Sotalol 160mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-03-2019
Summary of Product characteristics
(SPC)
13-03-2019
Active ingredient:
Sotalol hydrochloride
Available from:
Alliance Healthcare (Distribution) Ltd
ATC code:
C07AA07
INN (International Name):
Sotalol hydrochloride
Dosage:
160mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02040000
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOTALOL 80MG TABLETS
SOTALOL 160MG TABLETS
(sotalol hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
Ÿ
Keep this leaflet. You may need to read It again.
Ÿ
If you have any further questions, ask your doctor or pharmacist.
Ÿ
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.
Ÿ
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 Sotalol Tablets are and what are they used for
2.
What you need to know before you take Sotalol Tablets
3.
How to take Sotalol Tablets
4.
Possible side effects
5.
How to store Sotalol Tablets
6.
Contents of the pack and other information
1. WHAT SOTALOL TABLETS ARE AND WHAT ARE THEY USED FOR
Sotalol belongs to a group of drugs called beta-adrenergic blocking
agents or
"beta-blockers". Sotalol is used to treat irregular heartbeats. This
can be caused
by the lower heart chambers (ventricular arrhythmia) or the upper
heart chambers
(atrial or superventricular arrhythmias)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOTALOL TABLETS
DO NOT TAKE SOTALOL TABLETS IF YOU:
Ÿ
are allergic to sotalol hydrochloride or any of the other ingredients
in this
medicine (listed in section 6).
Ÿ
suffer from kidney failure or have untreated tumour near your kidney
(phaechromocytoma).
Ÿ
have a history of breathing difficulties due to a narrowing of the
airways
(bronchospasm)
Ÿ
suffer from low blood pressure or circulation failure.
Ÿ
suffer from metabolic acidosis or diabetic ketoacidosis.
Ÿ
suffer from renal failure (creatinine clearance <10 ml/min)
Ÿ
suffer from a condition causing discolouration (white or purple) of
the hands
and feet (Raynaud's syndrome)
Ÿ
suffer from very slow heart beat (bradycardia) including sick sinus
syndrome,
or long QT interval.
Ÿ
are suffering from a second or third degree AV heart
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sotalol 160 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sotalol Hydrochloride 160 mg
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Tablets;
Round blue flat bevelled edge tablets with a score line on one side.
The score line is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ventricular arrhythmias:
-
Treatment of life-threatening ventricular tachyarrhythmias;
-
Treatment of symptomatic non-sustained ventricular tachyarrhythmias.
Supraventricular arrhythmias:
-
Prophylaxis of paroxysmal atrial tachycardia, paroxysmal atrial
fibrillation,
paroxysmal A-V nodal re-entrant tachycardia, paroxysmal A-V re-entrant
tachycardia using accessory pathways, and paroxysmal supraventricular
tachycardia after cardiac surgery;
-
Maintenance of normal sinus rhythm following conversion of atrial
fibrillation or
atrial flutter.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Paediatric population
There is no relevant use of Sotalol in the paediatric population.
The initiation of treatment or changes in dosage with Sotalol should
follow an
appropriate medical evaluation including ECG control with measurement
of the
corrected QT interval, and assessment of renal function, electrolyte
balance, and
concomitant medications (see section 4.4).
As with other antiarrhythmic agents, it is recommended that Sotalol be
initiated and
doses increased in a facility capable of monitoring and assessing
cardiac rhythm. The
dosage must be individualized and based on the patient's response.
Proarrhythmic
events can occur not only at initiation of therapy, but also with each
upward dosage
adjustment.
In view of its beta-adrenergic blocking properties, treatment with
Sotalol should not
be discontinued suddenly, especially in patients with ischaemic heart
disease (angina
pectoris, prior acute myocardial infarction) or hypertension, to
prevent exacerbation
of the disease (see section 4.4).
_Method of Administration_
_ _
The following dos
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