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ENT INFORMATION LEAFLET

Atenolol 25mg, 50mg and 100mg 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, ask your doctor or pharmacist.

This medicine has been prescribed for you only.

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. See section 4

WHAT ATENOLOL IS AND WHAT IT IS USED FOR?

Atenolol belongs to a class of medicines called beta-blockers, which help slow the heart beat and relax blood vessels. This reduces blood pressure and the heart's demand for oxygen.

Atenolol is used to treat the following conditions:

High blood pressure (hypertension)

Chest pain (angina): Atenolol helps prevent or reduce chest pains which may occur when your heart cannot get enough oxygen, such as when doing exercise. Irregular heart beat: Atenolol helps control abnormal heart beats, by slowing the heart rate. Protect the heart after a heart attack: Atenolol helps reduce the damage to the heart if taken shortly after a heart attack and decrease the risk of continued illness.

0 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATENOLOL

You should only take this medicine if your doctor tells you to.

Do not take Atenolol if:

You are allergic to Atenolol or any of the ingredients of this medicine (listed in section 6)

You have heart problems such as:

- uncontrolled heart failure, which can cause shortness of breath or ankle swelling - 2nd or 3rd degree heart block, which may be treated with a pacemaker - weakened heart (cardiogenic shock)

- a slow heart rate (less than 45 beats per minute) or uneven heart beats (sick sinus syndrome)

You have low blood pressure You have very bad circulation.

You have untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney) You suffer from an increased acidity of the blood (metabolic acidosis)

Warnings and precautions Talk to your doctor before taking Atenolol

•    If you are an elderly person.

^•    If you have a tumor called phaeochromocytoma.

If you are unsure whether Atenolol Tablets are suitable for you, please discuss this with your doctor.

Other medicines and Atenolol

Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines, even those bought without a prescription or herbal preparations. You can take Atenolol Tablets with other medicines but there are some medicines, which can interfere with its actions, in particular, any of the following medicines:

^•    Medicines for regulating the heartbeat such as disopyramide, quinidine and amiodarone.

^•    Insulin and oral antidiabetic medicines to treat diabetes, such as metformin.

^•    Verapamil, diltiazem and nifedipine (for high blood pressure and chest pains (angina).

^•    Medicines for heart failure, such as digoxin (digitalis glycosides).

^•    Medicines which stimulate the heart, such as adrenaline known as epinephrine and noradrenaline known as norephinephrine (sympathomimetic amines).

^•    Medicines to relieve pain and inflammation, such as ibuprofen and indometacin (non-steroid antiinflammatory drugs - NSAIDs).

^•    Clonidine for high blood pressure or migraine.

If clonidine and Atenolol Tablets are used together your doctor will advise you to stop taking Atenolol Tablets several days before stopping clonidine. If Atenolol Tablets are going to be used instead of clonidine, your doctor will probably advise you to begin taking Atenolol Tablets several days after clonidine has been stopped.

^•    Alpha blockers to treat high blood pressure such as prazosin, alfuzosin, terazosin.

^•    Tricyclic antidepressants (medicine to treat depression e.g.amitriptyline, imipramine).

^•    Barbiturates(medicines to treat insomnia, epilepsy or as an anaesthetic e.g.phenobarbital).

^•    Phenothiazines(medicine to treat mental illness e.g. chlorpromazine).

Atenolol with food, drink and alcohol

You are advised to avoid alcohol whilst taking this medicine; it may cause an increased effect of low blood pressure.

Surgery

Atenolol Tablets may react with certain anaesthetics, so in the event you need any form of surgery, you should tell the medical staff at the hospital that you are taking Atenolol Tablets.

If you are told to stop taking Atenolol Tablets this must be at least 24 hours before surgery.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breast-feeding is not recommended whilst taking this medicine.

Driving and using machines

Atenolol Tablets are unlikely to have a serious effect on your ability to drive or use machinery. On rare occasions though you may feel a bit dizzy or more tired than usual. If this happens, do not drive or operate machinery

If you have ever had asthma or wheezing, you should not take this medicine unless you have discussed these symptoms with the prescribing doctor.

