SOTALOL 160MG TABLETS
Active substance(s): SOTALOL HYDROCHLORIDE
What Sotalol Tablets are and what they are 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 further information
1. What Sotalol Tablets are and what they are used for
Sotalol Tablets contain the active ingredient Sotalol. Sotalol belongs
to a group of drugs called beta-adrenergic blocking agents or
“beta-blockers.” Sotalol is used to treat irregular heartbeats.
2. What you need to know before you take Sotalol Tablets
Do not take Sotalol Tablets if:
• if you are allergic to sotalol hydrochloride or any of the other
ingredients in this medicine (listed in section 6).
• if you suffer from asthma, attacks of wheezing or any other
• if you have a very slow heart beat or low blood pressure.
• if you suffer from a condition causing discolouration (white or
purple) of the hands and feet (Raynaud’s syndrome).
• if you suffer from any severe circulation disorders.
• if you have suffered from heart disease (such as untreated
heart failure) or had a recent heart attack that your doctor does
not know about.
• if you suffer from a condition called metabolic acidosis.
• if you suffer from an untreated tumour of the adrenal gland
• if you suffer from kidney failure
If you are affected by any of the above you should tell your doctor
before taking this medicine.
Warnings 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.
Patients with low levels should not take Sotalol tablets.
Regular blood tests may be required during your treatment with
You must tell your doctor:
• if you are pregnant, planning to become pregnant or are
• if you have any kidney problems, as your dose of Sotalol
Tablets may need to be changed.
• if you 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 Tablets may also hide or reduce the
warning signs of low levels of sugar in your blood
• if you have an overactive thyroid, as Sotalol Tablets can
hide the symptoms or make them worse if treatment with
Sotalol Tablets is stopped suddenly.
• if you 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.
• if you suffer from psoriasis (a skin disease that causes itchy,
red, sore patches of skin).
• if you suffer from liver problems
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.
Sotalol Tablets are not recommended for use in children.
Other medicines and Sotalol Tablets
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 other’s
It is especially important that you tell your doctor if you are taking
the following medicines:
• for the treatment of high blood pressure, heart failure or an
irregular heartbeat (e.g. digoxin, amiodarone, verapamil)
• floctafenine (medicine used for the short term treatment of mild
to moderate pain)
• for the treatment of certain infections (e.g. amphotericin B,
• clonidine (sometimes used to treat hot flushes or headaches)
• for the treatment of hypertension (e.g. reserpine, guanethidine
or alpha methyldopa)
• for the treatment of diabetes (e.g. metformin or insulin)
• for the treatment of asthma and other diseases of the lung (e.g.
• for depression, anxiety, nervous disorders and mental
disturbances (e.g. methyldopa)
• for allergies such as hay fever (e.g. antihistamines)
• water tablets (diuretics)
Sotalol Tablets with food, drink and alcohol
Moderate amounts of alcohol will not affect Sotalol Tablets,
however you should check with your doctor first to see if drinking
is advisable for you.
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 essential.
You should not breastfeed while you are being treated with Sotalol
Driving and using machines
Sotalol Tablets does not usually affect your ability to drive.
However, if you feel light-headed or dizzy, do not drive or operate
3. How to take Sotalol Tablets
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your
• 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
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 disease.
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 Tablets 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.
Sotalol Tablets is not recommended for use in children.
If you take more Sotalol Tablets than you should
If you take too many tablets contact your doctor or go to your
nearest hospital emergency department immediately and take the
tablets and leaflet with you.
If you forget to take Sotalol Tablets
If you forget to take a dose, do not worry, just take it as soon as
you remember unless it is nearly time for your next dose then
you should miss the forgotten dose and continue as before. Do not
take a double dose to make up for a forgotten dose.
If you stop taking Sotalol Tablets
Do not stop taking Sotalol Tablets without consulting your doctor.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine, 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 heartbeat, heart failure, chest pain,
low blood pressure, difficulty in breathing, swelling, fainting
• nausea and vomiting, indigestion, abdominal pain, flatulence,
• anxiety, depression, mood changes, headache, light
headedness, dizziness, general weakness, tiredness, problems
with vision, sleeping, tingling in feet and hands (pins and
• sexual dysfunction, fever, rash, hearing problems, problems
with vision, changes in the way things taste.
If you are told to stop taking this medicine, return any unused
tablets to your pharmacist. Do not throw away any medicines via
wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will
help protect the environment.
6. Contents of the pack and other information
What Sotalol Tablets contain:
The active substance is Sotalol Hydrochloride. Each tablet contains
80mg Sotalol Hydrochloride.
The other ingredients are:
Calcium hydrogen phosphate dihydrate, maize starch, povidone
K30, sodium starch glycollate, type A,Talc and magnesium
What Sotalol Tablets look like and the contents of the pack:
Sotalol 40mg Tablets are round white to off white, flat bevellededged
Sotalol 80mg Tablets are round white to off white flat bevellededged
tablets with a score line on one side.
Sotalol 160mg tablets are round blue, flat bevelled edged tablets
with a score line on one side.
Sotalol Tablets, in each of the above strengths, are available in
blister packs containing 28, 30, 50 or 56 tablets.
Not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer:
Name and address:
Bristol Laboratories Ltd.
Bristol House, Unit 3, Canalside
Northbridge Road, Berkhamsted
HP4 1EG, UK
Telephone: 0044 (0)1442 200922
0044 (0)1442 873717
Sotalol 40mg Tablets; PL 17907/0258
Sotalol 80mg Tablets; PL 17907/0259
Sotalol 160mg Tablets; PL 17907/0260
Date of last revision: August 2017
To request a copy of this leaflet in Braille, large print or audio
format then please contact the Marketing authorisation holder at
the address (or telephone, fax, email) above.
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 you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side affects you can
help provide more information on the safety of this medicine.
5. How to store Sotalol Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the foil blister and carton. The expiry date refers to the last day of
Do not store the tablets above 250C.
Store in the original package to protect from light.
SAME SIZE ARTWORK
160 mm x 270 mm
V4 14-08-17 D0
PATIENT INFORMATION LEAFLET
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.