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Atenolol Tablets Bp 100mg

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PATIENT INFORMATION LEAFLET

ATENOLOL TABLETS BP 50mg AND 100mg

What you should know about Atenolol Tablets BP

Please read this carefully before you start to take your medicine. If you would like further information, have any questions or are not sure about anything, ask your doctor or pharmacist.

The name of your medicine is Atenolol Tablets BP 50mg or 100mg.

What is in your medicine?

Each tablet contains 50mg or 100mg of the active ingredient, atenolol BP. The other ingredients are microcrystalline cellulose, lactose, sodium starch glycollate, magnesium stearate, sodium lauryl sulphate, colloidal silicon dioxide, hydroxypropyl methylcellulose, ethylcellulose, diethylpththalate and orange colour containing sunset yellow lake (E110) and titanium dioxide (E171).

The active ingredient, atenolol, belongs to a group of medicines known as beta-blockers (beta-adrenoceptor blocking agents or antagonists).

The product is supplied in packs of 1 28, 30, 50, 56, 60, 100, 250, 500 and 1,000.

The product licence holder is: Sandoz Ltd, Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.

The manufacturer is: IPCA Laboratories Ltd, Plot No 255/1, Village Athal, Silvassa, India. Uses

Atenolol Tablets are used to treat hypertension (high blood pressure), angina pectoris (pain in the chest due to insufficient oxygen reaching the heart muscle), cardiac dysrhythmias (disturbances of heart rhythm) and for early intervention in the acute phase of myocardial infarction (heart attack).

Before taking your medicine

DO NOT take this medicine before telling your doctor if:

•    you are, or might be pregnant, or you are breast-feeding,

•    you have experienced sensitivity to atenolol, beta-blockers, or any of the other ingredients in this medicine,

•    you currently have bronchitis, asthma or other breathing difficulties, or a history of any of these

•    you have an extremely slow heart beat or suffer from missed beats (heart block),

•    you suffer from heart failure which is poorly controlled,

•    you suffer from sick sinus syndrome,

•    you are suffering from shock induced by heart circulatory collapse,

•    you have low blood pressure,

•    you have circulatory problems,

•    you have an untreated tumour of the adrenal glands,

•    you suffer with diabetes,

•    you are undertaking prolonged fasting, or prone to hypoglycaemia

•    you have an alcohol problem, or

•    you have kidney problems or you are on dialysis.

It is very important that you tell your doctor if you are taking any other medication, especially disopyramide, verapamil, nifedipine, quinidine, amiodarone, hydralazine, moxisylyte cardiac glycosides such as digoxin or digitoxin (all used for the treatment of heart problems including high blood pressure, angina or heart failure), or any other medicines for high blood pressure; monoamine oxidase (MAO) inhibitors such as phenelzine and other antidepressant medicines (for depression); insulin or oral anti-diabetic medicines; cimetidine (for stomach ulcers and digestive disorders); prostaglandin synthetase inhibiting drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) eg aspirin, ibuprofen, etc (for pain and inflammation); nasal decongestants such as phenylephrine or cold/flu preparations containing these; bronchodilators such as salbutamol, terbutaline (for asthma and respiratory difficulties); barbiturates including phenobarbitone (for epilepsy), phenothiazides eg chlorpromazine and trifluoperazine (for the treatment of psychoses), tropisetron (used to treat nausea and vertigo), anti-malaria drug (i.e. mefloquine), corticosteroids (e.g. hormone replacement), the contraceptive pill, heart stimulants like adrenaline, parasympathomimetics (e.g.pyridostigmine used to treat myasthenia gravis), anxiolytics and hypnotics such as diazepam, diuretics (often used to control hypertension), Ergotamine and Ergometrine (use to treat migraines), also medicines known as Alpha-blockers or Angiotensin-II Antagonists used to treat high blood pressure (e.g. prazosin or telmisartan) and certain parasitic worm treatments such as piperazine. You should also tell your doctor if you are taking any medicines you can buy without a prescription.

If you are going to have an operation involving an anaesthetic, tell the doctor or dentist who will be treating you that you are taking Atenolol Tablets, as the anaesthetist will need to know.

If you drink alcohol while taking atenolol the levels of atenolol in your blood will be enhanced. If you regularly drink alcohol, discuss this with your doctor.

Do not drive or operate machines if you feel tired or dizzy while taking atenolol.

Atenolol Tablets contain the colour E110 which may cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

Taking your medicine

Always follow your doctor’s instructions as to how and when to take your medicine, your pharmacist may be able to advise if you are not sure. Exactly how many tablets, and how often you must take them, will be written on the label. Please read it carefully.

