Package leaflet: information for the patient

Tenormin® 5 mg/ml Syrup

atenolol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Tenormin is and what it is used for

2.    What you need to know before you take Tenormin

3.    How to take Tenormin

4.    Possible side effects

5.    How to store Tenormin

6.    Contents of the pack and other information

1.    What Tenormin is and what it is used for

Tenormin contains a medicine called atenolol. This belongs to a group of medicines called beta-blockers. Tenormin is used to:

•    Treat high blood pressure (hypertension).

•    Treat uneven heart beats (arrhythmias).

•    Help prevent chest pain (angina).

•    Protect the heart in the early treatment after a heart attack (myocardial infarction).

It works by making your heart beat more slowly and with less force.

2.    What you need to know before you take Tenormin

Do not take Tenormin

•    If you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6).

•    If you have ever had any of the following heart problems:

-    heart failure which is not under control (this usually makes you breathless and causes your ankles to swell)

-    second- or third-degree heart block (a condition which may be treated by a pacemaker)

-    very slow or very uneven heart beats, very low blood pressure or very poor circulation.

•    If you have a tumour called phaeochromocytoma that is not being treated. This is usually near your kidney and can cause high blood pressure. If you are being treated for phaeochromocytoma, your doctor will give you another medicine, called an alpha-blocker, to take as well as your Tenormin.

•    If you have been told that you have higher than normal levels of acid in your blood (metabolic acidosis).

Do not take Tenormin if any of the above apply to you. If you are not sure, talk to your doctor

or pharmacist before taking Tenormin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tenormin if:

•    You have asthma, wheezing or any other similar breathing problems, or you get allergic reactions, for example to insect stings. If you have ever had asthma or wheezing, do not take this medicine without first checking with your doctor.

•    You have a type of chest pain (angina) called Prinzmetal's angina.

•    You have poor blood circulation or controlled heart failure.

•    You have first-degree heart block.

•    You have diabetes. Your medicine may change how you respond to having low blood sugar. You may feel your heart beating faster.

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

•    You have problems with your kidneys. You may need to have some check-ups during your treatment.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before

taking Tenormin.

Other medicines and Tenormin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Tenormin can affect the way some other medicines work and some medicines can have an effect on Tenormin.

In particular, tell your doctor if you are taking any of the following medicines:

•    Clonidine (for high blood pressure or migraine). If you are taking clonidine and Tenormin together, do 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 about how to do it.

•    Verapamil, diltiazem and nifedipine (for high blood pressure or chest pain).

•    Disopyramide, quinidine or amiodarone (for an uneven heart beat).

•    Digoxin (for heart problems).

•    Adrenaline, also known as epinephrine (a medicine that stimulates the heart).

•    Ibuprofen or indometacin (for pain and inflammation).

•    Insulin or medicines that you take by mouth for diabetes.

•    Medicines to treat nose or sinus congestion or other cold remedies (including those you can buy in the pharmacy).

Operations

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

•    Your medicine is not likely to affect you being able to drive or use any tools or machines. However, it is best to wait to see how your medicine affects you before trying these activities.

•    If you feel dizzy or tired when taking this medicine, do not drive or use any tools or machines.

Tenormin contains sorbitol (E420), methyl hydroxybenzoate and propyl hydroxybenzoate

Tenormin contains sorbitol (E420). If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicinal product. Each 5 ml spoonful contains up to 1.4 g of sorbitol (E420).

Tenormin also contains methyl hydroxybenzoate and propyl hydroxybenzoate both of which may cause allergic reactions (possibly delayed).

3. How to take Tenormin

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

•    Your doctor will tell you how much syrup to take each day and when to take it. Read the label on the container to remind you what the doctor said.

•    Tenormin should be swallowed.

•    Try to take your medicine at the same time each day.

Adults

•    High blood pressure (hypertension): the recommended dose is 50 mg to 100 mg (two to four 5 ml spoonfuls) a day.

•    Chest pain (angina): the recommended dose is 100 mg (four 5 ml spoonfuls) a day or 50 mg (two 5 ml spoonfuls) twice a day.

•    Uneven heart beats (arrhythmias): the recommended dose is 50 mg to 100 mg (two to four 5 ml spoonfuls) a day.

•    The early treatment of a heart attack (myocardial infarction): the recommended dose is 50 mg to 100 mg (two to four 5 ml spoonfuls) a day.

Elderly people

If you are an elderly person, your doctor may decide to give you a lower dose, particularly if you have problems with your kidneys.

People with kidney problems

If you have severe kidney problems your doctor may decide to give you a lower dose.

Children

Your medicine must not be given to children.

If you take more Tenormin than you should

If you take more Tenormin than prescribed by your doctor, talk to a doctor or go to a hospital straight away. Take along any left over syrup, as well as the container and label, so that the syrup can be identified.

If you forget to take Tenormin

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Tenormin

Do not stop taking Tenormin without talking to your doctor. In some cases, you may need to stop taking it gradually.

4. Possible side effects

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

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.

See your doctor as soon as possible if you get any of the following side effects:

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

•    You may become more prone to bruising or bleeding or have purplish marks on your skin - this could be a sign of changes to some of the cells or other parts of your blood and your doctor may want to take blood samples every so often to check this.

Other possible side effects:

Common (may affect up to 1 in 10 people)

•    You may notice that your pulse rate becomes slower while you are taking Tenormin. 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 (may affect up to 1 in 100 people)

•    Disturbed sleep.

Rare (may affect up to 1 in 1,000 people)

•    Heart block (which may cause an abnormal heart beat, dizziness, 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).

•    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.

Conditions that may get worse

If you have any of the following conditions, they may get worse when you start to take your medicine:

•    Psoriasis (a skin condition).

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

•    Asthma or breathing problems.

•    Poor circulation.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: 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 Tenormin

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

•    Do not store above 25^oC. Store in the original container.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Tenormin contains

The active substance is atenolol. Tenormin contains 25 mg (milligrams) of atenolol in each 5 ml (millilitre) spoonful.

The other ingredients are citric acid, lemon and lime flavour, methyl hydroxybenzoate, propyl hydroxybenzoate, saccharin sodium, sodium citrate, sorbitol (E420) and water.

What Tenormin looks like and contents of the pack Tenormin comes in bottles of 300 ml.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Tenormin 5 mg/ml Syrup is held by AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK.

Tenormin 5 mg/ml Syrup is manufactured by Nycomed Pharma AS, Solb^rvegan 5, 2409 Elverum, Norway.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name    Tenormin 5 mg/ml Syrup

Reference number    17901/0051

This is a service provided by the Royal National Institute of Blind People.

Leaflet prepared: November 2014.

© AstraZeneca 2014.

Tenormin is a trade mark of the AstraZeneca group of companies.

CV 14 0021c

UK PIL Tenormin Syrup CV 14 0021c (based on CV 09 0105) 04.11.14 BK Page 6 of 6