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Active substance(s): SOTALOL HYDROCHLORIDE

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231-30-85697-V LEA SOTALOL A/S TAB TUK


07 May 2015



Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it
• 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.

Pharma code 537 (Main)

1. What Sotalol is and what it is used for
2. Before you take Sotalol
3. How to take Sotalol
4. Possible side effects
5. How to store Sotalol
6. Further information



• 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.



DO NOT take Sotalol if you:
• are allergic (hypersensitive) to sotalol or any
of the other ingredients of this medicine
• are sensitive to sulphonamides e.g.
co-trimoxazole, sulfadiazine
• have any heart problems, other than those
for which your medicine has been
prescribed, in particular:
• abnormal heart rhythms called ‘long QT
• torsades de pointes
• atrioventricular (AV) block
• sick sinus syndrome (without a
• if your heart beats less than 50 times per
• if you suffer from uncontrolled heart failure
• if you are in shock due to heart problems
(a condition which may be associated with
low blood pressure, cold skin, a weak
pulse, mental confusion and anxiety)
• 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 walking)
• 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
• are due to have a general anaesthetic
• 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 III
antiarrhythmic agents)
• 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)


• 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).
If you are elderly, it is especially important for
you not to take Sotalol if any of the above
applies to you.
Take special care with Sotalol:
Sotalol may sometimes make an abnormal
heart beat worse or cause new heart rhythm
Tell your doctor before you start to take this
medicine if you have:
• 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.
• Never stop taking Sotalol abruptly (see 3.
How to take Sotalol).
Athletes should note that sotalol can cause
positive results in drug tests.
Taking 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 if you’.
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 beats)
• medicines that can cause high blood
pressure such as monoamine oxidase
inhibitors (MAOIs) e.g. moclobemide,
phenelzine, isocarboxazid.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice. Your
doctor may prescribe Sotalol during pregnancy
if it is clearly necessary. Do not take Sotalol
unless your doctor tells you to and always take
it exactly as prescribed.
Breast-feeding is not recommended during
treatment with Sotalol.
Driving and using machines
Sotalol may affect your eyesight or make you
feel dizzy.
Do not drive or operate any tools or machines
if you are affected.

Top of page cut-off to middle of registration mark: 44 mm.

SOTALOL 80 mg AND 160 mg



231-30-85697-V LEA SOTALOL A/S TAB TUK



Important information about some of the
ingredients of Sotalol
Sotalol tablets contain lactose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicine.



Always take Sotalol exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose is:
Adults (including the elderly):
The initial dose is 80 mg of Sotalol taken once
daily or in two divided doses at 12 hour
intervals. Your doctor will then gradually
increase this according to your needs.

• nausea, vomiting, diarrhoea, indigestion,
abdominal pain and flatulence
• cramp, muscle or joint pain
• sexual problems including impotence
• fatigue, dizziness, light-headedness, vertigo,
lethargy, headaches, depression, sleeping
difficulties, pins-and-needles, numbness,
In exceptional cases, there have been reports
of inflammation of the joints and connective
tissue (e.g. tendons) with skin rashes. These
symptoms usually disappear once treatment
is stopped.
If you have psoriasis, or intermittent
claudication (cramp-like leg pain brought on
by walking), your symptoms may become

Reporting of side effects
If you get any side effects, talk to your doctor
The usual dose is between 160 mg and 320 mg or pharmacist. This includes any possible side
of Sotalol taken in two or three divided doses
effects not listed in this leaflet. You can also
each day.
report side effects directly via the Yellow Card
Scheme at:
For certain patients who have a life-threatening
By reporting side effects you can help provide
irregular heart beat, the dose can be increased
more information on the safety of this
up to 480 mg or 640 mg of Sotalol daily.
Patients with kidney problems may require a
lower dose.


Due to a lack of data Sotalol is not
Keep out of the reach and sight of children. Do
recommended for use in children. Please check not use Sotalol after the expiry date that is
with your doctor.
stated on the outer packaging. Store in the
original package and protect from light.
Method of administration
You should swallow Sotalol whole with a full
Medicines should not be disposed of via
glass of water.
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
If you take more Sotalol than you should
longer required. These measures will help to
If you (or someone else) swallow a lot of the
protect the environment.
tablets all together, or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
doctor immediately. Please take this leaflet,
What Sotalol contains:
any remaining tablets and the container with
you to the hospital or doctor so that they know • The active ingredient is sotalol
which tablets were consumed.
• Each tablet contains either 80 mg or 160 mg
of sotalol hydrochloride.
If you forget to take Sotalol
• The other ingredients are lactose
If you forget to take a dose, take one as soon
monohydrate, maize starch, magnesium
as you remember, unless it is nearly time to
stearate, povidone and indigo carmine
take the next one. Never take two doses
together. Take the remaining doses at the
correct time.
What Sotalol looks like and contents of the
If you stop taking Sotalol
You must not stop taking Sotalol suddenly, as • Sotalol 80 mg Tablets are light blue, oval
shaped tablets, scored on one side and
this could cause severe heart problems,
debossed with the number “93” and “61” on
including heart attack and death.
each side of the score, plain on the other
Your doctor will decide when and how you
should stop taking Sotalol. You must follow
• Sotalol 160 mg Tablets are light blue, oval
your doctor’s instructions.
shaped tablets, scored on one side and
If you have any further questions on the use of
debossed with the number “93” and “62” on
this product, ask your doctor or pharmacist.
each side of the score, plain on the other
• The tablets can be divided into equal halves.
• The 80 mg product is available in pack sizes
Like all medicines, Sotalol can cause side
of 20, 28, 30, 40, 50, 60, 90 and 100 tablets.
effects, although not everybody gets them.
• The 160 mg product is available in pack sizes
of 20, 28, 30, 50, 60, 100 and 120 tablets.
The following side effects have been reported:
Not all pack sizes may be marketed.
• blood disorders (such as changes in the
numbers of white or red blood cells) which
Marketing Authorisation Holder and
may be characterised by unusual bleeding or Manufacturer
unexplained bruising, fever or chills, sore
The Marketing Authorisation Holder is
throat, ulcers in the mouth or throat. If you
TEVA UK Limited, Eastbourne, BN22 9AG
develop these symptoms, you should
This leaflet was last revised in: May 2015
contact your doctor.
• low blood sugar
PL 00289/0389-0390
• cold hands and/or feet
• problems with sight
• slow heartbeat, breathlessness, wheezing,
chest pain, palpitations, ankle swelling, ECG
(cardiogram) abnormalities, low blood
pressure, worsened irregular heartbeat,
fainting, heart failure
• skin rashes, itching, sweating, sensitivity to
160 x 323


07 May 2015

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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.