ACEBUTOLOL 400MG TABLETS, ACEBUTOLOL 100MG AND 200MG CAPSULES
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.
- Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.
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.
What Acebutolol Is And What It Is Used For
What acebutolol is
The name of your medicine is Acebutolol 400mg Tablets, Acebutolol 100mg Capsules or Acebutolol 200mg Capsules (called acebutolol throughout this leaflet). This belongs to a group of medicines called beta-blockers.
How acebutolol works
It works by slowing your heart rate or lowering your blood pressure.
Acebutolol can be used for
- Chest pain (angina)
- High blood pressure
- Uneven or unusually fast heart beats (arrhythmia)
Before You Take Acebutolol
Do not take acebutolol and tell your doctor if:
You are allergic (hypersensitive) to acebutolol hydrochloride, other beta-blockers or any of the other ingredients of this medicine (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 and check with your doctor before taking acebutolol 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 acebutolol with 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.
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).
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 should not breast-feed if you are taking acebutolol. This is because small amounts may pass into mothers’ milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.
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
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.
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.
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 side effects:
- Pain in your chest and feeling weak or dizzy. These could be signs of heart problems.
- Slow heart rate.
- Shortness of breath or difficulty breathing, cough, tiredness, fainting. These could be signs of inflammation in your lungs.
- Swelling of feet or ankles. These could be signs that your heart is not working properly.
- Feeling dizzy or weak. These could be signs of low blood pressure.
- 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.
- Seeing or hearing things that are not there (hallucinations), nightmares, confusion, or dizziness.
- Dry eyes, blurred vision.
- Skin rash.
- If you already have psoriasis, the symptoms of your psoriasis may get worse.
- Changes in behaviour or depression.
- Difficulty sleeping (insomnia).
- 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. This is rare.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet
- Lack of interest in sexual activities (low libido) or lethargy.
- Headache.
- Diarrhoea, feeling sick (nausea) or being sick (vomiting).
- Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia).
How To Store Acebutolol
- Keep out of the reach and sight 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. - Store in a dry place below 25ºC. Protect from light.
- 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.
Further Information
What Acebutolol Tablets contain
Each tablet contains 400mg of the active substance, acebutolol 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 Acebutolol Capsules contain
Each capsule contains 100mg or 200mg of the active substance, acebutolol 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 Acebutolol looks like and contents of the pack
Acebutolol 400mg Tablets are white to off-white circular tablets, marked ‘ACB 400’ on one side.
They are supplied in blister strip packs of 28 tablets or securitainers of 100 tablets.
Acebutolol 100mg Capsules are yellow and white, marked ‘ACB 100’.
They are supplied in blister packs of 84 capsules and securitainers of 100 or 500 capsules.
Acebutolol 200mg Capsules are yellow and pink, marked ‘ACB 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
Manufacturer
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 September 2009.
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