Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about DILATREND tablets.
It does not contain all the available information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking DILATREND against the benefits they expect it will 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 DILATREND is used for
DILATREND contains the active ingredient carvedilol.
DILATREND is used to treat heart failure.
DILATREND belongs to a group of medicines called beta-blockers. These medicines work by relaxing tightened blood vessels and slowing the heart rate. DILATREND has the additional effect of being an antioxidant.
Heart failure occurs when the heart can no longer pump blood strongly enough for the body's needs. Often the heart grows in size to try to
improve the blood flow but this can make the heart failure worse.
Symptoms of heart failure include shortness of breath and swelling of the feet or legs due to fluid build-up.
DILATREND reduces the pressure that the heart has to pump against as well as controlling your heart rate. Over 6 months or more this will reduce the size of an oversized heart and increase its efficiency.
DILATREND reduces the chances of you being admitted to hospital and/ or dying from this condition.
DILATREND is often used with other medicines to treat heart failure.
Your doctor, however, may have prescribed DILATREND for another purpose.
Ask your doctor if you have any questions about why DILATREND has been prescribed for you.
DILATREND is not addictive.
This medicine is available only with a doctor's prescription.
Before you take DILATREND
When you must not take it
Do not take DILATREND if:
1. you have had an allergic reaction to DILATREND or any ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include an itchy skin rash,
shortness of breath or swelling of the face or tongue.
2. you have asthma or other conditions which make you short of breath from time to time.
3. you have allergic disorders, including allergies which cause asthma or nose running/congestion.
4. you have a history of a very slow heart rate or uneven heart beating.
5. you have certain other heart conditions.
6. you have liver problems including liver failure.
7. you have very low blood pressure.
8. the package is torn or shows signs of tampering.
9. the expiry date (EXP) printed on the pack has passed or if the tablets appear damaged in some way.
If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure if you should be taking DILATREND, talk to your doctor.
Do not give DILATREND to people under 18 years of age. Safety and effectiveness in children have not been established.
Before you start to take it
Tell your doctor if:
1. you are pregnant or plan to become pregnant.
It is not known whether
DILATREND is harmful to an unborn baby when taken by a pregnant woman. If there is a need to take DILATREND when you are pregnant your doctor will discuss the risks and benefits to you and the unborn baby.
2. you are breastfeeding or plan
DILATREND passes into breast milk. Your doctor will discuss the risks and benefits of taking DILATREND if you are
3. you have any other health problems, especially the following:
- angina or chest pain/tightness which occurs even when you are at rest (also called unstable angina)
- low blood pressure
- high blood pressure which varies widely
- very poor circulation to your fingers and/or toes (also called peripheral vascular disease)
- a history of poor kidney function
- chronic bronchitis or emphysema causing breathing difficulties
- sudden low blood sugar levels (also called hypoglycaemia)
- thyroid disorders
- severe allergic reactions causing swelling and/or difficulty breathing
- a rare cancer called phaeochromocytoma
- skin disease such as psoriasis (hardened patches of red skin)
4. you are allergic to any other medicines, foods, dyes or preservatives.
5. you plan to have surgery.
Your surgeon and anaesthetist should know well ahead of the date of your surgery so they can allow for your condition and medications.
If you have not told your doctor about any of the above, tell them before you start taking DILATREND.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you have bought from a pharmacy, supermarket or health food shop. Some medicines may interfere with DILATREND. These medicines include:
rifampicin, a medicine used to treat tuberculosis (e.g. Rimycin®, Rifadin®)
cimetidine, a medicine used to treat stomach ulcers or reflux (e.g. Tagamet®, Cimehexal®, Magicul®, Sigmetadine®)
digoxin, a medicine used to treat heart failure (e.g. Lanoxin®)
monoamine-oxidase inhibitors (MAOIs) such as phenelzine (Nardil®) and tranylcypromine (Parnate®), medicines used to treat depression
clonidine, a medicine used to treat high blood pressure, migraine or menopausal symptoms (e.g. Catapres®)
diltiazem, a medicine used to treat high blood pressure or angina (e.g. Cardizem®, Auscard®, Cardcal®, Coras®, Diltahexal®, Diltiamax®, Dilzem®, Vasocardol®)
verapamil, a medicine used to treat high blood pressure, angina or fast heart rate (e.g. Isoptin®, Cordilox®, Anpec®, Verahexal®)
drugs for when your heart doesn't beat smoothly, including disopyramide (Rythmodan®, Norpace®), quinidine (Kinidin®), procainamide (Pronestyl®), mexiletine (Mexitil®), lignocaine, flecainide (Tambocor®) and amiodarone (Cordarone®, Aratac®).
drugs for diabetes, including insulin injections, glibenclamide (Daonil®, Glimel®), metformin (Diabex®, Diaformin®, Glucohexal®, Glucomet®, Glucophage®, NovoMet®), chlorpropamide (Diabinese®), gliclazide (Diamicron®), glipizide (Minidiab®, Melizide®) and tolbutamide (Rastinon®).
cyclosporin, a medicine used to treat certain problems with the immune system.
These medicines may be affected by DILATREND, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking DILATREND.
Ask your doctor or pharmacist if you are not sure about this list of medicines.
How to take DILATREND
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
How much to take
Take DILATREND exactly as your doctor has prescribed.