If you suffer from heart conditions such as, heart failure, controlled heart failure, a slow heart rate (5055 beats per minute), heart block (due to abnormal heart function).

If you have a type of chest pain (angina) called Prinzmetal's angina.

If you have low blood sugar levels. Atenolol Tablets may hide an increase in your heart rate, which is one of the warning signs of low blood sugar levels.

It may also reduce your body's sensitivity to insulin. If you have high levels of thyroid hormone in your body (thyrotoxicosis). Atenolol Tablets may hide the symptoms.

If you have kidney or liver problems. You may require a lower dose than stated.

If you have poor circulation (Raynaud's disease, intermittent claudication) as Atenolol Tablets may make the condition worse.

If you have allergies as Beta-blockers may increase the allergies and the seriousness of the allergic reaction.

If you have a skin disease causing scaly pink patches (Psoriasis).

If you are stopping treatment as this must be done gradually (see section 3). You should be monitored by your doctor when stopping treatment, especially if you have ischaemic heart disease.

If you are due to undergo surgery or a medical procedure under a general anaesthetic, please inform your doctor or anaesthetist that you are on Atenolol.

Important information about some of the ingredients of Atenolol Tablets

•    Atenolol 100mg Tablets contain the Azo colouring agent Sunset Yellow FCF (E110),

which may cause allergic reaction.

•    Atenolol 25mg, 50mg and 100mg Tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

HOW TO TAKE ATENOLOL

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Atenolol Tablets are for oral use only.

The recommended doses are:

High blood pressure (hypertension):

Normal dose is 100mg tablet daily. Some patients may respond better to one 50mg tablet daily. After 1 or 2 weeks of treatment, your high blood pressure should return to normal. If necessary your doctor may also prescribe you other antihypertensive medicines to reduce the blood pressure further.

Chest pain (angina pectoris):

Normal dose is one 100mg tablet once a day or one 50mg tablet twice a day.

Abnormal heart rhythm (cardiac dysrhythmias):

The initial step may be an injection to control the rhythm. To maintain your heart rhythm, the normal dose is one 50mg tablet or one 100mg tablet daily.

continued...

Till-Ver.8.1s

Heart attack (myocardial infarction):

Within 12 hours of chest pain and following an injection, if there are no side effects you may be given a 50mg Atenolol Tablet, followed by another 12 hours later. Another 12 hours after this a 100mg tablet is given once daily. Your doctor will monitor you closely since if your heart rate lowers or if you suffer from high blood pressure it may be necessary to stop treatment with Atenolol Tablets.

Elderly patients: the doses may need to be reduced, particularly if you suffer from kidney problems.

If you suffer from kidney failure: your doctor will advise you of the correct dose to take since Atenolol passes through the kidneys.

Atenolol is not recommended for use in children.

If y ou forget to take Atenolol

Take it when you remember, but if it is near to the time your next dose is due then take your normal dose as per normal. Do not take a double dose to make up for a forgotten tablet.

If you take more Atenolol than youshould

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. Symptoms of an overdose include a slow or irregular heartbeat, low blood pressure, difficulty breathing due to fluid in the lungs, acute impaired heart function, shock and fainting.

Do not stop taking Atenolol Tablets unless told to do so by your doctor. Stopping treatment with beta-blockers such as Atenolol Tablets should always be gradual and over a period of 10-14 days.

If you have any further questions on the use of 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

If you notice any of the side effects listed below or any not listed, please tell your doctor or pharmacist immediately.

Contact your doctor immediately if you have the following:

•    Allergic reaction, such as itchy rash, difficulty breathing, swelling of your face or throat.

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

Other possible side effects

Common (may affect up to 1 in 10 people)

•    Slower heart beat

•    Cold hands and feet

•    Diarrhoea

^•    Feeling sick (Nausea)

^•    Feeling tired

^•    Muscles feeling tired or exhausted

Uncommon (may affect up to 1 in 100 people)

•    Disturbed sleep.

