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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

DILZEM™

diltiazem hydrochloride 30 mg and 60 mg tablets

What is in this leaflet

This leaflet answers some common questions about DILZEM tablets. It does not contain all the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor weighed the risks of you taking DILZEM tablets against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine
You may need to read it again.

What DILZEM tablets are used for

DILZEM belongs to a group of medicines known as calcium channel blockers or calcium antagonists.

DILZEM tablets are used to prevent angina pectoris, a syndrome that arises from inadequate oxygen supply to the heart muscle. Oxygen supply depends on blood flow and DILZEM acts by opening up blood vessels, letting more blood reach the heart. It does not change the amount of calcium in your blood or bones.

Angina is severe pain in the chest that may be due to the blood vessels of the heart tightening or an obstruction restricting blood flow. Exercise, which demands an increased oxygen supply, can bring about angina.

Your doctor may have prescribed DILZEM tablets for another reason.

Ask your doctor if you have any questions about why DILZEM tablets have been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you take DILZEM tablets

When you must not take it

Do not take DILZEM tablets if you have had an allergy to:

Symptoms of an allergic reaction to DILZEM tablets may include:

Do not take DILZEM tablets if you have any of the following medical conditions:

Do not take DILZEM tablets if you are pregnant

Do not take DILZEM tablets if the packaging is torn or shows signs of tampering or if the tablets show visible signs of deterioration.

Do not take DILZEM tablets after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.

Before you start taking it

Tell your doctor or pharmacist if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you have or have ever had any other health problems / medical conditions, including:

Tell your doctor if you are pregnant or intend to become pregnant.
There is limited information on the safety of DILZEM tablets in pregnancy. Your doctor will discuss the risks and benefits of taking this medicine during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.
The safety of DILZEM in infants and children is not well known and an alternative method of infant feeding should be used.

If you are 65 years or older, you should be especially careful while taking DILZEM. Report any side effects promptly to your doctor. As people grow older, they are more likely to get side effects from medicines.

Do not stop taking DILZEM unless advised to by your doctor.
Sudden withdrawal may cause severe angina

DILZEM tablets are unlikely to produce an effect on the ability to drive or use machinery, however, care should be taken until you know how this medicine affects you.

There is no evidence this medicine is addictive

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with DILZEM tablets. These include:

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking this medicine

How DILZEM tablets are taken

DILZEM tablets should be taken with a full glass of water as instructed by your doctor or pharmacist. They should be taken whole and not chewed.

Tablets are usually taken four times daily before meals and at bedtime.

Your doctor will decide what dose of, and for how long you should take DILZEM tablets. This depends on your medical condition and other factors, such as your weight.

Carefully follow all directions given to you by your doctor. Their directions may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

While you are using DILZEM tablets

Things you must do

Be sure to keep all of your doctor's appointments so that your progress can be checked.

If you become pregnant while you are taking DILZEM tablets, tell your doctor.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking DILZEM tablets.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking DILZEM tablets

Things you must not do

Do not stop taking DILZEM tablets or lower the dosage without checking with your doctor. Stopping the tablets suddenly may bring on an angina attack.

Your doctor may want you to gradually reduce the amount of DILZEM tablets you are using before stopping completely.

Do not let yourself run out of tablets over the weekend or holidays.

Do not give DILZEM tablets to anyone else, even if they have the same condition as you.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DILZEM tablets.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Tell your doctor immediately if you notice any of the following:

Other side effects not listed above may occur in some patients.

Tell your doctor or pharmacist if you notice anything else that is making you unwell

Overdose

Immediately telephone a doctor, or the Poisons Information Centre (telephone 0800 POISON and 0800 764 766) or go to the accident and Emergency Department at your nearest hospital, if you think you or anyone else may have taken too many DILZEM tablets. Do this even if there are no signs of discomfort or poisoning.

Storage

Store DILZEM tablets below 30°C.

Do not store DILZEM tablets in the bathroom or near a sink. Do not leave it in the car on hot days. Heat and dampness can destroy some medicines.

Keep your tablets in the original pack they are provided in until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep it out of reach of children. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over

Product description

What it looks like

DILZEM 30 mg Tablet: Diltiazem HCl 30 mg is a white, circular, film-coated, biconvex tablet of approximately 6mm diameter embossed "D" on one side.

DILZEM 60 mg Tablet: Diltiazem HCl 60 mg is a white capsule shaped, film-coated tablet, 10mm in length and 5mm wide; with a breakline and 'DL60' engraved on one face.

DILZEM 30 mg & 60 mg tablets come in bottles of 100 tablets or blister packs of 30 tablets.

Other Ingredients

DILZEM 30 mg and 60 mg tablets: Lactose, Cutina HR, Aluminium hydroxide gel dried, Eudragit NE30D, Talc, and Magnesium stearate in the core and Opadry white (Y-IR-7000B) in the coating.

Sponsor

Douglas Pharmaceuticals Ltd
Central Park Drive, Lincoln
AUCKLAND 1008

Date of Preparation: 7th January 2004