Document: leaflet MAH GENERIC_PL 17907-0260 change

• leaflet MAH GENERIC_PL 16363-0129
• leaflet MAH GENERIC_PL 17907-0260

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PATIENT INFORMATION LEAFLET

Sotalol 40mg, 80mg and 160mg Tablets (Sotalol Hydrochloride)

Please read this entire leaflet carefully before you start

taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects become serious, please tell your doctor or pharmacist.

Sotalol Hydrochloride belongs to a group of medicines called beta-blockers, which help slow the heart beat and relax the blood vessels. This reduces blood pressure and the heart's demand for oxygen.

Sotalol Tablets are used to treat irregular heart beats (arrhythmias)

Before you take

Do not take Sotalol Tablets if:

•    you have a history of breathing difficulties, wheezing or asthma. Ask your doctor or pharmacist if you should take this medicine.

•    you are allergic to Sotalol hydrochloride or any of the other ingredients (listed in Section 6)

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

•    you have an irregular heart beat (due to Torsades de pointes, sick sinus syndrome or a long QT interval)

•    you have a heart problem which is not controlled by medicine and causes shortness of breath or ankle swelling (heart failure), a slower heart beat than normal (bradycardia) or other certain heart conditions

•    you have had a recent heart attack

•    you suffer from low blood pressure (hypotension)

•    you have poor blood circulation which makes the toes and fingers numb and pale or other circulation problems

•    you have an untreated rare tumour of the adrenal gland (pheochromocytoma)

•    you suffer from kidney failure

•    you have more acid than normal in your blood (metabolic acidosis)

Take special care with Sotalol Tablets 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.

•    you have diarrhoea

•    you are taking other medication for heart problems such as ACE inhibitors, diuretics or digitalis (see ‘Taking other medicines, section 2)

•    you have a history of serious allergic reaction which causes difficulty breathing or dizziness (anaphylaxis)

•    you have diabetes or a history of low levels of sugar in your blood

•    you have an overactive thyroid

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

If any of the conditions listed under 'Do not take' or 'Take special care' apply to you, please contact your doctor or pharmacist.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Medicines which should not be taken with Sotalol Tablets:

•    Medicines for irregular heart beat, such as disopyramide, quinidine, procainamide and amiodarone

Other medicines which may interact with or be affect by Sotalol Hydrochloride, if taken together include:

•    Other beta-blockers, such as Atenolol

•    Medicines for high blood pressure or chest pains (angina), such as verapamil and diltiazem (calcium antagonists)

•    Medicines for high blood pressure or heart failure, such as lisinopril (ACE inhibitor)

•    Other medicines for high blood pressure, such as nifedipine, guanethidine or alpha methyldopa

•    Medicines for treatment of asthma such as theophylline, salbutamol and aldesleukin

•    Medicines for heart failure, such as digoxin (digitalis glycosides)

•    Medicines used to relax muscles (for example during surgery), such as tubocurarine

•    Floctafenine, used to relieve pain and swelling

•    Medicines used to treat fluid retention (diuretics) which reduce potassium levels, such as chlorothiazide.

•    Medicines used to treat nausea and vomiting such as tropisetron

•    Other medicines which reduce potassium levels, such as:

-    amphotericin, an antifungal medicine

-    corticosteroids, such as prednisolone

-    certain laxatives, such as bisacodyl

Special care should be taken with the following medicines:

•    Clonidine and ergotamine, for high blood pressure and migraine. If you are taking Sotalol Tablets and Clonidine together,

you need to take care when stopping therapy. Sotalol Tablets should be gradually stopped several days before slowly discontinuing Clonidine.

•    Medicines which prolong the QT interval such as:

-    phenothiazines, for anxiety, feeling sick (nausea) or being sick (vomitting) or mental disorders

-    medicines for depression, such as amitriptyline, clomipramine (tricyclic antidepressants)

-    terfenadine, mizolastine and astemizole, for symptoms of hay fever (antihistamine)

•    Medicines which may increase the risk of a life-threatening irregular heart beat (torsades de pointes) such as:

-    erythromycin IV, an antibiotic used to treat bacterial infections

-    halofantrine and mefloquine, used to treat malaria

-    pentamidine, used to treat or prevent pneumonia

•    Medicines for diabetes, such as insulin or metformin.

The dose may need to be adjusted. Sotalol Hydrochloride may also hide or reduce the warning signs of low levels of sugar in your blood (hypoglycaemia)

Having an anaesthetic or urine test

You must tell the medical staff that you are taking Sotalol Tablets if you are going to have surgery under anaesthetic or urine test.

•    Anaesthetics - Anaesthetics may interfere with this medicine, in particular anaesthetics such as cyclopropane

and trichloroethylene

•    Urine test - This medicine may interfere with the results obtained.