works by slowing the electrical impulses in the heart muscle. This helps to regulate and restore disturbances in the heart rhythm.

Sotalol also blocks beta receptors that are found in the heart. This causes the heart to beat more slowly and with less force.

Sotalol Hydrochloride (referred to as Sotalol throughout this leaflet) is used:

■    To treat fast and irregular heartbeat (arrhythmias) some of which may be life-threatening.

■    As prophylaxis, to prevent the occurrence of new arrhythmias.

R What you need to know before you )rn take Sotalol

Do not take Sotalol:

■    If you have a history of breathing difficulties, wheezing or asthma

■    If you are allergic (hypersensitive) to Sotalol, other Beta-Blockers or any of the other ingredients of this medicine (see Section 6 "Contents of the pack and other information")

■    If you have an irregular heartbeat caused by sick sinus syndrome, long QT syndromes or Torsades de Pointes

■    If you suffer from a condition where the heart beats irregularly or much more slowly than normal (2nd or 3rd degree heart block) unless you have pacemaker

■    If you have a slower heart beat than normal (bradycardia)

■    If you suffer from heart failure which is not controlled by medicine

■    If you have had a recent heart attack

■    If you are going to have surgery and have an anaesthetic such as cyclopropane or trichloroethylene (see Section 2 'Other medicines and Sotalol')

■    If you have an untreated tumour of the adrenal gland (phaeochromocytoma)

■    If you suffer from low blood pressure (hypotension) unless this is a result of the irregular heartbeat

■    If you suffer from poor circulation causing the fingers and toes to be numb and pale (Raynauds phenomenon) or other circulation problems

■    If you have an increased amount of acid in your blood (metabolic acidosis)

■    if you suffer from kidney failure

Warnings and precautions

Talk to your doctor before taking Sotalol:

■    If you already suffer from a pre-existing irregular heartbeat or other heart problems, especially if you are female

■    If you are known to have low levels of potassium or magnesium in your blood. Your doctor may want to check the levels before commencing treatment with Sotalol

■    If you have diarrhoea

■    If you are taking other medication for heart problems such as ACE inhibitors, diuretics or digitalis etc (see 'Other medicines and Sotalol' section below)

■    If you have a history of severe allergic reaction (anaphylaxis) (see Section 4, "Possible side effects")

■    If you have diabetes or a history of low levels of sugar

in your blood

■    If you have an overactive thyroid, as Sotalol can hide the symptoms or make them worse if treatment with Sotalol is stopped suddenly

■    If you suffer from kidney problems

■    If you have a skin disease which causes scaly pink patches (psoriasis)

■    If you are elderly

Other medicines and Sotalol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

Medicines which should not be taken with Sotalol:

■    Medicines used to treat irregular heart beats such as disopyramide, quinidine, procainamide, amiodarone and bedpridil (antiarrhythmics)

■    Anaesthetics such as cyclopropane and trichloroethylene (see Section 2 'Do not take Sotalol')

Medicines which may interact with or be affected by Sotalol:

■    Floctafenine, a Non-Steroidal Anti-Inflammatory Drug (NSAID) used for the short-term treatment of mild to moderate pain and inflammation

■    Verapamil and diltiazem, used to treat high blood pressure, abnormal heart rhythms, chest pain (calcium channel blockers)

■    Medicines used to treat heart failure such as digoxin (digitalis glycosides)

■    Medicines used to treat high blood pressure such as reserpine, guanethidine or alpha methyldopa

■    If you are due to have a urine test, Sotalol may interfere with the results

■    Medicines used to treat high blood pressure or heart failure, such as lisinopril (ACE inhibitors)

Special care should be taken with the following medicines;

■    Medicines that prolong QT interval such as:

-    Phenothiazines, used to treat serious mental and emotional disorders and also severe nausea (feeling sick) and vomiting (being sick)

-    Pimozide, used to treat mental disorders

-    Tricyclic antidepressants, used to treat depression e.g. clomipramine

-    Terfenadine, mizolastine and astemizole, used to treat allergic conditions (antihistamines)

■    Medicines which may increase the risk of a life-threatening irregular heartbeat (Torsades de Pointes) such as:

-    Erythromycin IV, an antibiotic used to treat bacterial infections

-    Halofantrine, used to treat malaria

-    Pentamidine, used to treat or prevent pneumonia

-    Quinolone antibiotics, used to treat bacterial and urinary infections

-    Medicines that may affect potassium levels such as potassium-depleting diuretics (e.g. chlorothiazide), amphotericin B (IV) used to treat fungal infections, corticosteroids used to relieve inflammation (e.g. prednisolone) and some potassium-depleting laxatives (e.g. bisacodyl)

■    Clonidine, used to treat high blood pressure and migraine. If you are taking Sotalol and Clonidine together, Sotalol should be gradually stopped several days before slowly discontinuing Clonidine.

■    Medicines used to treat diabetes, such as insulin or metformin as the dose may need to be adjusted. Sotalol may also hide or reduce the warning signs of low levels of sugar in your blood (hypoglycaemia)

■    Other beta-blockers, such as atenolol

■    Magnesium-depleting medicines such as antacids (e.g. cimetidine)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

If you are pregnant you should not take Sotalol unless considered essential by your doctor.

Breast-feeding

If you are breast-feeding, you should not take Sotalol. Driving and using machines

Sotalol is not likely to affect you being able to drive or use

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