Friday, October 7, 2016

Atenolol Tablets




ATENOLOL TABLETS




Please read this leaflet carefully before you start to take this medicine. It gives an outline of the more important things you need to know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or pharmacist. You should keep this leaflet throughout the course of treatment.





The Name Of Your Medicine Is Atenolol Tablets



Atenolol Tablets contain the active ingredient atenolol. The tablets come in three strengths 25mg, 50mg and 100mg.



Other ingredients in Atenolol 25mg Tablets include maize starch, heavy magnesium carbonate, povidone K30, sodium starch glycollate and magnesium stearate.



Other ingredients in Atenolol 50mg and 100mg Film-Coated Tablets include maize starch, heavy magnesium carbonate, povidone, sodium starch glycollate, magnesium stearate and opadry orange OY-3455 which consists of methylhydroxypropylcellulose (E464), titanium dioxide (E171), polyethylene glycol and quinoline yellow aluminium lake (E104). Also contains sunset yellow FCF (E110), which may cause allergic reactions.



Atenolol 25mg Tablets are white, circular, biconvex tablets with ATL25 on one face and CP or plain on the reverse and contain 25mg of atenolol.



Atenolol 50mg Film-Coated Tablets are orange, circular, biconvex film-coated tablets with ATL50 on one face and CP or plain on the reverse and contain 50mg of atenolol.



Atenolol 100mg Film-Coated Tablets are orange, circular, biconvex film-coated tablets with ATL100 on one face and CP or plain on the reverse and contain 100mg of atenolol.



Atenolol Tablets are available in calendar packs of 28 tablets.




Marketing Authorisation Holder:




Wockhardt UK Limited

Ash Road North

Wrexham

LL13 9UF

UK




Manufacturer:




CP Pharmaceuticals Limited

Ash Road North

Wrexham

LL13 9UF

UK





How Does Your Medicine Work?



Atenolol belongs to a group of medicines known as beta-blockers. These medicines control the heart rate and blood pressure.





What Are Atenolol Tablets For?



Atenolol Tablets are used to reduce high blood pressure, to relieve angina (pains in the chest), to control the rhythm of the heart beat if it has become irregular and to protect the heart after a heart attack.





Before Taking This Medicine




Do not take Atenolol Tablets if you:-



  • have ever had a reaction or been told that you are allergic to atenolol or any of the other ingredients in the tablet. Check by reading the list of ingredients above


  • have a history of wheezing or asthma. (Speak to your doctor or pharmacist first.)


  • have a very slow heart beat or serious problems with the heart rhythm (second or third degree heart block) or if your heart is not pumping efficiently despite medication (uncontrolled heart failure)


  • have very low blood pressure


  • have intermittent claudication (leg cramps on walking) or other symptoms of very poor circulation


  • have been told you have a tumour of the adrenal gland (phaeochromocytoma) and are not being treated with an alpha-blocker, such as doxazosin


  • have been told that you have acidosis (excess acid in the blood)


  • are under 12 years of age.



You should let your doctor know if you are pregnant or wish to become pregnant while taking this medicine.



You should let your doctor know if you are breast-feeding or wish to start breast-feeding whilst taking this medicine. If you breast-feed whilst taking atenolol your baby should be monitored for any side-effects.



Taking another medicine while you are taking atenolol can affect how it or the other medicine works. Make sure that your doctor or pharmacist knows what other medicines you are taking. Do not take any other medicines while you are taking atenolol unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself.




Example of medicines that can affect atenolol are:



  • Anaesthetics (make sure the anaesthetist knows you are taking atenolol)


  • Adrenaline, ephedrine and noradrenaline, used to treat severe allergic reactions and to stimulate the heart


  • Amphetamines which are used to treat rare sleep disorders


  • Some non-steroidal drugs used for inflammation and pain such as ibuprofen and indometacin


  • Carbenoxolone, a drug used to treat stomach ulcers


  • Some drugs used to treat high blood pressure or heart problems, such as diltiazem, nifedipine, verapamil, doxazosin (an alpha-blocker), amiodarone, disopyramide, quinidine, digoxin, adrenaline, ephedrine, lisinopril (an ACE inhibitor) and losartan (an angiotensin II inhibitor)


  • Ergotamine, used to treat migraine


  • Clonidine (used for migraine, menopausal flushing and high blood pressure)


  • Some indigestion tablets containing calcium or aluminium hydroxide may reduce the absorption of atenolol if they are taken at the same time


  • Insulin and oral anti-diabetic drugs used to treat diabetes. With atenolol, there is a greater risk of hypoglycaemia (a "hypo" or low sugar levels) and you may not get the usual warning signs of a "hypo"


  • Mefloquine, a drug used to treat malaria


  • Tricyclic antidepressants (such as dosulepin), monoamine oxidase inhibitors (such as phenelzine) and tropisetron, used to treat depression


  • Benzodiazepines (such as diazepam) used to treat anxiety


  • Phenothiazines (such as thioridazine) used to treat schizophrenia


  • Some drugs used to treat muscle disorders such as myasthenia gravis (includes neostigmine, pyridostigmine, distigmine) and glaucoma (includes pilocarpine)


  • Oral contraceptives ('the pill') and oestrogen, a female sex hormone


  • Some drugs used to treat wheezing, such as theophylline


  • Ampicillin, an antibiotic used to treat infections


  • Aldesleukin, used in chemotherapy


  • Alprostadil, used to treat male impotence and heart defects in babies


  • Tropisetron, used for nausea and vomiting


  • Moxisylyte, used for poor circulation.



