PACKAGE LEAFLET: INFORMATION FOR THE USER
Sotalol 80mg Tablets
Sotalol 160mg Tablets
Read all of this leaﬂet carefully before you start taking this medicine.
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. Do not pass It on to others. It may
harm them, even If their symptoms 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.
In this leaﬂet:
What Sotalol Tablets are and what are they used for
What you need to know before you take Sotalol Tablets
How to take Sotalol Tablets
Possible side eﬀects
How to store Sotalol Tablets
Contents of the pack and other information
WHAT SOTALOL TABLETS ARE AND WHAT ARE THEY USED FOR
Sotalol belongs to a group of drugs called beta-adrenergic blocking agents or
"beta-blockers". Sotalol is used to treat irregular heartbeats. This can be caused
by the lower heart chambers (ventricular arrhythmia) or the upper heart chambers
(atrial or superventricular arrhythmias)
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOTALOL TABLETS
Do not take Sotalol Tablets if you:
are allergic to sotalol hydrochloride or any of the other ingredients in this
medicine (listed in section 6).
suﬀer from kidney failure or have untreated tumour near your kidney
have a history of breathing diﬃculties due to a narrowing of the airways
suﬀer from low blood pressure or circulation failure.
suﬀer from metabolic acidosis or diabetic ketoacidosis.
suﬀer from renal failure (creatinine clearance <10 ml/min)
suﬀer from a condition causing discolouration (white or purple) of the hands
and feet (Raynaud's syndrome)
suﬀer from very slow heart beat (bradycardia) including sick sinus syndrome,
or long QT interval.
are suﬀering from a second or third degree AV heart block unless a functioning
pacemaker is present
are suﬀering from cardiogenic shock
are being treated with anaesthesia that produces myocardial depression
are suﬀering from hypotension (except due to arrhythmia)
Warning and precautions
Talk to your doctor or pharmacist before taking Sotalol tablets.
Your doctor may wish to check the level of potassium and magnesium in your
blood before you start taking Sotalol tablets.
Regular blood tests may be required during your treatment with Sotalol tablets.
Please tell your doctor before you start to take your tablets if you:
have a history of allergy reaction
have any kidney problems, as your dose of Sotalol may need to changed.
suﬀer from liver problems
suﬀer from, or have recently suﬀered from diarrhoea, or if you have recently
had severe diarrhoea, or an attack that lasted a long time. This is because it
can aﬀect the levels of potassium and magnesium in the body, and you may
not be able to take Sotalol tablets.
suﬀer from diabetes, as it may be necessary to change the dose of insulin or
any other medicines you take to treat your diabetes. Sotalol may also hide or
reduce the warning signs of low levels of sugar in you blood (hypoglycaemia)
have an overactive thyroid, as Sotalol can hide the symptoms or make them
worse if treatment with Sotalol tablets is stopped suddenly.
suﬀer from psoriasis (a skin disease that causes itchy, red, sore patches of
are scheduled to have a urine analysis
suﬀer from myasthenia gravis (muscle weakness)
are pregnant, planning to become pregnant or are breast-feeding
If you need to have surgery, you should tell the doctor or anaesthetist that you are
taking Sotalol tablets as it can aﬀect anaesthetics. You may have to stop taking
Sotalol tablets before surgery and it should be gradually stopped over a period of
one week. Your doctor will tell you if this is necessary.
Other medicines and Sotalol
Tell your doctor if you are taking, have recently taken or might take any other
medicines, including those obtained without a prescription. Some medicines can
have an eﬀect on each others actions. It is especially important that you tell your
doctor if you are taking the following medicines:
Drugs for the treatment of high blood pressure, heart failure or an irregular
heartbeat (e.g. digoxin, amiodarone, verapamil, disopyramide, quinidine,
procainamide and bepridil)
Drug that prolongs QT interval (a type of change in ECG) e.g. phenothiazines
or tricyclic antidepressants; terfenadine, astemizole, erythromycin,
halofantrine, pentamidine and quinolone antibiotics.
Floctafenine (medicine used for the short term treatment of mild to moderate
Calcium channel blockers e.g. verapamil and diltiazem.
Diuretics (water tablet), corticosteroids, amphotericin IV and some laxatives as
these lower potassium levels.
Clonidine (sometimes used to treat hot ﬂushes or headaches)
Insulin and other oral medicines for diabetes
Tubocurarin a neuromuscular blocker
Beta-receptor stimulant drugs such as salbutamol (used in the treatment of
asthma or emphysema).
Treatment of hypertension (e.g. reserpine, guanethidine or alpha methyldopa)
Treatment of depression, anxiety, nervous disorders and mental disturbances
Treatment of allergies such as hay fever (e.g. antihistamines)
Also inform your doctor or pharmacist if you are taking or have recently taken, any
other medicine including those that you have bought without prescription.
