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Atenolol Tablets Bp 50mg

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Atenolol 25mg, 50mg and 100mg tablets



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.


Index

j What Atenolol tablets are and what they are used for ^ Before you take How to take Possible side effects How to store Further information


Take special care with Atenolol tablets and tell your doctor if you:

•    have a history of allergic reactions

•    have heart problems such as heart failure, untreated congestive heart failure, ischaemic heart disease, poor heart function (poor cardiac reserve) or first degree heart block.

•    suffer from blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue) or cramping pain causing limping (intermittent claudication).

•    suffer with diabetes mellitus (low blood sugar levels may be hidden by this medicine)

•    have impaired liver or kidney function.

•    are elderly.

•    suffer from a tight, painful feeling in the chest in periods of rest (Prinzmetal's angina)

•    have or have had psoriasis.

•    suffer from treated phaeochromocytoma (high blood pressure due to a tumour near the kidney).

•    have high levels of thyroid hormone in the body (thyrotoxicosis).


j What Atenolol tablets are and what they are used for

Atenolol belongs to a group of medicines called beta-blockers.

It is used to:

•    control high blood pressure.

•    relieve chest pain (angina pectoris).

•    control irregular heart beat.

•    protect the heart in the early treatment after a heart attack.

^1 Before you take

Do not take Atenolol tablets and tell your doctor if you:

•    are allergic (hypersensitivite) to atenolol or any of the other ingredients in Atenolol tablets (see section 6).

•    have second or third degree heart block.

•    have shock caused by heart problems.

•    have heart failure which is not under control.

•    suffer with heart conduction or rhythm problems

•    have a slow heart rate

•    have low blood pressure.

•    suffer from severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue)

•    suffer from an increased acidity of the blood (metabolic acidosis)

•    suffer from untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney).

•    have or have had breathing problems such as asthma, difficulty breathing due to narrowing of the airways or reversible obstructive airways disease. Do not take this medicine if you have a history of wheezing or asthma. Consult your doctor or pharmacist first.


Taking other medicines

Please tell your doctor or pharmacist if you are taking or

have recently taken any other medicines, including medicines

obtained without a prescription. Especially:

   clonidine (to treat high blood pressure)

   disopyramide, quinidine and amiodarone (to treat irregular heartbeat (arrhythmia)

•    medicines to treat diabetes including insulin

•    Non-Steroidal Anti-Inflammatory Drug (NSAIDs) e.g. indometacin

   digitalis glycosides such as digoxin (to treat heart conditions)

   nifedipine, diltiazem, verapamil, prazosin, alfuzosin and terazosin (to treat high blood pressure)

   sympathicomimetic agents (decongestant, asthma or heart medicine)

   isoprenaline or dobutamine (widens blood vessels)

   tricyclic antidepressants e.g. amitriptyline

   barbiturates e.g. phenobarbital (used for insomnia, epilepsy or as an anaesthetic)

   phenothiazines e.g. chlorpromazine (for mental illness).


Pregnancy and breast-feeding

If you are pregnant or planning to become pregnant, speak to your doctor before taking this medicine.

Breast-feeding is not recommended whilst taking Atenolol tablets.


Alcohol intake

You are advised to avoid alcohol whilst taking this medicine.

Driving and using machines

Atenolol tablets may cause dizziness or tiredness. Make sure you are not affected before driving or operating machinery.

Anaesthetics and surgery

If you are going to have an operation or an anaesthetic, please tell your doctor or dentist that you are taking Atenolol tablets as your heart beat might slow down too much and there may be an increased risk of developing low blood pressure.

Continued over page


How to take

Always take Atenolol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Take the tablets with water Doses:

Adults and children over 12 years

   High blood pressure: 50-100mg a day as a single dose.

   Angina: 100mg once a day or 50mg twice a day.

   Irregular heart beat: initial treatment will usually be by injection, followed by a maintenance dose by mouth of 50-100mg a day as a single dose.

   After a heart attack: initial treatment will usually be by injection, if no response followed by 50mg by mouth 15 minutes after the injection. A further 50mg 12 hours later and then 100mg 12 hours later. 100mg to be taken once a day thereafter.

