Patient leaflet - Acebutolol Aurobindo 400 mg film-coated tablets
1. What Acebutolol is and what it is used for
The name of your medicine is Acebutolol 400 mg Tablets. 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. What you need to know before you take Acebutolol
Do not take this medicine if:
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
- 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)
You are taking floctafenine (used to treat
pain), or sultopride (used to treat certain mental
illnesses)
You are breast-feeding
You have asthma or chronic obstructive
pulmonary disease in their severe forms”. 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Acebutolol
You should never suddenly stop your treatment without first asking your doctor’s advice because a sudden stop can put your life in danger.
You should also tell your doctor:
- If you have kidney problems
If you have heart failure that is controlled
with medicines
If you have a slow heart beat (also see
section ‘Do not take Acebutolol if’)
If you have breathing problems due to
long term lung problems (called ‘asthma’, ‘bronchitis’ or ‘emphysema’)
- If you have an overactive thyroid gland
If you have diabetes or low blood sugar
levels (hypoglycaemia)
- If you have psoriasis
If you have mild or moderate blood
circulation problems. You may have cold hands and feet that look darker than the rest of your body
If you have a form of chest pain known as
‘Prinzmetal’s’ angina
If 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).
Other medicines and Acebutolol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. An increased risk of depression has been reported when co-administered with diltiazem.
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, flupenthixol or sultopride
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.
- Lidocaine used by IV (a medicine used in anaesthesia)
Medicines likely to give torsades de pointes
(serious heart rhythm disorder)
- Medicines that can cause a drop in blood pressure when going from lying down to standing up (orthostatic hypotension)
- Dapoxetine (medicine used in ejaculation disorders in men)
- IV dipyridamole (medicine used to prevent thromboembolic accidents)
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, piroxicam and floctafenine)
- Fingolimod used for treating multiple sclerosis. Your doctor may perform monitoring at the start of treatment
- Pilocarpine (medicine used as eye drops in the treatment of glaucoma or as a tablet in the treatment of certain cases of dry mouth)
Baclofen (used to treat muscle stiffness)
because it can cause a more pronounced reduction in blood pressure. Blood pressure should be monitored more frequently and the antihypertensive dose reduced if necessary.
- Iodine X-ray contrast agents because they can cause shock and low blood pressure; beta blockers reduce the heart’s ability to respond to these reactions. Non-steroidal anti-inflammatory drugs (anti-inflammatory drugs) as they may reduce the ability of Acebutolol to lower blood pressure.
Corticosteroids (anti-inflammatory
medicines), tetracosactide (a medicine used in endocrinology) because they may reduce the blood pressure lowering effect of Acebutolol.
Mefloquine (used to treat malaria) as it can cause a reduction in heart rate.
Acebutolol with food, drink and alcohol
Take Acebutolol with or just after meals Pregnancy, breast-feeding and fertility
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 breastfeed 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.
Beta-blockers can reduce blood flow to the placenta, which can result in premature birth, newborn smaller than expected, intrauterine foetal death and abortion. 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.
Acebutolol Tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Version: 03
Date & Time: 12.12.2023 & 4.50 pm Submission Code: N18928_u15c
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 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 400 mg once a day at
breakfast or 200 mg twice a day
If necessary, your doctor may increase this
to 300 mg three times a day
- The maximum daily dose is 1200 mg
High blood pressure
The starting dose is 400 mg once a day at
breakfast or 200 mg twice a day
If necessary, after 2 weeks, your doctor may
increase this to 400 mg twice a day
Uneven or unusually fast heart beats (arrhythmia)
- The starting dose is 200 mg daily
If necessary, your doctor may increase this
to 400 mg to 1200 mg 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 tablets than you should
Tell a doctor or go to a hospital casualty
department straight away.
Take the medicine pack with you. This is so
the doctors know what you have taken.
The following effects may happen: Feeling dizzy or weak, difficulty in breathing
or wheezing, low blood sugar or serious heart problems.
If you forget to take Acebutolol
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Acebutolol
Keep taking Acebutolol until your doctor tells you to stop. If you stop treatment
suddenly your illness may get worse. When your doctor says that you can stop taking Acebutolol, you need to do this gradually. Your doctor will help you do this.
If you have any further questions about this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine 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: 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)
Not known (frequency cannot be estimated from the available data)
- Hair loss (Alopecia)
Blood tests
Acebutolol 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Acebutolol
Keep this medicine out of the sight and reach of children.
Store below 30 ºC.
Do not use this medicine after the expiry date which is stated on the label, carton and blister after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
The active substance is acebutolol
hydrochloride.
Each film-coated tablet contains 400 mg of acebutolol (as acebutolol hydrochloride)
The other ingredients are
Tablet core: Lactose monohydrate, Maize starch, Povidone (K-30), Talc, Silica colloidal Anhydrous, Magnesium Stearate Tablet coat: Hypromellose 6cp, Macrogol
6000, Titanium dioxide (E171)
What Acebutolol looks like and contents of the pack
Film-coated tablet.
White to off-white, oblong shaped biconvex film coated tablets having the length approximately 17.15 mm, diameter of body approximately 8.42 mm debossed with ‘AC’ and ‘4’ separated with breakline on one side and plain on the other side.
The tablet can be divided into equal doses Acebutolol film-coated tablets are available in blister packs.
Pack sizes:
Blister packs: 28, 30, 90 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited,
HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park West End Road
Ruislip HA4 6QD
United Kingdom.
or
Generis Farmacêutica, S.A.
Rua João de Deus,
19, 2700-487 Amadora
Portugal