Patient Information Leaflet

What you should know about ADIZEM®-SR tablets 120 mg

Diltiazem Hydrochloride

Please read this leaflet before you start taking your tablets.

If you have any questions or you are not sure about anything, ask your doctor or pharmacist.

Keep this leaflet in a safe place - you may want to read it again.

What is in the tablets?

The prolonged release tablets contain 120 mg of the active ingredient diltiazem hydrochloride.

The tablets also contain the following inactive ingredients:

• Lactose
• Hydrogenated castor oil
• Aluminium hydroxide
• Hypromellose
• Sucrose
• Polysorbate 80
• Acrylic resin
• Talc
• Magnesium stearate
• Titanium dioxide (E171)
• Glycerol

Caution: Glycerol can be harmful in high doses. It may cause headache, stomach upset and diarrhoea. The amount contained in Adizem-SR tablets is not considered a high dose.

In each container there are 56 tablets.

Diltiazem belongs to a group of medicines called calcium antagonists. They help more blood to reach the heart. They also reduce blood pressure.

What are the tablets for?

The tablets are used to treat angina and hypertension (high blood pressure). If you would like to know more about angina and hypertension, please read the section at the end of the leaflet.

Who can take the tablets?

Adults can take the tablets. They are not recommended for children.

Before you take the tablets, please tell your doctor or pharmacist if:

• you are pregnant or breast feeding,
• you are a woman of child bearing age,
• you are taking any other medicines for angina or hypertension,
• you are taking anti-arrhythmic drugs (drugs to treat an irregular or rapid heart beat),
• you are taking medicines for stomach ulcers,
• you are receiving dantrolene, digoxin, cyclosporin, carbamazepine or theophylline.

Also tell your doctor or pharmacist if you have any condition in the list below:

• Slow heart beat
• Heart problems, other than angina or hypertension
• Porphyria (a rare disease of blood pigments)
• You are allergic to any of the tablet ingredients.

If you are going to have an operation or a liver function test, please tell the doctor that you are taking these tablets.

 

Only take the tablets if they have been prescribed for you. Never give them to other people, even if their symptoms are the same as yours.

How do I take my tablets?

The label on your medicine will tell you how many tablets to take and how often. If you are not sure, ask your doctor or pharmacist.

Swallow your tablets whole with water. Don't crush or chew them.

The usual dose is one tablet taken every 12 hours. Your doctor may prescribe a different dose to this. You may want to discuss this with your doctor.

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.

It is important that you do not stop taking your medicine, even if you feel better, without talking to your doctor first.

Will I have any problems?

Most people will not have any problems when taking these tablets.

Problems that do occur are usually mild and wear off after the treatment is stopped. These problems include feeling sick, tired or dizzy, having a headache, flushing, or swollen legs. Rarely, patients may experience constipation or diarrhoea, low blood pressure, heart problems other than angina or hypertension, or hepatitis.

In rare cases, skin reactions may occur. These include exfoliative dermatitis (flaking skin), angio-oedema (swollen skin), erythema multiforme (red, swollen skin), and vasculitis (inflammation of the blood vessels). Another rare reaction is gingival hyperplasia (overgrowth of the gums).

If any of these trouble you or you have any other problems, please tell your doctor.

How should I keep my tablets?

There is a 'use-by' date on the box. For example, EXP 8.05 means that you should not take the tablets after the end of August 2005. After the 'use-by' date, take your tablets to a pharmacy.

Do not keep your tablets above 30°C (86°F). In order to protect from moisture store in the original package. Keep them in a safe place where children cannot see or reach them.

What are angina and hypertension?

Angina is chest pain caused by a reduction of oxygen to the heart muscle. It usually occurs, for example, during exercise and at times of stress.

Hypertension is also called high blood pressure.