Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions people ask about Colazide. It does not contain all the information that is known about Colazide.

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

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Colazide against the benefits they expect it will have for you.

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

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

What Colazide is for

Colazide capsules are used to treat and prevent ulcerative colitis for patients who are intolerant to sulphasalazine. Ulcerative colitis is when the lining of the lower bowel becomes inflamed (swollen and irritated). Colazide reduces the swelling and irritation.

Your doctor will have explained why you are being treated with Colazide and told you what dose to take.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

Colazide capsules are not addictive.

Before you take Colazide

When you must not take it

Do not take Colazide if you are allergic to any ingredient in Colazide; have a history of hypersensitivity to aspirin-type products; are very prone to bleeding; have severe liver problems; have moderate to severe kidney problems; are taking anti-bleeding medication; have an active peptic ulcer or are in the last weeks of pregnancy.

Pregnant women should not take Colazide unless your doctor says so. Ask your doctor about the risks and benefits involved. There is no evidence available at the moment to show that taking Colazide under your doctor's instructions is harmful to unborn babies.

Do not take Colazide while you are breastfeeding. Your baby can take in Colazide from breast milk if you are breastfeeding.

Do not use Colazide after the use by (expiry) date printed on the pack. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

Do not use Colazide if the packaging is torn or shows signs of tampering.

Do not use it to treat any other complaints unless your doctor says it is safe.

Do not give this medicine to anyone else.

Before you start to take it

You must tell your doctor if:
1. you have any allergies to:
any ingredient listed at the end of this leaflet
aspirin and aspirin-type products
other medicines used to treat ulcerative colitis
any other medicines, foods, dyes or preservatives.

If you have an allergic reaction, you may get a skin rash or hay fever, have difficulty breathing or feel faint.
1. you have any of these medical conditions:
mild liver problems
mild or history of kidney problems
asthma
stomach ulcer
bleeding problems

It may not be safe for you to take Colazide if you have any of these conditions.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including:
digoxin
methotrexate or similar-type drugs oral antibiotics
any other medicine that you buy at the chemist, supermarket or health food shop.

These medicines may affect the way Colazide works.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of these things, tell them before you take any Colazide.

Taking Colazide

How to take it

When you have symptoms - The usual dose is 3 capsules taken 3 times a day (a total of 9 a day). Take this until your symptoms are better. Do not take this dose for more than 12 weeks without discussing it with your doctor.

To prevent symptoms returning - The usual dose is 2 capsules taken twice daily. Your doctor may adjust this dose up or down depending on how you respond.

Swallow Colazide capsules whole, with food.

If it is less than 4 hours until your next dose, skip the dose you missed and take your next dose when you are meant to.

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

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

If you take too much (Overdose)

Telephone your doctor, the Poisons Information Centre (13 11 26) or go to casualty at your nearest hospital immediately if you think that you or anyone else may have taken too much Colazide even if there are no signs of discomfort or poisoning.

If you take too many Colazide capsules you may have a headache and stomach pains.

While you are taking Colazide

Things you must do

You must contact your doctor if you notice any unusual bleeding or bruising. Unusual bleeding or bruising may be a sign that you are experiencing a serious side effect of Colazide.

Use Colazide exactly as your doctor has prescribed.

Tell all doctors, dentists and pharmacists who are treating you that you are taking Colazide.

Tell your doctor if you become pregnant while you are taking Colazide.

Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Colazide. Colazide helps most people with ulcerative colitis, 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:
headache
stomach pain or heartburn
diarrhoea
nausea (feeling sick) or vomiting
bloating or wind.
worsening of colitis

These are all mild side effects of Colazide.

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:
unusual bleeding or bruising
rash
fever
excessive tiredness
muscle aches or pains.

These are all serious side effects. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor if you notice anything else that is making you feel unwell. Some people may get other side effects while taking Colazide.

If you forget to take a dose, take it as soon as you remember as long as it is 4 hours before it is due, and then go back to taking it as normal.

After using it

Storage

Keep your capsules in the bottle until it is time to take them. If you take Colazide out of the bottle it will not keep well.

A small container is provided with each pack. This is so you can carry a single dose of capsules safely, without having to carry the whole bottle.

Do not store capsules in the small container for more than 24 hours.

Keep the capsules in a cool dry glace where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it. A locked cupboard at least one-and-ahalf metres above the ground is a good place to store medicines.

Do not leave it in the car on hot days.

Disposal

Ask your pharmacist what to do with any capsules you have left over if your doctor tells you to stop taking them, or you find that the expiry date has passed.

Product description

What Colazide looks like

Colazide capsules are beige and are marked with "CZ" and the Astra logo in black.

Ingredients

Each Colazide capsule contains 750 mg balsalazide sodium as the active ingredient, plus:

Magnesium stearate (E 572), Silica-colloidal anhydrous, Gelatin (E 441), Shellac.

The gelatin capsules are coloured with titanium dioxide (E 171), iron oxide red CI77491 (E 172), iron oxide yellow CI77492 (E 172), and iron oxide black CI77499 (E 172).

Colazide is available in bottles of 130 capsules.
Colazide does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.
Manufacturer
Pharmatel Fresenius Kabi Pty Ltd
6/6-18 Bridge Road
Hornsby NSW 2077
Australia
Ph: 02 9482 9058
This leaflet was prepared in September 2004
Australian Registration Number
AUST R 77358