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ACEBUTOLOL 400MG FILM-COATED TABLETS

Active substance(s): ACEBUTOLOL HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

2. Before you take Sectral

Do not take this medicine and tell
your doctor if:
Ï You are allergic (hypersensitive) to
acebutolol hydrochloride, other betablockers or any of the other ingredients of
Sectral (see Section 6: Further information)
(acebutolol hydrochloride)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling
Your medicine is known by the above names,
of your lips, face, throat or tongue
but will be referred to as Sectral throughout Ï You have low blood pressure
this leaflet.
Ï You have severe heart problems or heart
This medicine is also available in other
failure not controlled by medicines
strengths (100mg and 200mg capsules)
Ï You have a very slow heartbeat - less than

50 beats per minute
Ï Your doctor has told you that you have
Read all of this leaflet carefully
an abnormal level of acid in your blood
before you start taking this
(called acidosis).
medicine
Ï You have serious blood circulation
• Keep this leaflet. You may need to read it
problems
again
• If you have any further questions, ask your Ï You have a tumour on the adrenal gland
(called phaechromocytoma)
doctor or pharmacist.
Do not take if any of the above apply to you.
• This medicine has been prescribed for
If you are not sure, talk to your doctor or
you. Do not pass it on to others. It may
pharmacist before taking Sectral.
harm them, even if their symptoms are
the same as yours
Take special care with Sectral
• If any of the side effects gets serious, or
Check with your doctor or pharmacist
if you notice any side effects not listed
before taking your medicine if:
in this leaflet, please tell your doctor or
p You have kidney problems
pharmacist
p You have heart failure that is controlled
In this leaflet:
with medicines
1. What Sectral is and what it is used for
p You have a slow heart beat (also see
2. Before you take Sectral
section ‘Do not take Sectral if’)
3. How to take Sectral
p You have breathing problems due to long
4. Possible side effects
term lung problems (called ‘asthma’,
‘bronchitis’ or ‘emphysema’)
5. How to store Sectral
p You have an overactive thyroid gland
6. Further information
p You have diabetes or low blood
sugar levels (hypoglycaemia)
1. What Sectral is and what it is
used for
p You have psoriasis
p You have mild or moderate blood
Sectral belongs to a group of medicines
circulation problems. You may have cold
called beta-blockers. It works by slowing
hands and feet that look darker than the
your heart rate or lowering your blood
rest of your body
pressure.
p You have a form of chest pain
Sectral is used for:
known as ‘Prinzmetal’s’ angina
• Chest pain (angina)
p You have a history of allergies
• High blood pressure
If you are not sure if any of the above
• Uneven or unusually fast heart beats
apply to you, talk to your doctor or
(arrhythmia)
pharmacist before taking Sectral.

Sectral® 400mg Tablets
Acebutolol 400mg
Film-Coated Tablets

• Fingolimod used for treating multiple
Operations or anaesthetics
sclerosis. Your doctor may perform
Tell your doctor or dentist you are taking
monitoring at the start of treatment
Sectral if you are going to have an anaesthetic
or an operation (including dental surgery).
Taking Sectral with food and drink
Take Sectral with or just after meals
Taking other medicines
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, diclofenac,
indometacin and piroxicam)

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 it may cause
problems with the foetus or newly born
baby.
• You are breast-feeding or planning to
breast-feed. You should not breast-feed
if you are taking Sectral. This is because
small amounts may pass into mothers’
milk.
Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.
Driving and using machines
You may feel tired or dizzy while taking this
medicine. If this happens, do not drive or use
any tools or machines.
Important information about some of the
ingredients of Sectral
This medicine contains:
• Lactose. This medicine contains lactose,
a type of sugar. If you have been told
by your doctor that you can not tolerate
some sugars, talk to your doctor before
taking Sectral.
3. How to take Sectral
Always take Sectral exactly as your doctor has
told you. You should check with your doctor
or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets with a drink of water
• If you feel the effect of your medicine is
too weak or too strong, do not change the
dose yourself, but ask your doctor

