ADIZEM-XL capsules 240 mg

• 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. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Adizem-XL capsules are and what they are used for
2. What you need to know before you take Adizem-XL capsules
3. How to take Adizem-XL capsules
4. Possible side effects
5. How to store Adizem-XL capsules
6. Contents of the pack and other information

• 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;
• are already taking a medicine called lomitapide used for the treatment of high cholesterol levels (see section : ‘Other medicines and Adizem-XL capsules)..

Children should not take these capsules.

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;
• have a history of heart failure, new shortness of breath, slow heartbeat or low blood pressure. As cases of kidney injury in patients with such conditions have been reported, your doctor may need to monitor your kidney function.

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.

In particular, do not take this medicine and tell your doctor if you are taking:

• Medicines containing lomitapide used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of the lomitapide that may lead to an increase in the likelihood and severity of liver related side effects.

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).

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.

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

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.

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.

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’.

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 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.

Call your doctor or hospital immediately. People who have taken an overdose may become very unwell and the following effects may happen: feel faint, have a slow heart beat, decrease of kidney function 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 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.

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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine

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)

Adizem-XL capsules are marked DCR followed by the strength (e.g. 120, 180 etc.) and are coloured as follows: 120 mg - pale pink/navy blue, 180 mg - dark pink/royal blue, 200 mg - brown, 240 mg - dark red/blue, 300 mg - dark maroon/pale blue.

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