Sotalol 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sotalol hydrochloride

Available from:

Apotex UK Ltd

ATC code:

C07AA07

INN (International Name):

Sotalol hydrochloride

Dosage:

80mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5060129470202

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
suffer from asthma, attacks of wheezing on any other lung disease
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 block unless a
function

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sotalol Hydrochloride 80mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sotalol hydrochloride 80mg.
Excipient with known effect:
Each tablet contains 26.75mg of lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets for oral administration.
White, round, biconvex tablets of diameter 6.9mm–7.1mm and height of
2.8mm-
3.2mm, marked “SOT” on one side and scored on the other.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sotalol hydrochloride tablets are indicated for:
Ventricular arrhythmias: treatment of life-threatening ventricular
tachyarrhythmias;
treatment of symptomatic non-sustained ventricular tachyarrhythmias.
Supraventricular arrythmias: 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
The initiation of treatment or changes in dosage with Sotalol
hydrochloride 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 4.4 Warnings and precautions).
As with other antiarrhythmic agents, it is recommended that Sotalol
hydrochloride 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.
Proarrhytbmic events can occur not only at initiation of therapy, but
also with each
upward dosage adjustment.
In view of its
β
-adrenergic blocking properties, trea