ACEBUTOLOL 400MG TABLETS
Active substance: ACEBUTOLOL HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
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)
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.
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.
Take special care with Sectral Check with your doctor or pharmacist before taking your medicine if:
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.
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 Prinzmetals 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.
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.
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).
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
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.
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.
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.
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.
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.
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.
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.
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 Raynauds phenomenon.
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 Leaflet date: 05.02.2013 Sectral is a registered trademark of Sanofiaventis group of companies. POM
PACKAGE LEAFLET: INFORMATION FOR THE USER
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)
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:
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.
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 can not tolerate some sugars, talk to your doctor before taking Acebutolol.
Take special care with Acebutol 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 Prinzmetals 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.
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.
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).
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
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.
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.
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.
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.
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.
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.
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.
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 Raynauds phenomenon.
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
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)
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.
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.
Take special care with Sectral Check with your doctor or pharmacist before taking your medicine if:
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.
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 Prinzmetals 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.
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.
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).
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
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.
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.
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.
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.
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.
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.
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.
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 Raynauds phenomenon.
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 Leaflet date: 05.02.2013 Sectral is a registered trademark of Sanofiaventis group of companies. POM
PACKAGE LEAFLET: INFORMATION FOR THE USER
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)
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:
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.
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 can not tolerate some sugars, talk to your doctor before taking Acebutolol.
Take special care with Acebutol 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 Prinzmetals 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.
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.
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).
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
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.
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.
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.
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.
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.
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.
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.
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 Raynauds phenomenon.
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
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
