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PACKAGE LEAFLET: INFORMATION FOR THE USER

VIAZEM® XL

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 get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Viazerrf XL is and what it is used for

2.    Before you take Viazerrf XL

3.    How to take Viazerrf XL

4.    Possible side-effects

5.    How to store Viazerrf XL

6.    Further information

1.    WHAT VIAZEM® XL IS AND WHAT IT IS USED FOR

The active ingredient in this medicine is called diltiazem. It belongs to a group of medicines called calcium antagonists which are used to treat high blood pressure, or to help control angina.

2.    BEFORE YOU TAKE VIAZEM® XL

Do not take Viazem* XL:

•    if you are allergic to diltiazem or any of the other ingredients in Viazem* XL (see list under ‘What Viazem* XL contains). Azorubine can cause allergic reactions including asthma. Allergy is more common in those people allergic to aspirin

•    if you have serious heart problems, particularly if a doctor has told you that you have any of the following conditions;

-    Severe bradycardia (a very slow pulse)

-    Heart block or pre-excitation syndrome or sick sinus syndrome (conditions in which there are problems with the control of your heart rate)

-    Left ventricular failure

•    if you have unstable angina

•    if the patient is a child

•    if you are pregnant or are breast-feeding.

If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Take special care with Viazem* XL:

•    if you have suffered from any other heart problems

•    if you have suffered a stroke

•    if you have had liver or kidney problems

•    if you suffer from Crohn’s disease or ulcerative colitis.

If you are not sure, talk to your doctor or pharmacist.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription, in particular any other drug that has been prescribed to treat your blood pressure or any heart condition that you have, such as digitoxin.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist. Diltiazem may inhibit the breakdown of certain medicines such as statins. This may lead to an increased and/or prolonged effect of these medicines including an increased number and severity of side-effects, such as muscle weakness and inflammation or liver infection.

Pregnancy and breast-feeding

You should not take this medicine if you are pregnant or are breast-feeding. Women of child-bearing potential should exclude the possibility of pregnancy before commencing treatment. If it is at all possible that you could become pregnant while taking this medicine you should use suitable contraception. You may wish to discuss this with your doctor.

Because diltiazem passes into breast milk, breast-feeding must be stopped while taking this medication.

Important information about some of the ingredients of Viazem* XL

The 120mg, 240mg and 300mg capsules contain azorubine (E122). Azorubine can cause allergic reactions including asthma. Allergy is more common in those people allergic to aspirin.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE VIAZEM® XL

Always take Viazem* XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Viazem* XL capsules have been specially designed so that you only have to take your capsules once a day. However, you must carry out the following steps to allow your medicine to work properly:

•    You must take this medicine as prescribed by your doctor. Usually this will be one capsule to be taken at the same time each day, preferably just before or during a meal.

•    You should swallow the whole capsule, preferably with a glass of water. Do not bite, chew or suck the capsule otherwise the medicine will not work properly.

•    Do not stop taking this medicine before telling your doctor.    *

Please read the back of this leaflet.

GENUS PHARMACEUTICALS

GEN-VZM-GEN-PIL-216_01

28/11/12