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SECTRAL 100MG CAPSULES

Active substance(s): ACEBUTOLOL HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Sectral 400mg Tablets
Sectral 100mg and 200mg
Capsules
Acebutolol (as hydrochloride)

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Phone 0845 372 7101 for help

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. 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, 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. Before you take Sectral
Do not take this medicine and tell
your doctor if:
 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
 You have low blood pressure
 You have severe heart problems or heart
failure not controlled by medicines
 You have a very slow heartbeat - less than
50 beats per minute
 Your doctor has told you that you have an
abnormal level of acid in your blood
(called acidosis).
 You have serious blood circulation problems
 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.
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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
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)
• Fingolimod used for treating multiple
sclerosis. Your doctor may perform
monitoring at the start of treatment

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 Tablets.
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

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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 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
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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 reach and sight 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.
Store below 25ºC. Keep the blister strip in
the outer carton in order to protect from
light and moisture.
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 tablet contains 400mg of the active
substance, acebutolol (as hydrochloride)
• The other ingredients are starch maize,
silica colloidal anhydrous (E551),
magnesium stearate (E572), talc (E553b),
Povidone K30, titanium dioxide (E171),
lactose monohydrate, hypromellose (E464)
and Macrogol.

What Sectral Capsules contain:
• Each capsule contains 100mg or 200mg of
the active substance, acebutolol (as
hydrochloride)
• The other ingredients are starch potato,
silica colloidal anhydrous (E551),
magnesium stearate (E572), yellow iron
oxide (E172), titanium dioxide (E171),
gelatin and Opacode S-1-8100 Black
(shellac, iron oxide (E172) lecithin and
antifoam DC 1591)
• The 200mg capsules also contain red iron
oxide (E172)
What Sectral looks like and contents of
the pack
Sectral 400mg tablets are white to off-white
circular tablets, marked ‘Sectral 400’ on one
side. They are supplied in blister packs of 28
tablets or securitainers of 100 tablets.
Sectral 100mg capsules are yellow and white,
marked ‘Sectral 100’.
They are supplied in blister packs of 84
capsules and securitainers of 100 or 500
capsules.
Sectral 200mg capsules are yellow and pink,
marked ‘Sectral 200’.
They are supplied in blister packs of 56
capsules and securitainers of 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Tel: 0845 372 7101

email: uk-medicalinformation@sanofi.com
Manufacturer
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.,
Avda. Leganés, 62, Alcorcón, 28923 (Madrid)
Spain
This leaflet does not contain all the
information about your medicine. If you
have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in 08/2014
© Sanofi, 1974 – 2014
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Artworks Department. Madrid. Spain
Product Description: Sectral compr. / caps.
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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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