Package Leaflet: Information for the patient

BI-CARZEM SR 60mg, 90mg and 120mg prolonged release hard capsules

(Each hard gelatine capsule contains 60mg, 90mg or 120mg diltiazem hydrochloride in sustained release sugar beads)

What Bi-Carzem SR is and what it is used for

The active ingredient in this medicine is diltiazem hydrochloride. It belongs to a group of medicines called 'calcium channel blockers'. It works by making your blood vessels wider. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood around the body. This helps to prevent the chest pain caused by angina.

Bi-Carzem SR is used to treat:

■    chest pain (angina)

■    high blood pressure

What you need to know before you take Bi-Carzem SR

Do not take Bi-Carzem SR if:

■    You are allergic (hypersensitive) to diltiazem hydrochloride or any of the ingredients of this medicine (listed in section 6, "Contents of the pack and other information”). Diltiazem can cause allergic reactions including rash, itching, shortness of breath, swelling of your lips, face throat or tongue

■    You are breast-feeding

■    You have heart problems, such as:

-    very slow heart beat - less than 50 beats per minute (severe bradycardia)

-    dizziness, fainting, chest pain, light-headedness or shortness of breath, unless you have a pacemaker (second or third degree heart block)

-    dizziness, fainting, confusion, palpitations, shortness of breath or tiredness unless you have a pacemaker (sick sinus syndrome)

-    shortness of breath, excessive sweating, anxiety and pale skin (left ventricular failure with lung congestion)

■    You are already taking a medicine containing ivabradine for the treatment of certain heart diseases

■    You are being treated with dantrolene injection (for severe muscle spasm or severe fever). (see "Other medicines and Bi-Carzem SR")

Warnings and precautions:

Talk to your doctor or pharmacist before taking this medicine if:

■    you have any other problems with your heart rhythm or reduced heart function

■    you are going to have an operation and will have anaesthesia

■    you are at risk of mood changes, including depression

■    you are at risk of gut problems

Your doctor will check you more closely, particularly when you first start taking the capsules, if:

■    you are elderly

■    you have liver or kidney problems

■    you have diabetes

Other medicines and Bi-Carzem SR:

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including those obtained without a prescription.

Bi-Carzem SR should not be taken with the following:

■ Dantrolene infusion, used to relieve severe muscle spasm or severe fever (called malignant hyperthermia) for conditions such as cerebral palsy, multiple sclerosis or spinal cord injury

Other medicines which may interact with or be affected by

Bi-Carzem SR:

■    Medicines used to treat high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol or acebutol

■    Medicines used for the treatment of irregular heart beat (e.g. amiodarone) or heart failure (e.g. digoxin)

■    Medicines for chest pain (angina) such as glyceryl trinitrate or isosorbide dinitrate (nitrates)

■    Carbamazepine, used to treat epilepsy

■    Theophylline, used to treat bronchial asthma

■    Ciclosporin, used to prevent rejection of transplant organs

■    Medicines used to treat stomach ulcers (e.g.cimetidine or ranitidine)

■    Lithium, used to treat depression or mania

■    Rifampicin, an antibiotic used to treat various infections, in particular tuberculosis

■    Midazolam, used for sleepiness or drowsiness before an operation, during minor surgery or as a premedication

■    Statins, used to treat high cholestrol e.g. atorvastatin, fluvastatin or simvastatin

■    Methylprednisolone (corticosteroid), used to treat inflammation

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist.

Bi-Carzem SR with food and drink

It is advisable to limit the amount of grapefruit juice you drink while taking Bi-Carzem SR as it can increase the blood levels of the active ingredient diltiazem and may increase your chance of getting side effects. If you are concerned you should stop drinking grapefruit juice and consult your doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking any medicine.

Pregnancy

You should not take this medicine if you are pregnant, think you may be pregnant. If it is at all possible that you could become pregnant whilst taking this medicine you should use suitable contraception. You may wish to discuss this with your doctor.

Breast-feeding

As low amounts of diltiazem pass into breast milk, breast feeding must be stopped whilst taking this medicine.

Driving and using machines

Bi-Carzem SR should not affect your ability to drive or operate machinery. However, common side effects of this medicine are feeling dizzy or unwell. If affected you should not drive or operate machinery.

Bi-Carzem SR contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Bi-Carzem SR

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your medicine comes in a prolonged release hard gelatin

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