Atenolol 100mg Film-Coated Tablets
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ATENOLOL 50MG FILM-COATED TABLETS ATENOLOL 100MG FILM-COATED TABLETS (Atenolol)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Atenolol Tablets are and what they are used for
2. What you need to know before you take Atenolol Tablets
3. How to take Atenolol Tablets
4. Possible side effects
5. How to store Atenolol Tablets
6. Contents of the pack and other information
1. What Atenolol Tablets are and what they are used for
The name of your medicine is Atenolol 50mg or 100mg film-coated tablets referred to as Atenolol tablets in the leaflet. It contains the active substance called Atenolol. This belongs to a group of medicines called beta-blockers.
Atenolol is used to:
• Treat high blood pressure (hypertension).
• Treat uneven heart beats (arrhythmias).
• Help prevent chest pain (angina).
• Protect the heart in the early treatment after a heart attack (myocardial infarction).
It works by making your heart beat more slowly and with less force.
2. What you need to know before you take Atenolol Tablets Do not take Atenolol tablets if:
• You are allergic (hypersensitive) to atenolol or any of the other ingredients of this medicine (listed in section 6).
• You have ever had any of the following heart problems:
- heart failure which is not under control (this usually makes you breathless and causes your ankles to swell)
- second- or third-degree heart block (a condition which may be treated by a pacemaker)
- very slow or very uneven heart beats, very low blood pressure or very poor circulation.
• You have a tumour called phaeochromocytoma that is not being treated. This is usually near your kidney and can cause high blood pressure. If you are being treated for phaeochromocytoma, your doctor will give you another medicine, called an alpha-blocker, to take as well as Atenolol.
• You have been told that you have higher than normal levels of acid in your blood (metabolic acidosis).
• you are suffering from ‘shock' caused by the heart not pumping strongly enough; the symptoms of shock are a significant fall in blood pressure, pallor, agitation, a weak, rapid pulse, clammy skin, and reduced consciousness.
• your heart does not pump strongly enough (congestive heart failure) and you are not being treated for it or the treatment you are receiving has not yet proved effective.
• you are receiving intravenous injections of certain medicines containing verapamil or diltiazem as active substances (used to treat heart conditions).
• you have severe asthma or other serious lung disorder (such as severe chronic obstructive pulmonary disease).
This medicine is not suitable for use in children
Do not take atenolol tablets if any of the above apply to you. If you are not sure, talk to your doctor
or pharmacist before taking atenolol tablets
Warnings and precautions
Talk to your doctor or pharmacist before taking Atenolol tablets if:
• You have asthma, wheezing or any other similar breathing problems, or you get allergic reactions, for example to Insect stings. If you have ever had asthma or wheezing, do not take this medicine without first checking with your doctor.
• You have a type of chest pain (angina) called Prinzmetal's angina.
• You have poor blood circulation or controlled heart failure.
• You have first-degree heart block.
• You have diabetes. Your medicine may change how you respond to having low blood sugar. You may feel your heart beating faster.
• You have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may hide the symptoms of thyrotoxicosis such as a fast heartbeat, tremor or excessive sweating.
• You have problems with your kidneys. You may need to have some check ups during your treatment.
• you suffer from cold fingers and / or toes (even without the use of medicines) or a feeling of pain, cramp, or numbness / fatigue in your leg(s) when you are walking, since these conditions can be aggravated.
• if you are elderly—your dosage may need to be adjusted
• you suffer from heart problems such as heart failure, untreated congestive heart failure, ischaemic heart disease, poor heart function.
• you have a slow heartbeat (50 to 55 beats a minute)
• you have ever suffered psoriasis (a chronic autoimmune disease that appears on the skin).
• Atenolol may cause more allergic reactions if you already have a history of allergic reactions and if adrenaline is used to treat allergic reactions then it may not be effective.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Atenolol tablets.
Other medicines and Atenolol tablets
Do not take this medicine and tell your doctor or pharmacist if:
• you are taking calcium channel blockers such as verapamil, nifedipine and diltiazem (medicines to treat high blood pressure or chest pain)
Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Atenolol can affect the way some other medicines work and some medicines can have an effect on Atenolol.
In particular, tell your doctor if you are taking any of the following medicines:
• Clonidine (for high blood pressure or migraine). If you are taking clonidine and Atenolol together, do not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine, your doctor will give you careful instructions about how to do it.
