Sectral 400mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Acebutolol hydrochloride

متاح من:

Neon Healthcare Ltd

ATC رمز:

C07AB04

INN (الاسم الدولي):

Acebutolol hydrochloride

جرعة:

400mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 02040000; GTIN: 5036850013988

نشرة المعلومات

PACKAGE LEAFLET:
INFORMATION FOR THE USER
SECTRAL 400MG TABLETS
SECTRAL 100MG AND 200MG CAPSULES
Acebutolol (as hydrochloride)
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the
same as yours
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What Sectral is and what it is used for
2. What you need to know before you take Sectral
3. How to take Sectral
4. Possible side effects
5. How to store Sectral
6. Contents of the pack and other information
1. WHAT SECTRAL IS AND WHAT IT IS USED FOR
1.
The name of your medicine is Sectral 400mg Tablets, Sectral 100mg
Capsules or Sectral 200mg Capsules (called Sectral
throughout this leaflet). This belongs to a group of medicines called
beta-blockers. It works by
slowing your heart rate or lowering your blood pressure.
Sectral is used for:
• Chest pain (angina)
• High blood pressure
• Uneven or unusually fast heart beats (arrhythmia)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SECTRAL
DO NOT TAKE SECTRAL:

if you are allergic to acebutolol hydrochloride, other beta-blockers
or any of the other ingredients of this medicine (listed
in section 6) Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your lips, face,
throat or tongue

if you have low blood pressure

if you have severe heart problems or heart failure not controlled by
medicines

if you have a very slow heartbeat - less than 50 beats per minute

if your doctor has told you that you have an abnormal level of acid in
your blood (called acidosis)

if you have serious blood circulation problems

if you have an tumo

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sectral 400mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 443.40mg of the active substance Acebutolol
hydrochloride
(equivalent to 400mg of base).
Also contains 21.20mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white, circular, biconvex, film-coated tablets with bevel
edges, one face
impressed ‘SECTRAL 400 or ACB 400. Plain reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The management of hypertension, angina pectoris and the control of
tachyarrhythmias.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Hypertension:_ Initial dosage of 400 mg orally once daily at
breakfast or 200 mg
orally twice daily. If response is not adequate within two weeks,
dosage may be
increased up to 400 mg orally twice daily; in some patients 1200 mg
orally daily,
given as 800 mg at breakfast and 400 mg in the evening may be
required. A further
reduction in blood pressure may be obtained by concurrent
administration of a
thiazide diuretic or other anti-hypertensive agent (except Rauwolfia
and its alkaloids).
_Angina pectoris:_ Initial dosage of 400 mg orally once daily at
breakfast or 200 mg
twice daily. In severe forms up to 300 mg three times daily may be
required. Up to
1200 mg daily has been used.
_Cardiac arrhythmias:_ When given orally, an initial dose of 200 mg is
recommended.
The daily dose requirement for long term antiarrhythmic activity
should lie between
400 and 1200 mg daily. The dose can be gauged by response, and better
control may
be achieved by divided doses rather than a single doses. It may take
up to three hours
for maximal antiarrhythmic effect to become apparent.
_Elderly:_ There are no specific dosage recommendations for the
elderly with normal
glomerular filtration rate. Dose reduction is necessary if moderate to
severe renal
impairment is present (see Section 4.4).
_Children: _Paediatric dose has not been established.
_ _
For all indication