PATIENT INFORMATION LEAFLET

I— co

CO    _

¹ ATENOLOL Tablets 25mg, 50mg and I00mg

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet, you may need to read it again. If you have any questions or are not sure about anything, 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Atenolol Tablets are and what they are used for

2.    Before you take Atenolol Tablets

3.    How to take Atenolol Tablets

4.    Possible side effects

5.    How to store Atenolol Tablets

6.    Further information

1.    What Atenolol Tablets are and what they are used for

This medicine is called a beta-blocker. It acts on the heart and decreases blood pressure. The medicine can help to reduce your blood pressure or treat your chest pain (angina). It may also help to keep your heart beating regularly if you have palpitations or to protect it after a heart attack.

2.    Before you take Atenolol Tablets

Do not take these tablets if:

•    you are allergic to atenolol or to any of the other ingredients of this medicine (see section 6)

•    you have low blood pressure

•    you have very poor circulation

•    you have phaeochromocytoma (high blood pressure caused by a tumour, usually near the kidney) which is not being treated

•    you suffer from metabolic acidosis (abnormal levels of acid in your blood)

•    you have another heart problem such as second or third degree heart block or uncontrolled heart failure

•    you have a slow or uneven heartbeat

•    you have or have had breathing problems such as asthma, wheezing or reversible obstructive airways disease. Do not take this medicine if you have wheezing or asthma. Talk to your doctor first.

Check with your doctor before taking these tablets if:

•    you have a condition called Prinzmetal's angina

•    you are going to have an operation

•    you are diabetic (signs of low blood sugar levels may be hidden by this medicine)

•    you have an over active thyroid gland (this medicine may hide the symptoms such as increased heart rate and appetite, tremor or sweating)

•    you have    myasthenia gravis (muscle weakness)

•    you have    problems with your liver or kidneys

•    you have    mental depression

•    you have    or have had psoriasis

•    you have    Raynaud's Syndrome, any other blood vessel disease or blood    circulation problem

•    you have    a condition known as ischaemic heart disease or any other    heart    disease

•    you have    heart failure, first degree heart block or poor heart function

•    you have    tiredness or ankle swelling due to heart disease

•    you get allergic reactions for example to insect bites

•    you are pregnant, planning to become pregnant or breastfeeding

•    you are elderly (as you may need to take a lower starting dose than the usual adult dose).

Speak to your doctor if any of the above applies to you, or if you are unsure about anything.

Taking other medicines:

Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are being treated with:

•    insulin or any other anti-diabetic medicine

•    anti-inflammatory medicines used to treat general aches and pains as well as arthritis, e.g. indometacin, ibuprofen and aspirin

•    medicines known as xanthines such as aminophylline or theophylline for asthma

•    medicines known as phenothiazines (including chlorpromazine, pericyazine or fluphenazine), which are used as tranquillisers, sedatives and anti-nausea medicines

•    medicines to treat high blood pressure and the heart such as clonidine, diazoxide, reserpine, disopyramide, amiodarone, quinidine, isoprenaline, dobutamine, calcium-channel blockers (e.g. verapamil, diltiazem, nifedipine) or alpha-blockers (e.g. prazosin, afluzosin, terazosin)

•    the hormone oestrogen (e.g. oral contraceptives, HRT products)

•    digoxin for heart failure

•    adrenaline (epinephrine), a heart stimulant or noradrenaline (norepinephrine) to treat very low blood pressure

•    antidepressants, e.g. amitriptyline or barbiturates e.g. phenobarbital

•    monoamine oxidase inhibitors used to treat depression (e.g. phenelzine) or those used to treat pneumonia, skin and soft tissue infections (e.g. linezolid). Atenolol should not be taken whilst taking a monoamine oxidase inhibitor

•    ergotamine, an anti-migraine drug and the medicine ergometrine to control bleeding

•    thymoxamine (moxisylyte) for Raynaud's Syndrome.

Other special warnings:

It is also important to consult your doctor if you are to be given an anaesthetic or to be treated with muscle relaxants such as gallamine, metocurine, pancuronium or tubocurarine. Your doctor may decide that your atenolol medicine needs to be discontinued before surgery.

Alcohol: You are advised to avoid alcohol whilst taking this medicine.

Driving and operating machinery:

Some people may occasionally feel dizzy or tired whilst taking these tablets. This should be taken into account if you are intending to drive or operate machinery.

Important information about one of the ingredients of Atenolol Tablets:

These tablets contain sunset yellow (E110), which may cause allergic reactions.

3.    How to take Atenolol Tablets

The tablets should be swallowed whole with a drink of water.

