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SOTALOL HYDROCHLORIDE 80 MG TABLETS

Active substance(s): 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 symptoms are the same as yours.
• 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 pharmacist.
In this leaflet:
1. What are Sotalol Hydrochloride tablets and
what are they used for
2. 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. Further 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. B E F O R E Y O U TA K E S O TA L O L
HYDROCHLORIDE TABLETS
Do not take Sotalol tablets if any of the
following apply to you.
• If you are allergic (hypersensitive) to sotalol, or
to any of the ingredients of sotalol tablets) (see
What Sotalol Tablet contains, section 6).(An
allergic reaction may include rash, itching,
swelling of face, lips, tongue, or hands/feet or
breathing difficulties).
• If you suffer from asthma, attacks of wheezing,
emphysema (lung disease) or bronchitis
(inflammation of bronchii).
• If you suffer from an untreated tumour of the
adrenal gland (phaeochromocytoma).
• If you have a very slow heart beat (bradycardia)
or low blood pressure.
• If you suffer from any severe circulation
disorders.
• If you suffer from a condition called Raynaud’s
syndrome [discolouration(white or purple
colour) of the hands and feet].
• If you suffer from a condition called metabolic
acidosis (abnormal levels of acid in your blood,
usually as a result of severe illness).
• If you suffer from kidney failure.
• 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 are affected by any of the above, you should
tell your doctor before taking this medicine.
Your doctor may wish to check the level of
potassium and magnesium in your blood before
you start taking Sotalol tablets. Patients with low
levels should not take Sotalol tablets.
Regular blood tests may be required during your
treatment with Sotalol tablets.
Sotalol tablets are not recommended for use in
children.
Take special care with Sotalol Hydrochloride
tablets if
• you are pregnant,planning to become pregnant
or are breastfeeding.
• you have any kidney problems, as your dose of
Sotalol may need to be changed.
• you suffer from diarrhoea 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
tablets.
• you suffer from psoriasis(a skin disease that
causes itchy, red, sore patches of skin).
• 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 may also hide or reduce the warning
symptoms of a drop in your blood sugar
levels)(hypoglycaemia).

• you have thyrotoxicosis (a condition caused by
an overactive thyroid gland). Sotalol may hide
the symptoms of thyrotoxicosis or make them
worse if treatment with Sotalol is stopped
suddenly.

If you are due to have surgery
You should tell the doctor or anaesthetist that you
are taking Sotalol tablets as it can affect
anaesthetics. You may have to stop taking Sotalol
tablets before surgery and it should be gradually
stopped over a period of one week. Your doctor
will tell you if this is necessary.
Taking other medicines
Please inform your doctor or pharmacist if you are
taking, or have recently taken, any other
medicines, including those medicines obtained
without a prescription.
Care is needed if you are taking:
• Other medicines used for treating abnormal
heart rhythms such as disopyramide, quinidine,
procainamide, amiodarone and bepridil.
• Other beta blocking agents such as
propranolol, atenolol, metoprolol.
• Medicines used for treating mental illnesses
such as phenothiazines (e.g. chlorpromazine,
trifluoperazine), or tricyclic antidepressants
(e.g. imipramine, amitriptyline, clomipramine,
desipramine).
• Terfenadine, astemizole (used for treatment of
allergies).
• Erythromycin
(intravenous),
quinolone
antibiotics
(e.g.ciprofloxacin,
ofloxacin,
levofloxacin, norfloxacin, gatifloxacin).
• Halofantrine (belongs to a group of medicines
known as antimalarials. It is used to treat
malaria, a red blood cell infection transmitted
by the bite of a mosquito).
• Pentamidine (used to treat Pneumocystis
carinii pneumonia, a very serious kind of
pneumonia. This kind of pneumonia occurs
commonly in patients whose immune system is
not working normally, such as cancer patients,
transplant patients, and patients with acquired
immune deficiency syndrome (AIDS)).
• Floctafenine (a pain relieving medicine
belonging to a group of medicines known as
Non-Steroidal
Anti-Inflammatory
Drugs
(NSAIDs)).
• Calcium channel blocking drugs such as
verapamil and diltiazem (used for treatment of
high blood pressure and certain heart
conditions).
• Water tablets (diuretics) (e.g. furosemide,
hydrochlorothiazide).
• Amphotericin B (intravenous) (an antifungal,
used for treating infections due to certain
fungi).
• Corticosteroids (systemic administration) (used
for treatment of immune disorders).
• Laxatives.
• Clonidine (used for high blood pressure or
migraine (headache)).
• Digitalis glycosides (used for certain heart
conditions).
• Catecholamine-depleting agents such as
reserpine, guanethidine, or alpha methyldopa
(medicines used to treat high blood pressure).
• Insulin and oral hypoglycaemics (used for
treatment of diabetes).
• Neuromuscular
blocking
agents
like
tubocurarine.
• Beta-2-receptor stimulants (e.g.,salbutamol,
terbutaline and isoprenaline) (used for the
treatment of asthma).
Pregnancy and Breastfeeding
Make sure you tell your doctor if you are pregnant
or planning to become pregnant. You should not
be given Sotalol tablets during pregnancy unless
your doctor thinks it is essential.
You should not breastfeed while you are being
treated with Sotalol tablets.
Taking with Food and Drink
Moderate amounts of alcohol will not affect
Sotalol, however you should check with your
doctor first to see if drinking is advisable for you.
Driving or operating machinery
Sotalol does not usually affect your ability to drive.
However, if you feel light-headed or dizzy, do not
drive or operate machinery.
Important information about some of the
ingredients of Sotalol tablets
These tablets contain lactose. If you have been
told by your doctor that you have intolerance to
some sugars, contact your doctor before taking
Sotalol tablets.
3. H O W
TO
TA K E
S O TA L O L
HYDROCHLORIDE TABLETS
Always take Sotalol tablets exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Swallow the tablet whole with a glass of water.
The tablet may be taken with or without food.

