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Atenolol 100mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ATENOLOL 25 mg, 50 mg & 100 mg TABLETS

Read all of this leaflet carefully before you start taking this medicine.

-    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.

Do not pass it on to others. It may harm them even if their symptoms are the same as yours.


THIS LEAFLET CONTAINS


1.    What Atenolol is for

2.    Before you take Atenolol

3.    How to take Atenolol

4.    Possible side effects

5.    How to store Atenolol

6.    Further information


1. WHAT ATENOLOL IS FOR


Atenolol belongs to a group of medicines called beta-blockers. It is used to:

•    control high blood pressure (hypertension)

•    relieve chest pain (angina pectoris)

•    control irregular heart beat

•    protect the heart if taken shortly after a heart attack.


2. BEFORE YOU TAKE ATENOLOL


Do not take Atenolol and tell your doctor if you

•    are allergic to Atenolol or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    have ever had any of the following heart problems:

-    heart failure which is not under control (this usually makes you breathless and causes ankle swelling)

-    second or third degree heart block (conditions which may make you feel dizzy and lightheaded, tired and prone to collapses)

-    very slow or very uneven heart beats, very low blood pressure or severe blood circulation problems

-    a problem (common in the elderly) related to poor control of the working of the heart (sick sinus syndrome)

-    failure of the heart to maintain adequate circulation of the blood (cardiogenic shock)

•    have been told that you have increased levels of acid in your blood (metabolic acidosis)

•    have a tumour called phaeochromocytoma, which is not being treated (this is usually near the kidney and can cause high blood pressure).

Take special care with Atenolol

Tell your doctor before you take this medicine if you

•    have asthma, wheezing or any other similar breathing problems. If you have ever had asthma or wheezing, do not take this medicine without first checking with your doctor

•    have a history of allergic reactions

•    have lung problems

•    have a type of chest pain called Prinzmetal's angina

•    have heart failure which is controlled

•    have first degree heart block, which is detected by having a tracing of the heart (ECG)

•    suffer from blood circulation problems, which can cause calf pain on walking, as Atenolol may make this worse

•    are elderly or have kidney problems, as you may need a lower dose of Atenolol


•    have diabetes, as symptoms of low blood sugar levels (hypoglycaemia) may be hidden by this medicine

•    have high levels of thyroid hormone in your body (thyrotoxicosis), as Atenolol may hide the symptoms of thyrotoxicosis

•    are being treated for phaeochromocytoma, as your doctor will give you another medicine, called an alpha-blocker, to take as well as Atenolol.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Atenolol works:

•    Medicines for high blood pressure or chest pain, such as Diltiazem, Verapamil, Nifedipine, Nisoldipine, Ramipril or Diuretics (e.g. Furosemide)

•    Clonidine for high blood pressure or migraines.

Do not stop taking Clonidine unless your doctor tells you to. If you have to stop taking Clonidine, your doctor will tell you how to

•    Medicines to treat irregular or uneven heart beat, such as Amiodarone, Disopyramide, Quinidine or Digoxin

•    Adrenaline for stimulating the heart

•    Moxisylyte for blood circulation problems like Raynaud's disease

•    Insulin or oral anti-diabetic medicines, such as Metformin

•    Medicines for pain and swelling, such as Ibuprofen or Indometacin

•    Theophylline, used for asthma

•    Cough or cold remedies bought over the counter

•    Calcium or Aluminium hydroxide for indigestion

•    Medicines for depression, such as MAO inhibitors (e.g. Moclobemide)

•    Amphetamines to treat Attention Deficit Hyperactive Disorder (ADHD)

•    Phenothiazines (e.g. Chlorpromazine) for mental health problems or nausea (feeling sick)

•    Medicines to help you sleep or for anxiety (e.g. Diazepam or Temazapam).

AVOID ALCOHOL whilst taking this medicine. Operations

If you go into hospital to have an operation, tell the anaesthetist or medical staff that you are taking Atenolol. This is because you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are taking Atenolol.

Pregnancy and breast-feeding

Do not take Atenolol if you are pregnant, planning to become pregnant or are breast-feeding, unless your doctor has told you to.

Driving and using machines

Atenolol may cause dizziness or tiredness. If affected do not drive or operate machinery.

Important information about some of the ingredients of Atenolol

Atenolol 25 mg, 50 mg and 100 mg tablets contain lactose. If you know you have an intolerance to some sugars contact your doctor before taking this medicine.

Atenolol 50 mg and 100 mg tablets also contain sunset yellow (E110), which may cause allergic reactions.


3. HOW TO TAKE ATENOLOL


Always take Atenolol tablets exactly as your doctor has told you. Do not crush or chew the tablets. Swallow them whole with a glass of water.

