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Active substance(s): SOTALOL HYDROCHLORIDE

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SOTALOL 80 mg and 160 mg Tablets
Package leaflet: Information
for the patient

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
• 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 Sotalol is and what it is used for
What you need to know before you take Sotalol
How to take Sotalol
Possible side effects
How to store Sotalol
Contents of the pack and other information

Pharma code 628


What Sotalol is and what it is used for

• Sotalol belongs to a group of medicines called
beta-blockers, which slow the heart beat, so the
heart beats more efficiently.
• Sotalol is used to prevent a recurrence of serious
heart beat problems.


What you need to know before you take

DO NOT take Sotalol:
• if you are allergic to sotalol, sulphonamides (e.g.
co-trimoxazole, sulfadiazine) or any of the other
ingredients of this medicine (listed in section 6)
• if you have any heart problems, other than those for
which your medicine has been prescribed, in
− abnormal heart rhythms called ‘long QT
− torsades de pointes (life-threatening irregular
heart beat)
− atrioventricular (AV) block or
− sick sinus syndrome (without a pacemaker)
(certain types of heart rhythm disturbances)
− your heart beats less than 50 times per minute
− uncontrolled heart failure
− shock due to heart problems (a condition which
may be associated with low blood pressure, cold
skin, a weak pulse, mental confusion and anxiety)
• if you suffer from any of the following conditions:
− asthma or any other breathing difficulties
− Prinzmetal’s angina (chest pain and palpitations
at rest, usually during sleep)
− problems with your circulation (e.g. Raynaud’s
phenomenon or pain in the calf muscles on
− phaeochromocytoma (a benign adrenal tumour)
which is not being treated
− low blood pressure (which is not due to an
irregular heartbeat)
− severe kidney problems
− metabolic acidosis (acidification of the blood)
• if you are due to have a general anaesthetic
• if you are also taking other medicines to correct an
abnormal heart rhythm, e.g. quinidine, hydroquinidine
or disopyramide (called class Ia antiarrhythmic
agents) or amiodarone, dofetilide or ibutilide (called
class ,,, antiarrhythmic agents)
• if you are also taking medicines used to treat
schizophrenia and other serious mental disorders
e.g. sulpiride, sultopride, amisulpride, thioridazine,
chlorpromazine, levomepromazine, trifluoperazine,
cyamemazine, tiapride, pimozide, haloperidol,
droperidol (called neuroleptics)
• if you are also receiving injections of erythromycin
(an antibiotic) or vincamine (which may be used to
treat some forms of brain disease, notably dementia),
or if you are taking bepridil (used to treat angina),
cisapride (used to treat certain gastrointestinal
problems), diphenamil (which may be used to treat a
slow heart beat), mizolastine (used to treat hayfever),
moxifloxacin (an antibiotic) or floctafenine (used to
treat pain).

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

If you are elderly, it is especially important for you not
to take Sotalol if any of the above applies to you.
Warnings and precautions
Sotalol may sometimes make an abnormal heart beat
worse or cause new heart rhythm problems.
Talk to your doctor or pharmacist before taking Sotalol
if you have:
• slow heartbeat (less than 50-55 beats per minute)
• heart failure which is being treated or a heart rhythm
disorder called ‘first degree atrioventricular (AV)
block’, or you have recently had a heart attack
• an electrolyte imbalance (low levels of potassium
and magnesium in your blood)
• severe or prolonged diarrhoea
• frequent allergic reactions
• an over-active thyroid gland
• psoriasis (patches of thickened and sore skin)
• diabetes, treated with insulin or sulphonylureas, as
warning signs of low blood sugar may be less
obvious than usual
• kidney disease.
Other precautions you should take:
• Tell the hospital staff or dentist you are taking Sotalol
if you are to have an operation requiring an
anaesthetic or need X-rays requiring iodised contrast
• Never stop taking Sotalol abruptly (see 3. How to
take Sotalol).
Athletes should note that Sotalol can cause positive
results in drug tests.
Other medicines and Sotalol
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Some medicines must not be taken at the same time as
Sotalol. These are listed above, under the heading ‘Do
not take Sotalol’.
Talk to your doctor if you are taking any of the
medicines listed below.
Sotalol should not generally be taken at the same time
as the following medicines because of the risk of
further heart problems:
• halofantrine (used to treat malaria)
• pentamidine (used to treat pneumonia)
• sparfloxacin (an antibiotic)
• methadone (which may be used to treat cough, pain
and heroin addiction)
• diltiazem or verapamil (called calcium channel
blockers or antagonists, used to treat abnormal heart
• medicines that can cause high blood pressure such
as monoamine oxidase inhibitors (MAOIs) e.g.
moclobemide, phenelzine, isocarboxazid.
Caution is also needed if you are taking:
• diuretics (water tablets)
• laxatives (used to treat constipation)
• glucocorticoids (used to treat inflammation and
allergic skin reactions)
• tetracosactide (mainly used to diagnose or treat
adrenal glands disorders)
• amphotericin B (administered intravenously) (used to
treat fungal infections)
• guanfacine (used to treat attention deficit
hyperactivity disorder [ADHS])
• digitalis glycosides including digoxin (used to treat
irregular heart rhythms or impaired heart function)
• class Ic antiarrhythmic agents (such as propafenone
or flecainide) or intravenously administered lidocaine
(used to control irregular heart rhythm)
• mefloquine (used to prevent or treat malaria)
• cholinesterase inhibitors such as donepezil,
rivastigmine, tacrine, galantamine, neostigmine,
pyridostigmine or ambenonium (used to treat
Alzheimer’s disease)
• pilocarpine (used to treat dry mouth or high pressure
in the eye)
• other beta-blocking agents, clonidine,
dihydropyridines or alpha-methyldopa (used to treat
high blood pressure)
• volatile halogenated anaesthetics (used in surgery)
• insulin and hypoglycaemic sulphonamides (used to
treat diabetes)
• baclofen (used to treat muscle spasm)
• non steroidal antiinflammatory drugs (NSAIDs) such
as ibuprofen, diclofenac (used to treat pain, fever or

