Adizem-XL 120 mg, 180 mg, 200 mg, 240 mg and 300 mg prolonged-release capsules
Diltiazem hydrochloride
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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Adizem-XL capsules are and what they are used for
2. 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. Further information
What Adizem-XL capsules are and what they are used for
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.
Before you take Adizem-XL capsules
Do not take Adizem-XL capsules if you:
- are allergic (hypersensitive) to diltiazem or any of the other ingredients of the capsules (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 capsules.
Take special care with Adizem-XL capsules
Before treatment with Adizem-XL capsules tell your doctor or pharmacist if you have porphyria (a rare disease of the blood pigments).
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 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 bendrofluazide) 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 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); - a specific type of antidepressant known as a tricyclic antidepressant (examples include amitriptyline or imipramine);
- 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.
Also tell your doctor if you have recently been given an anaesthetic.
Taking Adizem-XL capsules with alcohol
Do not take Adizem-XL capsules at the same time as an alcoholic drink.
Pregnancy and breastfeeding
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 which could affect your ability to drive (see section 4 for a full list of side effects). These 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.
Important information about some of the ingredients of Adizem-XL capsules
These capsules contain soya oil. If you are allergic to peanuts or soya do not take these capsules.
How to take Adizem-XL capsules
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.
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.
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 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 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.
Adizem-XL capsules Side Effects
Like all medicines, Adizem-XL capsules can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get swelling of the face or throat.
Common side effects (probably affecting more than 1 in 100 people taking Adizem-XL capsules)
- Gastrointestinal disorders (e.g. upset stomach), feeling sick.
- Dizziness, headache.
- Tiredness.
- Swelling of the legs.
- Facial flushing (redness of the face).
- Low blood pressure.
Uncommon side effects (probably affecting fewer than 1 in 100 people taking Adizem-XL capsules)
- A reduction in blood platelets which increases the risk of bleeding or bruising.
- Changes in muscle tone and/or abnormalities of movement.
- Skin problems such as an increased sensitivity to sunlight, itching, rash, redness, swelling, severe flaking or peeling of the skin.
- Inflammation of blood vessels (often with skin rash).
- A fast, slow or irregular heart beat.
- Bleeding, tender or enlarged gums.
- Breast enlargement in men.
- Inflammation of the liver.
Uncommonly, Adizem-XL capsules may affect the results of blood tests to check that your liver is working properly.
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.
How to store Adizem-XL capsules
Keep out of the reach and sight of children.
Do not use any capsules after the expiry date which is stated on the carton. EXP 08 2010 means that you should not take the capsules after the last day of that month i.e. August 2010.
Do not store your capsules above 25oC.
Do not take your capsules 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.
Further information
What Adizem-XL capsules contain
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
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.
In each box there are 28 capsules.
Marketing Authorisation Holder and Manufacturer
The capsules are made by
for the marketing authorisation holder
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:
0800 198 5000
You will need to give details of the product name and reference number.
These are as follows:
Product name: Adizem-XL prolonged-release capsules
Reference number: 16950/0010
This leaflet was last approved in July 2009
Adizem-XL capsules are protected by UK Patent No. 2258613.
Adizem and the NAPP device (logo) are Registered Trade Marks.
© 2009 Napp Pharmaceuticals Limited.
P0077-A UK AW R4V2 10-07-09
Adizem XL P0077-A R4V2 UK AW 10-07-09 (Approved)
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