• Alpha blockers such as prazosin, alfuzosin, terazosin (medicines to treat hypertension or Raynaud's disease)
• Isoprenaline or dobutamine(medicines which widens blood vessels)
• Barbiturates(medicines to treat insomnia, epilepsy or as an anaesthetic e.g.phenobarbital).
• Phenothiazines(medicine to treat mental illness e.g. chlorpromazine).
• Baclofen- for muscle cramps
• Ampicillin- for bacterial infections
• Phenothiazines(medicine to treat more serious mental illness).
• Diuretics- medicines that help reduce the amount of water in the body through urination
• Vasodilators- medicines that make blood vessels widen
• Suxamethonium halogenide and tubocurarine (peripheral muscle relaxants); concomitant use of atenolol could increase and extent the relaxative effect of muscle relaxants
• Disopyramide, lidocaine, procainamide quinidine or amiodarone (for an uneven heart beat).
• Digoxin (for heart problems).
• Adrenaline, also known as epinephrine (a medicine that stimulates the heart).
• Ibuprofen or indometacin (for pain and inflammation).
• Insulin or medicines that you take by mouth for diabetes.
• Anaesthetic agents such as cyclopropane, trichloropropane or trichloroethylene
• Medicines to treat nose or sinus congestion or other cold remedies (including those you can buy in the pharmacy).
Operations
If you go into hospital to have an operation, tell the anaesthetist or medical staff that you are taking Atenolol tablets. This is because you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are taking Atenolol.
Atenolol Tablets with food, drink and alcohol
Alcohol may cause your blood pressure to drop too low. You should avoid or limit how much alcohol you drink whilst taking this medicine. Discuss this with your doctor if you have any concerns. Pregnancy, breast-feeding and fertility
Talk to your doctor before taking Atenolol if you are pregnant, may become pregnant or are breast-feeding
Driving and using machines
• Your medicine is not likely to affect you being able to drive or use any tools or machines. However, it is best to wait to see how your medicine affects you before trying these activities.
• If you feel dizzy or tired when taking this medicine, do not drive or use any tools or machines. Atenolol tablets contain Lactose and sunset yellow
• Atenolol tablets contain lactose monohydrate and sunset yellow.
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
• Sunset yellow may cause allergic reactions
_3. How to take Atenolol Tablets_
Always take Atenolol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• Your doctor will tell you how many tablets to take each day and when to take them.
Read the label on the carton to remind you what the doctor said.
• Swallow your Atenolol tablet whole with a drink of water.
• Try to take your tablet at the same time each day.
Adults
Generally, treatment is initiated at a low quantity, e.g. 25 mg. In accordance with the instructions of the doctor who is treating you, the dosage is then built up to the following quantities over the course of a few days.
High blood pressure (hypertension)
The usual quantity for adults is 100 mg once a day, or whatever quantity your doctor advises. In some cases, e.g. in the case of older people or patients with kidney conditions, 50 mg may be enough.
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Certain types of chest pain (angina pectoris)
The usual quantity for adults is 50-100 mg once a day (possibly split into 50 mg twice a day), or whatever quantity your doctor advises.
Certain heart rhythm disorders (arrhythmias)
The usual quantity for adults is 50-100 mg once a day, or whatever quantity your doctor advises. Atenolol is best taken at the same time every day, with water, milk, or another fluid, preferably in the mornings.
After a heart attack
Initial treatment will be by intravenous injection. After 15 minutes this will usually be followed by a 50mg dose of atenolol given orally (by mouth). 12hr after the intravenous dose, a further 50 mg oral dose will be given. A 100mg oral dose will be given after a further 12hrs. Treatment will then continue as a once daily 100mg dose.
Elderly People
If you are an elderly person, your doctor may decide to give you a lower dose, particularly if you have problems with your kidneys.
People with severe kidney problems
If you have severe kidney problems your doctor may decide to give you a lower dose. Children:
These tablets are not recommended for children.
If you take more Atenolol Tablets than you should
If you take more Atenolol Tablets than prescribed by your doctor, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so that the tablets can be identified.
Symptoms of overdose include reduced heart rate, blood pressure, a feeling of tightness in chest due to cramps in the muscles surrounding the airways or sometimes loss of consciousness.
