FOURRTS (INDIA) LABORATORIES PVT. LIMITED PLANT II, Venkatamangalam, Chennai - 600 048

PATIENT INFORMATION LEAFLET

ATENOLOL 25mg, 50mg and 100mg TABLETS

Please read the leaflet carefully before you start taking Atenolol Tablets. This leaflet gives a summary of information available about your tablets. If you have any questions or are in any doubt about anything ask your doctor or pharmacist.

WHAT YOU SHOULD KNOW ABOUT YOUR TABLETS

The name of your tablets is Atenolol Tablets. The active ingredient in your tablets is atenolol. The package contains 28 (or 50) tablets. These tablets are for your personal use and should not be given to anyone else.

WHAT IS IN YOUR MEDICINE?

Each Atenolol 25mg Tablet contains 25mg of the active ingredient atenolol.

Each Atenolol 50mg Tablet contains 50mg of the active ingredient atenolol.

Each Atenolol 100mg Tablet contains 100mg of the active ingredient atenolol.

The tablets also contain lactose monohydrate, magnesium stearate, maize starch, cellulose microcrystalline and sodium starch glycollate (Type A).

Product MA Holder:

Fourrts (UK) Pharmacare Ltd, 2, Victoria Road, Harpenden, Hertfordshire, A15 4 EA, UK. HOW DO YOUR TABLETS WORK?

Atenolol Tablets belong to a group of medicines known as beta-blockers. These medicines help to treat hypertension (high blood pressure), chest pains caused by angina and some arrhythmias (disorders of heart rhythm).

They can also be used in early treatment of myocardial infarction (heart attacks).

BEFORE YOU TAKE YOUR TABLETS

Please tell your doctor before you start taking your tablets if any of the following apply to you:

•    You have had an allergic reaction to atenolol or any one of the other ingredients of the tablets.

•    You have asthma or you get allergic reactions, for example to insect stings. If you ever had asthma or wheezing. You should not take any of these tablets unless you have discussed the symptoms with your doctor who first gave you the tablets.

•    You have heart failure, which is not under control, cardiogenic shock, heart block, very slow or irregular heart beats, sick sinus syndrome, very low blood pressure, very poor circulation, phaeochromocytoma that has not been treated or metabolic acidosis.

•    You have a type of chest pain called Prinzmetal’s angina.

•    You have diabetes: Atenolol may change your normal response to low blood sugar, which involves an increase in heart rate.

•    You have thyrotoxicosis (a condition caused by an overactive gland) atenolol may hide the symptoms of thyrotoxicosis.

•    You have kidney problems, You may need to have some check ups during your treatment if you have any problems with your kidneys.

•    You are pregnant or breast-feeding.

•    You are an elderly

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

Atenolol should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7-14 days. Care should especially be taken in patients with heart disease.

If you see another doctor or go into hospital, let them know what medicines you are taking. Atenolol may need to be stopped before you have a general anaesthetic. Discuss this with your doctor or dentist before any surgery.

TAKING OTHER MEDICINES

Please be careful if you are taking any of the following medicines-

•    Tricyclic antidepressants (used to treat depression)

•    Barbiturates (sleep enhancing medicines)

•    Phenothiazines (used to control mental disorders)

•    Clonidine (for hypertension or migraine). If you are taking clonidine and atenolol together, you must not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine, your doctor will give you careful instructions on how to do it.

•    Alpha-blockers such as Prazosin (medicines used to treat high blood pressure)

•    Verapamil, Diltiazem and Nifedipine (which are used to treat hypertension or angina).

•    Moxisylyte used to treat circulatory problems

•    Anti-arrhythmics - medicines to treat irregular heart beats such as Disopyramide or Quinidine and Amiodarone.

•    Digoxin (for heart failure).

•    Adrenaline, also known as epinephrine, (a heart stimulant) and dobutamine (to treat heart attacks)

•    Ergotamine and methysergide (used to treat migraine)

•    Ibuprofen and indometacin , Oestrogens and corticosteroids (for pain and inflammation).

•    Insulin and oral antidiabetic drugs (for diabetes).

