Sectral 400mg tablets

Main information

  • Trade name:
  • Sectral 400mg tablets
  • Dosage:
  • 400mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Sectral 400mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02040000; GTIN: 5036850013988

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 15184/1835
  • Last update:
  • 09-05-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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. You 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 cannot tolerate some sugars, talk to your

doctor before taking Sectral Tablets

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

Sectral 400mg Tablets

(acebutolol hydrochloride)

Patient Information Leaflet

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 get serious, or if you notice any side effects not

listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Sectral 400mg Tablets but will be referred to as

Sectral throughout this leaflet.

In this leaflet:

What Sectral is and what it is used for

Before you take Sectral

How to take Sectral

Possible side effects

How to store Sectral

Further information

What Sectral is and what it is used for

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)

Before you take Sectral

Do not take this medicine and tell your doctor if:

*

You are allergic (hypersensitive) to acebutolol hydrochloride, other

beta-blockers 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 a 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.

®

Ref: 1835/230718/1/F

1

1

6

4

5

2

2

3

3

(acebutolol hydrochloride)

Patient Information Leaflet (continued)

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.

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.

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 medicine becomes discoloured or shows any other signs of deterioration,

consult your pharmacist who will tell you what to do.

Further information

What Sectral Tablets contain:

Each film-coated tablet contains 400mg of acebutolol (as hydrochloride)

The other ingredients are wheat starch, povidone, silica colloidal anhydrous,

talc, magnesium stearate, macrogol, hypromellose and lactose.

What Sectral looks like and contents of the pack

Sectral are white, oval shaped tablets with a score line on one side marked

RPR and 114 and plain on the reverse.

They are supplied in blister packs of 30’s or 60’s

Manufacturer and Licence Holder

This medicine is manufactured by Sanofi-aventis S.A., Ctra. C-35

(La Batlloria-Hostalric) Km. 63.09, 17404 Riells i Viabrea, (Girona) Spain

and is procured from within the EU and repackaged by the Product Licence

Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat,

Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or

pharmacist. They will have additional information about this medicine and

will be able to advise you.

PL 15184/1835

Sectral 400mg Tablets

Sectral is a registered trademark of SANOFI.

Revision date: 23/07/18

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414

for help.

POM

Ref: 1835/230718/1/B

4

5

6

Sectral 400mg Tablets

®

Acebutolol 400mg Tablets

(acebutolol hydrochloride)

Patient Information Leaflet

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 get serious, or if you notice any side effects not

listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Acebutolol 400mg Tablets but will be referred to as

Acebutolol throughout this leaflet.

In this leaflet:

What Acebutolol is and what it is used for

Before you take Acebutolol

How to take Acebutolol

Possible side effects

How to store Acebutolol

Further information

What Acebutolol is and what it is used for

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)

Before you take Acebutolol

Do not take this medicine and tell your doctor if:

*

You are allergic (hypersensitive) to acebutolol hydrochloride, other

beta-blockers 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

*

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 a 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.

Take special care with Acebutolol

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 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).

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 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. You doctor may perform

monitoring at the start of treatment

Taking Acebutolol with food and drink

Take Acebutolol 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.

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.

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

This medicine contains:

*

Lactose. This medicine contains lactose, a type of sugar. If you have been

told by your doctor that you cannot tolerate some sugars, talk to your

doctor before taking Acebutolol Tablets

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 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

Ref: 1835/230718/2/F

1

1

6

4

5

2

2

3

3

(acebutolol hydrochloride)

Patient Information Leaflet (continued)

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 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 treat-

ment 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.

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.

How to store Acebutolol

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 medicine becomes discoloured or shows any other signs of deterioration,

consult your pharmacist who will tell you what to do.

Further information

What Acebutolol Tablets contain:

Each film-coated tablet contains 400mg of acebutolol (as hydrochloride)

The other ingredients are wheat starch, povidone, silica colloidal anhydrous,

talc, magnesium stearate, macrogol, hypromellose and lactose.

What Acebutolol looks like and contents of the pack

Acebutolol are white, oval shaped tablets with a score line on one side

marked RPR and 114 and plain on the reverse.

They are supplied in blister packs of 30’s or 60’s

Manufacturer and Licence Holder

This medicine is manufactured by Sanofi-aventis S.A., Ctra. C-35

(La Batlloria-Hostalric) Km. 63.09, 17404 Riells i Viabrea, (Girona) Spain

and is procured from within the EU and repackaged by the Product Licence

Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat,

Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or

pharmacist. They will have additional information about this medicine and will

be able to advise you.

PL 15184/1835

Acebutolol 400mg Tablets

Revision date: 23/07/18

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414

for help.

POM

Ref: 1835/230718/2/B

4

5

6

Acebutolol 400mg Tablets