Adizem-SR 120 mg prolonged-release tablets
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 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 Adizem-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 Adizem-SR tablets
6. Further information
What Adizem-SR tablets are and what they are used for
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.
Before you take Adizem-SR tablets
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 Adizem-SR tablets
Before treatment with Adizem-SR tablets 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-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);
- 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-SR tablets with alcohol
Taking Adizem-SR tablets at the same time as an alcoholic drink is not recommended.
Pregnancy and breastfeeding
Do not take 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 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-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.
How to take Adizem-SR 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 Adizem-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.
Adizem-SR tablets Side Effects
Like all medicines, Adizem-SR tablets 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-SR tablets)
- 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-SR tablets)
- 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-SR tablets 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-SR tablets
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 2010 means that you should not take the tablets after the last day of that month i.e. August 2010.
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.
Further information
What Adizem-SR 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
What Adizem-SR tablets look like and the contents of the pack
Adizem-SR tablets are white, capsule shaped, film-coated tablets marked 120/DL on one side and with a scoreline on the other.
In each box there are 56 tablets.
Marketing Authorisation Holder and Manufacturer
The tablets 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-SR prolonged-release tablets
Reference number: 16950/0009
This leaflet was last revised in October 2009
Adizem, NAPP and the NAPP device (logo) are Registered Trade Marks.
© 2008-2009 Napp Pharmaceuticals Limited.
P0079-A R4V1 UK AW 28-10-09
Adizem SR tablets P0079-A R4V1 UK AW 28-10-09 (combined versions R2 & R3) 3(combined versions R2 & R3)
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