If you forget to take Atenolol Tablets
If you forget to take a dose, take it as soon as you remember. However, if it is almost 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 Atenolol Tablets
Do not stop taking Atenolol tablets without talking to your doctor. In some cases, you may need to stop taking it gradually.
I 4. Possible side effects I
Like all medicines, Atenolol can cause side effects, although not everybody gets them.
Allergic reactions:
Stop taking Atenolol tablets and see a doctor or go to hospital straight away if you notice any of the following serious side effects contact your doctor immediately:
• Allergic reactions: If you have an allergic reaction, see a doctor straight away. The signs may
include raised lumps on your skin (weals), or swelling of your face, lips, mouth, tongue or throat.
• An abnormal heart beat, feeling dizzy, tired or fainting. This could be signs of heart block.
• Shortness of breath or having swollen ankles. These could be signs of heart failure or your heart failure getting worse.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• You may notice that your pulse rate becomes slower while you are taking the tablets. This is normal, but if you are concerned please tell your doctor about it.
• Cold hands and feet.
• Diarrhoea.
• Feeling sick (nausea).
• Feeling tired or aching and tired muscles
• stomach pain and constipation Uncommon (may affect up to 1 in 100 people)
• Disturbed sleep.
• Increase in levels of liver enzymes Rare (may affect up to 1 in 1,000 people)
• Heart block (which can cause dizziness, abnormal heart beat,tiredness or fainting).
• Numbness and spasm in your fingers which is followed by warmth and pain (Raynaud's disease).
• Mood changes.
• Nightmares.
• Feeling confused, anxious or scared.
• Changes in personality (psychoses) or hallucinations.
• Headache.
• Dizziness (particularly when standing up).
• Tingling of your hands.
• Being unable to get an erection (impotence).
• Dry mouth.
• Dry eyes.
• Disturbances of vision.
• Thinning of your hair.
• Skin rash.
• Reduced numbers of platelets in your blood (this may make you bruise more easily).
• Purplish marks on your skin.
• Jaundice (causing yellowing of your skin or the whites of your eyes).
• Low blood pressure.
• Insomnia (difficulty in sleeping).
• Heart failure deterioration.
• Changes to some of the cells or other parts of your blood. Your doctor may take blood samples every so often to check whether Atenolol Tablets has had any effect on your blood.
• Depression.
Very rare (may affect up to 1 in 10,000 people)
• Changes to some of the cells or other parts of your blood. Your doctor may take blood samples every so often to check whether Atenolol has had any effect on your blood.
Conditions that may get worse
If you have any of the following conditions, they may get worse when you start to take your medicine. This happens rarely affecting less than 1 in 1,000 people.
• Psoriasis (a skin condition).
• Being short of breath or having swollen ankles (if you have heart failure).
• Asthma or breathing problems.
• Poor circulation.
• Existing cramping pains causing limping (intermittent claudication)
Do not be concerned by this list of side effects. You may not get any of them. 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.
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 Yellow Card Scheme at “www.mhra.gov.uk/ yejjowcard.” By reporting side effects, you can help provide more information on the safety of this medicine.
| 5. How to store Atenolol Tablets |
• Keep this medicine out of the sight and reach of children.
• Do not use your tablets after the expiry date which is stated on the carton {EXP}. The expiry date refers to the last day of that month.
• Store below 250C in the original package.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away any medicines that you no longer use. These measures will help to protect the environment.
| 6. Contents of the pack and other information |
• The active substance is atenolol
• The other ingredients are:microcrystalline cellulose (E460), lactose monohydrate, sodium starch glycollate, magnesium stearate (E572), sodium lauryl sulphate, colloidal anhydrous
silica, hypromellose 50, ethylcellulose 45, diethylphthalate, opaspray k-1-2433 orange (which contains E110 (sunset yellow FCF) (Titanium dioxide)), methanol and methylene chloride. What Atenolol Tablets look like and contents of the pack.
• Atenolol 50mg Tablets are orange, circular, film coated tablets plain on one side and marked A over 50 on the other.
• Atenolol 100mg Tablets are orange, circular, film-coated tablets plain on one side and marked A over 100 on the other.
• They are available in packs of 28, 30, 50, 56, 60, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
E-mail: info@bristol-labs.co.uk
Atenolol 50mg Film-coated Tablets; PL 17907/0094 Atenolol 100mg Film-coated Tablets; PL 17907/0095 This leaflet was last revised in February 2014
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
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