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SOTALOL TABLETS 160MG

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SOTALOL 80MG AND 160MG TABLETS
BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULLY
This leaflet contains a summary of the information about your medicine, Sotalol Tablets.
YOUR MEDICINE
Your medicine is in the form of a tablet. There are two strengths of Sotalol Tablets available, 80mg
and 160mg. The 80mg tablet contains 80mg of Sotalol Hydrochloride and the 160mg tablet contains
160mg of Sotalol Hydrochloride. Each tablet also contains calcium hydrogen phosphate, maize starch,
povidone, sodium starch glycollate, talc and magnesium stearate.
Sotalol Tablets 80mg are marked “SL | 80” on one side. Sotalol Tablets 160mg are marked “SL | 160”
on one side.
Sotalol Tablets are available in plastic bottles of 100 tablets and blister packs of 28 tablets*. Your
pharmacist will dispense the number of tablets prescribed by your doctor. (* Only marketed pack sizes
will feature in the printed leaflet.)
HOW DOES YOUR MEDICINE WORK?
Sotalol is a beta-adrenoreceptor antagonist or BETA-BLOCKER. Sotalol helps to block the effects of
naturally occurring substances within your body (catecholamines). In some patients catecholamines
may cause the heart to beat too quickly or irregularly. By blocking these effects, Sotalol can slow the
heart, and enable the heart to beat more normally and regularly.
Product Licence Holder: McDermott Laboratories, trading as Gerard Laboratories, Baldoyle Industrial
Estate, Dublin 13, Ireland.
Manufactured by: Generics [UK] Limited, Potters Bar, Herts, EN6 1TL.
WHY DO YOU NEED TO TAKE YOUR MEDICINE?
Sotalol Tablets can be used to correct or prevent an abnormal or irregular heart beat, including after
heart surgery. Sotalol tablets can also be taken after other treatment to control heart beat.
WHAT SHOULD YOU DO BEFORE TAKING YOUR MEDICINE?
Do not take Sotalol Tablets and tell your doctor if:
· you have taken a medicine containing Sotalol before and suffered an unusual or allergic reaction
· you have a history of lung disease or asthma (eg. wheezing or any breathing problem)
·you suffer from low blood pressure or a slow beating heart
·you have very poor blood circulation to fingers or toes (eg. Raynaud’s Syndrome).
·you have been told by a doctor that you suffer from heart block or sick sinus syndrome
·you suffer from heart failure
·You have severe kidney problems or kidney failure.
·you have been told by your doctor that you have a rare tumour called a phaeochromocytoma
(symptoms can include attacks of headache, sweating, palpitations, flushing of the face or pains in the
chest and stomach)
·you suffer from a serious condition called metabolic acidosis which causes dehydration, rapid
breathing and drowsiness.
DO NOT take Sotalol Tablets if you may be allergic to any of the tablet ingredients.

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Tell your doctor before taking Sotalol Tablets if:
·you are pregnant, plan to become pregnant or you are breastfeeding.
·you have a history of allergies or psoriasis.
·you suffer from heart disease, have an enlarged heart or are being treated for heart failure
·you are recovering from a heart attack
·you have a problem with your kidneys
·you are diabetic, as Sotalol can hide the effects of low blood sugar (hypoglycaemia)
·you have an over-active thyroid (hyperthyroidism)
·you suffer from prolonged or severe diarrhoea
·you know you have a low level of salts (potassium, magnesium) in your blood
·you are taking any of the following medicines;
*other medicine to treat abnormal heart beats (eg. Verapamil, Disopyramide, Quinidine,
Procainamide, Amiodarone, Bepridil); *medicine for angina or high blood pressure (eg. Methyldopa,
Diltiazem, Clonidine, Reserpine, Guanethinidine, other beta-blockers such as Atenolol), or medicine
for another heart condition (eg. Digoxin); *diuretics or “water” tablets (eg. Furosemide), *medicine to
treat depression (eg. Amitriptyline) or mental illness (eg. Chlorpromazine); *antihistamines or antiallergy medicine (eg. Terfenadine, Astemizole); *medicine (given by injection) to treat infection (eg.
Amphotericin, Erythromycin, Pentamidine); *antidiabetic medicine (eg. Insulin, Metformin,
Gliclazide); *medicine (given by injection) containing Adrenaline; *corticosteroids; *laxatives;
*Tubocurarine; *Vincamine; *Fenoxedil; *Floctafenine; *Halofantrine; *Sultopride. If you are unsure,
check with your doctor before taking this medicine.
WHILE TAKING SOTALOL TABLETS
Your doctor will check your heart with an ECG before starting treatment and if the dose needs to be
increased. You may also be given a blood test to check how well your kidneys work and the levels of
salts in your body.
If you need to have an operation requiring an anaesthetic, tell the doctor that you are taking Sotalol
Tablets
If you have a urine test tell the doctor that you are taking Sotalol Tablets
DO NOT drive or use machinery if Sotalol Tablets make you feel dizzy or tired.
HOW SHOULD YOU TAKE YOUR TABLETS?
The dose will be adjusted so that it is right for you. The usual starting dose is 80mg Sotalol daily,
either as a single dose or divided into two doses in the day. Your doctor may gradually increase this
dose every 2 - 3 days until you reach the correct dose to control your heart beat. This is usually
between 160 and 320mg Sotalol daily, divided into 2 doses, 12 hours apart. Higher doses up to 480 to
640 mg Sotalol per day may be prescribed for some patients.
If you have kidney disease the dose will be reduced.
Do not stop taking your tablets without telling your doctor. If you stop taking your medicine suddenly
your condition may worsen, especially if you have angina, have had a heart attack in the past or have
high blood pressure.
If you forget to take a dose take it as soon as you remember. However, if it is almost time for your
next dose, do not double the dose just take your next dose and carry on as before.
This product is not for use in children.
IF YOU TAKE TOO MUCH OF YOUR MEDICATION CONTACT YOUR DOCTOR
IMMEDIATELY OR GO TO YOUR NEAREST CASUALTY DEPARTMENT

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CAN YOUR MEDICINE HAVE ANY SIDE EFFECTS?
Side effects from taking Sotalol usually go away on continuing treatment or following a change in
your dose. Do not change your dose unless your doctor tells you to.
Tell your doctor immediately if you suffer from any of the following: a racing or irregular heart beat
(more common at high doses and in females) or you feel your condition isn’t improving or is getting
worse, chest pain, difficulty breathing, wheezing, swelling of the ankles, dizziness on standing up or
fainting.
Other common side effects include skin rash, feeling or being sick, diarrhoea, wind, stomach pain and
indigestion. Also muscle cramps, feeling unusually tired or weak, dizzy, lightheaded, suffering from
headaches, sleep changes, depression, mood changes, anxiety or an abnormal sensation (prickling or
burning feeling) in the limbs. Also fever, changes in sexual performance, eyesight, taste or hearing
changes.
Some patients taking other beta-blockers have experienced dry eyes; fingers and toes becoming cold
and turning blue, becoming painful with “pins and needles” sensations (Raynaud’s phenomenon); or
worsening of intermittent claudication (pain in the legs on exercise).
If you should suffer from any of these unwanted effects or any other undesired effect please tell
your pharmacist or doctor. Your doctor may wish to reduce the dose of Sotalol Tablets which
you are taking.
DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE SHOWN ON THE
CARTON.
REMEMBER this medicine was prescribed by your doctor for you.
DO NOT give it to others. It may harm them. Protect from light.
Date of revision: January 2008

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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