Elderly

Your doctor may prescribe you a lower dose if you are elderly, especially if you have impaired kidney function.

Children under 12 years

Not recommended.

Patients with kidney failure

Your doctor may prescribe you a lower dose if you have kidney failure.

   Mild to moderate kidney failure - 50mg a day or 100mg once every two days

   Moderate to severe kidney failure - 50mg once every two days or 100mg once every four days

Patients on haemodialysis should be given 50mg after each dialysis.

If you take more than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once. Symptoms of an overdose include a slow or irregular heart beat, low blood pressure, difficulty breathing due to fluid on the lungs, acute impaired heart function and shock, fainting.

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Never double up on the next dose to make up for the one missed.

If you stop taking the tablets

Do not stop treatment early, especially if you have ischaemic heart disease. Talk to your doctor before you stop taking the tablets and follow their advice.

^ Possible side effects

Like all medicines, Atenolol tablets can cause side effects, although not everybody gets them.

Contact your doctor at once if you have the following:

   an allergic reaction such as itching, difficulty breathing or swelling of the face, lips, throat or tongue.

   altered numbers and types of your blood cells. If you

notice increased bruising, nosebleeds, sore throats or infections, you should tell your doctor who may want to give you a blood test.

   breathing difficulties caused by narrowing of the airways in patients who have asthma or have had breathing problems.

   heart attack or shock.


Tell your doctor if you notice any of the following side

effects, they get worse or you notice any not listed:

•    Common (less than 1 in 10 users): slow heart beat, feeling sick, cold hands and feet, diarrhoea, tiredness, aching and tired muscles, GI disturbances such as stomach pains, heartburn and constipation.

•    Uncommon (less than 1 in 100 users): increased levels of liver enzymes, sleep disturbances such as difficulty sleeping

•    Rare (less than 1 in 1000 users): disturbances in thinking (depression, mood swings, hallucinations, paranoia -psychoses), confusion, reduced sexual potency in men (impotence), nightmares, headaches, dizziness, 'pins and needles' or tingling in the hands or feet, dry eyes, impaired vision, heart conduction problems (slowed AV-conduction or increase of existing AV-block causing dizziness, fainting or tiredness), heart failure deterioration, Raynauds phenomenon (condition causing pain, numbness, coldness and blueness of the fingers), liver disorders, disorder of the skin especially a rash, hair loss (alopecia), worsening

of psoriasis or skin reactions similar to psoriasis, insomnia, worsening of existing cramping pains causing limping (intermittent claudication), dry mouth, low blood pressure on standing

•    Very Rare (less than 1 in 10,000 users): an increase in anti nuclear antibodies

•    Unknown (can not be estimated from available data): depression, hands and feet which may be blue, being sick, pale or red irregular raised patches with sever itching (hives)

•    Other: symptoms of an overactive thyroid (increased heart rate and appetite, sweating, tremor, anxiety, weight loss and heat intolerance) or low blood sugar (muscle weakness, reduced movements, mental confusion and sweating) may be hidden by Atenolol tablets

T] How to store

Keep out of the reach and sight of children.

Do not store above 25°C.

Store in the original package.

Keep container in the outer carton.

Do not use after the expiry date stated on the label/carton/

bottle. The expiry date refers to the last day of that month.

Ask your pharmacist how to dispose of medicines no longer

required.


Further information

What Atenolol tablets contain

•    The active substance (the ingredient that makes the tablets work) is atenolol. Each tablet contains either 25mg, 50mg or 100mg of the active substance.

•    The other ingredients are: Calcium hydrogen phosphate dehydrate, silica colloidal anhydrous, magnesium stearate, maize starch, crospovidone, propylene glycol, sodium laurylsulphate, hydrogenated vegetable oil, titanium dioxide (E171), cellulose microcrystalline (E460), hypromellose 5cP (E464), purified talc (E553).


What Atenolol tablets look like and the contents of the pack

The tablets are white, circular, biconvex film-coated tablets with a score line on one face, plain on the reverse.

Pack size is 28.


Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in August 2010.


Actavis

Actavis, Barnstaple, EX32 8NS, UK


PhCode


PhCode


^actavis


Atenolol 25mg, 50mg and 100mg tablets

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.