•    Increase in liver enzyme levels (detected through blood tests)

Rare (may affect up to 1 in 1,000 people)

•    Heart block (which can cause dizziness, abnormal heart beat, tiredness or fainting)

•    Mood changes

•    Nightmares

^•    Difficulty in sleeping (insomnia)

^•    Feeling confused

^•    Changes in personality (psychoses), seeing or hearing things that are not real (hallucinations)

^•    Headache

^•    Dizziness

^•    Tingling or numbness in the hands or feet

^•    Light-headedness, fainting or dizziness especially when going from sitting or lying position to standing up (postural hypotension)

^•    Worsening of existing cramping pains causing limping (intermittent claudication)

^•    Poor blood circulation which makes the toes and fingers numb and pale

^•    Being unable to get an erection (impotence)

^•    Dry mouth

^•    Dry eyes

^•    Disturbances of vision

•    Hair loss

•    Skin rash or worsening of psoriasis

•    Reduced numbers of platelets in your blood, which may increase the risk of bleeding or bruising (thrombocytopenia)

•    Purplish marks on your skin

•    Skin rash caused by small blood vessels bleeding into the skin

•    Jaundice (causing yellowing of your skin or the whites of your eyes)

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

Not known (frequency cannot be estimated from the available data)

•    Depression

^•    Blue colouration on fingers and toes (Cyanotic extremities)

^•    Vomiting

^•    Serious allergic reaction which causes swelling of the face and throat (angioedema)

^•    Skin rashes with the formation of wheals (urticaria)

Other side effects

^•    Masked symptoms of overactive or enlarged thyroid (thyrotoxicosis)

^•    Masked symptoms of lack of glucose in the bloodstream (hypoglycaemia)

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 internet on

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 ATENOLOL

Keep this medicine out of the sight and reach children.

Store in the original package in order to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton after 'EXP', The expiry 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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Atenolol contain:

Active substance:

Each Atenolol 25mg Tablet contains 25mg of Atenolol Each Atenolol 50mg Tablet contains 50mg of Atenolol Each Atenolol 100mg Tablet contains 100mg of Atenolol

The other ingredients are:

Lactose, microcrystalline cellulose, talc, maize starch, povidone, lactose (tablettose), sodium starch glycollate, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, titanium dioxide (E171),

PEG 6000 and methylcellulose.

Atenolol 100mg Tablets also contain the colouring agent Sunset Yellow FCF (E110).

See Important Information about of the ingredients of Atenolol (bottom of Section 2 on page 1, second column)

What Atenolol looks like and the contents of the pack:

Atenolol Tablets are available in three strengths:

Atenolol 25mg Tablets: white round bi-convex film coated, unscored tablet marked "A25" of approximate size 6.4mm X 3.2mm (Product Licence No.

11311/0019)

Atenolol 50mg Tablets: white/off-white round bi-convex film coated, unscored tablet marked "A50" of approximate size 8.8mm X 3.6mm (Product Licence No. 11311/0014)

Atenolol 100mg Tablets: orange bi-convex film coated, unscored tablet marked "A100" of approximate size 10.4mm X 4.9mm (Product Licence No. 11311/0015)

All 3 strengths of Atenolol Tablets are available in pack sizes of 28 tablets. A plastic container containing 100 tablets may also be available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder & Manufacturer:

Tillomed Laboratories Ltd.

3 Howard Rd,

Eaton Socon, St. Neots.

Cambs, PE19 8ET UK

The leaflet was last revised in October 2013.

Product Name

Atenolol

Strength / Form	25mg, 50mg and 100mg Tabs
Type	Combined PIL
Dimensions	160 x 360 mm
Typefaces	Font SansSerif - Min. Text 8pt
Rev #	Till-Ver.8.1s
Last updated	06/11/13
No. of Colours	Pantone Black CVC