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.

•    If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What A dizem-SR tablets are and what they are used for

2.    Before you take Adizem-SR tablets

3.    How to take Adizem-SR tablets

4.    Possible side effects

5.    How to store A dizem-SR tablets

6.    Further information

These tablets have been prescribed for you to treat angina (chest pain caused by a reduction of oxygen to the heart muscle) or high blood pressure (hypertension). They contain the active ingredient diltiazem. Diltiazem belongs to a group of medicines called calcium antagonists. Calcium antagonists help more blood to reach the heart and reduce blood pressure. The other ingredients of Adizem-SR tablets are listed in section 6 of this leaflet.

Adizem-SR tablets are designed to work properly over 12 hours. If the tablets are crushed or chewed, the entire 12-hour dose may be absorbed rapidly into your body.

This can be dangerous, causing serious problems such as an overdose.

Do not take Adizem-SR tablets if you:

•    are allergic (hypersensitive) to diltiazem or any of the other ingredients of the tablets (see section 6 ‘Further Information’);

•    have a slow or irregular heart beat;

•    have heart failure (which can cause shortness of breath or ankle swelling).

Children should not take these tablets.

Take special care with . lrfcem-.STJ tablets

Before treatment with A dizem-SR tablets tell your doctor or pharmacist if you:

•    have liver or kidney problems as your doctor may monitor you more closely;

•    have porphyria (a rare disease of the blood pigments);

•    have bowel problems.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you tak e Adizem-SR tablets with some other medicines, the effect of Adizem-SR tablets or the other medicine may be changed.

Tell your doctor or pharmacist if you are taking:

•    any other medicines for high blood pressure, such as beta blockers (for example atenolol), diuretics (for example bendrofluazide) or ACE inhibitors (examples include captopril and enalopril);

•    medicines known as alpha blockers, which you may be taking to treat high blood pressure or prostate disorders (for example prazosin);

•    any medicines which may cause low blood pressure or slow heart beat (for example aldesleukin to treat cancer of the kidneys, or antipsychotics to treat mental and behavioural disorders);

•    ivabradine to treat angina;

•    anti-arrhythmic medicines to treat an irregular or rapid heart beat (for example digoxin, amiodarone or beta-blockers);

•    cilostazol to treat intermittent claudication (a condition that causes leg pain due to a restriction in blood supply to the muscles);

•    medicines known as statins to reduce cholesterol levels in your blood (examples include simvastatin, atorvastatin or lovastatin);

•    medicines known as H₂ antagonists to treat stomach ulcers, indigestion or heartburn, such as cimetidine or ranitidine;

•    carbamazepine or phenytoin to treat seizures, fits or convulsions;

•    medicines known as benzodiazepines to treat anxiety or help you sleep (examples include midazolam or triazolam);

•    medicines known as barbiturates to either treat fits or to help you sleep (examples include phenobarbital or primidone);

•    antidepressants known as tricyclic antidepressants (examples include amitriptyline or imipramine) or lithium;

•    rifampicin to treat tuberculosis;

•    ciclosporin, sirolimus or tacrolimus to prevent organ transplant rej ection or treat other immune system disorders;

•    a specific type of medicine known as a protease inhibitor to treat HIV (examples include atazanavir or ritonavir);

•    dantrolene (a muscle relaxant);

•    theophylline to treat breathing problems such as asthma;

•    medicines known as nitrate derivatives to treat angina or high blood pressure (examples include glyceryl trinitrate or isosorbide mononitrate);

•    medicines for inflammation or allergies, known as steroids (for example methylprednisolone).

Anaesthetics and Adizem-SR tablets

If you are having a general anaesthetic, tell your

doctor that you are talcing these tablets.

Taking Adizem-SR tablets with alcohol

liking Adizem-SR tablets at the same time as an alcoholic drink is not recommended.

Pregnancy and breastfeeding

Do not tske Adizem-SR tablets if you are pregnant, likely to become pregnant or are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

The tablets may cause a number of side effects such as dizziness and a general feeling of being unwell. These could affect your ability to drive (see section 4 for a full list of side effects) and are usually most noticeable when you start taking the tablets, or when changing to higher dose. If you are affected you should not drive or operate machinery.

