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Atenolol Tablets 100mg

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ATENOLOL 25 mg, 50 mg AND 100 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What Atenolol is and what it is used for

2.    Before you take Atenolol

3.    How to take Atenolol

4.    Possible side effects

5.    How to store Atenolol

6.    Further information

WHAT ATENOLOL IS AND WHAT IT IS USED FOR

*    Atenolol belongs to a group of drugs called beta-blockers, which affect the heart and circulation.

*    Atenolol Tablets are used in the management of angina pectoris (chest pain) and cardiac arrhythmias (heartbeat irregularities). It may also be used immediately following a heart attack.

DO NOT take Atenolol if you:

*    are allergic (hypersensitive) to atenolol or any of the other ingredients of this medicine

*    have a history of wheezing or asthma, or suffer from reversible obstructive airways disease

*    suffer from metabolic acidosis (an imbalance of the body's acid-base balance)

*    have an abnormal heart beat

*    suffer from low blood pressure

*    suffer from untreated heart failure

*    have an untreated phaeochromocytoma (tumour of the adrenal gland)

*    have any blood circulation problems

*    have severe narrowing of the arteries in your legs

*    suffer from a heart blockage

*    have a heart rhythm problem

*    suffer from Prinzmetal's angina (cardiac chest pain).

Take special care with Atenolol

Tell your doctor before you start to take this medicine if you:

*    have a history of allergic reactions

*    have first degree heart block or controlled heart failure

*    have low blood sugar levels

*    have an overactive thyroid gland

*    have kidney disease

*    are pregnant or breast-feeding

*    have some narrowing of the arteries in your legs

*    suffer from high blood pressure (caused by the portal artery in the heart)

*    suffer from Myasthenia gravis (causes muscle weakness).

Taking other medicines

Talk to your doctor if you are taking any of the following:

*    drugs to treat irregular heart rhythms, e.g. disopyramide, verapamil or diltiazem

*    clonidine (another drug used to treat high blood pressure), digitalis or a calcium channel blocker (e.g. nifedipine)

*    heart stimulating drugs such as dopamine, terbutaline, salmeterol, salbutamol, ephedrine, adrenaline, or phenylpropanolamine (phenylpropanolamine and ephedrine may be present in medicines for colds and nasal stuffiness)

*    anti-inflammatory pain-killers, e.g. ibuprofen or indometacin

*    insulin or oral diabetic drugs e.g. glibenclamide.

Tell your doctor or dentist you are taking Atenolol tablets if you are about to undergo surgery requiring anaesthetic.

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

Pregnancy and breast-feeding

*    If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor for advice before taking this medicine.

Driving and using machines

*    Atenolol may cause dizziness and fatigue, if affected do not drive or operate machinery.

Important information about some of the ingredients of Atenolol

*    Patients who are intolerant to lactose should note that Atenolol tablets contain a small amount of 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.

*    Sunset yellow (E110) and Ponceau red (E124) colouring, can cause allergic reactions, including asthma.This reaction is more common in those people who are allergic to aspirin.

HOWTO TAKE ATENOLOL

Always take Atenolol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed, preferably with a glass of water. Atenolol can be taken with or without food.

The usual dose is:

Adults

*    High blood pressure:

50 - 100 mg once a day.

*    Angina:

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

*    Abnormal heart rhythms:

The initial dose will be given by infusion.Thereafter, the maintenance dose is usually 50 - 100 mg taken once a day.

*    Treatment following a heart attack:

The initial dose will be given by infusion.This is followed by a 50 mg oral dose of Atenolol 15 minutes later. Another 50 mg oral dose of Atenolol is given approximately 12 hours after the infusion.Thereafter, the usual dosage is 100 mg of Atenolol taken once a day.

*    Kidney problems:

Patients with kidney problems may be given a reduced dosage to that described for adults above.

Haemodialysis patients usually take 50 mg following each dialysis.

Children

Atenolol is not recommended for use in children.

The Elderly

The adult dosage above may be reduced in the case of elderly patients, particularly in those with kidney problems.

If you take more Atenolol than you should

If you or someone else takes too many tablets, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause slow heart beat, high blood pressure, heart beat irregularities and difficulty breathing or wheezing.

Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Atenolol

If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

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

Stop taking the tablets and tell your doctor immediately

or go to the casualty department at your nearest hospital if the following happens:

*    an allergic reaction causing swelling of the lips, face or neck leading to breathing problems, or skin rash or hives, or if the skin becomes yellow (jaundice).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately if you experience any of the

following effects:

Effects on the heart

*    deterioration of heart failure

*    a slowing of the heart rate (heart block)

*    pain in your calves or legs

*    dizziness or fainting on standing up

*    cold hands and/ or feet, particularly if you have Raynaud's disease.

Effects in the blood

*    an increase in particular types of antibodies in the blood

*    a reduction in the number of red blood cells in the circulation

*    purpura (a particular blood disorder characterised by unusual bleeding or unexplained bruising or purplish spots under the skin).

Effects on the nervous system

*    dizziness

*    headaches.

Effects on breathing

*    if you suffer from bronchial asthma or have a history of asthma you could experience a tightening and spasms of the chest

*    problems breathing or wheezing.

Effects on the digestive system

*    liver problems (such as an increase in some types of liver

enzymes, or liver damage including bile duct problems)

*    dry mouth

*    abdominal pain (diarrhoea, constipation).

Effects on skin or eyes

*    dry eyes or blurring

*    skin rashes

*    reversible hair loss

*    patches of thickened and sore skin

*    psoriasis can be made worse, whilst taking this medicine. Effects on reproduction

*    impotence (inability to have or maintain an erection). Effects on the brain

*    numbness, pins and needles

*    confusion

*    psychoses and hallucinations

*    mood changes

*    sleep disturbances

*    nightmares.

Other

*    tiredness.

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.

HOWTO STORE ATENOLOL

Keep out of the reach and sight of children.

Do not store above 25°C. Do not transfer to another container. Do not use Atenolol after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month.

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 Atenolol tablets contain:

*    Each tablet contains either 25 mg, 50 mg or 100 mg of the active ingredient atenolol.

*    The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium and magnesium stearate (E572), colloidal anhydrous silica.The tablet coating contains hypromellose (E464), polyethylene glycol and the colour titanium dioxide (E171).

*    The 50 and 100 mg tablet coatings also contain the colours sunset yellow (E110), quinoline yellow (E104) and ponceau red (E124).These tablets are polished with carnauba wax.

What Atenolol tablets looks like and contents of the pack:

*    The 25 mg tablets are white film coated tablets, engraved 3U1 on one side and plain on the reverse.

*    The 50 mg tablets are orange film coated tablets, engraved 1U1 on one side and plain on the reverse.

*    The 100 mg tablets are orange film coated tablets, engraved 2U1 on one side and plain on the reverse.

*    The product is available in pack sizes of 28, 30, 50, 100, 250, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible

for manufacture:TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: February 2011

PL 00289/0732-0734