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SOTALOL HYDROCHLORIDE 160 MG TABLETS

Active substance(s): SOTALOL HYDROCHLORIDE / SOTALOL HYDROCHLORIDE / SOTALOL HYDROCHLORIDE

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PACKAGE LEAFLET – INFORMATION FOR
THE USER

SOTALOL HYDROCHLORIDE
80 mg TABLETS
SOTALOL HYDROCHLORIDE
160 mg TABLETS
(Sotalol Hydrochloride)
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 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.
In this leaflet:
1. What are Sotalol Hydrochloride tablets and
what are they used for
2. What you need to know before you take
Sotalol Hydrochloride tablets
3. How to take Sotalol Hydrochloride tablets
4. Possible side effects
5. How to store Sotalol Hydrochloride tablets
6. Contents of the pack and other information

1. What are Sotalol
Hydrochloride tablets and
what are they used for
Sotalol belongs to a group of medicines called
‘Beta-blockers’ or beta-adrenergic receptor
blocking drugs.
Sotalol tablets are used for the treatment of
certain types of irregular heartbeats.

2. What you need to know before
you take Sotalol
Hydrochloride tablets
Do not take Sotalol tablets if any of the
following apply to you.
• 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 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 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 need to have surgery, you should tell the
doctor or anaesthetist that you are taking Sotalol
Hydrochloride tablets as it can affect anaesthetics.
You may have to stop taking Sotalol Hydrochloride
tablets before surgery and it should be gradually
stopped over a period of one week. Your doctor
will tell you if this is necessary.
Children
Sotalol Hydrochloride tablets is not
recommended for use in children.
Other medicines and SOTALOL
HYDROCHLORIDE 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
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, verapamil)
• floctafenine (medicine used for the short term
treatment of mild to moderate pain)
• for the treatment of certain infections (e.g.
amphotericin B, pentamidine, halofantrine)
• steroids
• laxatives
• 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)
• antibiotics
• water tablets (diuretics)
• Neuromuscular blocking agents like tubocurarine.
SOTALOL HYDROCHLORIDE TABLETS with
food, drink and alcohol
Moderate amounts of alcohol will not affect
Sotalol Hydrochloride 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
Hydrochloride tablets during pregnancy unless
your doctor thinks it is essential.
You should not breastfeed while you are being
treated with Sotalol Hydrochloride tablets.
Driving and using machines
Sotalol Hydrochloride tablets does not usually
affect your ability to drive. However, if you feel
light-headed or dizzy, do not drive or operate
machinery.
SOTALOL HYDROCHLORIDE TABLETS
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 Sotalol
Hydrochloride tablets

Warnings and precautions
Talk to your doctor or pharmacist before taking
Sotalol Hydrochloride tablets.

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

Your doctor may wish to check the level of
potassium and magnesium in your blood before
you start taking Sotalol Hydrochloride tablets.
Patients with low levels should not take Sotalol
Hydrochloride tablets.

Adults
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
Hydrochloride 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.

Regular blood tests may be required during your
treatment with Sotalol Hydrochloride tablets.
You must tell your doctor:
• if you are pregnant, planning to become
pregnant or are breast-feeding.
• if you have any kidney problems, as your
dose of Sotalol Hydrochloride 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 Hydrochloride tablets may
also hide or reduce the warning signs of low
levels of sugar in your blood (hypoglycaemia).
• if you have an overactive thyroid, as Sotalol
Hydrochloride tablets can hide the symptoms
or make them worse if treatment with Sotalol
Hydrochloride 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
Hydrochloride tablets.
• if you suffer from psoriasis (a skin disease
that causes itchy, red, sore patches of skin).
• if you suffer from liver problems

Children
Sotalol Hydrochloride tablets is not
recommended for use in children.
If you take more SOTALOL HYDROCHLORIDE
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
HYDROCHLORIDE 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
HYDROCHLORIDE TABLETS
Do not stop taking Sotalol Hydrochloride 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 Hydrochloride
tablets (affecting more than 1 in 100 patients)
include the following:
• irregular heartbeat, abnormal heart rhythm,
slow heartbeat, heart failure, chest pain, low
blood pressure, difficulty in breathing, swelling,
fainting and palpitations.
• nausea and vomiting, indigestion, abdominal
pain, flatulence, diarrhoea, muscle 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, 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 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 effects you can help provide
more information on the safety of this medicine.

5. How to store Sotalol
Hydrochloride tablets
Keep out of the reach and sight of children.
Do not store above 25ºC. Store in the original
package.
Do not use your tablets after the expiry date
stated on the label or carton.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.

6. Contents of the pack and
other information
What Sotalol Hydrochloride Tablet contains?
• The active substance is Sotalol
Hydrochloride.
• The inactive ingredients are lactose, maize
starch, sodium starch glycollate (Type A),
magnesium stearate, hydroxypropyl cellulose
and colloidal anhydrous silica).(see section 2
for Important information about some of the
ingredients of sotalol hydrochloride tablets).
What Sotalol Hydrochloride Tablet looks like
and contents of the pack?
Sotalol Hydrochloride 80 mg tablets are white to
off white, round, biconvex, uncoated, debossed
with 'DR' on one side and plain on the other side.
Sotalol Hydrochloride 160 mg tablets are white to
off white, round, biconvex, uncoated, debossed
with 'DS' on one side and plain on the other side.
Sotalol Hydrochloride tablets are available as
blister packs in pack sizes of 7, 14, 21, 28, 56
and 100 tablets (Not all pack sizes may be
marketed).
Marketing Authorisation Holder and
Manufacturer
Accord Healthcare Limited,
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom.
This leaflet was last revised in August 2017.

INP001
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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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