SOTALOL 80MG TABLETS

Active substance: SOTALOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SOTALOL 40 mg, 80 mg & 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 symptoms are the same as yours.
- If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

THIS LEAFLET CONTAINS
1. What Sotalol is 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 FOR
Sotalol belongs to a group of medicines called betablockers. It can be used to treat problems affecting the beat
of your heart (arrhythmias, tachycardia).
If you are not sure why you have been prescribed this
medicine then please ask your doctor.

2. BEFORE YOU TAKE SOTALOL
Do not take Sotalol and tell your doctor if you:
• are allergic to Sotalol or any of the other ingredients in
the tablets (listed in section 6 of this leaflet). The signs
of an allergic reaction include a rash, itching or
shortness of breath
• have a history of asthma, wheezing or other lung
diseases
• have any of the following heart problems:
- second or third degree heart block (conditions which
may make you feel dizzy or light-headed, tired or
prone to collapses)
- very slow or very uneven heart beats
- a problem (common in the elderly) related to poor
control of the working of the heart (sick sinus
syndrome)

-

severe blood circulation problems
low blood pressure (hypotension) which can make
you feel dizzy or light-headed
- chest pain while resting (Prinzmetal’s angina)
• have severe kidney problems.
Do not take this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Sotalol.
You will not be given Sotalol if you:
• have a sudden and rapid fall in blood pressure
(cardiogenic shock)
• have heart failure which is not under control (signs
include breathlessness and swollen ankles)
• have high blood pressure caused by a tumour on the
adrenal gland which has not been treated. This is called
phaeochromocytoma
• have increased levels of acid in your blood (metabolic
acidosis).
You will not be given this medicine if any of the above
apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Sotalol.
Take special care with Sotalol
Tell your doctor before you take this medicine if you:
• have or have had heart problems (including heart
failure, first degree heart block, heart attack or uneven
heart beats) or have low levels of potassium or
magnesium in your blood (possibly due to severe
diarrhoea), as your doctor may do some tests on your
heart and blood before giving you this medicine
• suffer from blood circulation problems (Raynaud’s
phenomenon)
• have a skin problem called psoriasis
• have a history of allergic reactions or need anti-allergic
treatment e.g. following a wasp or bee sting
• have a thyroid problem, as the effects of an overactive
thyroid gland (thyrotoxicosis) may be hidden by this
medicine
• have kidney problems, as you will be given a lower
dose of this medicine
• have diabetes, as symptoms of low blood sugar levels
(hypoglycaemia) may be hidden by this medicine.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Sotalol.
Operations and tests
Tell your doctor, dentist or nurse you are taking Sotalol if
you:
• are going to have an operation or an anaesthetic
• are going to have any blood or urine tests.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
bought without a prescription. This is because Sotalol can

affect the way some medicines work. Also some medicines
can affect the way Sotalol works.
In particular, tell your doctor or pharmacist if you are taking
any of the following:
• medicines to treat asthma or other lung diseases, such
as theophylline
• medicines to treat irregular or uneven heart beat, such
as amiodarone, disopyramide, procainamide, flecainide,
quinidine
• medicines to treat high blood pressure or chest pain,
such as diltiazem, verapamil, bepridil, nifedipine,
ivabradine, ranolazine, nitrates such as glyceryl
trinitrate
• medicines to treat high blood pressure, such as
captopril (ACE inhibitors), doxazosin and prazosin
(alpha-blockers), furosemide and hydrochlorothiazide
(diuretics), hydralazine, moxonidine, guanethidine,
reserpine, methyldopa, diazoxide, candersatan
• digoxin to treat heart failure
• clonidine to treat high blood pressure or migraine. Do
not stop taking clonidine unless your doctor tells you to.
If you have to stop taking clonidine, your doctor will tell
you how to
• moxisylyte to treat blood circulation problems like
Raynaud’s disease
• medicines for stimulating the heart, such as adrenaline,
noradrenaline or dobutamine
• medicines to treat diabetes, such as gliclazide,
tolbutamide or insulin
• medicines for pain and swelling, such as ibuprofen or
indometacin
• ergotamine used for migraine
• medicines to treat anxiety, depression or mental health
problems, such as diazepam, temazepam, amitriptyline,
imipramine, phenelzine, chlorpromazine, thioridazine,
pimozide, sertindole, amisulpride, sulpiride, haloperidol,
zuclophenthixol
• droperidol, dolasetron or tropisetron to treat or prevent
nausea and vomiting
• levodopa to treat Parkinson’s disease
• muscle relaxants such as baclofen, tizanidine or
tubocurarine
• medicines to treat malaria, such as mefloquine,
halofantrine, artemether and lumefantrine
• antibiotics such as erythromycin (by injection),
sparfloxacin or moxifloxacin
• pentamidine to treat lung infections
• amphotericin (by injection) to treat fungal infections
• aldesleukin to treat cancer
• antihistamines such as astemizole, terfenadine or
mizolastine to treat allergies
• oestrogens used for contraception or hormone
replacement therapy (HRT)
• steroids such as hydrocortisone or prednisolone to treat
swelling and allergies
• pilocarpine to help produce more saliva and tears
• medicines to treat constipation (laxatives)
• carbenoxolone to treat ulcers

cisapride to treat heartburn or reflex disease
tolterodine to treat urinary problems
alprostadil for problems maintaining an erection
atomoxetine to treat Attention Deficit Hyperactive
Disorder (ADHD)
• cough or cold remedies bought over the counter.





