Sotalol 40mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Sotalol hydrochloride

Disponible depuis:

Tillomed Laboratories Ltd

Code ATC:

C07AA07

DCI (Dénomination commune internationale):

Sotalol hydrochloride

Dosage:

40mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 02040000; GTIN: 5024655000494

Notice patient

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOTALOL HYDROCHLORIDE 40MG AND 80MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
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.
WHAT IS IN THIS LEAFLET:
1.
What Sotalol is and what it is used for
2.
What you need to know before you take Sotalol
3.
How to take Sotalol
4.
Possible side effects
5.
How to store Sotalol
6.
Contents of the pack and other information
1 WHAT SOTALOL IS AND WHAT IT IS USED FOR
Sotalol Hydrochloride belongs to a group of medicines called
Beta−Blockers and works by slowing the
electrical impulses in the heart muscle. This helps to regulate and
restore disturbances in the heart
rhythm.
Sotalol also blocks beta receptors that are found in the heart. This
causes the heart to beat more
slowly and with less force.
Sotalol Hydrochloride (referred to as Sotalol throughout this leaflet)
is used:
•
To treat fast and irregular heartbeat (arrhythmias) some of which may
be life-threatening.
•
As prophylaxis, to prevent the occurrence of new arrhythmias.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE SOTALOL:
•
IF YOU HAVE A HISTORY OF BREATHING DIFFICULTIES, WHEEZING OR ASTHMA
•
If you are allergic to Sotalol, other Beta-Blockers or any of the
other ingredients of this medicine
(listed in Section 6)
•
If you have an irregular heartbeat caused by sick sinus syndrome, long
QT syndromes or
Torsades de Pointes
•
If you suffer from a condition where the heart beats irregularly or
much more slowly than normal
(2nd or 3rd degree heart block) UNLESS YOU HAVE PACEMAKER
•
If y

Résumé des caractéristiques du produit

OBJECT 1
SOTALOL 40MG TABLETS
Summary of Product Characteristics Updated 28-Aug-2020 | Tillomed
Laboratories Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Sotalol Hydrochloride 40mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 40mg sotalol hydrochloride.
Excipient with known effect:
Each tablet contains 13.37mg 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 5.4mm–5.6mm and height of
2.8mm-3.0mm, marked “SOT”
on one side.
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 nod