Index

j What Atenolol tablets are and what they are used for ^ Before you take How to take Possible side effects How to store Further information

j What Atenolol tablets are and what they are used for

Atenolol belongs to a group of medicines called beta-blockers. It is used to:

•    control high blood pressure.

•    relieve chest pain (angina pectoris).

•    control irregular heart beat.

•    protect the heart in the early treatment after a heart attack.

^ Before you take

Do not take Atenolol tablets and tell your doctor if you:

•    are allergic (hypersensitivite) to atenolol or any of the other ingredients in Atenolol tablets (see section

6).

•    have second or third degree heart block.

•    have shock caused by heart problems.

•    have heart failure which is not under control.

•    suffer with heart conduction or rhythm problems

•    have a slow heart rate

•    have low blood pressure.

•    suffer from severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue)

•    suffer from an increased acidity of the blood

(metabolic acidosis)

•    suffer from untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney).

•    have or have had breathing problems such as asthma, difficulty breathing due to narrowing of the airways or reversible obstructive airways disease.

Do not take this medicine if you have a history

of wheezing or asthma. Consult your doctor or pharmacist first.

Take special care with Atenolol tablets and tell your doctor if you:

•    have a history of allergic reactions

•    have heart problems such as heart failure, untreated congestive heart failure, ischaemic heart disease, poor heart function (poor cardiac reserve) or first degree heart block.

•    suffer from blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue) or cramping pain causing limping (intermittent claudication).

•    suffer with diabetes mellitus (low blood sugar levels may be hidden by this medicine)

•    have impaired liver or kidney function.

•    are elderly.

•    suffer from a tight, painful feeling in the chest in periods of rest (Prinzmetal's angina)

•    have or have had psoriasis.

•    suffer from treated phaeochromocytoma (high blood pressure due to a tumour near the kidney).

•    have high levels of thyroid hormone in the body (thyrotoxicosis).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

•    clonidine (to treat high blood pressure)

•    disopyramide, quinidine and amiodarone (to treat irregular heartbeat (arrhythmia)

•    medicines to treat diabetes including insulin

•    Non-Steroidal Anti-Inflammatory Drug (NSAIDs) e.g. indometacin

•    digitalis glycosides such as digoxin (to treat heart conditions)

•    nifedipine, diltiazem, verapamil, prazosin, alfuzosin and terazosin (to treat high blood pressure)

•    sympathicomimetic agents (decongestant, asthma or heart medicine)

•    isoprenaline or dobutamine (widens blood vessels)

•    tricyclic antidepressants e.g. amitriptyline

•    barbiturates e.g. phenobarbital (used for insomnia, epilepsy or as an anaesthetic)

•    phenothiazines e.g. chlorpromazine (for mental illness).

Pregnancy and breast-feeding

If you are pregnant or planning to become pregnant, speak to your doctor before taking this medicine. Breast-feeding is not recommended whilst taking Atenolol tablets.

Alcohol intake

You are advised to avoid alcohol whilst taking this medicine.

Driving and using machines

Atenolol tablets may cause dizziness or tiredness. Make sure you are not affected before driving or operating machinery.

Anaesthetics and surgery

If you are going to have an operation or an anaesthetic, please tell your doctor or dentist that you are taking Atenolol tablets as your heart beat might slow down too much and there may be an increased risk of developing low blood pressure.

Continued over page


Continued top of next column L19422IPC-30


25 mm


i'



ft


actavis


How to take

Always take Atenolol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Take the tablets with water Doses:

Adults and children over 12 years

•    High blood pressure: 50-100mg a day as a single dose.

•    Angina: 100mg once a day or 50mg twice a day.

•    Irregular heart beat: initial treatment will usually be by injection, followed by a maintenance dose by mouth of 50-100mg a day as a single dose.

•    After a heart attack: initial treatment will usually be by injection, if no response followed by 50mg by mouth 15 minutes after the injection. A further 50mg 12 hours later and then 100mg 12 hours later. 100mg to be taken once a day thereafter.

Elderly

Your doctor may prescribe you a lower dose if you are elderly, especially if you have impaired kidney function.

