Sectral Tablets 400mg
T
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Sectral 400mg Tablets Sectral 100mg and 200mg Capsules
Acebutolol (as hydrochloride)
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Read all of this leaflet carefully before
you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Sectral is and what it is used for
2. Before you take Sectral
3. How to take Sectral
4. Possible side effects
5. How to store Sectral
6. Further information
1. What Sectral is and what it is used for
The name of your medicine is Sectral 400mg Tablets, Sectral 100mg Capsules or Sectral 200mg Capsules (called Sectral throughout this leaflet). This belongs to a group of medicines called beta-blockers. It works by slowing your heart rate or lowering your blood pressure.
Sectral is used for:
• Chest pain (angina)
• High blood pressure
• Uneven or unusually fast heart beats (arrhythmia)
2. Before you take Sectral
XDo not take this medicine and tell your doctor if:
X 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 XYou have low blood pressure X You have severe heart problems or heart failure not controlled by medicines XYou 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 XYou have an tumour on the adrenal gland (called phaechromocytoma)
Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Sectral.
Take special care with Sectral Check with your doctor or pharmacist before taking your medicine if:
AYou have kidney problems A You have heart failure that is controlled with medicines
AYou have a slow heart beat (also see section ‘Do not take Sectral if’)
AYou have breathing problems due to long term lung problems (called ‘asthma’, ‘bronchitis’ or ‘emphysema’)
AYou have an overactive thyroid gland AYou have diabetes or low blood sugar levels (hypoglycaemia)
AYou have psoriasis AYou have mild or moderate blood circulation problems. You may have cold hands and feet that look darker than the rest of your body
AYou have a form of chest pain known as ‘Prinzmetal’s’ angina AYou have a history of allergies If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Sectral.
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Operations or anaesthetics
Tell your doctor or dentist you are taking Sectral if you are going to have an anaesthetic or an operation (including dental surgery).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Sectral can affect the way some other medicines work. Also some medicines can affect the way Sectral works.
In particular, tell your doctor if you are
taking any of the following:
• Other medicines for high blood pressure
• Clonidine used for migraine or high blood pressure. If you are taking clonidine and Sectral together, you should not stop taking clonidine unless your doctor tells you. If you have to stop taking clonidine, your doctor will give you instructions
• Medicines for chest pain (angina) such as verapamil, nifedipine or diltiazem. Verapamil must not be taken within several days of taking Sectral
• Medicines for heart problems such as amiodaraone, disopyramide or digoxin
• Medicines used for mental health problems (antipsychotic medicines) - such as haloperidol, sulpiride, pimozide or flupenthixol
• Some medicines used for depression (mono-amine oxidase inhibitors or tricyclic antidepressants) such as phenelzine, imipramine or amitriptyline
• Medicines to help you sleep (barbiturates) such as amobarbital
• Insulin or tablets to treat diabetes - such as glibenclamide. Your doctor may change your dose
• Medicines used for breathing problems -such as aminophylline, theophylline, salbutamol and terbutaline
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) - used to relieve pain (such as ibuprofen, naproxen, diclofenac, indometacin and piroxicam)
• Fingolimod used for treating multiple sclerosis. Your doctor may perform monitoring at the start of treatment
Taking Sectral with food and drink
Take Sectral with or just after meals
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if:
• You are pregnant, might become pregnant, or think you may be pregnant. Sectral should not normally be given during pregnancy as it may cause problems with the foetus or newly born baby.
• You are breast-feeding or planning to breast-feed. You should not breast-feed if you are taking Sectral. This is because small amounts may pass into mothers' milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may feel tired or dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Sectral Tablets
This medicine contains:
• Lactose. This medicine contains lactose, a type of sugar. If you have been told by your doctor that you can not tolerate some sugars, talk to your doctor before taking Sectral Tablets.
3. How to take Sectral
Always take Sectral exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the capsules/tablets with a drink of water
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
How much to take
Adults (including the elderly)
The usual dose of Sectral depends on your needs and the illness being treated. Your doctor will advise you.