The doses are given below. However, doctors sometimes prescribe different doses to these: if this applies to you, discuss it with your doctor, if you have not already done so.

The tablets should be swallowed whole with water.

Adults:

High blood pressure (hypertension): 1 x 50mg or 1 x 100mg tablet daily. Depending on your initial response, your doctor may adjust your dosage after 1 to 2 weeks or prescribe other medicines for high blood pressure in combination with this therapy.

Angina: 1 x 100mg tablet, once a day or 1 x 50mg tablet, twice a day.

Disturbances of heart rhythm (dysrhythmias): Once your heart rhythm is controlled, 1 x 50mg or 1 x 100mg tablet daily may be given to control your condition.

Heart attack (myocardial infarction): If you suffered a heart attack within the last 12 hours you may have had a slow atenolol injection into a vein. Fifteen minutes after the injection 1 x 50mg Atenolol Tablet may be given, followed by a further 50mg tablet 12 hours after the injection. Twelve hours after the second tablet, 1 x 100mg tablet may be given. Thereafter, 1 x 100mg tablet should be taken once a day.

Elderly patients or those with kidney problems:

If you are elderly, or have kidney problems, the above adult dosages will probably be reduced.

If you have kidney problems your dosage will depend on your body’s rate of clearance/blood levels of creatinine, which is derived from the muscle. If you have a creatinine clearance of 15ml to 35ml/minute/1.73m (equivalent to creatinine in the blood of 300 to 600 micromol/litre) you will be prescribed a dose of 50mg daily. If you have a creatinine clearance of less than 15ml/minute/1.73m (equivalent to creatinine in the blood of greater than 600 micromol/litre) your dose will be 50mg to be taken on alternate days. Patients on dialysis should be given 50mg after each dialysis under hospital supervision.

Children:

Atenolol Tablets are not recommended for children.

DO NOT stop taking the tablets without consulting your doctor as withdrawal may lead to worsening of the basic conditions. The tablets should be withdrawn gradually.

If you have accidentally taken one extra dose, this is unlikely to be a cause for concern. However if you or someone else has taken more than one extra dose or a large overdose, contact your doctor or local hospital accident and emergency department.

If you have forgotten to take your medicine, take it as soon as you remember and your next dose at the usual time. Do not take two doses at the same time. If your next dose is due within 6 hours, do not take the missed dose, but take the next dose at the usual time. If you are concerned, consult your doctor or pharmacist.

As with all medicines you may experience some unwanted effects whilst taking Atenolol Tablets including slow heart beat, a worsening of an existing heart block, low blood pressure, heart failure, cold/bluish-looking fingers and/or toes, Raynaud’s phenomenon (where the arteries of the fingers go into spasm when the hands are cold, symptoms of this are numb, uncomfortable, pale fingers), pins and needles, and an intermittent leg cramp induced by exercise but relieved by rest.

In addition, reports of fatigue, headaches, impaired vision, hallucinations, psychoses, confusion, dizziness, sleep disturbances, nightmares, depression or impotence have been made.

Rarely, gastro-intestinal problems may occur such as nausea, vomiting or diarrhoea.

Difficulties with breathing including wheezing may occur in patients with asthma or who have a history of asthmatic complaints or breathing difficulties. Skin disorders have been reported, especially rash and dry eyes. If you have any of these after starting to take atenolol see your doctor as your medication may need to be reviewed.

Atenolol, in common with other beta-blockers, may mask the symptoms of hypoglycaemia (low blood sugar) and thyrotoxicosis (where there is an excessive amount of thyroid hormones in the blood). If you are worried about either of these, discuss it with your doctor.

If you have any of these effects and they become severe or upsetting, or you experience any other unpleasant effects which you think could be due to taking Atenolol Tablets, you should contact your doctor or pharmacist for advice.

Storing your medicine

Do not take Atenolol Tablets after the expiry date shown on the label. Any out of date medicines should be returned to your pharmacist for disposal.

Atenolol Tablets should be stored in cool, dry place and protected from light.

If you notice any visible signs of deterioration in your tablets or defects such as chipped or broken tablets, take them to your pharmacist for advice before taking them.

Date of revision: January 2004.

Keep all medicines out of the reach and sight of children. Your medicines can harm them.

REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others, it may harm them even if their symptoms are the same as yours.

This leaflet applies to Atenolol Tablets BP 50mg and 100mg only.

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Only marketed pack sizes will be shown.