ACEBUTOLOL 400MG TABLETS

Active substance: ACEBUTOLOL HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Sectral® 400mg Tablets
(acebutolol hydrochloride)
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
Please note that this leaflet also contains
information about other strengths such as
Sectral 100mg and 200mg Capsules.

In this leaflet:
1. What Sectral is and what it is used for
2. Before you take Sectral
3. How to take Sectral
4. Possible side effects
5. How to store Sectral
6. Further information

1. What Sectral is and what
it is used for
The name of your medicine is Sectral
400mg Tablets, (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. Before you take Sectral
Do not take this medicine and
tell your doctor if:
X You are allergic (hypersensitive) to
acebutolol hydrochloride, other betablockers or any of the other ingredients
of Sectral (see Section 6: Further
information)
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or
tongue
X You have low blood pressure
X You have severe heart problems or
heart failure not controlled by medicines
X You have a very slow heartbeat - less
than 50 beats per minute
X Your doctor has told you that you have
an abnormal level of acid in your blood
(called acidosis).
X You have serious blood circulation
problems
X You have an tumour on the adrenal
gland (called phaechromocytoma)
Do not take if any of the above apply to you.
If you are not sure, talk to your doctor or
pharmacist before taking Sectral.

Take special care with Sectral
Check with your doctor or
pharmacist before taking your
medicine if:

 You have kidney problems
 You have heart failure that is controlled
with medicines
 You have a slow heart beat (also see
section ‘Do not take Sectral if’)
 You have breathing problems due to
long term lung problems (called
‘asthma’, ‘bronchitis’ or ‘emphysema’)
 You have an overactive thyroid gland
 You have diabetes or low blood sugar
levels (hypoglycaemia)
 You have psoriasis
 You have mild or moderate blood
circulation problems. You may have
cold hands and feet that look darker
than the rest of your body
 You have a form of chest pain known
as ‘Prinzmetal’s’ angina
 You have a history of allergies
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Sectral.

Operations or anaesthetics
Tell your doctor or dentist you are taking
Sectral if you are going to have an
anaesthetic or an operation (including
dental surgery).

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
amiodarone, 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)

Taking Sectral with food and drink
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 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 Tablets
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 capsules/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 capsules/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 sideeffects:
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 get
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)
If you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

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.
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.
If your tablets get discoloured or show any
other signs of deterioration stop using them
and take them to your pharmacist.

6. Further Information
What Sectral contains:

 Each film-coated tablet contains 400mg
acebutolol (as hydrochloride).
 The other ingredients are maize starch,
povidone K30, colloidal anhydrous silica,
talc, magnesium stearate, zein, lactose
monohydrate, butyl acetoricinoleate.

What Sectral looks like and contents
of the pack
Sectral are white to off-white, capsule
shaped, biconvex film-coated tablet with
bevel edges with a breakline on one side
and plain on the other.
They are supplied in blister packs of 30
tablets.

Manufactured by: SANOFI AVENTIS,
S.p.A., Viale Europa, 11, 21040 Origgio
(VA), Italy
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK
Sectral® 400mg Tablets,
PL No: 18799/2023

POM

Leaflet date: 05.02.2013
Sectral is a registered trademark of Sanofiaventis group of companies.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Acebutolol 400mg Tablets
(acebutolol hydrochloride)
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
Please note that this leaflet also contains
information about other strengths such as
Acebutolol 100mg and 200mg Capsules.

In this leaflet:
1. What Acebutolol is and what it is used for
2. Before you take Acebutolol
3. How to take Acebutolol
4. Possible side effects
5. How to store Acebutolol
6. Further information

1. What Acebutolol is and
what it is used for
The name of your medicine is Acebutolol
400mg Tablets, (called Acebutolol
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.
Acebutolol is used for:
• Chest pain (angina)
• High blood pressure
• Uneven or unusually fast heart beats
(arrhythmia)

2. Before you take Acebutolol
Do not take this medicine and
tell your doctor if:

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 Acebutolol can
affect the way some other medicines work.
Also some medicines can affect the way
Acebutolol 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
Acebutolol 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 Acebutolol
 Medicines for heart problems such as
amiodarone, 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)

Taking Acebutolol with food and drink
Take Acebutolol with or just after meals

Pregnancy and breast-feeding

X You are allergic (hypersensitive) to
acebutolol hydrochloride, other betablockers or any of the other ingredients
of Acebutolol (see Section 6: Further
information)
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or
tongue
X You have low blood pressure
X You have severe heart problems or
heart failure not controlled by medicines
X You have a very slow heartbeat - less
than 50 beats per minute
X Your doctor has told you that you have
an abnormal level of acid in your blood
(called acidosis).
X You have serious blood circulation
problems
X You have an tumour on the adrenal
gland (called phaechromocytoma)
Do not take if any of the above apply to you.
If you are not sure, talk to your doctor or
pharmacist before taking Acebutolol.

Talk to your doctor before taking this
medicine if:
 You are pregnant, might become
pregnant, or think you may be pregnant.
Acebutolol 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 Acebutolol. 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.

Take special care with
Acebutol
Check with your doctor or pharmacist
before taking your medicine if:

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
Acebutolol.

 You have kidney problems
 You have heart failure that is controlled
with medicines
 You have a slow heart beat (also see
section ‘Do not take Acebutolol if’)
 You have breathing problems due to
long term lung problems (called
‘asthma’, ‘bronchitis’ or ‘emphysema’)
 You have an overactive thyroid gland
 You have diabetes or low blood sugar
levels (hypoglycaemia)
 You have psoriasis
 You have mild or moderate blood
circulation problems. You may have
cold hands and feet that look darker
than the rest of your body
 You have a form of chest pain known
as ‘Prinzmetal’s’ angina
 You have a history of allergies
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Acebutolol.

Operations or anaesthetics
Tell your doctor or dentist you are taking
Acebutolol if you are going to have an
anaesthetic or an operation (including
dental surgery).

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 Acebutolol Tablets

3. How to take Acebutolol
Always take Acebutolol 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 capsules/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 Acebutolol 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 Acebutolol if necessary.

If you take more Acebutolol than you
should
If you take more capsules/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 Acebutolol
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 Acebutolol
Keep taking Acebutolol 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
Acebutolol, 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, Acebutolol can cause
side effects, although not everybody gets
them.
Stop taking Acebutolol 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 sideeffects:
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 get
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)
If you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

5. How to store Acebutolol
Keep out of the sight and reach of children.
Do not use Acebutolol after the expiry date
which is stated on the carton after ‘Exp’.
The expiry date refers to the last day of that
month.
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.
If your tablets get discoloured or show any
other signs of deterioration stop using them
and take them to your pharmacist.

6. Further Information
What Acebutolol contains:

 Each film-coated tablet contains 400mg
acebutolol (as hydrochloride).
 The other ingredients are maize starch,
povidone K30, colloidal anhydrous silica,
talc, magnesium stearate, zein, lactose
monohydrate, butyl acetoricinoleate.

What Acebutolol looks like and
contents of the pack
Acebutolol are white to off-white, capsule
shaped, biconvex film-coated tablet with
bevel edges with a breakline on one side
and plain on the other.
They are supplied in blister packs of 30
tablets.

Manufactured by: SANOFI AVENTIS,
S.p.A., Viale Europa, 11, 21040 Origgio
(VA), Italy
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK
Acebutolol 400mg Tablets, POM
PL No: 18799/2023
Leaflet date: 05.02.2013

Expand view ⇕

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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