Children under 12 years

Not recommended.

Patients with kidney failure

Your doctor may prescribe you a lower dose if you have kidney failure.

•    Mild to moderate kidney failure - 50mg a day or 100mg once every two days

•    Moderate to severe kidney failure - 50mg once every two days or 100mg once every four days

Patients on haemodialysis should be given 50mg after each dialysis.

If you take more than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once. Symptoms of an overdose include a slow or irregular heart beat, low blood pressure, difficulty breathing due to fluid on the lungs, acute impaired heart function and shock, fainting.

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Never double up on the next dose to make up for the one missed.

If you stop taking the tablets

Do not stop treatment early, especially if you have ischaemic heart disease. Talk to your doctor before you stop taking the tablets and follow their advice.

^ Possible side effects

Like all medicines, Atenolol tablets can cause side effects, although not everybody gets them.

Contact your doctor at once if you have the following:

•    an allergic reaction such as itching, difficulty breathing or swelling of the face, lips, throat or tongue.

•    altered numbers and types of your blood cells.

If you notice increased bruising, nosebleeds, sore throats or infections, you should tell your doctor who may want to give you a blood test.

•    breathing difficulties caused by narrowing of the airways in patients who have asthma or have had breathing problems.

•    heart attack or shock.

Continued top of next column L19422IPC-30

Tell your doctor if you notice any of the following side effects, they get worse or you notice any not listed:

•    Common (less than 1 in 10 users): slow heart beat, feeling sick, cold hands and feet, diarrhoea, tiredness, aching and tired muscles , GI disturbances such as stomach pains, heartburn and constipation.

•    Uncommon (less than 1 in 100 users): increased levels of liver enzymes, sleep disturbances such as difficulty sleeping

•    Rare (less than 1 in 1000 users): disturbances in thinking (depression, mood swings, hallucinations, paranoia - psychoses), confusion, reduced sexual potency in men (impotence), nightmares, headaches, dizziness, 'pins and needles' or tingling in the hands or feet, dry eyes, impaired vision, heart conduction problems (slowed AV-conduction or increase of existing AV-block causing dizziness, fainting or tiredness), heart failure deterioration, Raynauds phenomenon (condition causing pain, numbness, coldness and blueness of the fingers), liver disorders, disorder of the skin especially a rash, hair loss (alopecia), worsening of psoriasis or skin reactions similar to psoriasis, insomnia, worsening of existing cramping pains causing limping (intermittent claudication), dry mouth, low blood pressure on standing

•    Very Rare (less than 1 in 10,000 users): an increase in anti nuclear antibodies

•    Unknown (can not be estimated from available data): depression, hands and feet which may be blue, being sick, pale or red irregular raised patches with sever itching (hives)

•    Other: symptoms of an overactive thyroid (increased heart rate and appetite, sweating, tremor, anxiety, weight loss and heat intolerance) or low blood sugar (muscle weakness, reduced movements, mental confusion and sweating) may be hidden by Atenolol tablets

T] How to store

Keep out of the reach and sight of children.

Do not store above 25°C.

Store in the original package.

Keep container in the outer carton.

Do not use after the expiry date stated on the label/ carton/bottle. The expiry date refers to the last day of that month.

Ask your pharmacist how to dispose of medicines no longer required.

Further information

What Atenolol tablets contain

•    The active substance (the ingredient that makes the tablets work) is atenolol. Each tablet contains either 25mg, 50mg or 100mg of the active substance.

•    The other ingredients are: Calcium hydrogen phosphate dehydrate, silica colloidal anhydrous, magnesium stearate, maize starch, crospovidone, propylene glycol, sodium laurylsulphate, hydrogenated vegetable oil, titanium dioxide (E171), cellulose microcrystalline (E460), hypromellose 5cP (E464), purified talc (E553).

What Atenolol tablets look like and the contents of the pack

The tablets are white, circular, biconvex film-coated tablets with a score line on one face, plain on the reverse.

Pack size is 28.

Marketing Authorisation Holder

Actavis, Barnstaple, EX32 8NS, UK.

Manufacturer

Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria

This leaflet was last revised in August 2010.

Actavis, Barnstaple, EX32 8NS, UK