If you have any doubts about whether you should take this medicine then talk to your doctor or pharmacist.





Advice When Taking Atenolol Tablets




Care should be taken if:



  • you are diabetic.

  • You tend to suffer from serious allergies

  • You have minor problems with heart rhythm (first degree heart block),

  • You have thyroid, kidney or liver problems.

  • You have a muscle disorder called myasthenia gravis or a skin condition called psoriasis; atenolol may make these conditions worse.

  • You need an anaesthetic.

You should not drive or operate machinery if you feel dizzy or tired while taking Atenolol Tablets.



Drinking alcohol while taking Atenolol Tablets may cause dizziness.



You should not stop taking your tablets suddenly. When you need to stop taking them your doctor will gradually reduce your dose.






Taking This Medicine



The usual adult dose to treat hypertension (high blood pressure) is 50mg daily.



The usual adult dose to treat angina is 100mg a day or 50mg twice daily.



The usual adult dose to treat irregular heart beat is 50mg to 100mg daily, given as a single dose.



The usual adult dose following myocardial infarction (heart attack) is 50mg every 12 hours on the first day and thereafter 100mg daily.



If you are elderly or have liver or kidney problems you may need a lower dose. The tablets are not recommended for children under 12 years of age.



To obtain a tablet, press on the tablet from the blister (bubble) side, pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.



Your doctor will decide which dose is best for you. Always follow your doctor's instructions completely. Also, follow any special instructions or warnings which appear on the label that the pharmacist has put on the pack. If you do not understand, or are in any doubt, ask your doctor or pharmacist.



Unless told otherwise take your Atenolol Tablets with a glass of water.



You should continue to take your medicine for as long as your doctor tells you to.



It is dangerous to stop taking Atenolol Tablets suddenly. If your doctor decides to stop your Atenolol Tablets the dose will be reduced gradually.



If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all.



Never double the next dose to make up for the one missed.



If you accidentally take too many tablets contact your doctor or pharmacist or nearest hospital.



Take this leaflet and any tablets you have left to show the doctor or pharmacist.





Are There Any Side-Effects?



Like many medicines Atenolol Tablets may cause side-effects in some patients, particularly when you first start taking them.



The side-effects that some patients have had with Atenolol Tablets include very slow heart rhythm (heart block), cold hands and feet, worsening of Raynaud's disease (where your fingers turn white) and intermittent claudication (leg cramps which develop on walking), changes in the fat content of the blood, high or low blood glucose, blood disorders (with a tendency to bleed or bruise easily or sore throat and mouth ulcers), tiredness, dizzy spells, depression, anxiety, nervousness, confusion, mental disturbance, hallucinations, sleep problems, "pins and needles", numbness of the extremities, weakness of the muscles, muscle cramps, painful joints, headache, dry mouth, feeling sick, being sick, diarrhoea, constipation, stomach cramps, fever, itching, scaly rash, worsening of psoriasis, blurred vision, sore eyes or conjunctivitis, impotence, Peyronie's disease (a condition in men affecting the penis), and (rarely) temporary thinning of the hair. Atenolol may increase the levels of some liver enzymes in the blood but this is unlikely to cause you any problems. Stopping Atenolol Tablets suddenly can cause serious heart problems.



If taken in pregnancy, Atenolol Tablets may affect the baby's growth in the womb and cause premature delivery or stillbirth. Atenolol Tablets may also slow down the baby's heart beat, cause low blood pressure or breathing problems, or lower the amount of glucose in the baby's blood.



If you experience any of the side-effects listed, especially wheezing, cough, coughing up blood, breathlessness on exertion or when lying down, extreme tiredness, swelling of the ankles, blue lips or fingernails, a rash and and/or dry eyes, or feel that the medicine is affecting you badly, tell your doctor immediately.



Do not be alarmed by the list of possible side-effects. You may not have any of them.



As Atenolol Tablets may cause dizziness and tiredness, if you are affected you should not drive or operate machinery.





Safe Keeping For The Medicine



Do not take this medicine if the expiry date on the label has passed or if the tablets show signs of deterioration such as discoloration.



Do not store this medicine above 25°C. Keep the tablets in the package or container in which they were given to you. Do not transfer Atenolol Tablets to another container.



Keep out of the reach and sight of children.



Remember this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.



Unless your doctor tells you to, do not keep tablets that you no longer need. Give them back to your pharmacist.




DATE OF REVISION OCTOBER 2007





CPI



103606/2







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