Package leaflet: Information for the patient
Sotacor 80 mg 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 is in this leaflet:
What SOTACOR is and what it is used for
What you need to know before you take SOTACOR
How to take SOTACOR
Possible side effects
How to store SOTACOR
Contents of the pack and other information
1. What SOTACOR is and what it is used for
The name of this medicine is Sotacor . Each tablet contains 80 mg of sotalol hydrochloride as the active
Sotacor belongs to a group of drugs called beta-adrenergic blocking agents or “beta-blockers.”
Sotacor is used to treat irregular heartbeats.
2. What you need to know before you take SOTACOR
Do not take SOTACOR:
if you are
to sotalol hydrochloride or
any of the other ingredients in this medicine (listed in section
if you suffer from
, attacks of wheezing or any other lung disease.
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
if you suffer from any severe
if you have suffered from
(such as untreated heart failure) or had a recent heart attack that your
not know about.
if you suffer from a condition called
if you suffer from an untreated tumour of the adrenal gland
if you suffer from
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 Sotacor.
Your doctor may wish to check the level of potassium and magnesium in your blood before you start taking
Sotacor. Patients with low levels should not take Sotacor.
Regular blood tests may be required during your treatment with Sotacor.
You must tell your doctor:
if you are
, planning to become pregnant or are breast-feeding.
if you have any
, as your dose of Sotacor may need to be changed.
if you suffer from
, as it may be necessary to change the dose of insulin or any other medicines you
take to treat your diabetes. Sotacor may also hide or reduce the warning signs of low levels of sugar in your
if you have an
, as Sotacor can hide the symptoms or make them worse if treatment with
Sotacor is stopped suddenly.
if you suffer from, or have recently suffered from
, 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 Sotacor.
if you suffer from
(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 Sotacor as it can affect
anaesthetics. You may have to stop taking Sotacor before surgery and it should be gradually stopped over a period
of one week. Your doctor will tell you if this is necessary.
for use in children.
Other medicines and SOTACOR
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:
for the treatment of high blood pressure, heart failure or an irregular heartbeat (e.g. digoxin, amiodarone,
floctafenine (medicine used for the short term treatment of mild to moderate pain)
for the treatment of cert
amphotericin B, pentamidine, halofantrine)
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. ventolin inhalers)
for depression, anxiety, nervous disorders and mental disturbances (e.g. methyldopa)
for allergies such as hay fever (e.g. antihistamines)
water tablets (diuretics)
SOTACOR with food, drink and alcohol
Moderate amounts of alcohol will not affect Sotacor, 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 Sotacor during pregnancy unless your doctor
thinks it is essential.
You should not breastfeed while you are being treated with Sotacor.
Driving and using machines
Sotacor does not usually affect your ability to drive. However, if you feel light-headed or dizzy, do not drive or
SOTACOR contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. How to take SOTACOR
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
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 Sotacor 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.
not recommended for use in children.
If you take more SOTACOR than you should
and take the tablets and leaflet with you.
If you forget to take SOTACOR
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 SOTACOR
Do not stop taking Sotacor 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 Sotacor (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 and palpitations.
nausea and vomiting, indigestion, abdominal pain, flatulence, diarrhoea, cramps.
anxiety, depression, mood changes, headache, light-headedness, dizziness, general weakness, tiredness,
problems with vision, sleeping, 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 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:
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store SOTACOR
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 that month
Do not store the tablets above 25°C.
Store in the original package to protect from light.
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. Content of the pack and other information
What SOTACOR contains
The active substance is sotalol hydrochloride. Each tablet contains 80 mg sotalol hydrochloride.
The other ingredients are:
colloidal anhydrous silica, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose and
What SOTACOR looks like and contents of the pack
Sotacor 80 mg tablets are white in colour, round, biconvex, with a break bar on each side. The tablets are supplied
in blister packs of 14 a strip, or 10 a strip, and come in packs containing 28 or 30 tablets, respectively.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bristol-Myers Squibb Pharmaceuticals Limited
Uxbridge Business Park
Sanderson Road, Uxbridge
Middlesex UB8 1DH, United Kingdom
Bristol-Myers Squibb Holdings Limited
t/a Bristol-Myers Pharmaceuticals,
County Dublin, Ireland.
10 rue Bouché Thomas
This leaflet was last revised in October 2017