•    Nasal decongestants or other cold remedies (including the ones you can buy in the pharmacy).

WHAT ELSE YOU SHOULD KNOW BEFORE TAKING YOUR TABLETS?

If you suffer from lactose intolerance you should not take atenolol as it contains lactose as an inactive ingredient. If you undergo any surgery or receive anaesthetics (even at the dentist), you should make the doctor or dentist treating you aware that you are taking atenolol. Since atenolol may interact with some anaesthetics usually used.

Tell your doctor about any medicines you are taking that you obtained without prescription. You should not drive or operate machinery if you are dizzy or tired while taking atenolol.

Important information about some of the ingredients of Atenolol Tablets

Atenolol Tablets contain 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.

WHAT UNWANTED EFFECTS COULD YOUR TABLETS HAVE?

Like all medicines, Atenolol may have side effects in some patients Allergic reactions:

If you have an allergic reaction, see a doctor straight away. The signs may include raised lumps on your skin (weals), or swelling of your face, lips, mouth, tongue or throat.

Other possible side effects:

Common (affects less than 1 in 10 people)

•    You may notice that your pulse rate becomes slower while you are taking the tablets.

This is normal, but if you are concerned please tell your doctor about it.

•    Cold hands and feet.

•    Diarrhoea.

•    Feeling sick (nausea).

•    Feeling tired.

Uncommon (affects less than 1 in 100 people)

•    Disturbed sleep.

Rare (affects less than 1 in 1,000 people)

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

•    Numbness and spasm in your fingers which is followed by warmth and pain (Raynaud’s disease).

•    Mood changes.

•    Nightmares.

•    Feeling confused.

•    Changes in personality (psychoses) or hallucinations.

•    Headache.

•    Dizziness (particularly when standing up).

•    Tingling of your hands.

•    Being unable to get an erection (impotence).

•    Dry mouth.

•    Dry eyes.

•    Disturbances of vision.

•    Thinning of your hair.

•    Skin rash.

•    Reduced numbers of platelets in your blood (this may make you bruise more easily).

•    Purplish marks on your skin.

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

Very rare (affects less than 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. Conditions that may get worse

If you have any of the following conditions, they may get worse when you start to take your medicine. This happens rarely affecting less than 1 in 1,000 people.

•    Psoriasis (a skin condition).

•    Being short of breath or having swollen ankles (if you have heart failure).

•    Asthma or breathing problems.

•    Poor circulation.

If you notice any of the above-mentioned effects or you have any other unusual symptoms or feelings, you should contact your doctor.

HOW SHOULD YOU TAKE YOUR MEDICINE?

You should swallow your tablets with a drink of water before your meals. It is best to swallow them standing up, not lying down, to make sure they go down.

You should keep taking your medicines as advised by your doctor. The dose will depend on your conditions and whether you are taking any other treatment.

The usual dosages are as follow:

High blood pressure and irregular heart beat: The usual dose of atenolol is 50 to 100mg once daily by mouth. Chest pains and after heart attacks: The usual dose of atenolol is 100mg once or divided into 2 doses daily by mouth.

These tablets are not recommended for use in children.

Treatment with atenolol is usually long-term. Follow the doctor’s advice on how and when to take your medicine. If necessary ask your pharmacist for help.

Atenolol is for you. DO NOT give it to other people.

If you miss a dose just carry on with the next one as normal, but make sure you tell your doctor. Do not take any extra dose to make up.

If you, or anyone else, accidentally swallow more tablets than the recommended dose, contact your doctor immediately.

HOW SHOULD THE TABLETS BE KEPT?

Do not use this medicine after the expiry date, which is printed on the carton. Do not store above 25° C. Store in the original package.

Keep Atenolol tablets in a secure place where children cannot get at them.

If your doctor decides to end the treatment, take any left over tablets to your pharmacist. Only keep them if your doctor tells you to.

This information applies only to Atenolol Tablets.

Date of revision: 04/2014

PL Numbers: PL 39484/0010, 0011, 0009

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Name of the artwork Printed leaflet 320 x 230 mm Atenolol 25, 50 and 100mg tablets

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