Skip to Content


Active substance(s): SOTALOL HYDROCHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Patient Information Leaflet Beta-Cardone® Tablets 40 mg, 80 mg and 200 mg
Sotalol hydrochloride

261614_C01_P1131E_Layout 1 09/07/2012 10:22 Page 1

1. What Beta-Cardone is for

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.
In this leaflet:
1. What Beta-Cardone is for
2. Before you take Beta-Cardone
3. How to take Beta-Cardone
4. Possible side effects
5. How to store Beta-Cardone
6. Further information.

Beta-Cardone belongs to a group of
medicines called beta blockers.
Beta blockers help to control the rhythm
of your heart.
Beta-Cardone is used to treat serious
irregular heart beat problems called
arrhythmias. It is important to make
your heart beat regularly again,
especially if you have angina, heart
failure or have had a heart attack. BetaCardone can help prevent attacks of
angina and reduce the risk of having a
further heart attack. Beta-Cardone is
also used to lower high blood pressure
and reduce anxiety.

2. Before you take Beta-Cardone
Do not take Beta-Cardone if:
• You are allergic to sotalol hydrochloride
or any of the other ingredients of
Beta-Cardone (see section 6)
• You have ever had asthma or difficulty
breathing. Do not take this medicine if
you have a history of wheezing,
blocked lungs (obstructive airway
disease) or asthma as it may make
your breathing worse.
• Your heart beat is very slow or weak
(perhaps due to sick sinus syndrome,
a long QT interval)

• You have a particular heart beat
disturbance called Torsade de pointes
or heart block
• You suffer from congestive heart failure
or shock resulting from heart failure
• You get chest pain (angina) at rest
• You have low blood pressure
• You have a tumour near your kidneys
• You have poor circulation (eg.
Raynaud’s disease)
• You had, or have kidney disease
• You have diabetes
• You suffer from a condition called
metabolic acidosis
• You are a child.
If any of the above apply to you, do not
take Beta-cardone, talk to your doctor
or pharmacist.

• You have ever had psoriasis (scaly
skin caused by your skin cells being
produced too quickly)
• You have disturbed salt and water
balance which may give you
persistent diarrhoea
• You have an over active thyroid
• You have a cough or a cold
• You are a heavy or regular drinker of
• You are going to hospital to have an
operation or a general anaesthetic.
Take special care if you are diabetic since
Beta-cardone may hide the usual warning
signs that your blood sugar is low.
If any of the above apply to you talk to
your doctor or pharmacist.

Tell your doctor if you are taking any
of the following medicines:
Check with your doctor before taking
• Any medicines for your heart or
blood pressure including
Beta-Cardone if:
disopyramide, amiodarone,
• Your ankles swell up or you have
lignocaine, hydralazine, digoxin,
difficulty breathing
guanethidine, methyldopa, clonidine,
• You have been told that the lower
reserpine, verapamil, nifedipine or
chamber of the left side of your heart
diltiazem, or water tablets (diuretics)
(left ventricle) is unable to pump
• Medicines for depression including
blood effectively
tricyclic antidepressants and
• You suffer serious allergic reactions to

• Phenothiazines such as
chlorpromazine used for
• Halofantrine for malaria
• Medicines for pain or arthritis such as
• Medicines for relief of asthma
symptoms such as salbutamol
• Cimetidine for stomach ulcers
• Anti-histamines such as terfenadine or
astemizole used to treat allergies
• Insulin or oral medicine for diabetes.
• Tubocarine, a relaxant used with
general anaesthetics.
• Any other medicine, including
medicines obtained without a
If any of the above apply to you talk to
your doctor or pharmacist.
Taking Beta-Cardone with food and
Do not drink alcohol when taking BetaCardone as the effect of the medicine
may be increased. This may affect your
heart or blood pressure.

Pregnancy and breast-feeding
If you are pregnant, trying to become
pregnant or breast-feeding, ask your
doctor or pharmacist for advice before
taking Beta-Cardone. If you take these
tablets close to giving birth, your doctor
will monitor your new baby for 1 to 2
Driving and using machines
Beta-Cardone may cause you to feel
dizzy or tired. If this happens to you, do
not drive or use machinery.
Information on sugar intolerance
If you have an intolerance to any sugars,
tell your doctor before taking this

3. How to take Beta-Cardone
Always take Beta-Cardone exactly as
your doctor has told you.
Your doctor will choose the dose that is
right for you. Your dose will be shown
clearly on the label that your pharmacist
puts on your medicine. If it does not, or
you are not sure, ask your doctor or

261614_C01_P1131E_Layout 1 09/07/2012 10:22 Page 2

Remember: Swallow each tablet (whole)
with a drink of water. If you only have to
take the tablets once a day then take
them first thing in the morning.
Do not exceed the stated dose.
Do not suddenly stop taking this
medicine even if you feel better unless
your doctor tells you to - it could make
your condition worse.
It is likely that you will start with a low
dose which your doctor will gradually
increase. Your doctor may also check
your progress.
The following doses are a guide only:
The usual starting dose is 80 mg taken as
a single dose or divided into two 40 mg
doses. The dose is adjusted every 2 to 3
days whilst checking your heart beat.
Most people need 160 – 320 mg a day in
two divided doses.

