Dronedarone 400mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Dronedarone hydrochloride

Sẵn có từ:

Aristo Pharma Ltd

Mã ATC:

C01BD07

INN (Tên quốc tế):

Dronedarone hydrochloride

Liều dùng:

400mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 02030200; GTIN: 4251575902664 4251575902671

Ngày ủy quyền:

2019-05-22

Tờ rơi thông tin

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DRONEDARONE ARISTO 400 MG FILM-COATED TABLETS
dronedarone
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 Dronedarone Aristo is and what it is used for
2.
What you need to know before you take Dronedarone Aristo
3.
How to take Dronedarone Aristo
4.
Possible side effects
5
How to store Dronedarone Aristo
6.
Contents of the pack and other information
1.
WHAT DRONEDARONE ARISTO IS AND WHAT IT IS USED FOR
Dronedarone Aristo contains an active substance named dronedarone. It
belongs to a group of
medicines called anti-arrhythmics that help regulate your heart beat.
Dronedarone Aristo is used if you have a problem with your heart beat
(your heart beats out of
time – known as ‘atrial fibrillation’) and a treatment called
‘cardioversion’ has changed your
heartbeat back to a normal rhythm. Dronedarone Aristo prevents your
irregular heart beat returning.
Your doctor will consider all available treatment options before
prescribing Dronedarone Aristo
to you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DRONEDARONE ARISTO
DO NOT TAKE DRONEDARONE ARISTO

if you are allergic to dronedarone or to any of the other ingredients
of this medicine (listed in
section 6),

if you have a problem with the nerves in your heart (heart block).
Your heart might beat
very slowly or you may feel dizzy. If you have had a pacemaker fitted
for this problem, you
can use Dronedarone Aristo,

if you have a very slow heart beat (less than 50 beats a minute),

if

Đặc tính sản phẩm

Dronedarone Aristo 400mg film-coated tablets
Summary of Product Characteristics Updated 23-Oct-2020 | Aristo Pharma
Limited
1. Name of the medicinal product
Dronedarone Aristo 400 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains dronedarone hydrochloride salt corresponding to
400 mg of dronedarone.
Excipient with known effect
Each tablet contains 108.92 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
White, oblong shaped tablets with dimensions of 17.6 × 8.1 mm.
4. Clinical particulars
4.1 Therapeutic indications
Dronedarone Aristo is indicated for the maintenance of sinus rhythm
after successful cardioversion in adult clinically
stable patients with paroxysmal or persistent atrial fibrillation
(AF). Due to its safety profile (see sections 4.3 and 4.4),
Dronedarone Aristo should only be prescribed after alternative
treatment options have been considered.
Dronedarone Aristo must not be given to patients with left ventricular
systolic dysfunction or to patients with current or
previous episodes of heart failure.
4.2 Posology and method of administration
Treatment should be initiated and monitored only under specialist
supervision (see section 4.4). Treatment with
Dronedarone Aristo can be initiated in an outpatient setting.
Treatment with Class I or III antiarrhythmics (such as flecainide,
propafenone, quinidine, disopyramide, dofetilide, sotalol,
amiodarone) must be stopped before starting Dronedarone Aristo
There is limited information on the optimal timing to switch from
amiodarone to Dronedarone Aristo. It should be
considered that amiodarone may have a long duration of action after
discontinuation due to its long half life. If a switch is
envisaged, this should be done under the supervision of a specialist
(see sections 4.3 and 5.1).
Posology
The recommended dose is 400 mg twice daily in adults. It should be
taken as
• one tablet with the morning meal and
• one tablet with the eveni