Sotalol 160mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Sotalol hydrochloride

Dostopno od:

Teva UK Ltd

Koda artikla:

C07AA07

INN (mednarodno ime):

Sotalol hydrochloride

Odmerek:

160mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 02040000; GTIN: 5017007012337

Navodilo za uporabo

Top of page cut-off to middle of registration mark: 44 mm.
PAGE 1: FRONT FACE (INSIDE OF REEL)
•
amifostine (used during chemo- or radiotherapy)
•
dipyridamole (administered intravenously) (used to
prevent formation of a blood clot)
Interactions with laboratory tests:
If you have a blood test, please inform your doctor that
you are taking sotalol, as it may influence the results of
some blood tests.
ATHLETES
Athletes should be aware that this medicine contains
an active substance which may cause a positive
reaction to “anti-doping tests”.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Your doctor may prescribe Sotalol during pregnancy if it
is clearly necessary. Do not take Sotalol unless your
doctor tells you to and always take it exactly as
prescribed.
Breast-feeding is not recommended during treatment
with Sotalol.
DRIVING AND USING MACHINES
Sotalol may affect your eyesight or make you feel dizzy.
Do not drive or operate any tools or machines if you are
affected.
SOTALOL CONTAINS LACTOSE
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.
HOW TO TAKE SOTALOL
Always take this medicine exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
The recommended dose is:
ADULTS (INCLUDING THE ELDERLY):
The initial dose is 80 mg sotalol taken once daily or in
two divided doses at 12 hour intervals. Your doctor will
then gradually increase this according to your needs.
The recommended dose is between 160 mg and 320 mg
sotalol taken in two or three divided doses each day.
For certain patients who have a life-threatening
irregular heart beat, the dose can be increased up to
480 mg or 640 mg sotalol daily.
Patients with kidney problems may require a lower dose.
USE IN CHILDREN:
Due to a lack of data Sotalol is not recommended for
use

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sotalol 160 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 160 mg sotalol hydrochloride.
Excipient with known effect:
Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
160 mg: Light blue, oval-shaped tablet, scored on one side and
debossed with the
number “93” and “62” on each side of the score, plain on the
other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Sotalol is indicated in adults for prophylaxis of:
-
life-threatening ventricular tachycardias;
-
documented symptomatic and disabling ventricular tachycardias in the
absence of
uncontrolled heart failure;
-
documented supraventricular tachycardias in the absence of
uncontrolled heart
failure when the need for treatment is established. (e.g. maintenance
of sinus rhythm
after conversion of atrial fibrillation or atrial flutter.)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The initiation of treatment or change in dosage should follow an
appropriate medical
evaluation, including ECG control with measurement of the corrected QT
interval and
potassium levels, assessment of renal function and taking into account
concomitant
medication (see section 4.5).
As with other antiarrhythmic substances, it is recommended that
Sotalol is initiated and
doses increased under ECG control, because proarrhythmic events can
occur not only at
the initiation of therapy but also with every upward dosage
adjustment.
The treatment of life-threatening ventricular tachycardias must be
initiated under
monitoring in a hospital environment.
The initial dose is 80 mg administered either as a single or as two
divided doses
administered at 12 hours interval. Dosing increments should be
separated by an interval
of 2 or 3 days in order to attain a steady state and allow monitoring
of QT intervals.
Most patients respond to a daily dose of 160 to 320 mg in two (e.g. 2x
160 mg) or three
(e.g. 3x