SOTALOL 80 MG TABLETS

Active substance: SOTALOL HYDROCHLORIDE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER

Pharma code 236 (Main)

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 any of the side effects get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:

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

1

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.

2

BEFORE YOU TAKE SOTALOL

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
syndrome’
• torsades de pointes
• atrioventricular (AV) block
• sick sinus syndrome (without a
pacemaker)
• if your heart beats less than 50 times per
minute
• 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
blood)
• 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
problems.
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.

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

SOTALOL 80 mg AND 160 mg
TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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.
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.

3

HOW TO TAKE SOTALOL

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.







chest pain, palpitations, ankle swelling, ECG
(cardiogram) abnormalities, low blood
pressure, worsened irregular heartbeat,
fainting, heart failure
skin rashes, itching, sweating, sensitivity to
light
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,
anxiety.

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 worse.

If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
The usual dose is between 160 mg and 320 mg please tell your doctor or pharmacist.
of Sotalol taken in two or three divided doses
each day.
HOW TO STORE SOTALOL

5

For certain patients who have a life-threatening Keep out of the reach and sight of children. Do
irregular heart beat, the dose can be increased not use Sotalol after the expiry date that is
up to 480 mg or 640 mg of Sotalol daily.
stated on the outer packaging. Store in the
original package and protect from light.
Patients with kidney problems may require a
Medicines should not be disposed of via
lower dose.
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
Children:
longer required. These measures will help to
Due to a lack of data Sotalol is not recommended protect the environment.
for use in children. Please check with your
doctor.
Method of administration
You should swallow Sotalol whole with a full
glass of water.

6

FURTHER INFORMATION

What Sotalol contains:
• The active ingredient is sotalol
hydrochloride.
• Each tablet contains either 80 mg or 160 mg
of sotalol hydrochloride.
• The other ingredients are lactose
monohydrate, maize starch, magnesium
stearate, povidone and indigo carmine (E132).

If you take more Sotalol than you should
If you (or someone else) swallow a lot of the
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 looks like and contents of the
any remaining tablets and the container with
pack:
you to the hospital or doctor so that they know • Sotalol 80 mg Tablets are light blue, oval
which tablets were consumed.
shaped tablets, scored on one side and
debossed with the number “93” and “61”
If you forget to take Sotalol
on each side of the score, plain on the other
If you forget to take a dose, take one as soon as
side.
you remember, unless it is nearly time to take • Sotalol 160 mg Tablets are light blue, oval
the next one. Never take two doses together.
shaped tablets, scored on one side and
Take the remaining doses at the correct time.
debossed with the number “93” and “62”
on each side of the score, plain on the other
If you stop taking Sotalol
side.
You must not stop taking Sotalol suddenly, as
• The tablets can be divided into equal halves.
this could cause severe heart problems,
• The 80 mg product is available in pack sizes
including heart attack and death.
of 20, 28, 30, 40, 50, 60, 90 and 100 tablets.
Your doctor will decide when and how you
• The 160 mg product is available in pack sizes
should stop taking Sotalol. You must follow
of 20, 28, 30, 50, 60, 100 and 120 tablets.
your doctor’s instructions.
Not all pack sizes may be marketed.
If you have any further questions on the use of
Marketing Authorisation Holder and
this product, ask your doctor or pharmacist.
Manufacturer
The Marketing Authorisation Holder is TEVA
4 POSSIBLE SIDE EFFECTS
UK Limited, Eastbourne, BN22 9AG.
Like all medicines, Sotalol can cause side
This leaflet was last revised in: January 2009
effects, although not everybody gets them.
The following side effects have been reported:
• blood disorders (such as changes in the
numbers of white or red blood cells) which
may be characterised by unusual bleeding
or unexplained bruising, fever or chills, sore
throat, ulcers in the mouth or throat. If you
develop these symptoms, you should
contact your doctor.
• low blood sugar
• cold hands and/or feet
• problems with sight
• slow heartbeat, breathlessness, wheezing,

PL 00289/0389-0390

85697-T
160 x 323

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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.

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