Chest pains (angina)
• The starting dose is 400mg once a day at breakfast or 200mg twice a day
• If necessary, your doctor may increase this to 300mg three times a day
• The maximum daily dose is 1200mg High blood pressure
• The starting dose is 400mg once a day at breakfast or 200mg twice a day
• If necessary, after 2 weeks, your doctor may increase this to 400mg twice a day
Uneven or unusually fast heart beats (arrhythmia)
• The starting dose is 200mg daily
• If necessary, your doctor may increase this to 400mg to 1200mg daily
Patients with kidney problems
Your doctor may decide to lower your dose of Sectral if necessary.
If you take more Sectral than you should
If you take more capsules/tablets than you should
• Tell a doctor or go to a hospital casualty department straight away.
• Take the medicine pack with you. This is so the doctors know what you have taken.
• The following effects may happen:
Feeling dizzy or weak, difficulty in breathing or wheezing, low blood sugar or serious heart problems.
If you forget to take Sectral
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sectral
Keep taking Sectral until your doctor tells you to stop. If you stop treatment suddenly your illness may get worse. When your doctor says that you can stop taking Sectral, you need to do this gradually. Your doctor will help you do this.
0If you have any further questions about this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Sectral can cause side effects, although not everybody gets them. Stop taking Sectral and see your doctor or go to a hospital straight away if:
• You have an allergic reaction. The signs may include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Tell your doctor as soon as possible if you have any of the following side-effects: Very common (affects more than 1 person in 10)
• Blood tests may show changes to your immune system. Signs may include joint aches and pains, swollen joints, increased sensitivity to sunlight, mouth ulcers, hair loss, anxiety, fevers, night sweats and stomach pain.
Common (affects less than 1 person in 10)
• Changes in behaviour or depression, nightmares
• Pain in your chest and feeling weak or dizzy. These could be signs of heart problems or low blood pressure.
• Blurred vision
• Shortness of breath or difficulty in breathing, cough, tiredness, fainting. These could be signs of inflammation in your lungs.
Other side effects include:
• Seeing or hearing things that are not there (hallucinations), confusion
• Difficulty in sleeping (insomnia)
• Dry eyes
• Slow heart rate. Swelling of feet or ankles. These could be signs that your heart is not working properly
• Episodes of muscle cramps or muscle pain especially when you walk or exercise
• Fingers and toes changing colour when cold and tingling or painful on warming up. This could be Raynaud’s phenomenon.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days.
Very common (affects more than 1 person in 10) • Lethargy
Common (affects less than 1 person in 10) • Diarrhoea, feeling sick (nausea), headache
Other side effects include:
• Lack of interest in sexual activities (loss of libido)
• Being sick (vomiting)
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
Blood tests
Sectral can increase the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sectral
Keep out of the reach and sight of children.
Do not use Sectral after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
Store below 25°C. Keep the blister strip in the outer carton in order to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further Information
What Sectral Tablets contain:
• Each tablet contains 400mg of the active substance, acebutolol (as hydrochloride)
• The other ingredients are starch maize, silica colloidal anhydrous (E551), magnesium stearate (E572), talc (E553b), Povidone K30, titanium dioxide (E171), lactose monohydrate, hypromellose (E464) and Macrogol.
What Sectral Capsules contain:
• Each capsule contains 100mg or 200mg of the active substance, acebutolol (as hydrochloride)
• The other ingredients are starch potato, silica colloidal anhydrous (E551), magnesium stearate (E572), yellow iron oxide (E172), titanium dioxide (E171), gelatin and Opacode S-1-8100 Black (shellac, iron oxide (E172) lecithin and antifoam DC 1591)
• The 200mg capsules also contain red iron oxide (E172)
What Sectral looks like and contents of the pack
Sectral 400mg tablets are white to off-white circular tablets, marked ‘Sectral 400’ on one side. They are supplied in blister packs of 28 tablets or securitainers of 100 tablets.
Sectral 100mg capsules are yellow and white, marked ‘Sectral 100’.
They are supplied in blister packs of 84 capsules and securitainers of 100 or 500 capsules.
Sectral 200mg capsules are yellow and pink, marked ‘Sectral 200’.
They are supplied in blister packs of 56 capsules and securitainers of 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com Manufacturer
FAMAR HEALTH CARE SERVICES MADRID, S.A.U., Avda. Leganes, 62, Alcorcon, 28923 (Madrid) Spain i
This leaflet does not contain all the !
information about your medicine. If you have any questions or are not sure about : anything, ask your doctor or pharmacist.
This leaflet was last revised in 08/2014 © Sanofi, 1974 - 2014
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