Pregnancy, breast-feeding and fertility
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. You should
not be given Sotalol tablets during pregnancy unless your doctor thinks it is
You should not breastfeed while you are being treated with Sotalol tablets.
Driving and using machines
Sotalol is not known to have any eﬀect on your ability to drive or use machines.
But make sure that you are not having dizziness or fatigue before driving or
HOW TO TAKE SOTALOL TABLETS
Always take Sotalol Tablets exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Artwork Same Size
Size : 260 x 270 mm
Your doctor will initiate your treatment with a small dose. Your heart beat and
cardiac rhythm will be monitored closely. Your dose may be changed after
monitoring your response to the treatment.
The following dose schedule can be recommended:
The recommended daily dose is between 80 mg and 320 mg. Some patients may
need up to 640 mg a day or sometimes the doctor may prescribe a diﬀerent dose
from these. Lower doses are often used for elderly patients or those with kidney
Tablets should be swallowed whole with a glass of water and can be taken with or
without food. The dose may be taken either as a single dose or in two divided
doses. Check with your doctor or pharmacist if you are not sure.
For the ﬁrst few weeks after you start your Sotalol treatment your doctor will need
to see you regularly to check on your response, and may need to adjust the dose
to one that suits you.
This medicine is not recommended for children.
Patients with kidney problems:
Patients with kidney problems should consult their doctor for the correct dosage.
If you take more Sotalol Tablets than you should
Do not take more tablets than your doctor tells you to. If you take too many, go to
the nearest hospital casualty department taking the medicine with you or tell your
doctor immediately. Take any tablets leftover with you and also the box, as this will
allow easier identiﬁcation of the tablets.
If you forget to take Sotalol Tablets
If you forget to take a dose of Sotalol Tablets, take it as soon as you remember.
But if it is almost time for the next dose, do not double up on the dose.
If you stop taking Sotalol Tablets
Do not discontinue your tablets without consulting your doctor. Your doctor may
reduce the dose before completely stopping the tablets.
Withdrawal symptoms may occur if Sotalol Tablets abruptly stopped including
exacerbation of angina pectoris (a kind of chest pain), arrythmias and in some
cases heart attack.
POSSIBLE SIDE EFFECTS
Like all medicines, Sotalol Tablets can cause side eﬀects, although not everybody
gets them. Tell your doctor immediately if you get any of the following
symptoms: swelling of the face, lips, tongue and/or throat with diﬃculty in
swallowing or breathing. These may be signs of an allergic reaction and the
tablets will be stopped.
Side eﬀects seen with Sotalol tablets (aﬀecting more than 1 in 100 patients)
include the following:
irregular heartbeat, slow heart beat, heart failure, chest pain, low blood
pressure, swelling, fainting and palpitations.
nausea and vomiting, indigestion, abdominal pain, ﬂatulence, diarrhoea,
anxiety, depression, mood changes, headache, light-headedness, dizziness,
general weakness, tiredness, sleeping problems, tingling in feet and hands
(pins and needles).
sexual dysfunction, fever, rash, hearing problems, problems with vision,
changes in the way things taste.
Patients taking this type of medicine have complained of cold and/or blue ﬁngers
and toes, worsening of aches in their legs when walking, skin rash or dry eyes.
Reporting of side eﬀects
If any of these side eﬀects gets serious or if you notice any side eﬀects not listed in
this leaﬂet, please tell your doctor or pharmacist.
You can also report the side eﬀects directly via the yellow card scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play
or Apple App Store.
By reporting side eﬀects you can help provide more information on the safety of
HOW TO STORE SOTALOL TABLETS
Keep this medicine out of the sight and reach of children
Do not store above 25°C.
Store your tablets in the original package.
This medicine should not be used after the expiry date stated on the pack.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Sotalol Tablets contains
The active substance is sotalol hydrochloride, 80mg or 160mg. Other ingredients
are calcium hydrogen phosphate dihydrate, maize starch, povidone k30, sodium
starch glycollate (type A), talc and magnesium stearate. Sotalol 160mg Tablets
also contain indigo carmine (E132)
What Sotalol Tablets looks like and contents of the pack
Sotalol 80mg Tablets are round, white to oﬀ-white, ﬂat, beveled-edged tablets with
breakline on one side.
Sotalol 160mg Tablets are round, blue, ﬂat, beveled edged tablets with breakline
on one side.
The tablets are available in blister packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Ares, Odyssey Business Park,
West End Road, South Ruislip, HA4 6QD, United Kingdom
This leaﬂet was last revised in 02/2019