Taking Sotalol with food and drink
Do not drink alcohol while taking Sotalol. This is because
alcohol can change the way Sotalol works.
Pregnancy and breast-feeding
If you are pregnant or plan to become pregnant speak to
your doctor before taking Sotalol. Its effect in pregnancy is
not known but some beta-blockers can affect the growth of
the unborn baby.
Do not breast-feed your baby unless you have spoken to
your doctor first as Sotalol can pass into your breast milk.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
You may feel dizzy or tired while taking Sotalol. If this
happens, do not drive or use any tools or machines and tell
your doctor.

3. HOW TO TAKE SOTALOL
Always take Sotalol tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure. Take this medicine by mouth.
Adults
The usual starting dose is 80 mg a day, either as a single
dose or in two divided doses at 12 hour intervals. After 2-3
days your doctor may increase the dose. Most people need
160-320 mg a day, in two divided doses at 12 hour
intervals.
Patients with kidney problems
If you have kidney problems, your doctor will give you a
lower dose than stated above.
Children
Sotalol must not be given to children.
If you take more Sotalol than you should
If you take more Sotalol than you should, talk to a doctor or
go to a hospital straight away. Take the medicine pack with
you so the doctor knows what you have taken.
If you forget to take Sotalol
If you forget to take a dose, take it as soon as you
remember. However, if it is nearly time for the next dose,
skip the missed dose. Do not take a double dose (two
doses at the same time) to make up for a forgotten dose.
If you suddenly stop taking Sotalol

If you suddenly stop taking Sotalol your condition may
worsen. Your doctor will reduce your dose slowly over 2
weeks.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Sotalol can cause side effects, although
not everybody gets them.
If you get any of the following side effects, STOP
TAKING Sotalol and tell your doctor immediately or go
to the nearest hospital emergency department:
• an allergic reaction to Sotalol which may cause any
kind of skin rash, swelling of the face, lips, tongue or
throat, sudden wheezing, fluttering or tightness of the
chest or collapse
• difficulty in breathing, especially if you have a history of
asthma, wheezing or other lung diseases.
• slowing of the heart beat, an irregular heart rhythm or
missed beats (palpitations), heart failure (signs include
breathlessness and swollen ankles)
• low blood pressure (hypotension) which can make you
feel dizzy or light-headed
• fainting, feeling faint or light-headed
• poor blood circulation making the fingers and toes cold,
numb and pale (Raynaud’s phenomenon)
• worsening of cramp-like pains in the lower leg on
walking
• bleeding or bruising more easily or purplish marks on
the skin
• feeling thirstier than usual, feeling unusually tired or
passing more urine than usual, as Sotalol may be
affecting the amount of glucose (sugar) in your blood,
which can lead to diabetes.
Tell your doctor if you get any of these side effects:
• feeling depressed or anxious, mood changes
• loss of touch with reality (psychosis)
• problems sleeping
• headache, feeling dizzy or light-headed
• tingling or numbness in the arms and legs
• abnormal taste
• dry eyes, changes in eyesight
• hearing problems, a feeling of dizziness or spinning
(vertigo)
• feeling sick (nausea), being sick (vomiting), stomach
pain or discomfort, diarrhoea, wind, indigestion
• skin rash, worsening of psoriasis (dry flaky skin)
• hair loss
• muscle cramps
• chest pain
• feeling tired or weak, fever
• a build-up of excess fluid in the body (oedema) causing
swelling of the hands, arms, legs and ankles
• changes in sex drive (libido).

Taking Sotalol may lead to an increase in the risk of heart
rhythm disorders especially torsades de pointes. Your
doctor may want to monitor you.
If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

5. HOW TO STORE SOTALOL
Keep out of the reach and sight of children.
Do not use the tablets after the expiry date stated on the
pack. The expiry date refers to the last day of that month.
There are no special storage requirements for this
medicine.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Sotalol tablets contain
The active substance (the ingredient that makes the tablets
work) is sotalol hydrochloride.
The other ingredients are calcium hydrogen phosphate
dihydrate, maize starch, povidone, sodium starch
glycollate, talc and magnesium stearate. The 160 mg
tablets also contain indigo carmine (E132).
What Sotalol tablets look like and contents of the pack
The 40 mg tablets are round white to off-white tablets with
the Chatfield logo engraved on one side and a break line
and SOT40 on the other side.
The 80 mg tablets are round white to off-white tablets with
the Chatfield logo engraved on one side and a break line
and SOT80 on the other side.
The 160 mg tablets are round blue tablets with the
Chatfield logo engraved on one side and a break line and
SOT160 on the other side.
All three strengths of Sotalol tablets come in blister packs
of 14, 15, 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chatfield Pharmaceuticals Limited,
Kramer Mews, London SW5 9JL
Manufacturer
DDSA Pharmaceuticals Limited,

310 Old Brompton Road, London SW5 9JQ
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last approved in 05/2011

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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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