Your doctor will tell you how many DILATREND tablets to take each day.
The usual starting dose in heart failure is 3.125mg twice daily. The dose is usually increased every two weeks to 6.25mg twice daily, 12.5mg twice daily and then 25mg twice daily. However, this may be done more slowly if side effects occur. If the tablets slow your heart too much you may go back to a lower dose.
Your doctor will monitor you carefully each time the dose is increased.
How to take it
Swallow tablets whole or halved with a glass of water.
Do not crush or chew the tablets.
When to take it
Take DILATREND during or immediately after a meal, at about the same times each day. If you take DILATREND on an empty stomach, it may increase the risk of some of the side effects.
How long to take it
Your doctor will probably ask you to take DILATREND long-term to control your heart failure.
Continue taking DILATREND until your doctor tells you to stop. It is very important that DILATREND is not ceased suddenly. If you are to stop taking DILATREND your doctor will advise you to reduce the dose slowly over approximately two weeks.
If you forget to take it
Do not take an extra dose. Wait until the next dose and take your normal dose then.
Do not try to make up for the dose that you missed by taking more than one dose at a time.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering your dose, ask your pharmacist for some hints.
In case of an overdose
Immediately telephone your doctor, or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much DILATREND. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
The following are some symptoms, which may or may not occur.
low blood pressure, causing dizziness or fainting
a very slow heart rate
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.
While you are taking DILATREND
Things you must do
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.
Make sure you drink enough water during exercise and hot weather when you are taking DILATREND, especially if you sweat a lot.
Tell all doctors, dentists and pharmacists who are treating you that you are taking DILATREND. You should also tell your surgeon and anaesthetist if you are having surgery.
Tell your doctor if you become pregnant while taking DILATREND.
Tell your doctor that you are taking DILATREND if you are going to have any laboratory tests.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor if you feel the tablets are not helping your condition.
Be sure to keep all of your appointments with your doctor so
that your progress can be checked. Your doctor may examine your eyes, and test your blood glucose and kidney function from time to time.
Things you must not do
Do not stop taking DILATREND or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
DILATREND should only be stopped by gradually reducing the amount over a two-week period.
Do not give DILATREND to anyone else even if they have the same condition as you.
Do not use DILATREND to treat other complaints unless your doctor says to.
Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.
Things to be careful of
Be careful driving or operating machinery until you know how DILATREND affects you. DILATREND may affect your ability to drive a car or operate machinery when started or when the dosage is increased.
If you wear contact lenses you may also notice a reduction in the amount of tear fluid in your eyes.
When taken with grapefruit juice the amount of DILATREND absorbed by your body may be increased.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DILATREND. DILATREND helps most people with heart failure but it may have
unwanted side effects in a few people.
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.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
abnormal or blurry vision
slow heart rate
nausea or vomiting
high blood sugar
These are the more common side effects of DILATREND. Mostly these are mild and will decrease as you get used to your medicine.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
itching, dark urine, loss of appetite, yellowing of skin or eyes, or feeling "flu-like" with no clear cause.
shortness of breath or swelling of the mouth or tongue
uneven heart beating
swelling of the feet or legs due to fluid build up
bleeding or bruising more easily than normal
These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After taking DILATREND
Keep your tablets in the blister until it is time to take them. If you take the tablets out of the blister pack they may not keep well. DILATREND tablets are known to fade when exposed to light.
Keep DILATREND in a cool dry place where the temperature stays below 25 °C (3.125 mg tablets) or 30 °C (6.25, 12.5 and 25 mg tablets).
Do not store it, or any other medicine, in a bathroom or near a sink, or any other place where there is high humidity.
Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep DILATREND where young children cannot reach it. A locked cupboard at least
one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking DILATREND, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.
DILATREND comes in 4 tablet strengths, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg.
DILATREND comes in pack sizes of:
3.125 mg tablets - 30s
6.25 mg tablets - 30s, 60s
12.5 mg tablets - 60s
25 mg tablets - 60s
What DILATREND looks like
3.125 mg tablet - pale pink round tablet with raised centre, scored and with BM on one side and K1 on the other.
6.25 mg tablet - yellow round tablet with raised centre, scored and with BM on one side and F1 on the other.
12.5 mg tablet - pale peach round tablet with raised centre, scored and with BM on one side and H3 on the other.
25 mg tablet - white to pale yellow/beige round tablet with raised centre, scored and with BM on one side and D5 on the other.
Active ingredient - carvedilol
Each 3.125 mg tablet contains 3.125 mg carvedilol
Each 6.25 mg tablet contains 6.25 mg carvedilol
Each 12.5 mg tablet contains 12.5 mg carvedilol
Each 25 mg tablet contains 25 mg carvedilol
Inactive ingredients - each strength tablet also contains:
colloidal anhydrous silica
yellow iron oxide  (6.25 mg and 12.5 mg tablets only)
red iron oxide  (3.125 mg and 12.5 mg tablets only).
DILATREND tablets are gluten-free.
DILATREND is distributed by:
Roche Products Pty Limited
ACN 000 132 865
ABN 70 000 132 865
4-10 Inman Road
Dee Why NSW 2099
Australian Registration Number
3.125 mg AUST R 76800
6.25 mg AUST R 61106
12.5 mg AUST R 61107
25 mg AUST R 61108
This leaflet was prepared on
18 August 2008.