Adults
The usual starting dose is one Sotalol 80 mg tablet
taken daily as a single dose. The dose is then
increased gradually over the next few days whilst
checking the heart beat. Most patients respond to
a daily dose of 160 – 320 mg sotalol taken daily in
two divided doses. Some patients with severe life
threatening forms of heart rhythm disturbances
may require up to 480 - 640 mg of sotalol daily.
Patients with kidney problems
You may be prescribed a lower dose if you have
kidney problems.
For the first few weeks after you start your Sotalol
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.
Children
Sotalol tablets are not recommended for use in
children.
If you take more Sotalol tablets than you
should
If you or someone else swallows several of these
tablets all together, or you think a child has
swallowed any of these tablets, contact your
doctor or pharmacist or hospital emergency
department immediately. Always take any tablets
left over with you, also the box and leaflet as this
will allow easier identification of the tablets.
If you forget to take Sotalol tablets
If you forget to take a dose, take it as soon as you
remember. If it is almost time for your next dose,
do not take the missed dose and just carry on as
before. Do not take a double dose to make up for
a forgotten dose.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sotalol tablets can cause side
effects, although not everybody gets them.
If any of the following happens, stop taking
Sotalol tablets and tell your doctor
immediately or go to the casualty department
at your nearest hospital.
• Rashes, hives, itching, swelling of face, lips,
tongue and /or throat with difficulty in
swallowing or breathing.
Tell your doctor if you notice any of the following:
Side effects seen with Sotalol tablets (affecting
more than 1 in 100 patients) include the following:
• Slow, fast or irregular heartbeats.
• Chest pain.
• Fainting, light headedness (may be a
manifestation of low blood pressure).
• Breathlessness.
• Swelling over hands/feet.
• Muscle cramps.
• Hearing disturbances, vision disturbances,
altered sense of taste.
• Fever.
• Headache, dizziness, sleep disturbances,
mood changes, depressed mood, anxiety.
• Sexual dysfunction.
• Nausea (feeling sick), vomiting (being sick),
indigestion, pain in the belly, diarrhoea or loose
stools, wind.
• General feeling of being unwell, tiredness.
• Tingling in feet and hands (pins and needles).
Patients taking this type of medicine have
complained of cold and/or blue fingers and toes,
worsening of aches in their legs when walking,
skin rash or dry eyes.
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 pharmacist.
5. H O W
TO
STORE
S O TA L O L
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. FURTHER 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
Manufacturer
Accord Healthcare Limited,
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom.

and

This leaflet was last approved in {03/2012}.

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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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