Important information about some of the ingredients of Adizem-SR tablets

These tablets contain sucrose and lactose which are forms of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

Always take Adizem-SR tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often.

The usual dose is one tablet twice daily. However, if you are elderly or have kidney or liver problems then you may need to start on a lower dose. Your doctor will decide how many tablets you should take.

Children should not take these tablets.

Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.

Swallow your tablets whole with a glass of water. Do not chew or crush the tablets.

You should take your tablets every 12 hours.

For instance, if you take a tablet at 8 o’clock in the morning, you should take your next tablet at 8 o’clock in the evening.

If you take more Adizem-SR tablets than you should or if someone accidentally swallows your tablets

Call your doctor or hospital straight away. People who have taken an overdose may become very unwell, feel faint, have a slow heart beat and lose consciousness. They may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show to the doctor.

If you forget to take 1 dizem-SR tablets

If you remember within 4 hours of the time your tablet was due, take your tablet straight away. Take your next tablet at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Adizem-SR tablets

You should not stop taking these tablets unless your doctor tells you to. If you want to stop taking your tablets, discuss this with your doctor first.

If you have any further questions on the use of Adizem-SR tablets ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Adizem-SR tablets can cause side effects, although not everybody gets them.

Look out for the following severe allergic reactions. They have occurred in a small number of people, although their exact frequency cannot be estimated:

•    swelling of the face or throat;

•    skin rash or itching especially those covering your whole body, severe flaking, blistering or peeling of the skin, with or without a fever.

Tell your doctor immediately if you get any of these.

Very common side effects (probably affecting more than 1 in 10 people taking these tablets)

•    Swelling of the hands, ankles or feet.

Common side effects (probably affecting more than 1 in 100 people taking these tablets)

•    Feeling sick, abdominal pain, indigestion, constipation.

•    Dizziness, headache.

•    Flushing or redness of the skin.

•    A fast, slow or irregular heartbeat.

•    Generally feeling unwell.

•    Tiredness.

Uncommon side effects (probably affecting fewer than 1 in 100 people taking these tablets)

•    Diarrhoea, being sick.

•    A feeling of faintness, especially on standing up.

•    Nervousness.

•    Difficulty in sleeping.

•    A worsening in liver function tests (seen in a blood test).

Rare side effects (probably affecting fewer than 1 in 1000 people taking these tablets)

•    Dry mouth.

•    ttives.

Other side effects

Other side effects have occurred in a small number of people, but their exact frequency is unknown:

•    Fieart failure which can cause shortness of breath or ankle swelling.

•    Inflammation of the liver.

•    Changes in muscle tone and/or abnormalities of movement.

•    Mood changes, including depression.

•    Skin problems such as an increased sensitivity to sunlight.

•    A reduction in blood platelets which increases the risk of bleeding or bruising.

•    Breast enlargement in men.

•    Bleeding, tender or enlarged gums.

•    Inflammation of blood vessels (often with skin rash).

•    Gastrointestinal disorders (e.g. upset stomach).

•    Sweating.

•    Low blood pressure.

You may see the remains of the tablets in your faeces. This should not affect how the tablets work.

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.

Keep out of the reach and sight of children.

Do not use any tablets after the expiry date which is stated on the carton. EXP 08 2020 means that you should not take the tablets after the last day of that month i.e. August 2020.

Do not store your tablets above 25°C. Store in the original package.

Do not take your tablets if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.

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.

What Kfce/n-.V/i tablets contain

The active ingredient is diltiazem hydrochloride. Each tablet contains 120 mg of diltiazem hydrochloride.

The other ingredients are:

•    Lactose

•    Hydrogenated castor oil

•    Colloidal aluminium hydroxide

•    Acrylic resin

•    Talc

•    Magnesium stearate

•    Hypromellose

•    Sucrose

•    Glycerol

•    Titanium dioxide (E171)

•    Polysorbate 80

Marketing Authorisation Holder and Manufacturer

The tablets are made by Bard Pharmaceuticals Limited for the marketing authorisation holder Napp Pharmaceuticals Limited, both at Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.

This leaflet was last revised in September 2010

® Adizem, NAPP and the NAPP device (logo) are Registered Trade Marks. © 2008-2010 Napp Pharmaceuticals Limited.

04/10/2010 11:16