Sectral 200mg capsules

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Acebutolol hydrochloride

Fáanlegur frá:

Neon Healthcare Ltd

ATC númer:

C07AB04

INN (Alþjóðlegt nafn):

Acebutolol hydrochloride

Skammtar:

200mg

Lyfjaform:

Oral capsule

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 02040000; GTIN: 5036850013162

Upplýsingar fylgiseðill

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

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sectral 200mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 222mg of the active substance Acebutolol
hydrochloride
(equivalent to 200mg of base).
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule
Hard gelatin capsules, the bodies being opaque yellowish-buff and the
caps opaque
pink in colour. Length approximately 17mm, diameter of body
approximately 6mm.
Both body and cap are printed in black:
Sectral
or
ACB
200
200
The capsules contain a white or almost white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The management of all grades of hypertension, angina pectoris and the
control of
tachyarrhythmias.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Hypertension: Initial dosage of 400mg orally once daily at breakfast
or 200mg orally
twice daily. If response is not adequate within two weeks, dosage may
be increased
up to 400mg orally twice daily; if the hypertension is still not
adequately controlled
consideration should be given to adding a second antihypertensive
agent such as the
calcium antagonist nifedipine or small doses of a thiazide diuretic.
Angina pectoris: Initial dosage of 400mg orally once daily at
breakfast or 200mg
twice daily. In severe forms up to 300mg three times daily may be
required. Up to
1200mg daily has been used.
Cardiac Arrhythmias: When given orally, an initial dose of 200mg is
recommended.
The daily dose requirement for long term anti arrhythmic activity
should lie between
400 and 1200mg daily. The dose can be gauged by response, and better
control may
be achieved by divided doses rather than single doses. It may take up
to three hours
for maximal anti-arrhythmic 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 indicat