This medicine is not suitable for children.
If you take more Beta-Cardone than you
Do not take more Beta-Cardone than you
should. If you accidentally take too much,
immediately contact the nearest hospital
casualty department or your doctor. Too
much Beta-Cardone can seriously affect
your heart rate, blood pressure or
If you forget to take Beta-Cardone

4. Possible side effects
Like all medicines Beta-Cardone can
cause side effects, although not everybody
gets them.
Seek immediate medical help if you have
any of the following symptoms:
• An irregular or slow heart beat
• Breathlessness
• Chest pain
• Swollen ankles
• Feeling faint or fainting.

Other side effects:
Do not take a double dose to make up for
a missed dose. Take your next dose at the • Feeling sick or being sick
• Diarrhoea
usual time.
• Upset stomach
If you stop taking Beta-Cardone

Do not stop taking Beta-Cardone tablets
• Stomach pain
without first talking to your doctor.
Stopping them suddenly could make your • Wind or cramps
condition worse.
• Dizziness
If possible, the tablets should be stopped
• Feeling weak or tired
over 1 to 2 weeks as other medicines are
People with kidney disease
• Light-headedness
taken instead. Your doctor will tell you
If you have kidney disease your dose will

how to stop taking Beta-Cardone.
be reduced. Your doctor will choose the
• Problems sleeping
dose that is right for you.
If you have any further questions about
• Tingling or numbness in the hands or
If you have any queries about the amount the use of this medicine, ask your doctor
of medicine you have been prescribed, ask or pharmacist.

Cold, pale or blue extremities
your doctor.

• An increase in existing leg pain on
• Anxiety
• Mood changes
• Depression
• Altered sex drive or impotence
• Problems with your eyesight, hearing or
• Fever
• Skin rashes including flare ups of psoriasis
• Dry eyes and conjunctivitis.
If any of the side effects gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or

5. How to store Beta-Cardone
Keep out of the reach and sight of
Do not use Beta-Cardone after the expiry
date shown on the pack. The expiry date
refers to the last day of that month.
Store in the original package in order to
protect from light
Medicines should not be disposed of via
wastewater or household waste. Return
any medicine you no longer need to your

6. Further information
What Beta-Cardone contains
There are three strengths of Beta-Cardone
Tablets containing 40 mg, 80 mg and 200
mg of the active substance sotalol
The other ingredients include lactose,
starch maize, pregelatinised starch, talc
and magnesium stearate.
• The 40 mg tablets also contain indigo
carmine (E132) and quinoline yellow
• The 80 mg tablets also contain
cochineal (E124).
What Beta-Cardone looks like
Beta-Cardone is a tablet. The three
strengths are colour-coded to help identify
the strength.
• The 40 mg tablets are green with
“Evans/BC4” marked on them.
• The 80 mg tablets are pink with
“Evans/BC8” marked on them.
• The 200 mg tablets are white with
“Evans/BC20” marked on them.

Beta-Cardone Tablets 40 mg and 80 mg
are supplied in blister packs of 56 or
plastic bottles of 100 or 500 tablets. The
200 mg tablets are supplied in a plastic
container or bottle of 28, 30, 100 or 500
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
RPH Pharmaceuticals AB
Lagervägen 7, 136 50 Haninge, Sweden
Recipharm Limited, Vale of Bardsley,
Ashton-under-Lyne, OL7 9RR, UK
Distributed by Focus Pharmaceuticals Ltd.
This leaflet was last updated March 2012

If this leaflet is difficult to see
or read or you would like it in
a different format, please
contact RPH Pharmaceuticals AB
Lagervägen 7, 136 50 Haninge,



Other info


Pulse code


Min text size



Title to View


White Opaque 50gsm






Black and tints of Black


3 09/07/2012

Draft / Date



125mm (h) x 31mm (w)

Size folded

125mm (h) x 375mm (w)

Size flat

P1131E Beta-Cardone Leaflet

Product Description/Component

Cheshire. SK4 3QT

Heaton Mersey, Stockport

32-42 Station Road













261614_C01_P1131E_Layout 1 09/07/2012 10:22 Page 3

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.