How much to take
Adults (including the elderly)
The usual dose of Sectral depends on your
needs and the illness being treated. Your
doctor will advise you.
Chest pains (angina)
• The starting dose is 400mg once a
day at breakfast or 200mg twice a day
• If necessary, your doctor may increase
this to 300mg three times a day
• The maximum daily dose is 1200mg
High blood pressure
• The starting dose is 400mg once a day
at breakfast or 200mg twice a day
• If necessary, after 2 weeks, your doctor
may increase this to 400mg twice a day
Uneven or unusually fast heart
beats (arrhythmia)
• The starting dose is 200mg daily
• If necessary, your doctor may increase
this to 400mg to 1200mg daily
Patients with kidney problems
Your doctor may decide to lower your
dose of Sectral if necessary.
If you take more Sectral than you should
If you take more tablets than you should
• Tell a doctor or go to a hospital casualty
department straight away.
• Take the medicine pack with you. This is
so the doctors know what you have taken.
• The following effects may happen:
Feeling dizzy or weak, difficulty in
breathing or wheezing, low blood sugar or
serious heart problems.
If you forget to take Sectral
If you forget a dose, take it as soon as you
remember it. However, if it is nearly time for
the next dose, skip the missed dose. Do not take
a double dose to make up for a forgotten dose.
If you stop taking Sectral
Keep taking Sectral until your doctor tells you
to stop. If you stop treatment suddenly your
illness may get worse. When your doctor says
that you can stop taking Sectral, you need to do
this gradually. Your doctor will help you do this.
If you have any further questions
about this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Sectral can cause side
effects, although not everybody gets them.
Stop taking Sectral and see your doctor or
go to a hospital straight away if:
• You have an allergic reaction. The signs
may include: rash, swallowing or
breathing problems, swelling of your lips,
face, throat or tongue.
Tell your doctor as soon as possible if you
have any of the following side-effects:
Very common (affects more than 1 person
in 10)
• Blood tests may show changes to your
immune system. Signs may include joint
aches and pains, swollen joints, increased
sensitivity to sunlight, mouth ulcers, hair
loss, anxiety, fevers, night sweats and
stomach pain.
Common (affects less than 1 person in 10)
• Changes in behaviour or depression,
nightmares
• Pain in your chest and feeling weak or
dizzy. These could be signs of heart
problems or low blood pressure.
• Blurred vision
• Shortness of breath or difficulty in breathing,
cough, tiredness, fainting.These could be
signs of inflammation in your lungs.
Other side effects include:
• Seeing or hearing things that are not there
(hallucinations), confusion
• Difficulty in sleeping (insomnia)
• Dry eyes
• Slow heart rate. Swelling of feet or ankles.
These could be signs that your heart is not
working properly
• Episodes of muscle cramps or muscle pain
especially when you walk or exercise
• Fingers and toes changing colour when
cold and tingling or painful on warming
up. This could be Raynaud’s phenomenon.
Tell your doctor or pharmacist if any of
the following side effects gets serious or
lasts longer than a few days.
Very common (affects more than 1 person in 10)
• Lethargy
Common (affects less than 1 person in 10)
• Diarrhoea, feeling sick (nausea),
headache

Other side effects include:
• Lack of interest in sexual activities (loss of
libido)
• Being sick (vomiting)
• Unusual skin sensations such as
numbness, tingling, pricking, burning or
creeping on the skin (paraesthesia)
Blood tests
Sectral can increase the levels of liver
enzymes shown up in blood tests. This can
mean that your liver is not working properly.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse.
This includes any possible side effects not
listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help
provide more information on the safety of
this medicine.
5. How to store Sectral
Keep out of the sight and reach of children.
Do not use Sectral after the expiry date which
is stated on the carton after ‘EXP’. The expiry
date refers to the last day of that month.
If your tablets show signs of deterioration
or discolouration seek the advice of your
pharmacist who will tell you what to do.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.
6. Further Information
What Sectral Tablets contain
Each film-coated tablet contains 400mg
acebutolol (as hydrochloride).
Also includes: maize starch, povidone,
colloidal anhydrous silica, talc, magnesium
stearate, zein, butyl acetoricinoleate and
lactose.

What Sectral looks like and contents of the
pack
Off-white to cream colour, oblong, film
coated tablet, one face impressed with a
score-line and plain on the reverse.
Sectral are available in blister packs of
30 tablets.
Procured from within the EU and
repackaged by Product Licence Holder
Ennogen Healthcare Ltd,
Unit G4 Riverside Industrial Estate,
Riverside Way,
Dartford,
Kent DA1 5BS UK.
Who manufactured your medicine
Manufactured by Sanofi-Aventis S.p.A.,
Viale Europa,
11-21040 Origgio (VA),
Italy.
Leaflet date: 24 February 2015
Ref: Sect400/v2
PL: 40739/0024

POM

Sectral is a registered trademark of
Aventis Pharma SA

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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