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CAPADEX Capsules (CAP-ADD-EX)

Paracetamol and Dextropropoxyphene hydrochloride
(para-see-tah-mol and dext-ro-prop-ox-e-feen high-dro-klor-ride)

Consumer Medicine Information

Disclaimer

This document answers some common questions about CAPADEX.

It does not contain all of the available information about CAPADEX.

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 or your child taking CAPADEX against the benefits he/she expect it will have.

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

Keep this document with the medicine.

You may need to read it again.

What is CAPADEX

The name of your medicine is CAPADEX. The active ingredients are called paracetamol and
dextropropoxyphene hydrochloride.

Paracetamol belongs to a group of medicines called analgesics. Analgesics are used to block pain. It is also antipyretic; that means it helps reduce your body temperature if you have a fever.

Dextropropoxyphene hydrochloride also belongs to a group of medicines called analgesics. It is an opioid analgesic, and it acts by blocking pain and your emotional response to pain.

CAPADEX is available as a capsule.

What CAPADEX is used for

CAPADEX is used to treat a number of medical conditions:

• Nerve pain
• Period pain
• Rheumatism
• Arthritis
• Backache
• Toothache
• Mild to severe pain
• Fever

Your doctor, however, may have prescribed CAPADEX for another purpose.

Ask your doctor if you have any questions about why CAPADEX has been prescribed for you.

If you have any concerns, you should discuss this with your doctor.

This medicine is only available on a doctors prescription.

Before you take CAPADEX

When you must not take it

Do not take CAPADEX if you are allergic to:

   • CAPADEX or any of its ingredients.

Some of the symptoms of an allergic reaction to CAPADEX may include red, itchy skin rashes, difficulty breathing, hay fever, swelling of the face or throat or faintness.

Do not use CAPADEX after the expiry date (EXP.) printed on the pack or if the capsules do not look quite right.

If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.

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

Do not give it to children under the age of 14 unless your doctor has prescribed it.

CAPADEX is rated in Australia as a Category C drug for use in pregnancy. This means that it should not be used by pregnant women unless absolutely necessary and only then under medical supervision as there may be risks to the unborn baby.

CAPADEX is distributed to the breast milk but no harmful effects have been noted on the child. If you have any concerns you should discuss this with your doctor or pharmacist.

Elderly patients are more likely to have less effective kidney or liver function due to age. This may increase the risk of side effects. You should discuss how much CAPADEX to take with your doctor or pharmacist.

Before you start to take it

You must tell your doctor if you are:
1. allergic to any other medicines or any foods, dyes or preservatives.
2. you have any other medical conditions/ health problems, including:
    • liver disease, hepatitis
    • kidney disease
    • inflammatory bowel disease
3. you are a heavy drinker or drug user.
4. you have had a recent head injury
5. you regularly drive or operate machinery.

CAPADEX may make you drowsy or cause dizziness.

If you have not told your doctor about any of the above, tell them before you take any CAPADEX.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with
CAPADEX. These include:

• sedatives, tranquillisers or alcohol
• CNS stimulants or depressants
• medications for Parkinson's Disease
• medication for angina or heart disease
• antiepileptic drugs
• medications for blood disorders
• anticholigernics, used to treat stomach cramps or to dilate pupils
• chloramphenicol
• antiinflammatory and antiarthritic medications

The above medicines may either reduce the effectiveness of CAPADEX, reduce its own effectiveness and/ or react with CAPADEX resulting in untoward or sometimes dangerous side effects.

This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be
careful with or avoid while taking CAPADEX.

How to take CAPADEX

How much to take

The recommended doses are:

Adults and children over 14 years: 1 or 2 Tablets every 3 to 4 hours.

How to take it

Swallow the medicine with water.

How long to take it

If pain persists, see your doctor.

Continue taking CAPADEX as long as your doctor recommends it.

If you forget to take it

Take you dose 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 unsure about whether to take your next dose, speak to your doctor or pharmacist.

Do not try to make up for missed doses by taking more than one dose at a time. This may increase the chance of you getting an unwanted side effect.

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

If you take too much (Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much CAPADEX. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol (including any barbiturates or narcotics) which has been taken. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you take too much CAPADEX you may have symptoms of weakness, dizziness, lethargy, nausea, vomiting, sweating, mental and hypotension.

While you are using CAPADEX

Things you must do

Use CAPADEX exactly as directed or as your doctor has prescribed.

Tell your doctor if you feel CAPADEX is not helping your condition.

Visit your doctor regularly.

Your doctor needs to check your progress and see whether you need to keep taking CAPADEX.

Always discuss with your doctor any problems or difficulties during or after taking CAPADEX.

Things you must not do

Do not take any other medicines while you are taking CAPADEX without first telling your doctor.

CAPADEX may cause dizziness in some people and therefore may affect alertness. Make sure you know how you react to CAPADEX before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or have blurred vision.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Things to be careful of

DO NOT DRINK ALCOHOL while taking CAPADEX.

If you drink alcohol, it will make some of the unwanted and dangerous side effects of CAPADEX appear or get worse.

Some people may experience side effects such as nausea, vomiting, constipation, drowsiness, dizziness, which may further affect the risk when driving or using dangerous machinery.

Side effects

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

CAPADEX helps most people with medical conditions listed in the beginning of this leaflet, but it may have unwanted side effects in some people, especially in elderly patients or those with underlying disorders.

All medicines 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 any questions you may have.

Common Side Effects

Tell your doctor if you notice any of the following and they worry you:

• nausea (feeling sick)
• constipation
• dizziness
• lethargy
• vomiting.
• skin rashes
• weakness
• abdominal pain
• disturbances of vision
• signs of a blood disorder such as bruising

Some people may get other side effects of CAPADEX.

Check with your doctor as soon as possible if you have any problems while taking CAPADEX even if you do not think the problems are connected with the medicine or are not listed in this document.

After using CAPADEX

Storage

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep CAPADEX in a cool dry place where the temperature stays below 30°C and protect from light.

Do not store it, or any other medicines, in a bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Do not take CAPADEX if the capsules do not look quite right.

Keep your capsules in the blister pack they were provided in until it is time to take them.

Disposal

If your doctor tells you to stop taking the tablets OR they have passed their expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

CAPADEX are green and yellow capsules. They come in blister packs of 20.

Ingredients.

CAPADEX capsules contain paracetamol, dextropropoxyphene hydrochloride, magnesium stearate, croscarmellose sodium, gelatin, brilliant blue FCF CI42090, yellow iron oxide and titanium dioxide.

Sponsor or Supplier

Fawns and McAllan Pty Ltd (a member of the Sigma group of companies)

(A.C.N. 004 118 594)

1408 Centre Road
Clayton Victoria 3168
Australia

Telephone: 03 - 9839 2800

The Australian Registration Number for CAPADEX is AUST R 13437

This document was prepared on 18 December 1998 and updated on 19th May 1999.

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