Dosage

Your doctor will decide your dose and length of treatment, as it depends on your condition.


Adults:

High blood pressure: Typical dose is one 100 mg

tablet daily. Some patients may respond better to one 50 mg 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 medicines to reduce your blood pressure further.

Chest pain: Typical dose is one 100 mg tablet once a day or one 50 mg tablet twice a day.

Irregular heart beat: Initial treatment may be by injection, followed by a maintenance dose of one 50 mg tablet daily or one 100 mg tablet daily.

Heart attack: Within 12 hours of chest pain, initial treatment may be by injection. If there are no side effects you may be given a 50 mg tablet 15 minutes after the injection and then a further 50 mg tablet 12 hours later. Another 12 hours after this you may be given a 100 mg tablet once daily. Your doctor will monitor you closely.

Elderly: Your doctor may prescribe you a lower dose, especially if you have kidney problems.

Patients with kidney failure: Your doctor will decide the correct dose for you, as it depends on your condition.

Children: Not recommended for children.

If you take more Atenolol than you should

Contact your doctor or go to a hospital immediately. Take the package or container with you.

If you forget to take Atenolol

Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

If you stop taking Atenolol DO NOT STOP taking Atenolol suddenly, unless your doctor tells you to. Your doctor will reduce your dose gradually.


Uncommon (affects less than 1 in 100 people):

•    problems sleeping

•    abnormal liver function tests (increased transaminase levels found on blood test).

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

•    headache, dizziness, numbness or tingling in your arms and legs

•    dry eyes, changes in eyesight

•    mood swings, confusion, nightmares, hallucinations (seeing things that are not there)

•    loss of touch with reality (psychosis)

•    dry mouth

•    skin rash, worsening of psoriasis (dry flaky skin), or the development of skin problems like psoriasis

•    hair loss

•    inability to maintain an erection (impotence)

•    liver disorder causing itching, yellowing of the skin or whites of the eyes (jaundice).

Very rare (affects less than 1 in 10,000 people):

•    increase in antinuclear antibodies (ANA), found on blood test.

If any of the side effects become serious, or if

you notice any side effects not listed in this

leaflet, please tell your doctor or pharmacist.


5. HOW TO STORE ATENOLOL


Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use these tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


6. FURTHER INFORMATION


4. POSSIBLE SIDE EFFECTS


Like all medicines, Atenolol can cause side effects, although not everybody gets them.

If you get any of the following side effects, see a doctor straight away:

•    an allergic reaction, which may cause skin rash, itching, red and raised lumps (hives) or swelling of the face, lips, mouth or throat

•    difficulty in breathing or wheezing, especially if you have a history of asthma or breathing problems.

If you get any of the following side effects,

STOP TAKING Atenolol and see your doctor as soon as possible:

•    slow or irregular heart beat, which can cause dizziness, light-headedness and fainting

•    worsening of the symptoms of heart failure, with symptoms such as breathlessness or swollen ankles

•    low blood pressure (may make you feel dizzy or light-headed) or postural hypotension (feeling dizzy or light-headed when standing from sitting or lying down)

•    symptoms of heart block causing dizziness, tiredness, irregular heart beat or fainting

•    poor blood circulation making the fingers and toes numb and pale (Raynaud's phenomenon)

•    worsening of cramps in the calf or leg muscles on walking

•    unexplained bleeding and bruising. Your doctor may wish to give you a blood test to check the levels of different blood cells.

Other possible side effects:

Common (affects less than 1 in 10 people):

•    cold hands and feet, tiredness

•    stomach upsets.


What Atenolol tablets contain

The active ingredient in Atenolol 25 mg, 50 mg and 100 mg tablets is atenolol. The other ingredients are lactose, microcrystalline cellulose, maize starch, sodium starch glycollate, povidone, talc, magnesium stearate, sodium lauryl sulphate, colloidal silicon dioxide, stearic acid, hydroxy-propyl-methylcellulose, titanium dioxide (E171) and dibutyl phthalate. The 50 mg and 100 mg tablets also contain sunset yellow (E110).

What Atenolol tablets look like and contents of the pack

The 25 mg tablets are white, circular, film-coated tablets with the marking ATEN 25 on one side.

The 50 mg tablets are orange, circular, film-coated tablets with the marking ATEN 50 on one side.

The 100 mg tablets are orange, circular, film-coated tablets with the marking ATEN 100 on one side.

All three strengths of Atenolol tablets come in blister packs of 28 tablets and containers of 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chatfield Pharmaceuticals Limited,

Kramer Mews, London SW5 9JL

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last approved in 10/2011