ADIZEM-XL CAPSULES 120 MG - patient leaflet, side effects, dosage

1. What

These capsules 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-XL capsules are listed in section 6 of this leaflet.

Adizem-XL capsules are designed to work properly over 24 hours. If the capsules are crushed or chewed, the entire 24-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose.

2. what you need to know before you take adizem-xl capsules

Do not take

• are allergic (hypersensitive) to diltiazem or any of the other ingredients of the capsules (see section 6 ‘Further Information’);
• are pregnant, likely to become pregnant or are breastfeeding;
• have a very slow (less than 40 beats per minute) or irregular heart beat;
• have heart failure (which can cause shortness of breath or ankle swelling) and problems with blood flow to the lungs.

Children should not take these capsules.

Warning and precautions

Talk to your doctor or pharmacist before taking these capsules if you:

• have liver or kidney problems as your doctor may monitor you more closely;
• have any other problem with your heart apart from angina and those listed above;
• have porphyria (a rare disease of the blood pigments);
• have bowel problems.

Other medicines and

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. If you take Adizem-XL capsules with some other medicines, the effect of Adizem-XL capsules 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 bendroflumethi­azide) or ACE inhibitors (examples include captopril and enalapril);
• 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 a condition that causes leg pain due to a restriction in blood supply to the muscles, known as intermittent claudication;
• medicines known as statins to reduce cholesterol levels in your blood (examples include simvastatin or atorvastatin);
• medicines known as H2 antagonists used 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 (for example midazolam );
• 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 rejection 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-XL capsules

If you are having a general anaesthetic, tell your doctor that you are taking these capsules as some of the effects of the anaesthetic may be increased by these capsules.

Taking Adizem-XL capsules with alcohol

Do not take Adizem-XL capsules at the same time as an alcoholic drink.

Pregnancy, breastfeeding and fertility

Do not take Adizem-XL capsules 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 capsules 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 capsules, or when changing to higher dose. If you are affected you should not drive or operate machinery.

Adizem-XL capsules contain soya oil

If you are allergic to peanuts or soya do not take these capsules.

This medicine contains less than 1mmol sodium (23mg) per capsule, that is to say essentially ‘sodium-free’.

3. how to take

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

Adults (over 18 years of age)

The usual starting dose for adults is one 240 mg capsule every 24 hours. However, if you are elderly or have kidney problems then your doctor will probably suggest a lower starting dose of one 120 mg capsule every 24 hours. Your doctor will decide how many capsules you should take.

Children

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

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

Adizem-XL capsules are designed to work properly over 24 hours when swallowed whole. If a capsule is broken, crushed, dissolved or chewed, the entire 24-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as overdose.

You should take your capsules every 24 hours. For instance, if you take a capsule at 8 o’clock in the morning, you should take your next capsule at 8 o’clock the next morning.

If you take more Adizem-XL capsules than you should or if someone accidentally swallows your capsules Call your doctor or hospital immediately. 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 capsules with you to show to the doctor.

If you forget to take Adizem-XL capsules

If you remember within 4 hours of the time your capsule was due, take your capsule straight away. Take your next capsule 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 capsule.

If you stop taking Adizem-XL capsules

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

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

4. possible side effects

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

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

• allergic (hypersensitivity) reactions including 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 (known as Stevens-Johnson syndrome).

Tell your doctor immediately if you get any of these.

Very common side effects (May affect more than 1 in 10 people)

• Swelling of the hands, ankles or feet.

Common side effects (May affect up to 1 in 10 people)

• Feeling sick, abdominal pain, indigestion, constipation.
• Dizziness, headache.
• Flushing or redness of the skin, itching.
• A fast, slow or irregular heartbeat.
• Generally feeling unwell.
• Tiredness.

Uncommon side effects (May affect up to 1 in 100 people)

• Diarrhoea, being sick.
• A feeling of faintness, especially on standing up.
• Nervousness.
• Difficulty in sleeping.
• A worsening in liver function (seen in a blood test).

Rare side effects (May affect up to 1 in 1000 people)

• Dry mouth.
• A raised, itchy rash (hives).

Frequency not known (frequency cannot be estimated from the available data)

• Heart 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).
• Sweating.
• Low blood pressure.

5. how to store

Keep out of the sight and reach of children.

Do not use any capsules after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not store your capsules above 25°C. 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 to protect the environment.

6. contents of the pack and other information

What

The active ingredient is diltiazem hydrochloride. Each capsule contains 120 mg, 180 mg, 200 mg, 240 mg or 300 mg of diltiazem hydrochloride.

The other ingredients are microcrystalline cellulose, ethylcellulose, colloidal anhydrous silica, Polysorbate 80, dibutyl sebacate, magnesium stearate, sodium dodecyl sulphate, gelatin, shellac, soya lecithin, 2-ethoxyethanol, dimeticone, iron oxide (E172), titanium dioxide (E171).

The capsules also contain the following colourants:

120 mg, 180 mg and 240 mg -erythrosine (E127) and indigo carmine (E132)

300 mg – erythrosine (E127), indigo carmine (E132) and patent blue V (E131) What Adizem-XL

capsules look like and the contents of the pack

The capsules are packed in blister packs and then placed in boxes. In each box there are 28 capsules.

Marketing Authorisation Holder

Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0AB, UK.

Manufacturer

Bard Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.

ADIZEM XL CAPS PIL UK 1114–9 V2.indd 3