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• tricyclic antidepressants (e.g. imipramine),
phenothiazine neuroleptics (used to treat psychiatric
• amifostine (used during chemo- or radiotherapy)
• dipyridamole (administered intravenously) (used to
prevent formation of a blood clot)


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
Interactions with laboratory tests:
If you have a blood test, please inform your doctor that difficulty in swallowing or breathing. These may be signs
you are taking sotalol, as it may influence the results of of an allergic reaction and the tablets will be stopped.
some blood tests.
Other side effects:
• blood disorders (such as changes in the numbers of
white or red blood cells or platelets) which may be
Athletes should be aware that this medicine contains
characterised by unusual bleeding or unexplained
an active substance which may cause a positive
bruising, fever or chills, sore throat, ulcers in the
reaction to “anti-doping tests”.
mouth or throat. If you develop these symptoms, you
Pregnancy and breast-feeding
should contact your doctor.
If you are pregnant or breast-feeding, think you may be • low blood sugar

cold hands and/or feet
pregnant or are planning to have a baby, ask your
• problems with sight
doctor or pharmacist for advice before taking this
• slow heartbeat, breathlessness, wheezing, chest
pain, palpitations, ankle swelling, ECG (cardiogram)
Your doctor may prescribe Sotalol during pregnancy if it
abnormalities, low blood pressure, worsened
is clearly necessary. Do not take Sotalol unless your
irregular heartbeat, fainting, heart failure
doctor tells you to and always take it exactly as
• skin rashes, itching, sweating, sensitivity to light
• nausea, vomiting, diarrhoea, indigestion, abdominal
pain and flatulence
Breast-feeding is not recommended during treatment
• cramp, muscle or joint pain
with Sotalol.
• sexual problems including impotence
Driving and using machines
• fatigue, dizziness, feeling of weakness, headaches,
Sotalol may affect your eyesight or make you feel dizzy.
depression, sleeping difficulties, pins-and-needles,
anxiety, fever.
Do not drive or operate any tools or machines if you are
In exceptional cases, there have been reports of
inflammation of the joints and connective tissue (e.g.
Sotalol contains lactose.
tendons) with skin rashes. These symptoms usually
If you have been told by your doctor that you have an
disappear once treatment is stopped.
intolerance to some sugars, contact your doctor before
If you have psoriasis, or intermittent claudication
taking this medicinal product.
(cramp-like leg pain brought on by walking), your
symptoms may become worse.
3 How to take Sotalol
Reporting of side effects
Always take this medicine exactly as your doctor has
If you get any side effects, talk to your doctor or
told you. You should check with your doctor or
pharmacist. This includes any possible side effects not
pharmacist if you are not sure.
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
The recommended dose is:
Adults (including the elderly):
By reporting side effects you can help provide more
The initial dose is 80 mg sotalol taken once daily or in
information on the safety of this medicine.
two divided doses at 12 hour intervals. Your doctor will
then gradually increase this according to your needs.
5 How to store Sotalol
The recommended dose is between 160 mg and 320 mg
sotalol taken in two or three divided doses each day.
For certain patients who have a life-threatening
irregular heart beat, the dose can be increased up to
480 mg or 640 mg sotalol daily.
Patients with kidney problems may require a lower
Use in children:
Due to a lack of data Sotalol is not recommended for
use in children. Please check with your doctor.
Method of administration:
You should swallow the tablets whole with a full glass
of water.
The tablet can be divided into equal doses.

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 carton after EXP. The expiry date refers to
the last day of that month.
Keep the blister in the outer carton in order to protect
from light.
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.


Contents of the pack and other information

What Sotalol contains:
• The active substance is sotalol hydrochloride
• Each tablet contains either 80 mg or 160 mg of sotalol
If you take more Sotalol than you should
If you (or someone else) swallow a lot of the tablets all
• The other ingredients are lactose monohydrate,
together, or if you think a child has swallowed any of
maize starch, magnesium stearate, povidone and
the tablets, contact your nearest hospital casualty
indigo carmine (E132).
department or your doctor immediately. Please take this
What Sotalol looks like and contents of the pack:
leaflet, any remaining tablets and the container with
Sotalol 80 mg: Light blue, oval shaped tablet, scored on
you to the hospital or doctor so that they know which
one side and debossed with the number “93” and “61”
tablets were consumed.
on each side of the score, plain on the other side
If you forget to take Sotalol
Sotalol 160 mg: Light blue, oval-shaped tablet, scored
If you forget to take a dose, take one as soon as you
on one side and debossed with the number “93” and
remember, unless it is nearly time to take the next one. “62” on each side of the score, plain on the other side
Do not take a double dose to make up for a forgotten
Sotalol 80 mg is available in pack sizes* of 20, 28, 30, 40,
tablet. Take the remaining doses at the correct time.
50, 60, 90 and 100 tablets
If you stop taking Sotalol
Sotalol 160 mg is available in pack sizes* of 20, 28, 30,
You must not stop taking Sotalol suddenly, as this could 50, 60, 100 and 120 tablets.
cause severe heart problems, including heart attack
Not all pack sizes may be marketed.
and death.
Your doctor will decide when and how you should stop Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is TEVA UK Limited,
taking Sotalol. You must follow your doctor’s
Eastbourne, BN22 9AG
This leaflet was last revised in 08/2017. EBNUK2088a
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
PL 00289/0389-0390
160 x 323

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

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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.