Try to take these tablets at the same time every day. Always take the medicine as directed by your doctor. The label will also tell you how many tablets to take and how often. Ask your doctor or pharmacist for advice if you are worried.

Do not stop taking this medicine unless your doctor tells you to. You may need to stop this treatment gradually.

Adults:

High Blood Pressure:    50mg    - 100mg once a day.

Chest Pain (Angina):    50mg    twice a day or 100mg once a day.

Irregular heartbeat:    50mg - 100mg once a day.

Protection after heart attack:    15 minutes after an injection of atenolol, 50mg should be taken orally followed by another 50mg 12 hours after the

injection and 100mg 12 hours later. 100mg should then be taken once a day.

Elderly: Dosage requirements may be reduced especially in those with impaired kidney function.

Children: These tablets are not recommended for use in children.

If you forget to take a dose: Take your dose as soon as you remember and then your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSES.

If you have taken too many tablets: Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified. Signs of overdose are shortness of breath, low blood sugar, low blood pressure, slow or irregular heart beat, fainting, shock and heart failure.

4.    Possible side effects

Like all medicines atenolol may sometimes cause side effects although not everybody gets them.

If you notice any of the following effects contact your doctor straight away as they may be signs of an allergic reaction:

•    difficulty breathing • skin rash with itching or raised lumps on your skin

•    swelling of the face, lips, mouth, tongue or throat.

Also tell your doctor straight away, if you notice any of the following effects:

•    shortness of breath together with swollen ankles (as these may be signs of heart failure or worsening of existing heart failure)

•    abnormal heart beat with dizziness, tiredness or fainting (may be signs of worsening of existing heart block) or these effects and the veins in your neck sticking out (which may be signs of circulatory collapse)

•    limping or cramp-like pains and weakness in the legs which disappears when resting; numb and pale fingers, toes and/or nose (or worsening of these if you already suffer from them).

Other possible side effects

Common effects (that may happen to less than 1 in 10 people):

•    nausea (feeling sick), vomiting, diarrhoea, constipation • tiredness • slow or irregular heartbeat

•    low blood pressure (signs include light-headedness, fainting) • tired or aching muscles

•    shortness of breath • seizures (fits) • bluish discolouration of the fingers and toes or cold hands and feet.

Uncommon effects (that may happen to less than 1 in 100 people):

•    disturbed sleep.

Rare effects (that may happen to less than 1 in 1,000 people):

•    headache, dizziness (particularly on standing up) • disturbances of vision and dry eyes

•    breathing difficulties in people with asthma or who have had asthma in the past

•    chest pain • tingling hands • dry mouth • thinning hair

•    decreased sex drive and impotence (unable to get an erection)

•    nightmares, difficulty in sleeping, hallucinations, changes in personality, confusion, mood changes

•    skin rashes, red scaly patches or worsening of this if you already have psoriasis

•    reduced numbers of platelets in the blood which may cause easier bruising or bleeding and purplish marks on the skin

•    liver problems or disease, signs include yellowing of the eyes or the skin, itching, dark urine and pale stools.

Very rare effects (that may happen to less than 1 in 10,000 people):

•    increased levels of antibodies in your blood. Your doctor may take blood samples every so often to check whether atenolol has had any effect on your blood.

The following other effects may occur:

•    depression, swollen ankles and lower legs, paler skin due to poor blood flow to the skin.

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 Atenolol Tablets

Do not store above 25°C. Store in the original package or keep tablet container tightly closed in order to protect the tablets from moisture.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6.    Further information

Ingredients

Atenolol Tablets are available in 3 strengths. Each tablet contains either 25mg, 50mg or 100mg of atenolol as the active ingredient.

They also contain the inactive ingredients: calcium hydrogen phosphate, povidone, pregelatinised starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, orange coating (containing hypromellose, quinoline yellow E104, sunset yellow E110, titanium dioxide E171) and hypromellose. Additionally, the 100mg tablets also contain hydroxypropylcellulose and macrogol.

What the medicine looks like

Atenolol Tablets 25mg are orange, film coated, round tablets with the company logo on one side and A511 on the other.

Atenolol Tablets 50mg are orange, film coated, round tablets with the company logo on one side and A431 on the other.

Atenolol Tablets 100mg are orange, film coated, round tablets with the company logo on one side and A432 on the other.

Atenolol Tablets are supplied in blister packs of 28, 30, 56, 84 tablets or in bulk tablet containers of 1000 tablets. (Not all pack sizes may be marketed). Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED Date leaflet revised October 2013

If you would like this leaflet in a different format please contact the licence holder at the above address.