Sectral 400mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Acebutolol hydrochloride

متاح من:

Lexon (UK) 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

نشرة المعلومات

OTHER MEDICINES AND SECTRAL
Please tell your doctor or pharmacist if you are taking or have
recently taken
any other medicines. This includes medicines you buy without a
prescription,
including herbal medicines. This is because Sectral can affect the way
some
other medicines work. Also some medicines can affect the way Sectral
works.
In particular, tell your doctor if you are taking any of the
following:
*
Other medicines for high blood pressure
*
Clonidine used for migraine or high blood pressure. If you are taking
clonidine and Sectral together, you should not stop taking clonidine
unless
your doctor tells you. If you have to stop taking clonidine, your
doctor will
give you instructions
*
Medicines for chest pain (angina) such as verapamil, nifedipine or
diltiazem. Verapamil must not be taken within several days of taking
Sectral
*
Medicines for heart problems such as amiodaraone, disopyramide or
digoxin
*
Medicines used for mental health problems (antipsychotic medicines)
–
such as haloperidol, sulpiride, pimozide or flupenthixol
*
Some medicines used for depression (mono-amine oxidase inhibitors or
tricyclic antidepressants) such as phenelzine, imipramine or
amitriptyline
*
Medicines to help you sleep (barbiturates) such as amobarbital
*
Insulin or tablets to treat diabetes – such as glibenclamide. Your
doctor
may change your dose
*
Medicines used for breathing problems - such as aminophylline,
theophylline, salbutamol and terbutaline
*
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) – used to relieve
pain
(such as ibuprofen, naproxen, iclofenac, indometacin and piroxicam)
*
Fingolimod used for treating multiple sclerosis. Your doctor may
perform
monitoring at the start of treatment
*
Diltiazem as it may lead to increased risk of depression.
SECTRAL WITH FOOD
Take Sectral with or just after meals
PREGNANCY AND BREAST-FEEDING
Talk to your doctor before taking this medicine if:
*
You are pregnant, might become pregnant, or think you may be pregnant.
Sectral should not normally be given during pregnancy as

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